June, No.6 - Rhode Island Medical Society

Risk ManagementVolume 90 No. 6 June 2007

UNDER THE JOINTEDITORIAL SPONSORSHIP OF:The Warren Alpert Medical School ofBrown UniversityEli Y. Adashi, MD, Dean of Medicine& Biological ScienceRhode Island Department of HealthDavid R. Gifford, MD, MPH, DirectorQuality Partners of Rhode IslandRichard W. Besdine, MD, ChiefMedical OfficerRhode Island Medical SocietyBarry W. Wall, MD, PresidentEDITORIAL STAFFJoseph H. Friedman, MDEditor-in-ChiefJoan M. Retsinas, PhDManaging EditorStanley M. Aronson, MD, MPHEditor EmeritusEDITORIAL BOARDStanley M. Aronson, MD, MPHJay S. Buechner, PhDJohn J. Cronan, MDJames P. Crowley, MDEdward R. Feller, MDJohn P. Fulton, PhDPeter A. Hollmann, MDSharon L. Marable, MD, MPHAnthony E. Mega, MDMarguerite A. Neill, MDFrank J. Schaberg, Jr., MDLawrence W. Vernaglia, JD, MPHNewell E. Warde, PhDOFFICERSBarry W. Wall, MDPresidentK. Nicholas Tsiongas, MD, MPHPresident-ElectDiane R. Siedlecki, MDVice PresidentMargaret A. Sun, MDSecretaryMark S. Ridlen, MDTreasurerKathleen Fitzgerald, MDImmediate Past PresidentDISTRICT & COUNTY PRESIDENTSGeoffrey R. Hamilton, MDBristol County Medical SocietyHerbert J. Brennan, DOKent County Medical SocietyRafael E. Padilla, MDPawtucket Medical AssociationPatrick J. Sweeney, MD, MPH, PhDProvidence Medical AssociationNitin S. Damle, MDWashington County Medical SocietyJacques L. Bonnet-Eymard, MDWoonsocket District Medical SocietyCover: “Birch Tree,” linoleum and handstampedprint #2/5, by Gina M. Dimitri.Ms. Dimitri exhibited at The State of Artin RI (2005) and won Honorable Mentionin the Annual Juried Student Exhibition atURI (2005). She specializes in costume jewelrydesign, acrylic and fabric print design,ceramics, faux finishing and printmaking.E-mail: gdimitri@mail.uri.edu.Medicine HealthVOLUME 90 NO. 6 June 2007R HODE I SLANDPUBLICATION OF THE RHODE ISLAND MEDICAL SOCIETYCOMMENTARIES170 “…But I can still sue you, can’t I?”Joseph H. Friedman, MD171 A Brief Chronicle of AppendicitisStanley M. Aronson, MDCONTRIBUTIONSSPECIAL ISSUE: Risk ManagementGuest Editors: Patricia R. Recupero, JD, MD, and Lawrence W. Vernaglia, JD, MPH172 Risk Management: IntroductionPatricia R. Recupero, JD, MD, and Lawrence W. Vernaglia, JD, MPH173 Websites and E-mail In Medical Practice: Suggestions for Risk ManagementPatricia R. Recupero, JD, MD, and Samara E. Rainey178 Dangers of Self-Prescribing and Prescribing for Family MembersMarilyn Price, MD, and Bruce W. McIntyre, JD182 Patient Safety Efforts Target Communication at Rhode Island HospitalsMelinda Morin, MD187 Rhode Island Supreme Court Affirms Limited Nature of Peer-Review PrivilegeLawrence M. Kraus, JD, and Lawrence W. Vernaglia, JD, MPHCOLUMNS189 HEALTH BY NUMBERS – Trends In Tobacco Use (1990-2006) and Patterns of TobaccoUse Among Rhode Island Adults in 2006Jana Hesser, PhD, Yongwen Jiang, PhD, and Seema Dixit, MS, MPH191 ADVANCES IN PHARMACOLOGY – Atypical Antipsychotics for the Treatment ofDementia-Related Behaviors: An UpdateLori A. Daiello, PharmD195 GERIATRICS FOR THE PRACTICING PHYSICIAN – The Management of Insomnia in theOlder AdultAna C. Tuya, MD197 IMAGES IN MEDICINE – Ocular MelanomaIkue Shimizu, MD, Richard Gold, MD, and Edward Feller, MD198 PHYSICIAN’S LEXICON – The Vocabulary of Pathogenic BacteriaStanley M. Aronson, MD198 Vital Statistics200 June HeritageMedicine and Health/Rhode Island (USPS 464-820), a monthly publication, is owned and published by the Rhode Island Medical Society, 235Promenade St., Suite 500, Providence, RI 02908, Phone: (401) 331-3207. Single copies $5.00, individual subscriptions $50.00 per year, and $100per year for institutional subscriptions. Published articles represent opinions of the authors and do not necessarily reflect the official policy of the Rhode IslandMedical Society, unless clearly specified. Advertisements do not imply sponsorship or endorsement by the Rhode Island Medical Society. Periodicals postagepaid at Providence, Rhode Island. ISSN 1086-5462. POSTMASTER: Send address changes to Medicine and Health/Rhode Island, 235 Promenade St.,Suite 500, Providence, RI 02908. Classified Information: RI Medical Journal Marketing Department, P.O. Box 91055, Johnston, RI 02919,phone: (401) 383-4711, fax: (401) 383-4477, e-mail: rimj@cox.net. Production/Layout Design: John Teehan, e-mail: jdteehan@sff.net.VOLUME 90 NO. 6 JUNE 2007169

Commentaries“…But I can still sue you, can’t I?”“Sure you can. This is America. Anyonecan sue anyone else. But you couldn’twin. I’m doing you a favor.”“If I can’t sue you, then I won’t take it.”Mr X was a 35 year-old man in a veryunfortunate situation. I met him in theforensic unit of the state hospital. He hadbeen arrested after he stabbed a close relativebecause he thought the relative wasinvolved with his girl friend. Since thepatient suffered from paranoid schizophrenia,I had no idea whether this wasa real concern or not, but it hardly mattered.To get transferred from the jail tothe Institute of Mental Health requireda severe degree of mental illness.I was evaluating Mr X because of asevere movement disorder induced by hisantipsychotic medication. The medicationhe required to control his paranoiahad caused tardive dystonia (TD). Withthe drugs available to treat his psychosisat the time this occurred, TD was notuncommon, and all had the potential forcausing the problem. In most cases, theTD was so mild that it was not even noticedby the patient. In cases where it wasnoticed it was not usually disabling, buton rare occasion it was. The tardive dystoniawas, in fact, disabling for Mr X. Hehad involuntary spasms that caused himto look up at the ceiling, grimace violentlyand close his eyes. The spasms occurredabout every 10 seconds or so. He was aliving figure from a Breughel painting.As a result of this disorder he hadsued his doctors. Since he was on Medicaid,his options for doctors were even morelimited than the choices his doctors hadfor treating him. His doctors had quitegenerously arranged for him to be treatedat a different mental health center so asto avoid the conflicts of treating a patientwho was suing his treating physicians.At the time that I met him therewere no good treatment options. Treatthe psychosis and make the movementdisorder worse, or don’t treat the psychosisand hope that the movement disorderresolved. I, however, had a compassionateuse protocol for clozapine, not yetapproved by the FDA, an antipsychoticmore effective than any other, and completelyfree of movement disorder sideeffects, a drug that might treat the psychosiswithout worsening the TD. But itwas considered experimental in the1980s and required informed consent.Obviously a patient in the forensic unitis incapable, by definition, of providinginformed consent.I told Mr X to see me in my outpatientoffice after discharge so he could betreated with clozapine. When he showedup, he was better than he had been, psychiatrically,but still a long ways fromnormal. His facial and neck spasms werepainful to watch. When we discussed theadvantages of the drug he was quiet. “Butwhat about the side effects?”There used to be a “problem patientclinic” at Rhode Island Hospital. It was forpatients who complained a lot, and didn’thave identifiable medical problems to explaintheir symptoms. Or they had an organicdisorder but uncontrollable symptoms.I’m unsure if the “problem” part ofthe “problem-patient” was the problem ofthe patient or the problem caused by thepatient. A somatoform disorder clinic, if youwill. A lot of smoke, not much fire.There are lots of types of problempatients. A famous article in the NewEngland Journal of Medicine many yearsago was entitled, The Hateful Patient.There are hateful patients, ungratefulpatients, demanding patients, drug- seekingpatients, hopelessly depressed patients.Mr X was not a hateful patient.He was not seeking drugs and he wasn’tdepressed. He did not have a somatoformdisorder, complaining of dizziness, backpain, headache, nausea, diarrhea, tin-gling, chest pain and shortness of breath.He had the unfortunate concurrence ofsevere psychiatric and neurological diagnoses,one interfering with the other. Patientswith personality disorders sufferfrom these difficulties all the time. Theirpersonalities make them untreatable.When mentally ill patients seek treatment,their mental illness sets the stagefor treatment options. In the case of aparanoid person, since the paranoia is irrational,one can’t convince a patient, onecan only hope that the psychiatrist willeventually control the problem so that themedical illness can be treated. This is, ofcourse, a paradox for advocates for thementally ill, the reluctance to force treatmentin someone who is legally competentbut clearly, by choosing to not treatan illness, endures severe and long-termsuffering. Witness the mentally ill homelesswho choose no treatment over a stable,physically comfortable life.In the case of Mr X, one of life’smiracles occurred. I lost track of him (butthat was not the miracle), until a few yearslater when my secretary received a call.“This is Mr X. Please tell Dr Friedmanthat I got put on clozapine when theFDA approved it. My movement disorderwent away and my schizophrenia gotbetter too. I got my life together. Tell himthat I thank him for trying to help me.”Would all life’s stories end so well.Although a true story, it remains apocryphalas well. You never know what yournext “problem patient” may metamorphoseinto.– JOSEPH H. FRIEDMAN, MD170MEDICINE & HEALTH/RHODE ISLAND

A Brief Chronicle of AppendicitisEhrich Weiss was born on March 24, 1871, inBudapest, Hungary, one of seven Weiss children. His father,a rabbi, was recruited by a congregation in Appleton,Wisconsin; and so, in 1889, the family left Europe andmigrated to the American Midwest. Ehrich, called Harryby his family, was short, five feet and five inches, but otherwisephysically active with a love of sports and a fascinationfor traveling circuses. When the family moved toNew York City, a youthful Ehrich worked briefly as alocksmith’s apprentice; and in his free time he sought employmentas a trapeze-artist with one of the local circuses.In 1892, at age 21, Ehrich Weiss, declared himself to be amagician and, accordingly, changed his name to Harry Houdiniafter the renown 19th Century French magician, Jean Robert-Houdin.Houdini’s career blossomed, particularly because of hisinventive escape acts, freeing himself from jails, chains, handcuffs,straitjackets and even from locked, water-filled tanks.By 1914 Houdini had reached the pinnacle of his careeras an illusionist and escape artist, performing to enthusiasticaudiences throughout Europe and North America. He nowadded two parallel vocations: He shared his prestidigitationalsecrets with both the British and American Secret Services duringthe first World War; and, by 1920, he invested his energiesand resources in debunking so-called psychics and mentalists.This pursuit cost him the friendship of Arthur Conan Doyle,who was an implacable believer in spiritualism.Houdini’s final performance took place in Detroit’sGarrick Theater on October 24, 1926. After a strenuous performancehe retired to his dressing room couch. A student fromMcGill University, J. Gordon Whitehead, entered and askedHoudini if it was true that his abdominal muscles were strongenough to withstand blows of a human fist. Without waitingfor a reply, Whitehead struck Houdini’s abdomen repeatedlywith his fists until others restrained him. On the following dayHoudini complained of nausea and abdominal pain. He soughtadmission to Grace Hospital. A diagnosis of appendicitis wasmade and surgery revealed an inflamed, ruptured appendix.Peritonitis developed and Houdini died on the afternoon ofOctober 31 [Halloween], 1926. He was 52 years old. Mostphysicians declared that the blows to his abdomen played littleif any role in his encounter with appendicitis.During the last few centuries, appendicitis [inflammationof the appendix] has been a common occurrence. In the UnitedStates, the lifetime risk of developing acute appendicitis is about8.6% in males and 6.7% in females. Thus approximately onein 400 Americans develops appendicitis each year with a totalof close to 700,000 Americans who are its annual victims. Fewerthan 400 per year, however, die of the disease.The human appendix, a vestigial structure with no knowncurrent function, is an inconspicuous worm-like extension ofthe ascending segment of the large intestine. It is rarely morethan three inches in length. And while the appendix was clearlyillustrated in the anatomical drawings of da Vinci [1492] andin the anatomy texts of Vesalius [published in 1543], the structurewas not specifically named in any anatomy publicationuntil the writings of the Italian anatomist, Berengario Da Carpiin 1521.The first clinical recognition of disease of the appendix isassigned to an 1812 scientific paper written by a London physician,James Parkinson [1755 - 1824], who described a fiveyear-old boy suffering from acute abdominal pain associatedwith nausea. The child died within two days of the onset of thepains. An autopsy disclosed intense inflammation confined tothe appendix and Parkinson coined the word appendicitis togive the disease an identity. This was the same physician whowrote extensively on the need for democratic reform in England[he was charged with high treason by King George III].He also published extensively on geology, paleontology andauthored, in 1817, An Essay on the Shaking Palsy, now commonlyknown as Parkinson’s disease.A brief paper by Francois Melier added further autopsyderivedverification of appendiceal inflammation as a cause forpain in the right lower quadrant of the abdomen. But it wasn’tuntil June, 1886, when Reginald Heber Fitz, MD, [1843 –1913], Professor of Pathological Anatomy at Harvard, offereda scientific paper, “Perforating Inflammation of the VermiformAppendix: With Special Reference to its Early Diagnosis andTreatment,” that the disease became widely recognized. Therecognition was not total, however. In 1897, Dr. HarveyCushing, then in training in surgery at Johns Hopkins Hospitalin Baltimore, made the diagnosis of acute appendicitis onhimself. Few of his superiors believed it and Cushing, after 22hours of searching, finally found a surgeon brave enough tooperate. The diagnosis was confirmed and Cushing went onto become this nation’s most prominent surgeon in the earlydecades of the 20th Century.Well-documented epidemiological studies indicate that thefrequency of acute appendicitis is gradually diminishing. Despitethis, an estimated 2,300 Rhode Islanders will require surgeryfor the disease in the coming twelve months. Fortunately,few will be inconvenienced more that the usual four days ofhospital stay.– STANLEY M. ARONSON, MDVOLUME 90 NO. 6 JUNE 2007171

“Risk management” in medicine meansdifferent things to different people. Tosome physicians, it represents a hospitalimposedbureaucratic hassle interferingwith time that should be spent in directpatient care activities. Other physicianshave come to recognize that risk managementis not just about avoiding legal liability,but about improving patient careby optimizing procedures and avoidingcertain known or anticipated risks. Riskmanagement means better patient careand improved outcomes, with better resultsfor all.This issue, which we guest edited atthe request of the Journal, represents severalperspectives on risk management inmedicine. These are far from the onlyissues facing modern healthcare. Rather,they represent what we believe are voicesand approaches worthy of serious consideration,and which also provide someinsights into other ways that risk managementmay prove helpful in the healthcaresetting.Risk Management: IntroductionPatricia R. Recupero, JD, MD, and Lawrence W. Vernaglia, JD, MPHIn these pages, you will find discussionsabout risk management strategiesrelating to new models of physician-patientcommunications and the impact ofnew technology on practice patterns.These articles focus on industry-driven aswell as technology-driven changes tomedical practice. We have also includeda thoughtful piece on the dangers of prescribingfor oneself or one’s associates –not a new problem, but one which hasspecial implications for risk managementin the increasingly-regulated healthcaremarket. Finally, as the courtroom is thereal overlap between law and medicinein “risk management,” we focus on animportant decision from the Rhode IslandSupreme Court that challengesmany commonly-held notions about thebreadth of the “peer review” privilege.These articles not only showcase severalvaluable specific topics in risk management;they each offer insights into howthoughtful risk management practicesimprove patient outcomes and quality ofcare. We hope you find these articleshelpful to your practice. We look forwardto continuing this dialogue in theJournal as well as in the community.Patricia R. Recupero, JD, MD, is President/CEOof Butler Hospital and ClinicalProfessor of Psychiatry, The Warren AlpertMedical School of Brown University.Lawrence W. Vernaglia, JD, MPH, isan attorney specializing in health carewith Foley & Lardner LLP.CORRESPONDENCEPatricia R. Recupero, JD, MDButler Hopsital345 Blackstone BoulevardProvidence, RI 02906Phone: (401) 455-6360e-mail: Patricia_Recupero@brown.eduLawrence W. Vernaglia, JD, MPHFoley & Lardner LLP111 Huntington AvenueBoston, MA 02109Phone: (617) 342-4079e-mail: lvernaglia@foley.com172MEDICINE & HEALTH/RHODE ISLAND

Websites and E-mail In Medical Practice:Suggestions for Risk ManagementIncreasing numbers of patients seek informationonline before consulting theirphysicians. 1 Over 70% of Americaninternet users go online for health information;90% of them find the informationreliable. 2 Some health organizations,such as Dartmouth-Hitchcock MedicalCenter in Lebanon, NH, offer onlineconsultations for patients frustrated withthe difficulties of phone tag. 2 Some physicians,too, now have websites, and manyphysicians e-mail their patients. With thebenefits of new technology comes the necessityfor newer safeguards and strategiesto reduce risk. This article aims topresent some of the legal risks associatedwith the use of websites and e-mail inclinical practice, along with some suggestionsfor risk management.WEBSITES IN MEDICAL PRACTICEIn 2004, 28% of internet users hadresearched a specific doctor or hospitalonline. 2 Websites may be an inexpensivemarketing tool, attracting new patients.On websites providers can post informationabout their practices, links to healthinformation sites, and resources to increasepatients’ and families’ understandingof health issues.When designing a website, the physicianshould consider the complex legalramifications. Typically, the more interactivea website is, the greater the numberof legal risks and concerns its ownershould anticipate. We begin with a discussionof the classification of websitesunder the law.Patricia R. Recupero, JD, MD, and Samara E. RaineyWebsite Design and InteractiveFeaturesIn cyberspace, activities normallygoverned by state law, such as businesstransactions, may frequently cross stateboundaries. The courts have adopted a“sliding scale” test for determiningwhether a particular state court may exercisejurisdiction over a website’s owner. 3According to this test, a website may belongto one of three categories: passivewebsites, interactive websites, and businesswebsites. These categories differentiatewebsites according to their levels ofinteractivity, ranging from minimal toextensive, and the likelihood of sufficientcontacts for jurisdiction correspondinglyincreases. Passive websites amount to littlemore than advertisements. Interactivewebsites might contain feedback formsor self-screening tests. Business websites,such as online pharmacies, facilitate financialtransactions or contracts online.The degree of interactivity on a site, asidefrom possibly subjecting it to the jurisdictionof a distant court, may also affectthe perception of a physician-patient relationshipand the corresponding duty ofcare.Suppose that Dr. Smith creates apassive website that displays her curriculumvitae, a brief biography, a descriptionof her practice, directions to her office,and contact information. The followingactivities may directly affect thelevel of interactivity and risk in herwebsite:• posting hyperlinks to other healthinformation websites, especiallythose designed to promote particulartreatments or practices• hosting, and receiving money for,banner advertisements or other advertisementsor implied endorsementsof pharmaceutical companiesor other health companies• posting a hyperlink to her e-mailaddress, such that patients can clickon the link and e-mail her directly• encouraging, or soliciting, requestsfor advice• self-screening tests (e.g., “Am I atrisk for skin cancer? Take our free,confidential online screening.”)• invitations for site visitors to purchaseher books (with a link to thewebsite selling the books)• a form through which patients orvisitors can message her directlyWhen she adds an “intake form” toher website, and individuals from distantstates contact her for advice, her liabilityrisk may increase. Laws regulatingtelemedicine and cybermedicinechange frequently, and state laws are notuniform. Staying current on the relevantlaws would require additional researchand time. When designing awebsite, it would be prudent to investigateyour state’s law, ethical obligations,professional society requirements, andgeneral health law principles applicableto the website you are planning, in orderto understand how different featuresmight affect levels of risk.AdvertisingIn many cases, websites are advertisements.Because they can be more interactivethan simple media advertisements(e.g., television ads, brochures,etc.), and because they are usually accessiblethrough internet search engines,they may be an attractive networking toolfor professionals. However, like otherforms of advertising, websites are subjectto regulation by the Federal Trade Commission(FTC) and other regulatory bodies,such as the United States Food andDrug Administration (FDA), if they containclaims regarding particular medicinesor treatments. The FTC has takenaction against advertisers for false claimson websites about health treatments andfalse representations about privacy policies.4 The presence of hosted advertisements,as well as the choice of domain or“domain extension” (for example,whether it is a .com, .org, or .edu site)may affect the credibility of the website. 5When creating a website, physiciansshould be conscious of the advertisinglaws and avoid unsubstantiated claims,misleading statements, and trademark orcopyright infringement. For more informationabout legal risks related to advertising,see Professor Ronald L. Scott’s review,“Cybermedicine and Virtual Pharmacies.”6Disclaimers and Click-WrapAgreementsMany websites contain disclaimersto discourage unrealistic expectations onthe part of the visitor. Dr. Smith’s website,VOLUME 90 NO. 6 JUNE 2007173

174for example, might offer the following disclaimerabove a hyperlinked e-mail address:“Please note that not all e-mails willreceive replies. If you are not a patient,please call our office at [phone number]to set up an appointment. If you are anexisting patient, and this is an urgent matter,please call [phone number] immediately.”Physicians should not assume,however, that a disclaimer will necessarilyprotect them from liability, nor reducetheir ethical duties to patients. Simplyposting a disclaimer may not prevent amalpractice action if the physician providesadvice upon which the patient reliesto his detriment, or if the physiciandisregards communications concerningexisting patients. However, disclaimersmay clarify for patients and visitors thepurposes and limits of the physician’swebsite.Websites may also use click-wrapagreements (CWAs): electronic contractsin which a visitor indicates his acceptanceto the terms by clicking an “Iaccept” button. CWAs may be legallybinding and are typically enforceable. 7However, CWAs, like other contracts,may be invalidated by courts if they containobjectionable terms or do not sufficientlywarn the reader of rights or privilegeshe may be surrendering. For example,in Sanchez v. Sirmons, 8 the SupremeCourt of New York invalidated acontract (not a CWA) requiring arbitrationfor medical malpractice claimsagainst a physician, since the contracthad not adequately alerted the patientthat she was surrendering her right to ajury trial. Although the contract hadwarned that claims would have to be addressedthrough arbitration, the courtfound that the patient had not been affordedadequate time to fully considerand agree to the contract’s terms, andthat the contract did not call sufficientattention to the arbitration clause.While click-wrap agreements may helpto add an additional layer of protectionand may provide a forum to warn patientsor visitors of some risks, they cannotprevent lawsuits or insulate providersfrom all liability. For some activities,thorough informed consent is more appropriate,and physicians are cautionedto recognize that CWAs and disclaimerscannot substitute for a complete informedconsent discussion.MEDICINE & HEALTH/RHODE ISLANDE-MAIL IN MEDICAL PRACTICEIn a recent study of family physiciansand their patients, e-mail communicationbetween patients and physicians wasfound to improve satisfaction by bothphysicians and patients without affectingthe time required for physician-patientcommunication. 9 Some commentatorshave even speculated that increased patientinvolvement through e-mail mightlessen the practice of medical paternalismand its associated legal risks. 10 In theearly days of medicine, physicians oftencorresponded with distant patients bymail and frequently relied on patients’written descriptions of their conditionsin formulating diagnoses and treatmentplans. 11Simply posting adisclaimer may notprevent amalpractice actionif the physicianprovides adviceupon which thepatient relies to hisdetriment…ConfidentialityThe duty to protect a patient’s confidentialityhas its roots in the HippocraticOath. Confidentiality is a significant concernwith websites, e-mail, and electronicmedical records. Scholars have noted anincreasing number of tort lawsuits forbreach of confidentiality, 12 and stories ofprivacy violated as a result of computingerrors and hackers have attracted considerableattention from the media. 13Confidentiality risks abound whenusing e-mail with patients. While theserisks do not necessarily outweigh the potentialbenefits of e-mail, sound risk managementstresses the importance of obtainingpatients’ understanding and consentto these risks prior to correspondingwith them by e-mail. Among some of therisks to patient confidentiality are the following:• family members may read patients’e-mail if the computer is shared• a patient may check his e-mail atwork, not considering the possibilitythat his employer may be monitoringhis e-mail• a patient, or the physician, may beusing an insecure internet connectionand may be vulnerable to hackers,viruses, worms, or other technologicalerrors or problems thatmay lead to breached confidentiality• e-mails may be misdirected to unintendedrecipients• e-mails may be intercepted by softwareor surveillance• “deleted” e-mails frequently remainaccessible on servers or hard driveslong after users believe they havecompletely deleted them• e-mails may be subject to disclosurethrough legal process, such asthrough search warrants or subpoenas• e-mails sent through a patient’semployer’s computer system may beaccessible to the employerHIPAA 14 applies to e-mail containingprotected health information (PHI),and additional state laws may also apply.Patients should be informed that there isno way to guarantee patient confidentialitywhen transmitting PHI online, andthat there is always a risk of breached confidentiality.Patients may then choosewhether to consent to this risk, and withtheir physicians they can discuss safeguards,such as firewalls, encryption, andother safe practices, to help reduce risk.Physicians can then document thepatient’s understanding and consent inthe patient record.Many physicians are accustomed topresenting themselves as experts, but adistinction must be drawn between expertisein medicine and expertise in informationtechnology. Physicians shouldnot be afraid to admit that their knowledgeof technology and technologicalrisks is limited; understanding this, patientsmay be able to help physicians toimprove safeguards for the confidentialityof e-mail communications.“Matters of Business”E-mail communication may not besuitable for some patients, or for somesubjects. As one scholar explains, “…a

paranoid schizophrenic who has delusionsof thought insertion through the TVis definitely not a good candidate [fortelemedicine].” 15 Similarly, a patient undergoingtreatment for carpal tunnel syndromemay not be the best candidate forcorrespondence via computer keyboards.Physicians should exercise special cautionregarding the communication of test resultsand other sensitive information bye-mail. Some tests warrant face-to-facecounseling about the meaning of the results.With the patient’s written permission,pre-test HIV counseling may benefitfrom additional e-mail communication,such as sending patients links towebpages with general information aboutHIV and HIV testing. With the patient’sinformed consent, follow-up e-mails canprovide a written record to help patientsremember advice, questions, and informationcommunicated during an officevisit and, in some cases, may result in improvedpatient compliance and qualityof care. Communicating the actual testresults for conditions such as HIV, however,is not ideally suited to a perfunctorye-mail. Nor is e-mail thread is thebest substitute for discussions that wouldotherwise take place in the office or onthe phone, in part because e-mail removesmany of the cues that signal patient distressor clinician compassion.Unsolicited E-MailsSurprisingly, some physicians cannotresist temptation when receiving e-mailrequests for advice from non-patients.16 ,17 Prudence suggests, however,that providing medical advice to an individualwho is not already a patient mayincrease risk. Physicians receiving suchrequests should be wary of providing informationthat might foster the perceptionof a physician-patient relationshipand the corresponding duty of care.Physicans may also receive e-mails fromthird parties, such as a patient’s familymembers. Special risks may apply to thesee-mails. Providing information to thirdparties, answering their questions withoutthe patient’s consent, and correspondingwith them without informingthe patient may increase risk. E-mail createsa written record of the content ofthe communications, a factor absent frommost phone conversations. E-mails concerningexisting or possible future patients(e.g., initial e-mails requesting anappointment or consultation and describinga complaint or presentation) canbe saved in the patient’s medical record.Keeping e-mails in the medical recordmay reduce risk. If the practice uses electronicmedical records, the process of savinge-mails to the record may be doneautomatically.Keeping e-mails inthe medical recordmay reduce risk.Unavailability & Unanswered E-MailsPhysicians should not assume that allpatients understand that e-mail is an inappropriatemeans to communicate urgentmatters. Furthermore, patientsmight have different expectations aboutthe timeliness of replies or message receipt.It may be useful to create a policywith respect to timeliness for e-mails, andto adhere to it. Physicians may wish tocreate a separate e-mail account for usewith patients and to apply settings thatsend automatic replies to patients, includingthe expected response time and aphone number patients may call if a concernis urgent, or if it takes longer thanexpected for them to receive a reply.When traveling, an “out of office” autoreplymessage may alert patients how tocontact the covering physician. One mayalso encourage patients to request “readreceipts” on e-mails so that patients mayknow whether or not their doctor hasread a message. You may wish to avoidusing this feature if there is a chance thatthe receipt could be triggered inadvertently,such as by office staff.Additional risks with e-mail are numerousand may grow more complicated.However, if patients understand the risks,they may consent to them, and in manycases the benefits will outweigh the risks.Allowing patients to decide whetherthese risks are acceptable, which safeguardsthey want and what benefits theywill enjoy as a result of e-mail communication,may facilitate a dialogue and acooperative approach to risk managementthat involves the patient in the process,thereby further reducing risk through astronger treatment alliance. With hisphysician’s help, the patient who takessteps to protect his own safety may be lesslikely to blame the physician if a disclosedrisk occurs.IMPORTANT CONCERNSLicensing, Advice, and thePhysician-Patient RelationshipIf Dr. Smith provides advice to astranger, there is a risk that patients, andpossibly courts, may view this as creatinga physician-patient relationship, givingrise to additional responsibilities and risks.If the “patient” resides in a state whereDr. Smith is not licensed, she might beargued to be practicing medicine withouta license. In such a case, her malpracticeliability insurance may not reimburseher defense counsel fees andmay not reimburse her for any judgmentsassociated with a malpractice action in adistant state. Even if Dr. Smith is licensedin the distant state, being sued in anotherstate for malpractice proceedings or otherlegal issues can be costly and time-consuming.Even when fully licensed in thestate, physicians should be sensitive tolaws and regulations that apply specificallyto telemedicine or cybermedicinepractices within that state; such regulationsmay specify activities which may notbe conducted online.Treating and Communicatingwith the Wired PatientScholars have noted both benefitsand risks associated with the disinhibitingeffect of internet communication. 18 Thevolume of “spam” from online pharmaciesadvertising medicines for erectile dysfunctionsuggests that some patients mayfeel uncomfortable requesting such medicinesin the physician’s office; indeed, theHarris Poll found that among the six millionUS adults who had bought prescriptionmedicines online, Sildenafil (a drugfor treating erectile dysfunction) was oneof the most frequently purchased. 19Some patients may feel more comfortablebroaching uncomfortable subjects in thecontext of an e-mail discussion with theirphysicians.Also, some patients purchase medicinesonline without prior prescriptionsand without informing their doctors. InThe Lancet physicians report treating a64-year-old woman for bilateral cataractsand glaucoma resulting from overuse ofVOLUME 90 NO. 6 JUNE 2007175

176oral steroids she had purchased onlineafter diagnosing herself with myalgic encephalomyelitis.20 Further complicatingthis problem is the prevalence of counterfeitmedicines sold online 21 and thepatients who self- diagnose through theinformation and diagnostic tools on theworld-wide web. 22 These developmentsunderscore the importance of obtaininga full history of a patient’s use of prescriptionand over-the-counter medicines, includingnutraceuticals and supplements.Additional questions about patients’ experiencewith web-based health and druginformation may improve communicationbetween physicians and web-savvypatients.Practicing Online?Some activities, such as online prescribing,carry a very high degree of risk.Indeed, penalties have ranged fromwarning letters to disciplinary action bymedical boards, loss of license, and even,in some cases, prison terms. 23 However,even providing advice often constitutesthe practice of medicine, so experts advisephysicians to exercise caution in theirinternet activities. Some physicians knowinglyprovide medical services over theinternet or through other telecommunicationstechnology. While doing so is not,in itself, illegal or unethical, circumstancesvary greatly. Such practices arecommon in radiology, for example, but“questionnaire prescribing” online topatients not examined in person has subjectedphysicians to sanctions. While thepractices of cybermedicine andtelemedicine are beyond the scope of thisarticle, we encourage readers to consulttheir malpractice insurance providers forguidance regarding practice-related activitiesonline.ETHICAL GUIDELINES AND FURTHERREADINGFor physicians seeking to enhancetheir practice through the use of websitesor e-mail with patients, there are manyhelpful guidelines. The AMA’s Code ofEthics, which is accessible at the AMA’swebsite (http://www.ama-assn.org/ama/pub/category/2498.html), has sectionsspecifically applicable to e-mail andwebsites. With respect to websites, theAMA urges informed consent for interactivefeatures, as well as minimization ofMEDICINE & HEALTH/RHODE ISLANDconflicts of interest and commercialbias. 24 Physicians might go about thesesafeguards by clearly disclosing sponsorshipand being sure that their websitesponsorship (such as advertisements) doesnot trump patient interests. The AMAalso stresses the importance of technologicalsafeguards for patient privacy and confidentialityon sites where patient-specificinformation is involved. For physiciansseeking to develop practice websites, theAMA has additional resources to help25 ,26guide decisions and decrease risk.With respect to e-mail, the AMA’sCode of Ethics cautions that “E-mail correspondenceshould not be used to establisha physician-patient relationship” andthat physicians should adequately notifypatients of e-mails’ “inherent limitations,”such as risks to confidentiality or privacy,“difficulties in validating the identity of theparties,” and delayed responses. 27 TheAmerican Medical Informatics Associationalso has a helpful white paper on the useof e-mail with patients. 28The Federation of State MedicalBoards has also produced a helpful guidefor the use of the internet in clinical practice.29 This general guide covers aspectsof both e-mail and websites, as well asother areas of the internet that may applyto different physicians.CONCLUSIONThis article presents only some of thelegal risks associated with passive websitesand incidental e-mails with patients. Numerousadditional risks arise with respectto more interactive sites and businesswebsites, and with more extensive use ofe-mail. Readers interested in a morethorough discussion of these issues withrespect to websites, 30 e-mail, 31 orinternet-based treatment activities 32 areencouraged to consult references fromthe literature, malpractice insurance providers,professional organizations or affiliations(e.g., the AMA), state licensingboards, and official policies or guidelinesof their employers, institutions, and otherprofessional memberships.REFERENCES1. Hesse BW, Nelson DE, et al. Arch Intern Med2005;165:2618-24.2. Krane D. Healthcare News 2005;5(8): no page numbers.Accessed August 29, 2006 from http://www.harrisinteractive.com/news/newsletters/healthnews/HI_HealthCareNews2005Vol5_Iss08.pdf3. Haugh R. Direct connect at Dartmouth-Hitchcock.Hospitals & Health Networks Most Wired Magazineonline, August 15, 2005. Accessed 10/5/05from http://www.hhnmostwired.com/4. Fox S. Health information online. Pew Internet &American Life Project, May 17, 2005. Accessed August29, 2006 from http://www.pewinternet.org/pdfs/PIP_Healthtopics_May05.pdf5. Zippo Manufacturing Co. v. Zippo Dot Com,Inc., 952 F. Supp. 1119 (W.D. Pa. 1997)6. Neumeier MM, Kidwell BE. The Practical Lawyer2001;47:21-38.7. Walther JB, Wang Z, Loh T.. J Med Internet Res2004;6:e24.8. Scott RL. West Virginia Law Review2001;103:407-502.9. Grossman M, Hift AK, Rothman B. Click-wrapagreements: enforceable contracts or wasted words?Becker and Poliakoff, PA. Accessed June 23, 2005from http://www.becker-poliakoff.com/publications/articlearchive/clickwrap.htm10. Sanchez v. Sirmons, 467 N.Y.S.2d 757 (N.Y. Sup.Ct. 1983)11. Leong SL, Gingrich D, et al.. J Amer Board FamPract 2005;18:180-8.12. Slack WV. JAMA 2004;292:2255-62.13. Spielberg AR.. Amer J Law Med 1999;25:267-95.14. Terry NP. Amer J Law Med 2001;27:361-419.15. Wells J. Wrong MDs got patient records. San FranciscoChronicle, December 30, 2003.16. Health Insurance Portability and AccountabilityAct of 1996, 42 U.S.C. 1320d et seq.17. Stamm BH. Professional Psychology: Res Practice1998;29:536-542.18. Eysenbach G, Diepgen TL. JAMA1998;280:1333-5.19. Oyston J. J Med Internet Res 2000;2(3):e16.20. Suler J. CyberPsychology & Behavior 2004;7:321-6.21. Harris Interactive. Six million people have boughtprescription drugs online. Press release, March 23,2004. Accessed April 12, 2005 from http://www.harrisinteractive.com/news/printerfriend/index.asp?NewsID=779.22. Severn PS, Fraser SG. The Lancet 2006;368:618.23. Food and Drug Administration. FDA warns consumersnot to buy or use prescription drugs fromvarious Canadian websites that apparently sellcounterfeit products. FDA press release, August30, 2006. Accessed September 6, 2006 fromhttp://www.fda.gov/bbs/topics/NEWS/2006/NEW01441.html.24. Authors’ own research, 2006.25. Gunter TD, Srinivasaraghavan J, Terry NP. J AmerAcad Psychiatry Law 2003;31:10-426. American Medical Association Code of Ethics, E-5.-27, “Use of Health-Related Online Sites,” updatedSeptember 6, 2005. Accessed September8, 2006 from http://www.ama-assn.org/ama/pub/category/11965.html.27. Winker MA, Flanagin A, et al. Guidelines for medicaland health information sites on the internet:principles governing AMA web sites. AmericanMedical Assocation, 2001. Accessed September8, 2006 from: http://www.ama-assn.org/ama/pub/category/1905.html.

28. Rothschild MA. Building and implementingphysician practice wesites. Chicago: AmericanMedical Association, 2001.29. American Medical Association Code of Ethics, E-5.026, “The Use of E-mail,” updated August23, 2005. Accessed September 8, 2006 fromhttp://www.ama-assn.org/ama/pub/category/10828.html.30. Kane B, Sands DZ. J Amer Med Informatics Association1998;5:104-111. Accessed September 8,2006 from http://www.amia.org/mbrcenter/wg/kim/docs/email_guidelines.html.31. Federation of State Medical Boards of the UnitedStates: Model guidelines for the appropriate use ofthe internet in medical practice, 2002. AccessedSeptember 8, 2006 from http://www.fsmb.org/pdf/2002_grpol_Use_of_Internet.pdf32. Recupero PR.. Psychiatric Services 2006;57:450-2.33. Recupero PR. J Amer Acad Psychiatry Law2005;33:465-75.34. Recupero PR, Rainey SE. Amer J Psychotherapy2005;59:319-31.Patricia R. Recupero, JD, MD, isPresident/CEO, Butler Hospital, andClinical Professor of Psychiatry, The WarrenAlpert Medical School of Brown University.Samara E. Rainey is a Paralegal / ResearchAssistant at Butler Hospital.CORRESPONDENCEPatricia R. Recupero, JD, MDButler Hospital345 Blackstone BoulevardProvidence, RI 02906phone: (401) 455-6360e-mail: Patricia_Recupero@Brown.eduVOLUME 90 NO. 6 JUNE 2007177

178Dangers of Self-Prescribing and Prescribingfor Family MembersMEDICINE & HEALTH/RHODE ISLANDMarilyn Price, MD, and Bruce W. McIntyre, JDPhysicians prescribe for themselves andtheir family members despite ethicalguidelines that discourage the practiceand stress the need to avoid treatmentsituations in which objectivity may becompromised. 1 Many physicians are unawarethat state medical licensing boardshave regulations vis a vis treating and/orprescribing for themselves and familymembers absent an emergency. Additionalregulations govern the prescribingof controlled substances. While manyjurisdictions do not have explicit prohibitions,there will be regulations relatedto the doctor/patient relationship suchas those requiring that a history and physicalexam be performed and documented.Rhode Island law and regulation do notexplicitly prohibit self-prescribing, althougha number of legal requirementsplace restrictions on the practice. 2, 3In spite of the ethical considerationsand regulations discouraging the practice,Toyry noted that self-treatment wascommon and physicians begin self-prescribingearly in their careers. 4 A surveyof internal medicine residents demonstratedthat 52% had self-prescribed inthe past year. Convenience and the readyavailability of medication have beenviewed as factors promoting this practice.5 Christie and colleagues noted that42% of the residents who had self-prescribedmedications, obtained the medicationsfrom a sample cabinet; and 11%had obtained medications directly froma pharmaceutical representative. 5Self-prescribing appears to extendbeyond the first years of practice. Hemet al) surveyed all the medical graduatesfrom all 4 medical schools in Norway atone-year post graduation and then againat 4 and 10 years post graduation. 6 Ofthe physicians who had used any prescriptionmedications over the past year, 90%of those who were one year post graduation,86% of those 4 years post graduationand 84% of those who were 10 yearspost graduation had self-prescribed. Themost frequently prescribed medicationswere antibiotics, contraceptives, analgesicsand hypnotics. Those who had a mentalhealth problem needing treatmentwere more likely to self-prescribehypnotics and sedatives than those withoutperceived health problems. In thestudy by Christie the most commonly selfprescribedmedications included antibiotics,allergy medication and contraceptives.5 Westfall et al found that only 2 of55 physicians or staff members in a residenttraining setting had not takensamples for their personal or a familymember’s use in the past year. 7Self-prescribing can result in a delayin obtaining appropriate treatment.This can be seen as especially problematicwhen a mental illness could be affectingthe judgment of the physician.While only 2% of the residents inChristie’s sample admitted to self-prescribingpsychotropic medications, Toyryreported that two thirds of the physicianswho acknowledged having a mental disorderhad self-treated. 4 McCauliffe et alfound that 25% of their sample of physiciansin practice had treated themselveswith a psychotropic medication in thepast year. 8 Reinhardt and colleaguesfound that 5% of their sample of housestaff admitted using a sedative or hypnoticwithout a prescription in the previousyear. While the prevalence of recentdepressive symptoms was 30%, only 11%had consulted with a mental health professionalduring that same time period. 9The American Medical Association’sCode of Ethics, Opinion E-8.19 articulatesthe very real dangers inherent in prescribingfor self or family members. 1 TheAMA recommends that: “Physicians generallyshould not treat themselves or membersof their families.” The rationale isthat:Professional objectivity may becompromised when an immediatefamily member or thephysician is the patient; thephysician’s personal feelingsmay unduly influence his or herprofessional medical judgment,thereby interfering with thecare being delivered. Physiciansmay fail to probe sensitive areaswhen taking the medical historyor fail to perform intimate partsof the physical exam. Similarlypatients may feel uncomfortabledisclosing sensitive informationor undergoing an intimateexamination when thephysician is an immediate familymember.These factors are seen as especiallypertinent when the patient is a child. 1There are further fears that when treatingthemselves or family members, physiciansmay be more likely to treat problemsoutside expertise. Physicians arewarned that if problems arise as a resultof a negative medical outcome, therecould be ramifications in the personalrelationship. In addition Opinion E-8.19points out that the process of informedconsent is significantly impacted. Familymembers may feel that by seeking a secondopinion they are insulting the physicianor indicating a lack of confidence inhis/her ability.The AMA does allow for exceptions.“In emergency settings or isolated settingswhere there is no other qualified physicianavailable, physicians should not hesitateto treat themselves or their familymembers until another physician becomesavailable. In addition while physiciansshould not serve as a primary orregular care provider for immediate familymembers, there are situations in whichroutine care is acceptable for short-term,minor problems. Except in emergencies,it is not appropriate for physicians towrite prescriptions for controlled substancesfor themselves or immediate familymembers (I, II, IV).”The medical licensing boards havetaken various approaches in dealing withphysicians who prescribe for themselvesor family members. The College of Physiciansand Surgeons of Ontario recentlyrevised the policy about treating self and

family members. 10 The provincial regulationstates that:Physicians should not treat eitherthemselves or family members,except for a minor conditionor in an emergency situation,and only when anotherqualified health care professionalis not readily available.Where it is necessary to treatthemselves or family members,physicians must transfer care toanother qualified health professionalas soon as is practical.Physicians are advised that ifthey do not comply with thispolicy, they may be subject toallegations of professional misconduct.Even in states such as Rhode Islandthat do not explicitly ban this practice,the prescribing physician must meetpractice guidelines set by the state andthe United States Drug EnforcementAgency (DEA). A physician may not prescribefor a non therapeutic purpose andthere needs to be an adequate medicalrecord justifying the use of the medication.Rhode Island has a medical recordregulation, R5-37 MD/D0 sec 11.4which requires that the course of treatmentbe justified. 11 There needs to bedocumentation of the history, test results,drug prescribed or administered, reportsof consultations and hospitalizations. 11Physicians need to consider that the adequacyof their documentation will be animportant issue should there be a complaint.Documentation requirements arerarely considered by physicians prescribingfor themselves or a family member. 12When the prescribed medication isa controlled substance there could be furtherrequirements or restrictions. TheRhode Island Board of Medical Licensureand Discipline has issued guidelinesfor the administration of controlled substancesthat require the following be provided;history and physical examinations,treatment plan and objectives, informedconsent, periodic review of plan andtreatment, consultations with experts, accurateand complete records, and compliancewith State and Federal Laws(Rhode Island-225 ILCS60/MedicalAct of 1987).There are usually grounds for disciplininga physician who prescribes a controlledsubstance other than for a legitimatemedical purpose. Under Rhode IslandGeneral Laws § 21-28-3.04 (2006)one of the conditions for suspension orrevocation of registration includes “possessing,using, prescribing, dispensing, oradministering controlled substances exceptfor a legitimate medical or scientificpurpose.” 2 In addition, in defining unprofessionalconduct of a physician, R.I.General Laws §5-37-5.1 (2006) one ofthe behaviors noted is “violating any stateor federal law or regulation relating tocontrolled substances.” 3Physicians who selfprescribecontrolledsubstances such assedatives andnarcotics raisesuspicion of drugabuse/dependence.In Kentucky prescribing to self or tofamily members is not a violation of Kentuckylaw, but KRS 311.597 (1) statesthat “self-prescribing and prescribing toimmediate family members is contrary tothe law when the physician knows or hasreason to know that an abuse of controlledsubstances is occurring, or mayresult from such a practice.” 13The College of Physicians and Surgeonsof Ontario also makes it clear thatphysicians should never write a prescriptionfor themselves or family members fornarcotics, controlled drugs, psychotropicdrugs, or any drugs that are addicting orhabituating, even when another physicianis in charge of managing those medications.10In 2001, The Commonwealth ofMassachusetts Board of Registration inMedicine issued “Prescribing Practices:Policy and Guidelines.” Physicians are advisedto “maintain records that are detailedenough in nature that thephysician’s clinical reasoning is implicit inhis or her documentation. Treatmentplans should be explicitly recorded. Allpatients visit and telephone calls relatingto treatment should be documented. Prescriptionsshould be documented andchanges in medication dosage should beexplained.” 14 The Massachusetts guidelines(2001) warn:Prescribing to immediate familymembers is frequently associatedwith problems of selfmedicationand chemical dependencyby physicians and istherefore carefully scrutinizedby the Board. Treatment of immediatefamily members withcontrolled substances over a sustainedperiod of time may indicatea lack of objectivity andclinical detachment on the partof the physician. Physicians whoprescribe controlled substancesfor family members must takeextra precautions to insure thatthis privilege is not abused.The guideline/policy further cautionsthat “[t]he same examination requirementsapplicable to patients whoare not related to the physician applywhen the physician is prescribing controlledsubstances to the physician’s immediatefamily. Physicians should documentexamination results carefully andaccurately.”Massachusetts prohibits the prescriptionof Schedule II Controlled Substancesto family members. “Schedule IIcontrolled Substances, because of theirhigh potential for abuse, may not be prescribedto a member of a licensee’s immediatefamily, including a parent, child,sibling, parent-in-law, son/daughter-inlaw,brother/sister-in-law, step-parent, orspouse or equivalent, except in an emergency.”This prohibition includes otherrelatives permanently residing in the sameresidence as the licensee. The Board suggeststhat physicians consider refrainingfrom prescribing all controlled substancesfor family members and significant othersin non-emergency situations. 14The Board of Registration in Medicinein Massachusetts has even graverconcerns about self-prescribing. 14 Thesame document advises:Physician self-prescribing presentseven deeper concernsthan prescribing to family members.The prescription of drugsto oneself creates an enormousVOLUME 90 NO. 6 JUNE 2007179

180potential for abuse and places adifficult burden on the pharmacist,who is equally responsibleunder the law to determinewhether a prescription is valid.The Board has concluded thatthe potential for abuse of lowerschedule drugs far outweighsthe relatively minor inconveniencethat is caused by requiringphysicians to obtain prescriptionsfor their own use fromother physicians. For this reason,the Board has prohibitedphysicians from prescribingcontrolled substances in ScheduleII through IV for their ownuse.Massachusetts is not alone in the absoluteprohibition of self-prescribed controlledsubstances. In Georgia self-prescribing ofcontrolled medication is prohibited as a violationof Board Rule 360-3-.02(7). 15Of course physicians in all states arerequired to adhere to the DEA regulations.According to DEA regulation 21CFR 1306.04 (a) 16 the physician mustdetermine that there is a legitimate medicalpurpose for the patient to be prescribedthe controlled substance and theindividual practitioner must be acting inthe usual course of his/her professionalpractice as described in U.S. v Moore,U.S. 122, 1975.The DEA has developed aPractitioner’s Manual that offers guidanceon how the DEA determines that the prescribingpractice meets that the legal standardthat a controlled substance may onlybe prescribed, administered, or dispensedfor a legitimate medical purpose. TheManual provides examples of recurringpatterns that may be indicative of inappropriateprescribing or diversion. 17 Manyof these factors had been articulated in USvs. Rosen, 1978, 18 a Fifth Circuit Decisionin which the court upheld the convictionof a Louisiana Physician on chargesof dispensing and distributing controlledsubstances, a violation of 21 U.S.C.S. §841(a) and were reviewed again in U.S. vs.Rottschaefer 2006 a Third Circuit decision.19 These includeMEDICINE & HEALTH/RHODE ISLAND• An inordinately large quantity ofcontrolled substance prescribed orlarge numbers of prescriptions issuedcompared to other physiciansin the area;• No physical exam was given;• Issuing prescriptions knowing thatthe patient was delivering the drugsto others;• Issuing prescriptions in exchangefor sexual favors or for money;• The use of street slang rather thanmedical terminology for the drugsprescribed• No logical relationship between thedrugs prescribed and the treatmentof the condition allegedly existingStates can track prescriptions in theevent of a complaint. “Prescription MonitoringPrograms” are state programs thatcollect prescription information electronicallyfrom the pharmacies. States vary in theextent of information received and whetheror not they perform trend analysis in a proactiveapproach. In Rhode Island a reportto the Board can generate an investigationusing the database to verify that there is apattern and to determine the extent of thediversion or abuse. 20, 21 Rhode Island’s ElectronicData Transfer System, initiated in1997, allows the tracking of controlled substanceprescribing by patient, by prescribingphysician or by pharmacy. This can bea valuable tool when there has been a complaintor inquiry concerning prescribingpractices.The following vignette describes asituation that led to a complaint broughtbefore the Board. It was created for illustrativepurposes only and is not intendedto refer to any actual individual, event oroutcome.Dr. A had always been very close tohis younger brother who was an excellentstudent and always dependable. Dr.A was aware that his brother had been ina car accident 6 months earlier. Hisbrother had complained of back painfollowing the accident but had not beenadmitted to hospital. His brother reportedto him that he still had severe residualpain. Because of his exam schedulehe had missed an appointment withhis own physician and had run out ofOxycontin. He asked Dr. A if he wouldbe willing to write a prescription for aone-month supply. Dr. A. was hesitantbut nevertheless agreed to prescribe themedication. Dr. A was not aware that hisbrother was abusing Oxycontin as wellas other medications. The followingmonth his brother demanded that he fillthe prescription again. When Dr. A. refused,his brother threatened to reporthim to the Board. Dr. A. felt trapped andgave his brother another prescription oncondition that this would be the last time.When Dr. A. subsequently refused tocontinue the Oxycontin and suggestedthat his brother seek treatment for anaddiction, his brother filed a complaintwith the Board.Dr. A. could not produce a medicalrecord documenting that he had takenan appropriate history, performed aphysical exam, considered a treatmentplan, ordered or reviewed diagnostic testresults, or monitored the response totreatment. He had never documentedwhy he had arrived at the decision to treathis brother with Oxycontin. His brotheradmitted in his letter to the Board thathe had abused Oxycontin. The ElectronicData Transfer System indicated that hisbrother had filled numerous prescriptionsof Oxycontin from other providers.Dr. A. could not produce documentationthat he had prescribed for a legitimatemedical purpose. He was asked tomeet with the Board.Physicians are well advised to havetheir own treating physicians. Self-treatmenthas been viewed as a symptom ofpoor health care for physicians. 22 Physicianswho self-prescribe controlled substancessuch as sedatives and narcoticsraise suspicion of drug abuse/ dependence.Self-prescribing of controlled substancesincluding pain medication,stimulants and sedatives can influence thedevelopment of drug abuse and dependenceon these medications.While self-prescribing may be convenientand time-saving, the lack of objectivitymay result in inappropriate andeven dangerous self-treatment. Diagnosismay be delayed affecting prognosis.The lack of objectivity and concernsabout the absence of proper informedconsent should be considered when treatinga family member. It is important fortraining programs to foster discussionabout this issue which will allow traineesto consider the implications when prescribingfor themselves or for family membersand to learn to maintain appropriateprofessional boundaries. 5

REFERENCES1. The American Medical Association Code of Ethics,Ethics Opinion E-8.19, Issued June 1993, Last updatedAugust 26, 2005. Last accessed 9/20/06 htttp;/www.ama-assn.org/ama/pub/category/8510.html2. R.I. General Laws §5-37-5.1 (2006)3. R.I. General Laws § 21-28-3.04 (2006)4. Toyry S, Rasanen K, et al. Self-reported health,illness and self-care among Finnish Physicians.Arch Fam Med 2000; 9:1079-85.5. Christie JD, Rosen IM, et al. Prescription druguse and self-prescribing among resident physicians.JAMA 1998; 280:1253-5.6. Hem E, Stokke G, et al. Self-prescribing among youngNorwegian doctors, a follow-up study of a nationwidesample BMC Medicine 2005 available at htto:/www.biomedcentral.com/1741-7015/3/167. Westfall JM, McCabe J, Nicholas RA. JAMA1997; 278:141-3.8. McCauliffe WE, Rohman M, Santangelo S. NEJM1986; 315:895-910.9. Reinhardt T, Chavez E, et al. Survey of physicianwell-being and health behaviors at an academic medicalcenter. Med Edu Online [serial online] 2005;10:6available from http://www.med-ed-onlin.org10. College of Physicians and Surgeons of OntarioPolicy #7-06 Treating Self and Family Members,Last updated February 2007. Last accessed 3/07http://cpso.on.ca/Policies/drug_self.htm11. Rhode Island Board of Medical Licensure andDiscipline, Rules and Regulations Pertaining tothe Licensure and Discipline of Physicians MedicalRecord Regulations R-5-37 MD/DO sec 11.4.Last accessed 3/07 http://www.health.rigov/hst/bmld/records.php Medical Records12. Nist JB: Liability for over-prescription of controlledsubstances. J Legal Med 2002; 23:85-11313. KRS 311.597 (1)14. Commonwealth of Massachusetts Board of Registrationin Medicine, Prescribing Practices: Policyand Guidelines Adopted August 1, 1989,Amended December 12, 200115. Georgia Composite State Board of Medical ExaminersRule 360-3-.02(7) Last accessed 3/07 http:/www.rules.sos.state.gov.ga.us/doc/360/3/0216. DEA regulation 21 CFR 1306.04 (a)17. United States Department of Justice Drug EnforcementAdministration Practitioner’s Manual:An Informational Outline of the Controlled SubstanceAct, 1-61, 200618. U.S. v. Rosen, 582 F.2D 1032; 1978 U.S. App19. U.S. v. Rottschaefer, 127 S.Ct 274; 166 L. Ed.2d 152; 200620. Heinrich J. United States General AccountingOffice Report to the Subcommittee on Oversightand Investigations, Committee on Energy andCommerce, House of Representatives, PrescriptionDrugs, State monitoring programs provideuseful tool to reduce diversion GAO-02-634,May 200221. United States Department of Justice, Drug EnforcementAgency. A closer look at state prescriptionmonitoring. Last accessed 8/2/062006deadiversion.usdoj.gov/faq/rx_monitor.htm22. Rosvold EO, Tyssen R. Lancet 2005; 365:1375-365Marilyn Price, MD, is Director, TheLaw and Behavioral Health Program,Butler Hospital, and Assistant ClinicalProfessor of Psychiatry, The Warren AlpertMedical School of Brown University.Bruce W. McIntyre, JD, is LegalCounsel, Rhode Island Board of MedicalLicensure and Discipline.CORRESPONDENCEMarilyn Price, MDButler Hospital345 Blackstone BoulevardProvidence, RI 02906Phone: (401) 455-6382e-mail: Marilyn_Price@brown.eduVOLUME 90 NO. 6 JUNE 2007181

182Patient Safety Efforts Target Communication atRhode Island HospitalsMEDICINE & HEALTH/RHODE ISLANDMelinda Morin, MDThe 1999 Institute of Medicine (IOM)report, To Err Is Human, 1 sparked a publicoutcry over patient safety in US hospitals.This has resulted in attention tosystem factors as well as accountability atan individual level. Although technologicadvances have soared in many of ourhospitals, communication - a basic tenetof patient care - has suffered. This articleadvocates for a change in proceduresaround patient “hand-offs” and describesthe efforts at Rhode Island Hospital toreduce iatrogenic injury and liability forpractitioners and the hospital. These effortsinclude standardizing the process,improving communication, and minimizingreliance on the memory of patients,families and practitioners.The accurate transfer of informationbetween teams of caregivers is essentialfor the seamless continuity of care. However,“hand-off” communication hasbeen identified as the major cause of sentinelerror events and delay in treatmentwithin US hospitals. 2 Too often key informationis misstated or misunderstood.Five-year data from CRICO/RMF, themedical malpractice company for theHarvard Medical Institutions, indicatethat handoffs were involved in 268 claimsand suits, with more than half involvinga high severity patient injury. 3 As a result,the Joint Commission has includedthe implementation of a standardizedapproach to hand-off communications,with an opportunity to ask and respondto questions, as one of the required goalsfor 2006 and 2007. 4Communication strategies successfulin other high risk settings are being introducedinto the setting of medical care.Patterson et al 5 evaluated communicationmethods at NASA Johnson Space Center,nuclear power plants in Canada andrailroad and ambulance dispatch centers.Techniques found to be effective included:1) Face-to-face verbal updateswith interactive questioning; 2) Unambiguoustransfer of responsibility; 3)Overhearing others’ updates; and 4) Limitinginterruptions during update. Althoughlogical, these methods are rarelyutilized in current medical practice andshould be mandatory in sign-out at alllevels.Studies of thephysician sign-outprocess reveal it tobe a haphazardevent with greatvariation ininformation contentand process.In the United States, resident-physiciansprovide much of the direct patientcare.Previous work has identified coverageby house staff not primarily responsiblefor the patient (cross-coverage) as a significantcorrelate of risk for preventable adverseevents. 6 Cross-coverage by a differentphysician, principally at night, was afar better predictor of hospital complicationsand errors than was the severity ofthe patients’ illness. With the 2003 mandateof an 80-hour work-week for residents,the number of handoffs has substantiallyincreased. While targeting fatiguerelatederrors, this change has exacerbatedcommunication problems involving thehandoff of patient information.Table 1. SBAR Method of Communication SBAR Tool, Institute for HealthcareImprovement, Copyright Institute for Healthcare Improvement, 2007.

Table 2. SPEAK UP - Poster, The Joint Commission, 2007Studies of the physician sign-out processreveal it to be a haphazard event withgreat variation in information content andprocess. 7 The typical resident sign-out is a“one-liner” including diagnosis and theclinical impression, e.g. the patient is allright. It is often purely task-oriented. Thus,effectiveness of sign-out is currently restrictedby its inadequate content, particularlyregarding the plan of care for patients.Six Sigma is a process-focused businessstrategy aimed at improving quality, reducingcosts and improving efficiency. Thesigma level indicates the defect rate in agiven production or service process. In aneffort to achieve Six Sigma performanceand diminish the incidence of errors, theLifespan Health System, including RhodeIsland Hospital, Miriam Hospital and NewportHospital, is currently utilizing CPOE(computerized provider order entry system).CPOE is the portion of a clinical informationsystem that enables a patient’sprovider to enter an order for a medication,laboratory or radiology test, or procedureusing a computer system that providessome level of clinical alerts. CPOE allowsrapid, up-to-date, intra-hospital informationtransfer that is available, and HIPAA protected,at any computer terminal within anyof the hospitals. Rhode Island Hospital isimplementing a standardized sign-out systemfor resident sign-out that is electronicallylinked to CPOE. This system offers areadily available, cost-effective and userfriendlysign-out method, which could beinstrumental in decreasing reliance on vigilanceand memory, while communicatingthe plan of care.Another identified area of frequentcommunication failures centers aroundthe nurse-physician interaction. SBAR(Situation-Background-Assessment-Recommendation)is a situational briefingtechnique that conveys only the most criticalinformation and is one of several communicationmodels gaining momentum inAmerican healthcare. The SBAR model,which has proven successful in the nuclearsubmarine industry, has been adopted bythe Kaiser Permanente system. (Table 1).SBAR requires that information be communicatedin a standardized, consistentmanner. This method emphasizes the anticipationof what information the otherperson will need, the use of critical thinkingand assessment skills and, of particularimport, the goal of reaching a mutuallyacceptable plan.Undoubtedly, the change to an effectivemodel of communication requiresan enormous change in the very cultureof medicine. It requires a change to concernsabout an abnormality seen, not theperformance of specific tasks. It requiresa team approach, where nurses are notafraid to be wrong and are not afraid tostate that they are worried. It requireschange in the hierarchy of medicine. Physicianswould still be the de facto leaders inpatient management, but would need tobe more accepting of nursing input. Successfulimplementation would ablate thecurrent system of hinting and hoping bynon-physicians. The use of SBAR couldalso be expanded to the other healthcaresettings (e.g. outpatient office or nursinghome settings); incorporation into otherpractice situations (daily rounds, dischargesummaries); or incorporation into othertypes of hospitals outside of academic medicine(community hospitals).SBAR is being introduced into anothervital area of communication atRhode Island Hospital: nursing sign-out.Traditionally, shift change sign-out hasrelied on taped or written report whilephysically separated from the patient.VOLUME 90 NO. 6 JUNE 2007183

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There is minimal opportunity to ask questionsand the content is highly variableand inconsistent. It is an inefficientmethod, frustrating to both nurses andtheir patients. The Joint CommissionNational Patient Safety Goal #2 4 includesthe opportunity to ask questions duringsign out; thus, listening to taped reportafter the previous shift of nurses has departedwill no longer be adequate. 8 Theprinciples of SBAR communication, includinga standardized content, use ofcritical thinking and an emphasis on planof care, offer the promise of decreasedadverse advents as well as improved patientsatisfaction. The focus for nursingsign-out becomes the anticipated patientcourse and what should be done, not simplya description of what has already happened.Paid time for handoffs involvingboth participants is already included inthe RN budgets at many hospitals (personalcommunication).There are additional hurdles to theintroduction of a standardized model ofnursing sign-out. Nurses traditionally usea narrative style and are not trained tomake diagnoses. Nurses are often notcomfortable discussing difficult or sensitiveissues in front of patients. Sign-outtime is often utilized as a time for socialinteraction. These differences must beconsidered when SBAR is introduced andstaff must be involved in addressing thesebarriers.Although the use of SBAR in UShospitals is growing, there is minimalpublished data of its effectiveness. Hospitalsutilizing SBAR report increasedsatisfaction from all participants and hospital-wideuse of the technique has beenshown to improve medication reconciliationand decrease the rate of adverseevents. 9 Although SBAR is likely to resultin improved information transfer,long-term advantages remain ill defined.Communication between medicalprofessionals and their patients and familieshas also suffered. In the hectic pace oftoday’s hospital medicine, the simple act ofupdating patients is too often overlooked.Patient satisfaction data routinely cites communicationwith the healthcare team asproblematic. 10 A recent study evaluatingcommunication in the outpatient settingrevealed that physician-patient communicationerrors were associated with a lack ofpatient participation in the decision-makingprocess in terms of voicing expectationsor responses to their doctor’s recommendations.11 In response to the Joint Commissionrecommendation, Rhode IslandHospital has launched a Speak Up TM (Table2) campaign urging patients to participateactively in their healthcare. Posters and brochuresin multiple languages throughoutthe hospital advertise these efforts.A laudable practice gaining momentumin the United States is nursing signoutat the patient bedside, including a discussionwith the patient to make sure s/heunderstands the discharge plan and postdischargetreatment plan. Such a standardwould not only improve patient satisfaction,but also patient safety. Bedside rounds inthe ICU with the entire healthcare team 12have had an equally positive impact and isthe practice at Rhode Island Hospital.Although nursing and physicianleadership recognizes the importance ofcommunication, the front-line worker isoften unaware of its role in patient safety.Education remains the key to successfulimplementation of any change in practice;thus, efforts must be aimed at improvingcommunication at all levels toaffect a change to a culture of patientsafety. This represents a significantchange in the culture of medicine, nationally,as well as locally in Rhode Island.Incorporation into daily practice will bea slow, but ultimately successful process.REFERENCES1. Institute of Medicine. To err is human: Buildinga safer health system. Washington, DC: NationalAcademy Press; 1999.2. VA National Center for Patient Safety. NCPSMedical Team Training Program, Executive Summary,April 2006.3. Hoffman J. CRICO’s Handoff-related MalpracticeCases. CRICO/RMF Forum, March 25(1):4,2007.4. Joint Commission on Accreditation of HealthcareOrganizations. National Patient Safety Goals for2006 and 2007.5. Patterson ES, Roth EM, et al. Handoff strategiesin settings with high consequences for failure:lessons for heath care operations. Internat J forQuality Health Care 2004; 16:125-32.6. Petersen LA, Brennan TA, et al. Does housestaffdiscontinuity of care increase the risk for preventableadverse events? Ann Intern Med 1994; 121:866-72.7. Cook RI, Render M, Woods DD. Gaps in thecontinuity of care and progress on patient safety.BMJ 2000;320:791-4.8. JCAHO’s 2006 National Patient Safety Goals:Handoffs are biggest challenge. Hospital Peer Review2005;30:89-93.9. Leonard M, Graham S, Bonacum D. The humanfactor. Qual Saf Health Care.2004 Oct;13 Suppl1:i85-90.10. Boyle DK, Miller PA, Forbes-Thompson SA. Communicationand end-of-life care in the intensivecare unit: patient, family, and clinician outcomes.Crit Care Nurs Q. 2005;28:302-16.11. Barry CA, Bradley CP, et al. Patients’ unvoicedagendas in general practice consultations. BMJ2000;320(7244):1246-50. Erratum in: BMJ2000;321(7252):44.12. Anderson CD, Mangino RR. Nurse shift report.Nurs Adm Q. 2006;30:112-22.Melinda Morin, MD, is Director,Patient Safety Program, Rhode Island Hospital.CORRESPONDENCE:Melinda Morin, MDRhode Island Hospital593 Eddy StProvidence, RI 02903Phone: (401) 444-4201e-mail: MJMorin@lifespan.org186MEDICINE & HEALTH/RHODE ISLAND

Rhode Island Supreme Court Affirms Limited Natureof Peer-Review PrivilegeIn its recent opinion in Pastore v. Samson 1 ,the Rhode Island Supreme Court reaffirmedits view that the “peer-reviewprivilege” offers a limited protection tocertain information created by properlyconstituted peer-review boards. Theopinion provides useful guidelines as tothe type of information that may be protectedfrom disclosure to plaintiffs andother parties seeking information presentedat and created by peer-reviewboards. As will be discussed, the principlemessage from Pastore is that thepeer-review privilege is quite limited, andthat physicians and hospitals should bemindful that not everything they mayconsider as “peer-review privileged” materialactually is protected from discovery.A “Discovery Melee”Pastore’s estate commenced this lawsuitagainst Dr. Samson, a fellow doctor,and Kent County Memorial Hospital followingMr. Pastore’s death on July 12,1998. The plaintiff’s complaint allegedthat Pastore died as a result of negligentcare delivered by the defendant doctors.In addition to the medical malpracticeclaims against the doctors, the plaintiffalleged that the Hospital had negligentlycredentialed and granted privileges toDr. Samson.The lawsuit descended in what theCourt termed a “discovery melee,” inwhich the “discovery phase stalled asplaintiff and the hospital engaged in alengthy battle over certain hospitaldocuments concerning Dr. Samson.” Atissue were 750 pages that the Hospitalclaimed were protected by the peer-reviewprivilege, as well as other confidentialityprotections. The dispute reachedthe Supreme Court after numerous proceedingsin the lower court, stretchingoutover more than two and a half years.The specific ruling on appeal was thetrial court’s order rejecting theHospital’s claims of privilege, and orderingthat all 750 pages be turned over toplaintiff.Lawrence M. Kraus, JD, and Lawrence W. Vernaglia, JD, MPHThe Supreme Court affirmed theproduction of all but one page of thedocuments—and even that one page wasordered to be produced with certain informationremoved.THE PEER-REVIEW PRIVILEGE IS“STRICTLY CONSTRUED” ANDLIMITEDIn its analysis, the Court first reviewedthe Rhode Island statutes thatcreate the peer-review privilege as well asits past opinions interpreting the privilege.The Court noted that “two similaryet distinct Rhode Island statutes affordproviders of health care the peer-reviewprivilege,” “which create a privilege forthe ‘proceedings’ and ‘records’ of peerreviewboards, such that those documentsshall not be subject to discovery or beadmissible in evidence.” The Court identifiedthe principle underlying the peerreviewprivilege as “the social importanceof open discussions and candid self-analysisin peer–review meetings to ensure thatYou should notbelieve that extensivedocumentation orinformation can beprotected merelybecause it is labeled“peer-reviewprivilege.”medical care of high quality will be availableto the public.” Based on this principle,the Court has ruled in the pastthat—in the proper circumstances—ahospital is entitled to withhold “all recordsand proceedings before a peer-reviewboard,” even as pertaining to the allegedlynegligent treatment delivered to aplaintiff himself.Having done so, however, the Courtfocused the bulk of its opinion on justhow limited this protection is. Relyingin part on past precedent, the Courtstressed that this privilege is to be “strictlyconstrued” because it prevents potentiallyrelevant evidence from being brought tolight. 2 “The privilege must not be permittedto become a shield behind whicha physician’s incompetence, impairment,or institutional malfeasance resulting inmedical malpractice can be hidden fromparties who have suffered because of suchincompetence, impairment, or malfeasance.”In doing so, the Court explicitlyrejected the Hospital’s argument thatbecause the privilege serves the sociallybeneficial “remedial” purpose of improvingthe quality of medical care, it shouldbe broadly interpreted and applied.SPECIFIC EXAMPLES OFAPPLICATION OF PEER-REVIEWPRIVILEGEHaving interpreted the scope of theprivilege in general, the Court thenturned to the specific examples presentedby the case. 3 The results are instructiveas to how limited the privilege is.The first document considered wasa 51-page transcript of the proceedingsof a committee meeting “arising from acomplaint about Dr. Samson’s bedsidemanner while working in the emergencyroom[,]” much of which focused on interactionswith the patient and familymembers. Despite conceding that thetranscript was from a proceeding beforea hospital committee—a necessary prerequisitefor the privilege to apply—theCourt examined “whether a committeeinvestigating the bedside manner of adoctor qualifies as a peer-review board.”It does not. The Court held that thebedside manner of the Doctor was insufficientlyrelated to the purposes of thestatute to protect the transcript by theprivilege. “The [lower court’s] distinctionbetween a doctor’s bedside mannerand the actual medical care that a doctoradministers strikes us as sensible. Thepeer-review privilege was designed to alleviativean increase in medical malpracticelawsuits for substandard health care,VOLUME 90 NO. 6 JUNE 2007187

not to reduce the number of rude oruncompassionate health-care professionals– although the latter is certainly a commendableobjective.” Because the committeewas not engaged in the sort of investigationthat sufficiently met the objectivesof the statute, the Court agreedthat it was not a “peer-review board,” andordered the transcript to be produced.The second document consideredwas a one-page report from a peer-reviewboard that “focused not on Dr. Samson’sbedside manner, but on whether or nothe timely responded to a patient whoneeded care.” This document thereforeclearly constituted a “record” of a peerreviewboard, and certain information init was therefore protected by the peerreviewprivilege.Notably, however, even here theCourt did not say that the entire singlepage document could be withheld. Instead,it held that any restriction of thephysician’s privileges, as well as the list ofdoctors attending the meeting, were allsubject to disclosure. “Accordingly, thisreport is not privileged, and is discoverable,so long as it is redacted to cloak thesummary of key items discussed in themeeting.”GUIDELINES REGARDING SCOPE OFPRIVILEGEPastore highlights the limited natureof the peer-review privilege. The followingare some guidelines to be aware of:• While the peer-review privilege exists,it is strictly construed. Youshould not believe that extensivedocumentation or information canbe protected merely because it is labeled“peer-review privilege.”• Only “records” and “proceedings”of peer-review boards are protected,and not “documents orrecords otherwise available fromoriginal sources.” In other words,materials that were created outsidethe peer-review body – including,for example, patient records – arenot protected merely because theyhave been brought into peer-review.4• Similarly, the privilege only appliesto information generated by peerreviewbodies, and not, for example,“records made in the regular courseof business by a hospital.”• The identities of persons participatingin peer-review are discoverable.• The privilege prevents peer-reviewparticipants from testifying as to“findings, recommendations, evaluations,opinions, or other actions ofthe board,” but the imposition of arestriction of privileges or a requirementof supervision is not privilegedand is subject to discovery.In short, Pastore demonstrates thatthe peer-review privilege is alive in RhodeIsland—it just might not be as protectiveas you think.REFERENCES1. The case citation is 900 A.2d 1067RI2006.2. The Court noted that “[p]rivileges, by their nature,‘shut out the light’” on “the ascertainmentof the truth.”3. The Court noted with some chagrin the fact that750 pages of materials were at issue, the hospital’slawyers only discussed 2 documents, as a resultlimiting the Court’s analysis to those two documents.4. In fact, the Court ruled that if the hospital hassuch original documents in its possession, it shouldbe required to produce them, and that the Plaintiffwas not required to seek them from anotheroriginal source.Lawrence M. Kraus, JD, is a partnerwith Foley & Lardner LLP.Lawrence W. Vernaglia, JD, MPH, isan attorney specializing in health carewith Foley & Lardner LLP.CORRESPONDENCELawrence W. Vernaglia, JD, MPHFoley & Lardner LLP111 Huntington AvenueBoston, MA 02199Phone: (617) 342-4070e-mail:lkraus@foley.com188MEDICINE & HEALTH/RHODE ISLAND

RHODE ISLAND DEPARTMENT OF HEALTH • DAVID GIFFORD, MD, MPH, DIRECTOR OF HEALTHEDITED BY JAY S. BUECHNER, PHDTrends In Tobacco Use (1990-2006) and Patterns ofTobacco Use Among Rhode Island Adults in 2006Jana Hesser, PhD, Yongwen Jiang, PhD, and Seema Dixit, MS, MPHTobacco use is the single leading cause of preventable illnessand death in the United States and in Rhode Island. 1 Eachyear, more than 435,000 Americans and approximately 1,900Rhode Islanders die prematurely from smoking- related diseases.Annual health care costs in Rhode Island directly causedby smoking are estimated to be $506 million, 2 not countingcosts linked to exposure to secondhand smoke, smoking-causedfires, spit tobacco use, or cigar and pipe smoking. 2This report presents survey data on the trend in cigarettesmoking among Rhode Island adults from 1990 – 2006, andon the patterns of adult tobacco use and associated health risksin Rhode Island in 2006.METHODSTobacco use rates were calculated using self-reported datafrom Rhode Island’s Behavioral Risk Factor Surveillance System(BRFSS), a telephone survey administered in all 50 statesand 4 US territories with funding and specifications from theCenters for Disease Control and Prevention (CDC). 3 TheBRFSS monitors the population ages 18 and older for access tohealth care, certain health conditions, and behaviors that contributeto the leading causes of disease and death in the US,including tobacco use. Rhode Island has participated in theBRFSS since 1984.From 1990 to 1997, Rhode Island’s BRFSS had an annualsample size of approximately 1,800. Between 1998 and2005, RI’s BRFSS sample size varied between 3,600 and 4,500.Each year’s data are weighted to be representative of the age,sex and race composition of Rhode Island’s adult population.The BRFSS has asked the same “core” tobacco questionseach year since 1990. A person is identified as a “currentsmoker” if he/she had ever smoked 100 cigarettes and nowsmokes every day or some days. “Sedentary lifestyle” is definedas engaging in no leisure time physical activityor exercise in the past 30 days. “Chronic drinking”is defined for men as consuming 2 or morealcoholic drinks each day; for women, 1 or morealcoholic drinks each day. Indicators of poor qualityof life or poor mental health include: 14 or moredays in the past month of pain-related activity limitations,lack of sleep, lack of energy, poor mentalhealth, feeling sad/blue/depressed, and feeling worried/tense/anxious.4 Two other mental health indicatorsare having “ever been told you have ananxiety disorder”, and having “ever been told youhad a depressive disorder”. “Error” bars on thecharts represent the 95% confidence limits aroundthe estimates.RESULTSSmoking trend, 1990 - 2006From 1990 to 2006, smoking rates among RI adultsdropped from 25.6% to 19.2%. (Figure 1) Between 1992and 2001, annual rates fluctuated between 22% and 25%.Since 2001 smoking rates have dropped in each successive year.Current smoking in 2006About 1 of every 5 adults in Rhode Island, or roughly160,000 persons, is a current cigarette smoker. There is nosignificant difference in smoking rates between men andwomen. Smoking rates are highest among adults ages 18 – 24(35%), non-White non-Hispanics (26%), adults who are notcollege graduates (25%), adults in households with incomesless than $25,000 (28%), never married and divorced/separatedadults (28%), and among persons either unemployed(28%) or unable to work (37%). The lowest smoking rates areassociated with being 65 or older (9%), being a college graduate(10%), or having a household income of $50,000 or more.(Figure 2) More than half (60%) of all smokers reported thatthey quit smoking for one day or longer during the past year.(Figure 3)Smokers are at greater risk than non-smokers for having asedentary lifestyle (35% vs 22%). Eleven percent of smokersare chronic drinkers compared with 5% of other adults. Agreater proportion of smokers than non-smokers lack access todental care (29% vs 17%) and to a regular medical provider(25% vs 11%). (Figure 3)Smokers have higher rates than non-smokers for each of 8 indicatorsof poor quality of life and poor mental health. (Figure 3)Almost one-third of smokers had been told they had a depressivedisorder at some time in their lives; nearly one-quarter hadbeen told they had an anxiety disorder at some time in their life.Figure 1. Annual current smoking prevalence, ages 18 and older,Rhode Island, 1990 – 2006.VOLUME 90 NO. 6 JUNE 2007189

190Figure 2. Current smoking among Rhode Island adults (ages 18and older) within demographic subgroups, 2006.More than a third of smokers, compared with about a quarter ofnon-smokers, reported not getting enough sleep for 14 or moredays in the past month or not feeling very healthy or full of energy.(Figure 3)DISCUSSIONThe state of Rhode Island has enacted measures to discouragetobacco use. The state has increased cigarette taxes eachyear since 1994. The most recent increase of $.75 per pack,enacted in 2004, brought the retail price to $6.10 per pack in2005 (compared to $1.84 in 1994). The Rhode Island SmokeFree Public Place and Workplace Law, which went into effectMarch 1, 2005, banned smoking in all public and workplaces.Rhode Island was the seventh state to do so. In 2006 the legislaturemandated tobacco treatment coverage by all state healthinsurers, both public and private. During February 2005, justprior to implementation of the public and workplaces smokingban, and during March 2005, the Health Department’s1-800-Try-To-Stop line received about 1,500 calls each month,an eight-fold increase in the number of calls received frompeople wanting to stop smoking.Although smoking rates in Rhode Island’s adult populationoverall have been decreasing since 1990, smoking ratesamong some demographic groups remain high. Smokers areat increased health risk due to sedentary lifestyles, chronic drinking,and poor mental health. The poor mental health of smokersobserved in the BRFSS data is substantiated by other studies.5 One report estimates that “the mentally ill carry the burdenof nearly half of all US tobacco consumption”. 5Using nationally proven best practices, the Rhode IslandTobacco Control Program (RITCP) works in partnership withcommunity based organizations, voluntary agencies, health careproviders, and state-wide partners to prevent and control to-MEDICINE & HEALTH/RHODE ISLANDFigure 3. Health risks among Rhode Island adults by smokingstatus, 2006.bacco use, aiming specifically to reduce youth initiation of tobaccouse, to eliminate exposure to second hand smoke, and topromote cessation.REFERENCES1. Mokdad, AH, Marks JS, et al. Actual Causes of Death in the United States,2000. JAMA 2004; 291, ( 10).2. The Toll of Tobacco in Rhode Island. Campaign for Tobacco Free Kids Websitehttp://tobaccofreekids.org/reports/settlements/toll.php?StateID=RI3. Centers for Disease Control and Prevention (CDC). Behavioral Risk FactorSurveillance System. http://www.cdc.gov/brfss4. CDC Health-Related Quality of Life: http:// www.cdc.gov/hrqol.5. Lasser K, Booyd JW, et al. Smoking and Mental Illness. A Population-BasedPrevalence Study. JAMA 2000; 284, (20).ACKNOWLEDGEMENTData Source: Rhode Island Behavioral Risk Factor SurveillanceSystem, 1990 - 2006, Center for Health Data and Analysis,Rhode Island Department of Health, and supported in part bythe National Center for Chronic Disease Prevention and HealthPromotion, Centers for Disease Control and Prevention CooperativeAgreements U58/CCU100589 and U58/CCU122791.Jana Hesser, PhD is Program Director, Health Surveys, andBRFSS Project Director, Center for Health Data and Analysis,Rhode Island Department of Health, and a Clinical AssistantProfessor of Community Health, The Warren Alpert MedicalSchool of Brown University.Yongwen Jiang, PhD is a Public Health Epidemiologist, Centerfor Health Data and Analysis, Rhode Island Department ofHealth and a Clinical Assistant Professor of Community Health,The Warren Alpert Medical School of Brown University.Seema Dixit, MS, MPH, is Program Manager, Tobacco ControlProgram, Division of Community Health and Equity, RhodeIsland Department of Health.

ADVANCES IN PHARMACOLOGYAtypical Antipsychotics for the Treatment ofDementia-Related Behaviors: An UpdateLori A. Daiello, PharmDDementing illnesses are frequently associated with agitation,hallucinations, delusions and aggression. While loss of cognitiveand functional abilities is distressing both to patients withAlzheimer’s Disease (AD) and their caregivers, the psychiatricaspects are often cited as the precipitating factor for nursinghome placement. 1The most frequently used, but least descriptive, term forthe behavioral symptoms of dementia is “agitation.” Cohen-Mansfield describes agitation as inappropriate verbal, vocal, ormotor activity that does not result from identified need. 2 “Agitated”behaviors may include aggression, anxiety, phobias, diurnalrhythm disturbance, and motor restlessness.Antipsychotic drugs have been the primary treatment forpsychosis, agitation, and aggression in AD and other dementiasfor decades, although it was never clear if the drugs improvedthe behavior or provided a “chemical straitjacket” that reducedall behavior. The conventional antipsychotics such as haloperidolhave been supplanted by four of the newer or “atypical”antipsychotic drugs (risperidone, olanzapine, quetiapine,aripiprazole), although no medication has an FDA indicationfor the treatment of behavioral symptoms in patients with dementia.The prescribing of antipsychotics for neuropsychiatricsymptoms was stimulated by observations that psychosis ispresent in many patients with AD who exhibit agitated andaggressive behaviors. However, the biological basis of psychoticsymptoms in dementia is not well understood and likely differsfrom underlying mechanisms hypothesized for psychotic disorderssuch as schizophrenia. 3Widespread use of atypical antipsychotics for psychosis andother dementia-related behaviors preceded the availability ofan evidence base because of the perception of superior effectivenessand safety of these drugs over the older antipsychotics.Over the past 3 years, some placebo-controlled clinical trials ofatypical antipsychotics for behavioral symptoms reported smalltreatment effects coupled with troubling adverse effects at ratesthat exceeded those observed in placebo-treated patients. Reportsof increased risk of mortality and cerebrovascular accidentsin some trials of atypical antipsychotics in dementia populationsresulted in FDA-mandated changes to product labelingfor all atypical antipsychotic medication despite the factthat not all of drugs in the class have been studied in dementiapopulations. 4, 5 Controversies sparked by these changes andrecent clinical trial results fuel debate about the appropriateprescribing of these medications.Other classes of psychoactive medications (typicalantipsychotics, antidepressants, benzodiazepines, andanticonvulsants) are utilized in the treatment of neuropsychiatricsymptoms, but have not been as well studied as atypicalantipsychotics in dementia patients. 6 In light of the FDA warnings,potential medico-legal implications, and new clinical data,clinicians should understand the current data for atypical antipsychoticprescribing in patients with dementia. This articlesummarizes the 2 most recent publications on the efficacy andsafety of atypical antipsychotic medications used in the treatmentof agitation, psychosis and other behavioral symptoms.CLINICAL ANTIPSYCHOTIC TRIALS OF INTERVENTIONEFFECTIVENESS – ALZHEIMER’S DISEASE (CATIE-AD)CATIE-AD is the first head-to-head, prospective, randomized,double-blind, placebo-controlled effectiveness trial of antipsychotictherapy in AD. The unique design measured outcomesassociated with real-world prescribing of these medicationsto treat behavioral symptoms. 7 In the initial, 36-week phaseof the study, community-dwelling patients with mild-severe ADand behavioral symptoms (delusions, hallucinations, aggression,Table 1.Outcomes- EffectivenessOverall effectiveness (as measured by the time to drug discontinuation)was similar for olanzapine, risperidone,quetiapine, and placebo• Time to discontinuation for lack of efficacy was significantlylonger for olanzapine (22.1 weeks) andrisperidone (26.7 weeks) groups than in the placebogroup (9.0 weeks)• Discontinuation for intolerance of study drug, adverseeffects or death was greater for all groups receivingactive treatment (olanzapine (24%); risperidone (18%);quetiapine (16%)) than placebo (5%) treated patients• Except for quetiapine (56.5 mg), mean daily dosagesfor olanzapine (5.5 mg) and risperidone (1.0 mg) atendpoint were within the usual dose range for treatmentof neuropsychiatric symptoms in dementia studiedin earlier trials. The optimal therapeutic dose ofquetiapine remains unclear. While daily doses of 75-150mg are often prescribed, the dose range in 3 dementiaclinical trials varied from 25-600mg. 8Outcomes-Safety• Confusion and psychotic symptoms were observed atsignificantly higher rates with olanzapine than with placeboor the other antipsychotics.• Treatment emergent Parkinsonism was more commonin patients receiving olanzapine or risperidone.• Sedation occurred more frequently with active treatmentthan with placebo for all antipsychotics.• Despite higher rates of Parkinsonism and sedation inthe treatment groups, there were no differences in theincidence of falls, fractures or injuries across all treatmentgroups.VOLUME 90 NO. 6 JUNE 2007191

192MEDICINE & HEALTH/RHODE ISLANDagitation) of at least moderate severity were randomized to eitherolanzapine (N=100), risperidone (N=85), quetiapine (n=94)or placebo (N=142). Aripiprazole and ziprasidone were not includedin the study because they were not available in the US atthe time the trial was designed. The multi-center trial was fundedby the National Institutes of Mental Health.Physicians could adjust the dosage throughout the trial.Participants who adequately responded could continue the trialup to 36 weeks. If the patient’s response assessed as inadequatefor any reason after the initial 2 weeks of therapy, treatmentcould be discontinued. Patients whose therapy was discontinuedcould enter phase 2 of the trial to be randomized to one ofthe other antipsychotics or citalopram under double-blind conditions.To date, only phase 1 data have been published.The primary outcome was time to discontinuation of treatmentfor any reason in Phase 1 of the study. This type of novel outcomeallowed the composite effect (efficacy, tolerability, caregiverburden) of the interventions to be evaluated and compared.The study population was moderately cognitively impaired(MMSE 15±5.8) with a mean age of 77.9 ±7.5 years. Baselinebehavioral symptoms were moderately severe and 60% of thesubjects received adjunctive cholinesterase inhibitor therapyupon study entry.Treatment of psychiatric illness such as schizophrenia orbipolar disorder with some atypical antipsychotics has beenassociated with weight gain and metabolic abnormalities suchas hyperglycemia, hyperosmolar coma, Type 2 diabetes, andhyperlipidemia in younger individuals. It is unknown whetherthis phenomenon is a class effect, or a consequence of an interactionof antipsychotics with thecomplex diathesis of psychiatric illness,genetics, and dietary factors.Clozapine and olanzapine appearto be most commonly associatedwith metabolic adverse effects andaripiprazole and ziprasidone theleast implicated. In schizophreniaand bipolar disease trials,risperidone and quetiapine haveintermediate effects on weight gainand metabolic parameters. 9CATIE-AD was the first headto-headtrial to explore the associationbetween atypical antipsychotictreatment and development ofmetabolic adverse effects in olderadults with AD. Subjects receivingolanzapine, quetiapine, orrisperidone averaged a monthlyweight gain of 1.0, 0.7 and 0.4pounds on treatment, compared toweight loss among placebo-treatedpatients. Neither the changes inweight nor the mean changes inblood glucose, total cholesterol, ortriglyceride levels were statisticallysignificant for the active treatmentgroups compared with changes inthe placebo group. The modest weight gain and lesser changesin metabolic indices are consistent with data from other placebo-controlledclinical trials of atypical antipsychotics in dementiaand may reflect the dementia-related changes in proteinand carbohydrate metabolism that blunt antipsychotic effectson appetite, weight, and lipid metabolism. 10Analyses of pooled clinical trial data have linked atypicalantipsychotic treatment of behavioral symptoms in patients withdementia to an increased risk of cerebrovascular adverse events(CVAE) and increased mortality. The discovery of the increasedrisk of mortality in pooled data from risperidone, olanzapine,quetiapine, and aripiprazole placebo-controlled dementia trialsled the FDA to add a black box warning to the productlabeling for all atypical antipsychotics in 2005. The labelingfor olanzapine and risperidone also includes a warning aboutthe increased risk of CVAE.There were no observed differences in the rates of strokeor sudden death between the groups receiving atypical antipsychotictreatment and placebo-treated patients in CATIE-AD.The lack of a signal for increased incidence of stroke or risk ofmortality with atypical antipsychotic therapy is not surprisingwhen considering the differences between the dementia populationstudied in CATIE-AD and the populations under studyin the short-term (6-12 week) antipsychotic dementia trials.Many of the atypical antipsychotic trials included dementiapatients with significant cardiovascular risk factors; some includedfrail nursing home patients who were likely at higherrisk of adverse medication-related outcomes. 8

AGENCY FOR HEALTHCARE RESEARCH AND QUALITY(AHRQ) EFFICACY AND COMPARATIVEEFFECTIVENESS OF OFF-LABEL USE OF ATYPICALANTIPSYCHOTICSThis AHRQ analysis, published online in January 2007,retrospectively reviewed efficacy and safety data related to the4 most common off-label uses for the atypical antipsychotics -treatment of agitation in dementia, depression, obsessive-compulsivedisorder, posttraumatic stress disorder, personality disorders,and Tourette’s syndrome. 11Data for the agitation in dementia analysis were drawnfrom randomized, controlled trials in dementia, including theCATIE-AD trial. Conclusions about the relative effectivenessof risperidone, olanzapine, quetiapine, and aripirazole were ingeneral agreement with results of a recently published metaanalysisof 15 placebo-controlled atypical antipsychotic trialsthat reported small but significant benefits on agitation andpsychosis for risperidone and aripiprazole.A trend favoring the effectiveness ofolanzapine for psychosis in dementia thatdid not reach statistical significance wasalso noted. The 3 quetiapine trials weretoo different in design and outcome measuresto be analyzed and compared. Therewere no trials of ziprasidone in patientswith dementia.Table 2 summarizes the AHRQanalysis of safety data. The group did notanalyze trial-related mortality data, butcited a recently published meta-analysisthat included15 placebo-controlled trialsof risperidone, olanzapine, quetiapine, and aripiprazole. Riskof death was increased relative to placebo (odds ratio = 1.54(95% CI 1.06-2.23)) for patients with dementia randomizedto one of the four antipsychotics. The authors concluded thata small, but statistically significant increase in risk of death isassociated with use of atypical antipsychotics in dementia; however,there is insufficient evidence to determine differential riskbetween antipsychotics.Conventional antipsychotics may also increase the risk ofdeath in older adults. AHRQ’s Developing Evidence to InformDecisions (DEcIDE) program analyzed health care utilizationdata for British Columbia adults > 65 years to studythe association between use of conventional and atypicalantipsychotics and death. Those who were prescribed conventionalantipsychotics had a 35% greater mortality risk fromfatal outpatient cardiac events, pneumonia, and stroke comparedto patients who were prescribed atypical antipsychotics. 11PARSING POTENTIAL BENEFITS VERSUS RISKSSubgroup analyses across atypical antipsychotic trials indicatethat larger effect sizes are associated with greater cognitiveimpairment, residence in nursing home, and the presenceof severe agitation without psychosis. These results concur witholder studies of conventional antipsychotics in hospitalized patientswith dementia which reported that more robust treatmenteffects were associated with greater severity of agitationand aggression at baseline. 8The evidence base,although incomplete,suggests thatmodest treatmenteffect sizes areoffset by risk ofconsiderable adverseeffects.A post hoc analysis of pooled data from 6 trials comparingolanzapine to placebo, risperidone, or haloperidol is the onlypublication that has attempted to identify the patient-specificrisk factors associated with mortality and CVAEs in dementiaclinical trials. 5 Kryzhanovskaya et al reported that advancedage (age=80), treatment emergent sedation, benzodiazepineuse, and treatment-emergent pulmonary conditions were additionalrisk factors for mortality in olanzapine-treated patients.The group’s analysis of the CVAE data revealed that forpatients receiving either olanzapine or placebo, age > 80 yearsand diagnosis of mixed or vascular dementia were significantlyassociated with CVAE. Orthostatic hypotension and genderwere not significant risk factors.SUMMARYAtypical antipsychotics will continue to be prescribed forthe behavioral symptoms of dementia in the absence of moreeffective, better tolerated, and safer alternatives.The evidence base, although incomplete,suggests that modest treatmenteffect sizes are offset by risk of considerableadverse effects. How might this informationbe best applied to clinical practice?Non-pharmacologic strategies shouldbe implemented in routine clinical practice.Placebo-controlled clinical trials ofindividual antipsychotic agents have historicallyreported high placebo responserates; CATIE-AD reported that the sumtotal of the risk/benefit equation of atypicalantipsychotic therapy was no greaterthan that achieved by placebo.CATIE-AD was designed to study the effectiveness of atypicalantipsychotic treatment in community dwelling patients withAD. It is uncertain whether the results can be generalized to thepopulations of dementia patients residing in nursing homes withmore severe cognitive and behavioral impairment. There is somesuggestion that nursing home patients with dementia complicatedby severe behavioral symptoms, particularly agitation andaggression without accompanying psychosis, might achievegreater benefit from atypical antipsychotic treatment than patientswith milder behavioral symptoms. The finding that dementiapatients without psychosis may respond more robustly toantipsychotic treatment seems counterintuitive, but may supportthe hypothesis that the neurobiology of the “psychosis of AD”differs from the psychosis of schizophrenia or bipolar disease. 3, 8Adverse effects associated with antipsychotic therapyshould be aggressively monitored throughout therapy. Treatment-emergentsedation was associated with all of the atypicalantipsychotics in CATIE-AD and is probably an importantmediator of mortality risk in patients with dementia. Sedationexacerbates pre-existing cognitive impairment and increases therisk of complications such as aspiration pneumonia, so concomitantuse of benzodiazepines should be discouraged or limitedto short periods with careful observation. 5Once initiated, the effectiveness and tolerability of antipsychotictherapy should be evaluated routinely. In Alzheimer’sdisease, the severity and frequency of behavioral symptoms of-VOLUME 90 NO. 6 JUNE 2007193

ten decreases as illness progresses. In a stable patient, it is prudentto attempt to taper and discontinue the antipsychotic after2-8 months of therapy. 12Better understanding of the potential adverse effects ofantipsychotic therapy has increased interest in the effects ofthe dementia-specific medications on behavioral symptoms.Reductions in neuropsychiatric symptoms have been reportedfrom trials of individual cholinesterase inhibitors, memantinemonotherapy, and memantine combined with donepezil in ADpatients. 13, 14 Studies of small numbers of patients in open trialsof cholinesterase inhibitors (donepezil, rivastigmine,galantamine) and one double-blind placebo controlled trial(rivastigmine) have reported varying degrees of improvementof behavioral symptoms and psychosis of dementia with Lewybodies (DLB). 15 Delusions, hallucinations, apathy, and agitation/aggressionare cited as the symptom categories most likelyto show significant improvement. 13 Since few of these studieswere prospectively designed to study behavioral symptoms, resultsmust be interpreted cautiously.Treatment of behavioral symptoms in AD and otherdementias is challenging. The limitations of current approachesdrive the search for effective, well tolerated therapies.REFERENCES1. Franco KN, Messinger-Rapport B. Pharmacological treatment of neuropsychiatricsymptoms of dementia. J Am Med Dir Assoc 2006;7:201-2.2. Cohen-Mansfield J, Marx MS, Rosenthal AS. A description of agitation in anursing home. J Gerontol 1989;44:M77-84.3. Meeks TW, Ropacki SA, Jeste DV. The neurobiology of neuropsychiatric syndromesin dementia. Curr Opin Psychiatry 2006;19:581-6.4. Schneider LS, Dagerman KS, Insel P. Risk of death with atypical antipsychoticdrug treatment for dementia. JAMA 2005;294:1934-43.5. Kryzhanovskaya LA, Jeste DV, et al. A review of treatment-emergent adverseevents during olanzapine clinical trials in elderly patients with dementia. J ClinPsychiatry 2006;67:933-45.6. Sink KM, Holden KF, Yaffe K. Pharmacological treatment of neuropsychiatricsymptoms of dementia. JAMA 2005;293:596-608.7. Schneider LS, Tariot PN, et al. Effectiveness of atypical antipsychotic drugs inpatients with Alzheimer’s disease. NEJM 2006;355:1525-38.8. Schneider LS, Dagerman K, Insel PS. Efficacy and adverse effects of atypicalantipsychotics for dementia. Am J Geriatr Psychiatry 2006;14:191-210.9. Newcomer JW, Nasrallah HA, Loebel AD. The Atypical Antipsychotic Therapy andMetabolic Issues National Survey. J Clin Psychopharmacol 2004;24(5 Suppl 1):S1-6.10. Fillit H, Ding WH, et al. Elevated circulating tumor necrosis factor levels inAlzheimer’s disease. Neurosci Lett 1991;129:318-20.11. Shekelle P MM, Bagley S, et al. Comparative effectiveness of off-label use ofatypical antipsychotics. Comparative Effectiveness Review No. 6.: Agency forHealthcare Research and Quality. Rockville, MD; 2007.12. Alexopoulos GS, Katz IR, et al. The expert consensus guideline series. Pharmacotherapyof depressive disorders in older patients. Postgrad Med 2001;SpecNo Pharmacotherapy:1-86.13. Cummings JL, Schneider E, et al. Behavioral effects of memantine in Alzheimerdisease patients receiving donepezil treatment. Neurol 2006;67:57-63.14. Birks J. Cholinesterase inhibitors for Alzheimer’s disease. Cochrane DatabaseSyst Rev 2006:CD005593.15. Bhasin M, Rowan E, et al. Cholinesterase inhibitors in dementia with Lewybodies-a comparative analysis. Int J Geriatr Psychiatry 2007.Lori A. Daiello, PharmD, BCPP, is a Postdoctoral DementiaResearch Fellow, at The Warren Alpert Medical School ofBrown University, and at The Alzheimer’s Disease and MemoryDisorders Center, Rhode Island Hospital.CORRESPONDENCELori A. Daiello, PharmD, BCPPAPC 670Rhode Island Hospital593 Eddy St.Providence, RI 02903Phone: (401) 444-3337e-mail: ldaiello@lifespan.org194MEDICINE & HEALTH/RHODE ISLAND

THE WARREN ALPERT MEDICAL SCHOOLOF BROWN UNIVERSITYDivision of GeriatricsDepartment of MedicineGERIATRICS FOR THEPRACTICING PHYSICIANThe Management of Insomnia in the Older AdultAna C. Tuya, MDQuality Partners of RIEDITED BY ANA C. TUYA, MDAn 88 year-old man contacts the on-call physician on aSaturday afternoon with a chief complaint of being unable to fallasleep for three nights; he requests a new prescription to help himsleep. He has been on trazodone 75 mg for several years and takes itnightly, but it has not been effective for sometime. He has a medicalhistory of hypertension and hyperlipidemia, for which he takesmetroprolol, aspirin, atorvastatin, and a daily multivitamin. He is active,walks 2-miles daily, drives and is independent in ADL and IADL.He does not smoke or drink alcohol. What should the on-call physiciando—increase the trazodone? Start a new sleep medication? Askthe patient to wait until Monday when he can talk to his physician?Insomnia is exceedingly common in the older adult population;up to 33% use over the counter or prescription sleepaids, and close to 40% describe difficulty falling asleep. 1 Contributingfactors include changes in sleep architecture and circadianrhythm, increased incidence of sleep disorders, and lifestressors unique to the older adult. As with so many other decisionsin geriatrics care, the treatment must consider patients’multiple co-morbid diagnoses and long medication lists.The first step in evaluating a patient with insomnia is to take adetailed sleep history—duration of symptoms, nap history, life situationat start of symptoms, wake up times, bedtime, caffeine/alcohol/fluidintake, activities done in bed before and after trouble sleeping,sleep room characteristics, medication use, and detailed reviewof systems and family history. Also useful is a review of the sleephygiene “do’s and don’ts”. 2,3 Important medical diagnoses to ruleout by history and/or workup include sleep disorders (sleep apnea,restless leg syndrome, REM sleep behavior disorder) that are morecommon with aging. This evaluation may point toward focusedinterventions to improve sleep hygiene, or the need for diagnosticworkup to treat a sleep disorder. If neither of these results obtains,the next step is to decide whether to treat. If treatment is indicated,the choice is non-pharmacological versus pharmacological.Studies showing that non-pharmacological treatment is effectiveand long lasting abound. Interventions that have been proveneffective include stimulus control, bright light therapy, regular exercise,bathing before bed, cognitive therapy, sleep hygiene improvement,warm milk, back rub, and relaxation techniques. One particularlyinteresting study evaluated patients with Alzheimer’s dementiaand insomnia. In this randomized trial, one group of patientsand caregivers received extensive training and support on sleephygiene interventions, while the other group received one informationsession only, at the start of the study. After six months, theintervention group showed a significant trend toward increased satisfaction,with 50% reporting substantial benefit. The benefit continuedthroughout the follow up period. 4 The benefit was not onlyin satisfaction and self-reported benefit, but also in caregiver reportsof time awake and number of nighttime awakenings.When non-pharmacologic therapy fails, or when urgent interventionis required to temporarily alleviate sleeplessness while nonpharmacologictherapy is being instituted, medications are oftenprescribed. There are several drug classes from which to choose;adverse reactions, efficacy, safety and interactions vary significantly.These sedative hypnotic medications are for short-term use. Moststudies follow patients for only a few months – long-term use by anygroup has not been evaluated in detail. One meta-analysis demonstratedthat effectiveness of the benzodiazepines waned after twoweeks. 5 Older, but still often used, these drugs are plagued by adversereactions in the older adult population; for example, next-daysomnolence, dependence, dizziness, drug interactions, and increasedrisk of falls. This group is one of the drug classes listed among theBeer’s criteria of drugs to avoid using in the elderly due to unacceptablyhigh adverse effects. 6 For patients who have been on them foryears, it is recommended to wean them gradually.Another popular choice among sedative hypnotics for sleephas been trazodone. Its use has exceeded that of zolpidem (Ambien),which is estimated at over 27 million prescriptions. 7 It is reputedto be safe, effective, non-habit forming and more cost-effective.Of note, the use of trazodone (and mirtazepine, mentioned later)is off-label. A systematic review published in 2005 8 found 18studies in the literature for the period of 1980-2003 and includedall 18, regardless of inclusion or exclusion criteria, because of thesmall number. Of the studies included, only one was a randomizedplacebo control trial on the use of trazodone in patients withprimary insomnia. The majority of the remaining studies evaluatedits use in depression, and revealed improvement of insomniaas a secondary outcome.The primary insomnia study examined 306 patients ages to 65who were randomized to zolpidem 10 mg, trazodone 50 mg, orplacebo. The effect of the drug was measured using a subjectivesleep questionnaire; follow up was for two weeks. At week one,there was improvement in both the zolpidem and trazodone group,compared with placebo. By week two, zolpidem was better thanplacebo, but trazodone improvement was not statistically significantcompared with placebo. 8 In this study, follow up was short; and nopatients over age 65 were included. The remaining studies evaluatedin this systematic review had small sample sizes, used muchhigher doses of trazodone (>150 mg) and were in depressed patients.These results may not apply when trazodone is prescribed forprimary insomnia, especially in view of the much lower doses used.Safety analysis revealed several important side effects in significantproportions of subjects: drowsiness in 29%, dizziness in 21% andnext day fatigue in >10%. Less common but still disturbing adversereactions included orthostatic hypotension, priapism and QT intervalprolongation. The question of tolerance, and whether increasingthe dose would restore the initial effect, was not addressed by this orVOLUME 90 NO. 6 JUNE 2007195

196any study reviewed. Therefore, the evidence does not support thebenign profile that providers and the public have accepted.Another commonly used medication is mirtazapine, an antidepressantfound to have significant sedation effect when used in depressedpatients. It is similar to trazodone, and is used for insomniato capitalize on its side effect profile. It has also become a popularchoice among those who care for dementia patients who suffer fromboth insomnia and anorexia – increased appetite was another sideeffect noted when the drug was used in depressed patients. Ofnote, the side effects of increased appetite and sedation are typicallyseen with the lowest doses (7.5 mg or 15 mg). Case reports havedemonstrated clinical improvement in both insomnia and anorexiawhen the medication is used in Alzheimer’s patients. 9 However, morerigorous studies of mirtazapine’s tolerance and safety profile in elderlypatients are limited. A small study, examining its efficacy, notedthat 11% of patients discontinued use due to adverse events, 18%of which were falls. 10 Caution should be used when prescribing thisagent for insomnia in older adults.The newer drugs that capture the most media attention,and that patients request by name, are the “Z drugs,” whichinclude zaleplon (Sonata), zolpidem, and eszopiclone (Lunesta).One randomized trial compared zaleplon at 5 mg and 10 mgdoses to zolpidem 10mg and to placebo in 549 patients, all overthe age of 65. 11 The results demonstrate better sleep quality inboth groups as compared to placebo. Adverse events were similarin the four groups, with no increased adverse effects as comparedto placebo. However, the follow up time was only twoweeks. Another group of authors reviewed the literature to comparethe effectiveness of the Z drugs to placebo, and included24 trials. 12 Their final conclusions reflected disappointment: moststudies had small sample size, poor methodologic quality, and inmost, pharmaceutical funding. They recommended further studiesin the elderly, with more rigorous methodologic adherencebefore drawing clinical conclusions. 12Finally, ramelteon (Rozerem) warrants discussion. In the limitedbut promising existing studies, this melatonin receptor agonistwas found to produce improvements in all sleep components(latency, efficiency, and duration). 13 The agent has been found tobe effective and safe, with no concerns of dependence or next daysomnolence. It is best used for patients who have difficulty initiatingsleep. However, as a newer agent, more time and study inpost-marketing surveillance must be awaited before recommendationscan be made in vulnerable very old persons. Yet, amongthe options, this one t seems preferable for use in the older adultpopulation, and some studies have demonstrated that elderly patientscan use it safely without increased risk of falls or drowsinessthe following day. 14 Only time and clinical use will tell how trulysafe and effective it is. This agent has recently been added to theformulary at the Lifespan hospitals.In summary, the evidence supports the use of non-pharmacologictreatments as first line due to their proven efficacy,and for the long-term effects. Pharmacologic therapy has animportant role, but only for the short-term, and carries with itsignificant risk of adverse reactions. The newer agent ramelteonis promising, but will require further study and use in practice.Trazodone did not prove to be as safe and harmless as initiallythought, and its efficacy is also in question. The newer Z drugsalso proved efficacious, but had limited data in the older adultMEDICINE & HEALTH/RHODE ISLANDpopulation, are expensive, and are scheduled drugs, makinguse in long-term care settings more troublesome.For the patient presented at the beginning of this article, thefirst assessment the clinician must make is whether the situation isa sleep emergency or not. If the patient can wait, it would bebetter for him to discuss the problem and options with his primaryphysician, who knows him and his history best. This patienthas had three days of symptoms, but is retired and able to napduring the day; he should continue his current regimen untilMonday, when he can call his primary care doctor. Options atthat point include a more detailed review of sleep hygiene andrecommendations to discontinue drinking coffee after breakfast,to decrease caffeine intake and substitute a glass of warm milk orherbal tea after dinner. He should avoid napping during the dayand evaluate the quality of his bedroom for sleep promotion. Thetrazodone dose can remain the same, since there is no evidencebase for increasing the dose to regain initial effect, and strong considerationshould be given to discontinuing it altogether due tothe poor evidence base for its use in primary insomniaREFERENCES1. Alessi, C. Sleep Problems. In: Pompei P, Christmas C, Counsell SR, et al, eds, GeriatricsReview Syllabus, 6 th Edition, NY: American Geriatric Society, 2006: 249-57.2. Stanford University patient education webpage “How to Sleep Well” Link:http://www.stanford.edu/~dement/howto.html3. WebMD patient education webpage “How to Sleep Better” Link: http://www.webmd.com/sleep-disorders/guide/sleep-hygiene4. McCurry SM, Gibbons LE, et al. Nighttime insomnia treatment and educationfor Alzheimer’s disease. J Am Geri Soc 2005; 53: 793-802.5. Holbrook A, Crowther R, et al. The role of benzodiazepines in the yreatmentof Insomnia. J Am Geri Soc 2001; 49: 824-6.6. Fick DM, Cooper JW, et al. Updating the Beers criteria for potentially inappropriatemedication use in older adults. Arch Intern Med 2003;163:2716-24.7. IMS intelligence applied pharmaceutical marketing website. Link: http://www.imshealth.com8. Mendelson WB. A review of the evidence for the efficacy and safety oftrazodone in insomnia. J Clin Psychiatry 2005; 66: 469-76.9. Raji MA, Brady SR. Mirtazapine for treatment of depression and comorbiditiesin Alzheimer’s Disease. Ann Pharmacother 2001; 35:1024-7.10. Roose SP, Nelson JC, et al. Open-label study of mirtazapine orally disintegrating tabletsin depressed patients in the nursing home. Curr Med Res Opin 2003; 19: 737-46.11. Ancoli-Israel S, Walsh JK, et al. Zaleplon a novel nonbenzodiazepine hypnoticeffectively treats insomnia in elderly patients without causing reboundeffects. Primar Care Comp J Clin Psyc 1999; 1: 114-12.12, Dundar Y, Dodd S, , et al. Comparative efficacy of newer hypnotic drugs for theshort-term management of insomnia. Hum Psychopharmacol 2004; 19: 305-22.13. Brzezinski A, Vangel MG, et al. Effects of exogenous melatonin on sleep.Sleep Med Rev 2005 ; 9: 41-5.14. CenterWatch clinical trials listing service website. Link: http://www.centerwatch.com/patient/drugs/dru882.htmlAna C. Tuya, MD, is Assistant Professor of Geriatrics, Rhode IslandHospital, The Warren Alpert Medical School of Brown University.8SOW-RI-GERIATRICS -062007THE ANALYSES UPON WHICH THIS PUBLICATION IS BASED wereperformed under Contract Number 500-02-RI02, funded bythe Centers for Medicare & Medicaid Services, an agency ofthe U.S. Department of Health and Human Services. The contentof this publication does not necessarily reflect the viewsor policies of the Department of Health and Human Services,nor does mention of trade names, commercial products, ororganizations imply endorsement by the U.S. Government.The author assumes full responsibility for the accuracy andcompleteness of the ideas presented.

Images In MedicineOcular MelanomaIkue Shimizu, MD, Richard Gold, MD, and Edward Feller, MDFigure 1a. Figure 1b. Figure 1c.A 71 year-old man presented with severe nausea and vomitingfor several days. He had no visual complaints. Physicalexam was normal except for an enlarged, tender liver. AbdominalCT scan revealed a 12cm mass in the right liverlobe, shown to be melanoma by biospy. Skin exam did notreveal a primary cutaneous lesion. An ophthalmologic consultto evaluate for ocular melanoma demonstrated a lesionin the left choroid. Magnetic resonance imaging of the orbitshowed two choroidal masses in the left eye consistentwith melanoma: slightly hyperintense on the T1-weightedimage (Figure 1a), hypointense on the T2-weighted image(Figure 1b), and enhancement on the T1 post-gadoliniumimage with fat saturation (Figure 1c). The patient receivedright hepatic artery chemoembolization, and was dischargedon anti-emetics.The eye and orbit are the most common non-skin sites ofprimary or metastatic melanoma. 1 The most frequent locationis uveal, the majority are choroidal. Presentation of ocular melanomais diverse, including visual disturbance, ocular mass, cranialnerve palsy, orbital myopathy, or uveitis or vitritis. Severepain is uncommon. Some are detected by routine exam or discoveredduring evaluation of known extra-ocular melanoma.Uveal melanomas tend to spread hematogenously, most oftento the liver; as many as 60% of these melanomas have livermetastases at presentation. Diagnosis of uveal melanoma is usuallyestablished by an indirect fundoscopic exam. Fluorosceinangiography and ultrasound studies are also used to diagnoseuveal melanoma. 2 Magnetic resonance imaging can be helpfulin uveal melanoma staging and the evaluation of prognosticfactors such as tumor pigmentation, size, shape, location, retinaldetachment, extrascleral extension. 3REFERENCES1. Grin JM, et al. Ocular melanomas and melanocytic lesions of the eye. J AmAcad Dermatol 1998; 38:716-30.2. Char DH. Ocular melanoma. Surg Clin N Am 2003; 83:253-74.3. Lemke AJ, et al. Uveal melanoma. Radiol 1999;210:775-83.Ikue Shimizu, MD, is a 2007 graduate of The Warren AlpertMedical School of Brown University.Richard Gold, MD, is Clinical Associate Professor of DiagnosticImaging at The Warren Alpert Medical School of BrownUniversity.Edward Feller, MD, is a Clinical Professor of Medicine atThe Warren Alpert Medical School of Brown University.CORRESPONDENCEEdward Feller, MDe-mail: Edward_Feller@brown.eduVOLUME 90 NO. 6 JUNE 2007197

The binomial words defining the variousgenera and species of bacteria pathogenicto humans derive from two principalsources: first, as eponyms of the scientistswho laid claim to their initial identification;and second to a series of Greek rootsserving to describe some morphologicalfeature of the microbes.The numerous eponyms includeBrucella, Ehrlichia, Escherichia, Klebsiella,Listeria, Neisseria, Nocardia, Pasteurella,Salmonella, Shigella, andYersinia. Curiously, the discoverer of thetubercle bacillus and cholera vibrio, RobertKoch, has no genus bearing his name.The word, bacterium, derives froma Greek word meaning little staff or rodand gave rise to the Latin bacculum meaninggrape-like [but is only remotely relatedto the word, bacciferous, meaningbearing grapes which is directly relatedPhysician’s LexiconThe Vocabulary of Pathogenic Bacteriato Bacchus, the Greek god of grapes.]Coccus is yet another Greek wordmeaning berry-like. A number of Greekprefixes define it further: gono- meaningsexual or reproductive [as in the word,gonad], crypto- meaning hidden [as incryptogram], diplo- meaning double [asin diplopia or diplomat; it should be hastilystressed that diplomat does not meandouble-dealing but rather one who carriesa sanctioned diploma, which is afolded, or doubled, document], staphylomeaningclustering or grape-like, streptomeaningpliant or chain-like, andmeningo-, meaning membranous.Diphtheria was coined from a Greekroot meaning leather-like referring to thecharacteristic pharyngeal pseudo-membrane.Corynobacterium stems from aGreek root meaning club-like.Clostridium uses a Greek root meaningspinning or thread-like; the Greek Fate,Clotho , is a spinner of fabric. Botulismstems from a Latin word meaning sausage[from whence the bacteria were firstisolated.]Proteus is the name of the Greek seagodwho had the skill of easily changingform. Vibrio comes from a Latin wordmeaning to vibrate. Anthrax is from aGreek word meaning coal [as in anthracosisor anthracite]; and Chlamydia isderived from the Greek word for cloakor upper garment.– STANLEY M. ARONSON, MDRHODE ISLAND DEPARTMENT OF HEALTHDAVID GIFFORD, MD, MPHDIRECTOR OF HEALTHVITAL STATISTICSEDITED BY COLLEEN FONTANA, STATE REGISTRARRhode Island MonthlyVital Statistics ReportProvisional OccurrenceData from theDivision of Vital RecordsUnderlyingCause of DeathDiseases of the HeartMalignant NeoplasmsCerebrovascular DiseasesInjuries (Accidents/Suicide/Homicde)COPDJune2006Number (a)201176233428Reporting Period12 Months Ending with June 2006Number (a) Rates (b) YPLL (c)2,712 253.5 3,828.52,270 212.2 6,239.0436 40.8 615.0427 39.9 6,512.5476 44.5 367.5Vital EventsLive BirthsDeathsInfant DeathsNeonatal DeathsMarriagesDivorcesInduced TerminationsSpontaneous Fetal DeathsUnder 20 weeks gestation20+ weeks gestationDecember2006Reporting Period12 Months Ending withDecember 2006Number Number Rates948 12,831 12.0*894 9,885 9.2*(16) (89) 6.9#(4) (64) 5.0#443 6,974 6.5*229 3,169 3.0*491 4,788 373.2#120 802 62.5#(109) (743) 57.9#(11) (59) 4.6#(a) Cause of death statistics were derived fromthe underlying cause of death reported byphysicians on death certificates.(b) Rates per 100,000 estimated population of1,069,725(c) Years of Potential Life Lost (YPLL)Note: Totals represent vital events which occurred in RhodeIsland for the reporting periods listed above. Monthly provisionaltotals should be analyzed with caution because thenumbers may be small and subject to seasonal variation.* Rates per 1,000 estimated population# Rates per 1,000 live births198MEDICINE & HEALTH/RHODE ISLAND

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The Official Organ of the Rhode Island Medical SocietyIssued Monthly under the direction of the Publications CommitteeVOLUME 1 PER YEAR $2.00NUMBER 1 PROVIDENCE, R.I., JANUARY, 1917 SINGLE COPY, 25 CENTSNINETY YEARS AGO, JUNE 1917In “The Liver,” Charles F. Peckham, MD, discussed specifics,including liver cells, bile, enzymes, parasitic microorganisms,and dead protein.H.P. Lovewell, MD, in “A Study of Cardiorenal Types,”presented a review of 250 cases from a course in “Medicineand Pathology” at the Massachusetts General Hospital, using aclassification of Dr. R. Cabot, from a paper read before theAmerican Medical Association in 1914.[Dr. Cabot had foundthat 93% of “failing hearts” fell into 4 groups: rheumatic, arteriosclerotic,nephritic, syphilitic.] Of the 250 cases reviewed,Dr. Lovewell would put 70 under one of the 4 types.An Editorial urged “More Men for the Medical ReserveCorps.” “It is evident that the local profession is not sufficientlyimpressed with the fact that we are engaged in a real war.” TheEditorial warned that an army of 2 million soldiers would need20,000 physicians. “It should be a patriotic duty for us to [volunteer].”A Second Editorial, “Scientific Feeding of the People inWaiting,” cautioned readers that because of the war, Americanswere receiving less food from Europe (less acreage devotedto crops, poor crops, submarines). Consequently, physiciansneeded to counsel patients on how to achieve better nutritionwith less food. Physicians should “…offer gratuitousadvice on the proper feeding of the family in every home wevisit.”TWENTY-FIVE YEARS AGO, JUNE 1982Joseph R. Salvatore, MD, and LR Jenkyn, MD, in “Progressin Neurology,” contributed “Prophylactic Cranial Irradiationin Small Cell Carcinoma of the Lung,” which they called “acontroversial treatment.”Irving A. Beck, MD, in “The Providential Visits of Dr.Osler: The Great Master Keeps Alive Rhode Island Connections,”drew from the papers of Dr. Frank T. Fulton, includinghis correspondence with Dr. Osler.Frank M. D’Allessandro, MD, in “Diabetes Mellitus –Practical Aspects,” discussed the “serial determination of plasmainsulin levels” as a way to delineate the type of diabetes.Michael G. Pierik, MD, in “Fatal Staphylococcal SepticemiaFollowing Acupuncture: Report of 2 Cases [from St. Joseph’sHospital]” emphasized the “need for thorough medical evaluationbefore such procedures.”FIFTY YEARS AGO, JUNE 1957Herbert Fanger, MD, YS Song, MD, and Thomas H.Murphy, MD, contributed “Uterine Cancer: A Report of theFirst 2000 Cases of the State Cytology Program for UterineCancer.” The report drew from 2000 patients, submitted by210 physicians. In the first 3 months of testing, 40 tested inthe “positive and suspicious group;” 152, in the “atypical group.”Most (83.6%) tested negative.Charles L. Farrell, MD, president, Rhode Island MedicalSociety, in “Retrospect and Prospect – 1957,” in describingMedicare, warned: “National Socialism is being fed to youpiecemeal.”Francis P. Catanzaro, MD, and Anthony Merlino, MD,in “Adenomatous Polyps of the Gastrointestinal Tract,” summarizeddata from 49 patients, seen at St. Joseph’s from 1946-1957.200MEDICINE & HEALTH/RHODE ISLAND

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