Granisetron Transdermal System
Page 2 Volume 17; Issue 2 A Summary of the 2017 GOLD Guidelines Update (continued from page 1) Addition of hospital discharge and follow-up criteria, including use of integrated care team The 2011-2015 versions of the GOLD guidelines provided criteria for discharge (e.g. ability to use inhaler properly, ability to walk across room without getting winded, etc.) and recommended follow-up within four to six weeks (e.g. reassessment of inhaler technique, status of comorbidities, etc.). 3 The updated guidelines shorten the recommended follow-up period to 4 weeks, citing a reduced rate of readmission in patients seen within the shorter timeframe. 1,5 The guidelines also recommend additional follow-up three months post-discharge to ensure the patient has returned to stable clinical state. 1 While the guidelines do not mention the value of a pharmacist specifically, they do encourage the use of coordinated, integrated care for patients in all settings. Observational studies in patients with COPD have identified a relationship between poor inhaler use and symptom control. 6 The updated GOLD guidelines stress the importance of education and training in inhaler device technique, and assessment of dosing frequency and technique at each follow-up visit. 1 References 1. Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2017. Available from http://goldcopd.org. Accessed December 2016. 2. Soriano JB, Lamprecht B, Ramirez AS, et al. Mortality prediction in chronic obstructive pulmonary disease comparing the GOLD 2007 and 2011 staging systems: a pooled analysis of individual patient data. The Lancet Respiratory Medicine 2015; 3: 443-50. 3. Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2016. Available from http://goldcopd.org. Accessed December 2016. 4. Wedzich JA, Banerji D, Chapman KR, et al. Indacaterolglycopyrronium versus salmeterol-fluticasone for COPD. N Engl J Med 2016; 374:222-34. 5. Gavish R, Levy A, Dekel OK, et al The Association between hospital readmission and pulmonologist follow-up visits in patients with COPD. CHEST 2015; 148:375-81. 6. Melani AS, Bonavia M, Cilenti V, et al. Inhaler mishandling remains common in real life and is associated with reduced disease control. Respir Med 2011; 105:930-8.
Page 3 Volume 17; Issue 2 Angiotensin-Converting Enzyme Inhibitor and Angiotensin Receptor Blocker: Cost Saving Projections via Therapeutic Interchange Meera Vachhani, PharmD, PGY1 Pharmacotherapy Resident The angiotensin-converting enzyme inhibitors (ACEI) and angiotensin receptor blockers (ARB) drug class review completed for the Johns Hopkins Health System reviewed efficacy, cost, and safety among these medications. Based on this information, the drugs’ formulary status and therapeutic interchange protocols were developed for the JHHS. The formulary agents selected within the ACEI and ARB drug classes are captopril, enalapril, enalaprilat, and lisinopril, and irbesartan, losartan, and valsartan, respectively. Therapeutic interchange protocols were developed to interchange nonformulary ACEIs to lisinopril, and nonformulary ARBs to losartan. The implementation of the therapeutic interchanges outlined above are projected to result in approximately $25,000 in cost savings annually. These projections are calculated based on 12-month volume history from McKesson. Of note, a new combination therapy, valsartan and sacubitril (Entresto®), was also added to the JHHS formulary with restriction to continuation of a home medication. New initiations are restricted to patients on a cardiology service or those with a cardiology consult. The ACEI/ARB therapeutic interchange protocols are currently being built within Epic. Communication to the department will be disseminated prior to the build changes going live in Epic. The therapeutic interchange details are outlined in Lexicomp. References: 1. Furberg CD and Pitt B. Are all angiotensin-converting enzyme inhibitors interchangeable? J Am Coll Cardiol 2001; 37: 1456-60. 2. Heran BS et al. Blood pressure lowering efficacy of angiotensin receptor blockers for primary hypertension. Cochrane Database of S y s t e m a t i c R e v i e w s 2 0 0 8 ; 4 : C D 0 0 3 8 2 2 . D O I : 10.1002/14651858.CD003822.pub2. 3. Matchar DB et al. Systematic review: comparative effectiveness of angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers for treating essential hypertension. Ann Intern Med 2008; 148: 16-29. Granisetron Transdermal System for the Prevention of Chemotherapy-Induced Nausea and Vomiting Olivia Akah, Notre Dame of Maryland University, PharmD Candidate 2019 Lauren McBride, PharmD, BCOP, Clinical Pharmacy Specialist, Oncology Chemotherapy has helped millions of people in the fight against cancer by destroying cancerous cells. Unfortunately, healthy noncancerous cells are also destroyed in the process, leading to various unpleasant side effects. Chemotherapy-induced nausea and vomiting (CINV) is potentially the most severe and distressing adverse effect experienced by patients undergoing chemotherapy. To prevent CINV associated with chemotherapy regimens with a high emetic risk (i.e., incidence of emesis exceeds 90% if no antiemetics are administered), the American Society of Clinical Oncology (ASCO) currently recommends a 3-drug antiemetic regimen consisting of a NK-1 receptor antagonist (e.g., aprepitant, fosaprepitant) a type 3 serotonin (5-HT3) receptor antagonist (e.g., granisetron, ondansetron, palonosetron), and dexamethasone. 1,2 Granisetron is a first generation selective inhibitor of type 3 serotonergic (5-HT3) receptors with little or no affinity for other serotonin receptors. It is an antiemetic indicated for the prevention of nausea and vomiting in patients receiving moderately and/or highly emetogenic chemotherapy regimens of up to 5 consecutive days of duration. The drug is structurally and pharmacologically related to ondansetron. The antiemetic activity of granisetron appears to be mediated both centrally and peripherally via inhibition of 5- HT3. 2 Serotonin receptors of the 5-HT3 type are located peripherally on vagal nerve terminals and centrally in the chemoreceptor trigger zone of the area postrema. During chemotherapy, mucosal enterochromaffin cells release serotonin, which stimulates 5-HT3 receptors. This evokes vagal afferent discharge, inducing vomiting. 3 In select patients who are unable to swallow or digest tablets because of emesis, transdermal antiemetics such as granisetron transdermal system may be of value. In September 2008, the FDA approved the use of granisetron transdermal system (GTS) for CINV. The patch containing 3.1 mg of granisetron/24 hours is applied approximately 24 to 48 hours before the first dose of chemotherapy; maximum duration of the patch is 7 days. 3,4 The efficacy and tolerability of transdermal granisetron for the control of CINV associated with moderately and highly emetogenic multi-day chemotherapy was assessed in a phase III clinical trial. The trial (n=641) was a randomized, non-inferiority, active control, double-blind, double-dummy, parallel group, multinational study that compared GTS to oral granisetron. Patients were randomized to oral (2 mg/day, 3-5 days) or transdermal granisetron (one GTS patch, 7 days), before receiving multi-day chemotherapy. The primary endpoint was complete control of CINV (i.e. no vomiting/retching, no more than mild nausea, no rescue medication) from chemotherapy initiation until 24 h after final administration. The pre-specified non-inferiority margin was 15%. Results showed that GTS displayed non-inferiority to oral granisetron; complete control was achieved by 60% of patients in the GTS group and 65% in the oral granisetron group (treatment difference, −5%; 95% confidence interval, −13% to +3%). Both treatments were well tolerated. 5 The most common adverse effect of GTS is constipation. Skin reactions such as rash, redness, and itching may occur at the site of application. GTS is contraindicated in patients with known hypersensitivity to granisetron or to any of the components of the patch. The use of granisetron may mask a progressive ileus and/or gastric distention caused by the underlying condition. Development of serotonin syndrome has been reported with 5-HT3 receptor antagonists. Most reports have been associated with concomitant use of serotonergic drugs such as selective serotonin reuptake inhibitors (SSRI’s), mirtazapine, lithium, tramadol, (continued on page 4)