Compounding Matters Quarterly - Spring 2015

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and possibly through this language acknowledged that office-use sales or distribution is what is actually to be addressed. These three points of law will no doubt form the basis of any legal challenge to the MOU and where the line is between federal authority over mail-order prescription services. THE 2015 DRAFT MEMORANDUM OF UNDERSTANDING The FDA distributed a draft MOU on February 13, 2015 and then subsequently filed that document with the Federal Register on February 18, 2015. The public – including all health care stakeholders, regulatory agencies, consumers – are invited to review and submit comments on the draft no later than June 18, 2015 through the regulations.gov website. As proposed, the MOU goes far further than the language enacted by Congress, imposing substantial actions by state regulatory agencies that agree to sign the MOU. It’s important to understand that until those comments are reviewed and considered by the FDA, the MOU still does not officially exist. A revised draft may be offered for additional comment. A revised draft may go directly to the states for signing. The original draft, without any changes to content regardless of the comments submitted, may be presented to the states for signing. What’s contained in the draft? There is no scientific basis for the determination of what that means, especially given the varied nature of pharmacy practice and the geographies of states which are contiguous to multiple states where it’s not uncommon for patients to use an out-of-state pharmacy to meet their medical needs (e.g., New England, the Mid-Atlantic regions). Without specific definition by Congress, this is up to substantial interpretation or guesswork by a regulatory agency, , the FDA, or by the state agency that is entering into the MOU. It is entirely possible that “inordinate” may have two distinctly different meanings to each of those entities. • The law uses the terms “dispense” and “distribute.” These terms are not synonymous and are specifically used in different ways by Congress, further indicating that they are not interchangeable. Dispensing is a formal act by a pharmacist or other practitioner authorized to fulfill a valid prescription for a patient or, in some states, an office-use medication as defined both at the state level and within other sections of the FDCA. Distribution, meaning a sales transaction, is also similarly defined within the FDCA. As written in 503A, the MOU is intended to address the latter. No mention is made of the former proper and legal dispensing of medications. It does not appear that Congress intended to in any manner limit legal and appropriate interstate dispensing of valid patientspecific compounded preparations, at a minimum, REQUIRING STATE OVERSIGHT In the draft of the MOU, if a State enters into an MOU with FDA, the State where the pharmacist, pharmacy, or physician is located must investigate complaints received regarding compounded medications distributed outside the State. Complaints that the State must investigate include adverse drug experiences or product quality issues that could lead to public health risks: • An adverse drug experience can include an adverse event occurring in the course of the use of a drug product in professional practice; an adverse event occurring from drug overdose, whether accidental or intentional; an adverse event occurring from drug abuse; an adverse event occurring from drug withdrawal; and any failure of expected pharmacological action. • A product quality issue can include any incident that causes the drug product or its labeling to be mistaken for, or applied to, another article; any bacteriological contaminations; any significant chemical, physical, or other change or deterioration in the distributed drug product; or any failure of one of more distributed batches of the drug product to meet the applicable specifications. Contamination including mold, fungal, bacterial or particulate contamination is a product quality issue. The State investigation must include a determination of whether there is a potential public health risk or safety concern associated with the compounded medication and confirmation that any risk or safety concern is adequately contained. If a complaint is found to be valid, the State must take action to require the pharmacy 12 Spring 2015 | IACPRx.org/Publications
to determine the root of the problem and correct the issue, must notify FDA within 72 hours of receiving any complaint, and keep records of their actions for at least three years. Is that what the law, as written by Congress, says? While it places the responsibility for investigation of complaints squarely within the jurisdiction of the state agency, most likely the state Board of Pharmacy, it does not mandate or provide for a required reporting to the FDA within a specific time frame, nor does it define what constitutes a complaint, nor does it mandate recordkeeping. Is that what Congress truly intended? That question may have to be answered in the courts. Of particular concern to many Boards of Pharmacy is this: there will be a substantial financial burden to hire new investigators, new staff, and new technical infrastructure to comply with these requirements. This new “unfunded mandate” may have the untoward effect of preventing a state from even considering the MOU solely upon the basis of an economic impact on budgets that are already struggling with increased expenses. DEFINING INORDINATE QUANTITIES AND THE STATES’ RESPONSIBILITY In addition to the reporting requirements for adverse drug reactions or quality issues, the draft MOU requires that a State review compounding records during inspections. They need to determine whether the pharmacy, pharmacist or physician is distributing inordinate amounts of the compounded medications interstate. This is where the definition of “inordinate amounts” appears for the first time: • “Inordinate Amount”–If the number of units of compounded human drug products distributed interstate in a calendar month is equal to or greater than 30% of the number of units of compounded and non-compounded drug products distributed or dispensed both interstate and interstate. – The only exception to this rule – prescriptions that have been dispensed to an out-of-state patient at the facility in which the drug was compounded, and the patient or the patient’s agent carries that across state lines, are not counted in the calculation. If the State determines that the pharmacy, pharmacist, or physician has in fact distributed inordinate amounts of compounded drugs interstate, the State must notify FDA within seven days. The State must also take action against the pharmacy, pharmacist, or physician that may include a warning letter, enforcement action, suspension or revocation of a license, or other action consistent with State law. The FDA may also take action against the pharmacy, pharmacist, or physician. There’s another important issue here that may require judicial interpretation. The language of 503A specifies that the issue or distributing “inordinate amounts” be “addressed”; as proposed in the draft MOU, it requires We check your compliance before they do. Gates Healthcare Associates is a full-service pharmaceutical consulting firm with expertise in: • Strategic Planning and Business Development • Quality Assurance • Licensure and Accreditation • Regulatory Affairs • DEA/Controlled Substance Compliance Monitoring • USP Compliance • Pharmacy Practice and Training • Compounding Lab Design Visit our website to learn more about our capabilities. www.gateshealthcareassociates.com IACPRx.org/Publications | Spring 2015 13
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Page 3 and 4: IACP STAFF David G. Miller, R.Ph. C
Page 5 and 6: Preserve Your Access to Customized
Page 7 and 8: pharmacy because it will enable you
Page 9 and 10: REFILL Continued from Page 7 “NEC
Page 11: Congress removed the unconstitution
Page 15 and 16: THE MOU: A PHARMACIST’S PERSPECTI
Page 18 and 19: PERSONALITY OF PERSONALIZED CARE: L
Page 20 and 21: IACP FOUNDATION HISTORY by Lisa D.
Page 22: SAVE THE DATE FOR THESE UPCOMING PR

Compounding Matters Quarterly - Spring 2015

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