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Deadline Monday for pharmacies’ annual inventory of controlled dangerous substances

In this article, Oklahoma City Attorney Martin J. Lopez III discusses requirements pharmacies must abide by when submitting controlled substance inventories and the consequences they may face if they neglect to do so.

attorney Martin J Lopez III

Martin J. Lopez III is a litigation attorney who represents individuals and both privately-held and public companies in a wide range of civil litigation matters.

There seems to be increasing regulation of pharmacies in recent years, and this has been heightened by the responses to the opioid crisis. What are the various inventory requirements of the Oklahoma State Board of Pharmacy (OSBP)?

According to state regulation, and because of the dangerous propensities of these controlled medications, OSBP requires pharmacies to perform inventories much like any retailer, although there are some distinctions based upon the nature of the pharmacy’s product. The regulation, Oklahoma Administrative Code 535:15-3-10, sets forth four distinct circumstances where inventories must be performed: The first is an annual inventory of controlled dangerous substances (“CDS”). Most relevant for all pharmacies at this particular time, the OSBP requires an inventory of all CDS be performed between May 1 and July 1 of each year; this annual inventory must be included with the pharmacy’s annual license renewal application. This annual license renewal application must be in writing, must contain the names of the pharmacy’s owners and shall provide any other information deemed relevant by the board — including the CDS inventory. Inventory is required for a Change of Ownership or a change of the Pharmacist-in-Charge (PIC) and must be sent to the board within 10 days. The OSBP requires the inventory include the new manager’s name and registration number and recommends that it include the outgoing manager’s name, registration number, and current place of employment. The OSBP further recommends that both the incoming and outgoing managers sign the inventory. Inventory also may be triggered by circumstances such as theft. In the case of suspected loss, theft, or other event, the OSBP may require an inventory be performed and sent to the board within ten days of the completion of the inventory. Inventory is also required when a pharmacy closes and must be sent to the board within 10 days of the pharmacy’s closing.

What is a controlled dangerous substance for the purposes of the annual inventory to be performed between May 1 and July 1?

Generally, a CDS is a drug, substance or immediate precursor (a substance that serves as a chemical intermediary to manufacture a controlled dangerous substance) in Schedules I through V of the Oklahoma Uniform Controlled Dangerous Substance Act, found at Title 63, Sections 2-203 through 2-212 of the Oklahoma Statutes; these Schedules range from those with high potential for abuse and no accepted medical use (includes many “street” drugs like heroin) to those with low potential for abuse and which are accepted for medical use (such as pseudoephedrine—such as brands commonly known as Sudafed PE and Allegra D.

What happens if a pharmacy misses or fails to complete an inventory or doesn’t perform or submit the inventory on time? For example, what happens if a pharmacy doesn’t perform inventories of its controlled dangerous substances between May 1 and July 1?

If a pharmacy fails to comply with the annual CDS inventory, both the PIC and the pharmacy itself are deemed to have violated the administrative code. A violation of the administrative code amounts to a violation of the Oklahoma Pharmacy Act, over which the OSBP may take a number of actions, including a reprimand, probation, suspension, permanent revocation of a pharmacy’s license, or other disciplinary action in its discretion; the OSPB also can levy fines up to $3,000.

Martin J. Lopez III is an attorney with Phillips Murrah law firm.

FDA announces multi-step response plan to mitigate abuse of pain killers

By attorney Mary Holloway Richard

Mary Richard Oklahoma health care law

Mary Richard is a pioneer in Oklahoma health care law. She represents providers, patients and their families in a wide variety of transactional and regulatory matters.

In response to criticism that it has been too lenient in approving addictive narcotics and reticent to take action to mitigate abuse and overuse of these painkillers, the FDA announced on Friday a multi-step responsive plan of action:

  • It plans to convene an outside advisory committee to seek advice prior to approving new opioids that don’t have abuse-deterring properties.
  • It plans to convene a separate pediatric advisory committee to examine all proposed labeling changes related to children.
  • The FDA also intends to strengthen follow-up studies to provide more insight regarding safety, effectiveness of opioid’s long-term use and to step up physician training in order to mitigate over-prescribing practices.
  • Pharmaceutical companies will be encouraged to develop more painkillers that are less subject to abuse—difficult to break, crush and dissolve—and, therefore, more difficult to ingest quickly in large quantities by snorting or injecting.
  • Finally, the agency will engage in efforts to increase access to naloxone and other treatments to counteract the effects of heroin and opioid overdoses.

Some pundits suggest that this response by the FDA is designed to ease tense relations with senators and to prepare the way for confirmation of President Obama’s appointee for agency director. In the face of industry- and society-wide recognition of the “opioid epidemic,” even action potentially based upon self-serving agency motivation, if effective, will save lives and scarce resources.