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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.

Lopez: A bitter pill – medical malpractice liability for new resident physicians

While becoming a resident physician is undoubtedly an exciting next step in the process, it inherently comes with daunting new realities – a plethora of health care regulatory compliance issues, constantly developing reimbursement requirements, and medical malpractice liability. This short article focuses on minimizing the risk of negligence-based medical malpractice lawsuits.

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.

Medical school residency match day. It’s a chaotic, stressful revelation at which fourth-year medical students find out where they will spend the next few years of their lives as residents – newly minted physicians becoming experts in their respective fields.

While no practicing physician is immune from being sued, common-sense measures have proven effective in avoiding malpractice claims. And, although a resident physician’s liability is generally covered by the residency program, there remains ample reason to mitigate liability risk – notably, to avoid the stress, time, and hassle that comes with litigation.

Most obviously, physicians should provide the best medical care to their patients they possibly can. Lawsuits for medical malpractice involve determining whether the physician has met the standard of care owed to the patient; if she provided the best care she could have, she has positioned herself well from the outset.

Essential to providing a high level of care to the patient is communication about that care to the patient. Medical malpractice lawsuits often involve allegations of poor communication that may be rooted in a failure to convey respect, inadequate listening skills, and the use of technical medical jargon rather than patient-friendly language.

In a fast-paced environment with numerous patients to attend to, it’s understandably easy to use verbal medical shortcuts for efficiency’s sake; however, using patient-friendly language creates a stronger connection with patients, makes for well-informed patients, and may also manage patient expectations about treatment, diagnosis, and prognosis.

When a patient is dissatisfied, the physician should carefully listen and try to understand the basis for the concern or frustration and engage in meaningful dialogue about the issue. By making this concerted effort to proactively communicate and resolve issues, physicians affirm their commitments both to the patients and to a quality practice where people are treated with respect.

Another important aspect of mitigating liability risk is thorough detailed documentation in the medical record. Careful documentation is the foundation for quality and coordinated patient care, defending malpractice claims, and even for reimbursement issues by government programs – such as Medicare and Medicaid – and commercial insurers.

Proper documentation should include, but certainly isn’t limited to: details of discussions with patients, the physician’s thought and decision-making processes, results of laboratory tests and other ancillary services, proposed courses of treatment (including the impact of doing nothing), the bases for any physician recommendations, and communication of alternatives to the patient. In so carefully documenting, the physician establishes medical necessity for her services and creates admissible evidence in the event litigation arises out of the treatment.

While it may create extra work for physicians, taking the steps outlined in this article offers the benefits of more meaningful communication with patients, increases patient satisfaction, facilitates coordinated care with other providers on the patient’s behalf, and reduces the risk of medical malpractice lawsuit liability. Establishing these habits early in a medical career will undoubtedly offer great long-term rewards.

Martin J. Lopez III is a litigation attorney with the Oklahoma City law firm of Phillips Murrah.