Read any newspaper and you will be confronted with articles to related to the opioid crisis. Whether the news is highlighting death related to overdoses, over-prescriptions, a medication grey market or doctors sending patients to pill mills, the focus is one: too many opioids are being prescribed and it’s time for pharmacists to take on additional roles in the national fight against opioid addiction and death. Several states have implemented new rules related to a pharmacy’s reporting obligations while other states, such as New York, are taking distribution companies to court.
What role do pharmacies play in patient addiction and what should pharmacists do to prepare themselves if served with a subpoena or faced with an audit? Conscientious recordkeeping is of utmost importance. Pharmacists, at a minimum, should ask themselves the following when receiving prescription orders:
- How many doctors write prescriptions for the patient and how many of those prescriptions are for opioids?
- How often does the patient change doctors?
- For what condition is the opioid being prescribed?
- How many refills are ordered and does the patient seek early refills?
- Are several members of a household receiving prescriptions for controlled substances? If so, does the pharmacy have a relationship with those family members?
- Is the pharmacist aware, or has a reasonable belief, that the prescription was refused by another pharmacy?
- What percentage of prescriptions being filled by the pharmacy are for controlled substances?
- What percentage of pharmacy customers are filling prescriptions for opioids and for what period are they being refilled?
- What protocols are in place to prevent drug loss and/or theft?
- When filling prescriptions, are all pharmacists determining whether the prescription is being sought in order to fulfill a medical purpose and/or are in line with a physician’s prescribing practices?
Pharmacists play an essential role in patient health and pharmacists should not be on autopilot. In some instances, pharmacists step into the shoes of a patient who cannot advocate for him or herself or lack knowledge to ask the right questions.
For example, some patients are grossly unaware of all of the medications they ingest and rely on their pharmacists to advise them if multiple medications cannot interact with each other. While seemingly illogical, many patients cannot recite their medications by both name and dose. This puts doctors at a disadvantage if a patient has doctors in multiple hospital systems where records are not shared.
Extrapolating this problem into the opioid equation can lead to unsolvable problems. This is likely the rationale behind the “corresponding responsibility” rule found in 21 C.F.R. § 1306.04, “the responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription.”
Currently, lawsuits are focusing on drug distributors like RDC and McKesson, which distribute opioid drugs to pharmacies who in turn disseminate those drugs to patients. But from 2017 to the present, several pharmacy owners have been jailed and fined millions of dollars for filling fake prescriptions. For example, in 2017, a New Jersey pharmacist, Michael Ludwikowski, was convicted in federal court of distributing and illegally dispensing oxycodone from two pharmacies that he owned. In 2019, Pauline Tilton, a licensed pharmacist and owner of Oasis Pharmacy in Victorville, CA, was sentenced to 63 months in federal prison for illegally distributing oxycodone by filling hundreds of counterfeit prescriptions.
Pharmacies need to train staff on spotting faux prescriptions and with complying with state and federal laws, particularly as they relate to controlled substances.
Rania Sedhom, managing partner of the Sedhom Law Group, PLLC (www.bespokelawfirm.com) is dedicated to the bespoke approach to law.