APhA coronavirus watch: Inappropriate prescribing poses dilemma for pharmacists
There is scant evidence that chloroquine/hydroxychloroquine, alone or in combination with azithromycin, are effective treatments for COVID-19—but in the face of uncertainty and encouragement from President Trump, many health professionals have seized on their use. As pharmacies across the country have been flooded with fill requests for the drugs, troubling pharmacists and potentially contributing to shortages, pharmacy, medical groups, and state boards have taken a stand against the phenomenon.
Boards and associations speak out
State governments and boards of pharmacy in Idaho, Kentucky, Nevada, North Carolina, Ohio, Oklahoma, and Texas, with more considering policy, have taken action against inappropriate prescribing and hoarding, specifying that prescriptions must meet certain requirements to be filled.
The APhA Board of Trustees issued a statement as a follow-up to a referred APhA House of Delegates (HOD) proposed policy condemning the inappropriate and unethical prescribing and ordering of medications and medical supplies for personal use or for use by colleagues or family members.
“[Pharmacists] are being placed in the difficult position of deciding whether to dispense potentially inappropriate prescriptions for anticipated personal use of prescribers versus maintaining stock on-hand for patients confirmed to have COVID-19 and patients who use these medications for chronic conditions,” the statement read. The Board noted that this dilemma “may create friction among health care team members, as well as management, at a time when teamwork is critical.”
In addition to APhA’s Board statement, APhA, the American Medical Association, and American Society of Health-System Pharmacists released a joint statement on emphasizing ‘strong opposition’ of physicians’ and others’ prophylactic prescribing of medications currently identified as potential treatments for COVID-19—mainly chloroquine/hydroxychloroquine and azithromycin) for themselves, their families, or their colleagues; and some pharmacies’ and hospitals’ excessive purchasing of the medications in anticipation of potentially using them for COVID-19 prevention and treatment. Read the statement at https://apha.us/AMAJointStatement.
The statement’s signers highlight collective support for state and federal requirements that would mandate that a prescription for COVID-19 and other medications be written only for a legitimate medical purpose. The groups also strongly agree that pharmacists should use their professional responsibility to “make reasonable inquiries to a prescriber to resolve any questions about a prescription” and balance the needs of patients taking these medications on a regular basis for an existing condition.
“If a prescription is not for a legitimate medical purpose, it should not be written, and it should not be dispensed,” the statement reads. That determination can and should be made on a case-by-case basis by individual pharmacists, prescribers, and health care teams.
Steady level of diligence
Former federal prosecutors Steven Block, JD, and Sarah Hall, JD—now partner and senior counsel, respectively, at the law firm Thompson Hine LLP—agree with the use of professional judgment around suspicious prescriptions for drugs thought to be useful for treating COVID-19.
“A lot of pharmacists that I’ve talked to are really questioning what their ethical and their legal responsibilities are if they get requests that just don’t seem right,” Block said.
He has heard stories of pharmacists asked to fill chloroquine prescriptions called in by veterinarians and out-of-state doctors they’ve never worked with before. When questioned, some prescribers have claimed the prescription was for a relative with rheumatoid arthritis (RA) or a patient recently diagnosed with RA. “When they drill further, it doesn’t seem like the physician’s specialty would even treat RA,” Block said.
Physicians have responsibility in this situation too. “It’s not meant to put it all on the pharmacist; the pharmacist should be asking questions [to ensure] prevention and compliance,” Block said. “The best way for pharmacists to handle [suspicious orders] is to do some amount of diligence now [so they don’t] have to explain why they filled scripts with serious warning signs to a government regulator or a criminal prosecutor 2 years from now.”
Pharmacists must be scrupulous in decisions to fill prescriptions every day. “They have been facing these types of issues especially with the opioid crisis and other controlled substances that have recreational use and abuses,” Hall said. “Pharmacists shouldn’t suspend their ordinary diligence practices when evaluating fill requests just because we’re in the midst of a pandemic.”
Pharmacists are gatekeepers
Decisions of whether to dispense these medications also has professional implications.
The pandemic will eventually subside, Hall said. “But fill records are going to last forever, and they need to be cognizant of being able to defend how they filled the scripts.”
The U.S. Department of Justice (DOJ) and other regulators have a history of investigating data after crises, such as Hurricane Katrina and the Deep Water Horizon Oil Spill, where health care providers like pharmacists may have acted differently than they would under normal circumstances. “Exercising ordinary due diligence is the way to go, because while there may be a sense of panic now, pharmacists don’t want DOJ, the U.S. Department of Health and Human Services (HHS), Office of the Inspector General (OIG), or state licensing agencies to come knocking on their door one year from now and asking them a lot of questions about why they filled all these suspicious scripts,” Hall said.
“It will be a no-brainer for DOJ to look at what happened and point the finger, and when DOJ looks at individuals to target for prosecution, there is always a higher standard applied to individuals that hold licenses—doctors, lawyers, nurses, pharmacists, anyone who uses special skill and training in what they do,” Hall said.
Prescribers will be at the top of the pyramid. “But the pharmacist is a gatekeeper, so they’ll be held to high standards.”
Preparing for the worst
DOJ has already directed every U.S. Attorney’s office in the country to prioritize the detection and investigation of any criminal conduct related to the pandemic. Pharmacists don’t necessarily have to be scared, but they do have to be careful. “The government tends to have a very low threshold to investigate cases in the wake of disasters such as this one,” Block said.
“They’re not going to only be concerned about the pharmacist who filled a bogus order for 25,000 doses. They may also look at the possibly bogus order of 500 doses,” he said. “That’s why vigilance is required—the government will certainly be trying its best in the wake of this to detect any possible wrongdoing.”
In the context of a fast-moving public health crisis, “where people are going to be tired and overworked and scared, [pharmacists] simply need to be reminded to still take the steps they would normally take,” Block said.