SAN ANTONIO – Most attention paid to barriers for medication-assisted treatment of opioid use disorder has focused on prescribers and patients, but pharmacists are “a neglected link in the chain,” according to Hannah Cooper, ScD, an assistant professor of behavioral sciences and health education at Emory University, Atlanta.
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“Pharmacy-based dispensing of buprenorphine is one of the medication’s major advances over methadone,” Dr. Cooper told attendees at the annual meeting of the College on Problems of Drug Dependence. Yet, early interviews she and her colleagues conducted with rural Kentucky pharmacist colleagues in the CARE2HOPE study “revealed that pharmacy-level barriers might also curtail access to buprenorphine.”
Little research has examined those barriers, but Dr. Cooper noted. Further, anecdotal evidence has suggested that wholesaler concerns about Drug Enforcement Administration restrictions on dispensing buprenorphine has caused shortages at pharmacies.
Dr. Cooper and colleagues, therefore, designed a qualitative study aimed at learning about pharmacists’ attitudes and dispensing practices related to buprenorphine. They also looked at whether DEA limits actually exist on dispensing the drug. They interviewed 14 pharmacists operating 15 pharmacies across all 12 counties in two rural Kentucky health districts. Eleven of the pharmacists worked in independent pharmacies; the others worked at chains. Six pharmacies dispensed more than 100 buprenorphine prescriptions a month, five dispensed only several dozen a month, and four refused to dispense it at all.
Perceptions of federal restrictions
“Variations in buprenorphine dispensing did not solely reflect underlying variations in local need or prescribing practices,” Dr. Cooper said. At 12 of the 15 pharmacies, limits on buprenorphine resulted from a perceived DEA “cap” on dispensing the drug or “because of distrust in buprenorphine itself, its prescribers and its patients.”
The perceived cap from the DEA was shrouded in uncertainty: 10 of the pharmacists said the DEA capped the percentage of controlled substances pharmacists could dispense that were opioids, yet the pharmacists did not know what that percentage was.
Five of those interviewed said the cap often significantly cut short how many buprenorphine prescriptions they would dispense. Since they did not know how much the cap was, they internally set arbitrary limits, such as dispensing two prescriptions per day, to avoid risk of the DEA investigating their pharmacy.
Yet, those limits could not meet patient demand, so several pharmacists rationed buprenorphine only to local residents or long-term customers, causing additional problems. That practice strained relationships with prescribers, who then had to call multiple pharmacies to find one that would dispense the drug to new patients. It also put pharmacy staff at risk when a rejection angered a customer and “undermined local recovery efforts,” Dr. Cooper said.
Five other pharmacists, however, did not ration their buprenorphine and did not worry about exceeding the DEA cap.
No numerical cap appears to exist, but DEA regulations and the SUPPORT for Patients and Communities Act do require internal opioid surveillance systems at wholesalers that flag suspicious orders of controlled substances, including buprenorphine. And they enforce it: An $80 million settlement in 2013 resulted from the DEA’s charge that Walgreens distribution centers did not report suspicious drug orders.