The delicate balance between curbing controlled-drug diversion and meeting the critical needs of people with chronic pain has shifted to tougher regulation in recent months, according to pharmacists.
In interviews with Pharmacy Today, pharmacists say they have had to turn away substantial numbers of patients with valid pain therapy prescriptions because their wholesalers, under what some suggest is stepped-up DEA pressure, have set monthly limits on their orders and in some cases stopped shipments altogether.
“We’ve created an entire group of patients that we’re starting to call ‘opioid refugees’ because the pharmacies they went to cannot get their medication anymore because they’ve been cut back,” said K. Scott Guess, PharmD, owner of Pain Management Pharmacy in Santa Maria, CA.
An online survey released in January by the National Community Pharmacists Association (NCPA) found that three out of four (75%) of the nearly 1,100 responding pharmacies had experienced three or more delays or issues caused by stopped shipments of their controlled substances over the past 18 months, and more than two out of three (67.9%) could not obtain replacements from alternative suppliers.
B. Douglas Hoey, BSPharm, MBA, CEO of NCPA, said that pharmacists were acutely aware of the drug abuse problem in this country and “more than any other health care profession want to see prescription medications used appropriately."
But “the pendulum has really swung too far,” Hoey said, “and so instead of targeting the very small percentage of physicians who are writing these prescriptions, the DEA has started to go after pharmacies, started to go after wholesalers, and that has had a downstream effect on patient access to pain medications and other medications that they need to treat their conditions.”
Speaking for the wholesalers, John M. Gray, President and CEO of the Healthcare Distribution Management Association (HDMA), acknowledged that “given the DEA’s current approach to enforcement,” some of the group’s member companies have had to “cut off pharmacies” that order pain medications. The reason, he said, was that DEA in recent years had begun to target distributors in its battle to contain diversion and prescription drug abuse.
“I call this the chokehold program: if we squeeze off the wholesalers, then we can constrict supply,” Gray said. “And they’re right,” he added, “because we’re the narrow funnel where the product comes from the manufacturer and out to the pharmacy community. But this strategy comes at a price. Too many legitimate patients are not able to get their medicines. We need to create an environment that values collaboration and transparency.”
DEA denies that it has singled out wholesalers or that its regulatory actions have intensified. Barbara Carreno, a spokesperson for the agency, said the DEA’s enforcement approach has remained essentially unchanged since the passage of the Controlled Substances Act in 1970.
“We’re not out there trying to keep medicine from people,” Carreno said. “We’re not out there trying to hassle companies. When we take actions, they always [are] against egregious violations that have the effect of harming the public.” As an example, she cited the agency’s 2012 2-year suspension of Cardinal Health’s Lakeland, FL, distribution center license to distribute controlled drugs because it had allegedly “failed to maintain effective controls against the diversion” of oxycodone.
“Our administrative actions are intended to have the effect of bringing violators back into compliance with the law,” Carreno added, “which should have the effect of making these medications more available” to patients who need them.
Whatever the source of the stricter supply limits, the brunt of the impact is being felt by patients. “When pharmacies are back-ordered or when they’re not able to get these medications from their distributor, the patient has to go pharmacy-hopping to try to find it,” said Christopher Herndon, PharmD, BCPS, Associate Professor of Pharmacy Practice at the Southern Illinois University Edwardsville School of Pharmacy. Herndon’s practice site is the St. Louis University/Southern Illinois Healthcare Foundation Family Medicine Residency Program at St. Elizabeth's Hospital in Belleville, IL.
One result of patients’ hunt for new pharmacies, Herndon said, is that in the time it takes to find one willing or able to fill a prescription, patients can experience acute opioid withdrawal, sometimes leading to an emergency department visit and hospitalization. Another issue, he said, is that patients often sign pain agreements with their prescribers that limit them to a single pharmacy. If they go to another one, he said, it is technically a violation of the agreement. “If the prescriber draws a hard line in the sand, it creates the faulty impression of drug-seeking behavior,” Herndon said.
Many pharmacies have had to make painful decisions about which patients to service and which ones to turn away. In Melbourne, FL, for example, Mark Hobbs, BSPharm, President of Hobbs Pharmacy, said that while he has been able to service his current pain medication population, which includes a substantial number of hospice care patients, he has had to stop taking on any new chronic pain patients because of wholesaler supply restrictions.
When patients are turned away, Hobbs said, “it creates very bad continuity of care. Patients wander from pharmacy to pharmacy to get legitimate prescriptions filled, so there is no central repository of their prescription information.”
Pharmacies have also had to contend with narcotic delivery delays. Michael J. Kim, PharmD, owner and President of three Grubb’s Pharmacies in Washington, DC, said that his pharmacies had been hit by several delays in the past. “When you call to find out what’s going on, they basically tell you that you’ve met your threshold,” he said. The delay, he added, might extend to a week or even 2 weeks. In the past, he said, he would try to find an alternative supplier to bridge the gap. “But that’s kind of dried up too,” he said, because the secondary wholesalers “are now under scrutiny by the DEA. If they’re only selling narcotics to you,” that’s a red flag.
Kim said he has tried without success to get his wholesaler to explain the formula it uses to determine shipment thresholds. “I have been told by my wholesaler that the monthly limits are strictly a numbers game without any consideration for your patient mix, physician mix, or anything else that would have an impact on the prescribing and dispensing trends,” he said.
George Garmer, BSPharm, owner of Halethorpe Pharmacy in Baltimore, said that while he agreed that there needs to be monitoring of controlled drugs dispensed by pharmacies, there also needs to be “some sort of give” in allocating pain medications to pharmacies like his, which services hospice patients as well as others referred by a local orthopedic practice, whose physicians, he said, rely on Halethorpe’s ability to have pain and other medications on hand to treat their patients. “But the more patients you treat and try to help, the more scrutinized your business is,” he said.
“I realize,” he added, “that there are bad seeds out there that are filling prescriptions inappropriately,” said, “but they have hurt those of us that are legitimately taking care of patients.”
For Herndon, “the million-dollar question right now is how do we assure that patients who need these medications can continue to get them and keep them out of the hands of people using them for nonmedical purposes?”