Controlled Substances
Loren Bonner
In Arkansas, John Kirtley, PharmD, executive director of the Arkansas Board of Pharmacy, said that several pharmacies in the state have been threatened with the loss of their ability to purchase controlled substances.
Directly, Kirtley knows of two pharmacies that were cut off by their wholesaler for controlled substance sales and were unable to get a contract with the two other main wholesalers after that action was taken.
“What we see and hear is that if one cuts you off then the other two consider that action as well and it is very difficult if not impossible for you to get a contract with one of the other two entities since they are under the same scrutiny and agreement,” said Kirtley.
Wholesalers are doing all of this as part of their own DEA obligations for control and accountability in drug distribution.
“At DEA we certainly recognize that drug distributors who are selling controlled substances to pharmacies have obligations under federal law to develop systems to identify and report suspicious orders. Suspicious orders are generally orders of unusual size, pattern, or frequency,” said Matthew Strait, deputy assistant administrator at DEA’s Office of Diversion Control Regulatory, during a November 2023 APhA webinar.
“We don’t tell distributors how much [they] can sell, we only tell them that they have to establish systems to identify and report suspicious orders. Generally speaking, those systems, which are maintained by drug distributors nationwide, set limits on what they would consider to be in a norm for purchasing patterns for a particular pharmacy.”
Kirtley and others have seen issues with access to controlled substances ramp up for pharmacies in the last year or two with opioid lawsuits swirling around.
“We also hear about wholesalers flagging specific patterns of prescribing for combinations of controlled substances [opioids with either benzodiazepines or muscle relaxants] or flagging specific prescribers with action by other agencies,” said Kirtley, who has done extensive work to address this issue with wholesalers, legislators, and pharmacies.
“Times have changed, and the supply of many controlled substances is far less than was available previously,” Kirtley said. “We are facing both increased scrutiny in our practice across all health care providers as
well as real shortages of certain controlled medications throughout our country.”
The problem with buprenorphine
Buprenorphine seems to be the main controlled substance pharmacists won’t stock—either because they don’t want to exceed wholesaler limits or they can’t throw off their ratio of controlled versus noncontrolled prescriptions dispensed.
“My wholesalers demand a list of physicians who write for buprenorphine alone, how many prescriptions we fill for it, quantity filled, where we purchase it from, etc.,” said Tara Schneider, PharmD, an independent pharmacy owner in Lexington, KY.
She said one wholesaler told her that their numbers on buprenorphine without naloxone were too high.
“We knew that when we purchased the store in November, and have since stopped carrying buprenorphine alone,” said Schneider. “We will only dispense buprenorphine/naloxone (Suboxone) and are happy to do so.”
These restrictions have directly coincided with federal level efforts to increase prescriptions for buprenorphine and the numbers of individuals receiving treatment for OUD.
With the passage of the MAT Act in 2023, Congress increased health care providers’ ability to prescribe buprenorphine. This legislation effectively eliminated the need for prescribers to register and fill out the X-waiver, which served to control the number of prescribers who could prescribe buprenorphine. With the X-waiver requirement removed, all clinicians, including pharmacists in certain states who hold a DEA license, are now able to prescribe buprenorphine.
“As we expect to see an increase in prescriptions written because we want more people in treatment, there’s concern that these drug distributors need to be able to increase these thresholds [for] how much they will allow pharmacies to purchase,” said Strait in the 2023 webinar.
During the same webinar, Valerie Prince, PharmD, former APhA president and host of the session, said that she’s heard pharmacists say “I don’t want to be the first one here [who] will do it, [who] will carry [buprenorphine], because then everyone will come to me, I’ll get in trouble, and I won’t be able to fulfill the orders anyway because distributors will be restricting me… then I might flag myself to the DEA.”
Pharmacies—as well as distributors—also face legal risk carrying controlled substances.
“Through the opioid litigation at the distributor level and the pharmacy level, these companies are also reassessing their risk tolerance, which definitely has an impact on internal metrics, decision making, policies, and procedures,” said Strait.
The issue is complicated and multilayered, to say the least.
Solutions
Strait said that controlled substance access at the pharmacy level is largely a result of business decisions being made by drug distributors.
According to Strait, one of the ways they are trying to improve access to the supply chain is by examining the underlying reasons for the thresholds that distributors are setting when they sell to pharmacies.
DEA is trying to make sure distributors understand that these quantitative thresholds can be changed and amended, according to Strait, and that DEA—the organization responsible for overseeing them—recognizes and expects an increase in prescriptions.
“Under any normal circumstance [this] may be viewed as a suspicious order, but in this particular moment and time in our nation’s history, [these] are not suspicious orders. [Rather, orders for these medications] are expected to increase and we are looking forward to seeing those increases,” said Strait.
What can pharmacists do in the meantime?
Nicholas Carris, PharmD, who practices in Florida, said pharmacists could even try a warm introduction to another pharmacy for the patients unable to find controlled medications “to decrease the stigma of patients searching for a pharmacy to fill their medication.”
“Take care of the person in front of you as best you can given the laws of your state and policies of your store,” Carris said.
On the individual pharmacy level, Kirtley said communication is key. Some pharmacists in Arkansas, he noted, have done face-to-face roundtables and sharing sessions with prescribers to talk through the issues.
“Pharmacists must have positive relationships with both their patients and the prescribers sending in prescriptions so that they can have frank conversations regarding the complexities of medication supplies, especially with controlled substances,” Kirtley said. ■