Association Perspective
Michael D. Hogue, PharmD, FAPhA, FNAP, FFIP, Executive vice president and CEO of APhA
Over the past several months, independent pharmacy owners have occasionally let me know their wholesaler has discontinued business with them because of controlled substance thresholds or other reasons related to controlled substance dispensing. APhA has been called upon to investigate if there is something going on that is unusual or new as a result of wholesaler’s implementation of either the Department of Justice orders or the states’ attorneys general consent decree with the three largest wholesalers and settlements with pharmacy chains and others.
APhA staff have met with the top five largest wholesalers, and specifically with their compliance divisions. In addition, we’ve held productive discussions with the State Compliance Review Committee of the states’ attorneys general involved in the consent decree. In these conversations, APhA has pointed out three market forces and issues that we felt needed to be considered by both parties.
First, the rapid closure of pharmacies could quickly shift the volume of controlled substances filled in a given location. Secondly, and somewhat related to the first, we are learning that with pharmacy closures, fewer pharmacies have been willing to take on the business of servicing hospice organizations due to the lack of noncontrolled balancing prescriptions impacting the ratios of controlled to noncontrolled substances. Thirdly, there has been some question as to the nature of seasonal fluctuations in dispensing of controlled substances used for the treatment of ADHD, particularly in pharmacies that serve largely college and university students.
What has become incredibly clear to me and to our team at APhA is that both the courts/attorneys general and the wholesalers desire to support local pharmacies and ensure that patients have access to needed medications. They also believe that if a pharmacy is following the rules and regulations, they should have nothing to worry about in terms of the requirements regarding controlled substance dispensing. However, they acknowledge that algorithms and predictors of controlled substance dispensing abuses are not always fully accurate and require good communication and documentation by the community pharmacy’s pharmacist-in-charge.
Corresponding responsibility says that it is the pharmacist’s obligation to ensure that every prescription being dispensed is a legitimately prescribed medication for a legitimate medical purpose. Wholesalers/distributors, as a result of the consent decree, are now required to monitor pharmacies to ensure that they are exercising their corresponding responsibility. This means ensuring that prescription patterns are consistent, prescribers are not typically out of the area, and that the practices and procedures of pharmacies in handling-controlled substances prevent diversion.
In reality, the most important thing any pharmacist-in-charge or pharmacy owner can do is communicate directly with your wholesaler representative anytime there is a possibility of a variation in your controlled substance dispensing.
Let them know if there are pharmacies geographically near your practice that have closed recently or are closing. If a hospice agency is in need of a dispensing pharmacy, don’t be afraid to provide service to these patients—this circumstance is precisely why wholesalers have processes for increasing threshold limits. Apply for a threshold limit increase and communicate the circumstances in your area.
While not every pharmacist’s challenges with opioid and controlled substance dispensing will be solved through better wholesaler to pharmacy communication, the vast majority should be easily handled through better communication in every part of the supply chain.
For every pharmacist. For all of pharmacy. ■