October 2014, Vol 2, No 5 - The First Word
Donald J. Dietz, RPh, MS

"Pharmacies are now one of the entities that can become authorized collectors of unwanted controlled substances.”

On September 8, Attorney General Eric Holder announced a new Drug En­forcement Admin­istra­tion (DEA) regulation that would allow pharmacies, hospitals, clinics, and other authorized collectors to serve as take-back points for controlled substances.1 The DEA rule implements a 2010 law seeking to reduce abuse, misuse, diversion, and accidental ingestion of controlled substances from medicine cabinets.

Growing Confidence in Pharmacies
Effective October 9, 2014, pharmacies are now one of the entities that can become authorized collectors of unwanted controlled substances by registering with the DEA as a reverse distributor. Pharmacies have been able to accept unwanted noncontrolled substances for years, but this new rule expands their ability to accept controlled substances.

This can take the form of take-back events, a mail-back program, or collection receptacles.2 As a pharmacist, this new rule makes me proud that the government and the general public have confidence in their pharmacy to play an important role in removing unwanted controlled substances from public access. This is especially important for teens: “Nearly 4 in 10 teens who have misused or abused a prescription drug have obtained it from their parents’ medicine cabinet,” according to Attorney General Holder.1

How will this new rule impact pharmacies interested in taking back controlled substances from the community? Initially, there will be administrative paperwork to modify the pharmacy’s DEA registration to meet the new legal and security mandates for mail-back and collection receptacles. To accept controlled substances with the intent of destruction, pharmacies will need to register as reverse distributors.

Factors to Take into Account
Pharmacies will also need to develop and implement new training procedures for all pharmacy personnel focusing on the additional requirements to accept, store, do inventory, and return controlled substances. New internal audit processes will also be implemented to ensure ongoing training and compliance with this new role as reverse distributor.

New security concerns for the pharmacy will also need to be considered. If a limited number of pharmacy locations accept returned controlled substances, will those pharmacies be at greater risk for robbery or burglary from addicts seeking large supplies of controlled substances?

The new administrative paperwork, storage, training, shipping or destruction, auditing, and security do not occur without an additional expense to the pharmacy. Who is going to pay for these added costs? With more than 90% of all prescriptions paid by a third-party insurer, it is unlikely that pharmacies will be able to pass along this cost in the prescription pricing. It is also doubtful that many customers will willingly pay an out-of-pocket fee to the pharmacy to return their controlled substance medications.

Continued pressure on retail pharmacy margins will make it difficult for retail pharmacies to simply absorb the added expense of accepting controlled substances at all pharmacy locations. Compensation to pharmacies for this new value-added service remains an unanswered challenge.

Acknowledgment of the New Rule
Most state boards of pharmacy have not addressed controlled substance medication take-back programs for disposal, though a few states have. For example, in Pennsylvania, any medication take-back falls under the state’s Department of Environmental Protection and is restricted because it is considered hazardous waste.3 According to the Notification for Registration of Onsite Pharmaceutical Drug Collection Program, “controlled substances shall not be accepted.”4 Be sure to look into your state’s laws and regulations on the subject; states may decide to modify their existing laws and regulations based on this new regulation from the DEA.

There have been limited public comments from leaders of pharmacy organizations and leading pharmacy chains on this new DEA rule. Retail pharmacy organizations, from large chains to individual owners, will be examining the effort and cost needed to successfully implement, comply, and ensure the security of both personnel and product in their pharmacies before accepting controlled substances.

Some pharmacy owners may decline to become a reverse distributor. The DEA has stated that they have “no plans to sponsor more nationwide Drug Take-Back Days in order to give authorized collectors the opportunity to provide this valuable service to their communities.”5 The last scheduled Drug Take-Back Day was set for September 27, 2014.

References

  1. Department of Justice. Attorney General Holder Announces New Drug Take-back Effort to Help Tackle Rising Threat of Prescription Drug Addiction and Opioid Abuse. www.justice.gov/opa/pr/attorney-general-holder-announces-new-drug-take-back-effort-help-tackle-rising-threat. Published September 8, 2014. Accessed September 19, 2014.
  2. Drug Enforcement Administration, Department of Justice. Disposal of controlled substances [Docket No. DEA-316]. https://s3.amazonaws.com/public-inspection.federalregister.gov/2014-20926.pdf. Accessed September 15, 2014.
  3. Pennsylvania Pharmacists Association. DEA Issues Final Rule on Controlled Substances Return Programs. PPA Weekly Bulletin. September 17, 2014.
  4. Pennsylvania Department of Environmental Protection. Notification for Registration of Onsite Pharmaceutical Drug Collection Program. www.elibrary.dep.state.pa.us/dsweb/Get/Document-82549/2520-FM-BWM0010%20Instructions.pdf. Published November 2010. Accessed September 18, 2014.
  5. Drug Enforcement Administration, Department of Justice. DEA Releases New Rules That Create Convenient But Safe and Secure Prescription Drug Disposal Options. www.justice.gov/dea/divisions/hq/2014/hq090814.shtml. Published September 8, 2014. Accessed September 18, 2014.
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Last modified: May 21, 2015
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