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Controlled Substances Policies Help Identify Risks Before the DEA Comes Knocking

Today’s Pharmacy Law Topic:  Did you know that your controlled substances policies should be protecting your pharmacy and helping you identify risks before the DEA comes knocking?

By: Karen Davila

As I’ve said in earlier articles, controlled substances are a big part of the business and create significant risks faced by retail pharmacies.  But many of those risks can be mitigated through written policies and procedures and consistent adherence to those policies and procedures.  These are the first line of defense and one of the most important strategies to identify and mitigate the risk of regulatory enforcement action before the DEA comes knocking.

Regardless of the size of your pharmacy, you should have written policies and procedures addressing the core requirements of both federal and state law.  Below is a list of essential controlled substances policies relating to inventory controls, dispensing and destruction/reverse distribution.  Although not an exhaustive list, these are key to decreasing the myriad risks inherent in stocking and dispensing controlled substance prescriptions.

Inventory controls:  Policies should establish expectations and accountabilities for ordering and receiving all controlled substances by a pharmacist.  Appropriate manual or electronic logs of receipt of inventory and each dispensing of such inventory must be maintained.  Policies delineating the required secured storage and security cameras in areas where controlled substances are received, logged, stored, and removed from storage for dispensing should be in place.  Periodic inventory audits should be conducted to identify any possible theft or diversion.  Policies must require the prescription department manager to notify the Board of Pharmacy and the DEA of any theft or significant loss of any controlled substances within 1 business day after discovery of the theft or loss.

Dispensing:  A pharmacy’s dispensing policies should address the pharmacist’s corresponding responsibility and the expectations for the pharmacist to verify the validity of each controlled substance prescription before dispensing.  Completing each of these steps can provide meaningful information to assist the pharmacist in exercising his/her professional judgment as to whether to fill a prescription.  Dispensing policies and procedures should include requirements for:

  1. Validating that the form of prescription received is sufficient under law and contains the required prescription information.
  2. Validating patient identification (i.e., requiring photo ID and insurance card).
  3. Calling prescriber to validated diagnosis and existence of valid prescriber-patient relationship
  4. Using the state’s PDMP to review controlled substance medication profile of patient each time a controlled substance prescription is filled. Consider embedding the PDMP access within the pharmacist’s workflow.
  5. Restricting deliver of controlled substance prescriptions to patient only, except in well documented circumstances.
  6. Prohibiting early refills on CIII-CIV controlled substances.
  7. Prohibiting early fills on any CII prescriptions noted with “DO NOT FILL BEFORE” or any other similar notation.
  8. Establishing reporting expectations for any potentially fraudulent prescriptions.
  9. Establishing process for refusals to fill controlled substance prescriptions. When a pharmacist refuses to fill a prescription, the policy should specify the type of documentation to be maintained and any refusal to fill documentation should be available for evaluation in conjunction with any subsequent prescription presented for that patient or from that prescriber. The policy should also require reporting to local law enforcement of any prescription believed to be fraudulent.
  10. Creating record-keeping requirements for all controlled substances dispensed.

Controlled Substance Destruction/Reverse Distribution:  Policies must require controlled substances that are no longer usable (e.g., expired or adulterated drugs) to be securely stored until destroyed or reverse distributed.  The pharmacy’s policies must be written in compliance with both state and federal law specifying the method of destruction and reporting requirements.  One such method requires the destruction of the drugs on the premises and two witnesses, one of which must be the prescription department manager and the other must be either (a) a medical director or physician designee, (b) a director of nursing, or (c) a sworn law enforcement officer.  These individuals must witness the destruction of the controlled substances and sign the Form DEA 41 which is then submitted to the DEA within 1 day after destruction.  Another method of destruction allows controlled substances to be securely shipped to reverse distributors in conformance with federal guidelines.  Whatever procedure the pharmacy uses should be followed consistently to avoid irregularities and potential risk.

Closing Thoughts

Developing and enforcing unambiguous policies and procedures for the handling and dispensing of controlled substances is a sure-fire strategy to identify your risks before the DEA comes knocking.  The pharmacy must set minimum expectations for controlled substance inventory management (receiving, securing, and destroying) as well as dispensing.  Allowing the pharmacist to exercise his/her professional judgment in determining whether to fill any controlled substance prescription is essential but knowing that the pharmacist is following the right steps in that process is equally important.  Absent well-written policies and procedures, pharmacists may not fully appreciate the pharmacy’s expectations of them when exercising their “corresponding responsibility.”