Preventing Drug Diversion: Expectations of Pharmacy Professionals and Pharmacy Managers
Pharmacists, pharmacy technicians and pharmacy managers (i.e., Designated Managers and those who are in charge of a hospital pharmacy) have certain responsibilities to ensure that all controlled substances are securely stored and maintained and that all appropriate measures are taken to reduce the opportunities for diversion and manage any losses that are identified.
In this article, the College has outlined some of the key expectations that pharmacy professionals and
pharmacy managers must meet to prevent diversion, and to safely control and dispense narcotics regardless of practice setting. While many resources are outlined in this article, it is up to pharmacists, pharmacy technicians and pharmacy managers to ensure they are meeting all applicable legislation, standards, policies and guidelines. A good place to start is the Narcotics Practice Topic.
Safe Storage
Under the Narcotic Control Regulations, pharmacists must take all reasonable steps to protect the narcotics under their control. Pharmacy managers and pharmacy professionals must be familiar with policies and procedures to monitor and prevent narcotic losses. Pharmacy managers should be able to demonstrate the precautions they have taken to ensure narcotics are not easily accessible and that they have taken appropriate measures to identify and address any risks or gaps. Considerations for safe storage can include:
- Layout of the pharmacy/premises
- Inventory tracking procedures
- Access control (e.g. keys/protocols for
accessing narcotics) - Systems to hire and screen new staff
- Broader facility security and restricted access to the pharmacy and drug storage areas (e.g. hospitals)
Damaged, unserviceable or outdated narcotics need to be secured and appropriately destroyed. No prior authorization is required for destruction of these drugs. They can be destroyed locally on site at the pharmacy or hospital or returned to a company that is licensed to destroy the controlled substance. Regardless of the method used, it must be appropriately documented. Review the Fact Sheet: Destruction of Narcotics, Controlled Drugs and Targeted Substances.
Medication Reconciliation
Under the Medication Procurement and Inventory Management Policy, the pharmacy manager must do a regular physical count and reconciliation of all narcotics, controlled drugs and targeted substances at least once every six months.
Reconciliations are done to validate that the inventory count on hand is accurate and that the pharmacist has met their obligation to protect or secure the drugs. A reconciliation is a detailed audit of the quantity of a drug purchased and dispensed, compared with the current stock on hand to determine whether there are any losses or overages. This process can help identify a problem in dispensing processes or inventory control.
A reconciliation can only be done where there is a validated starting inventory and good record keeping processes, which include retaining purchase records, filing prescriptions and maintaining narcotic sales reports.
Where there is a high risk of diversion (e.g. large pharmacy/institution staff, change in ownership or management, staff turnover, concerns that security has been compromised, such as through a breach in procedures) inventory counts should be done more frequently (either with a full reconciliation or in between reconciliations). The count should never be conducted by the same person who enters narcotic, controlled drugs and targeted substances purchases into the purchase records.
Reporting of Losses and Forgeries
Pharmacists must report any thefts, losses or forgeries of controlled substances (or their precursor chemicals) to the Office of Controlled Substances no later than 10 days after its discovery. Thefts, forgeries and large unexplained losses should also be reported to the police.
Pharmacists are expected to take all reasonable precautions to ensure the validity of a narcotic prescription (see Fact Sheet: Identifying Forgeries and Fraudulent Prescriptions). Reporting a forgery is the same as reporting a loss with one exception: a forgery must be reported even if the forged prescription was not filled. The Health Canada reporting form has fields to indicate whether the forged prescription was filled or not filled, along with the required details. As part of its ongoing compliance and monitoring activities, Health Canada is conducting inspections at community pharmacies across Canada. Their Community Pharmacy Inspection Program Annual Report summarizes some of the key issues observed during their activities, including those related to security and recordkeeping.
Review the Fact Sheet: Narcotic Reporting of Forgeries and Losses and Health Canada: Loss, Theft and Forgery Reporting Forms.
Practicing Ethically
Pharmacy professionals must be guided by the principles and standards outlined in the Code of Ethics. Standard 4.11 requires that pharmacy professionals “take appropriate steps to prevent and report the misuse or abuse of substances by themselves, patients, colleagues, other healthcare professionals or other pharmacy employees.” To do this, they must be aware of and comply with all relevant legislation, standards policies and guidelines as well as recognize and respond to “red flags” that may present in practice.
If a pharmacist or pharmacy technician becomes aware of professional incapacity, incompetence or unethical behaviour by their pharmacy colleagues or any other healthcare professional (for example, physicians or nurses) they must report that to the appropriate regulatory authority (Code of Ethics 4.10). This reporting is in addition to any internal reporting procedures.