Community Pharmacy Inspection Program Annual Report, Fiscal Year 2015-2016

What We Do

The Office of Controlled Substances (OCS) regulates the distribution and sale of precursors and controlled substances. This includes administering legislation, regulations, policies and operational activities that support the monitoring of controlled substances such as oxycodone, morphine, fentanyl, and heroin and precursor chemicals used to make these and other drugs. This administration allows for oversight of licit controlled substances, and can therefore reduce the risk of substances moving from legitimate channels to illegal markets.

The Regulatory Operations and Regions Branch (RORB) carries out the operational functions that allow for the control of licit substances. This includes inspecting selected community pharmacies to ensure compliance with the Controlled Drugs and Substances Act (CDSA) and its relevant Regulations and following up with pharmacists or persons in charge after the release of the Inspection Report.

Background

OCS operates under the authority of the Controlled Drugs and Substances Act (CDSA) and its associated Regulations including the Benzodiazepines and Other Targeted Substances Regulations, the Narcotic Control Regulations (NCR), the Precursor Control Regulations and Parts G and J of the Food and Drug Regulations. The CDSA provides a framework to control substances that can alter mental processes and that may produce harm to health and to society when diverted or misused. Its purpose is to protect public health and maintain public safety by balancing the legitimate need for access to these substances for medical, scientific and industrial purposes with the need to minimize the risk of their diversion to the illegal market.

OCS conducts compliance and monitoring activities such as inspections to ensure regulated parties (pharmacists, researchers, licensed dealers, etc.) are compliant with the CDSA and its regulations. OCS staff work with other groups within Health Canada and with external partners including the Royal Canadian Mounted Police, local law enforcement, the Canada Border Services Agency, and provincial and territorial professional licensing authorities such as the Colleges of pharmacists and physicians and their professional associations to minimize potential situations in which controlled substances could be diverted to illegal markets, and that researchers, health care practitioners and patients alike are engaged in the proper storage, use and disposal of these substances. In addition, OCS refers suspicious activities to the relevant College and shares information with the Colleges and/or law enforcement agencies to assist in investigations when requested.

Through these and other activities, OCS is committed to minimizing the diversion and misuse of controlled substances.

Prescription Drug Misuse

Prescription drug misuse, particularly problematic opioid use, represents a complex and growing problem for public health and public safety in many communities across Canada.

As frontline health care service providers, pharmacists are important partners in supporting public health initiatives to prevent problematic opioid use. Increasing the number of pharmacy inspections and collecting, analyzing and reporting on the data will support the outcomes of Health Canada's new Opioid Action Plan, focusing on:

• preventing problematic drug and substance use;
• supporting innovative approaches to treatment and rehabilitation;
• supporting measures that reduce the negative consequences of drug and substance use; and
• addressing illicit drug production, supply and distribution.

Executive Summary

The OCS helps protect Canadians by authorizing the legitimate use of controlled substances and precursor chemicals using a risk-based assessment and evaluation process and by performing compliance and monitoring activities to minimize the risk of illicit diversion. From April 1, 2015 to March 31, 2016, RORB carried out 157 pharmacy inspections across Canada. The most common observations cited within a pharmacy inspection report were inventory reconciliation issues related to record keeping, and security issues linked to the required submission of loss and theft reports to Health Canada. The education of pharmacists on the requirements of the CDSA and its associated Regulations, may reduce the incidence of these types of observations.

Community Pharmacy Inspection Program

In 2015, Health Canada announced that it would conduct 1000 compliance promotion inspections in community pharmacies across the country by 2019 - 100 inspections were planned for April 2015 to March 2016 and 300 per year are planned for fiscal years 2016-17, 2017-18 and 2018-19. Health Canada has hired 19 new inspectors to conduct these inspections - 9 permanent and 10 temporary. Starting in fiscal year 2019-20, approximately 180 inspections will be carried out annually by the 9 permanent inspectors located across Canada.

The objectives of the Community Pharmacy Inspection Program are to: promote compliance among pharmacists; strengthen cooperation and communication between Health Canada, pharmacists and their provincial authorities and associations; and facilitate national information sharing to combat prescription drug misuse including problematic opioid use.

The selection of community pharmacies to be inspected is random but representative of the distribution of the estimated 9710 community pharmacies across Canada, as per Table 1 below.

During an inspection, Health Canada inspectors examine purchase records, prescription records, loss and theft reports, destruction protocols, inventory reconciliation, security measures in place at the pharmacy, and any other relevant information. Inspectors are looking for discrepancies between records and actual inventory, gaps in security measures, and overall practices in the management of controlled substances. All discrepancies are recorded in an inspection report which is provided to the pharmacist for discussion, to promote and encourage compliance and to undertake corrective action. In cases where significant discrepancies are observed, Health Canada may decide to conduct further targeted inspections at the pharmacy, and/or share the findings of the inspection with the relevant provincial regulatory College for follow-up.

Inspections and Observations

The Annual Report for fiscal year 2015-16 provides a summary of findings from the Community Pharmacy Inspection Program. Only 100 pharmacy inspections were planned for this year, however 157 were conducted, as additional inspections were added to provide on-the-job training opportunities for new inspectors prior to the launch of the program in November 2015. These additional 57 inspections were conducted in the first two quarters of the fiscal year and part of the third quarter.

In conducting inspections, inspectors record observations linked to regulatory requirements. These observations can be grouped into the three broad categories outlined below. In some cases, observations noted within an inspection required follow-up in the form of a targeted inspection to ensure that compliance measures were taken by the pharmacy after the initial inspection results.

1. Record Keeping Requirements

Under the CDSA and its regulations, pharmacists are required to keep records of transactions such as refills, prescription transfers, and orders received. Inspectors verify records kept by pharmacists to ensure that accurate records are kept. Of the total number of inspections, there were issues with recordkeeping approximately 64% of the time.

Inspectors often noted that inventory records were incomplete or inaccurate, or may have been corrected without an explanation if there was an overage or shortage of controlled substances. Another common finding was that a complete and accurate record of purchases of controlled substances made by pharmacies were not always kept so it was not possible to determine when and what types of substances were purchased by the pharmacy. There were also issues with the keeping of a special narcotics file. In accordance with the NCR, all records of a narcotic prescription must be recorded in a separate file. This file must be kept complete and current, and be made available upon request to a Health Canada inspector. Inspectors often found that narcotic prescriptions were filed with regular prescriptions and vice versa, or that a separate narcotics file was not kept at all.

Of the 7 pharmacies inspected that were referred for a targeted inspection, 4 were referred for record-keeping observations.

2. Security Requirements

There are also security requirements under the CDSA that are verified during an inspection. These requirements are in place to help pharmacies reduce the risk of loss or theft of controlled substances. Inspectors check practices such as the sharing of keys and/or alarm codes with pharmacy technicians or other pharmacy staff, the accessibility of the pharmacy after-hours, and the submission of loss and theft reports to Health Canada. During the 2015-16 Community Pharmacy Inspection Program, Health Canada inspectors observed security-related issues approximately 93% of the time. Most observations were of a minor or non-critical nature, however in some cases inspectors found that controlled substances were stored in unsecured locations such as unlocked safes, drawers, or open cabinets, meaning that the risk of loss or theft was higher.

Of the 7 pharmacies inspected that were referred for a targeted inspection, all 7 were referred for security-related observations.

3. Provide, Sale and Return Requirements

The NCR also requires that pharmacists appropriately carry out all activities related to the management of controlled substances, such as providing and selling controlled substances, as well as returning unused substances to vendors. This includes requirements around prescription filling and refilling, the return of controlled substances by the pharmacist to the licensed dealer when unused, and the management of methadone prescriptions. Of the total number of inspections, there were issues with stock management observed approximately 27% of the time. For example, some pharmacists over-filled prescriptions, exceeding the quantity specified by the medical practitioner, or dispensed a substance that was not identical to that indicated on the prescription, both of which can lead to irregularities in inventory reconciliation.

Of the 7 pharmacies inspected that were referred for a targeted inspection, 2 were referred for provision, sale and return observations.

Conclusion

In addition to conducting inspections to promote compliance with the regulations, the Community Pharmacy Inspection Program provides the opportunity for Health Canada to identify common issues with compliance to the regulations, which in turn facilitates the development of updated national guidance documents.

The most common observations cited within a pharmacy inspection report during this past year were inventory reconciliation issues related to record keeping, and security issues linked to the required submission of loss and theft reports to Health Canada. Increased security measures within a pharmacy and the education of pharmacists on requirements for controlled substances that were unaccounted for in an inspection may reduce the incidence of security-related observations. In addition, a new guidance document regarding how to report losses and thefts has recently been developed to promote compliance with the regulations.

Forward Planning

During the fiscal year 2015-16 Community Pharmacy Inspection Program the OCS recognized that there is no systematic way to categorize and describe inspection observations in order to classify an observation as being minor, major or critical in nature. As such, it has been a challenge to clearly depict pharmacists' compliance with the CDSA and its regulations in the current report. Health Canada will implement a new inspections rating system to assess and categorize observations as major, minor or critical. This risk-based approach will be used to carry out targeted inspections based on the results found in regular pharmacy inspections. Therefore, the data presented for fiscal year 2015-16 may differ from the data presented in fiscal year 2016-17 and beyond.

The implementation of the Community Pharmacy Inspection Program in fiscal year 2015-16 has had an immediate, observable, and positive impact on regulatory compliance within the pharmacist community. A significant amount of education and compliance promotion was conducted throughout the first year of the program and several individuals came forward and voluntarily reported instances of non-compliance to Health Canada so that immediate corrective actions could be taken. We anticipate that these positive results will lead to further enhanced rates of compliance in subsequent years, which will in turn contribute to Health Canada's efforts to reduce the harms associated with diverted prescription drugs, particularly problematic opioid use in Canadian communities.