Community Pharmacy Inspection Program Annual Report, Fiscal Year 2019-2020

Background

Health Canada helps protect Canadians by authorizing the legitimate use of controlled substances and precursor chemicals. Health Canada does this by using a risk-based assessment and evaluation process, and by performing compliance and monitoring activities such as inspections to minimize the risk of diversion.

The Office of Controlled Substances (OCS) of the Controlled Substances and Cannabis Branch 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. Through oversight of legal controlled substances, the OCS can therefore reduce the risk of substances moving from legitimate channels to illegal markets. The Controlled Substances Program of the Regulatory Operations and Enforcement Branch (ROEB-CSP) carries out the operational functions that ensure controlled substances are managed and monitored appropriately. Its compliance and enforcement mandate includes inspecting community pharmacies to ensure compliance with the Controlled Drugs and Substances Act (CDSA) and its associated regulations. OCS and ROEB-CSP operate under the authority of the CDSA and its associated regulations, including the Benzodiazepines and Other Targeted Substances Regulations, the Narcotic Control Regulations, the Precursor Control Regulations and Parts G and J of the Food and Drug Regulations. Health Canada conducts compliance and monitoring activities such as inspections to ensure regulated parties (pharmacists, licensed dealers, etc.) are compliant with the CDSA and its regulations. The CDSA provides a framework to control substances that can alter mental processes and may cause harm to health and to society when diverted or problematically used. 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. Health Canada works with partners including the Royal Canadian Mounted Police, local law enforcement, Canada Border Services Agency, and provincial and territorial professional licensing authorities, such as the colleges of pharmacists, and the colleges of physicians and surgeons. The program is designed to identify and minimize potential situations in which controlled substances could be diverted to illegal markets, and to ensure that health care practitioners are engaged in the proper storage, use and disposal of these substances, while patients are informed and aware of how to properly store, use and dispose of controlled substances. In addition, Health Canada may refer suspicious activities or share other information upon request with the relevant provincial or territorial regulatory authorities and/or law enforcement agencies, including information regarding pharmacies that have received a non-compliant inspection rating. Through these and other activities, Health Canada is committed to minimizing the diversion and problematic use of controlled substances.

Problematic prescription drug use

As frontline health care service providers, pharmacists are important partners in supporting public health initiatives to prevent the problematic use of prescription drugs. By conducting pharmacy inspections and by collecting, analyzing and reporting on the inspection data, Health Canada supports its mandate to maintain and improve the health of Canadians.

What we do – Community Pharmacy Inspection Program

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

Community Pharmacy Inspection Program annual report, fiscal year 2019 to 2020

This report provides a summary of findings from the inspections of selected community pharmacies for the fiscal year 2019 to 2020 (April 1, 2019, to March 31, 2020); 242 community pharmacy inspections (random, targeted, and blitz) were completed during this fiscal year, with a total of 81(33%) rated as non-compliant. In comparison, during fiscal year 2018 to 2019, a total of 438 community pharmacies were inspected, with 111 (25%) rated as non-compliant.

During a pharmacy inspection, Health Canada inspectors examine relevant information such as purchase records, prescription records, loss and theft reports, destruction protocols, inventory reconciliation and security measures. Inspectors look for discrepancies between records and actual inventory, gaps in security measures and overall practices in the management of controlled substances. Observations that are linked to regulatory requirements are recorded in an inspection report, which is provided to the pharmacist to promote and encourage compliance and to enable the pharmacist to undertake corrective action. In cases where significant discrepancies are observed, Health Canada may undertake further compliance action such as a targeted inspection at the pharmacy at a later date and/or sharing the findings of the inspection with the relevant provincial or territorial regulatory authority for follow-up.

Through the pharmacy inspection program, Health Canada inspectors raise awareness of the requirements of the CDSA and its regulations in order to reduce the incidence of these types of observations. Observations made during pharmacy inspections fall under the following categories: record keeping, security, transactions (provide, sale, return), and other.

Record-keeping requirements

Under the CDSA and its regulations, pharmacists are required to keep records of all transactions, such as refills, prescription transfers and orders concerning controlled substances, for a period of at least 2 years. Inspectors verify records kept by pharmacists to ensure their accuracy.

Security requirements

Security requirements under the CDSA are also verified during an inspection. These requirements are in place to help pharmacies reduce the risk of loss or theft of products containing controlled substances. Inspectors check security practices such as alarm systems, access precautions and loss and theft reports submitted to Health Canada.

Provide, sale and return requirements

Pharmacists have specific requirements that they must adhere to when performing activities such as the provision, sale or return of controlled substances. For example, pharmacists must comply with the CDSA and its regulations when returning unserviceable stock to a licensed dealer, providing controlled substances to another pharmacy for emergency purposes and verifying the identity of the practitioner who issued the order or prescription.

Other

The regulations under the CDSA contain provisions that do not fit into the categories listed above. These provisions, such as the improper advertising of controlled substances, are captured in this category.

Risk-based approach

Health Canada developed and implemented a risk-based approach to pharmacy inspections that characterizes and describes observations as critical, major or minor based on the risk of diversion. The purpose of this approach is to ensure national uniformity in the classification of observations and to assist in assigning inspection ratings as compliant or non-compliant.

When classifying an observation as critical, major or minor, inspectors consider the scope (number of occurrences and quantity of product) and severity (potential for diversion) of the deficiency or deviation from the requirements of the CDSA or its regulations. In addition, the previous compliance history, implemented corrective actions and the diligence of the pharmacist to correct previous observations (i.e., willingness to comply and ensuring corrective actions have been implemented) can be taken into consideration.

Critical observations

• Observations classified as critical represent the most serious contravention of the CDSA or its regulations.
• An observation is critical if it involves the possibility of deliberate fraud, misrepresentation or falsification of information to circumvent the CDSA or its regulations, or if it clearly increases the immediate risk of diversion, prevents the detection of diversion or prevents the pharmacy from taking action to address the risk of diversion.
• An example of a critical observation would be if the inventory reconciliation from the inspection revealed large, unexplainable inventory variances.

Major observations

• Observations classified as major represent a serious contravention of the CDSA or its regulations.
• An observation is major if it increases the risk of diversion, impairs the detection of diversion or impairs the pharmacy from taking action to address the potential risk for diversion.
• An example of a major observation would be if a pharmacy did not report the loss or theft of controlled substances to Health Canada.

Minor observations

• A minor observation represents a deficiency or deviation from the CDSA or its regulations.
• A minor observation may be issued if the pharmacist is generally able to prevent, detect and take actions to address potential risks for diversion, but improvements could be made.
• An example of a minor observation would be if some prescriptions were filed in the regular prescription file and not in the narcotics and controlled drugs file, as required.

Non-compliant inspection rating

• An inspection rating of non-compliance is assigned to a pharmacy if one or more critical observations are identified, or if the inspection identifies that the pharmacist has failed to take all reasonable steps to protect all controlled substances on their premises or under their control against loss or theft, demonstrated by a combination of several major observations.
• When a non-compliant rating has been assigned to an inspection, Health Canada initiates compliance and/or enforcement actions, such as a follow up inspection, a referral to the provincial or territorial professional licensing authority, or a referral to law enforcement. Health Canada can also consider restricting a pharmacist’s privileges to order controlled substances.

Corrective and Preventative Actions

Following every inspection, regardless of the inspection rating (i.e., compliant or non-compliant), an inspection report is developed summarizing the observations noted during the inspection. The report is sent to the pharmacist. If applicable, the pharmacist is required to provide an outline of the specific corrective and preventative actions they will take to address the observations cited during the inspection. The inspector will review the corrective action plan sent by the pharmacist to determine if the proposed measures will address the noted deficiencies and prevent their re-occurrence in the future. An inspection may be required as a follow-up to verify the implementation of the corrective actions.

Random inspections

Over the course of the fiscal year 2019 to 2020, community pharmacy inspections were conducted using a risk-based approach; the following is a summary of the results. The inspection results will help inform future compliance promotion activities for community pharmacies and assist Health Canada in developing guidance for pharmacists on how to comply with the CDSA and its regulations. The risk-based approach was designed to be flexible and accommodate for changes, as needed.

Due to variations in provincial and territorial regulations, there are differences in the frequency of some observations from province to province. For example, some provinces have explicit and strict requirements regarding the inventory of controlled substances (e.g., frequency of performing and documenting inventory reconciliation), whereas other provinces are less prescriptive on inventory control in community pharmacies. Health Canada works with pharmacy regulatory authorities to ensure consistency in the application of the CDSA across Canada. During the fiscal year 2019 to 2020, a total of 81 random community pharmacy inspections were conducted across Canada. A total of 367 observations were noted during these inspections: 5 observations were critical, 275 were major and 87 were minor. Of these inspections, 17 (21%) were rated non-compliant and most of these were referred to the relevant provincial regulatory authorities for further review or action, as needed.

Figure 1 - Number of random community pharmacy inspections in Canada and their compliance ratings

Figure 1 – Number of random community pharmacy inspections in Canada and their compliance ratings – Text description

The map of Canada shows the number of random community pharmacy inspections conducted in each province: 20 inspections were conducted in British Columbia, 0 in Alberta, 7 in Saskatchewan, 10 in Manitoba, 24 in Ontario, 11 in Quebec, 2 in New Brunswick, 6 in Nova Scotia, 1 in Prince Edward Island and 0 in Newfoundland. The pie chart shows that 79% of inspections were rated compliant, while 21% were rated non-compliant.

Figure 2 - Observation types and their associated risk classification noted during random community pharmacy inspections

Figure 2 - Observation types and their associated risk classification noted during random community pharmacy inspections: text description

The bar graph shows observations noted during random community pharmacy inspections in the categories of records, security, provide/sale/return and other. In the category of records, 21 observations were major and 54 were minor. In the category of security, 5 observations were critical, 234 were major and 16 were minor. In the category of provide/sale/return, 19 observations were major and 4 were minor. In the category of other, 1 observation was major and 13 were minor.

Targeted inspections

In addition to the 81 community pharmacies inspected through random inspections, inspectors also conducted targeted inspections of community pharmacies. Pharmacies are selected for a targeted inspection based on risk assessment criteria and compliance history. For example, pharmacies that previously received a non-compliant rating may undergo a subsequent targeted inspection to verify the implementation of their corrective and preventative actions. Pharmacies may also be selected for a targeted inspection based on loss or theft information received by Health Canada or as a result of a referral from a provincial regulatory authority (e.g., provincial colleges of pharmacists).

Health Canada has therefore established more stringent criteria for assigning a non-compliant rating as a result of a targeted inspection. As such, it is to be expected that a higher rate of non-compliance may be observed for targeted inspections in comparison to random inspections.

During the fiscal year 2019 to 2020, a total of 131 targeted inspections of community pharmacies occurred across Canada with a total of 582 observations noted: 26 observations were critical, 451 were major and 105 were minor. Of these inspections, 63 (48%) were rated non-compliant and referred to the relevant provincial regulatory authorities for further review or action, as needed.

Number of targeted pharmacy inspections in Canada

Figure 3 - Number of targeted pharmacy inspections in Canada and their compliance ratings

Figure 3 - Number of targeted pharmacy inspections in Canada and their compliance ratings: Text description

The map of Canada shows the number of targeted community pharmacy inspections conducted per province: 21 targeted inspections were conducted in British Columbia, 9 in Alberta, 6 in Saskatchewan, 4 in Manitoba, 65 in Ontario, 11 in Quebec, 2 in New Brunswick, 7 in Nova Scotia, 2 in Prince Edward Island and 4 in Newfoundland.

Figure 4 - Observation types and their associated risk classification noted during targeted inspections of community pharmacies

Figure 4 - Observation types and their associated risk classification noted during targeted inspections of community pharmacies: Text description

The bar graph shows observations noted during targeted inspections of community pharmacies in the categories of records, security, provide/sale/return and other. In the category of records, 21 observations were major and 54 were minor. In the category of security, 26 observations were critical, 404 were major and 15 were minor. In the category of provide/sale/return, 24 observations were major and 11 were minor. In the category of other, 2 observations were major and 25 were minor.

Pharmacy inspection blitz

In addition to the random and targeted community pharmacy inspections, Health Canada may conduct inspection blitzes across Canada based on regional intelligence. A blitz is defined as multiple targeted inspections conducted in specific area(s) with a focused and coordinated approach over a specified period of time to assess compliance with the CDSA and its regulations and/or mitigate a suspected, discovered or referred issue(s). Pharmacy inspection blitzes also provide an opportunity for Health Canada to share information with pharmacists regarding legislative and regulatory requirements for controlled substances.

During the fiscal year 2019–2020, Health Canada conducted an inspection blitz of 30 community pharmacies in Calgary, Alberta, and Eastern Canada (consisting of St. John’s, Mount Pearl and Bay Roberts, Newfoundland). A total of 105 observations were noted: 0 observations were critical, 83 observations were major and 22 were minor. Of these inspections, 1 (3%) community pharmacy was rated non-compliant and may have been referred to the relevant provincial regulatory authority for further review or action, as needed.

Figure 5 - Blitz inspection results 2019–2020

Figure 5 - Blitz inspection results 2019–2020: Text description

The pie chart shows that 97% of the community pharmacy inspections conducted during the 2019 to 2020 fiscal year in the Calgary and Newfoundland blitz were rated compliant, while 3% were rated non-compliant.

Figure 6 - Observation types and their associated risk classification noted during the blitz 2019 to 2020

Figure 6 - Observation types and their associated risk classification noted during the blitz 2019 to 2020: Text description

The bar graph shows observations noted during targeted inspections of community pharmacies conducted during the 2019 to 2020 blitz in the categories of records, security, provide/sale/return and other. In the category of records, 4 observations were major and 19 were minor. In the category of security, 70 observations were major and 1 was minor. In the category of provide/sale/return, 7 observations were major and 1 was minor. In the category of other, 2 observations were major and 1 was minor.

Conclusion

In addition to conducting inspections to promote compliance with the CDSA and its regulations, the Community Pharmacy Inspection Program provides the opportunity for Health Canada to identify common issues that may lead to an increased risk of diversion of controlled substances. Some of these issues can be addressed through the development of national guidance documents. The following guidance documents have been made available on the Government of Canada’s website:

• Guidance document: Reporting loss or theft of controlled substances and precursors (CS-GD-005)
• Guidance document: Handling and destruction of post-consumer returns containing controlled substances (CS-GD-021)
• Guidance document for pharmacists, practitioners and persons in charge of hospitals: Handling and destruction of unserviceable stock containing narcotics, controlled drugs or targeted substances

The most common observations cited within a pharmacy inspection report during this past year were consistent with those of previous years. Health Canada continues to explore ways to promote compliance with the CDSA and its regulations. This includes active engagement with national and provincial organizations, such as pharmacy colleges, that are partners in reducing risks associated with the diversion of controlled substances. Informed by the inspection of pharmacies, the risk-based approach to inspections has been adapted to address issues related to potential diversion. Increasing security measures within a pharmacy and educating pharmacists on regulatory requirements during an inspection may reduce the incidence of security-related observations.

Planning ahead

The ongoing data collected from this program will inform our pharmacy inspection approach in the future. Health Canada will shift toward risk-based inspection planning. therefore, future reporting may differ from the data presented for fiscal year 2019 to 2020.