Community Pharmacy Inspection Program Annual Report, Fiscal Year 2016-2017

Executive Summary

Health Canada helps protect Canadians by minimizing the diversion and problematic use of controlled substances. Health Canada does this, in part, 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 of community pharmacies.

The Office of Controlled Substances (OCS) of the Opioid Response Team 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 legal controlled substances, and can therefore reduce the risk of substances moving from legitimate channels to illegal markets.

The Controlled Substances Program of the Regulatory Operations and Regions Branch (RORB-CSP) carries out the operational functions that allow for the control of legal substances. Its compliance and enforcement mandate includes inspecting community pharmacies to ensure compliance with the Controlled Drugs and Substances Act (CDSA) and its associated Regulations.

Background

Health Canada 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 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 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. Health Canada works with internal and 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. The program is designed to minimize potential situations in which controlled substances could be diverted to illegal markets, and to ensure that researchers, health care practitioners and patients alike are engaged in the proper storage, use and disposal of these substances. In addition, Health Canada may refer suspicious activities to the relevant College and share information with the provincial Colleges and/or law enforcement agencies to assist in investigations when requested.

Through these and other activities, Health Canada is committed to minimizing the diversion and problematic use of controlled substances.

Problematic Prescription Drug Use

Problematic prescription drug use, 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 Federal Action on Opioids, which focuses 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 illegal drug production, supply and distribution.

What We Do – Community Pharmacy Inspection Program

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 address problematic prescription drug use including problematic opioid use. In 2015, Health Canada announced that it would conduct 1000 compliance promotion inspections in community pharmacies across the country by March 31, 2019. The selection of community pharmacies to be inspected is random but representative of the distribution of the estimated 10 000 community pharmacies across Canada, as per Table 1 below. 100 planned inspections were completed from April 2015 to March 2016, and 300 per year were planned for fiscal years 2016-17, 2017-18 and 2018-19.

Additionally, Health Canada carries out "targeted" inspections of pharmacies based on collected information that indicates an elevated risk of diversion or non-compliance with the CDSA. For the purposes of this report, only the results of planned inspections will be discussed.

Table 1. Number and proportion of pharmacies in Canada by province/territory for fiscal year 2015-16

Date	Province/ Territory	Estimated Numbers of Pharmacies in Canada as of October 2015	Estimated percentage of Pharmacies in Canada as of October 2015
2015-16	British Columbia	1235	13%
	Alberta	1121	12%
	Saskatchewan	359	4%
	Manitoba	403	4%
	Ontario	3933	41%
	Québec	1873	19%
	New Brunswick	216	2%
	Prince Edward Island	47	0.5%
	Nova Scotia	304	3%
	Newfoundland and Labrador	195	2%
	Northwest Territories	11	0.1%
	Yukon	8	0.1%
	Nunavut	5	0.1%
	Totals	9710	no data

Inspections and Observations

The Annual Report for fiscal year 2016-17 provides a summary of findings from the Community Pharmacy Inspection Program. A total of 300 planned pharmacy inspections were conducted this year.

Table 2. Total number of planned inspections and inspections by quarter, by province/territory for fiscal year 2016-17

Date	Province Inspected	Number of Inspections		Inspections by Quarter
		Planned	Completed	Q1 (Apr-Jun)	Q2 (Jul-Sep)	Q3 (Oct-Dec)	Q4 (Jan-Mar)
2016-17	British Columbia	38	38	23	14	1	0
	Alberta	35	35	22	11	2	0
	Saskatchewan	11	11	4	4	3	0
	Manitoba	12	12	7	5	0	0
	Ontario	121	122	31	31	58	2
	Québec	59	57	17	17	15	8
	New Brunswick	7	8	3	2	2	1
	Prince Edward Island	2	2	1	1	0	0
	Nova Scotia	9	9	4	2	1	2
	Newfoundland and Labrador	6	6	2	2	2	0
	Totals	300	300	114	89	84	13

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. Observations, which are linked to regulatory requirements, are recorded in an inspection report which is provided to the pharmacist for discussion, to promote and encourage compliance and to undertake corrective actions. In cases where significant discrepancies are observed, Health Canada may decide to 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 regulatory College for follow-up.

The education of pharmacists on the requirements of the CDSA and its associated Regulations may reduce the incidence of these types of observations.

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 in respect of controlled substances. Inspectors verify records kept by pharmacists to ensure their accuracy. In 2016-17, approximately 75% of the inspections conducted noted observations regarding record keeping.

Inspectors often noted:

• that inventory records were incomplete or inaccurate, or may have been adjusted without an explanation if there was an overage or shortage of controlled substances.
• 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.
• that narcotic prescriptions were filed with regular prescriptions or that a separate narcotics file was not kept at all.

2. 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 controlled substances. Inspectors check security practices such as alarm systems, access control, and the submission of loss and theft reports to Health Canada. During inspections completed in the 2016-17 fiscal year, Health Canada inspectors commonly observed security-related issues. Most observations were of a minor or non-critical nature; however, in some cases, inspectors found that controlled substances were stored in unsecured locations, meaning that the potential for diversion was higher.

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 a licensed dealer when unused, and the management of methadone prescriptions. Of the inspections conducted in the 2016-17 fiscal year, there were issues with stock management observed approximately 30% 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.

Corrective and Preventive Actions

Following every inspection, a report is developed based on the observations made during inspection. Pharmacists are given the opportunity to respond to this report, including any corrective or preventive actions they may take to address observations, such as changing where controlled substances are stored or improving inventory control. After a response has been received and reviewed, Health Canada will close out the inspection file.

In the fourth quarter of fiscal year 2016-17, there were three pharmacies that were deemed non-compliant and that were referred to the appropriate regulatory colleges. All three pharmacies were referred due to security and record keeping issues.

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 with compliance to the regulations, which in turn facilitates the development of national guidance documents.

As described above 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. Increased security measures within a pharmacy and pharmacists' level of awareness on the requirements for controlled substances that were unaccounted for during an inspection may reduce the incidence of security-related observations. In addition, a new guidance document regarding how to report losses and thefts has been developed to promote compliance with the regulations.

Forward Planning

During the fiscal year 2016-17, Health Canada began developing a systematic way to categorize and describe inspection observations. To date, Health Canada acknowledges it has been a challenge to clearly depict pharmacists' compliance with the CDSA and its regulations within the current format. As of April, 2017, Health Canada has implemented a new inspections rating system to assess and categorize observations as major, minor or critical. This risk-based approach will be used going forward to carry out targeted inspections based on the results found in regular pharmacy inspections. Therefore, the data presented for fiscal year 2016-17 may differ from the data presented in upcoming fiscal years.

The implementation of the Community Pharmacy Inspection Program in 2015 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 two years of the program. As a result, several pharmacies came forward and voluntarily reported instances of non-compliance to Health Canada so that immediate corrective actions could be taken. It is anticipated 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.