The National Association of Pharmacy Regulatory Authorities is honoured to appear before this committee today.
Our organization represents most of the provincial and territorial pharmacy regulatory authorities. During this presentation I'll be speaking to the role of the pharmacy regulatory authorities; the regulatory tools that are currently employed, specifically with regard to adverse drug reactions reporting; the challenges posed by mandatory ADR reporting; as well as the opportunity that partnerships could bring.
The Food and Drugs Act and the Controlled Drugs and Substances Act and their associated regulations define how prescription drugs may be manufactured, advertised, labelled, and sold. This legislation informs pharmacists and others of their responsibilities in the procurement, sale, and recording of the sale of prescription drugs.
However, the practice of pharmacy comes under provincial and territorial jurisdiction. The territorial governments retain responsibility for regulating the profession. However, the profession is self-regulating in the provinces, with the authority to regulate delegated through provincial legislation to the members of the profession. The fundamental role is protection of the public.
The Pharmacy Regulatory Authorities regulate people, places, and things. They regulate the practice of pharmacists, the operation of pharmacies, and the conditions of sale of non-prescription drugs. The regulation of pharmacists is accomplished through three core processes defined within legislation: registration or how to become licensed or enter practice, complaints resolution, and continuing competency assessment.
In addition to provincial acts and regulations, other regulatory tools include standards of practice, bylaws, and codes of ethics. These tools combined form a robust system that fully defines the expectations required of pharmacists in order to fulfill their duties. Any deviation from or dereliction of these duties is cause for complaints to be brought against a pharmacist. The complaints are investigated by the regulatory authority, and if sufficient evidence is found, the pharmacist is required to appear before a jury of his peers to answer to the allegations.
The reporting of adverse drug reactions is an expectation of practising pharmacists. In British Columbia, adverse drug reactions reporting is mandatory, as expressed in bylaws, which are approved by provincial government. Bylaw 44(4) states: “Where an adverse drug reaction as defined by the Health Protection Branch, Health Canada, Guidelines for Reporting Adverse Drug Reactions is identified, the pharmacist must notify the patient's practitioner, make an appropriate entry on the patient record and report the reaction to the BC Regional Adverse Drug Reaction (ADR) Reporting Centre.”
In Alberta, standard of practice number 4 states: “If a pharmacist determines that a patient has or is likely to have a drug-related problem, the pharmacist must take appropriate action.” This is further defined under section 4.2, “the appropriate response may include any one or more of the following:” and includes (g) reporting an adverse reaction to the Canadian adverse drug reactions monitoring program.
Ontario's standard of practice number 1.7 states: “The pharmacist documents and reports any unexpected adverse drug reactions to the prescriber and other health care providers as appropriate, and complies with formal adverse drug reactions reporting programs.”
Other provinces have addressed adverse drug reactions reporting within standards of practice, guidelines, and professional practice policies, or alternately, have referenced the Guidelines for Reporting Adverse Drug Reactions to Marketed Drugs publication by Health Canada. In short, the regulatory tools to encourage adverse drug reactions reporting by pharmacists already exist.
The reporting of adverse drug reactions is a key component of a robust, comprehensive post-marketing surveillance program on the use of medications in humans. Yet it has been estimated that only a small percentage, less than 10%, of these events are reported. The regulatory tools are already in place to require pharmacists to report adverse drug reactions where appropriate. Yet it seems that neither the presence nor the absence of regulatory tools is the trigger that drives adverse drug reactions reporting. This suggests there are many more challenges that need to be addressed and that mandating adverse drug reactions reporting does not seem to provide a plausible solution.
Many challenges have been identified to adverse drug reactions reporting, many of which have been previously addressed in the 2005 Health Canada discussion paper “Designing a Mandatory System for Reporting Serious Adverse Reactions”. They include lack of training and recognizing adverse reactions, lack of awareness of the existence and benefits of a reporting system, time and effort required to do so, and the lack of familiarity with how to report. I am uncertain that the implementation of a mandatory adverse drug reactions reporting system addresses these challenges.
Another challenge not identified in the discussion paper is the lack of comprehensive, reliable data upon which to assess whether or not an adverse drug reaction has occurred. Great strides have been taken in the development and implementation of a pan-Canadian electronic health record. It is Canada Health Infoway's goal for 50% of Canadians to have their electronic health record available to health professionals by the year 2010. However, until health professionals are able to access the electronic health record for all Canadians, the depth and the quality of information that's required may not provide the results desired with an adverse drug reaction reporting.
Enforceability is yet another issue, and brings forth the question of where the responsibility lies. Pharmacy regulatory authorities have the authority to perform practice audits and site visits to monitor registered pharmacists and licensed pharmacies. However, not all hospital pharmacies are licensed by the pharmacy regulatory authority in each province.
In addition, this is a very resource-intensive activity for the pharmacy regulatory authorities, who rely almost exclusively upon fees collected from licensing and registration of pharmacists and pharmacies as an annual source of revenue.
Finally, should adverse drug reaction reporting be mandated through federal regulation, there is now the question of who should have the responsibility for monitoring and enforcing the regulation.
NAPRA is supportive of adverse drug reaction reporting as part of a comprehensive post-marketing surveillance system that has the ability to look closely at real-world experiences with the goal to identify adverse drug reactions in populations outside a clinical trial setting in order to protect the Canadian public from harm. However, NAPRA does not feel that mandating adverse drug reaction reporting and increasing the regulatory burden will accomplish this goal. It may be more appropriate to adopt a systems approach with other partners and stakeholders contributing to a surveillance and reporting system with a common goal of promoting quality health outcomes.
What is required is a substantive culture change, facilitated through education and communication, to build awareness of the importance of adverse drug reaction reporting as well as the clarity of what is expected. Enhanced development of advanced technological solutions that are easy to use will encourage the reporting of adverse drug reaction to be incorporated into daily practice. Effective data analysis and reporting mechanisms to ensure that informed feedback is available and accessible to health professionals in a timely manner will serve to reinforce the practice of reporting.
We need to think about the role of the federal government, the provincial and territorial governments, professional regulatory authorities, and health professionals, as well as such stakeholders as industry, the Canadian Patient Safety Institute, the Institute for Safe Medication Practices, and academia. If attention can be focused here, and a willingness can be secured from all parties involved to make this issue a priority, it is a certainty that adverse drug reaction reporting events will continue to increase, as they have in the past, without the need to mandate.
Thank you.