When a drug is given regulatory approval to enter the marketplace, a much broader patient population than documented in clinical trials is exposed to the product. Not only is there less control on drug prescription than in a clinical trial, but there is also the chance that certain populations taking the drug may not have been closely studied. Sometimes, rare adverse effects are not even discovered until a product is in its post-approval phase.
As a regulatory affairs professional, you will play an important role in ensuring that pharmaceutical companies keep public safety a priority even after a drug is approved. Pharmacovigilance is defined as the practice of collecting, detecting, assessing, monitoring and preventing the adverse effects of pharmaceutical products post-approval. These activities are just as important as the regulatory guidelines that take place before and during clinical trials.
Health Canada’s Good Pharmacovigilance Practices (GVP) Guidelines provide a detailed outline of the following post-approval activities in regard to Adverse Drug Reporting (ADR):
- Procedures and Processes
- Collecting Adverse Effects Data
- Evaluating Data
- Reporting Data
- Annual Summary Report and Case Reports
Keep reading to learn more about these post-approval activities that are necessary to keep the public safe, ensure regulatory compliance, and maintain the integrity of pharmaceutical companies.
Defining Procedures and Processes is the First Step to Post-Approval Activities
Our Pharmaceutical Regulatory Affairs program provides a comprehensive certificate teaching the skills, techniques, and concepts needed to be successful in your new career. Whether you end up working directly for a pharmaceutical company or for a third party, it’s imperative to establish and follow the post-approval safety procedures and processes regarding Adverse Drug Reporting as outlined by Health Canada.
The first step to a successful and organized post-approval safety committee is defining the procedures and processes in writing regarding complaints and ADRs in detail. This includes, but is not limited to, details such as:
- How complaints about a drug with be received, handled and followed up
- How complaints will be tracked and logged in
- Identifying the personnel responsible for forwarding complaints to Health Canada within the appropriate timeframes
- Addressing and understanding all specific Canadian regulatory requirements
The clearer and more organized the procedures and processes are, the quicker the data can be analyzed, and any issues can be appropriately handled. During your educational journey at AAPS, you’ll strengthen your skillset and gain confidence in your abilities to successfully create and follow post-approval procedures and processes.
Pharmaceutical Regulatory Affairs Professionals Collect Data from Around the World
Effectively collecting data requires strong skills in research, written communication, and strict attention to detail. There are many different sources that need to be considered. Some examples include:
- Regulatory Authority Sources: Consumers, healthcare professionals, and manufacturers most commonly report any adverse effects of a pharmaceutical product to regulatory authority databases. In Canada, the Canadian Vigilance Adverse Reaction Online Database is a trusted source for post-approval surveillance. Within the United States, it is the FDA Adverse Event Reporting System.
- Unsolicited Reports: These include communication from a healthcare professional or consumer directly to a pharmaceutical company, a regulatory authority such as Health Canada, or any other related organization.
- Solicited Reports: This information comes from data collection systems such as surveys, clinical trials, post-approval named patient use programs, and so on.
- Literature Searches: Post-approval activities also include screening scientific literature across the globe using reference databases. Health Canada suggests this is done bi-weekly.
Not only does all this data need to be tracked, but it must be documented and reviewed in a timely manner to determine whether next steps need to be taken.
Evaluating Adverse Effects Data Within Expedited Timeframes
When analyzing the data, the seriousness and expectedness of adverse effects must be evaluated. Expectedness is determined from the information provided to a consumer, such as a product label or information sheet.
During your pharmaceutical courses, you’ll learn that there are 4 minimum criteria for required expedited reporting to regulatory authorities:
- An identifiable source or reporter
- An identifiable patient
- A suspected product
- An adverse reaction
Expedited reporting must be done within 15 days of receiving an adverse effect report.
If an adverse effect report does not qualify for reporting, then justification must be documented, explaining why. In addition, a qualified healthcare professional must also evaluate and assess adverse effects to determine if they should be reported.
Reporting Adverse Effects is a Crucial Post-Approval Activity
Once an adverse effect has been identified, it is of utmost importance that it be reported to Health Canada (or the governing regulatory authority of the region you are in). It is also important to keep in mind timeframes, such as Health Canada’s expedited reporting requirement of 15 days.
Failing to adhere to regulations and timelines not only puts patient health and safety at risk but can also lead to consequences for non-compliance and jeopardize the integrity of a pharmaceutical company.
Creating Annual Summary Reports and Case Reports
In addition to the previous post-approval activities, a report must be created that contains all the information gathered relating to the adverse effects of a drug every 12 months.
This information must also be critically analyzed within the report to determine whether the risks and benefits of the drug have changed. If there has been a significant change, regulatory authorities must be notified, in which case further steps will need to be taken.
Regulatory affairs play a role in every stage of drug development, of which post-approval is only one aspect. AAPS provides you with the education you need to be a successful link between pharmaceutical companies and regulatory authorities such as Health Canada. If you have a background in science and are looking for a stimulating and rewarding occupation, a career in regulatory affairs may be the perfect fit for you.
Are you interested in enrolling at a pharmaceutical school?
Contact AAPS for more information today!