Pharmacovigilance (PV) is defined by the World Health Organization (WHO) as ‘the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem’. It provides the foundation for monitoring and evaluating adverse drug reactions (ADRs) and is a key component of effective drug regulation, patient safety and the upkeep of public health.
What is an ADR?
An adverse drug reaction is a broad term referring to unwanted, uncomfortable, or dangerous effects that a drug may have. These can include symptoms or diseases temporally associated with the use of a medicinal product, that may not have been previously associated with that product.
Why do we need to monitor ADRs?
Although pre-market clinical trials are conducted for medicines and drug products, the scale and magnitude of such trials can vary. Some trials may include up to 10 000 subjects, whereas others, such as being conducted for ‘orphan drugs’ could have engaged only a dozen patients.
As a result of these limitations, less common and rare ADRs are unlikely to have been detected during clinical trials. Therefore, PV plays a vital role in detecting and monitoring these reactions once a drug is post-market and ensures that doctors and patients have enough information to make an informed decision when it comes to choosing a drug treatment.
What does PV entail?
Regulatory authorities such as Health Canada mandate pharmacovigilance for manufacturers. These requirements include:
- Designing PV systems
- Completing audits and inspections
- Generating Annual Summary Reports (PSURs, PBRERs)
- Product Risk Assessments & Mitigation Strategies
- Risk Management Plan (RMP)
- PV Training (Clinical Trial and Post Market Serious Adverse Event / Medical Device Problem Reporting)
- Writing Health Care Professional Letters / Public Advisories
Marketing Authorization Holders (MAH) and importers are also subject to GVP inspections in Canada.
How can AxSource Help?
AXSource Consulting supports Pharmacovigilance (PV) services for the health care industry in all of these areas and can customize solutions to meet your requirements. Contact us today to find out more at info@axsource.com.
