In the long lifecycle of drug development, there involves a phase of clinical trials before hitting the market and a sustained post marketing surveillance and pharmacovigilance phase aimed at patient safety and flawless use of the marketed therapies in the real-world markets.
Both pharmacovigilance and post-marketing surveillance are considered the strong pillars that work for patient safety throughout the lifecycle of a medicinal product.
Post-marketing surveillance tracks the performance of a drug. It is an extension of clinical trials that culminated in the drug’s launch. Early clinical trials of a drug, despite their satisfying outcomes, are not adequate to judge the efficacy, as they are only a fraction of the tests to assess the peak performance after use by a large and varied patient population.
The process of pharmacovigilance systems comprises spontaneous reporting by both healthcare professionals and patients on the positive and negative effects of a drug. The active surveillance readily detects any harmful signals.
Post-marketing Pharmacovigilance solutions
- PV planning and strategy development
- Making a PV safety database and its management
- Faster adverse event reporting
- Regulatory intelligence inputs
- Collating of safety and benefit-risk profiles
- Post-marketing safety surveillance
Many would say if there had been active post-marketing surveillance and pharmacovigilance, the Thalidomide tragedy in the 1960s could have been avoided.
The drug meant for morning sickness led to severe birth defects in its users and is a historic reminder about the critical need for drugs in the market for timely corrections, ensuring user safety and prevention of widespread harm in the communities.
Among post-marketing surveillance and pharmacovigilance, the latter monitors how the balance between benefits and risks works in a given drug. When there is a growing trail of feedback and new safety information, the ratio can change.
If there is evidence that the risks of a drug are overtaking its benefits for different patient groups, regulatory authorities will act appropriately. They can update product labels, introduce new warnings, caution for moderate usage, or pull out the drug altogether, as in the withdrawal of Vioxx.
Choice of clinical trial partner matters
The competence of companies like Allucent with multiple roles, including post-marketing pharmacovigilance (PV) solutions, integrates many facets of expertise, including medical, regulatory, clinical, technology and quality assurance, to drive efficiencies that minimize manual effort and help the end user with reduced costs.
Supporting Global Safety and Continuous Improvement
The FDA in the US and the EMA in Europe are examples of regulatory bodies that keep an eye on drug companies. These groups find pharmacovigilance activities and their proactive reporting of bad events to be very useful.
This makes safety standards better and encourages people all around the world to work together to keep an eye on medicine safety, which is very important for drugs marketed all over the world. Data from pharmacovigilance helps improve current drug formulations and helps make new drugs that are safer.
Going beyond the static launch phase, the post-marketing data collection and resulting updates augment the all-round performance of the drug with dynamic, continuous evaluation, keeping safer medications and patient safety in mind.
Summing Up
In order to sum up, both pharmacovigilance and post-marketing surveillance are solid safety nets addressing all drug-related concerns whenever a new drug product is released into the market.
