One of the most fundamental principles of all pharmaceutical companies is the safety of the patient.
The Pharma industry has records of tragic stories of how many patients suffered from the effects of medicines. Initially, no-one had thought to capture these reactions in a central system &and detect repeated events (known as signals). Probably the most commonly known story concerns Thalidomide (1965) and Phocomelia ((congenital limb defects) – where experts estimate that the drug thalidomide led to the death of approximately 2000 children and serious birth defects in more than 10 000 children. Thalidomide was marketed for insomnia, coughs, colds and headaches, yet pregnant women found it helped with their morning sickness. History tells their story …
Pharma learned a harsh lesson! and legislation changed. In 1970, the FDA legislated the incorporation of package Inserts to all medicines packs, together with structure and laws for reporting adverse reactions by healthcare professionals (HCPs) and consumers. Over time, these laws have been amended to include warnings in the package inserts.
And so, these events resulted in the birth of Pharmacovigilance….:
Introducing the science and activities relating to the:
• and prevention
of adverse effects or any other medicine-related problem (WHO Definition)
Pharma companies have a legal obligation to patients, to healthcare professionals and to the Regulatory authorities to constantly monitor their products to retain their license.
During the development phase, extensive and rigorous pre-clinical and clinical testing is done to establish a potential new medicine’s safety and efficacy. Unfortunately, not all side effects are identified during the testing phase. Some side effects only become apparent when a medicine has been in use for several years after massive populations over the world are exposed to the medicine, taking into consideration individual patient/user characteristics.
The continued safety monitoring of medicines after their launch is therefore also an essential part of pharmaceutical companies’ responsibility to patients. We continually work with the safety data to identify signals that suggest an adverse event may be associated with the use of one of our medicines. Some approved medicines are withdrawn from the markets due to safety concerns when data collected indicates that the risks outweigh the benefits of the medicine.
One of the highest costs incurred during the provision of healthcare is hospitalisation of patients due to preventable adverse drug reactions (ADR), often much higher than the costs of conducting clinical trials.
Pharmacovigilance is gaining more importance as the number of drug recalls increase.
Worldwide health authorities require that companies who develop, manufacture, distribute, market and/or licence medicinal products or devices must:
- ·Monitor the safety profile of their products
- Report certain types of events that occur during or following the use of their products in both clinical trials and marketed use within the prescribed timeframes, as described in international and local regulations
Ø Collect and monitor safety data from all sources (consistent standards)
Ø Perform ongoing analysis and identification of safety signals (uniform company position)
Ø Provide appropriate clarification, communication and action
BUT there remains a lack of awareness and reporting of these adverse reactions amongst the healthcare professionals as well as the patients, especially in developing countries. It has been reported that only 2-4% of all adverse reactions and 10% of serious ADRs are reported worldwide.
Healthcare professionals are vital to the success of this vigilance system as they are the front line between the patients, their drug reactions and the pharmaceutical companies. Their medical training provides them with extensive knowledge and therefore they have the expertise to manage medication safety through early detection, management and reporting of these safety concerns.
We rely on healthcare professionals, including physicians, pharmacists and nurses, to report any suspected adverse reaction, especially to newly authorised medicines. Safety assessment should be an integral part of everyday practice and reporting should become second nature to them.
This is the first in a series of articles to be provided by IPASA