The World Health Organization defines pharmacovigilance as 'the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem'.
Pharmacovigilance focuses on monitoring and evaluating the safety of medicines after they have been approved for sale. It involves all the scientific disciplines necessary for the protection of public health with respect to medicinal products. Since pharmacovigilance aims to detect, assess, understand, and prevent adverse effects, is required for any product that has been approved for sales. This sector of science keeps people safe by ensuring medicines have been properly tested and monitored for safety, quality, and performance. It is a constant process that involves recording reports about health problems in patients who have taken a particular medicine or drug. This information can be used to help keep medications safe for everyone who uses them.
Its primary objective is to find out any adverse reactions to medicines that cannot be predicted from clinical trials.
Pharmacovigilance is a monitoring system, reporting system and scientific discipline. It is also called ADR monitoring, pharmacovigilance or surveillance.
The primary objective of pharmacovigilance is to find out any adverse reactions to medicines that cannot be predicted from clinical trials. The aim of doing this is to identify these medicines before they reach the market and before they are used by patients.
Pharmacovigilance is required for any product that is approved for sales.
Pharmacovigilance is required for all medicines, including those that are over-the-counter (OTC). The global nature of pharmacovigilance means that it applies to everyone involved in the use and safety of approved medicines. This includes patients, healthcare professionals, pharmacists, and manufacturers. Pharmacovigilance is a legal requirement and any person who does not comply with this requirement may be committing an offense under the Medicines Act 1968 (as amended) or other relevant legislation.
The pharmacovigilance process involves five main steps.
The five main steps in the pharmacovigilance process are:
- Identification of the problem - The first step involves identifying whether an issue has occurred with a drug or a group of drugs. This can be done by monitoring adverse event reports, or through clinical studies and medical literature.
- Reporting the problem - Once it's identified that there are problems with a drug, reporting information about them is important so that other people using it can be aware of potential risks.
- Investigation - Once reported, your healthcare provider will look into what's going on and decide if further investigation is needed to confirm whether this is really happening more than expected, or if something else could explain why you think something may be wrong with your medicine.
- Communication - If any new information comes up during the investigation stage that pertains to what happened before this point (e.g., new research shows how long-term use might increase risk), then your healthcare professional will communicate this back out through channels like newsletters or websites so that everyone who uses this medication knows what's going on as soon as possible.
How do we ensure that adverse reactions are reported as quickly and effectively as possible, to ensure patients are protected?
In order to ensure that adverse reactions are reported as quickly and effectively as possible, we rely on a number of different groups. The first step is for patients to report the reaction themselves by seeing their doctor or pharmacist. If the reaction causes an emergency, then medical staff will also report it directly to the authorities. Finally, doctors can conduct clinical trials that report any adverse reactions observed during testing of new drugs.
What happens next?
Once you've reported an adverse reaction to your doctor, it's time to wait. The next step in the process is pharmacovigilance, which aims to ensure that medicines are properly tested and monitored for safety, quality and performance throughout their life cycle in order to protect public health. This is where an evaluation team will look into the report and determine whether or not there's a causal relationship between your medicine and your symptoms. This can take anywhere from a few days to several weeks.
Once they have decided that there is indeed a causal relationship between your medicine and its side effects, they will decide which agency should be notified of this finding. After the chosen agency has been notified of their findings regarding any safety issues with certain drugs on their market, it becomes part of an official report known as RARs (Risk Assessment Reports).
Pharmaco-vigilance is an important step that must be taken towards ensuring the safety of medicines. History has proven that those who have been involved with the development, production, and distribution of medicinal products have a responsibility to protect the public from harmful products.