Pharmacovigilance is an important scientific discipline for pharmacists. The word is derived from the Greek word pharmakon which means medical substance and the Latin word vigilia which means “to keep watch.”
Pharmacovigilance is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other medicine or vaccine-related problem. As a pharmacist, you are in a unique position to help ensure patient safety through this elaborate and systematic process.
History of Pharmacovigilance
Pharmacovigilance has been an existing practice for over 150 years, but it has continuously been evolving as various medical events take place. One significant event that further solidified the essence of pharmacovigilance is the thalidomide tragedy.
In the late 1950s, a drug called thalidomide was developed with the indication of being a sedative. Initial testing on animals saw that the drug was essentially nontoxic. This led to the drug being widely used as an over-the-counter treatment for various illnesses, including morning sickness among pregnant women.
In the following years, however, medical reports showed cases of congenital malformation among children whose mothers had taken the drug during pregnancy. Other reports, such as the one made by Miller and Stromland, also corroborated these findings with results that showed other developmental anomalies in various systems, like kidney malformations, ocular alterations, dental deformities, and other anomalies. It was formally withdrawn from the market in 1961, but not before affecting around 10,000 babies worldwide. This heartbreaking debacle uncovered critical matters regarding industry practices in drug safety, monitoring, and marketing. It sparked a change in reporting of adverse reactions, leading to the creation of a more systematized and regulated process. In 1964, a specialized form called the Yellow Card scheme was established in the UK. This system is used to report various safety and quality issues of medications and is being used until today.
Why Pharmacovigilance Is Important
Medicines undergo a series of clinical trials for short-term safety, efficacy, and approvals before being made available in the market. This series of tests is done only on carefully selected individuals and accounts for short-term safety and efficacy. This puts the need for the continuous monitoring of drugs for effectiveness and safety even after their release, further stressing the significance of pharmacovigilance as standard practice.
Pharmacovigilance covers all aspects of medicine safety, including:
- Prescribing errors – These are mistakes made during the process of prescribing medication, including wrong dosing or writing down the wrong drug completely.
- Product quality issues – these involve drug contamination, defective components, poor packaging, and more.
- Adverse reactions – this can arise from both prescription and over-the-counter medications and are characterized by an unintended response to a drug taken at normal doses and during normal use.
When unchecked, drug intake may lead to an adverse drug event (ADE), an instance wherein the patient is harmed by the medicine they are taking or by the way they are using the medicine. An ADE can be caused by medication errors, overdoses, and dose reductions. Medication errors can happen when prescribing, dispensing, or administering medicine.
ADEs can also be triggered by an adverse drug reaction (ADR), which is an unintended response to a drug taken at normal doses and during normal use. For instance, a patient may exhibit hemorrhaging as an adverse reaction to anticoagulants or blood thinners. In severe cases, this may lead to hospitalization. Pharmacovigilance entails the prevention of these hazards from happening to the patient.
Key Role of Pharmacists in Pharmacovigilance
The perception of pharmacists’ role in healthcare has transitioned from primarily being product-driven to patient-centric. As medicine experts, pharmacists can help ensure the safety of patients by catching prescribing errors, identifying possible ADRs and reporting them, as well as identifying other potential problems with medications. Enforcing proper dispensing of medicines is also a fundamental responsibility of pharmacists in guaranteeing patients’ safety.
Pharmacists are in an important and unique position to offer valuable information to patients and consumers about the pharmaceutical products they were prescribed to use. One study conducted in Saudi Arabia showed that patient counseling performed by pharmacists significantly reduced frequency of preventable ADEs to 1% compared to 11% in a control group, further illustrating the impact of pharmacists’ responsibility in patient counseling.
By maintaining a vigilant watch over the safety of medications, pharmacists can help ensure that patients receive the safest and most effective care possible. Unilab, with its mission to build a healthier Philippines through quality medicines, is one with pharmacists and healthcare professionals in the practice of pharmacovigilance.
Sources:
https://www.fda.gov.ph/pharmacovigilance/
https://www.pbm.va.gov/PBM/vacenterformedicationsafety/tools/AdverseDrugReaction.pdf
https://www.fda.gov/drugs/information-consumers-and-patients-drugs/finding-and-learning-about-side-effects-adverse-reactions
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6297296/
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3224344/
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6132952/#:~:text=The%20etymological%20roots%20for%20the,Latin)%20%3D%20to%20keep%20watch.
https://academic.oup.com/toxsci/article/122/1/1/1672454#63406514
https://www.sciencemuseum.org.uk/objects-and-stories/medicine/thalidomide
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5774321/
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6080998/
https://psnet.ahrq.gov/primer/pharmacists-role-medication-safety
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5065524/
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6080998/
https://link.springer.com/article/10.1007/s11096-018-0657-1
