According to the World Health Organization (WHO), pharmacovigilance is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. In simple terms, it is a system concerned with drug safety, and through which negative effects of pharmaceutical drugs are identified, assessed, understood and prevented. The two main thrusts of pharmacovigilance are safety and efficacy. The drug must work, and it must also be safe.
Why is pharmacovigilance necessary?
Pharmacovigilance became an important watchword internationally after the 1961 Thalidomide Disaster. It was after this disaster that the WHO created its Programme for International Drug Monitoring. The drug thalidomide was licensed in July 1956 for prescription-free over-the-counter sale in Germany and most European countries. It was marketed as a mild sleeping pill that was safe enough for even pregnant women to use. It also helped to reduce morning sickness, and soon became popular with expecting mothers.
According to Helix, “By 1960, thalidomide was marketed in 46 countries, with sales nearly matching those of aspirin.” By this time, concerns about its negative side effects began to emerge. This included children with impaired limbs and nerve damage. By 1961, a definite link was made between the drug and the disabilities reported. It became common knowledge that its side effects on unborn children were ‘teratogenic’ (monster-forming), and thalidomide was removed from the market. Over 10,000 children were born with thalidomide-induced disabilities.
Aims of Pharmacovigilance
Jamaica’s Ministry of Health lists the aims of pharmacovigilance as:
- “to enhance patient care and patient safety in relation to the use of medicines, especially with regard to the prevention of unintended harm from the use of drugs;
- to improve public health and safety in relation to the use of medicines by the provision of reliable, balanced information resulting in more rational use of drugs;
- to contribute to the assessment of the risk-benefit profile of medicines, thus encouraging safer and more effective use of medicines and a resolution of the sometimes apparently conflicting interests of public health and individual patient welfare.
- to establish mechanisms to detect and combat counterfeit medicines entering the local market.”
The strength of the global pharmacovigilance network is dependent totally on the active participation of healthcare professionals submitting drug-related problems through national pharmacovigilance centres.
PharmWatch Jamaica
PharmWatch Jamaica is a program in the Ministry of Health, Standards and Regulation Division that has been created with a view of monitoring adverse events locally, through the reports of healthcare professionals involved in the use of pharmaceuticals registered in Jamaica.
The PharmWatch Jamaica program represents the National Pharmacovigilance Centre, and submits as well as receives reports from the WHO adverse event monitoring centre located in Uppsala, Sweden.
The form used to collect information on suspected adverse events arising from the use of certain medicines can be obtained directly from the Ministry of Health’s head office, the hospital’s administrative office, or downloaded from their website.
Who collects the data? Pharmacovigilance at the local level
According the the WHO, the following practice pharmacovigilance:
Hospitals
“Almost all hospitals have medication error (ME) reporting systems. The most commonly used reporting methods are: incident report review, review of patient charts, direct
observation, interventions by pharmacists and adverse drug event (ADE) trigger tools.”
Consumer and Patient Organisations
“Patient and consumer organizations are dedicated to patient or consumer welfare. Almost all countries have consumer and patient organizations. They may be active at the local or national level, but can also play a role at the international level. They generally target one kind of disease and focus on all aspects relating to it, leading to provision of help for patients in their daily life and improvement of their quality of life. Patients and consumers also need to be more involved in pharmacovigilance networks.
“In recent years, the role of the patient in reporting adverse drug reactions (ADRs) has been increasing. Several studies have shown the importance of patient reports, the quality of patient reports of ADRs and MEs, and the growing interest shown by patients in their drug therapy. Involving patients in pharmacovigilance is important because:
• patients are better informed about their conditions and treatment; and
• patients or their relatives will be the first to notice any observable problems resulting from the medication.
“Patients for patient safety” (PFPS), a programme of the WHO World Alliance for Patient Safety, focuses on preventing MEs by educating patients about the concept of patient safety and by increasing patient awareness. This programme emphasizes the central role patients and consumers can play in efforts to improve the quality and safety of health care around the world. PFPS works with a global network of patients, consumers, caregivers and
consumer organizations to support patient involvement in the patient safety programmes of WHO Patient Safety.
“Local patient and consumer organisations are a valuable resource for collecting data on ADRs and MEs in the local environment. They also organize workshops for educating patients on:
• awareness of ADRs and MEs
• the importance of the culture of patient safety
• the importance of the culture of patient engagement to provide safer care
• strengthening patient awareness about the importance of reporting ADRs and MEs
• effective communication about drug safety.”
Sources:
Jamaica Ministry of Health: Pharmacovigilance
World Health Organisation: Pharmacovigilance
WHO: Reporting & Learning Systems for Medication Errors
Brought To Life Science Museum: Thalidomide
BBC: What’s Happened to Thalidomide Babies?
Helix: The Thalidomide Tragedy – Lessons for Drug Safety and Regulation