Pharmacovigilance is defined as the Science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problems.
There is no such thing as a safe drug, but there are ways to make the drug safer whether it is the medicinal product itself or the manner by which such drug is used.
There is an international program within the World Health Organization that undertakes drug safety monitoring. This program relies on the member countries of United Nations reports of their country experience in adverse drug reactions. Each country experience utilizes the reports detected by health professionals and institutions. The results of the scientific evaluation by WHO are their shared to the different stewards for drug safety, like the medicine regulatory authorities, drug companies, and academic and medical bodies for action. Ultimately, this provides that critical intelligence for us to exercise due diligence when prescribing and using medicines.
This is the essence of public health, the translation of the lessons learned in clinical cases for the public good. It is therefore an imperative for us to educate PCP doctors that they need to exercise their public health duty to report cases that they suspect to be drug reactions to the government regulatory agency (the Bureau of Food and Drugs) for databasing and submission to the WHO for evaluation.
An internist-specialist is in a unique position in the areas of adverse drug reaction. An internist prescribes medicine to patient for a specific condition, patient develops adverse drug reaction in another part of the body, patient seeks another specialist for that part of the body inadvertently affected by the medicines. The internist who prescribed the first drug might be put in an embarrassing position if the second doctor, who does not know how to communicate the correct views on medicines and erroneously explained that it was the fault of the first prescriber. Doctors and patients alike must understand that adverse drug reactions are unforeseen, untoward and unwanted effects of taking medicines that can occur at some points for taking medicines. Taking medicines is an informed choice and that the doctor and patient jointly undertake some basic risk-benefit evaluation. Simply put, one is willing to use a medicine with some known adverse effects because not using it will be more harmful to the patient with a disease condition.
Hence it is critical that an internist understand that he has a public duty:
• To keep learning about ADRs and to share this with colleagues
• To explain the potential adverse effects and side-effects before the drug is given or when the reaction has already occurred.
• To manage the ADR or to refer if needed
• To report the suspected or observed ADR to a body for analysis and feedback.
It is only when doctors agree to share detected ADR cases that public health is served, and that is to improve the overall patient care and their safety. The same principle applies when a doctor observes ADR, these can be reported to their hospital where they practice so that drug supply management can be improved and ultimately benefits the practicing internist and patients.
In many cases, a public health program will also use medicines for mass treatment. When a community is given medicines either to prevent an endemic disease, or to treat medical conditions, invariably, some persons may experience ADRs. They then seek consult with you. We then have a duty to share such experience with the perspective that it will ultimately help the public health programs (in terms of sourcing better quality drugs, in terms of avoiding certain subgroups of susceptible patients, in terms of drug interactions, in terms of modifying usage and indications, etc.)
One detected ADR may mean an insignificant report, but when there are many other places with just one report of similar ADR, collectively, they can be group as a potential Signal.
Basically the report will have the following facts: details of the patient, details of the drugs used, details of the reaction, and details of the reporter. To protect confidentiality, the details of patient and reporter are anonymized.
The BFAD ADR confidential report form is included in the next page and can be downloaded from:http://www.bfad.gov.ph/NADRAC/downloads/Report%20form.doc
Adverse events can be opportunities for improvement. A recent commentary in PJIM (Evangelista 2006) outlined the importance of having a critical, honest, blame free system to encourage reporting and for us to learn from these lessons particularly because a doctor manages a patient through a health care system and sometimes unintentional error can occur.
Evangelista MA. (2006) Adverse events as opportunities for improvement. Phil. J. Internal Medicine 44:VII-VIII.