Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems(WHO, 2002).
The aims of Pharmacovigilance are:
- 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 global pharmacovigilance programme had its genesis in 1968; a World Health Organisation (WHO) initiative to ensure there is never a repeat of the phocomelia tragedies of Thalidomide. 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.
Definition of Terms
WHO Technical Report No 498 (1972); “A response to a drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function.”
Note: This basic definition includes all doses prescribed clinically, but is intended to exclude accidental or deliberate overdose. The subclassification of “unexpected” was included to facilitate understanding of the type of adverse reaction which are most important to report to drug monitoring agencies.
Unexpected Adverse Reaction:
An adverse reaction, the nature or severity of which is not consistent with domestic labelling or market authorization, or expected from characteristics of the drug.
Adverse Event/Adverse Experience:
Any untoward medical occurrence that may present during treatment with a pharmaceutical product but which does not necessarily have a causal relationship with this treatment.
Note:This is a more recent term which some use interchangeably with “adverse reaction”, but, as indicated, it is better reserved for clinical phenomena occurring during drug treatment where the possibility of a causal connection has not been considered.
Any unintended effect of a pharmaceutical product occurring at doses normally used in man which is related to the pharmacological properties of the drug.
Note: This is an old term and is broad enough to include both positive and negative effects of a drug apart from its main properties or indications. Some use the term as synonymous with “adverse reaction”, but the proposed definition will improve clarity of use of this term.
Reported information on a possible causal relationship between an adverse event and a drug, the relationship being unknown or incompletely documented previously. Usually more than a single report is required to generate a signal, depending upon the seriousness of the event and the quality of the information.
Note: This describes the first alert of a problem with a drug. By its nature a signal cannot be regarded as definitive but indicates the need for further enquiry or action. On the other hand it is prudent to avoid a multiplicity of signals based on single case reports since follow up of all such would be impractical and time consuming. The definition allows for some flexibility in approach to a signal based on the characteristics of individual problems. Some would like a “signal” to include new information on positive drug effects, but this is outside the scope of a drug safety Programme.
Serious Adverse Event or Reaction
A serious adverse event or reaction is any untoward medical occurrence that at any dose:
- results in death
- requires inpatient hospitalisation or prolongation of existing hospitalisation
- results in persistent or significant disability/incapacity
- is life-threatening
To ensure no confusion or misunderstanding of the difference between the terms “serious” and “severe”, the following note of clarification is provided:
The term “severe” is not synonymous with serious. In the English language, “severe” is used to describe the intensity (severity) of a specific event (as in mild, moderate or severe); the event itself, however, may be of relatively minor medical significance (such as severe headache). Seriousness (not severity) which is based on patient/event outcome or action criteria serves as guide for defining regulatory reporting obligations.
Adverse Event Reporting
The safe, effective use of drugs and the prevention or minimization of unwanted events (adverse events) are essential components in the provision of quality healthcare to our population. Monitoring and surveillance of pharmaceutical agents employed in the treatment of the population and their impact have not only health, but economic and social consequences. 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 head office, the hospital’s administrative office, or downloaded below.
Download here: PharmWatch Drug Monitoring Form
The general aim of the counterfeit medicines monitoring programme will be to employ strategies that will prevent and detect the export, import and smuggling of falsely labeled, counterfeited or sub-standard pharmaceutical preparations.
A counterfeit medicinal product is a medicine which is deliberately and fraudulently misllabeled with respect to identity an/or source. counterfeiting can apply to both branded and generic products and counterfeit products may include product with correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging.