Author: Oscar Morrobel, Magdalena Almonte

Pharmacovigilance was defined in 2002 by the World Health Organization (WHO) as “the science of collecting, detecting, investigating and evaluating information on medications, biological products, medicinal plants and traditional medicines, with the purpose of identifying information on new adverse reactions and preventing harm to patients.”

According to the technical regulation for pharmacovigilance in the Dominican Republic national health system, approved via resolution No. 00017 of 20 September 2017, pharmacovigilance is defined as the “set of procedures and activities within the national health system, coordinated by the pharmacovigilance commission, which have the objective of collecting, analyzing, and drawing up information on the adverse reactions to these medications”. By way of summary and following the OMS guidelines, we can infer that it is the science and activities related to the detection, evaluation and prevention of the adverse effects of the medications and other health related problems.

In turn, the adverse effects of reference are noxious reactions which provoke a medication administered with a therapeutic purpose, at normal dosage, to an individual. Among the adverse effects may be:

  • Serious adverse effects: this is any identified adverse reaction which may be fatal, endanger life, imply incapacitation or invalid condition, or may have as a consequence hospitalization or prolonging same.
  • Unexpected adverse effects: this is an adverse reaction not mentioned in the summary of characteristics on the product or technical sheet.

Pharmacovigilance was created with the purpose of supervising medications, contributing to their safe and rational use by way of permanent evaluation of risks. Prevention is added to detection and evaluation of the risks associated with the medications once they are marketed. This is an activity shared with health authorities, the pharmaceutical industry and health professionals. In this regard, the contribution of all the actors plays a fundamental role in the monitoring and making of decisions about whether a medication bears a relation with adequate risk and benefit, or if marketing of same should be suspended, removing it from the applicable market.

In the Dominican Republic, the national system of pharmacovigilance is composed of:

  1. The Ministry of Public Health and Social Assistance, via the General Office of Medication Food and Health Products (Dirección General de Medicamentos Alimentos y Productos Sanitarios -DIGEMAPS).
  2. Health professionals.
  3. Health service and establishment.
  4. Manufacturers, owners and holders of medications.
  5. National Pharmacological Commission (Comisión Nacional de Farmacovigilancia).

Regarding this last item, the National Pharmacovigilance Commission emphasizes that, pursuant to the Medications Decree No. 246-06, it is the agency composed of pharmaceutical, chemical, medical and other professionals of the health sector named by the Ministry of Public Health and Social Assistance, with the function of advising and informing the Ministry of all things related to the identification and evaluation of the adverse effects of the use of the pharmacological treatments in the whole population, or in subsets of patients exposed to specific treatments.

The pharmacovigilance process is carried out in the official Laboratory for health oversight, control and analysis, for our country the Dr. Defillo National Public Health Laboratory, and any other which the Public Health Ministry may recognize or authorize for such purposes.

Finally, we break down the important duties of the health professionals, as part of the national pharmacovigilance system:

  1. Notifying the center of a suspicion of any serious adverse reaction within forty-eight (48) hours after being made aware of it, via the Adverse Reaction to Medication (Reacciones Adversa a Medicamentos – RAM) form made available by the Ministry of Public Health and Social Assistance.
  2. Notifying the suspicion of less serious adverse reactions within fifteen (15) days after being made aware of same, via the Adverse Reaction to Medication (Reacciones Adversa a Medicamentos – RAM) form made available by the Ministry of Public Health and Social Assistance.

Compliance with the obligations of all the actors in the national pharmacovigilance system provides medication to Dominican citizens, thus making it a fundamental duty of a proper health system.

For more information and assistance in complying with formal obligations by the manufacturer, contact us at / 1.809.566.7111