Download PDF version here: Pharmacovigilance in Dominican Rep.
Author: Oscar Morrobel, Magdalena Almonte
Pharmacovigilance was defined in 2002 by the World Health Organisation (WHO) as “the science of collecting, monitoring, investigating and evaluating information on the effects of medicines, biological products, medicinal plants and traditional medicines, with the aim of identifying information on new adverse reactions and preventing harm to patients”.
According to the technical regulation for pharmacovigilance in the national health system of the Dominican Republic, approved by 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 aims to collect, analyse and elaborate information on adverse drug reactions“. To summarise, and following the WHO line, we could infer that it is the science and activities related to the detection, evaluation and prevention of adverse effects of medicines and other related health problems.
Adverse reactions are harmful reactions caused by a medicinal product administered for therapeutic purposes, at normal doses, in an individual.
Adverse effects may include:
- Serious adverse reactions: any identified adverse reaction that is life-threatening, life-threatening, life-threatening, disabling or incapacitating, or which results in hospitalisation or prolongation of hospitalisation.
- Unexpected adverse reaction: an adverse reaction that is not mentioned in the summary of product characteristics or package leaflet.
Pharmacovigilance is created with the aim of monitoring medicinal products and contributing to their safe and rational use by continuously assessing their risks. In addition to detecting and assessing the risks associated with medicinal products once they have been placed on the market, it also includes prevention. This is an activity shared by health authorities, the pharmaceutical industry and health professionals. In this sense, the contribution of all actors plays a key role in monitoring and making decisions on whether a medicine has an adequate risk-benefit balance, or whether its marketing or use should be suspended and it should be withdrawn from the applicable market.
In the Dominican Republic, the National Pharmacovigilance System is composed of:
- The Ministry of Public Health and Social Assistance, through the General Directorate of Medicines, Food and Health Products (DIGEMAPS).
- Health professionals.
- Health facilities and services.
- Manufacturers, owners or holders of medicinal products.
- National Pharmacovigilance Commission.
Regarding this last member, the National Pharmacovigilance Commission, we emphasise that according to the Medicines Decree No. 246-06, it is the body made up of pharmacists, chemists, doctors and other health sector professionals, appointed by the Minister of Public Health and Social Assistance, with the function of advising and informing the Ministry on the identification and assessment of the adverse effects of the use of pharmacological treatments in the population as a whole, or in subgroups of patients exposed to specific treatments.
The pharmacovigilance process is carried out in the official laboratory for health control and surveillance analyses, for the Dominican Republic this is the Laboratorio Nacional De Salud Pública Dr. Defilló, and any other that the Ministry of Public Health recognises or authorises for such purposes.
Finally, we break down important duties of healthcare professionals as part of the National Pharmacovigilance System:
- Notify the centre of the suspected serious adverse reaction within forty-eight (48) hours of becoming aware of it, using the Adverse Drug Reaction (ADR) reporting forms available from the Ministry of Public Health and Social Assistance.
- Report suspected non-serious adverse reactions within fifteen (15) days of becoming aware of them, using the Adverse Drug Reaction (ADR) reporting forms provided by the Ministry of Public Health and Social Assistance.
Compliance with the obligations of all actors in the National Pharmacovigilance System ensures the proper supply of medicines to Dominican citizens, making it a fundamental duty for the proper functioning of the health system.
For more information and assistance in complying with the formal obligations of the manufacturer or about lawyers in Santo Domingo in sanitary registration, contact us via [email protected] / 809.566.7111.
