On February 24, the new regulations issued by the National Pharmacovigilance Program in Guatemala came into force, called “Pharmacovigilance Guidelines for Companies Responsible for the Sanitary Registration of a Drug”. It contemplates the various aspects that pharmaceutical companies must comply with in terms of Pharmacovigilance in the country, including:
1. Introduction and Importance of Pharmacovigilance: Pharmacovigilance is defined as the science and activities related to the detection, evaluation, understanding and prevention of the adverse effects of drugs or any health problem related to them. Also indicating that the approval of a drug for marketing implies that its efficacy has been demonstrated and that the unwanted effects detected in the pre-marketing studies were acceptable.
It also points out that Pharmacovigilance plays an important role in decision-making in pharmacotherapy and that it helps health professionals and patients to achieve the best benefit / risk ratio with a safe and effective therapy.
Guatemala has a National Pharmacovigilance Program (PNFV), belonging to the Department of Regulation and Control of Pharmaceutical and Related Products of the Ministry of Health.
2. Legal Basis:
• Health Code, Decree Number 90-97, Article 165.
• Government Agreement Number 712, Regulation for the Sanitary Control of Medicines and Related Products, Article 91.
3. Responsibilities: The attributions of the company responsible for the sanitary registry and the competent authorities are established, indicating that manufacturers and holders of sanitary authorizations are obliged to declare the unexpected and toxic effects of drugs.
The company authorized to market the product in Guatemala (authorized distributors) must have an appropriate Pharmacovigilance system, which must be registered as a Pharmacovigilance Plan of the Establishment, and must also permanently and continuously designate a responsible, qualified and competent person with experience in aspects of safety and efficacy of medicines.
The professional responsible for Pharmacovigilance must:
• Create, register and maintain a pharmacovigilance system.
• Prepare and submit Periodic Reports to the National Pharmacovigilance Program.
• Make sure to give a quick response to any request that the Program requires.
• Provide the Pharmacovigilance Center with any additional information of interest.
4. Good Pharmacovigilance Practices: Effective Pharmacovigilance comprises a set of rules, procedures and practices that must be followed to guarantee the quality and integrity of the data produced in certain types of investigations. The holder responsible for the health registry must verify compliance with Good Pharmacovigilance Practices to guarantee that the information collected by the Pharmacovigilance Plan is valid information.
5. Periodic Safety Reports (IPS): The purpose of the Periodic Safety Reports is to provide the health authority with updated information at defined intervals on the world experience in drug safety.
Once a drug is authorized in Guatemala, and even if it has not yet been marketed, the company responsible for the registry is obliged to send an IPS at the following intervals:
• Immediately at the request of the health authority.
• Every 6 months during the first two years, from the date of authorization.
• Then annually for the next two years.
• At the time of the first request for renewal of the sanitary registration.
• And every 5 years thereafter, along with the renewal application.
This point has been developed quite broadly in number 5 of the Pharmacovigilance Guidelines, within it the following are included:
a) General Principles.
b) Requirements for the presentation and frequency of the Periodic Safety Reports.
c) Report for each product that contains an active principle.
d) Products with more than one active ingredient.
e) Medicines authorized to more than one company responsible for the Registry.
f) Circumstances in which the IPS filing cycle may be modified.
g) Reference reports on safety.
h) Model periodic safety report.
6. Notification of Adverse Drug Reactions (ADR): The company responsible for the health registry is in charge of notifying the authorities of the National Pharmacovigilance Program of any suspected adverse reaction that may be caused by drugs that it manufactures or markets.
This section includes:
• Description of the RAM and scope of application.
• Lists and tables to be presented of the individual cases.
• Notification requirements issued, in print or by email to the Pharmacovigilance Program.
• Spontaneous notifications of ADRs communicated by health professionals, through authorized forms.
• Notifications of cases published in the world literature.
• Content of notifications of suspected serious ADR, including the drug, suspected ADR data, an identifiable patient and an identifiable reporter.
• Notification requirements in special situations, including use in pregnancy.
• Impact of the reported AMR on the overall safety profile of a product and its monograph.
7. Notifications for Lack of Efficacy: Which will not have to be communicated immediately, but must be discussed in the corresponding Periodic Safety Report.
8. Notification of Cases of Overdose: The competent authorities must be notified immediately in cases of accidental or intentional overdose, which produces suspicions of serious adverse reactions.
9. Presentation of Individual Cases: Which will include:
•General considerations.
• Cases presented in the form of lists.
• Presentation of the list.
• Summary table.
• Analysis of individual cases by the person in charge of the sanitary registry.
• Studies, clinical, non-clinical.
• Recent studies promoted by the company responsible for the sanitary registry.
• New Safety Studies planned, starting or ongoing during the reporting period.
• Published safety studies.
• Information regarding effectiveness.
• Last minute information.
• Overall safety assessment.
•Conclusion.
• Source Consulted.
At Latinalliance we can support you with the responsibility of pharmacovigilance, for more information contact rolivares@latinalliance.co