Grunenthal

Josefina Mendoza

Drug Safety Authority

Disclaimer: This article is an initiative under a personal authorship. I exclude all liability to Grunenthal regarding the content of this publication.

What is “Pharmacovigilance” (PV)? According to the WHO (World Health Organization) Pharmacovigilance is the science and the activities related to the detection, assessment, understanding, and prevention of adverse effects or any other medicine or vaccine related problem.

What is the impact of pharmacovigilance in the world?

Pharmacovigilance seeks to ensure that the benefit-risk ratio of medicines for human use remains favorable throughout their life cycle in the market. Sanitary Authorities perform analysis of safety data and risk management of the public health.

“Pharmacovigilance Systems” ensure mechanisms to monitor and promote the rational use of medicines.

Safer treatments have a direct impact on the quality of life of patients, family savings, labor and productivity improvement .The direct costs of treating preventable safety lapses is not only significant for families but for the entire health care systems.

What is the evolution of “Patient Safety”?

Initial regulatory experience of Pharmacovigilance Systems started in 1968 when the World Health Organization triggered  a pilot program collecting adverse drug reactions from multiple countries. Later on 1990 the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) were established. ICH's mission is to achieve greater harmonization worldwide to ensure that safe, effective and high quality medicines are developed, and registered. On 1993, MedWatch was founded, it is the Food and Drug Administration’s “Safety Information and Adverse Event Reporting Program.

Since then, almost all authorities worldwide maintain a local Regulation not only for  Pharmacovigilance but patient safety has achieved specializations regulating Technovigilance, Cosmetovigilance, Vaccine Vigilance and Safety Surveillance of Dietary Supplements.  

What are the current challenges of pharmacovigilance?

● Identifying signals and trends, with an enhanced focus on the post-marketing environment is a team effort from the patient to report and the Health Care Professionals to perform the notification. Several factors still need to be shaped in order to achieve better results on this team effort. Additionally, “safety information” is a list of situations beyond “Adverse Events”, definitely efforts are still needed to obtain these reports from HCPs.

● Larger and more complex datasets are being analyzed. The cost of PV is steadily rising in terms of expenditures and resources. All these factors have led to a shift in many PV strategies to proactive risk management using Artificial Intelligence tools.

● Worldwide implementation of identification of medicinal products (IDMP) by EMA developed by the International Organization of Standardization (ISO). Their purpose is to facilitate the reliable exchange of medicinal product information in a robust and consistent manner.

● Implementation of PV activities and risk minimization measures related to the use of medicinal products in genetic subpopulations, variations or activation/suppression of genome functions (Pharmacogenomics).

Myths & confounders behind “Pharmacovigilance”

Health Care Professionals (HCP) are not always certain about management of data privacy.

Re: Health Authorities request safety data for aggregate analysis, patient, and notifier data remains confidential.  Data privacy laws regulate management of data privacy by third parties, institutions and private companies. 

Physicians do not get responses regarding the outcome of  their Individual Drug Safety Reports.

Re: Physicians contribute to the system but it is not expected to provide feedback of individual cases to reporters. Notifications are assessed anonymously by local Competent Authorities and pharmaceutical companies for signal identification and quantification of risk.

How can physicians and patients  see the results of pharmacovigilance?

 Re: Summary Product Characteristics used by Physicians and the product insert/patient leaflet are continuously maintained using the final assessment of safety data.

The safety profile of medicinal drugs is maintained by the pharmaceutical companies and continuously communicated to local Competent Authorities, additional risk minimization measures are implemented accordingly when needed including any necessary regulatory actions.  

Not always patients know what to report and whom to report.

Re: all consumers of medicinal products can report “Adverse Events” choosing one of the alternatives e.g. to their doctor, local Competent Authorities or to the corresponding pharmaceutical company. The consumer does not need to be sure of the relationship between the product and the adverse event.