The document clarifies the aspects related to pharmacovigilance and its importance for ensuring continuous safety of medical devices allowed for marketing and use in the country.
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The document clarifies the aspects related to pharmacovigilance and its importance for ensuring continuous safety of medical devices allowed for marketing and use in the country.
The Egyptian Drug Authority (EDA), the country’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to detecting and reporting adverse reactions to pharmaceutical products and medical devices.
The document provides an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be taken into consideration by medical device manufacturers and other parties involved in operations with medical devices.
The authority also reserves the right to make changes to the guidance and recommendations provided therein, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation.
Definition and Scope of Pharmacovigilance
Pharmacovigilance, as defined by the World Health Organization (WHO), encompasses the science and activities linked to the detection, assessment, comprehension, and prevention of adverse effects or any other issues related to medicine.
This definition has been broadened to include other pharmaceutical products and medical devices.
The document further explains the difference between Adverse Drug Reaction (ADR) and Adverse Event (AE).
- ADR stands for any harmful and unintended response that emerges from doses typically utilized in humans for disease diagnosis, prophylaxis, therapy, or the alteration of physiological functions.
- AE refers to any adverse medical incident that can take place during the treatment with a pharmaceutical item, but without necessarily having a direct link with the medicine in question.
The critical distinction between ADR and AE is the suspected causal relation in the former, as determined by the health professional either reporting or reviewing the incident.
In contrast, an AE doesn’t inherently possess such a causal link.
The Importance of Pharmacovigilance
The authority also additionally emphasizes the importance of pharmacovigilance in the context of ensuring continued safety and effectiveness of healthcare products allowed for marketing and use in the country.
According to the document, marketing data on pharmaceutical items often lacks comprehensive information on adverse drug reactions for numerous reasons, including:
- Clinical trial participants being limited and not a true representation of the broader public.
- Differences in medicine usage conditions between clinical trials and actual clinical practice.
- The time-constrained nature of clinical trials.
Consequently, rare but potentially severe adverse reactions, chronic toxicities, drug interactions, or use in specific populations (e.g., elderly, children, or pregnant women) might be inadequately understood.
Consequently, post-marketing monitoring is vitally important for global healthcare professionals to report adverse reactions.
Objectives of Pharmacovigilance
As explained by the authority, pharmacovigilance aims to:
- Elevate patient care and safety concerning pharmaceutical product usage.
- Enhance public health and safety in relation to pharmaceutical products.
- Identify and swiftly communicate issues related to pharmaceutical product usage.
- Contribute to assessing medicines in terms of benefits, risks, effectiveness, and harm, ultimately promoting harm prevention and benefit maximization.
- Advocate for the safe, rational, effective, and cost-efficient use of medicines.
- Boost understanding, education, and clinical training in pharmacovigilance, ensuring effective communication with health professionals and the general public.
WHO Program for International Drug Monitoring
Another important aspect covered by the scope of the guidance relates to the international monitoring program introduced by the World Health Organisation (WHO).
Initiated in 1968, the WHO Program for International Drug Monitoring (PIDM) was designed as a platform for consolidating data on ADRs.
Originating as a pilot project across ten countries, the network expanded as more nations established national Pharmacovigilance centers.
WHO collaborates with the Uppsala Monitoring Centre (UMC) in Sweden, which maintains the global ADR database, Vigibase.
Egypt joined the PIDM in 2001, enabling communication with global vigilance centers, facilitating access to international safety data, and contributing Egyptian data to the global database.
Egyptian Pharmacovigilance System: Introduction
Established in December 2009, the Egyptian Pharmaceutical Vigilance Center (EPVC) operates within the Egyptian Drug Authority.
As Egypt’s national body for pharmaceutical product safety monitoring, EPVC also acts as the regulatory entity for pharmaceutical firms concerning pharmacovigilance.
Its role is to collect safety data, encompassing adverse events, drug interactions, medication errors, off-label use, and more.
Types of Adverse Drug Reactions
According to the guidance, the applicable legislation distinguishes several types of adverse drug reactions, namely:
- Type A: Augmented pharmacologic effects that are dose-dependent and predictable.
- Type B: Bizarre effects that are dose-independent, unpredictable, and often based on patient reactions.
- Type C: Chronic effects often related to the increased frequency of spontaneous disease.
- Type D: Delayed effects, like tardive dyskinesia from long-term use of specific antipsychotics.
- Type E: Effects resulting from discontinuation of drug treatment, like withdrawal reactions.
- Type F: Therapy failure.
Seriousness of Adverse Drug Reactions
Apart from the types outlined hereabove, the applicable legislation also distinguishes adverse drug reactions based on their seriousness in terms of consequences they could be associated with.
In particular, a serious adverse event or reaction relates to any medical occurrence linked to a medical product that results in outcomes like life-threatening situations, hospitalization, disability, congenital anomalies, and other medically significant events.
Examples range from acetaminophen overdoses to medicine dependency.
Spontaneous Reporting Structure
The document also briefly mentions the spontaneous reporting structure. This voluntary method is predominantly utilized by regulatory bodies to gather post-market safety data for pharmaceutical items and medical devices.
In Egypt, the EPVC employs the “Yellow Card” to record medicinal product ADRs and the “Pink Card” to document medical device incidents.
Special provisions exist for vaccine-related reporting and medical device vigilance.
Conclusion
In summary, the present EDA guidance outlines the key points associated with pharmacovigilance and the important role it plays.
The document highlights the main aspects to be taken into consideration by all the parties involved and provides additional clarifications regarding the existing legal framework.
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