What is pharmacovigilance


Synonyms: drug monitoring, drug safety

1 definition

Pharmacovigilance is a generic term for all activities that are related to the monitoring of the safety of pharmaceuticals or the identification and defense of pharmaceutical risks in the clinical trial phase and after approval.

2 background

Pharmacovigilance summarizes the events related to the discovery, documentation, evaluation and prevention of adverse drug reactions (ADRs) or other drug-related problems. Pharmacovigilance is used for risk management relating to the use of drugs. It records production errors or defective packaging or preparations, tries to prevent therapeutic errors and provides drug information. An important element of pharmacovigilance is the reporting of ADRs to the responsible authorities and the organization of a reporting chain, starting from the health care professionals via the pharmaceutical companies and their service providers to the authorities.

Modern medicines have profoundly changed the way diseases are treated and controlled. However, their great utility is offset by the fact that adverse drug reactions are a common and often preventable cause of illness, disability, and even death.

Before they were approved, drugs had been tested on relatively few patients. In addition, the patient collective corresponds only to a limited extent to the treatment collective after the market launch. Long-term effects are usually not recorded. The clinically tested safety of a medicinal product is therefore of a provisional nature. There is a risk that individual patients will develop specific and unpredictable sensitivity to a particular drug. Negative interactions with other drugs pose an additional problem. In practice, a good pharmacovigilance system is therefore required.

The extreme importance of this monitoring body was made clear by one of the most sensational drug scandals in the early 1960s. The active ingredient thalidomide (trade name Contergan), when taken by pregnant women, led to malformations in children (embryopathy). As a consequence, many countries started to establish pharmacovigilance systems.

3 goals

The WHO summarizes the goals of pharmacovigilance as follows:

  • Improving nursing care and safety in relation to the use of medicines and all medical and paramedical interventions
  • Improvements in public health and safety and related to drug use
  • Contribution to the assessment of the benefit, harm, degree of effectiveness and the risk of drugs, accordingly promoting safety and rational and efficient (also cost-efficient) use
  • Support understanding, education and clinical training in pharmacovigilance and effective communication to the public

4 Pharmacovigilance in Germany

The Medicines Act provides that after a medicinal product has been approved, experience with its use is continuously and systematically documented and evaluated

5 working methods in pharmacovigilance

5.1 Spontaneous reporting system

The spontaneous reporting system is one of the most important early detection systems in the field of pharmacovigilance.

What is reported? Suspected cases are reported in which adverse reactions are related to the administration of a drug (spontaneous reports). The temporal connection and the lack of another obvious cause for the observed effect are sufficient.

Who reports? Obligations to report suspected cases of side effects are regulated by law (Drugs Act) and professional code (professional code of doctors and pharmacists, AkdÄ or German Medical Association and AKDA) in Germany. The report is made to drug commissions or to the drug safety department of pharmaceutical companies.

The Drugs Commission of the German Medical Association (AkdÄ) evaluates spontaneous reports and communicates relevant safety problems in connection with drugs to specialist groups, e.g. via the German Medical Journal. If a previously unknown or underestimated safety problem of a drug is discovered, the report is forwarded to the competent higher federal authority (Federal Institute for Drugs and Medical Devices (BfArM), Paul Ehrlich Institute). Here, a decision is made on an officially ordered restriction of use, if necessary up to the revocation of an already granted drug approval.

5.1.1 Reporting of ADRs

  • The AkdÄ's ADR notification form can be downloaded from the BfArM's homepage. Pdf form
  • Alternatively, the online report is also possible online form

5.2 National Pharmacovigilance Centers

In addition to the spontaneous reporting system, regional pharmacovigilance centers have been set up in Germany. Their task is the active standardized recording and evaluation of ADRs, the estimation of the frequency and the processing of specific questions of the competent higher federal authorities. Advice and communication with the health professions as well as participation in medical training in the field of pharmacotherapy.

6 communication

Different possibilities lead to the same goal: communicating risks in pharmacovigilance:

Information resources ...

... the industry:Specialist information, package insert, labeling, Rote-Hand-Brief, Rote Liste, Yellowliste

... the authorities:Drug Information System (AMIS), quick drug information, notices, statements, press releases

... of the Medicines Commission of the Health Professions: Drug prescription in practice, therapy recommendations, newsletter, manual of the UAW Drug Bulletins: drug telegram, drug letter