Pharmacovigilance and Appropriate Drug Use—2nd Edition

Dear Colleagues,

Pharmacovigilance is a key public health process which helps monitor the safety of medicines and reducing the risks related to drug use in the post-marketing phase.

It works through the detection, assessment, understanding and prevention of adverse effects, or any medicine-related problems in general.

At the time of authorisation, each drug has been tested for a limited length of time in a small number of strictly selected patients. Therefore, its benefit–risk profile cannot be definitely known, and certain side effects may be detected with use in healthcare practice in a larger number of patients, for a longer period of time and with other medications.

The emergence of safety signals (new or changing safety issues) in this phase may result in regulatory action translating into modification of the terms of the marketing authorization or the way the drug can be used to protect public health. Regulatory actions include the following measures:

• Informing about the new information on the quality, safety or efficacy of a medicine;
• Advising to modify prescribing behaviour or how to use medicines to prevent or minimise risks;
• Restricting the use to exclude certain patient population.

Prior studies showed that almost all regulatory actions in the post-marketing phase have a negative impact on drug risk.

Nevertheless, the safety of a medicine is related not only to its pharmacological properties, but also the product’s quality and how it is used in clinical practice.

According to the World Health Organization (WHO), inappropriate drug use has been reported for more than 50% of all medicines in the market, resulting in various health risks and costs.

The appropriate prescribing, dispensing and use of drugs include several steps performed both by healthcare professionals (good diagnosis and good prescribing, providing the right drug to the right patient in the right formulation and posology, patient instructions and good stock management practice) and patients (good adherence/compliance).

Inappropriate drug use has been associated with an increased risk of adverse events, morbidity, mortality and healthcare utilisation.

Therefore, appropriate drug use helps prevent medication errors and increases drug safety.

Regulatory agencies can use several tools to control and manage each step of the process (from prescription to drug utilisation) in order to guarantee the appropriateness of medicine use.

The aim of this Special Issue is to provide an updated panorama of pharmacovigilance issues which result (or may result in the future) in regulatory actions and can be prevented by changing and controlling the prescribing behaviour.

Dr. Lucia Gozzo
Guest Editor

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• pharmacovigilance
• safety
• adverse drug reactions
• risk
• regulatory action
• appropriateness

• Pharmacovigilance and Appropriate Drug Use in Healthcare (11 articles)