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What Students Need To Know About The Need for Pharmacovigilance.

The role of pharmacovigilance is to determine which adverse events cross the line of a drug’s efficacy. In other words, analysing which side effects are worth the risk to patients compared with how effective they are at treating a disease. For instance, chemotherapy is known to cause some very serious side effects but when faced with life-threatening cancer, these side effects are considered acceptable given the potential to cure a patient. However, if a drug used to cure a headache caused similar side effects, the risk to the patient would be considered too great and the benefit not substantial enough to justify the potential damage. Pharmacovigilance is arguably the most essential function within a life science company. To develop, manufacture and commercialise a drug a company must adhere to strict regulations. Many of these regulations will focus on the patient’s safety and the added benefit to the patient derived from the drug.

Pharmacovigilance (also PV or PhV) covers all the activities focused on ADRs. Its main aims are to:

  • Provide patients with the highest possible standard of care.
  • Enhance the safety of medicines and medical interventions.
  • Improve health and safety for the general public in regard to medicine use.
  • Assess the benefits and effectiveness of medicines, as well as their potential harm and risks.
  • Promote safe, rational, effective, and cost-effective usage of drugs.
  • Improve education, understanding, and communication about pharmacovigilance.

In modern data-intensive era, pharmacovigilance information systems, operating like disease surveillance systems, can enhance the data collection, detection, assessment, monitoring and prevention of adverse effects. Effective and safe pharmacological treatment process requires a team work of the patient and healthcare professionals. Pharmaceutical care includes considering these risks on a patient-oriented basis by ‘‘identifying and solving (or avoiding)’’ drug therapy problems. Although the prescription is written by medical doctors in most countries, pharmacists and nurses have a crucial role in follow-up, since they can monitor and determine drug related problems; thus maintain safe use of medicines. Pharmacovigilance information systems, managed by pharmacists, can identify adverse drug reactions in developing countries where quality control of medicines is questionable. Another problem is ignorant use of herbs and herbal medicine. Since many herbal products contain active ingredients that can interact with prescription medicines, WHO prepared a guideline on monitoring of herbal medicine in the pharmacovigilance systems. In most countries, pharmacists go through an extensive education on medicinal plants which are used in traditional folk medicine, as well as the natural and synthetic medicines. Therefore, pharmacists already have the knowledge to detect safety signals of drugs of any origin.

Signal detection is important to identify the drug related adverse effects. However, the number of reports sent to national pharmacovigilance centers is also important as well as the quality of reports. The quality of reports is definitely superior when they are filled by health professionals who have pharmacology knowledge, i.e. pharmacists, doctors, nurses, physician assistants, dentists etc. It will be even better if it can be documented and retrieved from pharmacy information systems.

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When reporting an ADR, manufacturers must include at least the following:

  • Patient information, at a minimum, this should be the age and sex of the patient, but it can also include medical history and concomitant medications. (For this reason, each ADR report must pertain to an individual patient.) However, the report does not need to include identifiable information, like the name and address of the patient.
  • Contact information for the reporter.
  • Details about the medication, including its name, the dosage, the method of administration, and the dates of administration.
  • A description of the ADR. This should be a chronological account of the event, consisting of signs and symptoms, consequences of discontinuation (and reintroduction, if applicable), intervention, outcome, and a summary of any other details.
  • In addition to individual reports, manufacturers need to run aggregate data analyses. These are critical for confirming a causal relationship between the drug and the adverse event.

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