Back to Basics in Pharmacovigilance

Written by: Fleming. Team

Europe Pharma

6th Annual Pharmacovigilance & Risk Management strategies

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Pharmacovigilance (pharmaco meaning medicine in Greek and vigilare meaning keeping watch on in Latin), or known by its more common name, drug safety, focuses on prevention, monitoring and collection of data for adverse effects of pharmaceutical products.

The main objectives of Pharmacovigilance are:

  • Patient care – Improve patient care and safety
  • Public health – Early detection of safety problems
  • Assessment of risks and benefits – Benefits, effectiveness or harm
  • Communication – Promote to both professionals and the public

History shows us that being vigilant and not giving up can save lives. When Dr. Frances Oldham Kelsey learned that a new medicine was ready for the rubber stamp and marketing in the US, she withheld approval and asked for more data. No requirement for high–quality FDA–approved clinical trials existed before 1962. Dr. Kelsey was called a stubborn, unreasonable bureaucrat.Now we know that she actually stopped Kevadon (in Europe known as Thalomide), a drug responsible for more than 10,000 victims. She not only saved many US babies but she also gave rise to modern laws regulating pharmaceuticals. She was described as a heroine and she is also only the second woman in US history to be awarded the President's Award for Distinguished Federal Civilian Service, by President John F. Kennedy.Thalomide was supposed to cure nausea, but it caused problems in infants in over 20,000 cases in 1960 alone. The result was the WHO programme for International Drug Monitoring, which came into effect in 1968. What started as a pilot project with 10 countries now has 122 full member countries.Over the years, PV has transformed a great deal. Molière said: “To undergo treatment you have to be very healthy, because apart from your sickness you have to withstand the medicine.” Ironically, he died on stage, during his performance in a play called The Hypochondriac.Drug effects can be good or bad, expected or unexpected. We look at the good ones as a beneficial and the customers (patients) expect this result of the care. However, we have to be prepared for the adverse events (side effects). According to the European Commission, an estimated 8 – 12% of patients admitted to the hospital in the EU suffer from adverse events. If a good, comprehensive PV system is not in place, it can lead to poor products quality, ADRs, escalating healthcare costs as well as patient resistance and refusal.Do you want to stay vigilant? Focus on the latest trends in Pharmacovigilance:

  • Education – Public education campaigns to raise awareness and mobilize support for action are a major challenge.For PHP (public health programmes), developing countries should be a priority. According to the Uppsala Monitoring Centre, Africa’s ADR reporting capacity is weak (for example in Kenya, Zambia and Senegal). HIV, TB, immunization as well as bad infrastructure and equipment are also key issues here. The biggest WHO campaigns include 8 “World” events: World TB Day, World Health Day, World Immunization Week, World Malaria Day, World No Tobacco Day, World Blood Donor Day, World Hepatitis Day and World AIDS Day.
  • Wonders of the World Wide Web – Patients, doctors, hospitals, insurers, drug companies, NGOs and patient organizations need to and want to share data.The coverage that is now available because of modern technology is a good start. But it is not only patients who are looking for information online. When making clinical decisions, physicians spend twice as much time using online resources as compared to printed materials.
  • Digital Health – Patients look for information online and they are eager to share.Peer–to–peer healthcare with “tech” support that is not only rational and informational but also emotional is the key and quick responses are a must. Wearables or out–of–home means of monitoring are trending too. Smart watches, bracelets, apps for mobile phones, calorie counters, sleep pattern monitors, step counters… We could go on and on.
  • Personalized Medicine – Taking variables like a patient's family and medical record history into account is already a component part of practice.What more can we do? Targeting medicines to patients’ individual genes, trends like genetic mapping, more comprehensive labeling, nanotechnology and more represent the future.
  • International Harmonization – With the globalization of the market, changes in the society and rising innovation in the pharma industry, PV needs to be treated as a key public health system.There is a growing call for transparency and integration of data towards the goal of the highest ethical, professional and scientific standards in protecting and promoting the safe use of medicines. Because of individual case reports, data collection is moving more towards spontaneous reporting and new methodologies are arising.