Updated: Dec 19, 2022
The History of Pharmacovigilance roots back to the rise in awareness among clinicians and the public pertaining to the safety of drug use in the middle of 20th century. Despite concerns around health issues due to adverse reactions caused by intake of medicines, the discipline and practice of detecting, assessing, and understanding the adverse effects took more than century to come by.
However, the progress in Pharmacovigilance to ensure patient safety was evident from 1960s. Since then, Pharmacovigilance has evolved through new trends to become a vigilant mechanism to monitor the safety of therapeutics.
Pharmacovigilance (PV) deals with drug-related problems: detecting, understanding, and preventing adverse effects. Patient safety is the key goal of PV. Many approved medicines carry a risk of adverse effects. Although the benefits to the patient outweigh these risks, physicians and researchers need to remain cautious about any serious side-effects.
A successful PV system collects, analyses, and shares drug safety data while aiming to reduce risk to patients in the shortest time possible. PV applies to both; approved drugs and those under clinical trials.
During the COVID-19 pandemic, PV is more important than ever. Clinical trials, of both vaccinations and potential treatments for COVID, are taking place around the world. For example, the new anti-viral drug ‘remdesivir’ is being trialed, while several old drugs are being repurposed. Understandably, this research is receiving far more media attention than a “normal” clinical trial would. At the same time, many rumors – some based in fact, most not – about possible treatments are circulating on social media.
Doctors, public health specialists, and other healthcare providers urgently need accurate and up-to-date safety information on COVID-linked drugs and trials. Pharmacovigilance also has an important role to play in helping to fight misinformation.
Pharmacovigilance during COVID-19
Complete or partial lockdowns imposed across nations during the coronavirus outbreak peak-outs led to a steady decline in ongoing clinical trails due to the restricted availability of clinical resources and research staff. The lockdowns also brought a drastic change in work practices, routine audits, and safety inspections.
Increase in the use of drugs (either approved for COVID or off label use) have driven Global Health Authorities and healthcare industry to work round the clock. As it was rightly said by Secretary General of United Nations- António Guterres,” COVID-19 has been likened to an X-ray, revealing fractures in the fragile skeleton of the societies we have built.”
The need for providing patients with risk-free and effective remedies in a short period of time was promising challenge during Pandemic and also post-pandemic. As part of commitment to patient safety and wellbeing, Pharmacovigilance service providing companies, healthcare professionals etc. are coming together.
Pharmacovigilance post COVID-19 Pandemic
COVID-19 has undoubtedly thrown up many challenges for PV. However, there are also opportunities. Some Pharmacovigilance specialists hope that this pandemic may bring Pharmacovigilance and healthcare practice closer.
During the COVID-19 crisis, physicians frequently require to make treatment decisions that are not yet completely addressed by clinical trials. Instead, doctors must rely on observational data such as that found in adverse event databases. Swift analysis of this data will help to provide the guidance that doctors need on an urgent basis to keep their patients safe.
We tend to overlook the fact that even experienced healthcare workers are learning with time; this pandemic is new for everyone! This has led to different countries responding to the pandemic in very different ways. While some governments have ordered strict lockdowns and made the use of personal protective equipment mandatory, others have taken a “wait-and-see” approach or relied on social distancing alone.
Thanks to the wealth of reporting, on both mainstream and social media, the public is very aware of disagreements both within and between governments on how to handle this unprecedented situation. For this reason, effective risk communication is vital. Transparency and honesty will be key as the pandemic approaches its second year. Detecting and correcting false information, and effectively communicating risk to both the public and healthcare workers, is both a challenge and an opportunity for PV.
Information sharing within the PV community is also important. In particular, well-funded PV teams have the opportunity to assist colleagues in low-income countries, who may not have access to the same knowledge and resources. By facilitating access to PV databases, countries on the opposite side of the world could equally benefit from data sharing. Such collaborations could – and should – persist long after this pandemic is over, potentially improving safety for millions of patients.
The Pharmacovigilance community has been quick to respond to the pandemic.
In anticipation of the many COVID-19 therapies expected to be available in near future, the UK’s MHRA has launched a new online reporting system, called the Yellow Card. The Yellow Card service aims to track reports of adverse effects in any treatments, vaccines, diagnostic methods, or medical devices that might be used in the care of COVID-19 patients. This should create a robust knowledge base of safe treatments for the disease.
“While our aim is to ensure that potentially lifesaving COVID-19 treatments and medical equipment reach patients as quickly as possible, patient safety is our highest priority,” said Dr. June Raine, Chief Executive of the MHRA.
Some companies are using Big Data analytics in the fight against COVID-19. This refers to the in-depth analysis of data from multiple different sources. This technique should reveal patterns in the data that might not be possible to detect from any single database. Additionally, it may not only assist in finding solutions to the current medical issues but also predict any prospective problems.
Finally, the WHO has five established Collaborating Centres, set up to advance PV in countries around the world. The five centres handle Drug Monitoring, Statistics and Methodology, Advocacy and Training in PV, Strengthening PV Practices, and PV in Education and Patient Reporting, respectively.
Boom in Pharmacovigilance sector
As per a recent analysis by Emergent Research, the Pharmacovigilance market is expected to be valued at $12 billion by 2027, an indication of rapid growth in the sector post COVID. To be able to leverage such growth opportunities, the Pharmacovigilance industry is increasingly adapting to new trends attributed to better and more effective data collection and analysis.