Pharmacovigilance

What is pharmacovigilance?

The World Health Organization has a definition of pharmacovigilance that says “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.”

you can see WHO's pharmacovigilance definition here


The goals of pharmacovigilance are to bolster patient safety concerning medicine use by providing a system to collect, assess, and distribute drug safety data. Pharmacovigilance activities involve monitoring approved drugs and investigational medicinal products (IMPs) to:


Importance of pharmacovigilance

Pharmacovigilance (Pharma vigilance) is central to drug safety especially with regards to adverse events, adverse reactions and the like. Pharmacovigilance analysis conducted in Phase I, Phase II, and Phase III clinical trials gives drug companies data on the safety profile of the drug. This data can be used for further R&D if necessary or can be submitted to regulatory authorities to allow new markets to be accessed.

Both PV practices in clinical research and those done through medical professionals and consumers offer valuable insights into the safety profile of pharmaceutical medications.

When a new adverse reaction is identified, the list of side effects on the label must be updated. At times, PV data can lead to the removal of a drug from the market (drug recall) due to dangerous side effects.

Measuring importance

Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem. The main purpose of pharmacovigilance is to improve the patient's safety and enhance his care in terms of the use of medicines, including paramedical interventions. Pharmacovigilance also supports public health programs by providing reliable information for the efficient assessment of the risk-benefit profile of medicines, contribute to the assessment of benefits, uses, side effects, harm, effectiveness and risk of medicines, encouraging the safe, rational and more effective (including cost-effective) use of various medicines. Promote education, understanding and clinical training in Pharmacovigilance and its effective availability to the public. Additionally, health regulatory authorities such as the U.S. FDA and EMEA (European Medicines Agency) are now emphasizing on electronic submission of data which is also expected to drive the pharmacovigilance market.

The Pharmacovigilance Risk Assessment Committee of the European Medicines Agency (PRAC), the European Medicines Agency's (EMA) committee responsible for assessing and monitoring the safety of human medicine, launched a strategy in 2016 to improve safety monitoring practices and to determine which activities are most successful.

No doubt, pharmacovigilance is important and has proved its value in practice by far. But to be able to measure the impact of pharmacovigilance, we need to generate more evidence about the effectiveness and public health consequences of pharmacovigilance activities at the population level. It also elucidates information which could aid in the optimisation of the functioning of the pharmacovigilance system. It can provide valuable information how to improve pharmacovigilance by identifying which pharmacovigilance activities are most successful and enablers and barriers for generating positive health impacts. It will provide opportunities to focus resources on those activities that make a difference in daily health care. Pharmacovigilance should become next to practice based more evidence based.

Pharmacovigilance needs to measure the safety profile of drugs, but what is pharmacovigilance doing about this, are they asking patients in the real-world, are they all listening to the patients that take the products? Are adverse events and adverse reactions being recorded and reacted on?

Good pharmacovigilance practice

The goal of good pharmaceutical practices for pharmaceutical companies is to prevent harm to humans caused by adverse drug reactions from approved pharmaceutical drugs.

Good pharmacovigilance practices (GVP) vary slightly from one country to the next and are determined by the country’s regulatory authorities.

There are a variety of drug authorities that oversee pharmacovigilance. These vary by country and include:


Multiple organizations oversee international collaboration for pharmacovigilance. The World Health Organization (WHO) is one of the primary groups that facilitate the sharing of data between countries around the world.

Impact of pharmacovigilance

Assessment of the impact of pharmacovigilance actions at the population level is an area currently underinvestigated.

Methods, challenges, and interpretation of post‐approval evaluation of effectiveness of risk minimisation measures have been described by many. These evaluations typically investigate knowledge, attitudes, or behaviours of health care professionals or patients, the incidence of safety concerns, and their impact on the overall benefit‐risk balance.

A review of risk minimisation measures applied to EU centrally authorised medicines between 2006 and 2015 found that additional risk minimisation measures were imposed to approximately a quarter of them. Effectiveness measurements, though increasing in time, remained limited to a minority of instances. Recently, a descriptive overview of the analytical methods for impact research as there is currently no common methodological approach to guide impact evaluation.

After assessing 153 articles, of which 55% of studies measured changes in drug utilisation patterns, 27% evaluated health outcomes, and 18% targeted knowledge, behaviour, or changes in clinical practice. Unintended consequences like switching therapies or spillover effects were rarely evaluated.

The impact of pharmacovigilance can be increased the closer the data comes to the patient. real-world data and insights will help create a better effect and impact for the entire pharmacovigilance industry. Helping to Identify previously unknown adverse effects, recognise changes in the frequency or severity of known adverse effects, assess a drugs risk/benefit to determine if action is required to improve safety, while ensuring the accuracy of information communicated to healthcare professionals and patients, and to ensure information contained in patient information leaflets (PILs) is up to date.

Everything becomes easier and more relevant by listening to the patients.

There are different challenges when measuring the impact of pharmacovigilance activities. These include the following:

  1. The intertwining of the different steps of the pharmacovigilance pathway, which makes the assessment of impact for the individual steps complicated.
  2. Taking into account the unintended effects and other simultaneous events such as changes in clinical practice or secular trends in health outcomes.
  3. Determining and measuring the right outcomes, which can be challenging and might be further complicated by unavailability of data.


For instance, over‐the‐counter medication, without a medical prescription, or drugs which are not reimbursed, such as oral contraceptives in many countries, are rarely covered in secondary data sources. Large electronic health care databases can be used to assess usage patterns of medication or the occurrence of disease and symptoms. However, heterogeneity in their structure, validity, and access across Europe complicates the conduct of multi-database studies. Also, different databases are unlikely to capture all impact‐relevant outcomes, even when they are linked to one another. Data may be available on hard outcomes such as death, hospital admission, emergency room visit, or medical contacts; however, these might not be publically available to researchers. The assessment of changes in behaviours of health care professionals and patients needs a qualitative data collection approach in form of collecting questionnaires or performing interviews.

Although measuring the impact of pharmacovigilance activities is challenging, more appropriate research is needed, as has also been described for drug safety science as a whole. This requires various types of data, advanced study designs, and new methodologies that allow for a full evaluation of the impact on public health, taking into consideration the various factors that play a role throughout the pharmacovigilance pathway. The added value of new data sources and techniques, such as real‐life monitoring, should be assessed.

In 2018, the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) published guidance on methods for pharmacovigilance impact research. This guidance discusses challenges present with choosing the right study outcomes, as they are closely tied to the nature and objective of the pharmacovigilance activities and will be different for each drug and each type of risk. In addition, limitations of data sources, study design, and analytical methodology are discussed. However the inclusion of patient data from third apps and new digital devices are not yet interwoven into the plans.

Listening to patients

As the end users of medicines, patients can provide first-hand information on side effects. The issues they report add a richness to our understanding of medicine safety that we could never achieve by relying on healthcare professionals’ reports alone – so it’s crucial that we listen to them.

It’s shocking to hear that 72% of patients asked in a recent survey said they felt ignored by the pharmaceutical industry. Isn’t it time this changed, isn’t it time that patients using your products could tell you how they felt, sharing insights at scale and allowing you to help make better insight driven and truly patient centric products?

With a multi-seat subscription for your employees you not only get all the valuable insights into your patients around the world. You also get a badge which you can actively use in all your communication material. The badge lets your patients know you’re listening to them. Helping you create customer confidence and improving your reputation.

DrugsDisclosed.com listens and collates data from 352,044 patient reviews from global users of the scientifically validated DrugStars medication app. The service has over 55 million unique data points around medication reviews. The service is free for patients and patient organisations. Pharma and payers can subscribe for unlimited searches on the "mirror" website DrugsDiscovered.com. It provides anonymous secondary market patient insights for specific medications and conditions. 

DrugStars is committed to listening to and empowering patients. The company donates 20% of its revenues to over 240 global patient organisations and enables the users to earn donations for their chosen organisation. To date, DrugStars has donated £376,835 to patient organisations around the world.

How to prevent adverse drug reactions

It is worth considering how well a drug’s safety is defined prior to its approval and marketing. This will indicate how confident practitioners can be that a new drug’s safety profile has been fully defined. 

Most new drugs are approved with an average of 1,500 patient exposures and usually for only relatively short periods of time. However, some drugs cause serious ADRs at very low frequencies and would require many more exposures to detect the reaction. For example, bromfenac (Duract) was a non-steroidal anti-inflammatory agent (NSAID) that was removed from the market in 1998, less than 1 year after it was introduced. Bromfenac caused serious hepatotoxicity in only 1 in 20,000 patients taking the drug for longer than 10 days.1 To reliably detect the toxic effects of a drug with a 1 in 20,000 adverse drug reaction frequency, the new drug application database would have to include 100,000 patient exposures. A drug that is tested in a few thousand people 11 may have an excellent safety profile in those few thousand patients. However, within a short time after entering the market, the drug may be administered to several million patients. That means that for drugs that cause rare toxicity, their toxicity can only be detected after, not before, marketing. 

If one case of hepatotoxicity is seen during pre-marketing testing, it can be difficult, if not impossible, to ascertain whether it was secondary to the drug or just the background rate of disease that is seen in the population. 

So, the safety profile for new drugs that come on the market is never totally defined because new drugs are studied only in relatively small and homogenous patient populations. The complete safety profile of a new drug will be defined only after it has been approved and is in use on the market.

Ask and listen to patients.

When a drug arrives on the market it is now possible to monitor it by asking the patients taking it to review it, sharing real-world data back to the producer to help to make meds better for all. This new level of drug safety can stop an adverse event for a patient. Apps like DrugStars allow patients to review their medication every two weeks allowing adverse drug reactions to be tracked and monitored over time. It also gives a wider audience from which data can be collected. DrugsDiscovered allows you to start listening without all the red tape.