What is Pharmacovigilance and how does it prevent risks and encourage compliance

According to the World Health Organization (WHO), Pharmacovigilance is the practice of identifying, evaluating, understanding, and preventing any adverse effects — among other negative consequences — generated by the use of a drug after its approval and launch.

With this care, pharmaceutical companies and even health professionals can detect threats to the physical integrity of consumers even after a drug has been launched.

That is why it is so important for an organization to know deeply what Pharmacovigilance is, as well as to maximize its benefits and what are the good practices that promote successful control.

With that in mind, we have prepared this post with everything you need to know about the subject. Check!

What is Pharmacovigilance?

As the name implies, pharmacovigilance is the science that seeks to monitor the market in search of drugs that, after being approved and made available, cause harm to the health of their consumers.

In other words: Pharmacovigilance is an essential tool for companies to preserve the population’s safety. At the same time, it guarantees the effectiveness and quality of the products that the corporation offers in the market.

To carry out this follow-up, professionals in this area use epidemiological data, analyses of clinical and risk/benefit studies, and, mainly, reports of adverse events.

These events are basically the occurrences of some negative effect caused by the drug administered — relax, you will understand this concept better.

Therefore, pharmacovigilance is part of risk management efforts in the pharmaceutical sector. It mitigates the negative impacts of non-compliance cases while helping to prevent similar situations from occurring again.

It is precisely for this reason that having pharmacovigilance practices is one of the regulatory matters of the area’s supervisory body — in this case, the National Health Surveillance Agency (Anvisa).

Therefore, the pharmacovigilance ecosystem in Brazil has the following components:

• Manufacturers;

• Distributors;

• health professionals;

• Users;

• Researchers;

• educational and research institutions;

• and public agencies.

In practice, all these members can notify Anvisa about adverse events related to the drugs. This happens through the VigiMed system, which is an online platform that allows the registration, monitoring and analysis of notifications.

After receiving one of these warnings, Anvisa evaluates them and then can take a series of measures according to the severity of the event. Some of the most common are:

• issue alerts, communiqués and letters to health professionals warning about what happened;

• request additional information from manufacturers to better understand the situation;

• suspend or cancel the registration of drugs involved with adverse events;

• change package inserts or labeling taking into account the consequences of an adverse event (for example, adding a side effect).

Thus, the regulatory body seeks to safeguard the health of the population, as well as ensure that companies in the field are following all guidelines, good practices and standards that also aim at this end.

What is an adverse effect?

You’ve probably seen this term many times, including in the course of this article. It can also be called Adverse Drug Reaction (ADR), and it is common for some people to end up confusing the concepts of adverse effects – or ADR – and side effects.

To understand the difference, remember that a side effect is any effect that a drug or procedure causes in an organism beyond the one for which it was designed. For example, a motion sickness medication is thought to address this problem, but it can also cause drowsiness, which would help someone who has trouble sleeping.

In other words, the side effect is not necessarily a bad thing. On the other hand, an adverse effect is necessarily a negative consequence.

Let’s see how Anvisa defines this concept according to RDC 140:

“an adverse effect is any response to a drug that is harmful, unintentional, and that occurs at doses normally used in humans for prophylaxis, diagnosis, and treatment of diseases, or for the modification of a physiological function”.

In short, every adverse effect is a side effect; But not every side effect is also adverse.

The most common adverse effects

There is no universal standard for mapping the various forms of AMRs within pharmacovigilance. However, there is a consensus of categorization that takes into account the severity of the occurrences. Within this criterion, an ADR can be divided into: Mild, Moderate, Severe, and Lethal.

With this categorization, adverse reactions are divided between a simple skin allergy to a cardiac complication that leads to the patient’s death. Although the most common are of the mild or moderate type, there are still more serious consequences.

According to several studies, such as one carried out in a public hospital in Minas Gerais, Brazil, some of the most common ADRs (whether mild, moderate, severe or lethal) are:

• Dermatologic reactions;

• Cardiovascular disorders;

• Nausea and vomiting;

• Diarrhoea/constipation;

• Disorders that affect sleep (drowsiness or insomnia);

• Dizziness and vertigo;

• Headache;

• Fatigue;

• Indeterminate muscle cells;

• Loss of appetite;

• Sensation of abdominal distension.

What is an adverse event

Also according to Anvisa, an Adverse Event (AE) can be defined as: “any medical occurrence unfavorable to the patient or subject of the clinical investigation and that does not necessarily have a causal relationship with the treatment”.

That is, unlike adverse effects, an AE is not restricted to medications. They can also happen due to problems in procedures (surgeries) and other treatments.

Because it is a major threat to the health of patients, every adverse event needs to be registered in the Pharmacovigilance database of Drug Registration Holders, even if it has not yet been confirmed.

As with ADRs, EAs also have a classification that takes into account their severity. It is:

• Grade 1 – Mild event that causes noticeable discomfort, but does not affect the patient’s routine.

• Grade 2 – This level is considered moderate, as it encompasses the effects that affect a patient’s routine.

• Grade 3 – Severe levels, are those AEs that affect a patient’s routine very seriously, and may even prevent him from performing an activity completely.

• Grade 4 – These are adverse events that put a patient’s life at imminent risk.

• Grade 5 – It is death, that is when an AE causes the patient to die.

Within all these categories, the most frequent adverse events are:

• Suspected adverse drug reactions;

• Total or partial therapeutic ineffectiveness;

• Drug interactions;

• Overdose of medications;

• Medication abuse;

• Medication errors;

• Off-label use  of medication;

• Drug exposure during pregnancy/lactation;

• Adverse events due to quality deviation.

Learn more: How pharmaceutical companies should prepare for regulatory body audits

What is the importance of pharmacovigilance

With so many possibilities of problems that can arise due to the lack of quality of a drug, you have probably noticed that pharmacovigilance has a great benefit: it brings more safety — both to the general population and to your company.

But it doesn’t stop there. This practice also helps protect your company’s reputation, strengthens the quality of the drug market, and boosts compliance.

After understanding what pharmacovigilance is, see below for more about each of these points and understand its importance.

Comply with industry standards and regulations

As you have already seen, Anvisa is a regulatory entity that is very present in this market. The same happens with those agencies that take care of the sector in other countries — and it could not be different.

After all, ensuring the quality and efficacy of medicines is synonymous with protecting the well-being and health of the entire population. Therefore, these public agencies have restrictions, legislation, and rules that must be followed in the letter.

This presents a challenge for companies that must map, monitor and mitigate a series of potential non-conformities. That’s where pharmacovigilance comes into play.

Thanks to it, your company can do this control systematically and reliably. In this way, it has more security and confidence that the products it is taking to the market comply with all good manufacturing practices. This not only protects your brand’s reputation but also avoids fines and other sanctions by regulatory entities.

Protecting the health of the population

According to a 2023 Anvisa bulletin, there were more than 50 thousand notifications of adverse events that year. Of these, 70% were notified by health professionals.

In other words, there is a high incidence of AEs even with constant surveillance, especially of those who work in the health sector. This shows how efficient pharmacovigilance has the potential to safeguard people’s health by reducing exposure to potentially dangerous drugs.

This is how pharmacovigilance brings the general population peace of mind that the chances of suffering from an ADR or AE will be low. If your company seeks to take care of the well-being of its customers, it must not only have pharmacovigilance practices but also invest in it through continuous improvements.

Boosting the manufacture and improvement of medicines

Pharmacovigilance does not only protect people and companies but the market as a whole. This care arises when it assists in the production of new drugs and other health products, by providing information about their effectiveness, safety, and quality.

In addition, it is through pharmacovigilance that a company can understand the needs and expectations of users. This helps in the research, development, production, regulation, commercialization, and post-marketing of the products.

In this way, even before making a new drug available on the market, a corporation can evaluate the balance between risk and benefit. Thus, it objectively understands whether it is worth continuing with this release.

How to implement Pharmacovigilance in a company

To do this the right way, it is essential to have a Pharmacovigilance System. It will be the central point with all indicators, files, legislation, notifications and other activities of the pharmacovigilance sector.

This system can be pharmaceutical management software, which brings more agility, autonomy and efficiency, or another form of control. The important thing is that there is a structured way to carry out this work, ensuring that your Pharmacovigilance System enables:

• The collection and processing of all Adverse Event information of which your business has been notified;

• Compliance with the regulatory requirements of the relevant entities;

• Constant improvement aimed at detecting non-conformities and opportunities for improvement;

• Ways to quickly provide all benefit-risk assessments of your products to health authorities. This includes information on sales volume and studies related to the safety of their products; 

• The confidentiality of the reports received.

To make sure that all of this occurs in the day-to-day pharmacovigilance practices, you can follow the following five steps.

1. Create policies and procedures

Documenting policies and procedures is essential for your operation to be efficient, agile, and traceable, but this also ensures transparency and peace of mind in the case of audits.

Mandatorily, every company in the sector needs to have in its Pharmacovigilance System information on: structure, interfaces, work processes, responsibilities and activities related to risk management.

Therefore, pay attention to the moment to create the policies that will permeate the activities of the pharmacovigilance sector, as well as the various types of Standard Operating Procedure (SOP) that will be used in the operation.

To start this work, prioritize documents and SOPs that involve collection, registration, analysis, evaluation, notification, monitoring, and improvement of cases of adverse events.

2. Define who will be the responsible team

There is no point in having a series of documentation, procedures, information and guidelines if there are no trained people to put all this into practice.

Therefore, count on a qualified team that can not only handle all the work that involves pharmacovigilance but also create opportunities for constant improvement. To do this, bet on training and qualification.

This is even a legal requirement for all companies in the sector: to have duly approved training programs, each with its respective execution schedules. In addition, records of all these trainings need to be kept, as they will be needed in future inspections.

3. Collect and analyze adverse event data

Your company needs to properly store all reports it receives about adverse events related to its products. To do this, maintain a database aimed at the systematic, up-to-date, and routine recording of this information.

This data may be stored in the form of a form (including electronically), which will contain as much information as possible about the EA. Only then will this notification be considered valid and acceptable to be reported to the competent regulatory body.

The minimum amount of data you need to rely on for this is: 

• Identification of the notifier;

• Identification of the patient through one of the following: name or initials, gender, age or date of birth;

• Description of the Adverse Event that occurred;

• Name of the drug suspected to have caused this AE.

But it is not enough to just record and store all this information. After doing this, it is necessary to use statistical, epidemiological and pharmacological methods in search of:

• Standards;

• Trends;

• Risk factors;

• Gravity;

• Causality;

• Frequency;

• Impact of adverse events.

4. Investigate AE cases and notifications

After collecting all the information about the Adverse Event, the company that holds the Drug Registration must fill out the Adverse Drug Reaction Notification (SRAM). In many cases, it already brings guidelines on what conduct to adopt concerning the event.

Then, the company needs to carry out a series of actions that seek to classify and investigate the EA. See below what these activities are in the order in which they should be done:

1. Classify the event concerning its severity (in those categories we have already seen);
2. Classify the event according to its causality (defined, probable, possible and doubtful). To do this, the Naranjo Algorithm and/or the WHO definitions that apply are used;
3. Categorize the Adverse Event by analyzing its predictability (which can be expected or not expected);
4. Then, the investigation of the occurrence itself begins. In it, the analysis of the batch record, retention samples, and evaluation of raw material retention, among other ways of understanding what happened and what its cause is, will be carried out.

5. Constantly monitor and do periodic self-assessments

Constant vigilance is a mantra in this area. Therefore, also create internal guidelines and procedures that aim to monitor the drugs produced by your company and what their associated risks are, changes in the conditions of use, and changes in their safety profiles.

This work takes place through performance indicators, periodic benefit-risk assessment reports and internal and external audits. A good way to put this into practice is by performing a self-inspection. With it, a company can assess whether it is following Good Pharmacovigilance Practices (GMP).

In it you must describe how often this scan will be carried out, what are the responsibilities of those involved, the procedures carried out and other documents to be followed. Also, include an execution schedule. All of this needs to be done at least once a year.

Free Ebook: How to Implement Good Manufacturing Practices in the Pharmaceutical Industry

Conclusion

Now you not only know what pharmacovigilance is, but you also understand how this practice protects your health — and that of your company as well.

Remember to adopt good practices, follow legislation and guidelines, and pay close attention to quality control and compliance.

Looking for more efficiency and compliance in your operations? Our experts can help you identify the best strategies for your company with SoftExpert solutions. Contact us today!