Is the Spontaneous Reporting System for Adverse Drug Reactions delivering as it should?

To ensure public health safety, the use of drug products or medicines must be monitored using an effective pharmacovigilance (PV) system. A Qualified Person responsible for Pharmacovigilance (QPPV) is accountable and must ensure that all legal obligations of the Market Authorization Holder (MAH) are met in respect of pharmacovigilance and the monitoring of the drug product in the market.

In this blog, Navitas Life Sciences’ Director of Pharmacovigilance and Global QPPV, Dr. Philipp Hofmann, MD, explores the spontaneous reporting system of adverse drug reactions (ADRs) as he looks at whether it is delivering as it should.

The Spontaneous Reporting system of Adverse Drug Reactions

What is a Spontaneous Report?

According to the European Medicines Agency (EMA) a Spontaneous Report is ‘An unsolicited communication by a healthcare professional or consumer to a company, regulatory authority or other organisation (e.g. the World Health Organization, a regional centre, a poison control centre) that describes one or more adverse reactions in a patient who was given one or more medicinal products and that does not derive from a study or any organized data collection scheme.’

Dr Philipp Hofmann, MD

Director Pharmacovigilance,
Global QPPV

Navitas Life Sciences

In short, data volume is still insufficient.

According to the professional code, doctors are obliged to report ADRs. For this, the simple suspicion of an ADR is sufficient. However, many doctors do not appropriately comply with this obligation.

Reported ADRs are one of the most important tools for identifying risks after drug or vaccine administration and help to improve patient safety. Doctors, patients, pharmacists, health care professionals, and pharmaceutical companies are equally challenged.

Doctors and pharmacists have a professional obligation to notify ADRs to their respective Drug Commission for physicians or pharmacists. Those entities then forward the reports anonymously, without naming the patient or the doctor, to the responsible authorities. In some countries, like Germany for example, there is a requirement to differentiate between drugs and vaccines and file ADRs accordingly to either the Federal Institute for Drugs and Medical Devices (BfArM) or the Paul Ehrlich Institute for Vaccines and Biomedical Drugs (PEI). Doctors who have reported an ADR also receive feedback from their Drug Commission, which contains additional information on the suspect drug and, if necessary, an excerpt from the ADR database and further literature.

Patients and their health care professionals can report suspected ADRs of drugs and vaccines directly online to the Authorities.

Obligation to report under professional law

Throughout the COVID-19 pandemic, the Drug Commission of the German Medical Association has drawn attention to the fact that in view of the large number of cases reported in connection with COVID-19 vaccines, doctors not only have a professional obligation to report, but they must also inform the responsible health authorities about "reactions going beyond the usual level."

The basis for the spontaneous reporting system is the national or regional drug law, which requires Authorities to systematically collect and evaluate the experience gained in their use after the approval of a drug or vaccine. The hurdles for a report are deliberately kept low: In principle, the mere suspicion that a reaction to the intake of a drug or as a result of a vaccination is a side effect is sufficient. This applies in particular to ADRs that are not listed in the product information, or that exceed the information in the product information in their severity and frequency, ADR of drugs on the market for fewer than five years, and in principle, serious ADRs.

Europe-wide database

However, the spontaneous reporting system cannot provide information on the absolute frequency of an ADR and, usually, does not allow comparative evaluation of medicinal products, as it is not known how many ADRs are not reported, and how often a medicinal product is used. This is called under-reporting.

All notifications are sent to the central "European Database of Reported Suspected Cases of Adverse Drug Reactions (EudraVigilance)" located at the European Medicines Agency (EMA), which is intended to monitor drug risks throughout the EU.

"When evaluating this data, the use of artificial intelligence will also become increasingly important, for example, to automatically evaluate the quality of the messages," predicts Prof. Karl Broich, MD, President of the German BfArM. The greater the volume of data that is collected, the better the risk-benefit profile of a drug or vaccine can be assessed.

To give an example using data collected by the BfArM, 18,978 spontaneous cases were reported throughout Germany in 2020. 5,495 of those reports came from patients or their relatives. Health care professionals used the spontaneous reporting system 2,323 times and pharmaceutical companies 4,050 times. Likened to previous years, this represents a significant increase. By way of comparison: in 2012 only 7,216 direct reports were received from doctors, other healthcare care professionals, and patients or their relatives.

The number of incoming reports has also risen continuously at EudraVigilance. Last year, the database recorded 82,958 spontaneous reports in Germany from patients, their relatives and doctors, and health care professionals. In 2017 there were 60,323 and in 2018 78,253 cases.

Nevertheless, in practice, the spontaneous reporting system still does not seem to work satisfactorily in Germany. Not every ADR is reported. The reasons for the reluctant reporting behavior of Health Care Professionals and patients are manifold. On the one hand, patients do not inform their doctor about every observed reaction after taking a drug or administering a vaccine, because they either do not recognize the connection or would wrongly attribute the ADR to the underlying disease.

Lack of willingness to report

On the other hand, however, the willingness of doctors to report is sometimes low, as a survey performed in Germany on the attitude of doctors to the spontaneous reporting system between November 2017 and February 2018 has shown. The time required, the lack of knowledge of the reporting procedure and the organisations involved and ambiguities about what exactly should be reported often lead to doctors not fulfilling their reporting obligation.

In a bid to improve awareness about the spontaneous reporting system and the willingness to report, the Drug Commissions, Authorities or even the pharmaceutical companies regularly conduct lectures or training. Patients and doctors can also find out about the reporting system and the need for well-documented case reports on the respective homepages of the Authorities.

Pharmacovigilance obligations for the industry

In parallel to this system of drug commissions and authorities, pharmaceutical companies have an obligation to collect ADRs themselves. The MAH is responsible for continuously monitoring the safety of its medicinal products for human use, and for informing the authorities of any changes that might have an impact on the marketing authorization, as well as ensuring that the product information is kept up-to-date. MAHs need to record all suspected adverse reactions, which are brought to their attention spontaneously by the patients or their health care professionals, or occurring in the context of a post-authorization study. For all medicinal products, it is mandatory to maintain a Pharmacovigilance System Master File (PSMF). In addition, the MAH must submit to the competent authorities the information on suspected ADRs, in the form of Periodic Safety Update Reports (PSURs).

What is a QPPV?

The QPPV is the Qualified Person for Pharmacovigilance. Every company with a market authorization in the EU needs to have a QPPV available on 24/7 basis for the European Medicine Agency (EMA). The QPPV needs to maintain an oversight on all PV activities of a MAH, which includes quality, single cases, aggregate reports, and many other aspects.


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