Thursday, December 21, 2023, 12:39 p.m
Medicines go through far more checks in their life cycle than any other product in Germany. Only when it has been ensured that a drug is safe, of high quality and effective is it approved by the authorities and may be supplied in Germany. But before it can be used, every active ingredient must first pass a series of non-clinical tests and clinical trials on the way from research to the finished product. Even after approval, it is continuously monitored. There are few industries in which the safety, effectiveness and quality of a product is monitored as closely as in the pharmaceutical industry. National and European laws ensure this – but also the pharmaceutical companies themselves. Good news! Dr. Sigrid Lang, Head of Drug Safety/Pharmacovigilance at the Federal Association of the Pharmaceutical Industry (BPI), gives an overview of the areas in which the BPI and its member companies have been committed to drug safety for many decades.
BPI is a pioneer and sets milestones in drug safety
1969: The BPI introduces the “Red Hand Letters” and has the red hand logo protected by the Federal Patent Office. “To this day, the Red Hand letter is the established means of communication in Germany with which pharmaceutical companies and healthcare professionals independently inform themselves about newly recognized, serious drug risks. With the distinctive trademark of the letters – the raised red hand with the warning “Important notification about a Medicines” – pharmaceutical companies can recall defective batches of medicines or provide other important information about the medicine. Together with other associations, the BPI coordinates the Red Hand letters across the board and thus supports our member companies in their daily work. As the owner of the “Red Hand Letter” symbol, we have the trademark rights to the image at BPI. Anyone who wants to use it must officially request this from us,” explains Lang. At the same time (1969), the BPI committed itself to reporting side effects to the Drug Commission of the German Medical Association (AkdÄ). The legally binding reporting of individual cases of side effects by pharmaceutical companies to the responsible higher federal authority was only introduced in 1986.
1975: The BPI requires its member companies to follow a “package insert guideline” that prescribes warnings about possible side effects. In order to provide information to doctors and pharmacists, the BPI developed the “Information on Use for Specialists” from 1979 onwards, a binding information system specifically for specialist staff.
1976: After the thalidomide crisis (1957 – 1961), the BPI accompanied the expansion of the first Medicines Act (AMG) from 1961 to the second AMG. For the approval of new medicines, pharmaceutical companies must for the first time prove the pharmaceutical quality, effectiveness and safety of medicines. There are now precise procedural regulations from the operating sites to sales and package inserts – a gain for consumer protection. The reporting requirement for non-clinical tests and clinical trials was introduced for the first time. The second AMG from 1976 represented an adaptation to the European pharmaceutical law.
1990: The BPI developed the established sentence with: “For risks and side effects, read the package insert and ask your doctor or pharmacist.” Since then, this sentence has been mandatory in accordance with the Medicines Advertising Act and must be stated in audiovisual advertising primarily for non-prescription medicines outside of specialist circles.
Protection against counterfeit medicines
In order to make the legal supply chain in the supply of pharmaceuticals even safer, the pharmaceutical industry, wholesalers and pharmacists came together to form the organization “securPharm” 15 years ago. Together they have set up the German protection system against counterfeit medicines, which is regulated by law across Europe.
Here’s how it works: An individual serial number is stored in a square data matrix code, which must be on the majority of prescription and some non-prescription medicines, which the pharmacist scans before dispensing it to the patient and checks that it matches the information provided Manufacturer database checked. This is how the authenticity of the package is verified.
Making medicines even safer
How do pharmaceutical companies combat counterfeits?
“On the one hand, pharmaceutical companies have invested a lot of time, money and energy to set up the anti-counterfeiting system – always with the goal in mind that they can supply patients with even safer medicines. In addition, manufacturers provide the packages of prescription medicines with first-opening protection – the so-called anti-tampering device – so that they cannot be opened unnoticed. In addition, some companies equip their packaging with additional authenticity features. This can be done using UV colors, DNA-containing dyes, holograms, microwriting or iridescent elements,” explains Lang.
“In addition, the pharmaceutical industry is doing everything it can to combat criminal activities that counterfeit, distribute or illegally distribute medicines. In order to avoid risks, patients should definitely check the authenticity of a website when buying medicines online,” advises Lang. All official online pharmacies are listed in the mail order register of the Federal Institute for Drugs and Medical Devices (BfArM) and have a test seal.
Is a drug still monitored even after approval?
The use of medication is also monitored. The so-called “pharmacovigilance” records and processes, in particular, side effects and other drug risks and thus prevents treatment errors. Particularly important are the reports of side effects from patients, doctors and pharmacists to the responsible higher federal authorities.
“Pharmaceutical companies collect data on every drug and submit regular safety reports to the higher federal authorities. Clinical studies can also generate further data after approval. If the benefit-risk assessment changes, measures are taken at short notice and, for example, indications are restricted or special monitoring measures are ordered,” explains Lang.
Who monitors the safety measures of pharmaceutical companies?
The drug authorities control the work of pharmaceutical companies and their suppliers. For example, you take samples yourself and check the results of your company’s own controls. They also control wholesalers, pharmacies and parallel importers. These controls are carried out by the European Medicines Agency (EMA), the German state authorities and the higher federal authorities BfArM and Paul Ehrlich Institute (PEI) as well as other authorities worldwide – including in production facilities outside the EU and USA.
“Every incoming delivery of preliminary products, active ingredients or excipients is also checked by every pharmaceutical company for authenticity and quality before they are combined into a medicinal product,” adds Lang.
The companies’ pharmacovigilance system is regularly checked and monitored by the responsible higher federal authorities as part of pharmacovigilance inspections. Pharmaceutical companies also regularly carry out audits to ensure the functionality of their pharmacovigilance system.
What can patients do?
“Patients can also help make a medicine even safer by reporting possible side effects,” emphasizes Lang. They can do this in different ways: Either they contact the relevant higher federal authorities directly: On the joint website of BfArM and PEI Nebeneffekten.bund.de, consumers can enter possible side effects (also anonymously) directly online.
“Even if undesirable side effects are not always necessarily causally related to the medication, patients can of course also contact doctors or pharmacists directly. In addition, pharmaceutical companies also accept reports of side effects. Patients can find the relevant contact details in the leaflet,” says Lang.
You can find out more about drug safety here.
More BPI milestones can be found here.
Note: The use of the photo is free of charge provided the source is ©Shutterstock/Rob Byron and in connection with the press release.