Be careful who you entrust your health to and which medicinal product you use. A medicinal product that does not originate from the legal and controlled supply chain is a product of unknown origin, composition and quality and poses a serious risk to health.
Following the hospitalisation of female patients at the Clinic for Infectious Diseases of the Clinical Centre of Montenegro, who developed symptoms of botulism after an aesthetic treatment with Dysport (a medicinal product containing botulinum toxin type A), the Institute for Medicines and Medical Devices of Montenegro (CInMED) warns the public of the serious risks associated with the use of medicinal products obtained outside the legal and controlled supply chain.
Medicinal products obtained from unverified sources, including products obtained from abroad outside the legal distribution chain, pose a serious risk to health, particularly in the case of biological medicinal products, such as Dysport, which are subject to specific storage and transport conditions and for which traceability must be ensured. For medicinal products subject to specific temperature requirements, maintaining the so-called “cold chain” is of critical importance. This means that, from the manufacturer to the point of administration, the medicinal product must be transported and stored at the prescribed temperature. When a medicinal product comes from an unknown or illegal source, there is no reliable assurance as to what the package actually contains, where the product was manufactured, or the conditions under which it was transported and stored. It is precisely outside the legal supply chain that falsified medicinal products are most commonly distributed, having been obtained from unverified sources or via the internet and social media, which further complicates their identification and control.
The presence of falsified medicinal products is a global public health problem. According to data from the World Health Organization (WHO), at least one in ten medical products in low- and middle-income countries is substandard or falsified. Falsified medicinal products are, however, also detected in developed countries with very strong regulatory systems. In some cases, a falsified medicinal product contains none of the appropriate active substance, or contains it in a quantity lower or higher than that declared, and may even contain other active substances, impurities or potentially harmful ingredients. Medicinal products used for aesthetic purposes are frequently subject to falsification, as are medicines used for weight loss, the treatment of erectile dysfunction and pain relief, and even medicines used in cancer treatment. Falsified medicinal products have been identified worldwide, pose a major health risk and require cooperation between the competent institutions at both local and international level in order to prevent the manufacture and placing on the market of medicinal products that do not meet the prescribed standards of quality, safety and efficacy. Under the Law on Medicinal Products, where a falsified medicinal product is suspected, healthcare professionals, as well as legal and natural persons engaged in the distribution of medicinal products, are required to inform the Institute, the competent inspectorates and the marketing authorisation holder, which take appropriate measures within their respective competences in order to protect public health.
Dysport itself is one of the medicinal products for which falsified batches have been identified in various countries in recent years. In 2022, the WHO issued a specific alert following the detection of falsified batches of this medicinal product in several countries of the European Union, the United Kingdom, the Middle East and Latin America. For these reasons, CInMED once again warns the public that a medicinal product outside the legal supply chain is not merely a product of unknown origin – it is a product that lies outside the system of regulatory control. Medicinal products within the legal supply chain pass through a strictly controlled system – from manufacture and authorisation, through import and distribution, to the healthcare institution and the patient. Their origin and movement are traceable, and their transport and storage conditions are controlled.
It is not sufficient for the packaging to bear the name of a well-known medicinal product. What matters is where the medicinal product comes from, who procured it, and whether it reached the patient through channels subject to the control of the competent authorities. The packaging, name, and even the manufacturer’s details or batch number of a falsified medicinal product may appear convincing, while the active substance content may not be as declared. An unusually low price is often the only indication that a medicinal product may originate from illegal sources. At the same time, it is important to emphasise that the fact that a medicinal product is authorised and is within the legal supply chain does not mean that its use is entirely without risk. Like any medicinal product, botulinum toxin can cause adverse reactions, including very rare serious reactions. However, for an authorised medicinal product, its composition, quality, manufacturing process, storage conditions, authorised indications and risks are known, and its safety is continuously monitored. It is therefore clear that the use of a medicinal product originating outside the legal supply chain carries an incomparably greater risk to a patient’s health than the use of a medicinal product whose origin, quality, safety and traceability are ensured through the legal supply chain.
The quality, safety and efficacy of a medicinal product do not begin at the point of administration. They are ensured throughout the entire regulatory system – from the manufacturer to the patient.
For these reasons, CInMED once again calls on the public to obtain medicinal products exclusively through the legal distribution chain and on healthcare professionals to report any suspected quality defect or adverse reaction to a medicinal product.
We wish to emphasise that the Institute for Medicines and Medical Devices is responsible for medicinal products within the legal supply chain, while at the same time remaining fully available to all competent authorities for cooperation and the provision of expert support in combating falsified medicinal products. Within the scope of its competences, CInMED has carried out a verification of Dysport within the legal supply chain in Montenegro and confirms that the batches of the medicinal product currently available on the market may continue to be used in healthcare institutions and administered to patients in accordance with the approved product information.
The Institute for Medicines and Medical Devices of Montenegro will, within the scope of its competences and in cooperation with other competent authorities, continue to monitor all circumstances surrounding this case and will keep the public duly informed of all relevant information, as well as of any measures that may be taken.
