The Summary of Product Characteristics (SmPC) is the main document that contains key information for healthcare professionals and patients about the safety and efficacy of a medicinal product. The safety profile of any drug may change throughout its life cycle as new safety information becomes available. Therefore, the SmPCs should be regularly reviewed and updated as new data becomes available. Misleading information in the SmPC can lead to medical errors, side effects, inappropriate prescribing or treatment failure. SmPC is a reference document most commonly used by doctors even though other important documents with product information are being published in the EU. In our post, we describe the relationship between patient safety and timely SmPC update identifying the threats an untimely SmPC update poses.
SmPC update problems
The one of main problems with SmPCs is discrepancies in the drug registration dossiers of the same qualitative and quantitative composition of active substances. Recently, an article was published in the «IJERPH» addressing this issue. The authors report that an analysis which covered 31 medicinal products and showed that more than 60% of them contained significant (critical) differences between original and generic products. Fourteen medicines had discrepancies in the contraindication section. Of these, 71.5% of the medicines were assessed as demonstrating critical differences. Moreover, registration dossiers differed from country to country, probably due to different legislation. An assessment of the consistency in the information contained in the SmPCs of generic antimicrobial medicines led to similar conclusions. The absence of clinically significant information on pharmacokinetic properties was noted. Similar studies were conducted in various countries, including Ukraine, which indicates the prevalence of this problem.
Impact of SmPC update on patient safety
Disparities in the SmPCs of generic and original medicines are unfortunately a reality. According to the EMEA guidelines, all relevant aspects of the content of generic SmPCs should be consistent with the SmPCs of the reference medicinal products. Discrepancies in the SmPC could potentially lead to life-threatening or even fatal outcomes. which raises serious concerns. One of the potentially fatal inconsistencies the authors found involved adrenaline. In SmPC, one generic product was not contraindicated for use in patients with ventricular fibrillation, cardiac dilatation, or coronary insufficiency. This discrepancy may lead to ventricular arrhythmias and/or coronary ischemia in such patients. Another potentially fatal discrepancy concerned promethazine. Generic product labels lacked a contraindication for patients up to 2 years of age. This may lead to a risk of respiratory depression in this subpopulation. These discrepancies represent critically important patient safety gaps in SmPC.
Joint action to improve patient safety and SmPC update
If responsible parties do not continuously review the drug labels, publicly available scientific information will not be updated to include new side effects. Moreover, this key information will not be available to customers. This fact may lead to a lack of awareness among patients and physicians about potentially important safety information. According to estimates, prescribing errors occur for 5% of drugs used in general practice. Mistakes made by doctors are most often due to a lack of knowledge and the inappropriate presentation of drug information. Considering the possible huge impact of such non-compliances on the health and safety of patients, Regulatory agencies and MAHs should make every effort to eliminate them. The MAHs can do this by conducting constant literature monitoring of sources, which regularly publish the SmPC changes.
The DrugCard platform guards patient safety and pharma company awareness
New safety information can arise from a variety of sources. DrugCard platform is a database of medical and scientific literature sources, including EMA, WHO, FDA, MHRA, TGA etc. These are the main sources of information on drug safety, including publications on SmPC updates. Look how it works. From the DrugCard platform, you receive new information about drug safety. For example, information about the PSUSA results after they are published on the EMA website. Also, the platform will notify you after publishing such information on the website of the SEC of the MOH of Ukraine or other local regulatory authorities. Therefore you will immediately have new information and will be able to properly plan the SmPC update submission.
Conclusions for the healthcare system
SmPC is a key part of the marketing authorisation of any medicine and the basic information for healthcare professionals. It should be updated throughout the drug lifecycle as new efficacy or safety data becomes available. It is also used to prepare information addressed to patients in the package leaflet. Thus, the SmPC is a key document that contributes to public health by providing information on the benefits and risks of a medicinal product. That is why it is extremely important to ensure the reliability and completeness of this information. Continuous SmPC update ensures that doctors and patients will always have access to high-quality, verified drug information.