Data Dose November 2023 p.4

Customer use case. How Pharma companies improve MLM process

Pharmacovigilance, being related to drug safety, is one of the key processes for any pharmaceutical company. Good pharmacovigilance practices (GVP) guidelines and legal requirements strictly regulate all pharmacovigilance activities. Drug manufacturers must constantly monitor scientific publications in specialized medical journals to obtain information on the safety and effectiveness of the registered drug use, both globally and locally. For more than two years, the Ukrainian pharmaceutical market has operated under the COVID-19 pandemic conditions, and for the last six months under the conditions of a full-scale war with russian federation. Vladyslav Vesna, Head of Signal and Risk assessment Team / Pharmacovigilance department at JSC Farmak, tells how the Ukrainian pharmaceutical market leader in cooperation with the DrugCards Oü provides the process of literature monitoring. Read more...

Patient safety and SmPC update

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.?Read more...

Vaccines against COVID-19 and literature monitoring

Vaccination is one of the important achievements in public health. All medicines, including vaccines, have benefits and risks. Safety monitoring after approval is important to quickly identify any new or changing risks and take action. Of course, this also applies to vaccines against coronavirus disease. Unprecedented scientific collaborations have allowed COVID-19 vaccine research, development, and authorizations to be completed in an extremely short time frame. The first mass vaccination program started in early December 2020. As with all vaccines, regulators and companies are constantly monitoring the use of COVID-19 vaccines. Such monitoring is carried out to detect and respond to any safety issues.?Literature monitoring, as one of the main components of pharmacovigilance, also does not stand aside. Read more...

An unusual side effect of anticoagulants

Anticoagulants are amongst the most commonly prescribed medications worldwide. Anticoagulants are used to prevent blood clots in blood vessels. Blood clots can block blood vessels (an artery or a vein). These medications can help stop life-threatening conditions like strokes, heart attacks, and pulmonary embolisms, all of which can happen because of blood clots. Obviously, the most common risk with any anticoagulant is bleeding. Apart from bleeding, anticoagulants often may cause cutaneous reactions. Therefore, early recognition and timely management of the cutaneous signs and symptoms can prevent morbidity and mortality. Bullous hemorrhagic dermatosis (BHD) is a rare, generalized skin reaction with unknown pathogenesis, described as associated with anticoagulant therapy. We discuss two cases of this unusual side effect of anticoagulants in this post. These cases we found with the DrugCard platform during local medical literature monitoring in Spanish and Polish journals. Read more...