The additional value of an e-mail to inform healthcare professionals of a drug safety issue. A randomized controlled trial in the Netherlands.
Sigrid Piening, Pieter A. de Graeff, Sabine M.J.M. Straus, Flora M. Haaijer-Ruskamp, Peter G.M. Mol.
ESM Figure: The e-mail that was sent to the intervention group
An introduction was placed on top of the Dutch Medicines Evaluation Board (MEB) e-mail, to state its purpose.
ESM Figure: continued
Translation:
SUBJECT: MEB warning – Risk information Macugen
Dear Sir, Madam,
The information below was written by the Medicines Evaluation Board, in relation to safety issues of the drug Macugen (pegaptanib). Simultaneously a letter (‘Dear Doctor letter’) was sent to you about this issue by the pharmaceutical company.
You are receiving this e-mail in the framework of the CORE study (UMCG) which aims to improve the current risk communication of safety issues of medicines.
Kind regards,
The CORE team
Risk information Macugen
The Medicines Evaluation Board draws your attention to the following:
RISK OF SERIOUS INCREASE OF INTRAOCULAR PRESSURE WITH INJECTION OF EXCESS VOLUME OF MACUGEN
Information from clinical trials and clinical practice has shown that there is a risk when administering pre-filled syringes with pegaptanib (Macugen). The prefilled syringes contain an excess volume. It is important that this excess volume is properly removed, and not injected the eye. Two cases were reported where this has not been done and where the anterior chamber had to be pierced to lower the pressure.
This is written by Pfizer in a letter, a so-called Direct Healthcare Professional Communication (DHPC). The letter with this important risk information is sent to ophthalmologists and hospital pharmacists in consultation with the Board of the Medicines Evaluation Board (MEB) and the Health Care Inspectorate (IGZ).
The product information for doctors and pharmacists (SmPC) is also added to this letter.
Pegaptanib is prescribed for the treatment of patients with the wet type of age-related macular degeneration (AMD). This disease affects the central part of the retina (the macula) at the back of the eye and causes loss of vision when looking straight ahead.
Identifying and analysing adverse events throughout the life cycle of a drug is called pharmacovigilance. This is a core task of the MEB. In case of urgent and/or important safety issues healthcare professionals are informed by means of a ‘Direct Healthcare Professional Communication’. Click here for an overview of DHPCs.
This is the electronic newsletter of the Medicines Evaluation Board. You can respond to this newsletter via the button bottom right of the page or contact the Information and Communication Department of the MEB.