UK Patient Leaflets: Common Problems

Since the UK Medicines Control Agency issued its guidance on preparation of patient information leaflets in September 1993, certain common problems have come to light, reports MAIL, the MCA's updating service.

For example, while many medical and technical terms are hard for patients to understand, being selective in what to include is unacceptable. All indications, contraindications, warnings, adverse reactions and interactions listed in the Summary of Product Characteristics must be translated into lay terms for inclusion in the PIL. Some adverse reactions and interactions might be grouped together to be more meaningful to patients, eg nausea, vomiting and diarrhea as "stomach upset," or "skin rash" instead of a list of (non-serious) dermatological complaints.

For many products the "posology" in the SPC can be directly reflected in the PIL. Others, for which a wider dosage range is included, need careful consideration. A starting dose is often important and a dose range, maximum dose and dosage interval may also be necessary. Patients should have sufficient dosage data to ensure drugs are administered correctly and safely in the context of the instructions they will receive from their doctor.