The Medicines and Healthcare products Regulatory Agency (MHRA) has reviewed the warnings regarding addiction, dependence, withdrawal, and tolerance for gabapentin, pregabalin, benzodiazepines, and z-drugs. It has announced that the the Summary of Product Characteristics, Patient Information Leaflets and outer packaging of these medicines will have strengthened warnings to better communicate the risks of addiction, dependency, withdrawal and tolerance to healthcare professionals and patients.
Ordinarily, legal changes are made through a statutory instrument, such as Regulations, In this case, the changes to leaflets and packaging will be made through regulation 64 of the Human Medicines Regulations 2012 under which the MHRA has a duty as licensing authority to revise an assessment report whenever new information becomes available that is of importance for the evaluation of the quality, safety or efficacy of the medicinal product, and regulation 257D which says that the licensing authority may publish guidance on packaging and package leaflets applicable to products for sale or supply in the whole United Kingdom or parts of the United Kingdom. Such guidance may, in particular, include the wording of certain special warnings for certain categories of medicinal products.
Through the same process, the MHRA has announced that healthcare professionals can now prescribe isotretinoin to those under 18-years old without seeking the agreement of a second prescriber.
The Department of Health and Social Care has announced that the Human Medicines Regulations will be amended to make permanent some of the provisions introduced during the COVID-19 pandemic and to extend those provisions to any vaccine against an infectious disease caused by a virus or bacteria. The changes will introduce a new legal mechanism – Vaccine Group Direction (VGD). VGDs will permit registered healthcare professionals (including pharmacists and pharmacy technicians) to clinically assess, obtain informed consent and administer vaccinations to individuals without the need for them to be prescribed. VGDs will allow some tasks within the vaccination process, such as vaccine preparation, administration and record keeping, to be delegated to suitably trained registered and non-registered healthcare workers. Each VGD will specifically state which tasks can be delegated and to whom and this may vary between VGDs for different vaccination programmes. Delegation is likely to be subject to supervision…