Sale of unlicensed medicines in the UK
Posted: Thursday, February 28th, 2013
The MHRA reported on 7 February 2013, that there has been a growing number of unlicensed medicines being sold in the UK. A number of these unlicensed medicines appear to be originating in Poland and in other Eastern European countries. The MHRA have noted that 74 cases investigated last year concerned the sale of unlicensed medicines from such counties in “corner shops”. Such medicines have been sold in contravention of the requirement to have a prior MHRA Parallel Import Licence or a Parallel Distribution Notification in relation to medicines which are not licensed in the UK. In some of the cases, such medicines were not labeled in English, contrary to the requirement for medicines licensed for sale in the UK. The MHRA is currently working with the Polish medicines regulator on the matter.
For the MHRA press release, please see here.
Best practice for the supply and distribution of medicines
Posted: Thursday, February 28th, 2013
The Department of Health has updated the guidance in relation to the best practice for ensuring efficient supply and distribution of medicines to patients. Although there have been no changes in relation to the obligation on the NHS, the guidance has been updated to reflect the current law. The Department of Health flags the following as being the key aspects of this guidance: (i) the expectation that a pharmacy should receive medicines within a 24 hour period under normal circumstances; (ii) that there is regular communication taking place between manufacturers and wholesalers to ensure an understanding between the two in relation to supply and demand; (iii) when setting out the requirement to satisfy the wholesaler that there is patient need for the medicines in question, that; (a) the wholesaler is wary of the workload placed on dispensers, and also (b) that dispensers are aware of the need to keep patient information confidential; and (iv) the need to have in place contingency arrangements to source medicines when there are supply difficulties. The MHRA is in the process of conducting inspections, to ensure that there is compliance with the current duties in relation to the supply of medicines.
For the Department of Health press release, please click here.
Shortcomings of product information
Posted: Friday, February 22nd, 2013
The European Commission is required to publish a report in relation to the deficiencies and shortcomings with regards to medicine product information and to propose amendments to legislation in respect to the same, as is required pursuant to the Pharmacovigilence Directive (Council Directive 2010/84/EC). The advice of an Expert Advisory Group on Patient and Public Engagement and the Commission on Human Medicines have advised that changes to such legislation will lead to a necessary improvement in the quality of information provided to healthcare professionals and patients alike. The MHRA has stated in its open letter that patient information leaflets should be of a high quality, appropriately targeted, be readily accessible to healthcare professionals and patients, and contain balanced content with respect to any risks and benefits. The MHRA state that the pharmaceutical industry has not kept pace with respect to providing information to this standard.
The MHRA press release can be found here.
Posted: Thursday, February 21st, 2013
The MHRA has published guidance to streamline the reclassification of: (i) prescription only medicines to pharmacy medicines; and (ii) pharmacy medicines to medicines on the general sales list, entitled "How to change the legal classification of a medicine in the UK". The guidance provides a helpful summary as to the procedure involved when reclassifying a medicine and how the MHRA processes such applications. For interest, please click here for a list of recently reclassified medicines.
The GPhC’s Rolling Corporate Plan to get underway
Posted: Wednesday, February 20th, 2013
The GPhC will be reviewing the current CPD model, this being one of the objectives detailed in its rolling corporate plan for the period between April 2013 and March 2016. The key objectives detailed in this rolling corporate plan include the following strategies, namely to: (i) deliver core regulatory services in a way that is fit for current and future purposes; (ii) strengthen its capacity to measure and improve the efficiency and effectiveness of its operational performance; (iii) communicate and engage effectively with key stakeholders; (iv) anticipate and respond to developments in pharmacy and healthcare; and (v) ensure that it has the right people in place, with the right culture and organisational policies and procedures. As part of the first strategy, the GPhC will consider whether CPD records will continue to be called up by the GPhC. The GPhC will consider the outcomes of calling up CPD records and also the efficiency and effectiveness of the same. Duncan Rudkin has considered whether a sample of CPD records could just be requested instead. It is expected that the GPhC will develop its recommendations by the end of 2013. Duncan Rudkin has stated that this review will bring about significant changes in relation to the manner in which pharmacies and pharmacy professionals are regulated going forwards.
“All Trials” campaign
Posted: Wednesday, February 20th, 2013
The "All Trials" campaign, a public petition promoting the publication of all clinical trial results, has been receiving increasing support, with GSK being one of the latest major supporters. For a comprehensive list of the supporters to date, please click here. As detailed on the “All trials” campaign website, the campaign is an initiative of Sense About Science, Bad Science, the BMJ, the James Lind Initiative, the Centre for Evidence-based Medicine, as well as others from research, patient groups and medicine. The driver for the campaign stems from the fact that “around half of all clinical trials have not been published; some trials have not even been registered”. The petition goes on to say that “if action is not taken urgently, information on what was done and what was found in trials could be lost forever, leading to bad treatment decisions, missed opportunities for good medicine, and trials being repeated unnecessarily”.
Your chance to judge a student essay
Posted: Monday, February 18th, 2013
Cathal Gallagher, a PLEA member and academic at the University of Hertfordshire, is asking for volunteers to help judge the entries for the 2012/13 PLEA student essay award. He has reduced entries to a short list of 20 and needs PLEA members who are willing to judge up to three essays each.They are typically around 1-2,000 words and are all pretty good. They are anonymised and come with a clear marking grid. All each judge will have to do is give a mark and rank their essays from 1 to 3. This is a fantastic opportunity to engage students in law and ethics, as well as raising the profile of PLEA. The essays will be available from week beginning 25th February with three weeks for marking.
Could this be you? If so, email Cathal direct on email@example.com straightaway!
NHS Procurement Regulations laid
Posted: Friday, February 15th, 2013
The NHS (Procurement, Patient Choice and Competition) Regulations have been laid and come into force on 1st April 2013. They are intended to ensure that Commissioner's decisions on buying clinical services are transparent and fair. Explanatory notes to the Regulations have also been published.
Academic meeting -date change
Posted: Wednesday, January 30th, 2013
Due to a date clash, our academic seminar is now on Tuesday 2nd July at the University of Nottingham, not the 3rd July. We aim to cover the GPhC requirements regarding the Code of Conduct for students and School of Pharmacy Fitness to Practise procedures.
10th ed Dale and Appelbe due end May 2013
Posted: Sunday, January 6th, 2013
The 10th edition of Dale and Appelbe is due to be published at the end of May 2013. To reflect the revised content, it will be called Pharmacy and Medicines Law. It will be published by Pharmaceutical Press, London.
These news items are not exhaustive but are selected according to their relevance to pharmacy practice, NHS community pharmacy contracts and the regulation of the pharmacy profession. If you wish to add any items that you think we have missed, contact our news editor.