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AGM papers available

Posted: Thursday, May 9th, 2013

Please note that the agenda and papers for our AGM, in association with the seminar on Thursday May 16th, have been posted under the "events" tab. If you are intending to come to our seminar, please register now or send an email to the info@plea.org.uk address.

10th edition Pharmacy and Medicines Law now out

Posted: Wednesday, April 17th, 2013

The 10th edition of Dale and Appelbe's Pharmacy and Medicines Law is now available for pre-ordering. Click here for the editor's comments on the new book and here to make your pre-order. (Wait for the book icons to move and Dale and Appelbe will appear.)

Further MHRA simplification of regulations

Posted: Wednesday, April 3rd, 2013

The MHRA has announced a package of simplification proposals in response to the Red Tape Challenge. The package includes relocation of the MHRA website to the Government platform - gov.uk - intention to review medicines sanctions and penalties including s64 offences in the Medicines Act and relaxation of the legislation to permit the sale of certain GSL medicines on planes and trains. There is also a 41 page spreadsheet of the fate of all the medicines regulations included in this process.

Healthcare Professions Indemnity to be compulsory

Posted: Friday, March 8th, 2013

A consultation has been published on a Section 60 (Health Act 1999) Order to require all healthcare professionals to have insurance or indemnity cover in place as a condition of their registration. This will also implement Article 4 (2) (d) of the EU Directive 2011/25/EU on the application of patients' rights in cross-border healthcare. Whilst the pharmacy regulators (GPhC and PSNI) require declarations about indemnity at registration or renewal the sanctions are currently only exercisable through the fitness to practise procedures. Consultation closes on 17th May 2013.

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.

Reclassification Guidance

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 MHRA press release can be found here and the MHRA’s guidance is located here.

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.

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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.