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Good Clinical Practice Guide

Posted: Tuesday, November 6th, 2012

On 24 September 2012, the MHRA announced that it is launching the publication, the “Good Clinical Practice Guide” in relation to the conduct of clinical trials on humans in the UK. This guide will be relevant to a range of people including commercial and non-commercial sponsors, contract research organisations, clinical research consultants and other niche providers. It will also be relevant to the conduct of clinical trials across Europe, as well as beyond.

The publication will cover a range of areas in relation to clinical trials, including sponsor oversight, applying to the MHRA for the clinical trial authorisation, obtaining an opinion from an Ethics Committee, as well as the management of clinical trials. The purpose of this publication is to offer guidance on the implementation of current legislation, including the key piece of clinical trials legislation, namely the European Clinical Trials Directive (2001/20/EC), whilst reinforcing and working with other current published guidance. The European Commission and the European Medicines Agency have themselves published guidance on how to comply with such legislation.

Further information can be located here.    

Fee for Pharmacovigilance Activities

Posted: Tuesday, November 6th, 2012

On 14 September 2012, the European Commission published its concept paper introducing the idea of bringing into force fees charged by the European Medicines Agency for pharmacovigilance. The UK Government has now published its response to this concept paper, stating that it has concerns in relation to the risk of upwards spiraling of such costs which would in turn affect the costs of bringing products to market. For this reason, the UK Government believe that consideration needs to be made in respect to the governance of such pharmacovigilance fee structures, and it suggests that further discussions need to take place in relation to this. Although the UK Government agreed with the principles underlying the pharmacovigilance fees, such as transparency and equal treatment of Marketing Authorisation Holders, it stated that further detail was needed in relation to the actual calculation of such fees.

Further information can be found here.

Consultation on Sector Regulation of Health Management

Posted: Tuesday, November 6th, 2012

On 15 August 2012, the Department of Health published consultations focusing on how Monitor, the now sector regulator, will work in the best interests of patients, focusing on licensing and procurement, choice and competition. In summary, the consultation on licensing provides details as to which NHS funded service providers will be required to have a licence with Monitor to supply such services. Monitor will regulate private voluntary providers. The second consultation provides details with respect to: (1) minimum requirements in relation to procurement; (2) how patients’ rights to choice under the NHS Constitution are enforceable; (3) prohibiting commissioners from restricting competition; and (4) ensuring that commissioners manage conflicts of interest effectively.

Further information and additional links can be found here.    

New GPhC standards for pharmacy owners and superintendants

Posted: Tuesday, November 6th, 2012

On 13 September, the GPhC announced that new standards have been agreed in relation to ensuring that patients obtain the best outcomes on using registered pharmacies in Great Britain. One of the issues touched upon was in relation to Pharmacy (“P”) medicines, which require the supervision of a pharmacist. However, they may be flexibility in relation to the approach taken in pharmacies, such as self selection of such medicines by the patient. The pharmacy owners and superintendants may decide once these standards have been transformed into Rules and approved by Parliament, which is not expected until at least October 2013, that they do not wish P medicines to be available for self selection. However, those who do will need to meet certain criteria and standards.

On 1 October 2012, Duncan Rudkin warned pharmacy owners and superintendent pharmacists to be aware of the scale of changes that the GPhC’s new approach will bring, as well as the enforcement powers the GPhC will obtain, and to familiarise themselves with these new standards. The presentation given at the recent Pharmacy Show by Duncan Rudkin can be found here.

For further information, please see here and for a copy of the standards for registered pharmacies themselves, please see here.   

Operation Pangea V

Posted: Tuesday, November 6th, 2012

Between 25 September 2012 and 2 October 2012, Operation Pangea V to crackdown on counterfeit and unlicensed medicines was put into action. This culminated in 79 people being arrested, and counterfeit and unlicensed medicines to the value of £6.5 million being seized.  Illegal online pharmacies were also shut down. Please find the MHRA’s press release here.  

Extemporaneously prepared methadone

Posted: Tuesday, November 6th, 2012

On 14 September, the GPhC confirmed that it has concluded on the basis of recent judgments from the European Court of Justice, that the supply of unlicensed extemporaneously prepared methadone is not compliant with the law. This view overrules the exemption granted by the old RPSGB, and temporarily continued by the GPhC. For further information, please see here.

Consultation on proposed changes to the governance arrangements for controlled drugs

Posted: Tuesday, November 6th, 2012

On 27 September 2012, the DoH opened the Consultation on proposed changes to the governance arrangements for controlled drugs (the “Consultation”). The Consultation has become necessary because the Health and Social Care Act 2012 has made significant structural changes to the NHS, primarily the abolition of PCTs, rendering the Controlled Drugs (Supervision of Management and Use) Regulations 2006 unworkable. Therefore, the latter requires revision. This Consultation will close on 15 November 2012.   

Standards for podiatrist and other prescribing

Posted: Saturday, October 6th, 2012

The Health and Care Professions Council has launched a consultation on standards for independent prescribing by podiatrists/chiropodists and physiotherapists. They are expected to acquire independent prescribing rights in late 2013. The standards also cover supplementary prescribing by both groups and by radiographers. Consultation closes 4th January 2013.

NHSCB established

Posted: Tuesday, October 2nd, 2012

The NHS Commissioning Board for England was formally established on 1st October 2012. It will continue the functions of the transitional NHS CB Authority (principally the authorisation of Clinical Commissioning Groups) and will assume full responsibilities from April 2013 when PCTs and Strategic Health Authorities are abolished.

CDs Accountable Officer consultation

Posted: Tuesday, October 2nd, 2012

The Department of Health has published a consultation on changes to the Supervision and Management of Controlled Drugs Regulations 2006 in preparation for changes to NHS structures in England from April 2013. Consultation closes on 15th November 2012.

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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.