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NHS Outcomes Framework 2013 - 2014

Posted: Thursday, November 15th, 2012

On 13 November 2012, the Department of Health published its NHS Outcomes Framework 2013- 2014. This details the outcomes and their corresponding indicators which will reflect improvements made during that period. The Department of Health aims to improve health and reduce health inequalities by focusing on the framework detailed in the news item below. The framework document states that the main objectives are to (i) provide a national level overview of how well the NHS is performing: (ii) provide an accountability mechanism between the Secretary of State for Health and the NHS Commissioning Board for the effective spend of circa £95 billion of public money and (iii) act as a catalyst for driving up quality throughout the NHS by encouraging a change in culture and behaviour

NHS Mandate

Posted: Wednesday, November 14th, 2012

On 13 November 2012, the first Mandate between the Government and the NHS Commissioning Board was published. The Mandate “sets out the objectives for the NHS and highlights the areas of health and care where the Government expects to see improvements”. The NHS Mandate sets out the ambitions for the NHS for the next two years, concentrating on the following five areas: (i) helping people live longer, specifically by reducing the number of people who die from early deaths which could have been prevented by an early diagnosis and early treatment; (ii) managing ongoing physical and mental health conditions such as diabetes, dementia and depression, so that patients can become more independent and enjoy a better quality of life; (iii) helping people recover from episodes of ill health or following injury so that patients may become independent as soon as possible; (iv) making sure people experience better care and not just better treatment; and (v) providing safe care, which includes reducing the risk of avoidable health problems such as infections, blood clots and bed sores.

Please see here for the Department of Health press release.

The Red Tape Challenge

Posted: Wednesday, November 14th, 2012

The Red Tape Challenge commenced in April 2011 (see post dated March 2012), and since then, a number of regulations have already been revoked. The Healthy Living and Social Care theme of the Red Tape Challenge was launched on 6 November 2012. The public and healthcare professionals alike are invited to comment on over 500 regulations relating to public health, quality of care, mental health, the NHS and professional standards. The aim of this arm of the initiative is to assist the government with deciding which regulations should be removed and which should be improved upon. The window for feedback is open for 5 weeks until 11 December 2012.

For the Department of Health press release, please see here.

Department of Health consultation on national performers list for GPs, dentists and ophthalmic practitioners

Posted: Wednesday, November 14th, 2012

On 19 October 2012, the Department of Health opened its Consultation on a national performers list for GPs, dentists and ophthalmic practitioners. The purpose of this consultation is to sound out opinions on the proposal to have a national list of approved general practice doctors, dentists and ophthalmic practitioners to provide NHS primary care services. Through establishing such a list, Jeremy Hunt, Secretary of State for Health explained that the risk of allowing poor performers to “slip through the gaps between different local lists” will be greatly lowered. The closing date for responses is 14 December 2012.

MHRA review of sanctions and penalties

Posted: Wednesday, November 14th, 2012

The MHRA is in the process of reviewing the current range of sanctions and penalties for which it is responsible to ensure that these are proportionate and appropriate in the context of delivering public health responsibilities. As part of its review, the MHRA will consider whether civil sanctions would also be appropriate. Of particular interest to pharmacists is the arm of the review where consideration will be given to the balance between medicines legislation and pharmacy premises and professional regulation in the context of the supply of medicines. This will incorporate addressing specific issues such as the prosecution of pharmacists for dispensing errors, and whether such sanctions are appropriate and/or proportionate. The MHRA intend to start consulting with interested parties in the coming months.

For further information, please see the publication on the MHRA website here and on the website of the Department of Health here.   

Online Pharmacy Logo

Posted: Tuesday, November 6th, 2012

The European Commission published a Consultation Paper dated 17 October 2012 in which, pursuant to Directive 2011/62/EU, it has provided suggestions with respect to a common logo for online pharmacies, which would need to be displayed on every page of the relevant website. The European Commission flags that there is a risk that this logo may be copied, and so may not be a failsafe indicator that the online pharmacy is operating legally. Therefore, in corporation with the European Medicines Agency and Member States, it intends to launch an awareness campaign. Further, Member States are under an obligation to set up a website dedicated to providing a national list of all legally-operating online pharmacies and retailers. The closing date for comments on the proposed logos is 17 January 2012.

For further information, please see the article on the IPKat blog. 

Pricing tariff consultation

Posted: Tuesday, November 6th, 2012

The DoH opened its consultation entitled Consultation on ensuring fair and transparent pricing for NHS services (the “Consultation”) on 5 October 2012. It is the intention that the National Tariff, which is provided for in the recent Health and Social Care Act 2012, will: (1) provide information in relation to the prices to be paid for NHS services; (2) ensure that increasingly accurate pricing information is obtained; (3) ensure that more efficient payments are made by tailoring the National Tariff so that it can address adequate clinical complexity; (4) encourage Monitor to ensure that there is a greater integration of services to the benefit of patients; and (5) encourage there to be a broader range of services made available to patients. The intention is that the DoH will be responsible for the 2013/2014 tariff, but that responsibility will pass to Monitor for the publication of its first National Tariff for 2014/2015. The Consultation will close on 21 December 2012.

Call for opinions on healthcare regulators

Posted: Tuesday, November 6th, 2012

The Council for Healthcare Regulatory Excellence (“CHRE”) has requested feedback in relation to health and care regulators, including the GPhC, in order to gather information for its annual performance reviews. The first stage of these reviews will involve asking regulators how they are meeting the Standards of Good Regulation, which cover their work in: (1) guidance and standards; (2) education and training; (3) registration; and (4) fitness to practise. It is at the second stage that the CHRE will challenge the regulators’ evidence with the feedback it has received. Feedback is required by 1 December 2012 and can be submitted through the following here

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.

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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.