Invitation to comment on consultations currently open

14, Jul 2017 UKCPA Updates

Invitation to comment on consultations

Please find below list of consultations (NICE and other bodies) relevant to pharmacy, which have been assessed by the RPS and UKCPA and are currently inviting comments.


RPS ref 4138 Reflection paper on the use of extrapolation in the development of medicines for paediatrics. The main focus of the document is to provide a framework for extrapolation as a methodology to generate evidence for regulatory assessment in a target population. Specifically the framework addresses the use of quantitative methods to help assess the relevance of existing information in a source population to one or more target population(s) in respect of the disease, the drug pharmacology and clinical response. Based on this, predictions on the expected effects of treatment in the target population can be formulated. These predictions will be conditional on certain assumptions, and a specific extrapolation plan can be developed to address gaps in knowledge and assumptions, so that the totality of available evidence can address the scientific questions of interest for marketing authorisation in the target population. EMA deadline 14/01/2017

RPS ref 4137 Thyroid disease: assessment and management: Draft scope consultation. The Department of Health in England has asked NICE to develop a clinical guideline on thyroid disease. The guideline will be developed using the methods and processes outlined in Developing NICE guidelines: the manual. This guideline will also be used to develop the NICE quality standard for thyroid disease. NICE deadline 13/11/2017

RPS ref 4136 Regulation of nursing associates in England. The Nursing and Midwifery Order 2001 sets out the Nursing and Midwifery Council’s (NMC) powers and duties. Amendments need to be made to the order to provide the NMC with the necessary legal powers to regulate the nursing associate profession. It is intended that aspects and regulatory functions of the legislation will apply to the nursing associate profession in the same way as for nurses and midwives. Department of Health deadline 26/12/2017

RPS ref 4135 The regulation of medical associate professions in the UK. In recent years the health service has seen the emergence and increased use of new professional roles within multi-disciplinary teams as part of a continuing drive to provide safe, accessible and high-quality care for patients. Four of these roles are: physician associate (PA), physicians’ assistant (anaesthesia) (PA(A)), surgical care practitioner (SCP), advanced critical care practitioner (ACCP). This consultation seeks your views on the following proposals: To introduce statutory regulation for Pas, To seek further evidence on the most proportionate level of regulation for PA(A)s. To seek views on the position that statutory regulation of the SCP and ACCP roles is not proportionate, and whether alternative options for professional assurance should be considered. Department of Health deadline 22/12/2017

RPS ref 4134 Familial breast cancer: classification, care and managing breast cancer and related risks in people with a family history of breast cancer: Surveillance consultation. The clinical guideline for CG164 Familial breast cancer: classification, care and managing breast cancer and related risks in people with a family history of breast cancer has been checked by NICE for the need for update. NICE are proposing not to update the guidelines at this time and welcoming comments on this decision. NICE deadline 24/10/2017.

RPS ref 4133 NICE Guidance Implementation Survey. NICE is doing research to understand the perceptions and experiences of its users. NICE would like hear your thoughts about how you use its guidance and/or quality standards in your work and what could help you to use them. NICE deadline 27/10/2017

RPS ref 4132 Learning disabilities and behaviour that challenges: service design and delivery: Draft guidance consultation. This guideline covers services for people with a learning disability and behaviour that challenges, and their family members and carers. It recommends providing a range of services, including specialist support, in the community to minimise the need for inpatient admissions. It also promotes a lifelong approach to supporting people which emphasises prevention and early intervention. Recommendations cover services for children, young people and adults across health and social care. NICE deadline 20/11/2017

RPS ref 4129 Venous thromboembolism in over 16s: reducing the risk of hospital-acquired deep vein thrombosis or pulmonary embolism (Update): Draft guidance consultation. This guideline covers assessing and reducing the risk of venous thromboembolism (VTE or blood clots) and deep vein thrombosis (DVT) in over 16s in hospital. It aims to help healthcare professionals identify people most at risk of VTE. It describes treatments and interventions that can be used to prevent VTE. NICE deadline 15/11/2017

RPS ref 4125 GMC: Updating our expectations of newly qualified doctors in the UK: reviewing the Outcomes for graduates. The GMC are now consulting stakeholders with an interest in the Outcomes for graduates document on the current draft of the outcomes. They are particularly interested in hearing the views of patients and the wider public, medical schools and students, employers and doctors in training on whether anything should be added, what could be taken out and what we should emphasise. GMC deadline 10/01/2018

RPS ref 4122 Barking and Dagenham, Havering and Redbridge (BHR) CCGs ‘Spending NHS money wisely 2’ consultation. Barking and Dagenham, Havering and Redbridge (BHR) CCGs has launched ‘Spending NHS money wisely 2’, a consultation asking patients, residents and healthcare providers to get involved with helping the CCGs decide how to make savings locally. Those responding are asked to read the document that sets out their thinking and respond to our questionnaire. These documents are available on their websites:

BHR CCG deadline 15/11/2017

RPS ref 4120 GPhC seeking feedback on the draft evidence framework. GPhC have developed a draft evidence framework to support the creation of courses that will meet the new standards for initial education and training for pharmacy technicians. They are seeking feedback on the draft evidence framework, which aims to help course providers, pre-registration trainee pharmacy technicians and employers understand key concepts behind the learning outcomes set out in the standards. GPhC deadline 14/11/2017

RPS ref 4119 Consultation on the threshold level of qualification for entry to the Register for paramedics. HCPC are seeking views on changing the threshold level of qualification for entry to the Register for paramedics set out in the first standard of the Standards of education and training (‘SET 1’). This consultation proposes that the level specified in SET 1 for paramedics should be changed, seeking views on what level SET 1 should change to and on timescales for implementation. SET 1 is the contemporary level of education and training considered necessary for entry to the Register. A change in SET 1 would not directly affect existing registered paramedics, or students part way through pre-registration education and training programmes. HCPC deadline 15/12/2017

RPS ref 4114 Lyme disease: Draft guidance consultation. This guideline covers diagnosing and managing Lyme disease. It includes advice on clinical assessment for Lyme disease, which tests to use and when, and treatment with antibiotics. It aims to raise awareness of when Lyme disease should be suspected and ensure that people are given prompt and consistent treatment. It does not cover preventing Lyme disease. NICE deadline 06/11/2017

RPS ref 4112 Health Select Committee Inquiry: Brexit-medicines, medical devices and substances of human origin. The UK’ s withdrawal from the European Union (EU) and the European Atomic Energy Community (Euratom) means new regulatory arrangements must be put in place from 29 March 2019 to guarantee the safe and effective supply of medicines, medical devices, medical products and substances of human origin in the UK. Patients, the NHS and the UK’s life science industry need certainty about what the UK’s regulatory arrangements will be after Brexit and a smooth transition towards them. There are also major implications for the future of medical research and development. The Health Committee invites submissions on the options available to the UK Government, including the respective opportunities, risks and trade-offs involved. Health Select Committee deadline 26/10/2017

RPS ref 4111 Smoking cessation interventions and services. This guideline covers stop smoking interventions and services delivered in primary care and community settings for everyone over the age of 12. The recommendations focus on vulnerable groups who find it hard to quit or who smoke a lot. NICE deadline 01/11/2017

RPS ref 4104 Brexit: reciprocal healthcare inquiry launched. The House of  Lords EU Committee and its six Sub-Committees are conducting a coordinated series of short inquiries looking at the key issues that will arise in the negotiations on Brexit. Healthcare entitlements under EU law are tied to social security benefits. The EU’s rules-based social security coordination system is part of EU law on the free movement of persons. Its aims are to ensure portability of benefits across the EU, and equality of treatment with nationals within the host social security system. Benefits, including access to healthcare, are reciprocal and apply to UK citizens in the EU/EEA, and vice versa. The inquiry will focus on the reciprocal healthcare implications of Brexit for UK citizens travelling, living and/or working in the rest of the EU, and for EU citizens travelling, living and/or working in the UK, in both the short and medium term. House of Lords deadline 24/11/2017

RPS ref 4100 Sexual health, reproductive health and HIV: commissioning review. In 2016 Public Health England (PHE) and the Association of Directors of Public Health (ADPH), supported by NHS England and NHS Clinical Commissioners, carried out a survey of local authorities, NHS England and Clinical Commissioning Groups (CCGs) to highlight areas of challenge within the commissioning framework. The survey findings form the basis of an action plan published within the review.
Feedback and questions on the report can be sent to until 31 October 2017.Public Health England deadline 31/10/2017

RPS ref 4099 Proposed legal requirements to provide information about health service products. The Government is seeking views on draft requirements for the provision of information related to the sales and purchases of health service products. The proposed Regulations contain a range of requirements on different actors in the supply chain for medicines, medical supplies and other related products that are used for the purposes of the NHS. Department of Health deadline 14/11/2017

RPS ref 4087 Call for evidence and briefing note: EEA-workers in the UK labour market. The government has commissioned the Migration Advisory Committee (MAC) to advise on the economic and social impacts of the UK’s exit from the European Union and also how the UK’s immigration system should be aligned with a modern industrial strategy. Migration Advisory Committee (MAC) deadline 27/10/2017

RPS ref 4079 Recommendations for use of aminoglycosides in animals to reduce risk of antimicrobial resistance. The European Medicines Agency (EMA) has launched a public consultation on its new “Reflection paper on use of aminoglycosides in animals in the European Union (EU): development of resistance and impact on human and animal health”. EMA deadline 31/10/2017

RPS ref 4078 Reducing off-label use of antimicrobials in veterinary medicine to reduce risk of resistance. The European Medicines Agency (EMA) has launched a public consultation on its new “Reflection paper on off-label use of antimicrobials in veterinary medicine in the European Union”. EMA deadline 31/01/2018


Should you wish to comment on any of the above, please send your response at least 1 WEEK prior the deadline date given above to Sarah Carter ( This will ensure that all responses can be collated, endorsed by the RPS where appropriate, and submitted to the relevant consulting body by their deadline.