National Public Health Service for Wales Weight management/community pharmacists Weight management interventions by community pharmacists: a rapid review of the evidence Author: Dr Mary Webb, Public Health Practitioner Date: 11/02/2009 Version: 1.a Status: Final Intended Audience: LHB Heads of Pharmacy and Medicines Management Purpose and Summary of Document: The NPHS (pharmaceutical public health team) has been commissioned by the Welsh Assembly Government to develop pharmaceutical needs assessment tools. This work is in the context of the community pharmacy contractual framework in Wales. This rapid review of the evidence was produced in order to inform the development of a pharmaceutical needs assessment tool for the delivery of weight management interventions by community pharmacists in Wales. This report should be read in conjunction with other relevant documents on the pharmaceutical public health team document database. Publication/Distribution: Distribution to NPHS pharmaceutical public health team, Welsh Assembly Government, LHB Heads of pharmacy and medicines management Publication on the NPHS internet and intranet websites Author: Dr Mary Webb, Public Health Practitioner Version: 1.a Date: 11/02/2009 Page: 1 of 28 Status: Final Intended Audience: Pharmaceutical Public Health Team National Public Health Service for Wales Weight management/community pharmacists Table of contents 1. Executive Summary .................................................................................. 3 2. Introduction ............................................................................................... 4 3. Aims .......................................................................................................... 4 4. Methods .................................................................................................... 5 5. 4.1 Systematic searching......................................................................... 5 4.2 High level searching .......................................................................... 5 4.3 Inclusion Criteria ................................................................................ 6 Results ..................................................................................................... 6 5.1 Clinical guidelines/guidance recommendations ................................. 9 5.2 Barriers to implementation in community pharmacies ..................... 10 5.3 UK community pharmacy weight management services. ................ 11 5.4 Cost-effectiveness ........................................................................... 12 6. Conclusions ............................................................................................ 13 7. References ............................................................................................. 14 Appendix 1 Search terms and results ...................................................... 17 Appendix 2 Evidence levels and quality grading ...................................... 18 Appendix 3 Evidence table ...................................................................... 19 Appendix 4 Components of weight management programmes ............... 26 © 2009 National Public Health Service for Wales Material contained in this document may be reproduced without prior permission provided it is done so accurately and is not used in a misleading context. Acknowledgement to the National Public Health Service for Wales to be stated. Author: Dr Mary Webb, Public Health Practitioner Version: 1.a Date: 11/02/2009 Page: 2 of 28 Status: Final Intended Audience: Pharmaceutical Public Health Team National Public Health Service for Wales 1. Weight management/community pharmacists Executive Summary There is general consensus that obesity is becoming a major public health challenge and effective measures are urgently needed to address the problem. The pharmacy profession is increasingly recognising that it can play an important role in the new public health agenda. Community pharmacists (CPs), through the Community Pharmacy Contractual Framework, now take part in health promotion campaigns and some offer enhanced services such as weight management. Before commissioning such services it is essential to assess the evidence base for the clinical and cost effectiveness of such services. The aim of the present document was to perform a rapid review of the evidence on the effectiveness of CP led weight management interventions. The literature searches did not identify any good quality (Level 1 or Level 2) evidence to support the effectiveness of CP weight management interventions. There was one small randomised controlled trial performed in the United States with short follow-up that demonstrated a weight loss. There were however, several good quality literature reviews that were used to inform the present paper. These reviews identified four Level 3 studies, from which the evidence from Levels 3/4 was suggestive that weight loss does occur in individuals participating in the weight loss programmes; none of the studies were from the United Kingdom. There was considerable UK national guidance recommending the involvement of CPs in weight management. There was some evidence to indicate which interventions should be included in weight management programmes delivered by CPs and how to address the barriers to successful implementation. The evidence suggested that such programmes should include advice on lifestyle change, physical activity, behaviour modification and support to the client. Drug treatment in conjunction with lifestyle change may be required for some individuals. There are a considerable number of CP led weight management programmes being undertaken within the UK, but comprehensive evaluation data was not found. Author: Dr Mary Webb, Public Health Practitioner Version: 1.a Date: 11/02/2009 Page: 3 of 28 Status: Final Intended Audience: Pharmaceutical Public Health Team National Public Health Service for Wales 2. Weight management/community pharmacists Introduction The detrimental effects of obesity on health are well known, yet despite preventative methods its incidence is continuing to rise. Managing the problems caused by this issue has involved a range of health professionals, including doctors, dieticians, exercise physiologists, physiotherapists and psychologists. Over the last decade community pharmacy (CP) has been undergoing a paradigm shift in the focus of its practice. Community pharmacists have extended their role from dispensing medicines to providing a broad range of cognitive interventions through enhanced pharmacy services (EPS). With regard to obesity the question being debated is, can CPs provide a weight management EPS that could be integrated with the healthcare system and help treat overweight clients. The White Paper Pharmacy in England highlighted the UK government’s desire for pharmacists to provide weight management services to the public. 1 A recent survey across Europe indicated that the pharmacy profession is increasingly recognising the potential to be involved in weight management. 2 There is however controversy about the evidence in relation to whether pharmacy-run weight management services are effective in helping to solve the obesity epidemic. 3 As part of the on-going programme of pharmaceutical needs assessments (PNAs) led by the NPHS Pharmaceutical Public Health Team, the Local Health Boards in Wales were asked to prioritise topics for NPHS supported PNAs. The leading topic for development into a PNA during 2008/09 was weight management. Information was then required on which interventions that could be delivered by CPs are effective in promoting weight loss. 3. Aims The purpose of the present document is to report the results of a rapid review of the evidence for the effectiveness of weight management interventions delivered by CPs. Author: Dr Mary Webb, Public Health Practitioner Version: 1.a Date: 11/02/2009 Page: 4 of 28 Status: Final Intended Audience: Pharmaceutical Public Health Team National Public Health Service for Wales 4. Weight management/community pharmacists Methods Existing and ongoing research was identified through literature searching. 4.1 Systematic searching As per the protocol contained in The Evidence Checklist 4 a scoping search was initially performed to identify major papers on published evidence and refine the final search strategy. For the present overview, search terms contained in the search strategies were used from published reviews and they were kept broad to maximise retrieval of references. The basic search strategy is shown in Appendix 1. The type of literature on weight management interventions in CPs necessitated the use of a pragmatic approach to searching for evidence in order to achieve production of the review, within the short timescales for delivery. It is clear that there had to be a balance between timeliness and rigour and high quality evidence and systematic reviews, meta-analyses, health technology assessments and clinical guidelines were identified first. It should be emphasised that the review is not a systematic review of primary studies. 4.2 High level searching It is well known that the classical databases for medical literature, such as Medline, do not adequately index all relevant literature. The reviewer used previously described validated methods that involved the use of meta-search engines and other databases for ‘high level’ searching to quickly identify relevant evidence. For critical appraisal, the tables recommended for use in the National Institute for Health and Clinical Excellence guideline development methods manual 5 were modified to accept the type of studies identified for community pharmacy/ies/ists and weight management interventions. The quality of the evidence was graded using the NICE hierarchy of evidence and the quality checklists. Evidence was rejected if graded as poor quality, apart from where it was of Level 1 type (see Appendix 2 for explanation of evidence grading system) and was highly relevant to the questions. The data relevant to the research question was entered into an evidence table. (Appendix 3) Due to practical limitations a single reviewer performed the final selection, critical appraisal and data extraction. Author: Dr Mary Webb, Public Health Practitioner Version: 1.a Date: 11/02/2009 Page: 5 of 28 Status: Final Intended Audience: Pharmaceutical Public Health Team National Public Health Service for Wales 4.3 Weight management/community pharmacists Inclusion Criteria Search period January 2004 – December 2008 Papers in English, German, French or Spanish Papers relating to the effectiveness of weight reduction interventions for adults by CPs/community pharmacies Randomised controlled trials Systematic reviews Meta-analyses Guidelines Observational studies (where higher quality evidence was not available) 5. Results The scoping search revealed several up-to-date comprehensive reviews of the evidence for the effectiveness of CPs in improving public health that included weight management interventions. The Royal Pharmaceutical Society of Great Britain (RPSGB) had also published a comprehensive list of references on CPs and weight management interventions. 6 The results of the systematic search are shown in Appendix 1. There were a large number of hits for CP services and weight and date limits and publication type limits were applied, followed by filters for systematic reviews/reviews and randomised controlled trials (RCTs). High level searching indicated several relevant documents that were not indexed in the classical databases such as Medline and Embase and illustrate the problems with retrieval of evidence. The authors of two reviews covering the period 1990 to 2004 of both international peer reviewed and non-peer reviewed literature on community pharmacy’s contribution to improving public health concluded that the strength of the evidence base for CP interventions was poor. 7, 8 The reviews included only two studies for weight management by CPs, one observational study (Level 3) from Denmark and a RCT (Level 1-) from the United States (US). The Danish study 9 reported the results of slimming courses held at 19 CPs for 269 overweight clients. The average self reported weight loss was 5.3kg for women and 6.2kg for men and at 1 year, 20% of clients who completed the course had maintained the weight loss; problems with self reporting are well known. The trial from the US 10 randomised patients to a meal replacement (MR) or reduced calorie diet (RCD) plan. The programme involved three Author: Dr Mary Webb, Public Health Practitioner Version: 1.a Date: 11/02/2009 Page: 6 of 28 Status: Final Intended Audience: Pharmaceutical Public Health Team National Public Health Service for Wales Weight management/community pharmacists weekly visits to the CP and 88 participants who attended at least one follow up visit were included in the analysis. Follow up was 3 months for weight reduction and 10 weeks for weight management. Improvements in weight loss occurred and were similar for both the MR and RCD plans and were maintained during the follow up period. The third review from the same group published in 2008, 11 found six relevant studies that involved weight management, three of which involved the use of interventions; all the studies were of Level 3 type evidence. A service provided in a single pharmacy in the US resulted in a mean weight loss of 3.6kg among 216 people over a mean duration of 26 weeks. 12 The service involved an initial consultation with the pharmacist (scheduled for 1.5 hours) followed by 15 minute fortnightly follow ups until target weight was reached and then a three monthly follow up. The service was provided free during the study period and is now offered on a fee-paying basis. In a Swiss study, 3800 people who had participated in CP-based screening for diabetes were asked to take part in a programme of lifestyle counselling. Of the 1370 who took part, the mean weight loss was 0.6–1.9 kg at 3 months. People in the high-risk counselling group (245) showed weight loss of 2.25% at 3 months and 2.74% at 1 year. 13 The study reported by John et al. 2006, 14 in which CPs provided education about cardiovascular disease, identification of drug therapy problems, and the importance of routine blood pressure, pulse, and weight measurement in a workplace health-improvement programme did not find a significant effect on weight. This study however, included only 56 patients of which 37 had diabetes. An extensive study into developing an evidence based CP weight management project was performed in Australia.15 Evidence for the effectiveness of the various components was assessed and the details are described in Appendix 4. The evidence indicated that all successful weight management programmes involve some form of lifestyle change either on decreasing energy intake or increasing energy expenditure or both. Behaviour modification and support to the client, some medications, a very low energy diet or surgery may also aid treatment. 16 There is national guidance on drug treatments for obesity in England and Wales.17 Adding drug treatment to lifestyle approaches may be considered for individuals who have not reached their target weight loss, or for those who have reached a plateau with dietary, physical activity and behavioural change interventions. Drug treatment may be considered for overweight people who Author: Dr Mary Webb, Public Health Practitioner Version: 1.a Date: 11/02/2009 Page: 7 of 28 Status: Final Intended Audience: Pharmaceutical Public Health Team National Public Health Service for Wales Weight management/community pharmacists have co-morbidities or for people without co-morbidities who have a BMI ≥ 35kg/m2. The evidence for the effectiveness of anti-obesity drugs in addition to lifestyle changes indicates that patients lose an average of approximately 3-5kg more weight than with placebo in the first year.17 Continuing treatment into a second year helps to maintain the weight loss. There was however a lack of good quality evidence on long term effectiveness. 18 There are also many complementary therapies that claim to be effective for reducing weight that can be purchased over-the-counter. A systematic review that assessed the evidence for their effectiveness in reducing body weight was published in 2005. Six systematic reviews and 25 additional RCTs were reviewed. The evidence considered was from studies of acupuncture, acupressure, dietary supplements, homeopathy and hypnotherapy. There were small effects for hypnotherapy and ephedrine containing dietary supplements, but for the other treatments evidence was lacking. The intake of ephedrine containing compounds is however associated with an increased risk of adverse events. 19 Of relevance to the role of CPs in weight management was the literature review published by Brown20 on the management of obesity in primary care by nurses. Eleven studies were reviewed, two of which examined outcomes following attempts to implement evidence based protocols. The evidence of positive outcomes was inconsistent and the maximum number of patients that achieved a clinically significant weight loss was only 10%. A toolkit has recently been published by the Faculty of Public Health to provide further support for developing a local strategy to tackle overweight and obesity.21 It is primarily aimed at commissioners of public health services in primary care trusts (PCTs) and local authorities. It contains an assessment of the evidence for which interventions to choose and the rationale behind involvement of pharmacists. The conclusions for the role of CPs are based on two documents 18, 22 and are: Outline role of pharmacists in promoting health weight provision of physical activity leaflets and information issued with prescriptions opportunistic advice on physical activity signposting to local physical activity opportunities Personalised advice and support from pharmacists provision of healthy living advice Author: Dr Mary Webb, Public Health Practitioner Version: 1.a Date: 11/02/2009 Page: 8 of 28 Status: Final Intended Audience: Pharmaceutical Public Health Team National Public Health Service for Wales Weight management/community pharmacists referral to local weight management services delivery of weight management services or brief interventions where appropriate. The toolkit also stated that it remains unclear whether the source of delivery (both of the main intervention and ongoing support) has an influence on effectiveness and that none of the identified studies considered inter-agency or inter-professional partnerships. 5.1 Clinical guidelines/guidance recommendations The RPSGB produced a practical guide on public health for CPs, the aim of which was to determine which health development activities are most likely to be effective in a CP setting.23 The evidence from the published literature, both peer reviewed and grey literature was that further research is needed before conclusions can be made about the effectiveness of CP led programmes. The evidence for the contribution of pharmacy to improving health was also reviewed for the publication from the Department of Health “Choosing health through pharmacy” 22. The authors concluded that there was a strong evidence base for brief consultations on health behaviours linked to PCTs public health programmes. Brief consultations were not defined and despite considerable interest in the effectiveness of brief interventions delivered in primary care, there was a lack of good quality evidence to support their role in weight reduction or management.18 There was also some evidence that healthy eating programmes based in pharmacies are effective, if appropriate evaluation for weight reduction is carried out.22 The authors proposed a care pathway to be delivered by CPs:Raise awareness and provide information ↓ Raise the issue opportunistically and provide advice ↓ Refer as appropriate to specialist services, e.g. diet, physical activity, drugs, surgery ↓ Review and maintain progress A national clinical guideline on the prevention and management of obesity was published in 2006 by the National Institute for Health and Clinical Author: Dr Mary Webb, Public Health Practitioner Version: 1.a Date: 11/02/2009 Page: 9 of 28 Status: Final Intended Audience: Pharmaceutical Public Health Team National Public Health Service for Wales Weight management/community pharmacists Excellence. 18 In relation to the pharmacy profession, a number of roles were identified in relation to pharmacy. The guideline recommends: If someone has concerns about weight or diet then they should discuss these with a pharmacist. With specific training, staff such as pharmacy assistants or support staff in general practices may also be able to give advice and support. Multi-component interventions are the treatment of choice. Weight management programmes should include behaviour change strategies to increase people’s physical activity levels or decrease inactivity, improve eating behaviour and the quality of the person’s diet and reduce energy intake. The decision to start drug treatment, and the choice of drug, should be made after discussing with the patient the potential benefits and limitations, including the mode of action, adverse effects and monitoring requirements and their potential impact on the patient’s motivation. When drug treatment is prescribed, arrangements should be made for appropriate health professionals to offer information, support and counselling on additional diet, physical activity and behavioural strategies. Information about patient support programmes should also be provided. 5.2 Barriers to implementation in community pharmacies The attitude of pharmacists towards providing weight management services is an important factor in their successful implementation. There appeared to be very little published literature on this, but new data from a survey of 350 pharmacists in Europe, that included the UK, indicated that the pharmacy profession is increasingly recognising the potential to be involved in weight management. Ninety-six percent of the relatively small sample surveyed showed that the pharmacists in Europe believed that with support and training they are well placed to help people with their weight loss efforts. Ninety two percent thought that they should give advice on behavioural change, whilst 90% thought that that guidance on healthy eating should be provided; 74% thought that they should offer advice on drug therapy for weight loss. 24 A recently published report 25 shows that across Europe, 64% of people (out of a total of over 6,000 questioned in six countries) agreed that CPs should be developed as alternatives to doctors' clinics, so that they can have more choice in getting advice and treatment for common conditions. Support for extending pharmacy based health care was strongest in the UK and Poland. Over 75% of people in both countries supported the further development of pharmacies as alternatives to doctors' clinics. Author: Dr Mary Webb, Public Health Practitioner Version: 1.a Date: 11/02/2009 Page: 10 of 28 Status: Final Intended Audience: Pharmaceutical Public Health Team National Public Health Service for Wales Weight management/community pharmacists One review of the literature15 indicated that CPs are willing, but perhaps not always able to provide EPS and the major barriers to EPS have been identified by a number of studies. The evidence suggested that the capabilities of CPs to provide a weight management programme will be negatively affected by the following: 5.3 The cost of running the EPS - remuneration for the CP to undertake this EPS must cover the additional workload involved. This improves the likelihood of the program being adopted, implemented, and sustained in CPs Workload and personnel shortages, Accreditation: skill set, support and training, Facilities and staffing, Ethical barriers, Professional relationships and boundaries. UK community pharmacy weight management services. There are many CP initiatives that are being undertaken in the UK and further details and links to publication details can be found in the RPSGB’s 2008 publication.6 The Coventry PCT obesity management project was set up in March 2007 and the perceived success of the project was one of the major driving forces behind the recommendation in the Department of Health’s recommendation 1 that CPs should be involved in weight management services. In the project the patients would have a consultation with the pharmacist on a regular basis to discuss achievable and maintainable lifestyle goals. Ten pharmacies in Coventry took part in a pilot scheme for one year and recruited 160 obese patients identified as being at risk of developing longterm illnesses. The scheme helped 34 patients lose a total of 130kg. Pharmacy contractors were paid £20 for each initial patient consultation and a further £15 for each follow up consultation. It is estimated that the total cost per patient is £200. Between March 2007 and September 2007, 80% of adults (n= 140) on the programme had lost on average 5% of their body weight. The Healthy North Ayrshire project consists of the provision of health checks by CPs for people with risk factors for cardiovascular disease and has been running from April 2006. Evaluation of the project is currently being performed. One large pharmacy multiple offers weight loss services aimed at individuals with a Body Mass Index (BMI) of ≥ 28. The services consist of an initial Author: Dr Mary Webb, Public Health Practitioner Version: 1.a Date: 11/02/2009 Page: 11 of 28 Status: Final Intended Audience: Pharmaceutical Public Health Team National Public Health Service for Wales Weight management/community pharmacists consultation and assessment with a pharmacist, and where appropriate, the supply of an effective1 weight loss medicine, reviews and discounts on related products. A pilot weight reduction service was set up in a community pharmacy in Swansea in 2004. A preliminary communication was published, but no further publications were revealed by the search. 5.4 Cost-effectiveness No cost-effectiveness studies of relevance to CP led weight management programmes in the UK were found. The authors of the NICE obesity guideline18 commented on the lack of evidence on the cost effectiveness of any interventions for weight management, partly because of a lack of outcome measures that are amenable to health economic evaluations. Much of the evidence on the effectiveness of prevention strategies concerns crude measures such as average weight loss rather than response rates, and follow-up periods are usually short-term. More information is required from quality-of-life questionnaires throughout the intervention and follow-up period and this would help assess the value to the individual of any clinical improvement. This would allow greater comparison between types of intervention and improve the assumptions that need to be made in any cost-effectiveness analyses. 1 There is no mention of the evidence for this Author: Dr Mary Webb, Public Health Practitioner Version: 1.a Date: 11/02/2009 Page: 12 of 28 Status: Final Intended Audience: Pharmaceutical Public Health Team National Public Health Service for Wales Weight management/community pharmacists 6. Conclusions There was a lack of consistent good quality Level 1 and Level 2 evidence on the effectiveness of CP led weight reduction/ management interventions. The results from a small number of observational studies performed outside of the UK provide some support for the role of CPs in weight management. There are national guidelines/guidance recommending the involvement of CPs in helping individuals to lose weight. There is some evidence to indicate what interventions should be provided by CPs for effective weight loss and management and how to ensure successful implementation. Overweight and obesity are issues related to inequalities, and CPs are particularly well located to assist with weight management, as many of them are based close to residential areas and have few physical and psychological barriers related to access. The problem with all the available CP programmes in existence in the UK is the lack of published data on comprehensive evaluation of clinical and cost-effectiveness. New and existing interventions delivered by CPs need to be properly evaluated in the light of current and emerging evidence. There is also a need for research evaluating multi-component/ multiagency interventions to manage obesity in primary care, because factors such as the types of participant, the training of staff and the availability of resources may affect the results. The latest publication from the Faculty of Public Health, containing a toolkit with details on how to provide further support for developing a local strategy to tackle overweight and obesity, states that “local areas should not feel constrained by the lack of evidence on effectiveness. The evidence base will only improve if new methods are tried and evaluated properly”. Author: Dr Mary Webb, Public Health Practitioner Version: 1.a Date: 11/02/2009 Page: 13 of 28 Status: Final Intended Audience: Pharmaceutical Public Health Team National Public Health Service for Wales 7. Weight management/community pharmacists References (1) Department of Health. Pharmacy in England. Building on strengths – delivering the future. London: DH; 2008. Available at: http://www.dh.gov.uk/en/publicationsandstatistics/publications/publicationspoli cyandguidance/dh_083815. [Accessed 2nd December 2008] (2) Maguire T. The battle against obesity: European experts and pharmacists call for an increased role for pharmacy. Available at: http://www.gsk.com/media/pressreleases/2008/2008_pressrelease_10050.ht m [Accessed 2nd December 2008] (3) Maison G. BPC 2008: Obesity: a community pharmacy issue? The Pharmaceutical Journal 2008; 281:831 (4) National Public Health Service for Wales. Evidence checklist. Cardiff: NPHS; 2008. Available at: http://www.nphs.wales.nhs.uk. [Accessed 2nd December 2008] (5) National Institute for Health and Clinical Excellence. Guideline development methods. Available at: http://www.nice.org.uk [Accessed 2nd December 2008] (6) Royal Pharmaceutical Society of Great Britain. RPS e-PIC references on: pharmacy weight management schemes. London: RPSGB; 2008. Available at: http://www.rpsgb.org/pdfs/weightman.pdf [Accessed 2nd December 2008] (7) Anderson C; Blenkinsopp A; Armstrong M. The contribution of pharmacy to improving the public’s health. Report 1. Evidence from the peer-reviewed literature 1990-2001. London: PharmacyHealthLink, Royal Pharmaceutical Society of Great Britain: 2003. Available at http://www.pharmacyhealthlink.org.uk/files/Evidence%20Base%20Report%20 1.pdf [Accessed 2nd December 2008] (8) Blenkinsopp A, Anderson C, Armstrong M. The contribution of pharmacy to improving the public’s health. Report 2. Evidence from the UK non peerreviewed literature 1990-2002. London: PharmacyHealthLink, Royal Pharmaceutical Society of Great Britain: 2003. Available at Author: Dr Mary Webb, Public Health Practitioner Version: 1.a Date: 11/02/2009 Page: 14 of 28 Status: Final Intended Audience: Pharmaceutical Public Health Team National Public Health Service for Wales Weight management/community pharmacists http://www.pharmacyhealthlink.org.uk/files/Evidence%20Base%20Report%20 2.pdf [Accessed 2nd December 2008] (9) Tubro S et al. [Dietary guidelines on obesity at Danish pharmacies. Results of a 12 week course with 1 year follow up]. Ugeskr Laeger 1999; 161(38): 5308-13. Cited in ref. 7 (10) Ahrens RA, Hower M, Best AM. Effects of weight reduction interventions by community pharmacists. Journal American Pharmaceutical Association 2003; 43: 583. (11) Anderson C; Blenkinsopp A; Armstrong M. The contribution of pharmacy to improving the public’s health. Literature review update 20042007. Management summary. Pharmacy Health Link: 2008. Available at http://www.pharmacyhealthlink.org.uk/files/Evidence%20Base%20Report%20 5.pdf [Accessed 2nd December 2008] (12) Lloyd KB et al. Implementation of a weight management pharmaceutical care service. Ann Pharmacother 2007; 41: 185-92. (13) Botomino A et al. Change of body weight and lifestyle or persons at risk for diabetes after screening and counselling in pharmacies. Pharmacy World & Science. 2007; Nov 29 (Epub ahead of print) (14) John EJ et al. Workplace-based cardiovascular risk management by community pharmacists: impact on blood pressure, lipid levels and weight. Pharmacotherapy 2006; 26:1511. (15) Rieck A, Clifford R, Everett A. Community pharmacy weight management project. Stages one and two (2005-2002). Perth; University of Western Australia; 2005. Available at: http://www.guild.org.au/uploadedfiles/Research_and_Development_Grants_P rogram/Projects/2006-05-29%20CPWMP%20Final.pdf [Accessed 2nd December 2008] (16) National Health and Medical Research Council. Clinical practice guidelines for the management of overweight and obesity in adults. Canberra: Department of Health and Ageing; 2003. Available at: http://www.health.gov.au/internet/main/publishing.nsf/Content/obesityguidelin es-guidelines-adults.htm [Accessed 2nd Dec 2009] (17) National Prescribing Centre. The drug management of obesity. MeReC Bulletin 2008; 5:1. Author: Dr Mary Webb, Public Health Practitioner Version: 1.a Date: 11/02/2009 Page: 15 of 28 Status: Final Intended Audience: Pharmaceutical Public Health Team National Public Health Service for Wales Weight management/community pharmacists (18) National Institute for Health and Clinical Excellence. Obesity: guidance on the prevention, identification, assessment and management of overweight and obesity in adults and children. CG 43. London: NICE; 2006. Available at http://www.nice.org.uk/Guidance/CG43 [Accessed 2nd December 2008] (19) Pittler MH, Ernst E. Complementary therapies for reducing body weight: a systematic review. Int J Obes 2005; 29:1030. (20) Brown I; Psarou A. Literature review of nursing practice in managing obesity in primary care: developments in the UK. J Clin Nurs 2007; 17: 17 (21) Swanton K. Health weight, healthy lives; a toolkit for developing local strategies. London: Department of Health, National Heart Forum; 2008. Available at: http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/DH_088968 [Accessed 2nd Dec 2008] (22) Department of Health. Choosing health through pharmacy. A programme for pharmaceutical public health 2005–2015. London: DH; 2005. Available at: http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPo licyAndGuidance/DH_4107494 [Accessed 2nd December 2008] (23) Royal Pharmaceutical Society of Great Britain. Public health; a practical guide for community pharmacists. Available at: http://www.rpsgb.org.uk/pdfs/pubhlthguidcommph.pdf [Accessed 2nd December 2008] (24) ICM Research. Survey among 350 pharmacists in Europe, across Czech Republic, Germany, France, Poland, Slovakia, Switzerland and the UK. ICMR; 2008. Cited in reference 2 (25) The School of Pharmacy, University of London. Greater expectations. Pharmacy based health care – the future for Europe? London: University of London; 2007. Available at: http://www.pharmacy.ac.uk/fileadmin/documents/News/Greater_Expectations _web_edition.pdf [Accessed 2nd December 2008] Author: Dr Mary Webb, Public Health Practitioner Version: 1.a Date: 11/02/2009 Page: 16 of 28 Status: Final Intended Audience: Pharmaceutical Public Health Team National Public Health Service for Wales Appendix 1 Weight management/community pharmacists Search terms and results The following terms were used to search Ovid Medline, Embase, Cochrane Database of Systematic Reviews, ACP Journal Club, EBM reviews, Database of Abstracts of Reviews of Effects; Cochrane Central Register of Controlled Trials; British Nursing Index and Cinahl, and HMIC: ‘Services, pharmaceutical and weight control; services, pharmaceutical and obesity; pharmacist and weight control; pharmacist and obesity; community pharmacy and weight control; community pharmacy and obesity, obesity/prevention and control; obesity/therapy; individualised; value; expertise; primary care; pharmacy; public health; obesity, overweight, treatment/therapy, treatment efficacy, behaviour therapy, pharmacotherapy, cognitive behaviour therapy, meta analyses, systematic reviews, attitudes, incentives, gender issues, obesity management, weight management, commercial weight management, weight loss, commercial weight loss programmes, commercial slimming programmes’. SEARCHES RESULTS 1 pharmacists.mp. [mp=ti, ot, ab, hw, nm, sh, tn, dm, mf] 21068 2 community pharmacy.mp. [mp=ti, ot, ab, hw, nm, sh, tn, dm, mf] 2505 3 community pharmacy services.mp. [mp=ti, ot, ab, hw, nm, sh, tn, dm, mf] 1136 4 pharmacies.mp. [mp=ti, ot, ab, hw, nm, sh, tn, dm, mf] 7820 5 pharmaceutical services.mp. [mp=ti, ot, ab, hw, nm, sh, tn, dm, mf] 5639 6 ((#1 or #2 or #3 or #4 or #5) and health education).mp. [mp=ti, ot, ab, hw, nm, sh, tn, dm, mf] 25032 7 (#1 or #2 or #3 or #4 or #5 health promotion).mp. [mp=ti, ot, ab, hw, nm, sh, tn, dm, mf] 7902484 8 (#1 or #2 or #3 or #4 or #5 public health).mp. [mp=ti, ot, ab, hw, nm, sh, tn, dm, mf] 7902488 9 (pharmac* and diet).mp. [mp=ti, ot, ab, hw, nm, sh, tn, dm, mf] 10411 10 (pharmac* and body weight).mp. [mp=ti, ot, ab, hw, nm, sh, tn, dm, mf] 11789 11 limit 10 to yr="2004 - 2009" 4746 12 limit 9 to yr="2004 - 2009" 4883 13 limit 8 to yr="2004 - 2009" 2947613 14 limit 6 to yr="2004 - 2009" 10788 15 limit 13 to "core clinical journals (aim)" [Limit not valid in EMBASE; records were retained] 16 limit 15 to latest update Author: Dr Mary Webb, Public Health Practitioner Version: 1.a 1465718 5150 Date: 11/02/2009 Page: 17 of 28 Status: Final Intended Audience: Pharmaceutical Public Health Team National Public Health Service for Wales Appendix 2 Weight management/community pharmacists Evidence levels and quality grading (modified from NICE Guideline Methodology Manual) Level of Evidence 1++ 1+ 12++ 2+ 2- 3 4 Type of evidence High-quality meta-analyses, systematic reviews of RCTs, or RCTs with a very low risk of bias Well-conducted meta-analyses, systematic reviews of RCTs,or RCTs with a low risk of bias Meta-analyses, systematic reviews of RCTs, or RCTs with a high risk of bias High-quality systematic reviews of case–control or cohort studies. Highquality case–control or cohort studies with a very low risk of confounding, bias, or chance and a high probability that the relationship is causal Well-conducted case–control or cohort studies with a low risk of confounding, bias, or chance and a moderate probability that the relationship is causal Case–control or cohort studies with a high risk of confounding bias, or chance and a significant risk that the relationship is not causal Non-analytic studies (for example, case reports, case series) Expert opinion, formal consensus Quality grading ++ = good quality + = fair +/- = fair to poor - = poor Author: Dr Mary Webb, Public Health Practitioner Version: 1.a Date: 11/02/2009 Page: 18 of 28 Status: Final Intended Audience: Pharmaceutical Public Health Team National Public Health Service for Wales Appendix 3 Weight management/community pharmacists Evidence table STUDY POPULATION/ SETTING INTERVENTION/AIM OUTCOMES RESULTS Ahrens RA, Hower M, Best AM. Effects of weight reduction interventions by community pharmacists. Journal American Pharmaceutical Association 2003; 43: 583 (Reference 10) Adults attending a CP. To compare a meal replacement programme with a conventional RED for weight management using the pharmacy as the setting and the pharmacist as the point of contact for dietary advice. Meal replacement (MR): n = 45. BMI (kg/m2): 29.5 (SD 2.2) Weight (kg): 81.9 (SD 11.1) Waist circumference (cm): 89.1 (SD 8.5) Age (years): 47.6 (SD 7.9) Participants received free liquid meal replacement shakes (Slim-Fast) and were instructed to use these to replace two main meals per day for the first 12 weeks, and one main meal a day for the following 10 weeks. They were also given dietary advice involving instruction on healthy eating, the prescription of a daily energy intake in the first 12 weeks and assistance in self-selecting the rest of their diet. Participants were given physical activity (PA) advice at their initial visit. They returned to the pharmacy every 2 weeks for a 15 min review to discuss progress and to collect their shakes. Weight loss/ weight maintenance Length of followup = 12 and 22 weeks. Weight (kg): Over the 12-week intervention period, weight decreased significantly (p < 0.001) in both MR (– 4.9 [SE 0.3]) and RED (–4.3 [SE 0.3]) groups. There was no significant difference between the two groups. Participants were required to be free of specific medical conditions and have a BMI of 25–32 kg/m2. US Author: Dr Mary Webb, Public Health Practitioner Version: 1.a Date: 11/02/2009 Page: 19 of 28 During the weight maintenance phase, from week 12 to week 22, there was a significant (p = 0.02) further loss in the RCD group (–0.9 [SE 0.4]). The change in the MR group (–0.7 [SE 0.4]) was not statistically significant. There was no significant difference between the two groups. Loss to follow-up: Status: Final Intended Audience: Pharmaceutical Public Health Team COMMENTS Italics= reviewers comments Ninety-five participants (12.6% male) were randomised but data are only provided for participants who remained in the programme at week 2 This is the only significant RCT of CP intervention revealed by search. The primary outcome was to compare two methods of producing weight reduction/weight management. DESIGN EVIDENCE LEVEL/ QUALITY RCT 1- + National Public Health Service for Wales Weight management/community pharmacists Delivered by: A registered dietician reviewed diet plans and was consulted as needed. Two pharmacists provided all other support. The pharmacists received no special training. Conventional reduced-energy diet (RED): n = 43 BMI (kg/m2): 29.0 (SD 2.6) Weight (kg): 78.3 (SD 10.1) Waist circumference (cm): 87.0 (SD 8.2) Age (years): 47.8 (SD 9.5) Participants were given dietary advice involving instruction on healthy eating, the prescription of a daily energy intake and assistance in selfselecting their diet using diabetic exchange lists. After 12 weeks they were instructed to return to a healthy diet of their choice. Participants were given the same PA advice and support as the intervention group. 12-week intervention: n = 27/95 (28%) Weight maintenance: n = 40/95 (42%) Not reported for individual groups. Delivered by: As intervention group. Botomino A et al. Change of body weight and lifestyle of persons at risk for diabetes after screening and counselling in pharmacies. Pharmacy World & Science. 2007; Nov 29 (Epub ahead of print). (Reference 13) Nation wide diabetic campaign. Individuals > 18 years old, BMI of ≥25 and > 1 risk factor. Switzerland. Author: Dr Mary Webb, Public Health Practitioner Version: 1.a Investigation of pharmacy based counselling on lifestyle changes and body weight. Sample stratification: 1400 at moderate risk for diabetes received standard counselling (SC) in the pharmacy; 1500 ( moderate diabetes risk) received intensive counselling (IC) and 900 at high risk (HRC). Date: 11/02/2009 Page: 20 of 28 Differences in average BMI & weight, percentage of weight loss, percentage of subjects able to lose ≥5% of initial body All counselling groups ( SC; n=557, IC; n= 568, HRC; n=245) showed significant weight loss at 3 months. The HRC group showed a higher weight loss than the IC or SC Status: Final Intended Audience: Pharmaceutical Public Health Team The authors discuss the possible limitations of their study- high drop out rates, problems with self reported data, responder Qualitative survey 3 + National Public Health Service for Wales Weight management/community pharmacists Pharmacists were trained for counselling on risk factors in 2 obligatory evening courses. Questionnaires were sent at 3, 9, and 15 months. Brown I; Psarou A. Literature review of nursing practice in managing obesity in primary care: developments in the UK. J Clin Nurs 2007; 17 : 17. (Reference 20) Department of Health. Choosing health through pharmacy. A programme for pharmaceutical public health 2005-2015. London: DH; 2005 (Reference 22) Literature review Review of literature on primary care nursing practice to manage obesity. weight & self reported change in diet and exercise. Assessed the %age change with physician contact compared with CP contact. - Global Strategy document for pharmacists in all NHS sectors on interventions to improve public health. A review of the evidence for the effectiveness of CP in improving public health. UK Author: Dr Mary Webb, Public Health Practitioner Version: 1.a Date: 11/02/2009 Page: 21 of 28 - group at 3 months. bias. 11 studies were identified. The interventions could be categorised as general oral advice about nutrition and lifestyle. There was no evidence of positive outcomes from these interventions. In some cases advice was combined with calorie deficient diets and referral to physical activity and there was mixed evidence on a positive effect. Evidence was considered to be good for brief interventions by CPs on health behaviours that were linked to PCT public health programmes and for healthy eating The methods used by nurses in the community are applicable to CP led interventions. The fact that a maximum of only 10% of patients achieved a significant weight loss is a cautionary note for any CP led intervention and needs further investigation Literature review The care pathway proposed in the document lacks detail and the conclusion on the evidence for brief interventions is controversial Review/expert opinion Status: Final Intended Audience: Pharmaceutical Public Health Team 2++ + 3/4 + National Public Health Service for Wales John EJ et al. Workplacebased cardiovascular risk management by community pharmacists: impact on blood pressure, lipid levels and weight. Pharmacotherapy 2006; 26:1511 (Reference 14) Workplace Lloyd KB et al. Implementation of a weight management pharmaceutical care service. Ann Pharmacother 2007;41:185–92. (Reference 12) Pharmaceutical care centre in US university campus National Health and Medical Research Council. Clinical practice guidelines for the Management of overweight and obesity in adults. Canberra: Department of Health and Ageing; 2003 (Reference16) National Institute for Health and Clinical Excellence. Obesity: guidance on the prevention, identification, assessment and management of overweight Clinical guideline for obesity US Weight management/community pharmacists Assessment of the effectiveness of a CP delivered cardiovascular casemanagement programme. CPs provided case management for CV risk factors. The Heart Smart programme was provided on-site for 3 years before the analyses. BMI, BP, cholesterol profiles To describe the effects of implementation of a weight management pharmaceutical care service on a college campus. Retrospective review of 289 patient records. Changes in body weight and weight related conditions. Review of the evidence for effective weight reduction/management interventions and development of a clinical guideline. - programmes with evaluation. 96/107 employees were screened. 66/96 were eligible and 36 enrolled at the start of the programme with 22 enrolling over the next 3 years. There was no difference in weight The net change in weight per patient was a decrease of 3.6kg ( 10% of baseline weight). Weight related complications were also reduced Very small numbers Historical case series 3 +/- Results difficult to generalise to population attending community pharmacies in the UK. The autors discuss the limitations of their pre test-post test study. Good quality guideline with adequate description of methodology. Some evidence may be outdated Historical case series Good quality guideline with adequate description of methodology. Some evidence Guideline 3 +/- Guideline 4 ++ Australia Clinical guideline for obesity Author: Dr Mary Webb, Public Health Practitioner Version: 1.a Review of the evidence for effective weight reduction/management interventions and development of a clinical guideline. Date: 11/02/2009 Page: 22 of 28 - Managers and health professionals in all primary care settings should ensure that preventing and managing obesity is a Status: Final Intended Audience: Pharmaceutical Public Health Team 4 National Public Health Service for Wales and obesity in adults and children. CG43. London: NICE: 2006. (Reference 18) Weight management/community pharmacists priority. Dedicated resources should be allocated for action. Multicomponent interventions are the treatment of choice. Weight management programmes should include behaviour change strategies to increase people’s physical activity levels or decrease inactivity, improve eating behaviour and the quality of the person’s diet and reduce energy intake. Commercial weight loss programmes should only be offered if they follow best practice. When drug treatment is prescribed, arrangements should be made for appropriate health professionals to offer information, support and counselling on additional diet, physical activity and behavioural strategies. England & Wales Author: Dr Mary Webb, Public Health Practitioner Version: 1.a Date: 11/02/2009 Page: 23 of 28 Status: Final Intended Audience: Pharmaceutical Public Health Team may be outdated ++ National Public Health Service for Wales Weight management/community pharmacists Information about patient support programmes should also be provided. -up. Pittler MH, Ernst E. Complementary therapies for reducing body weight: a systematic review. Int J Obes 2005; 29: 1030. (Reference 19) Literature on complementary therapies for weight reduction. Systematic review of RCTs and additional literature on the effectiveness of complementary therapies in weight reduction. - Global Rieck A, Clifford R, Everett A. Community pharmacy weight management project. Stages one and two (2005-2002). Perth: University of Western Australia; 2005. (Reference15) Community pharmacies engaged in weight management programmes Australia Author: Dr Mary Webb, Public Health Practitioner Version: 1.a Stage one - literature review, policy review and mapping process” to identify; a potential role for CPs in weight management and the impact such a service would have on CP and value of the professional service offered. Stage two - to combine the findings of the literature review with the NHMRC clinical practice guidelines and other government policies for the management of overweight and obesity, and develop a CP weight management model. Date: 11/02/2009 Page: 24 of 28 - Six systematic reviews and 25 additional RCTs met the inclusion criteria. The evidence related to acupuncture, acupressure, dietary supplements, homeopathy and hypnotherapy. There was only evidence for hypnotherapy and ephedrine containing dietary supplements. The findings of the l literature review suggest that a CP weight management programme can be successful for CPs and the healthcare system in treating clients who are overweight and obese if the following key success factors are taken into account: client factors remuneration training and accreditation Status: Final Intended Audience: Pharmaceutical Public Health Team Systematic reviews 1- ++ Comprehensive review with information applicable to UK. Literature review 3 ++ National Public Health Service for Wales Royal Pharmaceutical Society of Great Britain. Public health; a practical guide for community pharmacists. London: RPSGB; 2004 (Reference 23) The School of Pharmacy, University of London. Greater expectations. Pharmacy based health care – the future for Europe? London: University of London; 2007 (Reference 25) Guide for CPs on the broader concepts of public health Weight management/community pharmacists Review of the evidence and expert opinion UK 6000 people surveyed in 6 European countries– France, Germany, Greece, Poland, Sweden and the UK. Questionnaire survey designed to review the development of community pharmacy in 5 European countries and compare it with the UK. Europe Author: Dr Mary Webb, Public Health Practitioner Version: 1.a Date: 11/02/2009 Page: 25 of 28 - pharmacists role and professional barriers The proposed evidence based model for CPs is described in detail with methods for implementation designed to try and overcome the known barriers. Stages 3 and 4 of the project will describe the results of implementation of the CP model The authors conclude that further research is required on the effectiveness of CP led weight management programmes Across Europe 64 per cent of people agreed that CPs should be developed as alternatives to doctors' clinics. Support for extending pharmacy based health care is strongest in the UK and Poland. Status: Final Intended Audience: Pharmaceutical Public Health Team Review/expert opinion 3/4 + Provides useful information on successful CP initiatives that could be of relevance to the development of a CP led weight management programmes Qualitative Level 3 ++ National Public Health Service for Wales Weight management/community pharmacists Appendix 4 Components of weight management programmes Community pharmacists provide the components of a weight management programme (except surgery) in a variety of ways. 15 These are examined in detail below:Dietary advice All community pharmacy programmes include dietary advice; however the level of specificity for each individual client varies. For some people, an increase in knowledge will be sufficient to produce a behaviour change, if they are well-motivated. However, some people may require more specific strategies. A focus group of obese clients reported that they had been given diet sheets and low-calorie recipes but still failed to lose weight. Commercial slimming programmes such as Weight Watchers provide clients with an individualised plan. A CP weight management programme must include dietary advice to create a negative energy balance. For some clients, it may be appropriate for pharmacists to educate the client with dietary advice, which creates this negative energy balance and promotes eating habits that can be maintained long term. For the type of client requiring more specific strategies, a plan individualised to the needs of the client is probably required, and if the pharmacist does this, this will take more time. Other options are referral to a dietician or use of an expert online or via telephone. Physical activity The evidence indicated that it is more difficult to create a negative energy balance for short term weight loss with physical activity than it is with dietary measures. Therefore most CP and non-community pharmacy programmes provide advice with respect to an increase in physical activity, but it does not appear to be a major focus of the programme. A CP programme should at least promote an increase in lifestyle based activity because even if it doesn’t assist in weight loss, it may result in improvements in other aspects of metabolic health. Behaviour modification Most CP programmes encourage some form of behaviour modification to try and achieve a more permanent weight loss solution. Some programmes provide written material or instructional audiovisual material. The wellmotivated client may not require as much help with behaviour modification, but a client with a history of failed diet attempts may benefit more from behaviour modification strategies. A greater intensity of intervention and individualised feedback, in comparison to giving clients general information to Author: Dr Mary Webb, Public Health Practitioner Version: 1.a Date: 11/02/2009 Page: 26 of 28 Status: Final Intended Audience: Pharmaceutical Public Health Team National Public Health Service for Wales Weight management/community pharmacists read, also improves compliance with a programme which may achieve better weight loss. Clients requiring more intense and individualised behaviour modification will require more time investment by the pharmacist. Referral or use of an expert via a telephone or online service may also be appropriate. Support Support of the client is provided in most CP accessible programmes and is provided in a variety of ways. Some community pharmacy accessible programmes require the clients to weigh themselves and record the results with the option to ring an expert if desired. This appears to require more client self-motivation. Some programmes have forums on the internet for discussions with other people undertaking the same weight loss journey. Other examples of support programmes provided by CP include information seminars/workshops. Strong social support from a partner, peer, friend or clinician can aid weight loss. One-to-one discussion on progress towards the weight loss goal appears to be beneficial, whether by telephone or face toface. Individualised support will require a regular time investment by the pharmacist. A telephone or on-line consultant could also be used. Weight loss product Community pharmacy accessible programmes may also include the client taking a weight loss product. Compared with most non-community pharmacy weight loss programmes, pharmacists are in the unique situation of being able to suggest a suitable evidence-based weight-loss product or facilitate referral to the GP, if this is deemed necessary and appropriate. A pharmacist can then monitor the use of the product for safety and efficacy including medication compliance. Programme support materials Information was provided via a variety of methods across all programmes reviewed. This included brochures, fact sheets, newsletters, booklets, audiovisual aids, audio tapes, and websites. In the case of some of the products that can be bought from the pharmacy, the internet is the only source of information for the weight management programme unless the products are used under the direction of a health professional who is also providing support. Being able to show the client their achievements with respect to improving measurements may be more effective if it is more visual. Decreased internet usage by lower socioeconomic groups and the over 55age group needs to be considered if provision of information on the internet is considered for a pharmacy programme. Visual aids for demonstrating achievements in weight loss to the client appear to be useful. Author: Dr Mary Webb, Public Health Practitioner Version: 1.a Date: 11/02/2009 Page: 27 of 28 Status: Final Intended Audience: Pharmaceutical Public Health Team National Public Health Service for Wales Weight management/community pharmacists Provision of other health-related services Where a programme is operated from a CP, there is the opportunity for the pharmacist to integrate other related services. These include reviewing the client’s other medications for any which may be causing weight gain, completing a compliance check if the client is taking a weight loss product as part of the programme, and performing measures on blood glucose levels, cholesterol and blood pressure, especially where weight loss and dietary change may result in an improvement in these conditions. The latter may then necessitate referral to the doctor for a review of other drug therapy. Pharmacists should understand when to refer a client to the doctor if they meet certain exclusion criteria for a weight loss programme Promotion of the programme to the client Media exposure is widely used for different areas of health promotion. For greater uptake of the intervention by consumers, media promotion of a pharmacy programme would appear beneficial so that in a prospective client’s mind it is one of the available options. This would need to be considered in the context of relevant pharmacy legislation. Programme intervention initiator The CP has the unique opportunity to raise the issue of weight management with a client who may be in the pre-contemplation or contemplation stages of behavioural change. This may be part of counselling associated with dispensing of prescription medication used to treat conditions potentially caused by the client being overweight. A CP programme may consider having different resources for clients at different stages of decision making for a behavioural change. This approach has been used successfully in some GP based studies. Some of the pre-contemplation or contemplation stage clients may move to a decision or action stage of readiness to change. . Length of programme Success of a weight management programme should be assessed by the ability to achieve and maintain a clinically helpful and significant weight loss and recognise the beneficial effects of this weight loss on other conditions such as type 2 diabetes, hypertension and dyslipidaemia. This highlights the importance of the maintenance phase in any weight management programme. Most of the programmes reviewed have a weight loss and maintenance phase. Relapses in obesity are common. Constant vigilance in monitoring energy input and expenditure predicts long-term success, and this can be aided by regular monitoring and encouragement from the “clinician” over the long term, and ideally for life. Author: Dr Mary Webb, Public Health Practitioner Version: 1.a Date: 11/02/2009 Page: 28 of 28 Status: Final Intended Audience: Pharmaceutical Public Health Team