..Information to Pharmacists
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Your Monthly E-Magazine
JUNE, 2004


CON BERBATIS

A Pharmacy Researcher Perspective

Australian Pharmacy at War Against Obesity :
Part 2. Campaigns on the Home Front

In Part 1 (i2P May 2004) Con Berbatis reported the global threat to health posed in 2004 by overweight in developed countries and the frontline role for pharmacy in fighting the war against obesity. Community pharmacy's weight-lowering weaponry has been strengthened by the advent on 1 May 2004 of pharmacist-only orlistat, one of just four weight reduction pharmaco-therapies approved in Australia. 1-14
Part 2 points to the spread of obesity into developing countries as well, the anti-obesity campaigns being waged by Australian pharmacy on the home front and future strategies for pharmacy to adopt.
Pharmacists with weight management expertise in New South Wales, Queensland and the Australian Capital Territory have reviewed drafts of Parts 1 and 2 but please email Con Berbatis before citing the data.

Background

On 22 May 2004 the annual WHO World Health Assembly in Geneva declared world war against obesity when a 'global strategy on diet, physical activity and health' was adopted by all countries.15 Non-communicable diseases due chiefly to obesity and tobacco smoking accounted worldwide for 60% of deaths and 47% of morbidities (eg cardiovascular disease, type 2 diabetes and cancers) .
They impacted heavily on younger people in developing countries compared to those in developed countries.
The WHO announced a strategy with a hierarchy of national policies from limiting the consumption of saturated fats, sugars and salt to consumer education and school food and physical activity programs. (15)

3.0 National policies for weight management

Australian guidelines for weight management have arisen largely in response to the high and increasing prevalence of overweight and obesity in Australia and the consequences for population health. For example, Australia's 2001 National Health Survey which is the reference indicator of population health in the country found 47.9% of all adults and 54.5% of adult males were overweight/obese or had this in combination with other risk factors such as smoking, sedentary/low exercise level and high/risky alcohol consumption.(16) According to national data , obesity-associated morbidity, deaths and costs in Australia are high and increasing. (17)
Efficient, appropriate and accessible weight reduction practices are in their infancy in Australia as reflected by the 2001 National Health Survey results and the high and rising cost of obesity-related health disorders in this country.

3.1 NH&MRC weight management guidelines

In 2003 an NH&MRC working party devised clinical practice guidelines for the management of overweight and obesity in Australia. 2a Pharmacy was unrepresented and the guidelines were provided free just to GPs.

Randomised controlled trials of weight management interventions such as diet, exercise, pharmacotherapies, behavioural and surgical intervention were analysed and the average weight losses up to two years and more than two years were compared to no treatment (Tables 1 and 2).
Behavioural actions include other health workers and support groups in management. The details of each trial and of the results may be referred to in the guidelines. (2a)
No over the counter agent or alternative treatment was regarded as efficacious .
Pharmacotherapies are effective in achieving weight loss in less than two years but just orlistat (Roche) with diet sustains significant weight loss over longer periods (Table 2) .
Very low energy diet which is available as Optifast VLCD (Novartis) is impressive in achieving, with lifestyle modifications, similar short and long term weight loss as orlistat and diet (Tables 1 and 2).

Table 1 . Weight loss from diet, physical activity, behavioural or surgical interventions (2b)

Management mode Weight loss in 1-2 years Weight loss in > 2years Sustained weight loss
No treatment -0.2kg +1.9 kg over 3-6yrs Unable
Very low energy diet (VLCD) -4.2 to -16.3kg -4.1 kg in 3-5 yrs Needs lifestyle modification
Diet + activity -7.5kg -3.1kg Some weight loss sustained
Physical activity -1.8kg -1.3kg 80 minutes + daily activity
Behaviour -4.7kg -2.8kg Some weight loss sustained
Surgery -31kg -25 to -54kg Permanent

Table 2 . Weight loss from pharmacotherapies (2b)

Weight loss in 1-2 years Weight loss in > 2years Retention of weight loss
Sibutramine +lifestyle -10.8kg NA Only if drug maintained
Sibutramine alone -5.6kg NA Only if drug maintained
Orlistat + mild low cal diet -8.4kg -6.9kg Drug and normal diet
Diethylpropion -6.5kg NA Only if drug maintained
Phentermine -6.3kg NA Only if drug maintained


3.2 The RACGP guidelines

The Royal Australian College of General Practitioners recommended the frequency of measuring weight to screen people should be increased with age and the presence of other risk factors such as family history of these disorders and smoking because controlled studies demonstrate sustained weight lowering leads to the prevention of weight-related morbidities such as type 2 diabetes and other obesity-associated disorders. (18)
This national body endorsed regular measurement of weight by GPs as an essential preventive activity in the war against obesity .

3.3 Relevance to pharmacy practice

The main applications for Australian pharmacy practice from the above initiatives are
(1) that orlistat is the most efficacious weight lowering pharmacotherapy when continued with a diet for more than two years ,
(2) very low calorie diet (Optifast VLCD) with lifestyle changes is similar to orlistat in achieving short and long term weight loss and
(3) measurement of weight for screening and monitoring individuals should become visible to the public and practiced routinely in pharmacies for them to have a significant impact in weight management .

The Pharmacy Guild and Pharmaceutical Society of Australia should seek representation in the NH&MRC working party before it next revises the weight management guidelines in 2006 and require the guidelines are provided free to pharmacies as well as to GPs . (2a)

4.0 Weight reduction activities in Australia's community pharmacies

The following results of weight reduction practices reported by a national survey of pharmacies, a pharmacy group in western Sydney and by the Pharmacy Guild of Australia reflect a rapidly growing role by pharmacists in weight management in Australia.
The results provide a platform to quantify the impact of weight-management activities in pharmacies on the population health of Australians.
The Pharmaceutical Society of Australia has just released a continuing education publication entitled ' Weight management' which is a valuable reference for the requirements and resources for a pharmacy-based weight management service.
It advocates measuring for screening overweight people and pharmacies providing weight-lowering products other than orlistat. (19)

4.1 National Pharmacy Database Project 2002-03 (NPDP)

In the NPDP, 8.7% of community pharmacies reported in 2002 having staff trained in weigh reduction , 1.6% charged a fee and another 2.1% planned to introduce the service by July 2003.
These figures were much lower than those reported for diabetes, asthma, smoking cessation or even wound care management. (6b)
Just 6.7% of pharmacies performed one or more anthropometric tests per month for screening undiagnosed clients. (6c)
The NPDP and another study performed by the University of Sydney researchers found that testing is performed more productively and economically in pharmacies which engaged nurses in this activity. (6c)

4.2 Orlistat and Lifeweight in weight management in 2004

The Lifeweight weight management program for pharmacies was launched in March 2004.
National pharmacy bodies , pharmaceutical wholesalers and the manufacturers of orlistat have cooperated to produce and distribute a weight loss assistance program in a kit form for pharmacies. (20)
It includes a 'Weight Category Package' with electronic weight scales, anthropometric measuring tape, patient record forms, an educational CD-rom and support materials including pharmacy assistant training, customer leaflets on a step approach to weight loss , a detailed exercise guide and in-store pharmacy displays .
It sells for $300 (+ GST) and in May more than 2400 pharmacies had purchased the Lifeweight program ( K Sclavos private communication, May 2004), which makes it the quickest adopted pharmacy practice since the Quality Care Pharmacy program (QCPP) which has enrolled more than 90% of Australia's community pharmacies in the three years since its inception. (20), (21)

4.3 Very low calorie diet study in a west Sydney pharmacy

A pharmacy in west Sydney has achieved an average weight loss of 9 kg over six months in 117 clients issued a very low calorie diet product (Optifast VLCD) and the implementation of lifestyle changes) under the strict guidance of a qualified nutritionist even after 50 dropouts ( A Ferguson, private communication, April 2004).
These results are similar to the levels of weight loss and percentage of dropouts reported in controlled studies with a mean loss of 4.2 to 16.3 kg over 1-2 years using this product even with 50% dropouts (Table 1) .(2b)
This is a promising development, because if the effectiveness and safety are confirmed then another efficacious weight-lowering pharmacist-only product has been shown to be effective in the hands of community pharmacists, hence widening the treatment options for the profession .

5.0 Strategies for community pharmacy in weight management

The rapid uptake of the Pharmacy Guild's Lifeweight program will lift involvement from 8.7% of Australia's community pharmacies reported in July 2002 (Section 4.1) to more than 50% participation by July 2004.
This high national commitment to weight management may achieve better results if the program is modified in the following ways:
* A coalition of national pharmacy bodies including the PSA, CHAPANZ and COPRA (refer Part 1) should join the Pharmacy Guild to
(i) set standards for involvement by pharmacies in weight management,
(ii) oversee accreditation of pharmacies ,
(iii) ensure high standards of performing weight management as is currently implemented by PSA NSW and Quality of Care Pharmacy Support Centre for S2 and S3 medicines (22) and
(iv) administer the rigorous evaluation of pharmacies in weight management similar to Monash University's Geoff Sussman's outstanding evaluation entitled " Wound healing and cost impacts of interventions by pharmacists in community settings" conducted in 2002-2003 in 2600 subjects in nursing home beds in Victoria.

* National bodies of pharmacy should press for representation in the NH&MRC working party before it next meets to revise the guidelines given the above data on the high participation and provision of weight management by community pharmacies in this country.

* Primary prevention has the highest benefit-cost or return on investment of any health activity . Pharmacy is now able to grasp the opportunity to implement anthropometric testing ( eg BMI and waste: hip ratios measured by tape) for screening purposes. This has been advocated as the least intrusive, most economical and potentially the most cost-efficient form of clinical testing in pharmacies . (23)

* The advent of the impressive pharmacist-only orlistat and the presence of other efficacious weight-lowering agents such as very low calorie diet products and cholesterol-lowering OTC agents such as psyllium provides pharmacies with a growing armamentarium to join the war against obesity.

* Weighing machines and body tape measures should be openly and universally available in accredited pharmacies for screening overweight and identify 'high risk' people who may be referred for medical assessment and active management leading to many of them receiving long-term management with anti-hypertensive, hypo-cholesterolaemic or other primary prevention drugs.
The challenge of devising a selective or 'case screening' rather than a mass screening approach is being explored by the University of Sydney pharmacy researchers.

* That primary prevention as currently practiced is not working well in Australia is shown by persistent evidence of persistently high proportions of undiagnosed and untreated people with diabetes or pre-diabetes, hypertension and high cholesterol .
A larger role by pharmacies in screening and primary prevention is long overdue (refer C Berbatis. "Strategies for pharmacy in the 21st century". i2P Issue 25, April 2004).


* Pharmacies are now able to conveniently order kits with measuring devices for screening and monitoring weight management (Section 4.1).
Pedometers should be included in the kits so that clients can self-monitor and record compliance with physical activity regimens.

* More owners or managers should engage nurses to perform measurement because both the NPDP and a University of Sydney study found that nurses may be the most productive and economical option for screening people in pharmacies. (6c)
Banner groups should take up the challenge by competing more vigorously in health-related services by engaging nurses in testing.


The WHO and the NH&MRC have declared war against obesity internationally and in Australia (Parts 1 and 2) .
Obesity is overtaking tobacco smoking as the largest cause of morbidity and mortality in many developing and developed countries.
The introduction of orlistat as a pharmacist-only agent in Australia on 1 May 2004 should now galvanise pharmacy to become a formidable member of the coalition in the war against obesity.

Con Berbatis
29 May 2004.
Email : berbatis@git.com.au

References

1. Advertorial. Profession and industry unite over Xenical's new pharmacist-only status. Aust J Pharm 2004; 85: 232-233.
2a. National Health and Medical Research Council (NHMRC). Clinical practice guidelines for the management of overweight and obesity in adults. Canberra: Commonwealth of Australia, 2003. www.obesityguidelines.gov.au accessed 26 April 2004.
2b. National Health and Medical Research Council (NHMRC). Clinical practice guidelines for the management of overweight and obesity in adults. Canberra: Commonwealth of Australia, 2003. www.obesityguidelines.gov.au accessed 26 April 2004: xiii.
3. Center for Disease Control. Fact Sheet : Physical inactivity and poor nutrition catching up to tobacco as actual cause of death. Atlanta (Georgia): Office of Communication, March 9 2004. www.cdc.gov./od/oc/media/pressrel/fs040309 . Accessed 24 April 2004.
4. Berbatis CG, Horsfall WJ, Morgan DJ et al. Smoking, drugs and smoking cessation. Canberra: Pharmaceutical Society of Australia, 1989 (38 pages).
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6a. Berbatis C, Sunderland VB, Bulsara M, Mills C. National pharmacy database project. School of Pharmacy, Curtin University of Western Australia. www.guild.org.au/public/r&d.adpreports# accessed 10 March, 2004. The report and questionnaire can be found in the "Reports and Reviews of Completed Projects" section of this page. Refer Section M (Q33) for pharmacy turnover.
6b. ibid, Section B (Q7) for enhanced pharmacy services.
6c. ibid Section G ( Q16-18) for primary preventive services .
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