HAI News

International Strategies on Antibiotics

By Mary Hemming and Ken Harvey*

The appropriate use of drugs is a challenge for even the most experienced prescriber. The competent prescriber needs to be abreast of the latest literature and have a thorough knowledge of clinical pharmacology, together with a detailed understanding of individual patient characteristics that may influence the prescribed therapy. Also, factors such as safety and cost need to be taken into consideration.

With antibiotics there are added layers of complexity, so the proper choice of agent is particularly difficult. The infecting organism can be any one of a myriad of pathogens, antibiotic susceptibility can change as well and many systems in the body may be involved. Because of these difficulties, it is hardly surprising that excessive and inappropriate antibiotic use prevails.

Apart from the risk to patients receiving unnecessary or unacceptable medication, environmental issues are of significant consequence as widespread use of antibiotics is an important factor in the development of antibiotic resistance.

At present, there is an increasing incidence of antibiotic-resistant pathogens in both hospitals and the community without a corresponding increase in new antimicrobial drugs. This represents the present state of microbial evolution versus mankind's ingenuity. With the growing realisation that the world is scraping the bottom of the antibiotic barrel, international action is finally being taken to combat the problem.

The World Health Organization

The World Health Organization (WHO) has urged all Member States to adopt a four-point plan in order to contain and prevent antibiotic resistance, "a leading cause of concern for public health".

- First, surveillance in order to define resistance patterns, adjust treatment strategies and evaluate the impact of intervention.

- Second, education of policymakers, prescribers and the public in order to reduce overuse and misuse of antimicrobial drugs.

- Third, regulation to achieve quality antimicrobial agents in world markets, and control of unethical promotion.

- Fourth, new antimicrobial agents must be developed with novel mechanisms of action.

United Kingdom

A United Kingdom Department of Health committee has outlined a national strategy to combat this problem. The central strategy is for a National Campaign on Antibiotic Treatment (CAT) in primary care with the theme: four things you can do to make a difference:

- No prescribing of antibiotics for simple coughs and colds;

- No prescribing of antibiotics for viral sore throats;

- Limit prescribing for uncomplicated cystitis to three days in women who are otherwise fit;

- Limit prescribing of antibiotics over the telephone to exceptional cases.

There is also a proposal for a National Advice to the Public (NAP) campaign, acknowledging the importance and influence of patients' expectations and demands on prescribing.

Canada

A Canadian coalition, including eight leading health, medical, patient and pharmacy organisations, has endorsed an action plan aimed to reduce community antimicrobial use by 25% over three years. The Canadian Action Plan also focuses on reducing antimicrobial usage in respiratory infection.

A multi-year campaign, Antibiotics: Use Them Wisely, commenced in 1996. Public (and physician) opinions regarding antibiotic use were researched and the information obtained is being used to develop tools and educational material for physicians, pharmacists and the public.

A Gallup poll found that 50% of Canadians believed that antibiotics were active against viral infections such as colds and influenza.

Physicians cited perceived patient demand, diagnostic uncertainty and concern that patients would go elsewhere as the main barriers to withholding antibiotics when a viral infection was diagnosed. Ironically, this perception that patients exert pressure for antimicrobial therapy has been challenged by research that found that patient satisfaction correlated with the amount of time spent with the physician and an improved understanding of the disease.

Among the information aids being developed is an 'alternative-prescription' pad to provide physicians with a vehicle to explain why an antibiotic is not part of a course of treatment while offering practical advice on symptomatic relief.

Additional strategies include prescribing guidelines, peer education and feedback to physicians on their prescribing practices.

United States of America

The United States of America Centers for Disease Control have organised a partnership, similar to that in Canada, between the Centers for Disease Control, State Health Departments and professional organisations. The Cause (Careful Antibiotic USE to prevent resistance) campaign was launched in 1995 and is slowly building momentum. The aim is to reduce antibiotic resistance through promotion of more judicious antibiotic use.

The strategies include public media campaigns, professional education, applied research and surveillance. Hospital and veterinary use of antibiotics have also been targeted.

A quarterly newsletter lists the status of activities and the availability of educative material.

Australia

Concerns about the use of antibiotics have been voiced within Australia for many years. Over 20 years ago, in response to a rising incidence of antibiotic-resistant bacteria in Australian hospitals and local evidence that excessive and inappropriate antibiotic use was an important factor in the development of such resistance, the first edition of Antibiotic Guidelines was produced.

This book was originally produced for junior doctors in just one Australian state. In successive editions the authorship of the book was expanded to ensure input from the most eminent Australian experts. The scope of the book was extended to cover all the common, and some uncommon diagnoses. The prime users of the book now include experienced as well as inexperienced prescribers in all States and Territories of Australia. It is also an invaluable educative resource for other health practitioners and students, and an audit standard against which individual treatments can be compared. Thus the book has evolved into National evidence-based treatment guidelines, which are concise, up-to-date and disease oriented.

Despite its widespread use, it was found that the mere production and distribution of Antibiotic Guidelines did little to change prescribing habits. However, guidelines coupled with drug audits, prescriber feedback and specific educational campaigns have been shown to improve prescribing.

Ten years ago, with increasing awareness of the multitude of factors that influence prescribing and the apparently widespread inappropriate use of all therapeutic groups of medicines, there was demand for a comprehensive, national approach to medicinal drug use.

In response, Australia put in place a number of strategies to promote the quality use of medicines. These activities have been mostly coordinated by the Pharmaceutical Health And Rational Use of Medicines (PHARM) committee but they are now also the responsibility of the National Prescribing Service.

Measures specifically directed at improving the use of antibiotics have included National Medicines Week (with appropriate use of antibiotics as a major theme in 1996), support for an electronic version of Antibiotic Guidelines and a number of grass-roots projects involving general practitioners and consumers.

The evaluation of the 1996 National Medicines Week included a survey that revealed that over 70% of the population considered it inappropriate to take antibiotics for colds, influenza or a sore throat.

This is in contrast with prescribing data, which showed that 57% of Australian urban general practitioner encounters (and 73% of rural general practitioner encounters) for these conditions resulted in an antibiotic prescription. One study has shown that it was the doctors' perception of patient expectations, rather than actual patient expectation, that was a stronger predictor of prescribing.

One grassroots project, involving consumers as well as practitioners in a Melbourne general practice group, targeted antimicrobial use in respiratory tract infections and produced a significant reduction in antibiotics prescribed as well as increased compliance with recommendations in the Antibiotic Guidelines. This work has confirmed previous experience; general practitioners will change their prescribing habits if they find their prescribing deviates from evidence-based national guidelines and can reflect upon, and discuss such differences, amongst themselves.

Administrative strategies for government-subsidised medicines have included the use of restrictions and warnings, as well as audits of compliance with centrally imposed prescribing restrictions. However, there is evidence that some bureaucratic interventions merely shift prescribing to other inappropriate antibiotics.

Other relevant activities include the National Antibiotic Resistance Surveillance Program and also the Joint Expert Technical Advisory Committee on Antibiotic Resistance of the Departments of Primary Industry and Health, which is grappling with the vexed subject of antimicrobial use as growth promoters in animals.

The combination of all these efforts has resulted in only a slight reduction in antibiotic use. Antibiotic use in Australia has been high in comparison to the United Kingdom, Canada and the US; however, yearly increases were observed to plateau in the mid-90's.

The Australian government has recently committed substantial resources to a new National Prescribing Service which, in association with the Pharmaceutical Health And Rational Use of Medicines committee, has the potential to overcome the above problems. In addition, general practice accreditation requirements and practice incentive payments could provide the necessary impetus for general practice groups and individual practitioners to engage in this area. In summary, the time is ripe for Australia to build upon the solid foundations that have been laid, to join with other countries to commit to grassroots based national campaigns aimed at further reducing and optimising antibiotic use. In short, to think globally and act locally.

Perhaps a lesson can be learnt from a recent example of international cooperation that has resulted in the Australian Antibiotic Guidelines being translated, adapted and published in Japan for Japanese practitioners. The selfless enthusiasm that made this collaboration possible is to be commended.

References for this article are available from the editors.

Mary Hemming is Chief Executive Officer for Therapeutic Guidelines Limited. Ken Harvey is Senior Lecturer with the School of Public Health, La Trobe University.

Africa

Our network partners in Africa have been working hard to initiate activities in the region. For the interest of all network partners, this issue of HAI News focuses on the activities in Africa.

The poor pay more

African consumers pay relatively high prices for their drugs, concludes new pricing data collected from more than 20 African countries. This finding supports the conclusion of a HAI Asia international pricing survey that consumers in developing countries are paying too much for drugs in the retail sector (see HAI News, April 1998).

Because the 1998 HAI Asia survey included pricing data from only South Africa, Tanzania and Zimbabwe, HAI Africa contacts agreed to use the same methodology and collect pricing data to complement existing data. Between May and September 1998, data were collected from 23 African countries, including data from nine Francophone countries - a first. The report concluded:

On average, African countries pay US$27 for their basket of commonly used drugs. This is less than what consumers in Asia-Pacific countries pay, but almost equivalent to the prices in OECD countries.

Today, South African consumers pay the highest prices for the basket of drugs (approximately US$55). Not surprisingly, neighbouring countries, Lesotho and Swaziland, which must purchase most of their drugs from South Africa also pay high prices.

The data indicate that Africans spend, on average, more than twice the amount for patented drugs than for competitors' products.

Capoten 25 mg, Tagamet 200 mg, and Zantac 150 mg remain the most expensive drugs sampled in the survey.

In light of the results, the report recommends that countries introduce policies on generic prescribing, substitution and parallel importing. This would help make low-cost drugs available to consumers. Governments should extend their national essential drug lists to cover both the public and private sectors to contain costs. For example, Eritrea's government only allows the importation, distribution and sales of drugs found on its national list of drugs. Eritrea, on average, pays the least for its drugs.

Compiling these data was a useful and important network-building exercise. Not only did these efforts help fill a major gap in global pricing data, it helped raise awareness locally in many African countries about the prices of medicines. Sharing and comparing these data has opened the way for awareness-raising discussions on drug supply and competition, trade and patents, which are also key aspects in examinations about access to medicines. Participants in the HAI workshops in Africa also have seen how pricing data can be used in local media campaigns on the affordability and availability of medicines. And, the addition of Francophone data raises the possibility of a beginning of subregional comparative analyses.

Copies of the pricing data from 23 African countries can be obtained by contacting the HAI Europe office.

Burkina Faso

Independent drug information

From 22-27 November, twenty-seven participants from nine countries in Francophone Africa attended a workshop on Independent Drug Information, in Ouagadougou, Burkina Faso. This workshop was organised by the HAI-Europe Africa Programme in collaboration with the Documentation and Information Center (CEDIM) and the League of Consumers of Burkina. Participants came from consumer organisations, medicine supply and development NGOs, independent drug information providers and the health ministry.

Presenters from Cameroon, Burkina Faso, Benin and Guinea outlined the need for greater public access to independent drug information, which also includes traditional medicine. Regulators too, need to have access to more independent drug information. Discussions and recommendations centred on ways consumers, government officials, and regulators could increase access to independent drug information.

Participants also discussed drug donations and procurement. They called for greater attention and implementation of the WHO-issued Guidelines on Drug Donations. The region's current dependence on medicines produced in France reduces its ability to get the most competitive pricing for imported drugs.

Problems with drug promotion are related to lack of access to independent drug information. There were calls for greater adherence to the WHO Ethical Criteria for Medicinal Drug Promotion.

A topic of special significance in the Francophone region is the elimination of the black market in medicines.

Participants recognised that networking is required to tackle this cross-border problem. The development of the HAI Africa network is a way to facilitate communications and coordination on this issue. Participants worked in country groups to develop action plans of proposed activities to follow up on the workshop. Action plans for Benin, Burkina Faso, Cameroon, Chad, Cote d'Ivoire, Guinea, Mali, Niger and Senegal were presented.

Progress made at the HAI Southern Africa regional workshop (Johannesburg, June 1998) in organising the HAI Africa network was discussed. Participants enthusiastically organised themselves into two subregions and chose subregional coordinators and advisors.

Francophone West Africa (Benin, Burkina Faso, Cote d'Ivoire, Guinea, Mali, Niger and Senegal) Coordinator: Jacques Arbi Akerekoro Address: ARAMBE, 03 BP 259, Cotonou, Benin; Tel: 229-321.264 Fax: 229 306.316 Email: arambekafu_ata@yahoo.com Advisor: Jonas Kintega, Pharmacie Mamsi, Tenkadogo, Burkina Faso. Francophone Central Africa (Cameroon and Chad) Coordinator: Thierry Dzukou Address: Network for Rational Use of Drugs, Hospital de Lagdo, BP 1531, Garoua, Cameroon Tel: 237 273.391 Fax: 237 271.978 Email: dzukou@camnet.com Advisor: Odjimbeye Ngarmbatina Karmel, Conseil de l'ordre des pharmaciens du Tchad.

A workshop report will be available in French and an executive summary of it in English. Publication is expected in the first part of 1999. Those wishing to receive a copy should contact the HAI-Europe office.

Angola

Public comment invited

During the HAI Southern Africa workshop on consumer involvement in NDPs held in Johannesburg in June, Dr. Adelino J. Manacas, from the Ministry of Health, WHO Representative Office, Essential Drugs Programme, and Dr. Alexandre Saul (Church Action Angola) discussed ways to increase public participation in discussions about the Angolan national policy on essential drugs. They continued these discussions upon return home. In September, Dr. Manacas began a series of open meetings with NGOs, academics and others to discuss the draft national drug policy and update information on the essential drugs programme and policy. Nine meetings, culminating into a national workshop were planned between September and December. While it is too early to summarise all of these meetings and their impacts, the very fact that they were organised must be applauded. The effort stemmed from participating and networking in a HAI workshop helps underscore the importance of these HAI Africa activities.

Nigeria

Follow-up activities

A one-day symposium on the rational use of medicines was organised at the Adventist Seminary of West Africa in Nigeria in November. This was a follow-up to the HAI Southern Africa regional workshop held in Johannesburg, South Africa in June 1998. The objective was to create public awareness on the following issues:

· Fake/adulterated drugs in Nigerian markets

· Self medication

· Traditional herbal preparations

· Patient compliance to treatment regimen

· Patient rights

· Healthy living

Participants included students, health professionals, administrators and religious leaders. Students from the public health department at the Adventist Seminary of West Africa entertained the audience with a drama presentation on the rational use of medicine. The interest generated by this symposium is a building block for future HAI Africa programmes in Nigeria.

WHO roll back malaria initiative

In October, HAI Africa accepted an invitation from WHO Action Programme on Essential Drugs to send a representative to participate in a preliminary and exploratory meeting of experts to propose a structure for a technical support network that could give guidance to countries seeking antimalarials of acceptable quality. This effort is part of the WHO Roll Back Malaria campaign, which is in the process of being organised. The meeting was held over three days at WHO headquarters in Geneva. Dr.Jessica Ocholla, who works at the Kenya Medical Research Institute in Nairobi, agreed to participate on behalf of HAI Africa. She has experience and expertise in antimalarial drugs supply and prevention.

Two AIDS vaccine projects launched

Two new research partnerships to develop HIV vaccines have been launched. The first of these collaborations is between scientists at the University of Oxford and the University of Nairobi in Kenya. The second is between scientists at the University of Capetown in South Africa and the US biotechnology company, AlphaVax.

Both products will target strains of the HIV virus which are common in Africa. So far, most AIDS vaccines have targeted HIV strains prevalent in North America and Europe. However, more than 90% of new HIV infections occur in developing countries where patients have little access to antiretroviral therapy, and many scientists believe that developing a vaccine is the only long-term solution to the AIDS pandemic.

First clinical trials for the Oxford-Nairobi vaccine are due to begin in less than a year and will target the A strain of HIV which is common in sub-Saharan Africa.

Recruitment will begin in Oxford next summer of volunteers who are at very low or no risk from contracting HIV. The trial will take about six months, and will be followed by similar Phase I trials in Nairobi in late 2000. (SCRIP No. 2392, UK, Dec 2, 98)

Pharmac blamed for heart attacks

A cardiac patient group in New Zealand is calling for an immediate independent public inquiry into the drug subsidy agency, Pharmac, following publication of a study that showed an increase in hospital admissions for heart attacks, strokes and other serious conditions in patients who had changed their cholesterol-lowering medicines.

In 1997, Pharmac set the subsidy level on statin hypolipaemics at that of the lowest-priced product, Novartis's Lescol (fluvastatin). As a result, many patients previously taking pravastatin changed to fluvastin to avoid the patient part-payment. Pharmac claimed that all three statins had the same or similar effects in lowering cholesterol levels, but the subsidy cuts were attacked by cardiologists, who argued that fluvastatin was less effective than the other two in preventing heart attack, stroke and death.

The study, carried out by Drs Merlin Thomas and Jim Mann of Otago University Department of Medicine, compared a six-month period after patients changed to fluvastatin with the previous six months when they were taking simvastatin. It found that 27 patients required hospital treatment during the fluvastatin period, a three-fold increase over the simvastatin treatment period.

Of the 27 patients, six had heart attacks, four had strokes, 15 had unstable angina, and two had acute limb ischaemia. One patient died. Cholesterol levels increased in 94% of the patients. The average time after the medication switch before hospital admission was 17 weeks, with some patients requiring hospital treatment after eight weeks. (SCRIP No. 2396, UK, Dec 16, 98)

Improving access to essential drugs

In the new spirit of co-operation between the WHO and the pharmaceutical industry, representatives of both are to set up a joint working group to improve access to essential drugs and vaccines worldwide.

The WHO says that one third of the world population is deprived of easy access to the most essential medicines and vaccines, and that 100 million people could benefit from the initiative. The joint working group will analyse the situation and make recommendations to 'overcome existing bottlenecks'. It is to be set up to start work.

As part of moves to open up co-operation with NGOs and the private sector, the WHO Director-General launched the round table initiative at the World Health Assembly in May. The first meeting took place at the beginning of October with representatives of non-governmental organisations. An informal seminar was also held at the end of September at WHO headquarters with 25 business leaders. WHO representatives proposed areas of co-operation and discussed matters of possible contention in its relation with the private sector, such as the public health approach versus profit-making, tobacco promotion, breast milk substitutes, health technology and health insurance. (SCRIP No. 2383, UK, Oct 30, 98)

Indian market: US$10 billion by 2010

The pharmaceutical market in India is expected to grow to around US$10 billion by 2010, maintaining a compound annual growth rate of 15%.

With the increasing buying power of the Indian consumer, and more than 200 million people in the middle and upper middle class, with these segments growing by 5-10% per annum, the market potential for pharmaceuticals is enormous; Indian companies are likely to enter into a number of agreements and alliances with multinational companies. Contract research organisations will look to the country to conduct product development work and clinical trials.

The report predicts that there will be consolidation and mergers among Indian pharmaceutical companies, and at least a dozen such companies will soon be active in innovative R & D. There is a large pool of highly skilled scientific and technical researchers in India, for whom the cost of employment is likely to be lower than in other countries, it notes.

India is also expected to take more of a role as a manufacturing centre for multinational companies, as well as exploiting its expertise in the manufacture of generics. (SCRIP No. 2392, UK, Dec 2, 98)

Antipsychotic drug suspended

Lundbeck Ltd., the manufacturers of Serdolect (sertindole), are voluntarily suspending its availability from the 2nd of December 1998. This suspension is due to concerns about reports of cardiac arrhythmias and sudden cardiac death associated with its use. In light of this information, the availability of Serdolect will be suspended in the best interests of patient safety pending a full evaluation of its risks and benefits in collaboration with the UK Medicines Control Agency (MCA) and other European regulatory authorities.

Prescribers are advised as follows:

· No further patients should be initiated on Serdolect.

· Existing patients should be recalled for review by their psychiatrist.

· No patient should have Serdolect stopped until a suitable alternative treatment has been prescribed.

· Serdolect should be withdrawn and replaced with an alternative treatment.

· Serdolect may be stopped immediately and the patient transferred straight away to an alternative treatment, such as another atypical antipsychotic.

· Alternatively, if the psychiatrist judges it appropriate for a particular patient, Serdolect may be tapered off by a stepwise reduction over a period of up to two weeks whilst the replacement antipsychotic therapy is initiated.

(Message from Prof. M Rawlins, Chairman, Committee on Safety of Medicines, received through the E-drug bulletin)

The World Development Report 1998/99: Knowledge for Development, Oxford University Press, Inc, New York, 1999, 251 pp.

Knowledge on how to treat diarrhoea has existed for centuries yet millions of children continue to die because their parents do not know how to save them. The annual income of the world's 2.5 billion poorest people is equal to the assets of the world's 225 richest people. Such disparities exist due to the lack of knowledge.

This 21^st annual report of the World Bank examines the role of knowledge in furthering economic and social well-being.

The unequal distribution of knowledge know-how, classified as knowledge gaps, is addressed in part one. The first four chapters discuss the power of knowledge, and acquiring, absorbing and communicating knowledge.

Part two centres on addressing information problems, with emphasis placed on the poor. Policy issues are taken on in the final section.

This report will be particularly useful to those working in the field of social development.

Available from: The World Bank, 1818 H Street, N.W., Washington DC, 20433, USA.

WHO Global Database on Child Growth and Malnutrition, compiled by Mercedes de Onis and Monika Blossner, published by WHO, Geneva, 1997, 710 pp.

The WHO Global Database on Child Growth and Malnutrition is a standardised compilation of anthropometric data from nutritional surveys conducted around the world since 1960. The purpose of the Global Database is to provide an accurate picture of child growth as a basis for making intercountry and interregional comparisons, and to facilitate monitoring of national, regional and global trends.

The book is divided into two parts. Part one provides the scientific and technical basis for the Global Database. It describes data interpretation, and presents global and regional estimates of levels and trends. Part two gives the full data and references currently available in the database. The Global database will be of interest to national and international health authorities, particularly when they are planning and evaluating nutrition-related public health interventions.

Available from: WHO, 1211 Geneva 27, Switzerland.

Olle Hansson Award To recognise the work of an individual from a developing country who best demonstrates the qualities of Olle Hansson in promoting the rational use of drugs. 'It is time to act! It is time to act for all of us who believe in human dignity and justice'. - Olle Hansson The Award is named in honour of Olle Hansson, a Swedish paediatric neurologist internationally known for his advocacy of SMON victims who were paralysed or blinded after using clioquinol, an antidiarrhoeal drug. Olle Hansson was a powerful campaigner against unethical promotion and marketing of drugs. In many ways, he represented the conscience of the medical profession. His influence was felt not only in Sweden and Japan, which have thousands of SMON victims, but also in Europe and developing countries. Olle Hansson will be remembered by all who campaign for the rational use of drugs. Although he died of cancer on May 23, 1985, at the age of 49, he remains a continuing source of inspiration for public interest workers every-where. May 23 is commemorated each year as 'Olle Hansson Day'. The Award was first given in 1987. The recipients included Dr Mira Shiva of India and Dr Alfredo Bengzon of the Philippines. Nominations Nominations are invited for the Olle Hansson Award. This Award recognises the work of an individual from a developing country who has contributed the most to: · Promoting the concepts of essential drugs and their rational use, and · Increasing the awareness among consumers of the dangers of irrational and hazardous drugs. Nominations for the award, which can come from any individual or organisation, should contain: A one-page biodata of the candidate (including educational background, positions held, affiliations, honours and awards) A 500-word statement of the nominee's qualities and achievements in the field of rational drug use. Please provide documentation of work done. A recent photograph of the nominee. The nominator's name, affiliation and address. Closing Date Nominations will close on April 30, 1999. The recipient will be chosen by an international panel of judges, and named on Olle Hansson Day, May 23. The Prize The award, which is given annually, carries a prize of US$2,000 and a commemorative certificate. Management The Olle Hansson Award Fund is managed by Consumers International Regional Office for Asia

Production: Lin Min Min

HAI News is produced six times a year by the Regional Office for Asia and the Pacific of Consumers International (CI). For more information about the publication or to subscribe, contact HAI-Asia.

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