| PURPOSE AND CONTENT Experience has shown that even when drug supply is based on an essential drug list, ample opportunity exists for ineffective, unsafe, or wasteful prescribing. Standard treatments list the preferred drug and non-drug treatments for common health problems experienced by people in a specific health system. As such, they represent one approach to promoting therapeutic effective and economically efficient prescribing. Standard treatments are currently used in the U.S., Europe, Latin America, Asia, Africa, and the Western Pacific. When implemented effectively, standard treatments offer advantages to patients (more consistency, treatment efficacy), providers (gives an expert consensus, quality of care standard, basis for monitoring), supply managers (makes demand more predictable, allows prepacks), and health policy makers (provides focus for therapeutic integration of special programs, promotes efficient use of funds). But effective implementation is perhaps the greatest challenge in introducing standard treatments. To develop your ability to:
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INTRODUCTION Local manuals are needed in every health system because of differing decisions about drug choices and the patterns of illness within a country. Disease oriented manuals are called treatment guidelines (STGs), treatment protocols, or prescribing policies. Drug Oriented manuals are called Therapeutic Formularies. The selection of drugs to be included on the essential drug list is based on the prevalent pattern of illness and the standard treatments decided upon to treat these conditions. Training, drug supply, assessment and quality evaluation are based on these standard treatments. Thus developing and updating standard treatments are a very important part of any essential drugs program and a basic component of any effort to improve rational use of drugs. This session will review the dangers of therapeutic anarchy, discuss the advantages of standard treatments, and assess the impacts of standard treatments. The final part of the session will review the development and implementation of standard treatments. A. THE NEED: A SOLUTION TO THERAPEUTIC ANARCHY Standard treatments have existed for as long as the art of healing has existed. Traditional healers developed their standard set of cures and now pass them from generation to generation. The history of early scientific medicine was one of identifying patterns of signs and symptoms which revealed an underlying disease, assigning a name to that disease, and searching for the effective remedy for it. In this century, however, modern medicine has gone far beyond the stage where each disease has but one treatment. Instead, each disease may have many acceptable treatments. And if individual symptoms are treated without at least a working diagnosis, the number of possible treatments can be endless. Doctors, nurses, pharmacists, community health workers, and other health care providers learn about all of the treatments which could be used, instead of focusing on the best treatment that should be used. Casual observation as well as more systematic study of prescribing practices frequently reveals a pattern of tremendous diversity among prescribers in the treatment of even the most common conditions. Polypharmacy is one problem; for example, three, four, five, six, and sometimes more drugs for acute viral gastroenteritis, for which only oral rehydration therapy is effective in reducing morbidity and mortality. Other common problems considered in greater detail elsewhere are incorrect drug choices, overdosing, underdosing, and choice of more expensive drugs when less expensive drugs would be equally or more effective.
Standard treatments -- also known as standard treatment schedules (STS); standard treatment protocols; therapeutic guidelines; and so forth -- list the preferred drug and non-drug treatments for common health problems experienced by people in a specific health system. Each drug treatment should include for each health problem the name, dosage form, strength, average dose (pediatric and adult), number of doses per day, and number of days of treatment. Other information on diagnosis and advice to the patient may also be included. Standard treatments should consider both drug and non-drug treatments. "Reassurance," for example, might be the proper standard treatment for a child who is shorter than other children of his or her age, but who shows a normal growth curve, no signs of malnutrition or chronic disease, and has shorter than average parents.
Health problems including specific diagnoses ("malaria"), symptoms ("headache"), and preventive health services (EPI immunizations, antenatal vitamin and mineral supplements) may also be included in such a manual. Standard treatments are currently in use in parts of the U.S., Europe, Latin America, Asia, Africa, and the Western Pacific. Experience shows that even the shortest essential drug list offers ample opportunity to misuse drugs by improper treatment of common problems. Thus, essential drug programs are finding that the development of standard treatments is necessary for therapeutically effective and economically efficient use of drugs. Standard treatments are used at different points of the therapeutic process. They may be used for diagnosis, to decide on treatment and drug supply and to assist with adherence to the prescribed treatment. This will hopefully lead to the desired clinical outcome.
Figure 1 STANDARD TREATMENTS IN THE THERAPEUTIC PROCESS
B. ADVANTAGES OF STANDARD TREATMENTS Standard treatments offer a number of potential advantages for patients, health providers, supply managers, and health policy makers. Figure 1 illustrates the points in the therapeutic process at which standard treatments can act. Potential benefits of introducing standard treatments include the following:
For Patients
For Providers
For Supply Management Staff
For Health Policy Makers
Standard treatments do not take the thinking out of health care. Instead, they focus the thinking on other critical aspects of the therapeutic process: careful identification of signs and symptoms; correct diagnosis; and effective patient counseling on proper use of those few drugs or non-drug treatments that will truly benefit the patient. Sometimes medical school faculty, consultant physicians, and other health care providers oppose standard treatments, fearing they will lead to "cook book" medicine and loss of the "right to prescribe." This fear has proven largely unfounded; doctors in the most prestigious medical institutions in developed and developing countries are writing and promoting such handbooks.
C. KEY FEATURES OF STANDARD TREATMENTS Standard treatments have been used for many years in some countries. Standard treatments now exist for common illnesses of children, common adult illnesses, and obstetrics and gynecology. The existence of these treatments has reportedly had a major impact on the consistency, effectiveness, and economy of prescribing. Key features of standard treatments, as they have been implemented for instance in Papua New Guinea, include:
D. DEVELOPMENT OF STANDARD TREATMENTS Experience from several countries suggests the following important considerations in the development of standard treatments:
In the interest of therapeutic and economic efficiency, standard treatments should target those conditions which contribute the most to rates of morbidity and mortality. Note that some conditions which contribute substantially to the number of patients treated, and therefore to the total cost of drugs provided, contribute little to mortality. Skin conditions are a common example of this. Such problems may nevertheless be priorities for the development of standard treatments precisely because they do absorb a large percent of the drug budget. In terms of selection of health problems, standard treatments fall into one of three categories:
Information on local disease patterns should also be considered. Seldom do PHC workers have access to clinical laboratories. But results from surveys using available district, regional or national laboratory facilities can be used to make scientifically-based selections of preferred drugs for certain types of diarrhea, ARI, malaria, tuberculosis and other infectious diseases. Dynamic standard treatments are periodically updated to reflect changes in treatment patterns. Development of standard treatments should aim at therapeutic integration through coordination with special programs such as diarrhea disease control, ARI, malaria, and so forth. PHC standard treatments should reinforce recommendations of special programs and, at the same time, PHC experience should be used by special programs in developing their treatment recommendations. [Link to CDR site ] Individual drug selections should, of course, be based on the principles of choosing the fewest drugs necessary to effectively treat an individual condition, on choice of the most cost-effective treatment, and on the essential drug list (if one exists). If an essential drug list does not exist for the level of health care at which the treatments will be used, then the process of producing standard treatments should also produce an essential drug list. Development of standard treatments must involve respected clinicians from all levels. This might include leading professors from local medical schools as well as experienced district medical officers and outstanding community health staff. In Zimbabwe the "best and the brightest" field staff were invited to participate in the revision. Finally, the patient perspective must be considered. Issues of patient adherence to treatment (compliance) and prevailing patient preferences must be weighed against considerations of efficacy, safety, and cost. There are many examples of standard treatments available, some of which are listed in Annex One. The Australian guidelines are particularly useful in that they are revised regularly, and the text is available on computer diskette so that it can be easily adapted to other settings, which is what Botswana did.
The address of the Australian group is: http://www.tg.com.au The World Health Organization's Drug Action Programme in Geneva can also assist with resource materials. [DAPmail@who.ch]
E. IMPLEMENTATION OF STANDARD TREATMENTS In terms of impact on prescribing and drug use patterns, the greatest weakness in past efforts to introduce standard treatments has probably not been in the development of reasonable standards, but in the effective implementation of the standards once they have been developed. Prescribing patterns change slowly. The following are important elements for a plan to implement standard treatments:
Printed reference materials can include manuals, posters, and training materials. Depending on the number of treatments involved, printed references may be in the form of wall charts, pocket handbooks, or larger "shelf-size" reference books. Some people feel that wall charts provide a better reminder to health workers, are more permanent, and help the patient better understand the treatment process. Others feel that a handbook is more effective, provided it fits into the pocket, is durable, and is well-organized. Pocketbooks can also include information about individual drugs or other reference data. The contents of pocket manuals can be organized in summary tables, in diagnostic and treatment decision trees or flow charts, or simply in written text. An official launch is very important. The Minister of Health, the Chairmen of professional bodies, leading clinicians should present the new guidelines at a public forum. Ideally, the presentation should be covered by the press and broadcast media and attended by representatives of health worker associations. Initial training is also important. Ideally, standard treatments should be introduced during formal pre-service training for doctors as well as other health care providers. Use of the standard treatments and the reference manual or wall chart from early in training develops good habits for later clinical practice. This implies that examinations should include questions on standard treatments. The length of initial in-service training will depend on the number and complexity of standard treatments. Training should specifically consider prescribers' inhibitions about using standard treatments. Some may be afraid that "looking things up in front of the patient" will detract from their credibility. Participants should therefore practice the use of reference materials in actual patient care situations or in role plays. Other prescribers may not appreciate how the treatments were prepared and at first may not trust the treatments. Most importantly, if the standard treatments differ substantially from current practice (for example, fewer injections or fewer antibiotics than currently prescribed), these differences should be identified and discussed. Participants should be strongly encouraged to accept the standard treatments -- perhaps even by signing a written agreement. Especially for health care providers already in practice, reinforcement training during the first six to twelve months after the initial training can play an important role in re-emphasizing the importance of following standard treatments and allow an opportunity to respond to questions which have arisen from attempts to apply the treatments. Finally, the monitoring system and supervisory efforts should focus on the priority health problems and standard treatments for these problems. Routine reports which focus on high priority problems such as diarrhea disease and ARI can also include information on treatment of these problems and, of great importance, on adequacy of supply for the few drugs needed for these conditions. The development of standard treatment guidelines can be a very useful early phase of an essential drugs program. By involving prescribers in the production, review, and revision of the materials, they can be co-opted into the guidelines. Once the guidelines are produced, it is critical that they are implemented consistently by role-model prescribers. Monitoring and supervision of the use of the guidelines are also important. Standard treatment guidelines can have considerable impact if they are developed, promoted, and used in a sensible fashion. They can also be an expensive waste of effort! With standard treatment guidelines, the process of production and implementation and use is more important than the product.
PUBLICATIONS RELEVANT TO DEVELOPMENT OF STANDARD TREATMENTS
WORLD HEALTH ORGANIZATION Manual for Rural Health Workers: Diagnosis and Treatment with Essential Drugs Action Program on Essential Drugs, 1991 Respiratory Infections in Children: Management in Small Hospitals, 1988 The Rational Use of Drugs in the Management of Acute Diarrhea in Children, 1990 Control of Sexually Transmitted Diseases, 1985 Drugs used in anesthesia, 1989 Drugs used in parasitic diseases, 1990 Drugs used in mycobacterial diseases, 1991 The treatment and prevention of acute diarrhea, 1989 The management of diarrhea and use of oral rehydration therapy, 1985 Management of severe and complicated malaria: a practical handbook, 1991 The New Emergency Health Kit, 1990 Available from: World Health Organization Publications Department 1211 Geneva 27 Switzerland [www-pll.who.ch/programmes/pll/pll_index_frames.html] MÉDICINS SANS FRONTIERES Clinical Guidelines: Diagnostic and Treatment Manual, 1990 Essential Drugs - drug information sheets, 1990 Gestes medico-chirurgicaux en situation d'isolement (guidelines for surgical treatment, in French), 1989 Available from: Médicins sans Frontières Medical Dept. 8 rue Saint-Sabin 7554 Paris Cédex 11 France
Therapeutic Guidelines: Analgesic, 3rd ed, 1997 Therapeutic Guidelines: Cardiovascular, 3rd ed, 1999 Therapeutic Guidelines: Dermatology, 1st ed, 1999 Therapeutic Guidelines: Endocrinology, 1st ed, 1998 Therapeutic Guidelines: Gastrointestinal, 2nd ed, 1998 Therapeutic Guidelines: Neurology, 1st ed, 1997 Therapeutic Guidelines: Psychotropic, 3rd ed, 1996 Therapeutic Guidelines: Respiratory, 2nd ed, 2000 Management Guidelines: People with Developmental and Intellectual Disabilities, 1st ed, 1999 The guidelines are available in an HTML-based format and samples are available on our website. The Guidelines are available from: Therapeutic Guidelines Limited Level 2, 55 Flemington Road, North Melbourne Victoria 3051, Australia Telephone: (+61 3) 9329 1566 Facsimile: (+61 3) 9326 5632 Freecall (Australia only): 1 800 061 260 E-mail: sales@tg.com.au Website: http://www.tg.com.au Past editions of these guidelines may be available for the cost of postage.
BRITAIN British National Formulary, Available from: British Medical Association/Royal Pharmaceutical Society of Great Britain Tavistock Square London WC1H 9JP England
EASTERN CARIBBEAN Eastern Caribbean Regional Formulary and Therapeutics Manual, 1991 Available from: Eastern Caribbean Drug Service PO Box 179, The Morne Castries, Saint Lucia West Indies
KENYA
Kenya Manual for rural health workers, 1986 Available from: Ministry of Health Nairobi, Kenya Management Schedules for Dispensaries: A Manual for Rural Health Workers, 1979 Therapeutic Guidelines: A Manual to Assist in the Rational Purchase and Prescription of Drugs, 1980
Available from: African Medical and Research Foundation PO Box 30125 Nairobi, Kenya BHUTAN Bhutan Standard Treatment Guide, 1989 Available from: Bhutan Essential Drugs Programme Ministry of Social Services, Thimpu, Bhutan UGANDA
Uganda Essential Drugs Manual, 1991 Available from: Ministry of Health Uganda Essential Drugs Management Programme Central Medical Stores PO Box 16 Entebbe, Uganda
ZIMBABWE EDLIZ (Essential Drugs List for Zimbabwe), 1994 [zimbcomp] A series of 15 modules on clinical and management topics are also available Available from: Zimbabwe Essential Drugs Action Programme Ministry of Health Box 8168 Causeway, Harare Zimbabwe
BOTSWANA Botswana Antibiotic Guidelines, 1989 Available from: National Standing Committee on Drugs Ministry of Health Gaborone, Botswana MALAWI
Standard Treatment Guidelines/ Available in both pocket and desktop versions Malawi National Formulary, 1990 Available from: Ministry of Health PO Box 30377 Lilongwe 3, Malawi
TANZANIA Standard Treatment Guidelines and The National Essential Drug List for Tanzania, 1991 Available from: Ministry of Health Dar es Salaam United Republic of Tanzania
PAHO
Development and Implementation of Drug Formularies, 1984. Scientific Publication 474.
525 Twenty-Third Street, N.W. Washington, DC 20037 NEPAL
Nepalese National Formulary 1997 Available from: Department of Drug Administration Bijulbizar, Naya Baneshwor Katmandu Nepal Fax (977-1) 244927 e-mail dda@npl.healthnet.org
JAMAICA Jamaican National Formulary 1997 Available from: Pharmaceutical Services Division Ministry of Health, Kingston 5, Jamaica.
CASE STUDY: A SECOND EDITION? STANDARD TREATMENTS IN PAGALIA
Rationale Designing and implementing standard treatments which truly improve prescribing practices is challenging. It requires an understanding of the issues involved in each step of the process. It also requires sufficient commitment, cooperation, financial resources, and effort. This case study is intended to stimulate thinking and discussion about some of the critical issues in the effective introduction of standard treatments in a health care system.
Questions to Consider
A SECOND EDITION? STANDARD TREATMENTS IN PAGALIA
ONE MORNING, MID-1998 Dr. Pedro, the Director of Health Services, sat patiently, only half listening to Dr. Karma's animated review of the new Essential Drug component of the Health Financing Project. The characteristic twinkle in Dr. Pedro's eye remained, despite the fact that he had heard this same introduction at least twice before this month. The essential drug component of the project was to achieve "therapeutic and economic efficiencies" which would help the Ministry make maternal and child health services more widely available and more effective. Mr. Joko from Planning and Mrs. Soma from the Pharmaceuticals Directorate were also at the meeting along with several of their assistants. Dr. Pedro thought the assistants seemed particularly taken with Dr. Karma's energetic presentation. "So, my friends," Dr. Karma announced, "by next Monday we must present Mr. Domingo [the project officer for the major sponsoring donor], with a first year workplan for improving drug use. Your thoughts, please."
HEALTH STATUS AND HEALTH CARE IN PAGALIA While Mr. Joko raised a few points regarding recent negotiations with the donor, Dr. Pedro reflected on the current health situation in the country. From his position in the Ministry, Dr. Pedro felt he had a good grasp of needs at the health center level. Pagalia is divided into 10 provinces and 80 districts. Health care is considered a central responsibility, so national authorities play a major role in health care policy. Pagalia's population of over 20 million receives primary health care services from a network of nearly 300 health centers and 2,300 sub-centers. In addition, there is a small hospital in nearly every district and over 15 provincial general and specialty hospitals. UNICEF estimated that last year almost 120,000 Pagalians died -- one-half of whom were under age 5. The infant mortality rate is believed to have dropped below 85 deaths per 1000 live births. As expected, the leading causes of death among the under-five age group were diarrhea disease, ARI, neonatal tetanus, measles, and other immunizable diseases. In terms of health center attendances, Mr. Joko's staff in Planning had recently completed a study that showed ARI accounted for 36 % of under-5 illness visits; skin disease 17 %; and diarrhea disease 15 %. For adults, ARI accounted for 18 % of attendances, skin diseases 18 %, anemia and nutritional deficiencies 10 %, and diarrhea disease 6 %. Although many health centers have doctors assigned to them, a recent study from one province indicated that only about one in 4 patients sees a doctor. The rest are diagnosed and treated by nurses and paramedics.
PUBLICATION OF THE STANDARD TREATMENT After Mr. Joko finished his questioning, Dr. Pedro began the discussion of methods to improve drug use patterns. "The only solution is the dissemination of standard treatments. Standard treatments will straighten everything out." He went on to describe the process which led two years ago to the publication of Standard Treatments for Health Centers. The essential drug list had been developed in 1991, and in 1993 concern about drug use led to the beginning of work on standard treatments. A committee consisting of four doctors from Preventive Health Services, another person from the Ministry, three people from the Faculty of Medicine, and one outside member began work in earnest on the project. In early 1996 the Standard Treatments for Health Centers were published. The Standard Treatments for 100 conditions were included in the manual along with information on drug interactions, growth curves, and other reference information. The manual included, for each health problem, key diagnostic features and recommended treatments. The Treatments were published in a compact, but not quite pocket-sized manual with a glossy green cover which bore the Ministry logo. The manuals eventually were sent to all health centers. Since schools of medicine and other health education institutions fall generally outside the control of the Ministry of Health, little effort was made to have direct contact with these educational programs. "However," concluded Dr. Pedro, "since publishing the Standard Treatments for Health Centers, the CDD Program (Control of Diarrhea Disease), the ARI Program, and the TB (tuberculosis) program have all changed their treatment recommendations. Clearly what is needed to promote proper drug use is to revise, reprint, and redistribute the Standard Treatments."
HEALTH CENTER TREATMENT PATTERNS --1997. Mrs. Soma, from Pharmaceuticals, had been quiet up to this point, but Dr. Pedro's last comment troubled her. Politely, but firmly she began: "I'm not quite so sure that revising and redistributing the Standard Treatments is the answer." She then went on to briefly review two surveys which she and her colleagues at Pharmaceuticals had recently carried out. The first study, in which Mr. Joko's staff had also been quite active, took last year's drug order and compared it to a rough estimate of what would have been needed if the disease pattern reported by the monitoring group at Preventive Health Services had been treated according to Dr. Pedro's standards. "Look here," said Mrs. Soma, "your standard treatments would have the health center staff using large amounts of procaine penicillin, oral penicillin, and co-trimoxazole, while last year they ordered almost none of those antibiotics. Your treatments would have cut back on tetracycline, ampicillin, chloramphenicol, some of the injectibles, and other popular drugs." The drug names meant nothing to Mr. Joko, but he understood that the standard treatments implied quite different consumption patterns than current practice. Now in full stride, Mrs. Soma moved on to the second study, which her group had completed only last week. "The Standard Treatments were sent out in 1996. We have just completed a survey of 2500 patient cards from six randomly selected districts in East Kalija province." In the treatment of common gastroenteritis (omitting cases of dysentery or suspected cholera), for which Dr. Pedro's group recommended only rehydration, the average patient was getting over three drugs. Virtually every patient was getting an antibiotic. More vitamins and minerals were being prescribed that oral rehydration salts. Antibiotics used for the under-fives alone included oxytetracycline injection, tetracycline capsules, metronidazole, trisulfa, tetracycline syrup, ampicillin syrup, chloramphenicol suspension, and procaine penicillin injection. Some of the drugs recommended in the standard treatments are not available. Similarly, for influenza and acute upper respiratory infections, Dr. Pedro's group had recommended paracetamol for fever and aches, antihistamines for congestion, and a cough medicine. Yet, nearly every patient got an antibiotic. This was supplemented by an average of two other types of drugs. The range of different antibiotics prescribed was again quite impressive, at least a dozen by Mrs. Soma's tally. Mr. Joko was again mystified by most of Mrs. Soma's drug names, but he clearly sensed her feeling that bright green Standard Treatments for Health Centers had not achieved their purpose. The twinkle in Dr. Pedro's eye was beginning to fade.
A SECOND EDITION? Having shared the results of the directorate's studies, Mrs. Soma somehow felt less compelled to support Dr. Pedro's plan to simply revise, reprint, and redistribute the Standard Treatments. The meeting continued another 15 minutes. Mr. Joko raised some procedural questions, and Dr. Pedro asked the group's opinion about the design and color of the cover. Dr. Karma, always the diplomat, suggested that the project perhaps could support both Dr. Pedro's revision of the Standard Treatments and another series of studies by Soma's group. He asked the group members to accompany him to the meeting with Mr. Domingo to propose how best the treatment guidelines could be revised and implemented. |
Therapeutic
Guidelines: Antibiotic, 10th ed, 1998
