10 PG Standard Treatment Guidelines Final 08
10 PG Standard Treatment Guidelines Final 08
Training Course
Session 10.
Standard Treatment
Guidelines
Participants Guide
This document was made possible through support provided by the U.S. Agency for
International Development, under the terms of cooperative agreement number HRN-A-00-0000016-00. The opinions expressed herein are those of the author(s) and do not necessarily reflect
the views of the U.S. Agency for International Development.
Recommended Citation
The materials may be freely abstracted, quoted and translated in part or in whole by non-profit or
educational organizations (for reference or teaching only) provided the original source is
acknowledged. They should not be sold nor used for any other commercial purpose.
Management Sciences for Health and World Health Organization. 2007. Drug and Therapeutics
Committee Training Course. Submitted to the U.S. Agency for International Development by the
Rational Pharmaceutical Management Plus Program. Arlington, VA: Management Sciences for
Health.
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CONTENTS
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Acknowledgment
This session is based on the World Health Organization and the International Network for
Rational Use of Drugs. Promoting Rational Drug UseStandard Treatments (PowerPoint and
Study Guides). http://mednet3.who.int/prduc/rducd/TOC.htm
Participants Guide
Management Sciences for Health and World Health Organization. 1997. Managing Drug
Supply. 2nd ed. West Hartford, CT: Kumarian Press. (Chapter 11, Treatment Guidelines
and Formulary Manuals)
Key Definition
Standard treatment guidelineA systematically developed statement designed to assist
practitioners and patients in making decisions about appropriate health care for specific clinical
circumstances
Introduction
The Drug and Therapeutics Committee (DTC) is responsible for numerous important
pharmaceutical management functions. The committee is responsible for evaluating new
medicines for the formulary, identifying and correcting medicine use problems, assessing and
controlling adverse drug reactions among other functions. Session 10 concentrates on an
important strategy for improving medicine use in the health care systemSTGs. Guidelines are
a valuable resource in the management of pharmaceutical therapy because
Applying the most effective treatment benefits both the patient and the health care
system.
Formulary management will have only limited impact if medicines are used incorrectly.
The development and implementation of STGs is a necessary task in a health care system where
numerous treatments may be available. Physicians and nonphysician providers will use their own
knowledge base, training, and preconceived ideas on the treatment rationale for each patient.
Frequently, this approach is effective and reasonable and results in optimal care. Just as
frequently, however, it may result in less than optimal care and in fact may result in dangerous
medical care, leading to poor outcomes for the patient. The use of STGs is a time-honored
system that works well and improves patient outcomes.
oral rehydration therapy is effective in reducing morbidity and mortality. Other common
problems are making incorrect medicine choices, overdosing, underdosing, and choosing a more
expensive medicine when less expensive ones would be equally or more effective.
STGsalso known as standard treatment schedules, standard treatment protocols, therapeutic
guidelines, and so forthlist the preferred pharmaceutical and nonpharmaceutical treatments for
common health problems experienced by people in a specific health system. Each
pharmaceutical 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.
STGs should consider both pharmaceutical and nonpharmaceutical 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, shows no signs of malnutrition or chronic
disease, and has shorter than average parents.
Health problems, including specific diagnoses (e.g., malaria), symptoms (e.g., headache), and
preventive health services (e.g., immunizations or prenatal vitamin and mineral supplements)
may also be included in the guidelines.
STGs are currently in use in parts of the United States, Europe, Latin America, Asia, Africa, and
the Western Pacific. Experience shows that even the shortest essential medicine list or formulary
list offers ample opportunity to misuse medicines by improper treatment of common problems.
Thus, essential pharmaceutical programs are finding that the development of standard treatments
is necessary for therapeutically effective and economically efficient use of medicines.
Standard treatments are used at different points of the therapeutic process. They may be used to
diagnose, decide on treatment and pharmaceutical supply, and assist with adherence to the
prescribed treatment. This use will more likely lead to the desired clinical outcome.
Although the advantages to using STGs are many, some disadvantages have also been
encountered.
Advantages
The use of STGs can benefit health care providers, health care officials, supply management
personnel, and patients in the following ways.
Encourages the best quality of care since patients are receiving optimal therapy
Utilizes only formulary or essential medicines, so the health care system needs to
provide only the medicines in the STGs
Provides valuable assistance to all practitioners, especially to those with lower level
skills
Provides a basis for evaluating quality of care provided by the health care
professionals
Can be a vehicle for integrating special programs (e.g., diarrhea disease control, acute
respiratory infection (ARI), tuberculosis control, malaria) at the primary health care
facilities using a single set of guidelines
Supply management
{
Utilizes only formulary or essential medicines, therefore the health care system needs
to provide only medicines in the STGs
Provides information for forecasting and ordering (because medicines and quantities
for common diseases will be known)
Patients
{
Enables consistent and predictable treatment from all levels of providers and at all
locations within the health care system
Allows for improved availability of medicines because of more consistent use and
ordering
Helps provide improved outcomes because patients are receiving the best treatment
regimens available
Lowers cost
Disadvantages
STGs have drawbacks as well
Inaccurate or incomplete guidelines will provide the wrong information for providers and
therefore do more harm than good. Guidelines may not be based on the most reliable
information.
Developing and updating guidelines is difficult and time-consuming and must be done on
a regular schedule or they will become obsolete very quickly.
Guidelines provide a false sense of security; that is, many providers will limit their
evaluation of a particular patient as soon as it fits into a particular standard treatment.
Standard treatment guidelines are disease-oriented whereas formulary manuals are medicineoriented documents. These two documents provide the very essence of the DTCs efforts to
provide rational pharmaceutical therapy. Every effort should be made to publish both of these
manuals, have them readily available for all practitioners, and update them regularly to ensure
accuracy of the information provided.
Establishing STGs
Establishing STGs is a lengthy process, one that must be done methodically and completely to
have a product that all practitioners are willing to accept. The process can be described in eight
steps
1. Establish a committee to address the development of the guidelines. The DTC may take
responsibility for this task, or it may select individuals to form a new committee for the
purpose of establishing the guidelines.
2. Develop an overall plan for guidelines. A comprehensive plan with well-defined time
frames is necessary to ensure that the product is started and finished within a reasonable
period. Select a format. Recruit contributors, writers, and reviewers.
3. Identify the diseases that the STGs will cover. The most common and serious diseases
and medical conditions should be selected from available morbidity statistics. All of the
medical departments and specialty areas should be consulted to identify important
diseases to be addressed in the guidelines.
5. Determine what information should be included in the STG. Information provided in the
STG can vary widely. The following elements are suggestions for comprehensive STGs.
Clinical condition
Nonpharmaceutical treatment
Referral criteria
The amount of information to provide is a difficult decision. Ideally, the STG manual
should be concise and small enough to fit into a practitioners pocket, but also, the STGs
must be comprehensive enough to describe the medical condition and its appropriate
treatment.
6. Draft the STGs for comments and pilot testing. STGs are controversial documents and
may not be accepted by all practitioners in a hospital or clinic. The draft document must
be circulated to obtain comments on the content, ease of use, presentation, and overall
acceptability. This step is vital to determine future use of the guidelines and to garner
buy-in from practitioners in the hospital.
7. Publish and disseminate. After completion and approval of the final draft, the document
must be published and distributed widely to the professional staff. An official launch,
training of users, and monitoring and evaluation are all necessary components to the
distribution of the guidelines. This important activity is described in greater detail later in
this session (see Implementing the Guideline).
8. Revise and update. Treatment recommendations change rapidly and, consequently, so
must the STGs. STGs should be updated regularly to reflect changes in accepted
treatment strategies. If a regular schedule for updating the STGs is not used, they will
quickly lose their credibility.
Treatment guidelines must have the most up-to-date and accurate information available. Any
attempt at providing a guideline without this accurate information will lead to failure of the
guideline. Therefore, the use of evidence-based medicine in preparing the guideline and the use
of expert authors and reviewers cannot be overemphasized.
SimplicityThe number of health problems is limited. For each health problem, a few
key clinical diagnostic criteria are listed. Medicine and dosage information is clear and
concise.
CredibilityThe treatments are initially developed for patients by the most respected
clinicians in the country using evidence-based information. Revisions based on actual
experience will further add to the credibility. Input from paramedical staff should be
actively sought and acknowledged.
Same standards for all levelsDoctors and other health care providers use the same
standard treatments. The referral criteria differ, but the first-choice treatment for a patient
depends on the patients diagnosis and condition, not on the prescriber. If a patient
attends a teaching hospital or a low-level dispensary with a common condition, the
treatment will be exactly the same. If the patient does not respond to treatment, he or she
may be referred to a higher level to receive the second-line therapy, which would be
given in hospital.
Dynamic (regular updates)As bacterial resistance patterns change or other factors alter
therapeutic preferences, the standards are revised to reflect current recommendations.
Durable pocket manualsThe STGs are published as small, durable pocket manuals,
which makes them convenient to carry and use.
In the interest of therapeutic and economic efficiency, standard treatments should target those
conditions that have the highest morbidity and mortality rates. Note that some conditions that
contribute substantially to the number of patients treated, and therefore to the total cost of
medicines provided, contribute little to decreasing morbidity and mortality. Skin conditions are a
common example. Such problems may nevertheless be priorities for the development of standard
treatments precisely because they do absorb a large percentage of the pharmaceutical budget.
In terms of selection of health problems to be addressed, standard treatment falls into three
categories
IndividualStandard treatments are prepared for only one problem or set of problems,
such as only diarrheal disease, only ARI, or only malaria.
ComprehensiveStandard treatments are prepared for 30, 50, 100, or even more
common health problems. When published, this collection of standard treatments
becomes more like a textbook than a basic reference.
The number of treatment guidelines developed should be appropriate to the specific situation.
But individual treatments developed one by one may miss the opportunity to use the process to
integrate several special programs. At the other extreme, comprehensive standard treatments risk
overwhelming health workers with new information, thus reducing the chance that any of the
standard treatmentseven those for common, high-priority problemswill be followed. There
may be a place for targeting different levels of the health system with manuals containing
differing amounts of information.
Information on local disease patterns should also be considered. Seldom do primary care clinics
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
medicines 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 diarrheal disease control, ARI, malaria, and so forth. Hospital or
primary health care standard treatments should reinforce recommendations of special programs
and, at the same time, special programs should use their experience in developing their treatment
recommendations.
Individual medicine selections should, of course, be based on the principles of choosing the
fewest medicines necessary to effectively treat an individual condition, choosing the most costeffective treatment, and adhering to the essential medicines list (if one exists). If an essential
medicines 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 medicines list.
Development of standard treatments must involve respected clinicians from all levels, including
perhaps leading professors from local medical schools as well as experienced district medical
officers and outstanding community health staff. Department heads of major hospitals should
also be consulted and their advice obtained in preparing and authoring the document. Involving
many end-user staff-level physicians and pharmacists is also necessary to obtain a broad-based
participatory approach, one that will ensure buy-in later when the manual is completed.
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, quality, and cost.
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.
Pocket-sized books can also include information about individual medicines or other reference
data. The contents of pocket manuals can be organized in summary tables, in diagnostic and
treatment decision trees or flowcharts, or simply in written text.
An official launch is important. The Minister of Health, the leaders of professional bodies, and
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
preservice training for doctors and other health care providers. Use of the standard treatments
and the reference manual or wall chart early in training develops good habits for later clinical
practice. It 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 important, if the standard treatments differ substantially from current
practice (e.g., 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 6
to 12 months after the initial training can play an important role in reemphasizing the importance
of following standard treatments and can allow the DTC to respond to questions that 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 that focus on high-priority
problems such as diarrheal disease and ARI can also include information on treating these
problems and, of great importance, on adequacy of supply of the few medicines needed for these
conditions. Using drug use evaluations (DUEs) can be helpful in monitoring and ensuring
compliance with the STGs.
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The DTC intends to address this problem with several different strategies, including educational
programs for medical providers, the institution of a DUE program for several antimicrobial
medicines, and a revision of the STGs.
Meet in your usual groups and collaborate on the development of an STG for cesarean section
antimicrobial prophylaxis. (If time allows, you may also be asked to develop an STG for
childhood pneumonia.) Keep the guideline brief, but address all of the important aspects of care
that are necessary to guide the appropriate treatment and improve patient outcomes with this
disease or medical condition. Provide as well a brief workplan on how the guideline would be
implemented in your hospital.
The STG that you develop in your groups will be discussed in plenary where the facilitators will
help you reach a consensus between all the groups on one guideline for everyone to use. The
plenary group will then develop a form to test whether patients are being treated in accordance
with the guideline, and this form will be used during the field trip to a local hospital later in the
course.
Should a second edition of the STGs be prepared at this time? Is it the best use of time
and money?
What should be done? What should be proposed to Mr. Domingo at the next meeting?
What other pharmaceutical management problems exist in this case study and how would
you deal with them?
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Summary
STGs constitute one of the most important concepts in providing rational use of medicines.
These guidelines have been shown to provide valuable guidance to practitioners at all levels,
especially those with minimal training.
Guidelines need to be prepared with the ultimate goal of providing a protocol for the health care
system to follow that will produce improved patient care and outcomes.
STGs will improve outcomes for patients by
Producing the best quality of care because patients are receiving optimal therapy
Using only formulary or essential medicine so the system need only provide the medicine
in the guideline
Providing invaluable assistance to all practitioners, especially those with lower skill
levels, as it provides the guidelines necessary to ensure good quality care
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A Second Edition?
Standard Treatments In Pagalia
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centers have doctors assigned to them, a recent study from one province indicated that only about
one in four patients sees a doctor. The rest are diagnosed and treated by nurses and paramedics.
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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 injectables, and other popular medicines. The
medicine 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 manuals were sent out in 1996. We have just
completed a survey of 2,500 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. Pedros group recommended only rehydration, the average patient was
getting more than three medicines. Virtually every patient was getting an antibiotic. More
vitamins and minerals were being prescribed than oral rehydration salts. Antibiotics used for the
under age five patients alone included oxytetracycline injection, tetracycline capsules,
metronidazole, trisulfa, tetracycline syrup, ampicillin syrup, chloramphenicol suspension, and
procaine penicillin injection. Some of the medicines recommended in the Standard Treatments
are not available.
Similarly, for influenza and acute upper respiratory infections, Dr. Pedros group had
recommended paracetamol for fever and aches, antihistamines for congestion, and a cough
medicine. Yet, nearly every patient got an antibiotic, which was supplemented by an average of
two other types of medicines. The range of different antibiotics prescribed was again quite
impressive, at least a dozen by Mrs. Somas tally.
Mr. Joko was again mystified by most of Mrs. Somas medicine names, but he clearly sensed her
feeling that the bright green Standard Treatments for Health Centers had not achieved its
purpose. The twinkle in Dr. Pedros eye was beginning to fade.
A Second Edition?
Having shared the results of the directorates studies, Mrs. Soma somehow felt less compelled to
support Dr. Pedros 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 groups opinion about the design and color of the cover.
Dr. Karma, always the diplomat, suggested that the project perhaps could support both Dr.
Pedros revision of the Standard Treatments and another series of studies by Mrs. Somas 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.
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Title
Antibiotic Guidelines, 9th ed.
(1997)
Psychotropic Drug Guidelines, 2nd
ed. (1993)
Analgesic Guidelines, 3rd ed.
(1997)
Gastrointestinal Drug Guidelines,
1st ed. (1994)
Neurology Guidelines, 1st ed.
(1997)
Available from
Victorian Medical Postgraduate Foundation Inc.,
Therapeutics Committee, Chelsea House 3rd Floor,
55 Flemington Road, North Melbourne, VIC 3051,
Australia
[www.csu.edu.au/faculty/health/conference/vmpf.htm]
E-mail address: vmpf@vicnet.net.au
Past editions of these guidelines may be available for
the cost of postage.
Botswana
Great
Britain
Jamaica
Kenya
Malawi
Nepal
South
Africa
Tanzania
Uganda
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Country
Zimbabwe
Title
EDLIZ (Essential Drugs List for
Zimbabwe) (1994)
A series of 15 modules on clinical
and management topics is also
available.
Available from
Zimbabwe Essential Drugs Action Programme,
Ministry of Health, Box 8168, Causeway, Harare
Zimbabwe
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