The irrational use of drugs has become a serious problem in Ethiopia. One of the causes for irrational drug use is the absence of a standard treatment guideline for the most common diseases in the country. Only a limited number of diseases, such as malaria, tuberculosis and sexually transmitted diseases have adapted standard treatment guidelines. This has led both prescribers and dispensers to prescribe and dispense different drugs for the same disease, making treatment non-uniform and paving the way for irrational drug use. A collaborative effort among prescribers, dispensers and drug consumers is required to address the problem. The formulation of a standard treatment guideline is one of the most important measures that could be taken to promote the rational use of drugs.
The present STG contains guides to general and special prescribing; specific treatment guidelines for a large number of common health conditions in Ethiopia, and relevant annexes that are useful for treatment and prevention. Diseases are classified into sections: infectious, noninfectious, common pediatric problems, common obstetric/gynecological problems, common skin conditions and acute/emergency problems. Every disease has a brief description on the disease pattern, including ways of diagnosis and treatment. Both non-drug and drug treatments have been given whenever applicable. With regard to drug treatment, both first line and alternatives drugs are listed for the treatment of a given disease. Under drug treatment, information on doses, course of therapy, dosage forms, side effects, contraindications and drug interactions are given for first line and alternative drugs.
These standard treatment guidelines are designed to be used as a guide to treatment choices and as a reference book to help in the overall management of patients.
It is emphasized that the choices described here have the weight of scientific evidences to support them, together with the collective opinion of a wide group of recognized national experts.
The content of these treatment guidelines will undergo a process of continuous review comments or suggestions for improvement are well come. Those comments or suggestions for addition of diseases should include evidence of prevalence as well as a draft treatment guideline using the format set one in this guidelines. In the cases of a request for a new drug or replacing a listed product with another product, the evidence base must be clearly defined and included with the request.
These comments or suggestions should be sent to
The Drug Administration and Control Authority (DACA) of Ethiopia
P.O.Box 5681
Addis Ababa, Ethiopia
GENERAL GUIDANCE
A. Rational Use of Drugs
Effective treatment of patients requires rational use of drugs. Drugs should only be prescribed when they are necessary, and in all cases the benefit of administering the medicine should be considered in relation to the risks involved. Bad prescribing habits lead to ineffective and unsafe treatment, exacerbation or prolongation of illness, distress and harm to the patient, and higher cost. Thus, it is very important that steps are taken to promote the rational use of drugs in order to effectively promote the health of the public and to use meager resources maximally. One way of promoting such practice is developing standard treatment guidelines.
Rational approach to therapeutics requires careful evaluation of the health problem and selecting appropriate therapeutic strategies. Making the right diagnosis is the cornerstone for choosing the right kind of therapy. Based on the diagnosis, health workers may select more than one therapy and the selected therapy should be agreed with the patient. The selected treatment can be non-pharmacological and/or pharmacological. It is important to take into account the total cost of all therapeutic options in the selection process.
It is important to bear in mind that the patient does not always need a drug for treatment of his/her condition. Very often, health problems can be resolved by a change in life style or diet, use of physiotherapy or exercise, provision of adequate psychological support, and other non-pharmacological treatments.
The selection process must consider benefit/risk/cost information. This step is based on evidence about maximal clinical benefits of the drug for a given indication (efficacy) with the minimum occurrence of adverse effects (safety). It is well known that most drugs have adverse effects, but much of the adverse effects observed throughout the world are caused by inappropriate selection of drugs. The prescriber must check whether the active substance chosen is suitable for the particular patient. As far as possible, drug treatment should be individualized to the needs of each patient.
B. Prescription writing
A prescription is an instruction from a prescriber to a dispenser. The prescription is the link between the prescriber, the pharmacist (or dispenser) and the patient. A properly written prescription is the basis for giving appropriate information, instructions and warning to the patient. It ensures adherence to therapy and protects the patient from unnecessary harm related to therapy.
The prescriber is not always a doctor; he/she could be a paramedical worker, such as a medical assistant, a midwife or a nurse. Likewise, the dispenser is not always a pharmacist, but can be a pharmacy technician, an assistant or a nurse. In any setting, it is important to ensure that prescriptions are correctly interpreted and leave no doubt about the intention of the prescriber. The prescription should be clear, legible and indicate precisely what should be given. The prescriber’s name and address must be indicated on the prescription form. This will allow either the patient or the dispenser to contact the prescriber for any clarification or potential problem with the prescription. The following details should be shown on the prescription:
• Date of the prescription
• Name, form and strength of the drug; the International Nonproprietary Name of the drug should always be used
• The pharmaceutical form (for example tablet, oral solution, or ointment) should also be stated
• The strength of the drug should be stated in standard units that are consistent with the Systeme Internationale (SI). Abbreviations that are not standard should be avoided. Avoid decimals whenever possible; if unavoidable, a zero should be written in front of the decimal point.
• Directions specifying the route, dose and frequency should be clear and explicit; use of phrases such as take as directed or take as before should be avoided.
• The quantity of the medicinal product to be supplied should be stated. Alternatively, the length of treatment course may be stated.
C. Adherence (compliance) with drug treatment
It is often assumed that once the appropriate drug is chosen, the prescription correctly written, and the medication correctly dispensed, the drug will be taken correctly and treatment will be successful. Unfortunately, this is very often not the case, and physicians overlook one of the most important reasons for treatment failure - poor adherence (compliance) with the treatment plan.
There are sometimes valid reasons for poor adherence, as with the case of a drug that may be poorly tolerated, may cause obvious adverse effects or may have been prescribed in a toxic dose. Failure to adhere with such a prescription has been described as intelligent non-compliance. Bad prescribing or a dispensing error may also create a problem, which patients may have neither the insight nor the courage to question. Even with rational prescribing, failure to adhere to treatment is common. Factors may be related to the patient, the disease, the doctor, the prescription, the pharmacist or the health system and can often be avoided.
In general, women tend to be more adherent than men, while younger patients and the very elderly are less adherent. People living alone are less adherent than those with partners or spouses. Conditions with a known worse prognosis (for example cancer) or painful conditions (for example rheumatoid arthritis) elicit better adherence rates than asymptomatic perceived as 'benign' conditions such as hypertension. Health workers may cause poor adherence in many ways by failing to inspire confidence in the treatment offered, by giving too little or no explanation, by thoughtlessly prescribing too many medications, by making errors in prescribing, or by their overall attitude to the patient. Many aspects of the prescription may also lead to non-adherence. It may be illegible or inaccurate; it may get lost; it may not be refilled as intended or instructed for a chronic disease. And it may be too complex; it has been shown that the greater the number of medications, the poorer the adherence. Multiple doses also decrease adherence, especially if more than two doses per day are given. Not surprisingly, adverse effects like drowsiness, impotence or nausea negatively influence adherence and patients may not admit the problem.
The pharmacist’s personality and professional manner, like that of the doctor, may have a positive impact, supporting adherence, or a negative one, raising suspicions or concerns. This has been reported especially in relation to generic drugs when substituted for brand name drugs. Pharmacist information and advice can be a valuable reinforcement, as long as it tallies with the doctor’s advice. The health care system may also be the biggest hindrance to adherence. Long waiting times, uncaring staff, uncomfortable environment, exhausted drug supplies, etc, are all common problems in developing countries, and have a major impact on adherence. An important problem is the distance of the clinic from the patient and its accessibility. Some studies have confirmed the obvious, that patients furthest from the clinic are least likely to adhere to treatment in the long term.
A good health worker-patient understanding is important for effective adherence to therapeutic regimens. Adequate time must be given to explaining the health problem and the reason for the drug treatment. Health workers must keep treatment regimens simple and write appropriate notes for patients. Teamwork and collaboration with pharmacists is important when advising the patient. It may be appropriate to Involve the partner or another family member, when necessary.
D. Adverse Drug Reactions
An adverse drug reaction (ADR) may be defined as any response to a drug which is noxious, unintended and occurs at doses normally used for prophylaxis, diagnosis, or therapy. ADRs are, therefore, unwanted or unintended effects of a medicine, including idiosyncratic effects, which occur during its proper use. They differ from accidental or deliberate excessive dosage. It is well recognized that clinical trials, however thorough, cannot be guaranteed to detect all adverse effects likely to be caused by a drug. Health workers are thus encouraged to record and report to their national pharmacovigilance center any unexpected adverse effects with any drug to achieve faster recognition of serious drug-related problems. One of the common predisposing patient factors to ADRs is extreme age. The very old and the very young are more susceptible to ADRs. Drugs which commonly cause problems in the elderly include hypnotics, diuretics, non-steroidal anti-inflammatory drugs, antihypertensives, psychotropics and digoxin. Children, and particularly neonates, differ from adults in the way they respond to drugs. Some drugs are likely to cause problems in neonates (for example morphine), but are generally tolerated in children. Other drugs (for example valproic acid) are associated with increased risk of ADRs in children of all ages. Other drugs associated with problems in children include chloramphenicol (grey baby syndrome), antiarrhythmics (worsening of arrhythmias), aspirin (Reye’s syndrome).
Another common factor is the presence of co-existing illness. If besides the condition being treated the patient also suffers from another disease, such as kidney, liver or heart disease, special precautions are necessary to prevent ADRs. Also, the genetic make-up of the individual patient may predispose him/her to ADRs.
E. Drug Interactions
Interactions may occur between drugs that compete for the same receptor or act on the same physiological system. They may also occur indirectly when a drug-induced disease or a change in fluid or electrolyte balance alters the response to another drug. Interactions may occur when one drug alters the absorption, distribution or elimination of another drug, such that the amount which reaches the site of action is increased or decreased. Drug interactions are some of the commonest causes of adverse effects. When two drugs are administered to a patient, they may either act independently of each other, or interact with each other. Interaction may increase or decrease the effects of the drugs concerned and may cause unexpected toxicity. As newer and more potent drugs become available, the number of serious drug interactions is likely to increase. It is important to remember that interactions which modify the effects of a drug may involve non-prescription drugs, non-medicinal chemical agents, and social drugs such as alcohol, marijuana, and traditional remedies, as well as certain types of food.
The physiological changes in individual patients, caused by such factors as age and gender, also influence the predisposition to ADRs resulting from drug interactions. Patients who have been or are taking traditional herbal remedies may develop ADRs. It is not always easy to identify the responsible plant or plant constituent
F. Incompatibilities between drugs and IV fluids
Drugs should not be added to blood, amino acid solutions or fat emulsions. Certain drugs, when added to IV fluids, may be inactivated by PH changes, by precipitation or by chemical reaction. Benzylpenicillin and ampicillin lose potency after 6 -8 hours if added to dextrose solutions, due to the acidity of these solutions. Some drugs bind to plastic containers and tubing, for example diazepam and insulin.
HOW TO USE THE STANDARD TREATMENT GUIDELINE
This Standard Treatment Guideline is prepared to improve the treatment practice of health workers at Health center and Health post level. It does not, however, provide all the necessary references to establish the diagnosis of the disease/illness for which the patient is visiting the health care system; it assumes that health workers at various levels have the required training and competence to make diagnosis that is appropriate for that level. In light of this the guideline has been organized by level of use, from Zonal Hospital to Health Station.
Once diagnosis is established, the guideline is useful to administer the most appropriate drug, in the Ethiopian context, using the right dose of the drug for the right duration of treatment. It also gives the recognized side effects, contraindications and other useful information about each drug. All drugs included in the Standard Treatment Guideline are those that ate included in the current National Drugs List for Ethiopia.
Diseases are categorized according to the nature of the disease, the population most affected by the disease, and other conditions requiring special attention. Thus, it contains major infectious and noninfectious disease according to the first criteria; major obstetric/gynecological and pediatric diseases according to the second criteria; and other major conditions such as sexually transmitted diseases, skin disorders and acute emergencies as per the third criteria. One can search the document and obtain the necessary information based on the above criteria. For quick reference, the list of diseases included in the STG and the drugs recommended are organized in the index at the end of the guideline.
This is the first attempt to formulate a Standard Treatment Guideline for the country. Your comments and suggestions on the use of the guideline could go towards improving subsequent editions, and, therefore, you are requested to send these to the Drug Administration and Control Authority.
