prn8099 - Number 25, October 1999
Quality, safety and efficacy, QSE in short, are three keywords when it comes to medicinal drug therapy. In fact, they permeate through the whole pharmaceutical process. Some 15 years ago, the QSE principle become entrenched into the Malaysian pharmaceutical sector when the Drug and Cosmetic Regulations 1984, was promulgated. Beginning in 1985, medical drug substances - poisons non-poisons, traditional medicines and even cosmetics are gradually being registered with the Ministry of Health. Various systems of evaluation and testing were set up to ensure that the QSE criteria comply to international standards and norms.
In a nutshell, the stringent criteria of Good Manufacturing Practice (GMP) were adopted in ensuring that the desired standards for medicinal drug products are not being compromised. As a result the local pharmaceutical market place has never been safer for the ordinary citizens. The selection of products available in the country were reduced to almost half in favour of those meeting QSE benchmarks. Consumers, both nationally as well as international are given the assurance that only medicinal drug products with acceptable quality standards, safety records, and proven efficacy are allow to be on sale for public comsumption. There were also adequate monitoring and enforcement procedures being systematically implemented to ensure that the market is well regulated.
All these are important development that shaped public confidence with regard to the availability of medicines in this country. In other words, a system has been put in place to allow for greater protection of public health interest.
With this new found assurances, namely, only 'good' drugs are being made available to consumers, it is time to examine yet another scenario. This is in recognition of the fact that 'good' drugs can and have been badly used. This phenomenon is generally known as the 'irrational use of drugs.' It borders on the question of safety that could range from the occurrence of unwarranted side-effect at life-threatening mishaps leading to death.
There are many ways that this can happen especially when the principles of rational drug use are violated. Some of them are summarised in Table 1, and some of the reasons for these to happen are as indicated in Table 2.
Table 1 When are 'good' drugs being badly used?
This can happen in any one of the following situations, where drugs are given:
- to the wrong patient,
- in the wrong doses,
- at the wrong time and frequency, and
- for the wrong reasons
The above situation worsened as the number of drugs given or used concurently at any one time increased.
Table 2 Why are 'good' drugs being badly used?
This generally involved factors that lead to poor decisions making. Some of the reasons include:
- poor communication with peers and clients
- succumbing to patient demands - 'real' and 'perceived'
- work related stress and pressure
- unconsciously influenced by drug promotional activities
- using drugs fashionably
- inaccessible to objective, evidence based information, and
- cultural beliefs and practices.
The World Health Organization's Essential Drugs Monitors (WHO EDM, No. 23, 1997) in an editorial entitled 'Improving drug use' admitted that "although good teaching and access to scientifically validated information is a prequisite for appropriate drug use, many factors are involved. Thus despite the claim of competencies by many parties, irrational use of drugs leading to a number of drug misadventures and wastaged are not as uncommon as it seems. The strength of this view is borne out in a US National Patient Safety Foundations' public opinion survey on patient safety conducted in 1997. The research survey identified careless, negligence, and in competence of professional staff as the main causes of medical mistakes. A number of separate studies reported that millions of dollars were being wastages when drugs are improperly used, at the same time putting the patients to unnecessary risk.
Assuming that the medical practices in Malaysia are as rigorous and as responsible as that in the US, there are arguably still potential avenues for mistakes to occur. In a Penang-based cross-sectional study carried out by the National Poison Centre, some of the findings seems to mirror such concern. This is fully reported in the section on PRN Consult (see page 3).
There is no doubt that the use of drugs can be very complex. "Drug use is impacted by a complex web of knowledge, attitudes, practices and influences that goes far beyond the use biomedical model, and that can vary widely between countries, professional groups and the general public", notes the WHO EDM. It is difficult therefore to ensure safety when any one these factors are ignored and not taken into consideration. And as competitiveness in health trade and practices increased as seen today, it could be assumed that the probability of irrational practices could also be on the increase. To quote one observation in the US, from 1940s to the 70s, "...it was clear that harms associated with medical care were often attributable to new pharmaceuticals and to infectious agents in hospitals..."
In other words, deliberations on safety issues on medicinal drug use must now be extended to the other end of the spectrum that is, how do one ensure that 'good drug' are not badly used, misused or even abused? How can drugs be used rationally as intended?
This has been an important topic of discussion for more than a decade. In 1985, World Health Organization sponsored the Nairobi Conference of Experts to discuss the importance of rational drug use. Indeed today the concept of rational drug use still remain as one of the pillars for safe drug therapy. In 1997, WHO co-sponsored the International Conference on Improving Use Medicines (ICIUM) which among others attempted to describe the "state of the art" in relation to improving the use of medicinal drugs especially in developing countries. During the Conference, the Director of WHO Action Programme on Essential Drugs emphasised that "people are dying because they are misdiagnosed, under - dosed or overdosed. There is a need for urgent and comprehensive actions. While educational and training strategies are importance components in the promotion of safe drug therapy there are also urgent policy considerations. The Conference endorsed eight (8) ways to further promote improvement in consumer use of medicines.
In the among WHO Bi-Regional Working Group Meeting, 13-15 October 1999, involving participants and resource persons from more than 20 countries, the roles of pharmaceutical therapeutic committee (PTC) and drug information services (DIS) will be explored to further enhance rational drug use. These are of particular importance in continously improving quality assurances in drug prescribin (Figure 1).
Other approaches to improve quality is by reducing errors. Suggestions by the Institute for Healthcare Improvement in the US includes the following:
- Reducing errors from complexity in information need. For example, providing information system that offers relevant information about the patient and medications to anyone who needs it. And limit formularies to essential drugs and doses, with few duplications.
- Reducing errors from multiple, competing tasks. For example, involving patients as active partners in checks, such as identifying themselves, assessing drug choices and doses, and reviewing allergy information. Or place key information on patients and their medications in convenient locations on the care unit, through electronic informations system when feasible. Or establish standard drug administration times, and avoid interruptions of those times.
- Reducing errors from the complexity of intermingling medications. For example, remove or diffentiate look-alike drugs and packages. And remove high-risk medications and label high-risk drug to indicate their danger.
On top of these, the results of the above mentioned National Patient Safety Foundation's Survey also recorded that 75 per cent of the respondents believed that sanctions againts health care professionals with bad track records would be effective in preventing mistakes.
In short, it is also imperative that appropriate systems specific for monitoring drug use be implemented to further protect public interest. There are already widely accepted principles of Good Prescribing Practice (GPP), as well as Good Dispensing Practice (GDP) that could be adopted without much delay. Moreover, the current initiative by the government to institute Essential Drug Concept in both the public and private sector will go along way to systematically reduce error and putting safety in their comprehensive perspective.
We also need to be reminded that any effort to accord safety in medicinal drug use the patient's level must take into consideration the Patient's Charter agreed by each of the national medical, dental and pharmaceutical associations and the consumers. Indeed the Charter recognises that patients are partner in health care and should be fully consulted, informed and educated in relation to drug use. Health care professionals are not more than a support system to ensure that this remain so. They must help the patients and consumers to be reponsible of their health, and regain control of the own body. As suggested by Ivan lllich in his book Medical Nemesis, in order to regain our health, we must regain the control now held by doctors and medical institutions. This the reality of health care in the new millennium - moving the patients closer to the point of active participation as partners in health care.
Special Review on
by Mohamed Izham Mohamed Ibrahim, PhD
DRUGS SHOULD BE ACCESSIBLE and affordable to the society. When good quality drugs are used rationally, they save lives and improve health. Government of the developing and Third World nations are concerned about drug costs. One of the mechanisms in solving drug cost from escalating is through implementing Essential Drug Concept. Others include a comprehensive national drug policy with the aim to ensure or improve the quality of medicines, ensure equitable access, ensure rational use and ensure that only the selected essential drugs would be imported and use, especially by the public sector. In addition, goverments should urge all importation, manufacturing, registration, prescribing and dispensing of drugs are by generic names only, at least in the public sector.
Malaysia is a multiracial society (i.e. Malay, Chinese, Indian, Kadazan, Iban (etc.) of an approximately 22 million population. It consists of 13 states and 2 federal territories. It is estimated that the number of people per household is between 4 to 5 people. The use of pharmaceutical drugs, modern and traditional, among the society in the country are widespread, but the pattern of use is not well studied.
The misuse of drugs can be harmful (e.g., poisoning) and can lead to drug wastages. Waste and poisoning could be avoided by ensuring that drugs are appropriately used and prescribed only when needed.
On the contrary, consumers do not always do what health professional advise them to do. They sometimes stop taking the prescribed drugs sometimes take the wrong dosage. Another problem is that drugs are either purchased by individual for self-medication, be it over-the-counter or prescription medications (e.g.; oral antibiotics). The latter are often potent drugs, and self-medication can lead to serious negative consequences (e.g., adverse effects, poisoning). Furthermore, anti-infectives are vital drugs, but they are over prescribed and overused in the treatment of minor disorders such as simple diarrhea, coughs and colds. When antibiotics are used too often in sub-optimal dosages, bacteria become resistant to them. The result is treatment failure where patients continue to suffer from serious infections despite taking the medication.
Especially in development countries many still believe that every illness should be treated with drugs (i.e., 'a pill for every ill'). At the onset of all kinds of minor disorders they immediately take drugs. Vitamin and paracetamol, though relatively safe are the most commonly used drugs in many countries. Still, this is not without risks. Paracetamol, if taken in excess can cause death. Some vitamin can lead to toxicity.
Abstract: The problem of inappropriate use of medicines in developing and third world countries is large, and it grows in importance as health care costs rise. The misuse and reuse of unwanted medicines are harmful. In addition, the information on the label is an intrinsic part of the medicines and must be informative and understandable.
The present study explored such problems in the Malaysian community. A cross-sectional study using questionnaire and face-to-face interviews were carried out. The study was conducted in nine selected residential areas in the state of Penang.
Questionnaires were distributed to 439 households. The key information gathered were:
- the number of medicines collected
- the source of medicines
- the type of drug formulation.
- drug information on the labels
Summary or result:
Number of households participated in the study were 399 (90.9). A total of 451 type of drugs were collected from 101 households, Most of them were obtained from clinics (58%), in the from or tablets (51%), drug regimen were stated (81%), without an expiry date (92%), withour the name of medicines (61%) and without the drug indication (65%).
Results indicate that a comprehensive and sound national drug policy on drug use safety is timely.
Keywords: Drug policy, drug wastage, drug use, community, drug labeling.
To date, little is known about the drug use behaviour patterns among the general public in Malaysia. There is no systematic and comprehensive data on the utilisation of medicines in the Malaysian community after they have been marketed and prescribed. This preliminary study aims at exploring this.
The general outcome of this study is to provide public, researchers, health professionals and policy makers with preliminary baseline data of drug provision and utilisation in communities. it is hope that this will help all parties to understand current problems pertaining to drug utilisation and enable them to take appropriate actions for ensuring safe, rational and cost-effective drug use. Specifically, the objectives of the research were to study:
- the trend of drug use in Malaysian community,
- the extent of drug wastage,
- the extent of proper labelling of medicines, and
- the type of drug formulations being kept in homes.
The results from the baseline survey can be used to develop a nationwide study, and consequently to develop strategies for rational use of drugs, rational prescribing and to seriously implement an Essential Drug Concept and develope a comprehensive national drug policy for Malaysia.
A preliminary survey was conducted to determine the drug utilisation pattern in the Malaysian communities. The study design was a cross-sectional study using questionnaires and face-to face interviews.
The questionnaires include personal data about respondent/head of house hold, and about the common sites of medicine storage in the home kitchen, bathroom, bedroom). The questionnaires were pre-tested prior to the study. In addition to the questionnaires and interviews, the data collectors sought permission from the house hold to inspect the sites of medicine storage and to collect unused drugs. The un-used drugs were then analysed in terms of the quantity, type of formulations and information available on the label.
The study was conducted in the general community, in 9 selected residential areas in the state of Penang, Malaysia. The study population in this research project consisted of households in the nine selected areas. The sampling method used in this study was a convenient samples of household. Respondents were 18 years old and above, and possibly the head of the household.
Questionnaires were distributed to 439 households. A letter explaining the purpose of the study, questionnaire and a piece of plastic bag were given to the 439 households. The address of the houses were noted. Two days later, data or information and unused medicines were collected. The following were some of the outcome measures used in this study:
- the number of medicines collected;
- the source of medicine (i.e.,place drug are obtained);
- the type of drug formulation, and
- drug information on the labels.
Data were first coded and input the computer. Statistical Analysis System (SAS) software version 6.04 on a IBM-compatible laptop computer were used to analyse these data.
Of the 439 questionnaires distributed to the households, 399 were returned and usable, which means that these households had participated in this study. This gave a response rate of 90.0%. Table 1 showed the number of questionnaires distributed and received from the households.
Table 1 Number of households participated in this study and amount of drugs collected
Unused drugs were collected from 101 (25%) houses (see Table 1). A total of 451 type of drugs were collected. Results in Table 2 showed the sources from which the drugs were obtained; most of which were obtained from private clinics (58.1%).
Table 2 Sources of drugs and their dosage forms (n=451)
|Source of drugs|
|Drug dosage forms|
Results in Table 2 also showed the different dosage forms of drugs that were collected. Approximately 51% of the drugs collected were in the table form. Table 3 showed the results on the drug information (i.e, name of medicine, drug indication, drug regimen and expiry date of the medicine) which were found on the labels or containers/packages. Most of drugs collected were:
- 61.4% without names
- 65.0% without the indication of medicines
- 80.9% were with the regimen of medicines
- 91.8% were without any expiry date
Table 3 Information on drug labelling (n=451)
|Name of medicines|
|Indication of medicines|
|Regimen of medicines|
|Expiry date of medicines|
|With expiry date|
|Without expiry date|
The results generally indicate that there still room for improvement in drug use at the community level. From the interview conducted, it is shown that the phenomenon "when somebody is sick, he or she may visit a doctor and obtain medicines or may self-medicate" is common. Medicines are powerful as they could be harmful if not properly used. Thus, the instructions received must be adequate, factually correct and in a form that we can be understood and easily used in the best interest of the consumers. We must take the medicines with great care ensuring that we carry out the instructions given.
Irrationality in drug use exists at different levels, for example those of manufacturing, prescribing and consumption. There is a need to create awareness at the society level regarding rational use of drug. Community awareness is far more difficult in developing countries because of problems such as illiteracy, ignorance, misconceptions lack of information and language barriers.
Drug appearance based on verbal information alone is not sufficient to ensure correct drug use. It is necessary to have written instructions giving details on how to use drugs separately written out for each drug prescribed. Without proper written drug information will expose individual more easily to receiving the wrong medicine in the wrong amount at the wrong time. Usually the drug name will not be written on the package. In the case where the individual fails to recover from the illness or suffer from serious adverse effects, no one will be aware of the medicine(s) given.
Community education is not an indepent regim or programme. It should be an integral part of the national drug policy. Education should be seen as a process of empowerment. This should be a part of an effort to educate people about drugs, their costs and benefits, and the right of patients to know about the relevance, efficacy and adverse effects of the drugs. Community education should be designed so that it makes the public aware and are empowered to avoid drug use problems (e.g., wastage and mususe). Then they are more capable of taking care of themselves and ensuring that drugs are used rationally.
The trend of usage is more towards wastage because the consumers are generally not fully aware of the types of medication used and how to use and store them properly.
Out of 399 households participated in this study, a total of 451 type of drugs were collected. These unused drugs were collected from 101 houses. Most of them were obtained from clinics (58%), in the form of tablets (51%), with 81% drug regimen stated (81%), without an expiry date (92%), without the name of medicines (61%) and without the drug indicaton (65%).
Generally, users tend to keep drugs longer than necessary and has the tendency of reusing and sharing them. These can lead to undersirable drugs effects extending even to poisoning. Drug policy should stress on the provision of better product information and labelling for the consumers.
The implementation of a comprehensive Malaysia national drug policy is indicated. To ensure success it should involve the major stakeholders which includes the government, relevant health professionals, academia, pharmaceutical industry and consumers. The policy should promote the Essential Drug Concept in both the public and private sectors. Urgent steps were needed to reduce unnecessary wastage of money on useless or non-essential drugs as well as to regulate the drug use process and promoting public drug education. It can help reduce the increasing costs of drugs, especially during the present economic crisis which is a crucial problem for both the public and private sectors.
Y2K & Health
Phenomenon exists in the Information Technology (IT) industry because historically many computer programmes make use of dates represented by only two digits (for example, 95 rather than 1995). However common this practice might be, causes programmes (both system and application) that perform arithmetic operations comparisons, or sorting of date fields to yield incorrect results when working with years outside the range of 1900-1999.
The scope of the Year 2000 challenge spans the entire IT industry. A data mismatch can exist in any level of hardware or software from microcode to application programs, in files and data bases, and is present on ALL platforms. In recent years, the IT trade press has given ever greater attention to this phenomenon with increasingly ominous predictions.
However dramatic all this may sound, consider the following scenarios to help put the phenomenon and its business ramifications into perspective. Imagine if in the first quarter of the year 2000 your company cannot process its 1999 end-of-year billing or end-of-year payroll properly; your corporate credit card holders are refused most transactions because their accounts appear delinquent; your 1999 year-end profit data cannot be calculated properly; and your utility companies cut off their services due to your apparent late bill payments. Similarly, your household and personal financial situation could encounter a similar dilemma if your creditors do not also strive to meet this challenge.
Although referred to as the Year 2000 issue this is really a 2-digit-year problem. Your IS organization needs to plan for and address the date changes well in advance of 1 January 2000.
All organizations are affected by this issue from a business and administrative perspective.
However, public health information and surveillance systems at all levels of local, state, federal, and international public health are especially sensitive to and dependent upon dates for epidemiological and health statistics reasons. Date of events, durations between events, and other calculations such as age of people are core epidemiologic and health statistic requirements.
Moreover, public health authorities are usually dependent upon primary data providers such as physician practices, laboratories, hospitals, managed care organizations, etc., as the spice of original data upon which public health analyses and action take place. This meant that it is not sufficient to make internal systems compliant to the Year 2000 to address all of the ramifications of this issue.
One aspect that effects most people relates to the use of pharmaceuticals. To prepare for the Year 2000 the following is a list of prudent steps that you can take to ensure that you and your family are prepared for any medical situation at any time, not just on January 1,2000.
- Make a list of prescription and important nonprescription medications you and your family are currently taking. Include the name of the medication, the family member taking it, the dosage and the doctor prescribing it. When you go to a doctor or hospital for medical treatment, you are currently taking. This list will help.
- Keep up-to-date on getting refills. It is advisable to get a normal refill of your medication when you have a 5 to 7 day supply of medication remaining. The supply system is resilient and can correct any issue that might arise within 5 to 7 days. This is good practice regardless of Y2K. And remember, if your insurance coverage will change at the end of the year, be sure to tell your physician and pharmacist.
- Create a personal health record for you and your family. Document important medical information, including drug allergies, existing medical conditions, past medical treatment and operations, information on any medical devices, physician names and phone numbers and the name and phone number of someone to notify in case of emergencies medical treatment and operations, information on any medical devices, physician names and phone numbers and the name and phone nembers and the name and phone number of someone to notify in case of emergencies.
You can keep a copy on your home, and perhaps have a copy in your wallet or purse. If you need emergency treatment, this information can be very important.
- Keep records of your insurance claims. This makes sense the same way keeping copies of your bank statements or tax copies of your bank statements or tax returns is good financial management.
- Carry your current insurance card with you. In order to receive the medications you need, it is important to have evidence of your coverage with you.
This is particularly important if you will be covered by a different insurance plan in the new year make sure you provide this information to your physician and pharmacist.
Five simple steps consumers can take to prepare for Y2K
- Keep up to date on getting refills. It is advisable to get a normal refill of your medication when you have a five-to seven-day supply of medication remaining.
- If you order medications through the mail, allow a few extra days for mail handling, as you normally would.
[This service is not available in some countries like Malaysia].
- Maintain a list of prescription and important non-prescription medications you and your family take.
- Create a personal health record for you and your family including drug allergies, existing medical conditions, past medical treatments and physician contact information.
- Keep records of your insurance claims and carry your current insurance card with you.
- The Year 2000 Issue. Implications for public Health Information and Surveillance Systems, Centers for Disease Control and Prevention White Paper - May 1996.
- Pharmaceutical Alliance for Y2K Readiness, Sept.22, 1999
FIVE LEVELS OF RATIONAL USE
Dr. Andrew Herxheimer
Former Senior Lecturer in Clinical Pharmacology and Therapeutics at Charing Cross and Westminster Medical School, University of London;
Former Editor of the Drug and Therapeutic Bulletins; and currently Advisor to the International Society of Drug Buleltins (ISDB).
Wherever we work - teaching hospital or rural clinic, developing or industrialised country - we are still far from the rational and optimal use of drugs. This is not to say that progress in some respects and places has not been impressive yet the goal remains elusive In asking why, we need to look at the essential elements of rational drug use:
First and foremost, we have to decide whether a drug is in fact necessary at all for treatment of a problem or whether there is a better alternative. Headache, for example, any be relieved by lying down in a quiet place; diarrhoea is better managed by rehdydration therapy than by a medicine.
If we decide that a drug is needed then the type of drug action desired must be identified. For instance in a man with infected chronic bronchitis and some bronchial spasm, should an antibiotic, a bronchodilator, or a drug to loosen or liquefy the brochial secretions - or more than one of these, be selected? And it we want to use a brochodilator, do we want a sympathomimetic, a theophylline preparation or a corticosteroid?. This widen the air ways by different mechanisms and each has its advantages and disadvantages. Of the selective sympathomimeric bronchodilators, salbutamol and terbutaline are equally effective and safe, and the choice depends on the a availability and cost of the most suitable preparations.
Having chosen the type of drug action available the drug for the purpose in the most appropriate form must then be selected, taking into account efficacy, safety, convenience and cost. For example, tetracycline, ampicillin and erythromycin may be available for a patient we wish to treat with an antibiotic. Choice will be influenced by the patern of bacterial resistance in the community - if many strains of the relevant bacteria are resistant to tetracycline then it is unlikely to work. If the patient is allergic to penicillins then ampicillin cannot be used. At the same time the form of the drug has to be chosen, whether tablets, capsules, a liquid medicine or an injection.
Although tablets are the simplest and cheapest, some drugs cannot be maintained in this form and have to be given in capsules. And while injections are absorbed more completely and usually more quickly - advantages if treatment is urgent - they cost much more, must be given by a trained person, and some drugs are too irritant to be injected into muscle or directly into vien.
Next the dose has to be considered: how often the drug should be taken, at what intervals and how long treatment should be continued. Clearly, if too little of the drug is given or the right dose for the wrong period of time, the treatment is less effective. Conversely if the dose is too high or too frequent, or the treatment continues for longer than necessary, the patient id more likely to suffer unpleasant or even dangerous side effects, and valuable medicine will be wasted.
For each drug preparation there is a recommended starting dose. Often this is different for adults, babies, older children, and people over the age of 60 years. A large heavy person may need a bigger dose than a small person. Furthermore people vary in their responses to drugs; a correct dose is enough to achieve the desired effect, and if the dose first chosen does not achieve this and the drug is well tolerated, then it should be increased.
Frequency depends on how long the effect of one dose lasts, and on whether the effect is intended to be continous. Antibiotics for example should be given in such a way that the amount in the body is always enough to kill the bacteria or to prevent them multiplying, e.g. doses of ampicillin are given every 6 hours. On the other hand for an analgesic to relieve a pain which is likely to get less within a few hours, as after a sprained ankle, it is not necessary for the drug to act continuously. It is better to wait and see whether pain s still a problem when the effect of the drug has worn off. The correct duration of treatment depends on what the drug is meant to do. If it is used to relieve a symptoms, then it is needed only while the symptom is there. An antibiotik to cure an infection must be given for long enough to allow the body,s defences to kill the infecting organisms, and this varies with different types of infections and with the site of the infection. A tuberculous infection must be treated for at least 6 months, whereas an active pneumonia may only require treatment for 7 days.
Lastly, the patient (or someone on his behalf) needs certain information about the medicine if it is to be used effectively and safety. Patients should be active partners in the treatment process, not passive receptacles for a medicine. They should know its name, understand what it is for, and how it is meant to help. They must also know how to take it correctly; how much, how often, whether with food or on an empty stomach, and for how long. They should know what to do if the medicine does not work as expected, that is has unwanted effects, and what these might be in order to take appropriate action.'
The health worker who prescribes or gives the patient the medicine can explain this. Some of the information can also be put on the label of the drug container, although there is not room for much. But most patients find it hard to take in everything, and even, more difficult to remember later when they are back home, so it is helpful to give them written information about the medicine wherever posibble. Even if the patient cannot read, there is often someone in the family or a neighbour who can and will be able to remind him or her about important points. Many countries are now producing and testing standard information leaflets and others are experimenting with the use of diagrams, e.g. of a rising and setting sun to indicate intervals drug when should be taken.
Progress towards rational drug use has so far been greatest on level 3, the selection of drugs within therapeutic categories. This has been a major target or WHO's Essential Drugs Programme. Progress has also been notable on level 1, with the increasing replacement in many countries of symptomatic and ineffective anti-microbial treatment for diarhoea by oral rehydration therapy. The other 'levels of rationality' have had much less attention. All health workers, from doctors, nurses and pharmacists to village health workers need clear guidelines for the treatment of common conditions, giving sufficient detail on 'level 4'; when and how to use the most important drugs. WHO has begun to produce model guidelines of this kind, but their extension, further development and adaptation to differing regional, national and local needs deserve high priority in national drug policies.
In all this activity however the patients have been largely neglected, although their active involvement could have real impact on rational drug use and contribute greatly to their health. But waiting until people are ill is to choose the least effective teaching time. What we should be doing is to teach the healthy adult - or better still child - the basic principles that underline the use of medicines, such as what happens to drugs in the body, and that large doses are more likely to cause unwanted effects than smaller ones. To the best of my knowledge at the present time, this sort of teaching is not being done systematically anywhere in the world.