| PURPOSE AND CONTENT The purpose of this session is to train participants how to describe the drug use situation in a particular setting. Experience from many countries has encouraged the development of a standard method of measuring drug use practices, based on drug use indicators. This unit will expose you to the process of implementing a drug use indicator study. The three activities will help you to gain experience in carrying out the basic steps of a real study through simulation exercises. By the end of the session, you will be able to:
Researchers and need to understand drug use problems so that they can work to improve performance. (see Introduction to "How to Investigate Drug Use in Health Facilities"). "Drug Use" involves not only the actual prescribing of drugs but also a wide range of behaviors that occur during the drug use encounter, the interaction between the prescriber (provider) and the patient. These behaviors include the processes of making a diagnosis, prescribing, dispensing, and use of drugs by the patient. Drug use indicator studies can be used for four main purposes. (See Table 4, P. 26 of the WHO Manual). These purposes are:
For each different purpose, different sampling methods may be required. In assessing drug use, you would ideally want to know about the whole process of care, but unfortunately this is not always possible. A set of limited indicators, namely the Drug Use Study Indicators, has been developed to assist in such an assessment. These indicators have been selected through a process of discussion, field testing, and revision, involving a wide range of people coordinated by INRUD, with support from WHO/DAP. Other indicators may be used when different needs arise. The WHO/DAP indicators are divided into three groups: Prescribing Indicators; Patient Care Indicators; and Facility Indicators. The list of the indicators follows:
PATIENT CARE INDICATORS 6. Average Consultation Time 7. Average Dispensing Time 8. Percentage of Drugs Actually Dispensed 9. Percentage of Drugs Adequately Labeled 10. Patients' Knowledge of Correct Dosage FACILITY INDICATORS 11. Availability of Copy of Essential Drugs List or Formulary 12. Availability of Key Drugs B. DESIGNING A DRUG USE INDICATORS STUDY The design of a drug use indicators study will vary from setting to setting. The nature and scope will depend on many factors, such as: • the information needs of health managers • the capabilities of the record systems • the types of providers whose behavior is to be described • the resources available to carry out the work The purpose of the study will determine which indicators to use and how the study should be designed. Possible purposes of drug use indicators studies are: • Describe current treatment practices
• Compare performance among health facilities or regions
• Assess the impact of an intervention
• Periodic monitoring of drug use.
A great deal of work has been done to determine the optimum sampling arrangement to assess a drug use situation. (See Session Guide, Sampling for Drug Use Studies and the Annex to the WHO Manual)] When an assessment of the drug use situation in a region or a set of health facilities is required, a sample of 30 prescriptions from each of 20 sites is the optimal arrangement. If the number of sites can be increased this should be done. When a survey is undertaken to measure impact of an intervention or to assess practices in individual facilities, at least 100 prescriptions per site should be studied. The basic design for an indicator study carried out to characterize drug use practices in a region would call for a sample of at least 20 health facilities, with at least 30 encounters being recorded in each facility. Studying 20 facilities, or more if possible, will increase the reliability and generalizability of indicators. If you have identified fewer that 20 health facilities of interest, clearly all facilities should be included, and the number of encounters studied in each facility should be increased to ensure that 600 observations or prescriptions are included. However in this case, because the number of facilities studied is low, conclusions about practices in other facilities that were not studied should be advanced cautiously. If there are more than 20 facilities in the study areas that will be included in the prescribing survey, it may be necessary to draw a sample of facilities for the study from the larger population. There is danger of introducing error into the results of the prescribing analysis at this step by selecting facilities for the sample which share a certain bias that might influence their prescribing patterns. One example would be only selecting and collecting data from facilities that are easier to reach; because they are more accessible, such facilities might also have more reliable drug supply and because of this, their prescribing practices might be different.
Percent Prescribed by Generic Name Percent of Patients Receiving Antibiotics Percent of Patients Receiving Injections Percent of Drugs Prescribed on the EDL Two forms for collecting these indicators (the Simple Prescribing Indictors Form and Detailed Prescribing Indicators Form) included in Annex 1. The following steps describe the process for measuring the prescribing indicators.
One of the basic decisions to be made in designing an indicators study is whether to use retrospective data extracted from historical records, or prospective data collected from current patients as they are treated. There are advantages and disadvantages to both types of data collection. Retrospective treatment records exist in many facilities, although often in different forms. These records are typically kept as part of the normal morbidity or drug consumption recording and reporting systems, or else as part of a facility-based system of medical or pharmacy records. Retrospective data are usually easier to collect than prospective data, and suffer fewer potential biases. If they are well-maintained, it is often possible to define a retrospective study period of a year or longer, and spread cases throughout this period. This serves to minimize any possible bias due to seasonal variations in health problems. It also means that treatment is observed at many points in the drug supply cycle. If practices tend to change during periods of drug shortage, this will be reflected in the data sampled from these different periods. The major weakness of retrospective data is that they are often incomplete. Individual or entire series of records can be missing, either because they were misplaced or because they were simply not recorded in the first place. The validity of retrospective data is often difficult to verify. Since retrospective records are usually kept for a different purpose than prescription analysis, key data elements such as an exact identification of the pharmaceutical prescribed, health problem, or even whether a drug was dispensed as prescribed, can be consistently missing or of uncertain accuracy. Prospectively collected data have the advantage that they are usually complete. However, since prospective treatment data are often collected over a very short period of time, they can suffer biases due to seasonality, peculiarities in staffing, inconsistencies in the supply cycle, or most importantly, due to the fact that providers are aware that their behavior is being observed. Of course, in the absence of retrospective sources of data, study planners have little choice but to collect data prospectively, and try to guard against these possible sources of bias. Both sources of data have been validated in INRUD studies. The principle question to answer in deciding to use retrospective or prospective encounter data is whether adequate sources of retrospective data exist. The useful elements for designing a retrospective sample that these historical data provide include:
Whenever possible, use retrospective data spread over the past year. Draw a sample of records using one of the techniques described in the sampling module (usually systematic or multistage sampling.)
There are many different types of prescribing encounters that take place in an outpatient health facility. There are sometimes separate clinics for adult and pediatric cases, and even when these cases are mixed in the same clinic, prescribing practices for them will be quite different. New patients are frequently separated from re-attendance for an existing health problem, both in a record-keeping system and also in the type of care they receive. Similarly, cases presenting for curative care are managed differently from those who attend to receive preventive services such as vaccinations, prenatal or postnatal care, or child health services. The usual indicator study includes new patients attending for curative complaints.
EXCLUDE REPEAT ATTENDANCE AND PREVENTIVE OR PROMOTIVE CASES. 3. Define Drugs to be Included as Antibiotics There are a number of different ways in which anti-microbial agents are classified in different settings. Sometimes drugs such as anti-protozoals, anti-helminthics, or anti-tuberculosis agents will be placed in a separate category from other antibiotics, while other systems organize all of these products under a single category of anti-infectives or anti-microbials. The indicators of antibiotic use are quite sensitive to whether or not certain groups of drugs are included as antibiotics, especially in environments where problems such as parasitic infestation or tuberculosis are common. Another issue in the definition of antibiotics for an indicators study is whether to include antibiotic topical preparations, such as skin creams, ophthalmic ointments, or ophthalmic drops. In areas where trachoma, bacterial conjunctivitis, or bacterial skin infections are common, these products may be widely used. Metronidazole is a problem to classify. At primary level it is used as an anti-parasitic agent, though it can be effective against anaerobic bacteria. For purposes of indicator studies, we recommend that metronidazole NOT be classified as an antibiotic. See Page 15 of Manual for further explanation and for the recommended list of drug groups to include as antibiotics.
4. List Drugs to be Classed as Generic Data collectors and coders will need to have specific lists of drugs they are to class as generic in order to be able to compute the proportion of drugs prescribed as generic products. Often an essential drug list or national formulary will be written in generic terms and can be used as the basis for such a list of generic products supplied in a health system. There are certain drugs that are difficult to class as generic or branded. For some products, such as aspirin, it makes sense to include all generic and branded forms as generic, since they are used interchangeably and tend to have similar costs. Although most combination drugs would not be classed as generic, there are some combinations in common use that would qualify, such as co-trimoxazole (trimethoprim-sulfamethoxazole). Panadol is often thought to be a generic name though it is not. Abbreviations (e.g. CQ as chloroquine or HCT as hydrochlorthiazide may be counted as generics.) The second major category of INRUD indicators measures the adequacy of the patient care process according to certain minimum standards of performance. These indicators include:
The length of time that a health worker spends with a patient and the type of examination performed set important limits to the adequacy of diagnosis and treatment from both a clinical and social perspective. Patients who emerge from the clinical process with prescribed pharmaceuticals should, at a minimum, understand the timing and amount of each oral and topical medication.
The following activities are recommended to plan data collection for the patient care indicators.
To determine how and when the data required to measure the indicators of patient care will be collected, it is necessary to become familiar with the organization of services at sample health facilities. In particular, data must be collected about both the clinical examination and drug dispensing procedures. In addition, a non-disruptive way must be found to intercept and interview patients at some convenient point after their drugs have been dispensed. It may be impractical to observe in advance the clinic activities in all facilities in the sample. However, health facilities in a region are often organized in a similar way, so observations in a few facilities should be sufficient to design efficient data collection processes for the patient care indicators. However, if there are different types of facilities to be studied, for example, large multi-provider polyclinics and smaller, single-provider health centers, a few facilities of each type should be observed to ensure that data collection can be organized in all. Training of data collector should prepare them for different situations.
To measure the length of time the patients are seen in the treatment and dispensing process, it is necessary to develop a method for observing the starting and ending times of these processes for individual patients. To smooth some of the variations in time that occur with different diagnoses, it is recommended that the patient care process be timed for at least ten individual patients. Based on the logistics of care at health facilities, you will need to describe the procedures to be used to record times for ten patients. There are two basic alternatives:
An example of a form in which to enter this information is included in Annex 1. Whichever method is selected, it is resting the beginning of observations takes place at a random point in the middle of a clinic day. This way, the results will not be overly influenced by the rush to see patients at the beginning or end of a clinic, or by freshness or fatigue on the part of health workers. 3. Define Criteria for Adequate Patient Knowledge about Medicines At some point during the examination or dispensing process, medications prescribed for a patient should be explained. Ideally, this explanation would include the reasons why each particular medication is being given, how each drug should be taken, and any precautions or possible side effects explained.
AT A MINIMUM, PATIENTS SHOULD BE ABLE TO DESCRIBE WHEN AND IN WHAT QUANTITY EACH SELF-ADMINISTERED DRUG IS TO BE USED. Because of the difficulty in reliably evaluating other factors, it is recommended that the minimum criteria of timing of administration and dose be used. These criteria should be evaluated for each oral or topical medication received by the patient during the visit. Failure to know about any of the drugs prescribed should result in patient knowledge being scored as inadequate. 4. Describe the Procedures for Evaluating Patient Knowledge about Medications A procedure must be defined for intercepting and interviewing patients after they have received their medications from the dispensary. Because such a process can disrupt patient flow as well as intimidate health workers, an effort should be made to find an area to do this that is removed from the main clinic area. The method for recording results will differ depending on the pharmaceutical knowledge of data collectors. If data are being collected by pharmacists or physicians who are familiar with each drug, it will be possible for them to evaluate adequacy of knowledge in the field and simply record each patient interviewed as having adequate or inadequate knowledge. If this system is used, the proper dosing of all major medications should be reviewed during the training of data collectors, and the data collectors should be provided with a drug list containing this information to refer to in the field.
If data collectors are less experienced, they may simply record the information on each drug and the patient's knowledge about it during the interview, and allow these records to be evaluated for adequacy later by a single experienced person on the study team. If this method is chosen, the data collector should record, for each oral and topical drug prescribed to the patient, the drug name, strength, number of units (pills, tubes, etc) dispensed, and the patient's explanation of how and when the drug is to be taken. As with the other two patient care indicators, it is best to sample patients from the middle of a clinic day.
The ability of prescribers to use drugs rationally is influenced by many features of the environment in which they practice. These features include access to relevant, impartial pharmaceutical information; adequate supply of products needed to treat common health problems; and a regulatory climate that encourages the proper use of drugs in the private sector. There are two core drug use indicators aimed at measuring factors at the facility level, including:
The activities needed to plan for measuring these indicators are described below.
One sign of the acceptance of the concept of essential drugs by national authorities and the basis for rational drug use in the public sector is the development of a national essential drug list. In order for such a list to be most effective, it should be disseminated to all health facilities at the local level to guide decisions about the purchase and therapeutic use of drugs. It should be determined before the study whether there is a national essential drug list, when the list underwent its most recent revision, and in what form the list has been distributed to health facilities. While in the field, data collectors are expected to ask prescribers in each facility to show them a copy of the list in some form. The list must be in the facility.
Identify key products (name and formulation) to survey for availability in facility stores. It is important for data collectors to know all common proprietary names as well as generic names for these drugs, since from a therapeutic perspective branded and generic drugs are equivalent. Choose between 10 and 15 drugs. [See page 23 of WHO/DAP manual.] On a summary form for each facility, data collectors should check the products on each list that are found in any amount in health facility stores. An example of such a form appears in Annex 1. 1. Preparation Careful preparation for the survey is essential. After the steps listed above have been completed, the next stages in doing the survey are:
2. Data Collection When collecting data in the field, follow these steps:
It is most important that the quality of data collection is supervised in the field. There are two levels of analysis that are done. First, at the facility itself a report should be made to the staff about the survey. Second, the data for the twenty facilities should be aggregated to produce a combined result. 1. Presenting at the Health Facility At the end of the survey activities in each facility, add up and calculate the percentage or average results. Then ask all the staff involved, including the registration clerk, the dispenser, and the dispensary assistant, to sit down to review the results. Always start off positively -- identifying something good that has been observed. Fill in the Facility Indicator Reporting Form [link] (see Annex 1) and leave it with the staff. Start with the prescribing indicators and discuss how their average drugs per consultation, percentage antibiotics, injections, and generics compare with what should be, what occurs in other facilities in their country, and other countries. Then discuss the patient care form. Start by discussing the diagnostic process. Talk about history, examination, diagnosis, prescription, dispensing, and patient education. Point out how each of these activities takes time, and how important physical examination is, both for making a diagnosis and for patient satisfaction. Then describe their results and talk about how their results compare with other studies. A table of results from different studies is available in the WHO manual. Finally, discuss the facility form, examining the availability of drugs, and the presence or absence of the essential drugs list. 2. Aggregating Facility Results As each facility is studied, enter the summary results into the Drug Use Indicators Consolidation Form (Annex 1). Add up and average these results. These results will then be the summary results for the survey. It is always interesting to look at the individual facilities, but with a small sample size of prescriptions, it is not possible to make absolute comparisons. The differences may be interesting, but are not conclusive and would need to be followed up with further studies. The data from the consolidation form can be graphed, as shown in the examples below. EXAMPLES OF GRAPHS FROM FACILITY DATA
Sample-wide Distribution of Antibiotic Use
Sample-wide Distribution of Consulting Times
Facility Specific Antibiotic Use
Facility Specific Consultation Times
It is possible to undertake a Drug Use Indicators study in nearly all possible environments. Members of the INRUD network have done a great deal of work with support from WHO to standardize the methods and to make the process as easy as possible. When undertaking such a survey the more attention which can be paid to detail the greater the value and the accuracy of the survey. Once reliable data are available it are often possible to identify the priority problems and to decide which problem to address first with an intervention. Data Collection and Entry Rationale In this activity you will process the data collected from a prescribing study and do calculations and tabulations. Instructions
WORKSHEETS TO BE USED :
RANDOM NUMBER TABLE
ACTIVITY TWO DATA PRESENTATION Rationale In this activity you will review the results shown on Worksheet 2.1. You should prepare to present the results of a facility to the staff members. Instructions 1. Review the results of the facility allocated to your group. 2. Identify what are good and bad results compared to other facilities and to other countries (Page 74 of the WHO Manual). 3. Decide if you want to show the results using visual aids. If so, prepare them. 4. Start off your presentation with the positive -- the "good" results. 5. Then identify the problem areas -- the "bad" results. 6. Discuss with the facility members the possible reasons for the results. 7. Make an action plan with the participants for what they will do about their problems.
NOTE: Not every group will present. Groups will be randomly selected. Worksheet #2.1 EXAMPLES OF INDICATOR RESULTS FROM DIFFERENT FACILITIES
Annex 1 : Examples of Forms Examples of Forms (note that there should be 2 copies of the forms in the binder) Prescribing Indicators Form Detailed Prescribing Indicators Encounter Form Patient Care Form Facility Summary Form Facility Indicators Reporting Form Drug Use Indicators Consolidation Form
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Average number of Drugs Prescribed
