Session Guide
Managerial and
Regulatory Strategies
to Improve Drug Use
MANAGERIAL AND REGULATORY STRATEGIESSESSION GUIDE
Managerial and Regulatory Strategies to Improve Drug Use
SESSION GUIDE
PURPOSE AND CONTENT
Educational approaches to promoting effective, safe and economical drug use are appealing and potentially quite successful. At the same time, policymakers, health managers, and other officials may find that educational strategies alone are not sufficient to achieve the desired results. Managerial and regulatory strategies can be an important supplement to educational approaches.
Managerial strategies attempt to structure information, information flow, and the decision process to achieve more cost-effective use of pharmaceutical resources. This implies the involvement of relevant decision-makers at appropriate points in the process. Managerial strategies may take a major effort but are likely to be the most successful and sustainable.
Regulatory strategies are generally aimed at saving money or preventing improper use of drugs. Regulatory approaches tend to be focused and rather inflexible. Because there is limited opportunity to make adjustments once a regulatory effort has been initiated, it is important that regulatory initiatives be well-conceived and well-tested before being launched on a large scale. Regulatory actions may have adverse unintended impacts which could adversely affect the program. Great care should be taken in planning, implementing and monitoring the intended and unintended impacts of any regulatory action.
OBJECTIVES
[VA1]
To develop your ability to:
1.Recognize and understand the range of managerial and regulatory strategies which might be used to improve drug use.
2.Select for testing and possible implementation those strategies which appear best suited to your program's needs, circumstances, and resources based on consideration of expected magnitude of impact, likelihood of success, political and cultural feasibility, technical feasibility, and cost (economic feasibility).
- Develop and implement chosen strategies as successfully as
Possible within the constraints of your program and environment.
PREPARATION
Read the Session Notes.
FURTHER READING
Managing Drug Supply 2nd edition, Chapter 31, "Promoting Rational Prescribing," 1996, pp. 472479.
WEB SITE ADDRESSES
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MANAGERIAL AND REGULATORY STRATEGIESSESSION GUIDE
Managerial and Regulatory Strategies
to Improve Drug Use
SESSION NOTES
A.OVERVIEW
Educational approaches to promoting effective, safe and economical drug use are appealing and potentially quite successful. At the same, those with responsibility over large numbers of prescribers and dispensers, and those responsible for public essential drug programs may find that educational strategies alone are not sufficient to achieve the desired results. Managerial and regulatory strategies can be an important supplement to educational approaches.
[VA2]
Managerial strategies attempt to structure information, information flow, and the decision process to achieve more cost-effective use of pharmaceutical resources. This implies the involvement of relevant decision-makers at appropriate points in the process.
TABLE 1
Possible Managerial Strategies to Improve Drug Use
Structure Decisions
Selection & Procurement
•Essential drug lists/national formulary
•Morbidity-based quantification
•Drug procurement review & feedback to decisionmakers
Distribution
•Distribution review process
Prescribing & Dispensing
•Structured drug order forms
•Standard diagnostic & treatment guidelines
•Course-of-therapy packaging
•Effective labeling complete symbolic
•Audits plus "feedback" to providers
•Required consultations or justifications
Financing
•Pricing drugs according to health impact
•Patient costsharing (e.g., $0.20 per prescription)
Table 2 lists possible regulatory strategies to improve drug use. This listing of strategies does not necessarily mean that the strategy is recommended or that it has been proven to be effective in improving drug use. For example, public drug revolving funds often adjust drug prices according to the health impact of a drug (eg. lower prices on antimalarials), so this possibility is listed in Table 1.
[VA3]
1.Selection Procurement
Essential drug lists (EDLs) can be used to set procurement priorities for the country or program which establishes and implements the list. Drugs on the list should represent the safest, most effective, locally appropriate, economical choices possible.
To the extent that inappropriate drug use occurs as an unintended result of poor quantification of drug requirements, use patterns might be improved by better forecasting of needs. A morbidity-based approach to quantification, using standard treatments and prevailing morbidity patterns could improve the situation.
Often drug ordering (requisitioning from above or procurement from the outside) is a low priority for senior medical officers and other senior health officials who may be best able to make judgements about the cost-effectiveness of particular choices. As a result, procurement officers acting with inadequate information or personal bias may make poor ordering decisions.
Systematically reviewing draft drug orders according to expenditures by therapeutic class and within therapeutic class and providing this information to key decisionmakers has been shown to result in improved drug orders improved in terms of the therapeutic benefit derived from a limited drug budget.
2.Distribution
Similarly, a retrospective review of drugs distributed to various facilities can provide valuable insights. In one small country, for example, the drugs requisitioned by individual districts are periodically reviewed. District averages are compared, and districts whose pattern differs significantly from the others are informed of the difference. This has resulted in reduction in the overuse by some districts of products such as injectable B vitamins.
Kit systems have been used to guarantee that some drugs reach peripheral health facilities. With these systems there are nearly always shortages and overstocking. But the cost of the drugs may be competitive and security may be improved. When these systems are combined with training and the provision of standard treatment guidelines, prescribing may improve. However, kits are better suited to emergency situations rather than for long term-drug supply. (See Chapter 27 of MDS2 Pages 408-418)
[VA4]
3.Prescribing and Dispensing
There are a number of management techniques which directly target prescribing and dispensing. Perhaps the most potentially powerful technique is the development and implementation of standard treatments.[Link to session on Standard Treatments] Particularly when they are focused on a selected number of priority health problems, standard treatments can serve as the common thread uniting the essential drug list, health worker training (preservice and inservice), monitoring, and supervision. Often standard treatment guidelines are combined with training in proper diagnosis. These standard treatments can also be used for examining students, assessing quality of care and auditing performance.
Structured drug order forms provide the prescriber with a drug order sheet containing a preprinted list of preferred drugs and dosage regimens for key drugs (usually antibiotics). Such forms have proven to increase the cost-effectiveness of prescribing for hospital inpatients in the United States. Structured drug order forms can be used in certain outpatient settings as well as inpatient settings. [Space for scanned image of drug order form File name strucord.gif]
Automatic stop orders may be useful particularly in hospital settings. With this system, when a drug is ordered there is an automatic review after a specified period of time and if the drug is not reordered, it is stopped. In some nursing homes for elderly patients sedatives may be overused. There is a place for regular review. Some drugs (e.g. diazepam) lose their effectiveness after a period and their continuous use should be discouraged.
Establishing a courseoftherapy prepackaging system encourages prescribers to agree upon the most costeffective average length of therapy for commonly used drugs hopefully avoiding overdosing or underdosing. It also increases the chance that patients will actually be given a full therapeutic course of a drug. Prepacks may also help with dispensing. [Link to Role of Dispensers]
Absent, incomplete, or unreadable labeling of drugs dispensed to patients reduces the chances they will be used correctly once they are in the hands of the patient. Effective labeling, including the possibility of color-coded and symbolic labeling, may prove quite important. Labeling for nonliterate people may also be necessary for some village health workers to correctly dispense even the small variety of drugs which they may have.
Audit plus feedback to providers has been shown to be a very effective technique for changing prescribing behavior. The "audit" consists of a systematic review of individual prescription patterns. It may reveal, for example, that one provider uses chloramphenicol more than any other antibiotic, while other providers use primarily ampicillin or cotrimoxazole. This information is fed back to the provider. Typically, analysis based on one's own prescribing and comparisons with one's peers are effective stimulants of change.
The audit and feedback process can be costly. But in a hospital which is consuming large quantities of drugs, the process can be costeffective, that is, it can save more money than it costs to run.
[VA5]
Case study from Uganda (
Prescribing audit with feedback intervention in six regional hospitals and Mulago referral and teaching hospitals (Uganda). Ogwal-Okeng JW, Anokbonggo WW, Birungi H.
In Uganda malaria and infectious diseases are leading causes of mortality and morbidity in Uganda. But there are shortages of antimalarials and antimicrobial agents in health units. Irrational prescribing is thought to be the main reason for this shortage.
An intervention was undertaken to reduce the use of chloroquine injections and to increase the use of oral chloroquine in uncomplicated malaria; to reduce use of antimicrobials in malaria and trivial infections; to reduce use of multiple antimicrobial agents per case and to encourage the use of generics in prescriptions.
A study was undertaken in six hospitals, selected on the basis of being regional referral units and training centers for various medical cadres; and Mulago, the national referral and a university teaching hospital. The units were randomly distributed to control and study units. One hundred prescriptions from each hospital were collected and analyzed during each phase of the survey.
In the intervention results of the first survey were fed back to three study hospitals in a face-to-face discussion with prescribers. Mulago results were discussed with the director who passed a circular to the prescribers. (A regulatory response). A second survey was conducted three months later and the results were similarly fed back to six regional hospitals. An evaluation was finally done three months later in all the seven hospitals.
The results of the study showed that in the study hospitals there was a significant reduction in prescriptions of chloroquine injections and an increase in the use of chloroquine tablet prescriptions for uncomplicated malaria. There was also a reduction in the use of antimicrobial agents in malaria. In Mulago Teaching Hospital, where the director chose an administrative measure, the effect was dramatic in improving the prescriptions, but the change was
short-lived. [Put 2c3_grp1 and 2 here]
The conclusions of the researchers was that face-to-face feedback of survey information improved prescriptions for uncomplicated malaria but had no effect on polypharmacy in this condition.
In another study carried out in Nepal ( researchers assessed the effect of regular supervision and they found that there was a significant decrease in injection practices, an increase in consultation time and an increase in prescribing in accordance with standard treatment schedule.
While this method takes considerable effort the results are consistently positive and this strategy can be recommended. For more information, see MDS 2 Pages 472-475. If a Drug and Therapeutic Committee exists in a hospital this approach may be one of the methods the committee could use to improve prescribing.
Some health services, particularly at hospitals, require specialty consultations or documented justification for using certain drugs. Newer antibiotics, some gastrointestinal drugs, cancer drugs, and cardiac drugs are often put in this category.
4.Financing
Public sales programs (drug revolving funds) sometimes adjust drug prices according to the health impact of an individual drug (e.g., lower prices on antimalarials, higher prices on cough medicines). This should encourage patients to accept prescriptions for vital and essential drugs, while making nonessential drugs less attractive. Although there is common sense in this approach, there is little evidence to show that it actually works in a primary health care setting.
[VA 6]
C.REGULATORY STRATEGIES
Regulatory strategies are generally aimed at saving money or preventing improper use of drugs. Regulatory approaches imply a degree (sometimes large) of arbitrariness. They tend to be focused and rather inflexible. Because there is relatively less flexibility to make adjustments once a regulatory effort has been initiated, it is important that regulatory initiatives be wellconceived and welltested before being launched on a large scale. There are always risks of unintended adverse effects of such regulations.
TABLE 2
Possible Regulatory Strategies to Improve Drug Use
Restrict Decisions
Selection
•Registration based on medical need
Distribution Controls
•Levelofuse distribution restrictions
Prescribing Controls
•Levelofuse prescribing restrictions
•Automatic stop orders
Dispensing Controls
•Limits on number of different drugs per patient (e.g.,"3-drug rule")
•Limits on quantities of each drug (e.g., "3 day rule")
[VA7]
1.Selection
In some countries, such as Norway before they joined the European Union, regulations required not only that a drug be shown to be safe and effective, but that it also be shown to be medically needed. "Medical need" usually implies that the product offers distinct therapeutic advantages over other products on the market, and at a reasonable price. Such an approach may not be possible at a national level but could implemented in a regional or hospital formulary. In some countries drugs have been banned because they were dangerous or ineffective. WHO has promoted this approach for antidiarrheal drugs. (
The main intervention used by WHO was the distribution of some 15,000 copies of a WHO review document on "antidiarrhoeal" drugs through a variety of official and NGO channels, against the background of worldwide media coverage and activities of dedicated groups and individuals. In 1994 they studied the effect of their actions on countries' regulatory positions. They found that during the five year period 1989-1993, regulatory actions occurred in 16 countries on 21 occasions. Most actions concerned antimotility drugs; a few were against adsorbents, "antidiarrhoeal" drugs containing antimicrobials, or adult formulae. Six countries acted against large and
heterogenous groups of "antidiarrhoeal" drugs. Most actions occurred in the two-year period immediately after distribution of the review document. What is not clear is if actual prescribing to patients actually improved.
2.Distribution Controls
Levelofuse distribution restrictions prohibit distribution of certain groups of drugs to health facilities where the usual staff are not adequately trained to use the restricted drugs. For example, in Zimbabwe, drugs on the Essential Drugs List are grouped into S, A, B, and C categories, according to level of usage.
3.Prescribing Controls
Levelofuse prescribing restrictions limit prescribing of certain drugs available at health facilities to doctors, and perhaps to specialists. This is an alternative to requiring specialty consultation or documented justification for using certain drugs. As with consultation or documentation, newer antibiotics, some gastrointestinal drugs, cancer drugs, and cardiac drugs are often put in this category. One danger of this approach is that busy doctors or specialists may sign prescriptions in advance in case they are not available when the drug is needed. This defeats the whole point of this approach.
Automatic stop orders already mentioned as managerial strategies can be established for hospitals to specify that after a certain number of days, the order for an individual drug will automatically be stopped unless it is renewed by the doctor. Symptomatic drugs may be discontinued after three days, for example, and antibiotics after five to ten days.
4.Dispensing Controls
Typical dispensing controls limit the number of different drugs per patient (to perhaps two or three) or the quantity of each drug (to perhaps three or five days' supply). Either type of limit is arbitrary and risks certain negative consequences. For example, a "3drug rule" in a setting in which an antibiotic, a vitamin, and an antidiarrheal are the provider's first three preferences before oral rehydration salts (as is still the case in some places), would mean no ORS for the patient.
Detailed studies have been undertaken in the United States on the effect of introducing a "cap" on the number of drugs which could be dispensed. In 1982, a 3-drug limit was placed on patients in one state (New Hampshire). Researchers compared New Hampshire patients who prior to the cap had received more than 3 drugs with similar patients in another state (New Jersey) who were unaffected by the cap.
The study showed that the number of drugs utilized did fall, but there was an associated increase in nursing home admissions. Almost twice as many patients were admitted.
This study clearly showed that unexpected effects may occur as a result of regulatory approaches.
Monthly Proportions of Study Patients
in Nursing Homes - Effect of Caps
On the other had, a "3day rule" might save money, but also contribute to underdosing, to increased bacterial resistance, and to giving patients the false impression that only three days' supply is needed for any medicine.