Session Guide
Managerial and
Regulatory Strategies
to Improve Drug Use
MANAGERIAL AND REGULATORY STRATEGIES
SESSION 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.
3.
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PREPARATION
Read the Session Notes.
FURTHER READING
Managing Drug Supply 2nd edition, Chapter 31, "Promoting Rational
Prescribing," 1996, pp. 472-479.
WEB SITE ADDRESSES
http://www.who.ch/programmes/dap/icium/posters/4A1_Text.html
http://www.who.ch/programmes/dap/icium/posters/4A4_Text.html
http://www.who.ch/programmes/dap/icium/posters/4B1_Text.html
http://www.who.ch/programmes/dap/icium/posters/4B2_Text.html
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SESSION 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.
[VA3]
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 decision-makers
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 cost-sharing (e.g., $0.20 per prescription)
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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.
[VA4]
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 decision-makers
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
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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)
[VA5]
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 treatmentsParticularly 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 (pre-service and
in-service), 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 pre-printed 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
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 course-of-therapy pre-packaging system encourages prescribers to
agree upon the most cost-effective 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.
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 non-literate people may also be necessary for some village
health workers to correctly dispense even the small variety of drugs which they may
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have.
[VA6]
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 cost-effective, that is, it can save more
money than it costs to run.
[VA7]
Case study from Uganda
(http://www.who.ch/programmes/dap/icium/posters/2C3_Text.html)
Prescribing audit with feedback intervention
in six regional hospitals and Mulago referral
and teaching hospitals (Uganda). OgwalOkeng 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.
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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.
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.
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In another study carried out in Nepal
(http://www.who.ch/programmes/dap/icium/posters/2e3_txtf.html) 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.
[VA 8]
A randomized controlled trial to test the impact of standard treatment guidelines (STGs)
plus training and supervision on rational prescribing was carried out in Uganda (Kafuko
J, Zirabumuzale C, Bagenda D; 1994, UNICEF Uganda). Prescribing quality, as judged
by the % of prescriptions (Px) conforming to standard treatment guidelines, did not
improve when only guidelines were disseminated, but greatly improved if dissemination
of the guidelines was accompanied by training and supervision.
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Impact of training & supervision on
treatment according to STGs in Uganda
% STG compliance
60
50
40
30
20
10
0
Control
STG
Pre
STG+train
STG+train+sup
Post
Managerial and Regulatory Strategies
4.
8
Financing and economic strategies
Economic strategies [VA10] are managerial strategies that use economic incentives to
influence the decision process of prescribers and patients such that they use medicines
in a more cost-effective manner. Providers may be induced by budgets and financial
incentives and patients by cost sharing.
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 non-essential 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.
Unfortunately many health systems include perverse financial incentives whereby there
are economic inducements to providers or patients to use drugs irrationally. Some
examples are discussed below.
[VA 11-14]
User fees may also have an impact on drug use. A pre-post controlled study of the
effects of different kinds of user fees on prescribing quality was conducted in rural
Nepal (Holloway et al; Health Policy and Planning; 2001, 16(4):421-427). In 1992 all 3
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study districts charged the same flat fee per prescription. In 1995 the control district
charged the same fee, one district charged a single fee per drug item and a second
district charged a higher fee per expensive item and a lower fee per cheap item. The
item fees covered a complete course for each item. It was found that prescribing quality
was significantly better and prescribing costs significantly lower with item fees as
compared to a flat prescription fee. All changes were statistically significant (p<0.025).
Polypharmacy & Vit use on changing from a
fee per Px (PxF)
PxF) to a fee per drug item (IF)
4
Av. no. drugs per patient
3
30
% patients pres vitamins, tonics
20
2
10
1
0
0
PxF
1-band IF
PxF
2-band IF
1-band IF
2-band IF
1992 1995
1992 1995
Managerial and Regulatory Strategies
10
Injection and antibiotic use on changing
from a fee/Px
fee/Px (PxF)
PxF) to a fee/drug item (IF)
25
20
15
10
5
0
% patients prescribed injections
% patients pres. antibiotics
80
60
40
20
0
PxF
1-band IF
1992
1995
2-band IF
PxF
1-band IF
1992
2-band IF
1995
Managerial and Regulatory Strategies
11
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Treatment cost and compliance with STGs
on changing from fee/Px
fee/Px (PxF)
PxF) to a fee/drug
item (IF)
% patients treated according to STGs
Av. drug cost per patient (NRs)
60
40
40
30
20
20
10
0
0
PxF
1-band IF
1992
2-band IF
PxF
1-band IF
1992
1995
2-band IF
1995
Managerial and Regulatory Strategies
12
[VA 15]
Another study was done in Nigeria to compare the prescribing and patient care in
primary health care facilities operating and not operating the Bamako Initiative
(Scuzochukwu et al, HPP, 2002). The study clearly shows that the availability of
essential drugs and use of essential drugs is much greater in facilities operating the
Bamako Initiative, where user fees are charged at cost price. At the same time, the use
of medicines - in terms of number of drugs, antibiotics and injections, is much greater
and much less rational in the facilities operating the Bamako Initiative as compared to
those not operating the Bamako Initiative.
PHC prescribing with & without Bamako
initiative in Nigeria Scuzochukwu et al, HPP, 2002
15.3
no.EDL drugs avail
35.4
21
% pres EDL drugs
93
25.6
% Px with antibiotics
64.7
38
% Px with injections
72.8
2.1
5.3
no.drug items/Px
0
20
21 Bamako PHCs
40
60
80
100
12 non-Bamako PHCs
Managerial and Regulatory Strategies
14
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MANAGERIAL AND REGULATORY STRATEGIES
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[VA16]
Many studies have shown that prescribers who also dispense and sell drugs prescribe
more drugs and more expensive drugs than those prescribers who do not dispense or
sell drugs. A study was done in Zimbabwe to compare the prescribing and patient care
of dispensing and non-dispensing doctors (Trap et al, HPP 2001 and ICIUM 2004). The
study clearly showed dispensing doctors spent less time with their patients in
consultation yet prescribed more drugs, more antibiotics and more injections.
Prescribing by dispensing and nondispensing doctors in Zimbabwe Trap et al 2000
13
8.65
consultation time (mins)
48
% Px with antibiotics
9.5
% Px with injections
58
28.4
1.67
2.31
no.drug items/Px
0
10
dispensing doctors
20
30
40
50
60
70
non-dispensing doctors
Managerial and Regulatory Strategies
17
Therefore one regulation that may be very effective but which many countries have
failed to implement is to separate the prescribing and dispensing functions i.e. to
prohibit prescribers from selling drugs. This has been done in Korea with some
reduction in antibiotic use for viral infections (Parke et al, icium2004
http://www.icium.org).
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MANAGERIAL AND REGULATORY STRATEGIES
C.
SESSION GUIDE
REGULATORY STRATEGIES [VA 17-21]
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 well-conceived and well-tested before being launched on a
large scale. There are always risks of unintended adverse effects of such regulations.
Some unintended effects of regulation include:
•
•
Getting around restrictions
– Changes in record keeping (“diagnosis creep”)
– Creation of a black market
– Shifts from public to private sector
Substitution effects
– Alternate drugs may not be safer, more clinically appropriate, or less costly
– Restricting drugs may increase other services
TABLE 2
Possible Regulatory Strategies to Improve Drug Use
Restrict Decisions
Selection
•
Registration based on medical need
Distribution Controls
•
Level-of-use distribution restrictions
Prescribing Controls
•
Level-of-use 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")
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MANAGERIAL AND REGULATORY STRATEGIES
1.
SESSION GUIDE
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. (http://www.who.ch/programmes/dap/icium/posters/4A1_Text.html)
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
Level-of-use 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.
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MANAGERIAL AND REGULATORY STRATEGIES
3.
SESSION GUIDE
Prescribing Controls
Level-of-use 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 "3-drug 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.
[VA 16]
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.
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Monthly Proportions of Study Patients
in Nursing Homes - Effect of Caps
On the other had, a "3-day 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.
In most countries there are regulations which categorise drugs into those that can be
freely available over the counter (OTC) and those that should only be available with
prescription. Unfortunately in many countries prescription-only drugs are often available
over the counter. In Chile, the government became very concerned about the level of
irrational over use of antibiotics and successfully enforced the introduction of a
regulation prohibiting the availability of antibiotics without prescription as shown in the
figure below [VA20]. The introduction of the regulation was only achieved after much
lobbying and negotiation and getting agreement from all stakeholders. The introduction
of the regulation was accompanied by an education campaign for all providers and
consumers.
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Impact of enforcing a presciptiononly policy for antibiotics in Chile
0.35
0.3
0.25
DDD / 1000 inhabitant days
0.4
0.2
1996
1997
1998
1999
2000
Source:
, ICIUM2004
Cabello
Source:Ballesteros
Ballesterosand
andCabello,
Cabello,
ICIUM2004
D.
2001
2002
Managerial and Regulatory Strategies
20
CHOOSING STRATEGIES TO TEST AND IMPLEMENT [VA 22]
You might find that, in addition to the above techniques, there are other managerial and
regulatory strategies that could be considered for your country or your program. It is
important to choose a small number of strategies likely to succeed, test them on a pilot
basis, and then to implement the strategy as effectively as possible. Always look for
unintended effects of such actions!
The following factors should be considered in choosing strategies:
•
Expected magnitude of impact -- If the strategy is successful, what is the likely
impact? That is, will it affect only a few drugs, only a few providers, or only
save a small amount of money? Or will the impact be great? Obviously,
preference goes to strategies likely to have greater impact on priority drug use
problems.
•
Likelihood of success -- All things considered, how likely is success? Will
opposition be so great or the task so complex that success is unlikely? What
has happened in other countries or similar situations?
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•
Unintended effect -- What are the unintended effects that might occur? How
can these effects, if any, be minimized?
•
Political and cultural feasibility -- How acceptable is the strategy in the local
context? Will political and cultural factors favor development and
implementation of the strategy, or will they severely hinder it?
•
Technical feasibility -- What are the technical requirements of the strategy?
Computers? A highly developed information system? How much technical
help (people, systems, equipment) will be needed?
•
Cost (economic feasibility) -- What is the cost, particularly compared to
available resources and to the potential benefits of successfully implementing
the strategy?
•
Potential for donor support -- Will donor support be needed? Requested?
How likely is it that the donors with whom you work will support the proposed
approaches?
If an informal review of possible strategies has reduced the number to relatively few
(perhaps two to eight), then a decision matrix could be made using the alternative
strategies as one dimension and the above six selection factors as the other dimension.
Whatever strategies are chosen, they should be test in advance wherever possible and
the impact of their implementation should be carefully monitored.
Some of the strategies listed may be effective only in combination with other
interventions. Essential drug lists by generic name are generally associated with cost
savings in procurement. But even the shortest essential drug list allows considerable
opportunity for ineffective, unsafe, or wasteful drug use. At the same time, standard
treatments cannot be implemented without an essential drug list which includes the
drugs used in the standard treatments. Thus, an essential drug list and standard
treatment guidelines are complementary interventions when used in combination.
In summary, managerial and regulatory interventions must be seen as part of a
coordinated effort to improve drug use, and the merits of each intervention must be
carefully considered. Furthermore, the aim of these interventions is not to save money
by preventing improper use of drugs, but also to improve quality of patient care through
more effective, safe and economical use of pharmaceuticals.
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ACTIVITY ONE
Managerial Strategies to Change
Generic Drug Use in a Teaching
Hospital
The chairman of the hospital Drugs
and Therapeutics Committee called
the poorly attended DTC meeting to
order and asked the pharmacist to
give her monthly report. After the
usual listing of short or out of stocks
drugs the pharmacist surprised the
meeting by saying,
"I have something I want to
raise. The Ministry has a
policy of promoting rational drugs but our practice in this hospital is a scandal.
I reviewed the OPD prescriptions for last month and found that less than 40%
of prescriptions were generic. I looked at the inpatient notes and found that it
varies by consultant from 23% to 94% generic usage. I spoke to a resident
last week and he clearly did not know the generic names of drugs and I had to
translate them into brand names he knew. This is a teaching hospital and we
should do better. I propose that all prescriptions in brand names should not be
substituted as at present and the doctor should have to rewrite the
prescription."
There was a gasp from the other members of the meeting. The senior surgeon
muttered in his beard,
"I have never liked this generic business. If you send the prescriptions back
the patients will have to wait for long periods. Since I am often in surgery, they
would have to wait for me to finish."
Everybody knew this observation was true as many of the doctors would see their
hospital patients in the morning and then rush off to their private practices.
The chairman cut through the chatter,
"The government policy is clear, we should use generic names, but I don't like
the idea of keeping patients waiting. Has anybody else got any ideas?
The newly appointed junior lecturer in clinical pharmacology spoke up,
"At a recent course that I attended, I heard of an intervention called audit and
feedback. In this method we review the records of each prescriber, calculate
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MANAGERIAL AND REGULATORY STRATEGIES
SESSION GUIDE
the average generic rate, and then we tell the prescriber how he or she
compares with the standard and with other prescribers."
The chairman nodded approvingly,
"I think that might work, but I see some problems. Can we try to list the issues
we think would need to be resolved before we try to decide whether to try this
new approach?"
There was a storm of suggestions and questions which the secretary wrote on a flip
chart in the committee room which was also used as a classroom.
These were:
*
Sources of Data?
*
Which prescribers to include?
*
Which patients to include?
*
How would generic be defined?
*
How would the results be fed back?
*
What would happen to the best generic prescribers and what would happen to
the worst?
*
Who would know the results of the surveys?
*
How often should surveys be done?
*
When would the surveys be stopped?
*
Should the staff be told that their prescribing was being 'watched'?
*
Who should do the surveys?
*
How could the senior management of the hospital be persuaded to support
such a new idea?
Task for the groups.
Discuss the case and try to answer the questions. Group one takes the first two
questions, group two the second two questions and so on. If you finish your two
questions continue with the other questions until all groups are ready to report.
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MANAGERIAL AND REGULATORY STRATEGIES
SESSION GUIDE
ACTIVITY TWO
List and discuss regulatory strategies that have been used in your countries
STRATEGY
COUNTRIES
Product Registration including banning
Selection and Product Availability
Professional Licensing
Prescribing
Dispensing
Controls on Marketing and Promotion
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