Transcript Generic SIGN Presentation - World Health Organization

Rational Use of Injections
within National Drug Policies
World health organisation
Essential Drugs and Medicines Policy
Safe Injection Global Network
Cairo October 2000
A National Drug Policy
• Expresses the goals and objectives set by a government for
the pharmaceutical sector and identifies the main strategies
for achieving them.
– it is the documented framework within which the activities of the
pharmaceutical sector are prioritised and coordinated
– it should specify the roles of the public and private sectors and all
stakeholders and is concerned with efficiency, equity, and
sustainability
Every country needs
a national drug policy because of:
• (1) medical reasons
– 25-40% of the world population has no access to drugs
– up to 50% of the worlds drugs may be used inappropriately
• (2) cost reasons
– drugs are 20-40% of health budgets - antibiotics & injections are
most expensive
Goals of a national drug policy
• to set objectives and identify priorities for action
and gain government commitment for these
Objectives
• to make essential drugs available and affordable to those
who need them
• to ensure the safety, efficacy and quality of all medicines
provided to the public
• to improve prescribing and dispensing practices and to
promote the correct use of medicines by health workers
and the public
The problem of unsafe inappropriate injections
• Overuse
• 5-48% of outpatients received injections in 12 developing
countries
• Inappropriate use
• 22-80% of injections were found to be unnecessary in 3
developing countries
• Unsafe use
• 40% of sterilised needles and syringes in Tanzania showed
bacterial contamination
The consequences of unsafe inappropriate use
• Children aged 2years in Zaire averaged 24 injections and
HIV seropositivity was associated with injection frequency
• 39-57% of the population in Moldova received an injection
over 1 year and 50% of cases of Hepatitis B were
associated with injection use
• 75% of children with paralytic polio in India received an
unnecessary injection just before onset of paralysis
Developing a national drug policy
• Organise the policy process - MOH is the most appropriate
lead agency
• Identify and analyse the problems - involve all stakeholders
• Set goals and objectives - aimed at the highest priority
problems
• Draft the policy, circulate and revise it
• Obtain formal endorsement for the policy and launch the
policy
Implementing a national drug policy
• Depends on political will, resources, shared values
between the NDP and powerful interest groups,
economic situation, technical expertise, and
committed people
• Policies often fail due to lack of political will, lack of
resources and corruption
Comparative analysis of national drug policies,
WHO/DAP/97.6 (1)
• A study in 12 countries (Bulgaria, Chad, Colombia, Guinea,
India, Mali, Philippines, Sri Lanka, Thailand, Vietnam,
Zambia, Zimbabwe) to evaluate NDP effectiveness.
• all countries had drug regulatory authorities with mandates
which included drug registration and inspection;
• most countries had established structures, but
implementation was not always working, and monitoring
and evaluation was rarely done;
• it was much easier to improve drug availability than to
change drug use behaviour;
Comparative analysis of national drug policies,
WHO/DAP/97.6 (2)
• generic policies resulted in lower cost of treatment in the
public sector;
• withdrawal of irrational drugs led to less irrational use;
• good quality assurance led to better acceptance of
generics, prescribing, dispensing;
• good registration had a positive impact on drug use;
• an appropriate financing system led to better prescribing;
• procurement through tender led to better drug availability;
• public sector training led to better prescribing in the public
sector as compared to the private sector.
Role of national drug policies to reduce unsafe
inappropriate injections (1)
• Government commitment to safer more appropriate
injections may be secured through the body responsible for
the NDP (national drug authority, MOH).
• A national task force – a subcommittee of the NDP body could coordinate an initial assessment of unsafe
inappropriate injections and an action plan to improve use
• The national drug policy can reduce unsafe inappropriate
injections by:
(1) Selection of appropriate injectable drugs and equipment
e.g. public sector EDL, market withdrawal of inappropriate injections
Role of national drug policies to reduce unsafe
inappropriate injections (2)
(2) Increasing availability of appropriate injections and alternatives to
injections
(3) Reducing inappropriate availability through effective registration of
drugs and dispensing outlets
(4) Ensuring appropriate training on the use of injections for
healthcare workers
(5) Encouraging appropriate public education concerning injections
(6) Regulation and monitoring of promotional activities and material
(7) Establish functional drug and therapeutic committees
(8) Identify and eliminate economic incentives that encourage overuse of injections
Components of a National Drug Policy (1)
• Legislations and Regulations
–
–
–
–
–
drug regulatory authority
drug registration and licensing
pharmaceutical quality assurance
postmarketing surveillance (drug efficacy and safety)
regulation of prescription and distribution
• Drug Selection, EDL
– criteria (efficacy, safety, quality, cost) and process
• Supply
– Local production, procurement, distribution, storage
Components of a National Drug Policy (2)
• Rational Drug Use by providers & consumers
– Objective drug information - formulary, bulletin
– Controlled promotional activities
• Economic strategies for drugs
– role of government in the pharmaceutical market
– public drug financing mechanism
– pricing policies e.g. retailer margins, producer prices
• Human resource development
– role of health professions
– HRD development plan
– education, pre- & in-service training
Successful interventions to reduce unsafe and
inappropriate injections (1)
• Interactional group discussions in Indonesia
Hadiyono, Suryawati, et al, SSM, 1996, 42(8):1177-83
• RCT of the effect of interactional group discussions, each
lasting 1-2 hours and including 6 prescribers and 6 patients
over a 4-week period. Data from 100 prescriptions per
facility, 3 months pre- and post intervention.
% patients
prescribed
injections
Pre-intervention
Post-intervention
Change
Intervention
(n = 12)
Control
(n =12)
69.5
42.3
-27.2%
75.6
67.1
-8.5%
Successful interventions to reduce unsafe and
inappropriate injections (2)
• Treatment and Sterility Guidelines in Tanzania
Gumodoka et al, TMIH, 1998, 3(4):291-6
• Pre-post study on the effect of local development and
introduction of guidelines for treatment and sterilisation in
66 health facilities.
Indicator of injection use
% patients prescribed
injections
% patients that received
avoidable injections
% sterilis. needles
contaminated
Pre-
Post-
Change
23%
10%
-13%
16%
6%
-10%
44%
22%
-22%