Dr Jane Robertson
Policy, Access and Use Team, EMP
4 November 2014
1 |
TBS November 4,2014

 Relies on a number of elements
– Availability, affordability, and use in practice of effective medicines
 Availability
– Procurement, distribution of quality-assured essential medicines
– Regional, urban/rural differences in LMICs; private vs public sector
 Affordability
– Medicine prices (also taxes, mark-ups, dispensing fees etc.)
– Role of insurance and social protection policies, public financing
 Use in practice
– Prescribing & dispensing accord with national EMLs, STGs
2 |
TBS November 4,2014

 WHO definition of ‘rational use of medicines ’:
– ‘ Medicine use is rational (appropriate, proper, correct) when patients receive the appropriate medicines, in doses that meet their own individual requirements, for an adequate period of time, and at the lowest cost both to them and the community.
Irrational (inappropriate, improper, incorrect) use of medicines is when one or more of these conditions are not met.’
 ‘ Responsible use of medicines ’
– ‘ the activities, capabilities, and existing resources of health system stakeholders are aligned to ensure patients receive the right medicines at the right time, use them appropriately, and benefit from them’.
3 |
TBS November 4,2014

 Examples of irrational use of medicines
– Medicines are prescribed when they are not needed
• Antibiotics to treat viral infections
– Using more medicines than are required
– Using ineffective or unsafe medicines
(e.g. anabolic steroids for growth)
– Prescribing medicines of limited value
(e.g. some tonics and vitamins)
4 |
TBS November 4,2014

 Examples of irrational use of medicines
– Underuse of effective medicines
• ORS and zinc for childhood diarrhoea
• Low rates of prescribing for mental health conditions
– Medicines used incorrectly
• Incomplete courses of antimicrobials
• Excessive use of injection formulations (may be considered more effective)
5 |
TBS November 4,2014

 Some consequences of irrational use of medicines
– Delaying access to appropriate care
• Takes longer to get the correct treatment and medicine
• Later presentation with more advanced illness may require hospitalisation with higher costs
– Increased risk of adverse events from ineffective medicines
6 |
TBS November 4,2014

 Some consequences of irrational use of medicines
– Poor injection practices risk the transmission of blood-borne infections such as HIV/AIDS, Hepatitis B and C
– Promoting antimicrobial resistance
• Then when antimicrobials are needed, may need 2 nd or 3 rd line medicines
– Waste of scarce resources for both the health system and families who must pay for medicines
7 |
TBS November 4,2014

 Factors underlying irrational use of medicines
– Health system
• Medicines not available/expired, poor quality (SSFFC), unaffordable
• Perverse financial incentives (if supply of medicines is a source of revenue)
– Prescriber
• Pressures to prescribe (patients, peers, workload pressures, industry)
• No access to STGs, no independent information, no continuing education
8 |
TBS November 4,2014

 Factors underlying irrational use of medicines
– Dispenser
• Financial incentives to dispense/recommend medicines
• No access to information, shortages of dispensing materials
– Patient and community
• Beliefs about medicines, injections, reliance on self-medication
9 |
TBS November 4,2014

 Access
– Availability of key medicines
– % of prescribed medicines dispensed in public health facilities
– Average stock-out duration; adequate record keeping
– Affordability of treatment for adults and children <5 years of age
– Price of key medicines/ Average cost of medicines
– Price of paediatric medicines
– Geographical accessibility of public health facilities
 Quality
– % medicines expired;
– adequacy of storage and handling
10 |
TBS November 4,2014

 Rational use of medicines
– % medicines adequately labelled
– % patients knowing how to take medicines
– Average number of medicines per prescription
– % patients prescribed antibiotics
– % patients prescribed injections
– % prescribed medicines on the essential medicines list
– % medicines prescribed by generic name (INN)
– Availability of standard treatment guidelines
– Availability of essential medicines list
– % tracer cases treated according to protocols/STGs
– % prescription medicines bought with no prescription

|
TBS November 4,2014

 Other information
– % of facilities complying with the law (presence of a pharmacist)
– % facilities with dispensing by a pharmacist
– % facilities with dispensing by nurses, pharmacy aide/health assistant or untrained staff
– % facilities with prescribing by a doctor
– % facilities with prescribing of prescription medicines by nurses, trained health workers/health aides
– % facilities with prescribers trained in rational drug use
 Purpose: to identify problems, investigate, and develop interventions
12 |
TBS November 4,2014

 Policy level
– Are laws on licensing [facilities and personnel] being followed?
– Affordability problems – taxes, mark-ups, underuse of generics?
– Human resources problems – retaining trained staff?
 Procurement and supply issues
– Availability – why are key medicines not available?
– Geographic variability – are there issues with distribution?
– Stock-outs, expired stock, problems with storage – causes?
 Health facility level
– Rational use issues – EML medicines, compliance with STGs
– Overuse of antibiotics, injections
13 |
TBS November 4,2014

 Availability of STGs
– Which STGs? Are these relevant for the setting? Are the STGs up-to-date?
 % of patients receiving antibiotics
– Which antibiotics?
– What are they prescribed for?
– Were the medicines prescribed available in the public facility?
 % patients receiving injections
– Which medicines?
– What are they prescribed for?
– Why are injections prescribed? Is an oral form available?
14 |
TBS November 4,2014

 Quantitative research – numerical data
– to describe variables (descriptive studies);
– to examine relationships among variables (correlational studies);
– to determine cause-and-effect (various experimental designs).
 Qualitative research – describes experiences, meanings
– Participant observation: watch behaviours in their usual context
– In-depth interviews: individuals’ personal histories, perspectives and experiences, particularly useful for sensitive topics
– Focus groups: elicit cultural norms of a group; for broad overviews of issues of concern to the groups or subgroups
 Many studies use both quantitative & qualitative methods
15 |
TBS November 4,2014

 Drug utilization studies
– Extent of use of use of classes of medicines
– Relative use of medicines within a class
(e.g. which ACE inhibitors)
 Prescription audits
– Assess concordance with STGs and protocols
– Can compare prescribers
 Facility audits
– Compare units within a hospital (wards, clinics)
– Compare facilities in a district, region, nationally
 Consumer
– Understand their medicine choices and preferences
16 |
TBS November 4,2014

Reference: Lancet Infect Dis Published online March 20, 2014
Figure 1 Total antibiotic use in 12 European countries and Kosovo, 2011
17 |
TBS November 4,2014

 Sources of data
– Data sources were not always ideal – use what you have!
– Relied on sales data from medicines wholesalers, however this had the advantage of including sales without prescription
– Not always complete (excluded hospitals, some sectors), but enough to understand the patterns of use
 How to classify the range of antibiotics used
– WHO anatomical therapeutic chemical (ATC) classification
 Expressing outcomes in a common unit for comparisons
– Used Defined Daily Doses ( a standardising unit)
– Adjust for the population size: DDD/1000 inhabitants/day
18 |
TBS November 4,2014

 Variability in levels of use: range 15.3 - 42.3 DDD/1000/day
– Turkey highest – has stimulated interventions to address RUM
– Armenia lowest – may be underuse related to poor availability
– High levels of outpatient injectable antimicrobials some countries
 Self-medication common; >50% sold OTC most countries
 Choices of antibiotics varied by country
– underuse of first line treatments
– overuse of combination amoxicillin+ β-lactamase inhibitors
– overuse of respiratory quinolones
– high use of amphenicols some countries (chloramphenicol had been widely used for diarrhoea treatment)
19 |
TBS November 4,2014

 Investigating the reasons for
– Potential overuse: Is it prescriber practices, widespread OTC availability, patient demand, lack of diagnostic facilities?
– Is low use actually underuse – availability, affordability?
– Why high outpatient prescribing of injectable antimicrobials?
 Why self-medication?
– Lax enforcement of laws on prescription only access
– Poor access to medical services (services not available)
– Can ’t afford access to medical care
 Antimicrobial choices
– Protocols/STGs available? Are these promoted and used?
20 |
TBS November 4,2014

[Source: WHO 2002; Laing et al 2001]
 Establish a mandated multi-disciplinary national body to co-ordinate medicine-use policies.
 Implementing procedures for developing, using and revising standard treatment guidelines (STGs)
 Implementing procedures for developing and revising an essential medicines list (or hospital formulary) based on treatments of choice
 Establish a drugs and therapeutics committee in districts and hospitals, with defined responsibilities for monitoring and promoting rational use of medicines

|
TBS November 4,2014

 Using problem-based training in pharmacotherapy based on national STGs in undergraduate curricula
 Continuing in-service medical education as a licensure requirement and targeted educational programs by professional societies, universities and the government
 Developing a strategic approach to improve prescribing in the private sector through regulation and collaborations with professional societies
 Monitoring, supervision and using group processes to promote rational medicine use
22 |
TBS November 4,2014

 Training pharmacists and drug sellers to offer useful advice to consumers and supplying independent medicines information
 Encouraging involvement of consumer organizations and devoting government resources to public education about medicines
 Avoiding perverse financial incentives
 Ensuring sufficient government expenditure (personnel and finances) and enforced regulations
23 |
TBS November 4,2014