TBS November 4, |1 | Responsible and appropriate (rational) use of medicines Dr Jane Robertson Policy, Access and Use Team, EMP 4 November 2014

TBS November 4, |2 | Appropriate use of medicines 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

TBS November 4, |3 | Terminology: rational, responsible, appropriate 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’.

TBS November 4, |4 | Rational or responsible use of medicines I 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 )

TBS November 4, |5 | Rational or responsible use of medicines II 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 )

TBS November 4, |6 | Rational or responsible use of medicines III 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

TBS November 4, |7 | Rational or responsible use of medicines IV 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

TBS November 4, |8 | Rational or responsible use of medicines V 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

TBS November 4, |9 | Rational or responsible use of medicines VI 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

TBS November 4, | WHO Level II Studies - indicators 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

TBS November 4, | WHO Level II Studies - indicators 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, | WHO Level II Studies - indicators 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

TBS November 4, | Types of questions that might arise 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

TBS November 4, | Some questions 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?

TBS November 4, | Study types 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

TBS November 4, | Some types of studies to consider 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

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

TBS November 4, | Looks complicated! 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

TBS November 4, | Did they identify some important issues? Variability in levels of use: range 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)

TBS November 4, | With this information – what next? 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?

TBS November 4, | Core strategies to promote rational use of medicines [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, | Core Strategies II 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

TBS November 4, | Core strategies III 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