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Quality prescribing in Ireland: Quality prescribing in Ireland: The Programme of Preferred Medicines The Programme of Preferred Medicines Dr Helen Flint Dr Helen Flint Medicines Management Programme Medicines Management Programme Clinical Strategy and Programmes Directorate Clinical Strategy and Programmes Directorate Health Services Executive, Dublin, Ireland Health Services Executive, Dublin, Ireland
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Quality prescribing in Ireland: Quality prescribing in Ireland: The Programme of Preferred MedicinesThe Programme of Preferred Medicines

Dr Helen FlintDr Helen FlintMedicines Management Programme Medicines Management Programme

Clinical Strategy and Programmes DirectorateClinical Strategy and Programmes DirectorateHealth Services Executive, Dublin, IrelandHealth Services Executive, Dublin, Ireland

““The prescribing of medicines is the The prescribing of medicines is the commonest healthcare intervention in commonest healthcare intervention in developed countriesdeveloped countries””

National Medicines Information Centre, 2004

Drugs have changed the world…..

MorMorbidity and mortalitybidity and mortality Eradication of diseases Eradication of diseases Childhood vaccination Childhood vaccination People can recover readily from illnesses and events People can recover readily from illnesses and events

that were previously lifethat were previously life--threateningthreatening People can avoid illnesses and eventsPeople can avoid illnesses and events Levels considerations of socioLevels considerations of socio--economic status economic status

Prescribing medication

Relatively safe

Relatively cheap

Number of prescriptions

No published Irish studies relating to the number of prescriptioNo published Irish studies relating to the number of prescriptions ns written here on a daily basiswritten here on a daily basis

Difficult to capture that information as details of purely private prescriptions (i.e. where the patient does not make a claim under the DPS) would be recorded only on individual GP records

Annual report from the PCRS details the number of prescription items that pharmacists were reimbursed for on the GMS, DPS and LTI scheme

This could be used as a guide to the number of prescriptions written under these community schemes

Approximately 10,000 medicinal products authorised for use in Approximately 10,000 medicinal products authorised for use in IrelandIreland

this includes products authorised nationally and through EU this includes products authorised nationally and through EU assessment procedures, with no national licenses issued for someassessment procedures, with no national licenses issued for some of of the latter, which is how the IMB countthe latter, which is how the IMB count

the figures relate to product the figures relate to product authorisationsauthorisations ((licenceslicences), rather than to ), rather than to substances, so includes a significant number of generics as wellsubstances, so includes a significant number of generics as well as as ‘‘product familiesproduct families’’, i.e. different strengths and formulations of the same , i.e. different strengths and formulations of the same brand/substance etc., as each is the subject of an individual brand/substance etc., as each is the subject of an individual authorisation (authorisation (licencelicence))

includes parallel product includes parallel product authorisationsauthorisations ((PPAsPPAs), where ), where licenceslicences are are granted for products which are already the subject of an authorigranted for products which are already the subject of an authorisation, sation, but there is parallel importation of version for sale, usually bbut there is parallel importation of version for sale, usually because of ecause of priceprice

““The annual cost to the State of supplying The annual cost to the State of supplying medicines exceeds medicines exceeds €€2.24 billion 2.24 billion –– a greater than sixa greater than six--fold increase has occurred over a decade. This level fold increase has occurred over a decade. This level of growth in expenditure is unsustainableof growth in expenditure is unsustainable””

Tilson and Barry, 2010Tilson and Barry, 2010

Where does taxpayer invest?

Lipid modifying agents Lipid modifying agents -- €€160M160M Acid Related Disorders Acid Related Disorders -- €€127M127M ReninRenin--Angiotensin system Angiotensin system -- €€75m75m Drugs for Obstructive Airways Disease Drugs for Obstructive Airways Disease -- €€110M110M Clinical Nutritional Products Clinical Nutritional Products -- €€52M52M Psycholeptics and Psychoanaleptics Psycholeptics and Psychoanaleptics -- €€149M149M

The above groups accounted for 36% (23m) of all prescriptions anThe above groups accounted for 36% (23m) of all prescriptions and d 53% of all drug costs under the GMS / DPS / LTI schemes in 200853% of all drug costs under the GMS / DPS / LTI schemes in 2008

Disinvestment: new drugs for old

““……the funding of new, expensive the funding of new, expensive medicines relies increasingly on releasing funds by medicines relies increasingly on releasing funds by displacing other treatments displacing other treatments

Hughes and Hughes and FernerFerner, 2010, 2010

Unsupervised sources of medicines

OverOver--thethe--counter medicinescounter medicines

Medicines purchased overseasMedicines purchased overseas

Counterfeit medicines. Counterfeit medicines. They include products without active They include products without active ingredients, or with the wrong active ingredients, or with insufingredients, or with the wrong active ingredients, or with insufficient ficient active ingredients, or with fake packaging. Sometimes they contaactive ingredients, or with fake packaging. Sometimes they contain in substitutes, or are diluted with foreign or toxic bodies, to incsubstitutes, or are diluted with foreign or toxic bodies, to increase the rease the quantity of the original medicinequantity of the original medicine

Medicines purchased on the InternetMedicines purchased on the Internet

Non-adherence

““A worldwide problem of striking magnitudeA worldwide problem of striking magnitude”” (WHO, 2010)(WHO, 2010) Improving adherence has become a priorityImproving adherence has become a priority 3030--50% of patients do not take their medication for chronic 50% of patients do not take their medication for chronic

conditions as prescribedconditions as prescribed Cost of nonCost of non--adherence is a missed opportunity for treatment adherence is a missed opportunity for treatment

gaingain Unused or unwanted medicines Unused or unwanted medicines ££million annuallymillion annually 75% reported a visit to community pharmacy in last 6 months 75% reported a visit to community pharmacy in last 6 months

Potentially inappropriate prescribing (PIP)

One third of the Irish population aged <70 years were prescribed at least one potentially appropriate medicines

Significant association between polypharmacy and PIP

Most frequent PIPs1.proton pump inhibitors max therapeutic dose <8 weeks2.NSAIDs for <3 months3.Benzodiazepines> one month4.Drug duplication with the same therapeutic class

Total expenditure on potentially inappropriate drugs was €45,631, 319 in 2007 or 9% expenditure on aged <70 years

Cahir et al, 2010

Medicines in older people

ExcessiveExcessiveoveruseoveruse

Inappropriateirrational useirrational use

InadequateInadequateunderunder--useusefailure to prescribe an effective drugfailure to prescribe an effective drug

Older people and mental health

““In our studies, dementia is overwhelmingly and In our studies, dementia is overwhelmingly and consistently the largest contributor to disabilityconsistently the largest contributor to disability””

Sousa R Sousa R et al, et al, November 2009November 2009

General guidance

““Medicines should be prescribed only when they Medicines should be prescribed only when they are necessary, and in all cases the benefit of are necessary, and in all cases the benefit of administering the medicine should be considered in administering the medicine should be considered in relation to the risk involvedrelation to the risk involved””

British National Formulary 2011British National Formulary 2011

Medication management cycle

There may be a problem at any point in the process

Medical profession

Medical undergraduates knowledge

2,413 25 UK medical schools2,413 25 UK medical schools 38% felt 38% felt ‘‘confidentconfident’’ about prescription writingabout prescription writing 35% had filled in a hospital prescription more than three times35% had filled in a hospital prescription more than three times 74% felt that the amount of teaching was 74% felt that the amount of teaching was ‘‘too littletoo little’’ or or ‘‘far too far too

littlelittle’’ 56% disagreed with the statement that their assessment 56% disagreed with the statement that their assessment

‘‘thoroughly tested knowledge and skillsthoroughly tested knowledge and skills’’

Heaton A, Webb DJ and Maxwell SRHeaton A, Webb DJ and Maxwell SR

Transcribing

Widespread practiceWidespread practice Doctor from DoctorDoctor from Doctor Nurses from medical officerNurses from medical officer Serious risks of inadvertent transcription errors or duplicationSerious risks of inadvertent transcription errors or duplication of of

medicinesmedicines Essential to actively use the Essential to actively use the ““analyticalanalytical”” (system 2) decision(system 2) decision--

making process to check prescriptions before transcribing themmaking process to check prescriptions before transcribing them Not accredited or auditedNot accredited or audited Only guidelines available from Only guidelines available from An Bord Altranais Guidance to An Bord Altranais Guidance to

Nurses and Midwives on Medication Management (2007)Nurses and Midwives on Medication Management (2007)

Factors influencing physician’s prescribing behaviour

Personal formulary (Robertson Personal formulary (Robertson et alet al., 2001)., 2001) 7070--90 medicines90 medicines Experience rather than evidenceExperience rather than evidence--base (McFarlane base (McFarlane etet al.al., 1997), 1997) Prescribing cascade (Rochon and Gurwitz, 1997)Prescribing cascade (Rochon and Gurwitz, 1997) Errors occur more frequently with medicines with which Errors occur more frequently with medicines with which

prescribers are familiarprescribers are familiar Patient expectationPatient expectation Medication reviewMedication review Nurse prescribing: September 2007 Nurse prescribing: September 2007

Figure 3.2 Medication by ATC categories between sites 2002

ATC categories by site 2002

0

200

400

600

800

1000

A B C D G H J L M N P R S V

ATC categories

No. dru

gs

per

ATC

ca

tegori

es SITE A

SITE BSITE CSITE D

Patient expectation

Patient adopts the Patient adopts the ““sick rolesick role”” Receiving a prescription Receiving a prescription legitimiseslegitimises the illnessthe illness Receiving a prescription implies a cure for the conditionReceiving a prescription implies a cure for the condition Medicines that are freely available are perceived as less Medicines that are freely available are perceived as less

important because they are accessible to everybodyimportant because they are accessible to everybody Cost is becoming a significant factorCost is becoming a significant factor

Effect of patient payment status

80% antibiotics prescribed by GPs80% antibiotics prescribed by GPs Recent study compared GMS with private Recent study compared GMS with private GMS 54 years: private 34 yearsGMS 54 years: private 34 years Antibiotics prescribed at 3,407 consultationsAntibiotics prescribed at 3,407 consultations Private patients were 23% more likely to receive a prescription Private patients were 23% more likely to receive a prescription

for antibiotics overallfor antibiotics overall Private patients were more likely to receive a delayed or Private patients were more likely to receive a delayed or

deferred prescription deferred prescription In general patient In general patient <<65 years less likely to receive a prescription65 years less likely to receive a prescription ?private patients present at a later stage or unwillingness to ?private patients present at a later stage or unwillingness to

return for a second visit due to costreturn for a second visit due to cost Authors suggest patient expectationAuthors suggest patient expectation

NMIC, 2011NMIC, 2011

Nursing profession

Nurses knowledge

The amount of time nurses in clinical practice spend on aspects The amount of time nurses in clinical practice spend on aspects of care of care related to medication is not reflected by the amount of time devrelated to medication is not reflected by the amount of time devoted to oted to pharmacological teaching (Ashurst, 1993)pharmacological teaching (Ashurst, 1993)

Nurses have a limited understanding of pharmacology (King, 2004)Nurses have a limited understanding of pharmacology (King, 2004)Dissatisfaction with graduates knowledge base in pharmacology Dissatisfaction with graduates knowledge base in pharmacology (Bullock and Manias, 2002)(Bullock and Manias, 2002)

Lack of teaching hours in the UK curriculum: Lack of teaching hours in the UK curriculum: 18 18 DipHE, 26 ANG DipHE, 26 ANG accelerated nursing for graduates, 28 DCN degree combined with accelerated nursing for graduates, 28 DCN degree combined with nursing (Morrison nursing (Morrison --Griffiths Griffiths et al, et al, 2002) 2002)

Nurses are more likely to learn the effects of medications throuNurses are more likely to learn the effects of medications through gh experiential learning and sometimes through medication errors (Wexperiential learning and sometimes through medication errors (Wolf olf etetalal, 1995), 1995)

Pharmacy profession

Pharmacy profession

Traditional compounding and dispensing roleTraditional compounding and dispensing role Various other services available Various other services available Traditional training pathway until recentlyTraditional training pathway until recently Public perception Public perception InterInter--professional perceptions professional perceptions Customer advice and services at different levelsCustomer advice and services at different levels ConfidentialityConfidentiality Funding still primarily tied to dispensing and drugs Funding still primarily tied to dispensing and drugs

margins margins

Irish Medicines Board Patient Survey 2012

Almost three in four of those surveyed claim to read product information (on the leaflet and label) before taking a prescription medicine for the first time

Among those who do not read the product information, the vast majority qualified this by explaining that their GP or pharmacist give them the necessary information

67% read the product information before taking an over the counter medicine for the first time

One quarter of adults (25%) use the internet as a source of infoOne quarter of adults (25%) use the internet as a source of information about medicines. Of rmation about medicines. Of the 1 in 4 consumer who do go online the 1 in 4 consumer who do go online 30% are attempting to diagnose health symptoms (self diagnosis)

Half (49%) of those surveyed always seek advice from a healthcarHalf (49%) of those surveyed always seek advice from a healthcare professionale professional–– typically a typically a pharmacist pharmacist –– before taking a new over the counter medicinebefore taking a new over the counter medicine

GPs (68%) and pharmacists (25%) are by far the most trusted sourGPs (68%) and pharmacists (25%) are by far the most trusted sources of medicines adviceces of medicines advice

Pharmacy Ireland 2020 Working Group

The emphasis for pharmacists has now shifted to assume The emphasis for pharmacists has now shifted to assume responsibility for responsibility for pharmacotherapeuticpharmacotherapeutic outcomesoutcomes

Frontline role of the community pharmacistFrontline role of the community pharmacist

Minor ailments scheme Minor ailments scheme

Switching of medicines so that they are more readily accessible Switching of medicines so that they are more readily accessible to patients: new legal category to patients: new legal category ““Pharmacist PrescriberPharmacist Prescriber””

Health screening advantages of reach, accessibility and cost Health screening advantages of reach, accessibility and cost effectivenesseffectiveness

Pharmacist extended role

2003, Dutch Healthcare Inspectorate2003, Dutch Healthcare Inspectorate USA, Canada, UK indicators for drugUSA, Canada, UK indicators for drug--related morbidity in related morbidity in

primary careprimary care Portugal, community pharmaciesPortugal, community pharmacies East Anglia, community pharmacist intervention did not lead to East Anglia, community pharmacist intervention did not lead to

reductions in hospital admissions in contrast to those found in reductions in hospital admissions in contrast to those found in trials of specialist nurses in heart failure (Holland et al, 200trials of specialist nurses in heart failure (Holland et al, 2007)7)

2009 National Audit Office evaluation of National Chlamydia 2009 National Audit Office evaluation of National Chlamydia Screening Programme found that local commissioning of Screening Programme found that local commissioning of opportunistic screening had led to duplication of efforts and opportunistic screening had led to duplication of efforts and costs (pharmacy least effective)costs (pharmacy least effective)

Medicines Use Review

Structured meeting between an accredited pharmacist and a Structured meeting between an accredited pharmacist and a patientpatient

Identify any problems a patient may be experiencing with their Identify any problems a patient may be experiencing with their medicinesmedicines

Provide information and support to improve the patients Provide information and support to improve the patients knowledge, understanding and use of their prescribed knowledge, understanding and use of their prescribed medicinesmedicines

Research has been done to assess the uptake of Research has been done to assess the uptake of MURsMURs by by community pharmacists (Bradley et al, 2008)and pharmacist community pharmacists (Bradley et al, 2008)and pharmacist attitudes to performing them (attitudes to performing them (LatifLatif and Boardman, 2008)and Boardman, 2008)

No studies have yet evaluated whether No studies have yet evaluated whether MURsMURs improve improve adherence to medicationadherence to medication

Early evidence indicates that asthma targeted Early evidence indicates that asthma targeted MURsMURs are are beneficialbeneficial

NICE clinical guideline 76: medicines adherence

Adapt your consultation style to each patientAdapt your consultation style to each patient’’s needss needs

Establish the level of involvement the patient wants in decisionEstablish the level of involvement the patient wants in decisions about s about treatment with medicines; encourage and support patients, familitreatment with medicines; encourage and support patients, families and es and carers to keep an upcarers to keep an up--toto--date list of prescription and nondate list of prescription and non--prescription prescription medicines and allergies or adverse reactionsmedicines and allergies or adverse reactions

Establish the patients perspective by asking what he/she knows aEstablish the patients perspective by asking what he/she knows and nd believes about a medicine. Discuss the aims of the treatment andbelieves about a medicine. Discuss the aims of the treatment and any any concerns that they have before prescribing and when reviewing concerns that they have before prescribing and when reviewing

Prescribing by Dentists

2010, 5.1 million prescription items, at a Net Ingredient Cost 2010, 5.1 million prescription items, at a Net Ingredient Cost (NIC) ( i.e. basic price of a drug) of (NIC) ( i.e. basic price of a drug) of ££12.4 million were 12.4 million were prescribed by dentists and dispensed in the communityprescribed by dentists and dispensed in the community

4.8% rise in prescription items and a 19.7% rise in NIC when 4.8% rise in prescription items and a 19.7% rise in NIC when compared to 2009 compared to 2009

Prescription forms do not identify the Primary Care Trust of thePrescription forms do not identify the Primary Care Trust of theprescriber or patient prescriber or patient

Neither the number of dentists prescribing nor the number of Neither the number of dentists prescribing nor the number of patients treated is availablepatients treated is available

Ireland 2009: Ireland 2009: €€0.79 million in respect of Dental Treatment 0.79 million in respect of Dental Treatment Services prescriptions (1,570 agreements) Services prescriptions (1,570 agreements)

Programme Preferred Medicines

Clinical Strategy and Programmes (CSP) Directoratedefining how health services are delivered, measured and resourced

… established to improve and standardise patient care throughout the organisation by bringing together clinical disciplines and enabling them to share innovative solutions to deliver greater benefits to every user of HSE services

To improve:• the quality of care we deliver to all users of HSE services • access to all services • cost effectiveness

Dr. Barry White, National Director, Clinical Strategy and Programmes

“…it is evident that we are facing new challenges in funding very high-cost medicines with insufficient evidence to prove cost–effectiveness”

Barry Barry et al.et al., 2010, 2010

Programme Preferred Medicines

Agreement from all consultants on PPMs Agreement from all consultants on PPMs Although there are no headAlthough there are no head--toto--head trials, clinical experts do not head trials, clinical experts do not

consider there to be clinically significant difference between tconsider there to be clinically significant difference between the he currently authorised agentscurrently authorised agents

Guidelines for good medication management would involve Guidelines for good medication management would involve selecting the cheaper of two optionsselecting the cheaper of two options

In line with list of interchangeable drugsIn line with list of interchangeable drugs Open discussions with patient representativesOpen discussions with patient representatives Preserve clinical freedom: however, prescribing which is not Preserve clinical freedom: however, prescribing which is not

evidenceevidence--based should be the exception rather than rulebased should be the exception rather than rule

National Clinical Care Programmes developing guidelines

Developing clinical evidenceDeveloping clinical evidence--based questionsbased questions Systematically searching for the evidenceSystematically searching for the evidence Incorporating health economic adviceIncorporating health economic advice Distilling and Distilling and synthesisingsynthesising the evidence and writing the evidence and writing

recommendationsrecommendations Grading the evidence statementsGrading the evidence statements Agreeing the recommendationsAgreeing the recommendations

Sources of concern with algorithms for therapy

Irish health service is not used to working within strict Irish health service is not used to working within strict parametersparameters

USA: Funding depends on adhering to standards USA: Funding depends on adhering to standards (BTA)(BTA)

UK: Funding directed by NICE which has statutory UK: Funding directed by NICE which has statutory powers (BTE)powers (BTE)

The argument is The argument is ““medicine by numbersmedicine by numbers”” Clinicians to evaluate both the evidence and the Clinicians to evaluate both the evidence and the

intellectual argumentsintellectual arguments

Mission statement Strategic overview

Clear leadership to enable the delivery of safe, effective, evidence informed medicines usage in the context of patients care pathways

Develop and deliver patient focused services that optimise the use of medicinesProvide patient focused services that ensure the safe, cost- effective and best value use of medicines

Medicines expertiseObtain and apply core knowledge and skills to ensure the legal, safe, cost-effective and best value use of medicines

Support and develop the workforce in a team approach Ensure appropriate skill mix so that health and social care professionals are supported and competent in the roles that they are undertaking in relation to medicines

Adapted from Adapted from National Prescribing Centre, 2011 National Prescribing Centre, 2011

…“…“prescribing is a technically difficult and prescribing is a technically difficult and morally complex issuemorally complex issue””

Royal Pharmaceutical Society, 1997Royal Pharmaceutical Society, 1997

“…“…better is possible. It does not take better is possible. It does not take genius. It takes diligence. It takes moral clarity. It genius. It takes diligence. It takes moral clarity. It takes ingenuity. And above all, it takes a takes ingenuity. And above all, it takes a willingness to trywillingness to try””

AtulAtul GawandeGawande


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