WORKSHOP I. CLINICAL PHARMACY_VORU, ESTONIA - - PowerPoint PPT Presentation

WORKSHOP I. CLINICAL PHARMACY_VORU, ESTONIA

Moderators: Fialová Daniela, PharmD, PhD, BCCP Dimitrow Maarit, PharmD, PhD

University Educational Centre in Clinical Pharmacy Faculty of Pharmacy, Charles University in Prague , Czech Republic, Department of Geriatics and Gerontology, 1st Faculty

• f Medicine, Charles University, Czech Republic

daniela.fialova@faf.cuni.cz

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QUESTION I: The highest proportion of older adults in Europe is nowadays in:

1/ Poland, Slovac Republic and Czech Republic 2/ UK, Spain and Portugal 3/ Italy, Germany, Sweden 4/ Ireland, Norway and Netherlands

EUROPEAN COUNTRIES

• population 65+

Ageing of Europe, World Healrh Statistics, 2017

QUESTION II: Considering the aging of the world population, the highest old-age dependency ratio (N of

• lder patients/N of productive population 14-

65 years) is expected in 2050 in: 1/ Poland, Germany 2/ Finland, Sweden 3/ developing countries, e.g. India 4/ USA, Canada

Prognosis of „old-age dependency ratio“ (65+ years/100 population 15-64 years)

United Nations´Assembly on World Population Ageing, Figure: Prognosis for the old-age dependency ratio (ratio of the population aged 65+ per 100 persons 15-64 yrs old)

QUESTION III: Among „Top 3“ Eastern and Central EU countries with the highest proportion of older adults in 2050 year are expected to be: 1/ Poland, Slovakia, Hungary 2/ Hungary, Romania, Belarus 3/ Slovenia, Bulgaria, Czech Republic 4/ Croatia, Slovakia, Moldova

Central and Eastern European countries

• growth in the proportion of older adults

(65+, by 2050)

2050 year (% 65+) 1. Slovenia- 33.7% 2. Bulgaria- 31.1% 3. Czech Republic- 30.6% 4. Poland- 30.6% 5. Croatia- 29.3% 6. Slovakia- 29.4% 7. Hungary- 29.1% 8. Romania- 28.8% 9. Belarus- 28%

• 10. Moldova- 26.8%

Mamolo M, Scherbov S. Population projections for fourty-four European countries: The ongoing population ageing. European Demographic Research Papers 2/2009, pp43-44 . Vienna Institute of Demography of the Austrian Academy of Sciences, Vienna, Austria (2009). www.oeaw.ac.at/vid/download/edrp_2_09.pdf

QUESTION IV:

Expenditures for home care and nursing home care services are expected to increase by 2050 year (according to US statistics):

1/ about 30% 2/ about 50% 3/ will double 4/ will triple

Expected Increase in HC Expenditures for HC and NHC services by 2050

2017 2050 US National Statistics ´ Bureau, 2012

QUESTION V:

According to the EU „ADHOC- AgeD in Home Care project“ (representative samples of HC older clients in 11 EU countries), the prevalence of polypharmacy and excessive polypharmacy in HC

• lder clients was:

1/ > 30% 6+ drugs and >10% 9+ drugs 2/> 30% of 9+ drugs and> 60% of 6+ drugs 3/> 50% of 6+ drugs and >20% of 9+ drugs

POLYHARMACY

MEDS USE CZ CZ EN EN FIN IT IT NL NL ICE DE DE NO NO Total N N=428 N=289 N=187 N=412 N=198 N=405 N=400 N=388 N= 2707 >=1 97,7% 96,5% 95,2% 93.7% 95,0% 97.8% 93,3% 91,8% 95,1% 6>= 68,5% 48,4% 73,3% 36,2% 35,4% 63,7% 50,5% 33,8% 51,0% 9>= 39,0% 20,1% 41,2% 7,0% 13,1% 31,6% 18,0% 11,1% 22,2% ADHOC EU project (HC older patients)

Finne- Soveri H et al. Major drug-related characterstics of HC older population in Europe. 42nd ESCP Symposium in Prague, Czech Republic, 16.-18.10,2016

QUESTION VI:

The subjective need or objective need for help in managing medications was assessed in EU home care clients in:

1/ > 15% of HC clients 2/> 30% of HC clients 3/> 40% of HC clients 4/ >60% of HC clients

POLYHARMACY

Finne- Soveri H et al. Major drug-related characterstics of HC older population in Europe. 42nd ESCP Symposium in Prague, Czech Republic, 16.-18.10,2016

QUESTION VII: The most problematic ethical issue in individualized drug therapy in older patients is the fact that:

1/ medications and their basic efficacy and safety are not fully tested in RCTs 2/ we statistically estimate appropriate drug dosing for the majority of drugs in older population 3/ polypharmacy users are mostly older patients and there is a poor evidence on efficacy and safety

• f medications and polypharmacy in older patients

Evidence-B(i)ased Medicine

Age Polypharmacy

RCTs Users

• f meds

60 85

• Age-related changes (fa-ki, fa-dy,

homeostasis)

• Multiple chronic disorders (drug-

disease int., geriatr.is syndromes)

• Functional impairment, frailty
• Long duration of treatment

(changes in goals of care, effectiveness, safety, etc.)

• Noncompliance, psychosocial

factors (dependency, rutine in drug use, expectations,..)

• Highly individual outcomes
• Quality of life, drug

safety/tolerability and cost- effectiveness are priorities

Geriatric patient

(PREDICT project, 2009)

INDIVIDUALIZED DRUG PRESCRIBING

QUESTION VIII:

Adequate geriatric dosing can be tested

• nly in specific small-scale geriatric studies. Standard

low-dose drug regimens has already been proved in geriatric patients for these drugs/drug groups (e.g.): 1/ Ca-blockers, ACHE-I, nitrates and ASA 2/ some NSAIDs, some statines, citalopram, omeprazol, some BBs 3/ some NOACs, pentoxyphylline, amiodarone and LABA

EFFICACY OF LOW-DOSE DRUG REGIMENS

léčivo doporučené denní dávky efektivní dávky u seniorů

hydrochlorothiazid 25mg 12,5mg captopril 50- 75mg 25mg bid enalapril 5mg 2,5mg atorvastatin 10mg 5mg lovastatin 20mg 10mg ibuprofen 400- 800mg tid 200mg tid diclofenac 100- 200mg 75mg misoprostol 200rg qid 50 - 100rg qid celecoxib 100mg bid 50mg bid ranitidin 150mg bid 100mg 2 krát qd

• meprazol

20mg 10mg nefazodon 100, 200 mg 100 mg 2 krát qd

Drug Standard dose CT on ger. dosing

Cohen J, JAGS 2000

x x x Geriatric dose

QUESTION IX:

The ethiology of geriatric syndromes is usually complex and drugs belong to important causal risk factors of geriatric syndromes. Among major drug- related geriatric syndromes does not belong: 1/ incontinence 2/ cognitive impairment- dementia 3/ osteoporosis 4/ instability

GERIATRIC SYNDROMES

SOMATIC PSYCHIATRIC SOCIAL

• mobility problems
• vertigo- instability
• falls and injuries
• incontinence
• Impairment of

termoregulation

• nutritional problems
• skin problems(decubitus)
• et al.
• dementia
• depression
• delirium
• behavior changes
• maladaptation
• et al.
• ↓ self performance
• ↑ dependence
• isolation
• violence
• abusive behavior
• family problems
• etc.

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Health factors Socio-economic factors Drug-related

QUESTION X: Which of these drugs do not usually cause geriatric syndromes?

1/ beta-blockers and diuretics 2/ PPIs 2/ metoclopramide and benzodiazepines 3/ metformin

DRUG-RELATED GERIATRIC SYNDROMES

Central anticholinergic syndrom- cognitive impairment, dementia, deliria, confusion (indometacine, ranitidine, metronidazol, chinolones, benzodiazepines, digoxine, theofylíne, prednisolone, aj.) Drug-related depression (metoprolol, methyldopa, indomethacine) Drug-related parkinsonism (metoclopramide, typical antipsychotics, risperidone) OH and falls, fractures (benzodiazepiny, TCA, antipsychotika, antihypertenziva, vasodilatancia, sedativní antihistaminika) Malnutrition (PPI, polypharmacy)

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QUESTION XI: Definitions of inappropriate prescribing evolved during decades and the most updated definitions differ from previous mostly in:

1/ specification of individual PIMs that should not be precribed 2/ emphases on preventability of ADEs by reducing excessive use of PIMs 3/ suggestions of safer drug alternatives

DIFFERENT DEFINITIONS OF PIMs

BEERS 1997 criteria

„…drugs (procedures) where the risk of ADEs substantially exceeds the benefit of treatment in the elderly and safer alternatives exist…„

Mc LEOD 1997 criteria

„…. inappropriate prescribing presents substantial risk of serious ADEs and safer and widely available drug alternatives exist ….or the overall change in the prescription decreases substantially morbidity and mortality in the elderly…“

AGS 2015 criteria

„….avoiding the use of inappropriate and high-risk drugs is an important, simple, and effective strategy to reduce negative outcomes in the elderly. PIMs are medications having an unfavorable balance of risks and benefits by themselves and considering alternative treatments available (including non-pharmacological strategies)…. PIMs are still inappropriately used as first-line therapy.

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EXPLICITE CRITERIA - PIMs

„Potentially Inappropriate Medications in the Elderly“

BEERS criteria

1991- NH residents (Beers et al, Arch Intern Med. 1991) 1997- CC and NH residents (Beers et al., Arch Inter Med.1997) 2001 (Zhan et al.)

• hierarchy of inappropriateness

(Zhan et al., JAMA. 2001) 2003 (Fick et al.) (Fick et al Arch Intern Med. 2003) 2012- AGS (Amer.Geriatr.Soci., JAGS 2012) 2015- AGS update (Amer.Geiatr. Society, JAGS 2015) and 2016- EU7 criteria

______________________________________

Marc H. Beers 1954-2009 Donna Fick

Other explicite criteria

Beers (2003, 2012) USA McLeod (1997) Canada Rancourt (2004) Canada Laroche (2007) France STOPP/START (2008) Ireland Winit- Watjana (2008) Thaiwan NORGEP (2009) Norway

Method Delphi Delphi Delphi Delphi Delphi Delphi Delphi Population >65 >65 >65 >75 >65 NA >70 PIMs (N of items) 68/124 38 111 34 65 77 36 Drug-disease interactions YES YES NO YES YES YES NO Drug-drug interactions YES YES YES YES YES YES YES Duplicite prescribing YES YES YES YES Recommendation of safer alternatives NO YES NO YES NO NO NO Chang CB et al. Drugs Aging 2010

QUESTION XII: Among negative consequences

• f PIM use in older patients have not been yet

proved in epidemiological studies:

1/ higher healthcare costs 2/ mortality 3/ decrease in functional status 4/ cognitive impairment

Negative consequences of PIM use in epidemiological studies

• Proved negatives

consequences

• hospitalisations
• higher prevalence of

ADEs/ADRs

• Functional status

impairment

• Cognitive impairment
• Higher utilization of

healthcare and healthcare costs

• No impact
• mortality

Havlíková Š, Fialová D. Negativní dopady PIMs v publikovaných studiích. DP KSKF FaF UK 2017

QUESTION XIII: Among examples of PIMs does not belong:

1/ long-term use of Z-drugs 2/ long-term use of PPIs 3/ apixaban 4/ spironolacton > 50mg/day

Examples of PIMs

___________________________________________________________________________________________________

• long-term BZDs
• short-term BZDs in nongeriatric dosing (alprazolam >

0,5mg j.d., bromazepam > 1,5mg/den, atd.)

• spironolakton > 50mg/day
• SSRI in hyponatremia
• metoklopramide
• dabigatran
• long/term use of NSAIDs
• long/term use or high doses of PPIs
• zolpidem > 5mg/day and long/term use
• etc.

QUESTION XIV: PIM prevalence among NH residents in Europe has been confirmed as:

1/ less then 30% in countries having implemented MRS 2/ over 30% in countries having implemented MRS 2/ over 50% in countries not having implemented MRS 3/ over 40% in countries not having implemented MRS

OTHER STUDIES: PIM PREVALENCE IN NH RESIDENTS IN EUROPE (N> 500 subjects)

• England and Wales, N= 10 378

– 33% (95% CI: 31.7%- 34.3%), 2008-2009 (comparable to the USA) Shah SM et al., Br J Gen Pract, 2012

• Ireland, N=732, 15 NH facilities

– 53.4% in 2010 O´Sullivan DP et al., Drugs Aging, 2013

• Austria, N=1844, 48 NH facilities

– 70.3% (95% CI: 67.2%- 73.4%) in 2011 Mann E., Wien Klin Wocheschr., 2013

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0% 10% 20% 30% 40% 50% 60% 70% Total GER CS FIN ISR IT NL EN FR % Beers´s 2003 criteria (adj.) % all criteria

Prescribing of PIMs in seniors in EU NHs

project SHELTER (Services and HEalth in Long-Term care, 7.RP EC, 2009-2014)

Fialová D., Reisigová J.. et al. SHELTER project 2017

different criteria

QUESTION XV: PIM prevalence in HC setting has been documented to be:

1/ higher then in NH setting 2/ not much different in different EU countries 3/ about 20% in total sample 4/ was not influences by country-specific precribing habits

POTENTIALLY INAPPROPRIATE MEDICATION USE IN EUROPE- combined criteria

Fialová D, Topinková E, Gambassi G et al., JAMA 2005; 293 (11):1348-1358

Differences between Eastern and Western EU (41% CZ vs. 15,6% av.) Differences in approved PIMs (32% NO vs. 70,1% IT) Role of regulatory measures (DEN 6%)

QUESTION XVI: PIMs are mostly prescribed in different settings of care to (state what is false):

1/ Depressive patients 2/ Polypharmacy users 3/ Patients subjectively reporting poor health 4/ Very old patients

Factors associated with PIM use in other studies

More likely if: > 14 prescriptions/year OR= 2.9 (<.001) poor subjective health OR= 2.7 (<.001) poor economic situation OR= 2.48 (<.001) polypharmacy (6+) OR= 2.19 (<.001) use of anxiolytic drugs OR= 2.19 (<.001) depression OR= 1.37 (<.012) treated with psychotropics OR= 1.5- 2.09 (<.001) Less likely if: living alone OR 0.71 (< .001)

• lder (75+, 85+)

OR 0.64- 0.77 (<.01) severe dependency in ADL OR 0.69 (<.04)

Zhan CH, Sangl J, Bierman AS, et al. Potentially inappropriate medication use in Community-Living elderly, JAMA 2001 Fialová D, Topinková E, Gambassi G., et al., JAMA 2005; 293 (11):1348-1358

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1.00 1.97 3.22 10.96 5.41 2 4 6 8 10 12 14 16 18 20 1 2 3 4-6 Number of associated factors Odds ratio (n=312) (n=746) (n=859) (n=559) (n=231) 1.18-3.34 1.96-5.34 3.28-9.02 6.39-18.95

Exponential increase in the OR of the use of PIMs with increasing number of risk factors

Fialová D., Gambassi G., Topinková E. et al. Potentially inappropriate medication use in HC elderly in Europe- results from the ADHOC project. JAMA 2005; 293 (11):1348-1358

QUESTION XVII (opinion): Medication reviews and medication management services can be provided:

1/ Only in hospital setting because of availability of comprehensive patient and medication data 2/ Only by highly skilled professionals 3/ Only when there is a regulatory and financial support of these services in individual EU country

Role of pharmacists in medication reviews

Type Sources Specialist

Simple (1) Drug anamnesis Pharmacist Semi-advanced (2a) Drug anamnesis and consultation Pharmacist- consultation centres Semi-advanced (2b) Patient documentation Clinical pharmacist „BACK OFFICE“ Pokročilé (stupeň 3) Patient documentation, direct interdisciplinary patient care Clinical pharmacist in different settings

• f care (AC, HC, PC,

NHC, GPs) „FRONT OFFICE“