WORKSHOP I. CLINICAL PHARMACY_VORU, ESTONIA

Transcription

1 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 of Medicine, Charles University, Czech Republic

2 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

3 EUROPEAN COUNTRIES - population 65+ Ageing of Europe, World Healrh Statistics, 2017

4 QUESTION II: Considering the aging of the world population, the highest old-age dependency ratio (N of older patients/n of productive population years) is expected in 2050 in: 1/ Poland, Germany 2/ Finland, Sweden 3/ developing countries, e.g. India 4/ USA, Canada

5 Prognosis of old-age dependency ratio (65+ years/100 population 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 yrs old)

6 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

7 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, pp Vienna Institute of Demography of the Austrian Academy of Sciences, Vienna, Austria (2009).

8 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

9 Expected Increase in HC Expenditures for HC and NHC services by US National Statistics Bureau, 2012

10 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 older 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

11 POLYHARMACY ADHOC EU project (HC older patients) MEDS USE CZ EN FIN IT NL ICE DE 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% Finne- Soveri H et al. Major drug-related characterstics of HC older population in Europe. 42nd ESCP Symposium in Prague, Czech Republic, ,2016

12 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

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

14 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 of medications and polypharmacy in older patients

15 Polypharmacy INDIVIDUALIZED DRUG PRESCRIBING Evidence-B(i)ased Medicine RCTs Users of meds (PREDICT project, 2009) Age Geriatric patient Age-related changes (fa-ki, fa-dy, homeostasis) Multiple chronic disorders (drugdisease 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 costeffectiveness are priorities

16 QUESTION VIII: Adequate geriatric dosing can be tested only 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

17 EFFICACY OF LOW-DOSE DRUG REGIMENS efektivní dávky léčivo Drug Standard doporučené dose denní dávky Geriatric CT on ger. dosing u seniorů dose hydrochlorothiazid 25mg 12,5mg captopril 50-75mg 25mg bid enalapril 5mg 2,5mg atorvastatin 10mg 5mg lovastatin 20mg 10mg ibuprofen mg tid 200mg tid diclofenac mg 75mg misoprostol 200rg qid rg qid celecoxib 100mg bid 50mg bid ranitidin 150mg bid 100mg 2 krát x qd omeprazol 20mg 10mg nefazodon 100, 200 mg 100 mg 2 krát x qd Cohen J, JAGS 2000

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

19 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. Health factors Socio-economic factors Drug-related

20 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

21 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)

22 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

23 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.

24 EXPLICITE CRITERIA - PIMs Potentially Inappropriate Medications in the Elderly Marc H. Beers BEERS criteria NH residents (Beers et al, Arch Intern Med. 1991) 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) AGS (Amer.Geriatr.Soci., JAGS 2012) AGS update (Amer.Geiatr. Society, JAGS 2015) Donna Fick and EU7 criteria

25 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/ Drug-disease interactions YES YES NO YES YES YES NO Drug-drug interactions YES YES YES YES YES YES YES Duplicite prescribing 0 0 YES YES YES 0 YES Recommendation of safer alternatives NO YES NO YES NO NO NO Chang CB et al. Drugs Aging 2010

26 QUESTION XII: Among negative consequences of 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

27 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

28 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

29 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.

30 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

31 OTHER STUDIES: PIM PREVALENCE IN NH RESIDENTS IN EUROPE (N> 500 subjects) England and Wales, N= % (95% CI: 31.7%- 34.3%), (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

32 Prescribing of PIMs in seniors in EU NHs project SHELTER (Services and HEalth in Long-Term care, 7.RP EC, ) 70% different criteria % Beers s 2003 criteria (adj.) % all criteria 60% 50% 40% 30% 20% 10% 0% Total GER CS FIN ISR IT NL EN FR Fialová D., Reisigová J.. et al. SHELTER project 2017

33 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

34 POTENTIALLY INAPPROPRIATE MEDICATION USE IN EUROPE- combined criteria Fialová D, Topinková E, Gambassi G et al., JAMA 2005; 293 (11): 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%)

35 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

36 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= (<.001) Less likely if: living alone OR 0.71 (<.001) older (75+, 85+) OR (<.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):

37 Exponential increase in the OR of the use of PIMs with increasing number of risk factors Odds ratio (n=312) (n=746) (n=859) (n=559) (n=231) Number of associated 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):

38 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

39 Role of pharmacists in medication reviews Type Sources Specialist Simple (1) Drug anamnesis Pharmacist Semi-advanced (2a) Drug anamnesis and consultation Pharmacistconsultation centres Semi-advanced (2b) Patient documentation Clinical pharmacist BACK OFFICE Pokročilé (stupeň 3) Patient documentation, direct interdisciplinary patient care Clinical pharmacist in different settings of care (AC, HC, PC, NHC, GPs) FRONT OFFICE