Improving the Appropriateness of Improving the Appropriateness of Prescribing in Elderly Patients. Prescribing in Elderly Patients.

Is it feasible? Is it feasible? A comprehensive Approach in the A comprehensive Approach in the Local Health Unit of Parma, ItalyLocal Health Unit of Parma, Italy

Presenting Author: Presenting Author: Stefano Del Canale, M.D., Ph.D.Stefano Del Canale, M.D., Ph.D.

Co-authors:Co-authors:Ettore Brianti, M.D.Ettore Brianti, M.D.Massimo Fabi, M.D.Massimo Fabi, M.D.

Scott W. Keith, Ph.D., M.S.Scott W. Keith, Ph.D., M.S.Kellie Dudash, PharmDKellie Dudash, PharmD

Megan Templin, M.S.Megan Templin, M.S.Vittorio Maio, PharmD, M.S., MSPHVittorio Maio, PharmD, M.S., MSPH

BackgroundBackground Potentially inappropriate medications (PIMs) are those Potentially inappropriate medications (PIMs) are those

medications whose adverse risks exceed their health benefitsmedications whose adverse risks exceed their health benefits11

PIMs use in the community-dwelling elderly is associated with PIMs use in the community-dwelling elderly is associated with negative patient health outcomesnegative patient health outcomes2,32,3

Using the Beers Criteria, preliminary data in the Emilia-Using the Beers Criteria, preliminary data in the Emilia-Romagna Region, Italy, showed that 1 out of 5 elderly patients Romagna Region, Italy, showed that 1 out of 5 elderly patients are subject to PIMs in ambulatory settingsare subject to PIMs in ambulatory settings44

1) Stuck AE, Beers MH, Steiner A, et al. Inappropriate medication nuse in community-residing older persons. Arch Intern Med. 1994;154:2195-2200.

2) Fu AZ, Liu GG, Christensen DB. Inappropriate medication use and health outcomes in the elderly. J Am Geriatr Soc J. 2004;52:1934-1939.3) Jano E, Aparasu RR. Healthcare outcomes associated with Beer’s Criteria: a systematic review. Ann Pharmacthero. 2007;41(3):438-447.4) Maio V, Yuen E, Novielli K, et al. Potentially Inappropriate Medication Prescribing for Elderly Outpatients in Emilia Romagna, Italy: A Population-Based Cohort Study Drugs & Aging 2006; 23(11):915-924

ObjectiveObjective

To enhance physicians’ knowledge of To enhance physicians’ knowledge of prescribing for the elderly and improve the prescribing for the elderly and improve the quality of prescribing in the primary care quality of prescribing in the primary care setting in the Local Health Unit (LHU) of setting in the Local Health Unit (LHU) of Parma, ItalyParma, Italy

MethodsMethods A 3-year, multi-phase prospective demonstration project A 3-year, multi-phase prospective demonstration project

targeting all 303 general practitioners (GPs) in the LHU of targeting all 303 general practitioners (GPs) in the LHU of Parma, Italy, was established in 2007Parma, Italy, was established in 2007

Q1-Q3 2007

Key Elements of multi-phase Intervention:

Development of PIMs list

Q4 2007

Dissemination of PIMs list to GPs & annual review of PIMs prevalence data

Dissemination of alternative list of drugs to GPs

Q1-Q3 2008

Annual review of PIMs prevalence data

Development of case studies on PIMs

Case studies presentation & annual review of PIMs prevalence data

Q4 2009 Q4 2008Q1-Q3 2009

2007

2010

PIMs list determined by expert panel category and generic drug namePIMs list determined by expert panel category and generic drug name55

Always AvoidedAlways Avoided

AmitriptylineAmitriptyline ChlorpropamideChlorpropamide CimetidineCimetidine

Clonidine (oral)Clonidine (oral) Digoxine (>0/125 mg/day)Digoxine (>0/125 mg/day) DisopyramideDisopyramide

Ferrous sulphate (>325 Ferrous sulphate (>325 mg/day)mg/day)

IndomethacinIndomethacin Ketorolac (injectable, >2 days)Ketorolac (injectable, >2 days)

MethyldopaMethyldopa Nifedipine (short-acting)Nifedipine (short-acting) NitrofurantoinNitrofurantoin

NSAIDs (oral, >15 days)NSAIDs (oral, >15 days) Oestrogens (oral)Oestrogens (oral) OrphenadrineOrphenadrine

PentazocinePentazocine TestosteroneTestosterone

Rarely AppropriateRarely Appropriate

TiclopidineTiclopidine DoxazosinDoxazosin FluoxetineFluoxetine

Some IndicationsSome Indications

AmiodaroneAmiodarone Clonidine (patch)Clonidine (patch) Atypical antipsychotics*Atypical antipsychotics*

*The following selected drugs were included in the analysis: risperidone, clozapine, olanzapine, quetiapine, aripiprazole

5) Maio V, Del Canale S, Abouzaid S, et al. Using explicit criteria to evaluate the quality of prescribing in elderly Italian outpatients: a cohort study. J Clin Pharm Ther. 2009;34:1-11.

Renal effectsof NSAIDs and COX-2 inhibitors

HyperkalemiaRenal Failure Acute Prerenal ATN

PGE2 /PGI2

Sodium retention Peripheral oedema Hypertension CHF

Arachidonic acid cascade

COX-2NSAIDsCOXIBs

Perazella, M. Perazella, M. Expert Opin Drug Saf. Expert Opin Drug Saf. 2002;1:53-64.2002;1:53-64.

Severe ADRs resulting in Hospital Admission Severe ADRs resulting in Hospital Admission showed for Drug Classes (GIFA STUDY)showed for Drug Classes (GIFA STUDY)

Onder, JAGS 2002; 50: 1962-8

27

22

17

14

14

13

12

11

10

8

7

0 5 10 15 20 25 30

NSAIDs

ASA - Antiplatelets

Diuretics

Digoxin

Antineoplastics

Antibiotics

Steroids

Ca- channel blockers

Antipsychotics

Insulin

ACEI

MethodsMethodsStudy DesignStudy Design Pre-post design to analyze the change in quarterly rates of Pre-post design to analyze the change in quarterly rates of

PIMs. The neighboring Reggio Emilia LHU was evaluated as PIMs. The neighboring Reggio Emilia LHU was evaluated as the comparator populationthe comparator population

Time FrameTime Frame Q4 2007 (baseline) to Q4 2009 (end of follow up period)Q4 2007 (baseline) to Q4 2009 (end of follow up period)

PopulationPopulation Elderly patients aged 65 years and older living in Parma LHU Elderly patients aged 65 years and older living in Parma LHU and Reggio Emilia LHU with at least 1 pharmacy claim during and Reggio Emilia LHU with at least 1 pharmacy claim during the time frame the time frame

Measurement of Rates Measurement of Rates of PIMsof PIMs

Percentage of elderly exposed to PIMs by quarterPercentage of elderly exposed to PIMs by quarter

Statistical TestsStatistical Tests Differences in overall chi-squared rates of PIMs and for each Differences in overall chi-squared rates of PIMs and for each PIM over time between Parma LHU and Reggio Emilia LHU PIM over time between Parma LHU and Reggio Emilia LHU were evaluated by the Breslow-Day test of homogeneous odds.were evaluated by the Breslow-Day test of homogeneous odds.

Results: Parma LHU By QuarterResults: Parma LHU By QuarterPrevalence of elderly receiving always inappropriate prescribed medications (PIMs) in Parma Prevalence of elderly receiving always inappropriate prescribed medications (PIMs) in Parma LHU from Q4 2007 through Q4 2009LHU from Q4 2007 through Q4 2009

Measurement Measurement periodperiod

Subjects Subjects receiving receiving

PIMsPIMs

Subjects Subjects receiving any receiving any medicationsmedications

Proportion of Proportion of subjects subjects

receiving PIMs receiving PIMs (%)(%)

Comparison to Comparison to baselinebaseline

(% change)(% change)

Comparison to Comparison to previous previous quarterquarter

(% change)(% change)

2007 Q4 2007 Q4 (Baseline)(Baseline) 64166416 7850678506 8.178.17 -- --

2008 Q12008 Q1 57625762 7876678766 7.327.32 -10.49-10.49 -10.49-10.49

2008 Q22008 Q2 57555755 7886778867 7.307.30 -10.71-10.71 -0.25-0.25

2008 Q32008 Q3 53225322 7775777757 6.846.84 -16.25-16.25 -6.20-6.20

2008 Q42008 Q4 52585258 7951479514 6.616.61 -19.09-19.09 -3.39-3.39

2009 Q12009 Q1 47164716 7958079580 5.935.93 -27.49-27.49 -10.38-10.38

2009 Q22009 Q2 50705070 7982079820 6.356.35 -22.28-22.28 7.187.18

2009 Q32009 Q3 45834583 7857678576 5.835.83 -28.63-28.63 -8.17-8.17

2009 Q4 2009 Q4 (Follow-up)(Follow-up) 45754575 8025080250 5.705.70 -30.24-30.24 -2.26-2.26

Proportion of elderly receiving PIMs in Parma LHU and Reggio LHU by QuarterProportion of elderly receiving PIMs in Parma LHU and Reggio LHU by Quarter

Breslow-Day test, p=0.004Breslow-Day test, p=0.004

SummarySummary

A quality intervention program looking at A quality intervention program looking at improving knowledge in primary care improving knowledge in primary care physicians on prescribing for the elderly physicians on prescribing for the elderly patients resulted in a substantial reduction of patients resulted in a substantial reduction of the rate of PIMs  the rate of PIMs 

The greatest impact was seen in users of The greatest impact was seen in users of digoxin and NSAIDs, with a significant digoxin and NSAIDs, with a significant potential benefit for patientspotential benefit for patients

LimitationsLimitations

PIMs with a low rate of use at baseline may be PIMs with a low rate of use at baseline may be impossible to lower any further and may impossible to lower any further and may diminish the overall impact of our interventiondiminish the overall impact of our intervention

The study does not measure the impact of the The study does not measure the impact of the intervention on other healthcare resource use intervention on other healthcare resource use or patient outcomesor patient outcomes

Future DirectionsFuture Directions

Additional analyses should be performed to Additional analyses should be performed to further investigate: further investigate:

Which physicians were less prone to change Which physicians were less prone to change prescribing and use results to design targeted prescribing and use results to design targeted educational interventionseducational interventions

Whether the observed change may be retained over Whether the observed change may be retained over timetime

Thank you!Thank you!

Any questions?Any questions?