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Reducing the Risk of Adverse Drug Events in Older Patients Nicole Slater, PharmD, BCACP July 14, 2018 Consultant Certification and Geriatric Pharmacotherapy

Reducing the Risk of Adverse Drug Events in Older Patients · likely to cause an adverse drug event in the older patient? ... (1 PPD x 45 years). She also has a medical history of

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Page 1: Reducing the Risk of Adverse Drug Events in Older Patients · likely to cause an adverse drug event in the older patient? ... (1 PPD x 45 years). She also has a medical history of

Reducing the Risk of Adverse Drug Events in Older Patients

Nicole Slater, PharmD, BCACPJuly 14, 2018Consultant Certification and Geriatric Pharmacotherapy

Page 2: Reducing the Risk of Adverse Drug Events in Older Patients · likely to cause an adverse drug event in the older patient? ... (1 PPD x 45 years). She also has a medical history of

DISCLOSURE/CONFLICT OF INTEREST

I, __Nicole Slater________, have no actual or potential conflict of interest in relation to this program.

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OBJECTIVES

At the completion of this knowledge-based activity, the participant will be able to: Define polypharmacy.

Identify common errors made when prescribing medications for the elderly population.

Recognize key recommendations in the BEER’s Criteria guidelines.

Optimize the patient’s drug therapy, given a case scenario.

Page 4: Reducing the Risk of Adverse Drug Events in Older Patients · likely to cause an adverse drug event in the older patient? ... (1 PPD x 45 years). She also has a medical history of

MEDICATION REVIEWS IN THE OLDERPOPULATION…WHY ARE THEY NEEDED?

Increase in co-morbid disease states

Physiological changes

Increased susceptibility to: Polypharmacy

Drug interactions

Adverse drug reactions

Poor compliance

Potentially inappropriate prescribing

Page 5: Reducing the Risk of Adverse Drug Events in Older Patients · likely to cause an adverse drug event in the older patient? ... (1 PPD x 45 years). She also has a medical history of

INAPPROPRIATE PRESCRIBING

Under-prescribing Not giving clinically indicated therapies despite no contraindication

to use

Mis-prescribing Unfavorable choice of medication therapies, dose, or duration for

use

Over-prescribing Excessive medication use

Higher doses than necessary

Longer durations than needed

Polypharmacy

Page 6: Reducing the Risk of Adverse Drug Events in Older Patients · likely to cause an adverse drug event in the older patient? ... (1 PPD x 45 years). She also has a medical history of

SOME EXAMPLES OF OVER-PRESCRIBING

NSAID HTN Anti-HTN med

HCTZ Gout Allopurinol

Amlodipine Edema Diuretics

Page 7: Reducing the Risk of Adverse Drug Events in Older Patients · likely to cause an adverse drug event in the older patient? ... (1 PPD x 45 years). She also has a medical history of

HOW MANY IS TOO MANY?

How many medications must an older adult take in order to put him or her at risk for polypharmacy? 3 5 10 15

Page 8: Reducing the Risk of Adverse Drug Events in Older Patients · likely to cause an adverse drug event in the older patient? ... (1 PPD x 45 years). She also has a medical history of

POLYPHARMACY

There is no set definition of how many medications constitute polypharmacy but some studies suggest more than 5, while others suggest more than 7 or 10.

Page 9: Reducing the Risk of Adverse Drug Events in Older Patients · likely to cause an adverse drug event in the older patient? ... (1 PPD x 45 years). She also has a medical history of

COMPLEX MEDICATION REGIMENS

Large number of medications Expensive medications Complex or frequency of dosing schedule Adverse reactions experienced Confusion related to brand/generic Difficult to open containers Other routes of administration (rectal, vaginal, subQ) Limited patient education

Page 10: Reducing the Risk of Adverse Drug Events in Older Patients · likely to cause an adverse drug event in the older patient? ... (1 PPD x 45 years). She also has a medical history of

“BUT I BOUGHT IT OVER-THE-COUNTER”

Self-medicating complicates Polypharmacy

OTC, Vitamins, and Herbals ARE STILL MEDICATIONS and COUNT

Use of OTC’s are highly prevalent among the older adult population

Generally NOT reported to the providers

Serious drug-interaction potential

Page 11: Reducing the Risk of Adverse Drug Events in Older Patients · likely to cause an adverse drug event in the older patient? ... (1 PPD x 45 years). She also has a medical history of

OUR BODIES CHANGE!?

Which of the following physiological changes is most likely to cause an adverse drug event in the older patient? Decreased fat tissue Increased hepatic metabolism Decline in renal function Alteration in gastric pH

Page 12: Reducing the Risk of Adverse Drug Events in Older Patients · likely to cause an adverse drug event in the older patient? ... (1 PPD x 45 years). She also has a medical history of

PHARMACOKINETICS

Absorption Bioavailability: The fraction of a drug dose reaching the systemic

circulation that affects the body

Distribution Locations in the body where a drug penetrates (i.e fat tissue)

Metabolism Conversion of a drug to alternative compounds which may or may

not be pharmacologically active

Elimination The final route of exit for a drug, which is expressed in half-life or

clearance

Page 13: Reducing the Risk of Adverse Drug Events in Older Patients · likely to cause an adverse drug event in the older patient? ... (1 PPD x 45 years). She also has a medical history of

AGING PHYSIOLOGICAL CHANGES

Important Physiological changes Absorption: Increased gastric pH, delayed gastric emptying

Distribution: Changes in lean body weight and body fat can alter distribution to different body compartments Malnutrition can affect protein binding potential

More body fat and less muscle mass

Hepatic metabolism: Typically decreases by roughly 40% in the older adult A decline in first-pass clearance causes build up of toxic medications

including warfarin and opioids

Renal elimination: Typically decreases up to 50% by age 80, but will differ in each individual

Substance abuse can also effect drug metabolism (mainly alcohol) when the liver is impaired from long-standing use

Page 14: Reducing the Risk of Adverse Drug Events in Older Patients · likely to cause an adverse drug event in the older patient? ... (1 PPD x 45 years). She also has a medical history of

AGING PHARMACODYNAMIC CHANGES

Dopaminergic (dopamine) Age related decrease in dopamine turnover = increased

parkinsonism

Serotonergic (serotonin) Decreased 5-HT receptors and serotonin = more depression seen

Norepinephrinic (Nor-Epi) Decrease in Nor-Epi leads to sluggishness

Cholinergic (acetylcholine) Decrease in acetylcholine = dementia

Gabanergic (gaba) Decrease in gaba = hyper-excitability

Page 15: Reducing the Risk of Adverse Drug Events in Older Patients · likely to cause an adverse drug event in the older patient? ... (1 PPD x 45 years). She also has a medical history of

MONITORING PK AND PD CHANGES

Generally result in decreased clearance of drugs which leads to increased sensitivity to many medications

Lower doses, longer intervals, and slower titrations are recommended to prevent intolerance and/or toxicity

Monitor older patients more often and more closely with medication therapies

Consider non-pharmacologic therapy when able

Balance over- vs. under prescribing

Page 16: Reducing the Risk of Adverse Drug Events in Older Patients · likely to cause an adverse drug event in the older patient? ... (1 PPD x 45 years). She also has a medical history of

CLINICAL TOOLS TO HELP YOU

The BEERS Criteria Accessible on the American Geriatrics Society Website:

http://www.americangeriatrics.org

STOPP and START Criteria Accessible online at

http://www.ncbi.nlm.gov/pmc/articles/PMC2810806/.

Page 17: Reducing the Risk of Adverse Drug Events in Older Patients · likely to cause an adverse drug event in the older patient? ... (1 PPD x 45 years). She also has a medical history of

SO HOW DO I KNOW WHAT IS BEST FORTHE PATIENT?

Which of the following was designed to assist prescribers in identifying omissions in therapy for an older adult? The Beer’s List The START Criteria The STOPP Criteria The DE-prescribing algorithm

Page 18: Reducing the Risk of Adverse Drug Events in Older Patients · likely to cause an adverse drug event in the older patient? ... (1 PPD x 45 years). She also has a medical history of

THE BEER’S CRITERIA

Most widely used consensus data for POTENTIALLY inappropriate medication use in the elderly Goal is to help reduce the risk of adverse events

Utilization intended for ambulatory, acute, and institutional settings

Not recommended for hospice or palliative cases

Published first in 1991

Last updated 2015

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POCKET CARD

Page 20: Reducing the Risk of Adverse Drug Events in Older Patients · likely to cause an adverse drug event in the older patient? ... (1 PPD x 45 years). She also has a medical history of

GENERAL RECOMMENDATIONS FOR THEBEER’S CRITERIA

Drug Rationale Recommendations

Anticholinergics-Hydroxyzine-Promethazine-Diphenhydramine

Risk of confusion, dry mouth, constipation

Avoid

Anti-infection-Nitrofurantoin

Potential for pulmonary toxicity, hepatoxicity, and peripheral neuropathy

Avoid when CrCl < 30 mL/min or long term use

Peripheral alpha-1 blocker-Terazosin

High risk of orthostatichypotension

Avoid for hypertension treatment

Amiodarone Higher toxicities than other antiarrhythmics

Avoid as 1st line for A fib unless patient has heart failure or substantial LV hypertrophy

Page 21: Reducing the Risk of Adverse Drug Events in Older Patients · likely to cause an adverse drug event in the older patient? ... (1 PPD x 45 years). She also has a medical history of

GENERAL RECOMMENDATIONSCONTINUED…

Drug Rationale Recommendation

Antipsychotics-convention and atypical

Increase risk of cerebrovascular accident and greater rate of cognitive decline and mortality in persons with dementia

Avoid, except for schizophrenia, bipolar, or short-term antiemetic in chemotherapy

Benzodiazepines short-acting-Lorazepam-Temazepam

Increase risk of cognitiveimpairment, delirium, falls, fractures and MVA

Avoid

Benzodiazepines long-acting-Clonazepam-Diazepam-Flurazepam

Increase cognitive impairment, delirium, falls, fractures and MVA

May be appropriate for seizure disorders, severe GAD, REM Sleep disorders

Page 22: Reducing the Risk of Adverse Drug Events in Older Patients · likely to cause an adverse drug event in the older patient? ... (1 PPD x 45 years). She also has a medical history of

GENERAL RECOMMENDATIONSCONTINUED…

Drug Rationale Recommendation

PPI’s-Omeprazole

Risk of Clostridium difficileinfection, bone loss, and fractures

Avoid schedule use for > 8 weeks unless high risk

Insulin sliding scale Higher risk of hypoglycemia without improvement in hyperglycemia regardless of care setting

Avoid

Testosterone Potential for cardiac problems, contraindicated in prostate cancer

Avoid, unless indicated for confirmed hypogonadism with clinical symptoms

Page 23: Reducing the Risk of Adverse Drug Events in Older Patients · likely to cause an adverse drug event in the older patient? ... (1 PPD x 45 years). She also has a medical history of

BEERS CRITERIAKEY PRINCIPLES TO GUIDE OPTIMAL USE

1. Medications in the AGS 2015 Beers Criteria are potentially inappropriate, not definitely inappropriate

2. Read the rationale and recommendations statements for each criterion. The caveats and guidance listed there are important

3. Understand why medications are included in the AGS 2015 Beers Criteria, and adjust your approach to those medications accordingly

4. Optimal application of the AGS 2015 Beers Criteria involves identifying potentially inappropriate medications, and where appropriate offering safer non-pharmacologic and pharmacologic therapies

5. The AGS 2015 Beers Criteria should be a starting point for a comprehensive process of identifying and improving medication appropriateness and safety

6. Access to medications included in the AGS 2015 Beers Criteria should not be excessively restricted by prior authorization and/or health plan coverage policies

7. The AGS 2015 Beers Criteria are not equally applicable to all countries

Page 24: Reducing the Risk of Adverse Drug Events in Older Patients · likely to cause an adverse drug event in the older patient? ... (1 PPD x 45 years). She also has a medical history of

START & STOPP CRITERIA

AIM: to improve medication appropriateness, prevent adverse drug reactions, and reduce drug costs

START: Screening Tool to Alert Doctors to Right Treatments Consider for people over age 65 with certain conditions

where no contraindication exists

Way to identify “omissions” to patient’s med list

STOPP: Screening Tool of Older People’s Potentially Inappropriate Prescriptions Consider for people over age 65 where the medications are

linked to an increase in adverse drug events and hospitalizations

Not comprehensive

Page 25: Reducing the Risk of Adverse Drug Events in Older Patients · likely to cause an adverse drug event in the older patient? ... (1 PPD x 45 years). She also has a medical history of

START & STOPP CRITERIA

START Cardiovascular system (8) Respiratory system (3) Central Nervous system (2) GI system (2) Musculoskeletal system (3) Endocrine system (4)

STOPP Cardiovascular system (17) Central Nervous system

(13) GI system (5) Musculoskeletal system (8) Respiratory system (3) Urogenital system (6) Endocrine system (4) Analgesics (3) Falling (5) Duplicate classes (1)

Page 26: Reducing the Risk of Adverse Drug Events in Older Patients · likely to cause an adverse drug event in the older patient? ... (1 PPD x 45 years). She also has a medical history of

CONSIDER STARTING THESE…

Metformin: Patients with Type II diabetes

ACE inhibitor or ARB: Patients with heart failure, post-MI, diabetic nephropathy

Aspirin: Prevention for cardiovascular events in patients with diabetes and one major cardiovascular risk factor

Statin: Patients with cardiovascular disease, cerebrovascular event, or peripheral vascular disease as well as patients with diabetes and one or more additional cardiovascular risk factor

Calcium and vitamin D: Patient with osteoporosis

Page 27: Reducing the Risk of Adverse Drug Events in Older Patients · likely to cause an adverse drug event in the older patient? ... (1 PPD x 45 years). She also has a medical history of

CONSIDER STOPPING THESE…

Cardiovascular HCTZ with gout history

Aspirin over 150mg

CNS TCA’s

SSRI’s with clinically significant hyponatremia

Musculoskeletal NSAIDS

Falling Benzo’s

First generation antihistamines

Page 28: Reducing the Risk of Adverse Drug Events in Older Patients · likely to cause an adverse drug event in the older patient? ... (1 PPD x 45 years). She also has a medical history of

CONSEQUENCES OF POLYPHARMACY

Drug-drug interactions Drug-disease interactions Drug-food interactions Drug toxicity Increase hospitalizations/readmissions Increased falls Possible mortality Confusion Side effects/adverse events

Page 29: Reducing the Risk of Adverse Drug Events in Older Patients · likely to cause an adverse drug event in the older patient? ... (1 PPD x 45 years). She also has a medical history of

ADVERSE DRUG EVENT (ADE)

An injury resulting from medical intervention related to a drug

Unintended effect from a drug that produces symptoms sufficient to cause a person to seek medical attention

May produce symptoms sufficient to affect function or quality of life

Can happen ANYWHERE (hospital, LTCF, outpatient)

Many are preventable

Adverse Drug Reaction (ADR): response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease or for the modification of physiologic function. This is a type of ADE and is different from a side effect

Page 30: Reducing the Risk of Adverse Drug Events in Older Patients · likely to cause an adverse drug event in the older patient? ... (1 PPD x 45 years). She also has a medical history of

COMMON CULPRITS OF ADE’S

Antipsychotics NSAIDS Insulin Antiplatelet Anticoagulants Diuretics

St. John’s Wort Ginseng Gingko biloba Saw palmetto Kava

Page 31: Reducing the Risk of Adverse Drug Events in Older Patients · likely to cause an adverse drug event in the older patient? ... (1 PPD x 45 years). She also has a medical history of

COMMON ADVERSE EVENTS IN THEOLDER POPULATION

Falls Fatigue Cognitive decline Constipation/Urinary retention Delirium Pain Insomnia Depression

Page 32: Reducing the Risk of Adverse Drug Events in Older Patients · likely to cause an adverse drug event in the older patient? ... (1 PPD x 45 years). She also has a medical history of

RECOGNIZING ADVERSE DRUG EVENTS

Many times, these are mistaken for new disease states in elderly patients

Always consider the side effects of the drug

Ask appropriate questions to gather information about the ADE

Page 33: Reducing the Risk of Adverse Drug Events in Older Patients · likely to cause an adverse drug event in the older patient? ... (1 PPD x 45 years). She also has a medical history of

REPORTING ADVERSE EVENTS/REACTIONS

Med watch Voluntary reporting to the FDA by health care providers and patients

Manufacturer Health care providers and patients may report directly to the

manufacturer who then is responsible for submitting to the FDA

What happens? Product recalls or withdrawal

Black Box Warnings formulated

Contraindications are modified

Monitoring recommendations are created

Med Guides are developed

Letters to health care professionals are disseminated

Page 34: Reducing the Risk of Adverse Drug Events in Older Patients · likely to cause an adverse drug event in the older patient? ... (1 PPD x 45 years). She also has a medical history of

DE-PRESCRIBING

Should be a shared decision Complete a full medication review first Assess adherence Assess appropriateness with BEERS and START/STOPP Discuss the patient’s preferences and values Explain the goals of therapy Prioritize medication discontinuation Obtain buy-in from the patient Seek guidance from healthcare team members (i.e. pharmacist!)

Page 35: Reducing the Risk of Adverse Drug Events in Older Patients · likely to cause an adverse drug event in the older patient? ... (1 PPD x 45 years). She also has a medical history of

PATIENT CASE

You, the pharmacist, received a discharge letter from a patient in your practice who was discharged from the hospital 5 days ago after being admitted for an exacerbation of chronic obstructive pulmonary disease (COPD) and was also treated for a Urinary Tract Infection (UTI). SJ is 74 year old WF who is an ex-smoker (1 PPD x 45 years). She also has a medical history of diabetes mellitus and hypertension, which are both controlled at this time. All of her labs and blood studies are WNL. You are asked to perform a medication reconciliation on SJ and determine appropriateness of her medications.

Her medications before hospitalization were are as follows: Metformin 1000mg twice daily Glipizide 10mg twice daily Amlodipine 10mg once daily Tiotropium inhaler (18 micrograms) 1 puff once a day Pro-Air HFA 2 puff every 4 to 6 hours as needed for shortness of breath Citalopram 20mg once daily

Page 36: Reducing the Risk of Adverse Drug Events in Older Patients · likely to cause an adverse drug event in the older patient? ... (1 PPD x 45 years). She also has a medical history of

MEDICATIONS UPON DISCHARGE

Tiotropium inhaler (18 micrograms) 1 puff once a day Advair Diskus 250/50 1 puff twice a day Albuterol nebulizers 1 every 4 – 6 hours as needed Sliding scale insulin: per instructions given at discharge Glipizide 10mg twice daily Ramipril 10 mg once a day Amlodipine 10 mg once a day Citalopram 20 mg once a day Omeprazole 20mg once a day Temazepam 15 mg at night Prednisolone (short course) 30 mg once a day for 7 days Nitrofurantoin (short course) 100 mg four times a day for 7 days

Page 37: Reducing the Risk of Adverse Drug Events in Older Patients · likely to cause an adverse drug event in the older patient? ... (1 PPD x 45 years). She also has a medical history of

WHAT CHANGES NEED TO BE MADE?

Review the patient’s medication list and make any recommendations that are potentially inappropriate for this patient. Also consider medications that may need to be started based on her PMH.

Page 38: Reducing the Risk of Adverse Drug Events in Older Patients · likely to cause an adverse drug event in the older patient? ... (1 PPD x 45 years). She also has a medical history of

QUESTIONS?

Thank you for your time!

Page 39: Reducing the Risk of Adverse Drug Events in Older Patients · likely to cause an adverse drug event in the older patient? ... (1 PPD x 45 years). She also has a medical history of

REFERENCES

Masnoon N, Shakib S, Kalish-Ellett L, et al. What is polypharmacy? A systematic review of definitions. BMC Geriatrics (2017) 17:230

Pretourius R, Gataric G, Swedlund S, et al. Reducing the Risk of Adverse Drug Events in Older Adults. Am Fam Phys 2013:87(5);331-336.

Lavan A, Gallagher P. Predicting risk of adverse drug reactions in older adults. Ther Adv Drug Saf2016:7(1);11-22.

Hajjar ER, Hanlon JT, Artz MB, et al. Adverse Drug reaction risk factors in older outpatients. Am J GerPharmacotherapy 2003;1(2):82-89

Reporting Adverse Drug Events. Available from: https://www.uspharmacist.com/article/reporting-adverse-drug-events US Pharm. 2010;35:HS-15-HS-19.

Adverse Drug Events: Overview. Available from: https://health.gov/hcq/ade.asp. Accessed 25 June 2018. START and STOPP Criteria: Available from: http://www.ncbi.nlm.gov/pmc/articles/PMC2810806/. BEERS Criteria: Available from: http://www.americangeriatrics.org Deprescribing: Available from: https://deprescribing.org/resources/deprescribing-guidelines-algorithms/ BEERS Criteria pocket card: Available from:

https://geriatricscareonline.org/ProductTypeStore/pocketcards/10/ Mortazavi S, Shati M, Keshtkar A, et al. Defining polypharmacy in the elderly: a systematic review protocol.

BMJ Open 2016;6: e010989. Davies EA, O’Mahony MS. Adverse Drug reactins in special populations-the elderly. British J of Pharmcol

2015; 80(4). Available from: https://bpspubs.onlinelibrary.wiley.com/doi/full/10.1111/bcp.12596


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