PHARMACY CONNECTION ARTICLE

Coroner’s Inquest, Polypharmacy and the Elderly

Published on: February 1, 2015

Inquest into Death of an Elderly Patient on Fentanyl

A 95 year old woman, TP, the subject of a coroner’s inquest, died a year after being placed in a retirement home. The reported cause of death was acute myocardial infarction, secondary to coronary artery disease and a left hip fracture, with dementia reported as a contributor.

Documentation irregularities and concern about the use of fentanyl for pain control led the coroner’s jury to refer the case for review to the Geriatric and Long-Term Care Review Committee (GLTCRC). The Committee’s review and its recommendations to several institutions, in the areas of appropriate pain assessment, evaluation and titration of opioid pain medications, documentation and falls prevention as well as education of healthcare professionals on medication use in the elderly are summarized in Appendix B.

Case History:

Apart from documentation irregularities, this case highlights areas where a frail elderly patient on multiple medications was exposed to avoidable risks, with several missed opportunities for timely intervention and optimization of health outcomes.

On admission to the retirement home in April 2011, TP, observed to be in no overt distress, had several documented co-morbid conditions, including chronic kidney disease, hypothyroidism, osteoarthritis, diverticulitis, controlled hypertension, recent TIA and remote history of stroke. Medications in TP’s chart that month and updated at various time points, documented as medication reviews, are listed in Appendix A. An initial physiotherapist visit on April 11 identified the patient to be at high risk of falls and a management plan was outlined. A later note, but dated April 4, recorded the finding of two fentanyl patches on the patient.

Over the next few months, TP began to exhibit signs of confusion and a tendency to fall. In May, she had a temporary episode of day/night reversal and a hand injury when going to the bathroom. In September, she suffered a few broken ribs from a fall in the bathroom. Pain from the fall led to an increase in dosage of acetaminophen (now scheduled) and a doubling of her fentanyl patch to 50 mcg every three days. A medication review at this time failed to capture the doubled dose of fentanyl. TP’s confusion increased and a week later her fentanyl dose was reduced back to 25 mcg. In November, TP fell and sustained a head injury. That month, episodes of increased blood pressure and angina culminated in two emergency room visits and the prescribing of nitroglycerin patch, after which no further angina was recorded. TP suffered another episode of day/night reversal in January 2012 and three falls during February and March 2012, after which a medication review was recorded. Her family, concerned that TP’s pain medication was resulting in confusion, asked that a different doctor assume her care. TP had another fall that month, the fourth in the span of six weeks. This resulted in a hip fracture necessitating surgery. In April 2012, three weeks post-op, TP died of a myocardial infarction.

This is another example where the Principles of Professional Practice should draw attention to an especially vulnerable population.

Polypharmacy and the Elderly

While some elderly adults remain fit and active as they age, many are assailed by complex chronic health conditions. This makes them prey to polypharmacy, defined as taking five or more medications.

• In Canada, a 2009 nationwide population survey reported polypharmacy in over 50 per cent of seniors in institutions and 13 per cent of those at home¹.
• A 2012 report by the Canadian Institute of Health Information (CIHI) cites 66 per cent of Canadian seniors with claims for five or more drug classes, and close to 40 per cent of seniors over the age of 85 with claims for 10 or more drug classes². These figures do not take into account any additional over-the-counter medications.

These statistics give rise to concern because the well known risks of polypharmacy are heightened in the elderly³:

• Age-related physiologic changes influence the metabolism and response to medications
  • Many medications therefore have increased potential for harm in the elderly and are considered inappropriate.
• Presence of complex co-morbid conditions, requiring the use of multiple medications, increases risks of
  • Drug interactions and adverse effects
  • Non-adherence due to complex and multiple drug regimens
  • Prescribing cascades to treat adverse effects of an existing medication
  • Impaired function and cognition in older adults.
• Efficacy and safety of medications is not always well established in older patients
  • Despite being the largest consumers of medications, older patients are often underrepresented or excluded from drug efficacy trials.

The consequences of polypharmacy in the elderly, in addition to adverse drug effects and impact on function and cognition, include increased risk of falls, poorer health quality of life, hospitalizations and death⁴. Between 20 per cent and 30 per cent of adults over the age of 65 fall each year from multiple and often avoidable causes. A strong association with fall risk has been observed when certain medications such as antidepressants, antipsychotics, benzodiazepines or those that cause drowsiness, dizziness, hypotension, ataxia and visual impairment are included in the polypharmacy mix.⁵

Lists and criteria for potentially inappropriate medications (PIMs) in the elderly, i.e., medications where actual or potential harms outweigh the benefits, have been developed for clinician reference by expert panels and include the updated Beers criteria^6,7, the STOPP criteria⁸ and the Anticholinergic Burden Scale9. Indiscriminate prescribing of PIMs, however, continues to be reported. In 2012, CIHI reported more than a third of Canadian seniors using a PIM as identified by the Beers Criteria². Internationally, the results of a systematic review suggest one in five prescriptions for community dwelling older patients are inappropriate¹⁰. This does not include medications or herbals bought without a prescription, many of which could be inappropriate in themselves or have dangerous interactions with other prescribed medications.

Mitigating Risks of Polypharmacy

One way to mitigate the risks of polypharmacy and PIMs is by ‘deprescribing’, a term gaining increasing prominence, and the subject of current research. It involves assessing the benefits and risks of medications, followed by a process of tapering, stopping or withdrawing medications that are not required or that have potentially harmful consequences for the individual patient.¹¹

Available evidence indicates that medications may be withdrawn successfully with little or no harm to the patient¹¹.

• Benefits shown from cohort and observational studies include improved patient health outcomes from resolution of adverse drug events when specific medication classes are withdrawn.¹²
  • Studies have generally been of insufficient duration to determine long-term clinically significant benefits such as reduced hospitalization or improved functionality. Some trials, however, have demonstrated reduced fall risk.
• Risks of stopping medications include the potential for adverse drug withdrawal reactions , pharmacokinetic and pharmacodynamic changes and return of the medical condition.
  • Risks can be mitigated with appropriate tapering, monitoring after withdrawal and reinstating the medication if the condition returns.¹²
• Barriers¹³ to stopping a medication that has been prescribed over months or years is complicated by many factors, including but not limited to
  • Patient reluctance and physician inertia, due to fear of unknown negative consequences of discontinuing medications
  • Lack of insight on harms of PIMs
  • Lack of sufficient data on methods to safely discontinue medications, resulting in clinicians having to rely on their experience and clinical judgement when attempting to taper or stop medications.
    

Empowering clinicians with evidence based guidance to safely and effectively discontinue inappropriate medications is the subject of current research:

• The Ontario Pharmacist Research Collaboration (OPEN)¹⁴, with its team of experts, led by pharmacist and scientist Dr. Barbara Farrell and scientist James Conklin, has been awarded a three year grant by the Ministry of Health & Long-Term Care in 2013 to develop deprescribing guidelines for the elderly.¹⁵
• Reeves et al¹² have proposed a patient-centred deprescribing process, utilizing a five-step cycle that includes a comprehensive medication history, identifying PIMs, assessing if any PIM can be discontinued, planning the withdrawal process – e.g., tapering, and providing monitoring support and appropriate documentation.

Role of Pharmacist

Pharmacists can play an important role as part of the circle of care for the elderly. As medication experts, and ranking amongst the most approachable and accessible of healthcare providers in Canada, pharmacists are in a position to positively impact the health outcomes of their patients, including the especially vulnerable senior population.

Focusing on the individual patient’s needs is pivotal, guided by evidence and with direct input from the patient/caregiver. The acronym MINDFUL below sets out a common-sense approach enabling the pharmacist to optimize the health outcomes of their senior patients^3,11,12:

• Medical History (M)
  • Review the patient’s medical and medication history:
    • Ask about prescribed and non-prescribed (over-the-counter) medications, including herbals and vitamins.
    • Ask about changes to health status and medications at every visit.
  • Match medication therapy to the patient’s condition, age and goals.
  • Assess appropriateness of each medication by considering
    • Patient-specific co-morbid conditions, age, renal and liver function
    • The need for existing or new medications e.g., for a palliative care patient with a short life expectancy, prescribing a prophylactic medication that requires several years to realize a benefit may not be considered appropriate.
• Identify PIMs (I)
  • Use evidence to identify medications that have significant interactions, are unnecessary, constitute duplication of therapy, PIMs, as well as conditions not receiving optimal treatment
  • Assess benefits vs risks of continuing or stopping PIM in that individual patient.
• Negate PIMs (N)
  • Use available evidence and patient-specific criteria to determine the process for safely discontinuing PIM (e.g., taper if in doubt)
  • Obtain patient consent and contact the prescriber to provide the recommendation and rationale and effect the change.
• Document the decision and rationale (D)
• Follow up with the patient (F)
  • Monitor the outcome of the change and provide education and support.
• Understanding (U)
  • Elicit patient understanding of the changes and information provided to ensure medications are taken as indicated.
• List all current medications (with any changes) (L)
  • Provide an updated medication list for the patient to carry
  • Inform all relevant healthcare practitioners in the patient’s circle of care of medication changes.

Deprescribing guidelines such as those by the OPEN group, once published, will enhance the ability of clinicians to more confidently reduce medications that are inappropriate or no longer necessary for older patients, thus helping to decrease risks of adverse drug effects and optimize health related quality of life. It is hoped that such guidelines will translate ultimately into a cultural shift in healthcare where reassessing medications as people age becomes part of routine care.^11,14,15

REFERENCES

1. Ramage-Morin, PL. Medication use among senior Canadians. Health Matters. March, 2009 Statistics Canada, Catalogue no. 82-003-XPE • Health Reports, Vol. 20, no. 1, March 2009 . Accessed November 2014 at http://www.statcan.gc.ca/pub/82-003-x/2009001/article/10801-eng.pdf
2. Canadian Institute for Health Information. Drug Use Among Seniors on Public Drug Programs in Canada, 2012 (Ottawa, Ont.: CIHI, 2014). Accessed December 2014 at https://secure.cihi.ca/free_products/Drug_Use_in_Seniors_on_Public_Drug_Programs_EN_web_Oct.pdf
3. UpToDate. Drug prescribing for older adults. Accessed December 2014 at http://www.uptodate.com/contents/drug-prescribing-for-older-adults?source=search_result&search=elderly&selectedTitle=2%7E150b
4. Fried TR, O’Leary J, et al. Health outcomes associated with polypharmacy in community-dwelling older adults: a systematic review. J Am Geriatr Soc. 2014 Dec;62(12):2261-72
5. Seniors falls in Canada. Second report. Public Health Agency of Canada 2014. Accessed online at http://www.phac-aspc.gc.ca/seniors-aines/publications/public/injury-blessure/seniors_falls-chutes_aines/assets/pdf/seniors_falls-chutes_aines-eng.pdf
6. Campanelli CM. American Geriatrics Society Updated Beers Criteria for Potentially Inappropriate Medication Use in Older Adults:The American Geriatrics Society 2012 Beers Criteria Update Expert Panel. Am Geriatr Soc. 2012 April ; 60(4): 616–631. Accessed online at http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3571677/
7. AGS Beers Criteria for Potentially Inappropriate Medication Use in Older patients. From the Amrican Geriatric Society. Accessed online at http://www.americangeriatrics.org/files/documents/beers/PrintableBeersPocketCard.pdf
8. Gallagher P, O’Mahoney D. STOPP (Screening Tool of Older Persons’ potentially inappropriate Prescriptions):application to acutely ill elderly patients and comparison with Beers’ criteria. Age and Ageing 2008; 37: 673–679. Accessed online at http://ageing.oxfordjournals.org/content/37/6/673.full.pdf+html
9. Anon. ABC Anticholinergic Burden Scale. Helping physicians do no harm. Available online at http://www.agingbraincare.org/tools/abc-anticholinergic-cognitive-burden-scale/
10. Opondo D, Eslami S, Visscher S, et al. Inappropriateness of Medication Prescriptions to Elderly Patients in the Primary Care Setting: A Systematic Review. PLoS ONE 2012: 7(8):e43617. Accessed online at http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3425478/
11. Thompson W, Farrell B. Deprescribing: what is it and what does the evidence tell us? Can J Hosp Pharm. 2013 May;66(3):201-2. Accessed online at http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3694945/pdf/cjhp-66-201.pdf
12. Reeve E, Shakib S, Hendrix I et al. The benefits and harms of deprescribing. Med J Aust. 2014 Oct 6;201(7):386-9.
13. Anderson K, Stowasser D, Freeman C et al. Prescriber barriers and enablers to minimising potentially inappropriate medications in adults: a systematic review and thematic synthesis. BMJ Open 2014;4:e006544. doi:10.1136/bmjopen-2014-006544. Accessed online at http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4265124/#R20
14. Ontario Pharmacist Research Collaboration (OPEN). Deprescribing guidelines for the elderly. Accessed online at http://www.open-pharmacy-research.ca/research-projects/emerging-services/deprescribing-guidelines
15. Cross C. Introducing deprescribing into culture of medication. CMAJ. 2013 Sep 17;185(13):E606.Accessed online at http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3778460/

Appendix A. TP’s medications

April 20, 2011 (admission month)	May 4, 2011 (documented as a ‘six month review’)	Sept. 14, 2011 (documented as a ‘six month review’)	March 14, 2012 Medication review
Scheduled: • Fentanyl patch 25 mcg q3days PRN: • Pain: Acetaminophen • Allergies: Dimenhydrinate • Nausea: Diphenhydramine • Bowel regimen laxatives: Fleet enema, glycerin , loperamide, lactulose, senossides, milk of magnesia • Antacid: Magnesium hydroxide /aluminium hydroxide • Cough: Guaifenesin	Scheduled: • Fentanyl patch 25 mcg q3days • Metoprolol 25 mg bid • Clopidogrel 75 mg daily • Rabeprazole 10 mg daily • Venlafaxine XR 75 mg daily • Levothyroxine 112 mcg daily • Tiotropium inhaler daily PRN: • Salbutamol inhaler • Nitrospray	Scheduled: • Fentanyl patch 25 mcg q3days • Metoprolol 25 mg bid • Clopidogrel  75 mg daily • Rabeprazole 20 mg daily • Venlafaxine XR 75 mg daily • Levothyroxine 0.125 mg daily • Spiriva inhaler daily • Acetaminophen 650 qid • Alendronate 70 mg every Wednesday • Candesartan 16 mg/HCT 12.5 mg daily • Docusate 100 mg tid  • Domperidone 10 mg tid ac • Ferrous gluconate 300 mg daily • Lorazepam 1 mg at bedtime PRN: • Nitroglycerin spray • Salbutamol inhaler • Medical directive for Acetaminophen Diphenhydramine Dimenhydrinate Milk of magnesia Magnesium hydroxide/ aluminium hydroxide Fleet enema Glycerin Guiafenesin Loperamide Lactulose Sennosides	Scheduled: • Fentanyl patch 25 mcg q3days • Metoprolol 25 mg bid • Clopidogrel  75 mg daily • Rabeprazole 20 mg daily • Venlafaxine XR 75 mg daily • Levothyroxine 125 mcg daily • Tiotropium inhaler daily • Acetaminophen 650 qid • Alendronate 70 mg every Wednesday • Candesartan 16 mg/HCT 12.5 mg daily • Docusate100 mg tid  • Domperidone 10 mg tid ac • Ferrous gluconate 300 mg daily • Lorazepam 1 mg at bedtime • Nitroglycerin patch 0.2mg/ hr PRN: • Salbutamol inhaler • Medical directive for Acetaminophen Diphenhydramine Dimenhydrinate Milk of magnesia Magnesium hydroxide/ aluminium hydroxide Fleet enema Glycerin Guiafenesin Loperamide Lactulose Sennosides

Appendix B. GLTCRC Review

Issue	Review	Recommendations
Documentation	Difficulties in interpreting and analyzing medical and nursing notes:  – inconsistent charting methods – notes in English or French  – notes written out of order, not labeled as ‘late entry’ – difficulty reading medication administration sheets in both electronic and printed formats.	To the Retirement Home: – Conduct a review of documentation policies – Focus on standardizing how dates are written – Ensure notes are dated correctly with late entries recorded as such. – Records selected for photocopy or scan should be legible.
Pain Management	– No formal assessment conducted  on the cause, type, location, severity of  pain, nor of  the appropriateness of pain medications, on admission or on subsequent fall-related increase in pain – Inappropriate doubling of fentanyl patch for new  acute pain caused by rib fractures, leading to worsening cognition in TP –  Family’s concerns for TP’s cognition and narcotic use could have been addressed, for example, by reviewing and discontinuing the fentanyl patch, and titrating a shorter acting  narcotic to  determine an  optimal opioid dose to  balance pain  relief  and cognitive function.	1. To Ontario Ministry of Health and Long-Term Care (MOHLTC) and Ontario Association of Long-Term Care Physicians: Reminders to healthcare providers that – falls prevention  in any seniors’  facility requires an inter-professional approach, and the physician is an important part of that approach. Falls should prompt a review. – while narcotics for musculoskeletal pain in the elderly may be indicated, appropriate use requires: • Accurate diagnosis and description of pain • Frequent re-evaluation and appropriate titration • Use of short acting opiates for treatment of acute musculoskeletal pain • Description of goals of therapy e.g.,  mobility 2. To MOHLTC, Ontario Association of Long-Term Care Physicians, College of Physicians and Surgeons, Ontario College of Family Physicians, Ontario College of Pharmacists and medical schools in Ontario: Education directed to the appropriate health professionals regarding drug therapy for the elderly should be a national priority at all levels: undergraduate, graduate, and continuing education.
Falls Prevention	– Despite the physiotherapist’s note indicating TP to be at high risk of falls, and despite ensuing multiple falls, there was no evidence of review by the attending physician of potential medical or medication-related causes for falls. – Multiple medications, associated with increased risk of falls in the elderly, were prescribed for TP, including lorazepam, venlafaxine, metoprolol,  nitroglycerin  and narcotics.
Bowel regimen	– A  PRN bowel regimen is insufficient to prevent serious constipation in an elderly patient on narcotics. – The nausea for which domperidone was prescribed might have been secondary to inadequately  managed constipation. – Occasional diarrhea in this case  may have been  caused  by  overflow and  the directive  to  use  loperamide  was  inappropriate.
Anticholinergic load	Despite  cognitive  impairment, TP was  prescribed  dimenhydrinate and diphenhydramine, medications with known anticholinergic effects. Anticholinergics have the propensity for severe adverse effects including confusion, constipation, dizziness and falls and are considered potentially inappropriate in the elderly.