Christine Chim, PharmD, BCACP
Josh Rickard, PharmD, BCPS, CDE
At the end of this case, students will be able to:
- Define medication-use safety and the importance to public health
- Identify risk factors associated with medication safety and reasons for unsafe medication use in elderly patients
- Examine the pharmacist’s role and tools used to improve medication safety
- Recommend resources pharmacists can provide to patients with physical impairments to overcome medication-related issues
- Recommend a plan of action using the Medication Appropriateness Index (MAI)
Medication use safety is an important aspect of the healthcare delivery system to consider in all patients as it can affect the patient’s overall health at home and within the healthcare system. When thinking about this issue, it is common to consider the use of medication in specific populations (such as elderly patients), language barriers, adverse drug events (ADE), drug shortages, and acquisition of medications.
ADEs often result from unsafe medication use, leading to more than one million visits to the emergency room and 350,000 hospitalizations on an annual basis.1 Billions of dollars are spent addressing ADEs, with the elderly population particularly at risk.2-4 Reasons for this include physiologic changes, health literacy barriers, health disparities, polypharmacy, and nonadherence. Nonadherence can be intentional or unintentional and affected by medication efficacy, perceptions of one’s health or illness, or cultural beliefs.5 The inherent nature of medications can also predispose patients to ADEs.4,6 Although not limited to the elderly, physical impairments can also result in medication nonadherence and ADEs. Impairments can include, but are not limited to, dexterity, vision, mental status, and hearing.
Due to the large impact on public health, pharmacists have access to many tools and resources that have been developed to prevent and resolve ADEs. For example, many medications that may be unsafe for older adults (e.g., anticholinergics, antihypertensives, antipsychotics, insulin, and sedatives) exist on the Beers Criteria for Medication Use in Older Adults.7 Pharmacists can use these criteria to determine the appropriateness of an older adult patient’s medication regimen and seek alternative therapeutic choices. As one of the most widely used resources, the Criteria is regularly updated based on the most current research to support the safe and effective use of the listed medications along with corresponding strengths of recommendation. The combination of the Screening Tool of Older People’s Prescriptions (STOPP) and Screening Tool to Alert to Right Treatment (START) criteria can also be used to determine potentially inappropriate prescribing in older adults while offering treatment alternatives.8The Medication Appropriateness Index (MAI) is another tool that can be used to prevent ADEs; this tool consists of 10 questions that a pharmacist may ask regarding each drug a patient is taking.9 The questionnaire assesses a medication’s indication, effectiveness, dose, directions for use, administration, interactions, duration of use, and cost. Based on a score ranging between 0 and 18, the MAI provides a final rating of appropriateness: appropriate, marginally appropriate, or inappropriate. Additional screening tools and scales used to assess a patient’s understanding of medications and diseases include the Drug Regimen Unassisted Grading Scale (DRUGS), Medication Management Instrument for Deficiencies in the Elderly (MedMaIDE), Medi-COG, and the Self-Administration of Medication (SAM).10,11,12
You are a pharmacist working in a family medicine clinic.
CC: “I need a refill on my shots”
HPI: GR is a 79-year-old female patient (65 in, 77 kg) presenting to her family medicine clinic for follow-up for her chronic disease states. The patient has been in India the past four months with family members and indicates no healthcare concerns at this time. She reports no hypoglycemic events and states that her blood sugar levels are “good”. The patient did not bring her blood glucose log to clinic.
PMH: T2DM; HTN; HLD; severe osteoarthritis in her hands
- Mother: T2DM, breast cancer
- Father: MI at age 57
- Metformin 500 mg BID
- Insulin glargine 42 units SQ at bedtime (vials and syringes for insurance purposes)
- Glyburide 10 mg daily
- Atorvastatin 80 mg daily
- Lisinopril 20 mg daily
- Hydrochlorothiazide 25 mg daily
- Acetaminophen 500 mg four times daily as needed for pain
- Na 140 mmol/L
- K 4.2 mmol/L
- Cl 101 mmol/L
- CO2 27 mmol/L
- BUN 16 mg/dL
- SCr 0.92 mg/dL
- Ca 9.6 mg/dL
- Glucose 148 mg/dL
- HgA1c 9.1%
- LDL: 98
- HDL 41
- Triglycerides 137
- Total cholesterol 166
- Alk phos 64 U/L
- AST 25 U/L
- ALT 32 U/L
- BP 138/72
- HR 84 bpm
- RR 12/min
SDH: Because GR’s English proficiency is low, she is accompanied by her son to her appointment to aid in translation.
Additional context: Upon interviewing the patient (by way of her son), you found that she ran out of her insulin glargine while she was in India. While in India, her nephew ordered insulin online from an internet pharmacy because the pharmacy she normally uses could not acquire the medication due to a current shortage. She also states that her nephew thinks that she should be cooking with extra turmeric and cinnamon to help with her diseases rather than using the “chemicals” found in medications.
1. Identify and describe the areas of increased medication safety concern for this patient.
Due to her limited English proficiency, patient has to rely on son for translation: the son’s level of health literacy is also uncertain. The patient’s osteoarthritis is severe, which may warrant as a challenge in using medications, like her insulin and/or opening medication bottles. A pharmacist could work with the insurance company to make a switch from insulin vials to insulin pens so that she could safely use it. She is taking medications that can cause adverse effects such as sedation and dizziness, which are fall risks. Lastly, although the patient has been advised by her nephew to eat turmeric/cinnamon, it would be important to have a discussion about her beliefs in using insulin, and to reiterate the importance of taking her insulin.
2. Based on the MAI, which medication is least appropriate for this patient? How should this be addressed?
According to the MAI, glyburide is least appropriate for this patient. Without completing the MAI, glyburide is listed as a medication on the Beer’s Criteria, in which it states that long-acting sulfonylureas, such as glyburide, are not recommended in older adults due to the risk of hypoglycemia. This patient’s risk of adverse events (specifically, hypoglycemia, and subsequently, falls), is also heightened by the concurrent use of insulin glargine. Depending on her level of diabetes control/clinician’s goal A1c for the patient:
- Glyburide can be switched to a short-acting sulfonylurea (i.e. glipizide)
- Discontinue glyburide and increase metformin dose (pending eGFR is WNL)
3. How would you address her statement about her nephew’s beliefs in the use of turmeric and cinnamon instead of her prescription medications?
There could be many correct approaches to this situation. The pharmacist should assess the patient’s own beliefs on the use of herbal products rather than her prescribed medications. You could educate the patient regarding limited studies for the use of these products. She should be counseled on purchasing vitamins, minerals, and herbal products from a reputable source. Another suggestion is to buy products that contain the USP verified mark on the label to ensure that the product actually contains the declared ingredient in the designated dose, is free from any contaminants, and was manufactured in a setting up to FDA standards. An explanation of why the patient takes each medication, how the medication works physiologically and their benefits to patient’s health may also ease concerns she may have. Always perform a drug interaction screening as some herbal products have clinically significant drug interactions. Cultural sensitivity has an important role in this case, and many patients may put more of their trust in these treatment options.
4. The patient’s insulin glargine is currently on back order due to a medication shortage. What are some of the resources the pharmacist could turn to gather information on this shortage?
There are a few resources available to the pharmacist, so there may be many correct answers. In particular, the FDA Drug Shortages Database may be a good starting point. This database provides the pharmacist with specific manufacturers affected by the shortage along with information about estimated availability, reason for shortage, and any other relevant information. ASHP has a similar database which also includes a list of available products.
5. Because the patient’s son bought her insulin online, this medication is at high risk of being counterfeit. What is the most common source of counterfeit medication? Identify the safety concerns related to counterfeit medication use.
Internet pharmacies. The use of counterfeit medications is associated with many different safety concerns, including but not limited to the following: no active ingredient contained in the purchased product, the inclusion of harmful substances, incorrect dose of active ingredient, and incorrect active ingredient.
Pharmacists are the key professionals positioned to address medication safety by ensuring appropriate prescribing, dispensing, administration, lab monitoring, and adherence. Drug shortages may also cause a number of safety concerns through delays in treatment that may compromise clinical outcomes.13 Drug shortages have also been linked to medication errors and an increase in adverse events and death.13,14 Counterfeit medications may arise due to difficulty in acquiring medications such as drug shortages, high costs for the patient, convenience of internet pharmacies, and breakdowns in the medication supply chains.15 Counterfeit medications have been shown to present as safety concerns for patients, and multiple instances have occurred where purported ‘medications’ have no active ingredient whatsoever.15 Other safety concerns include the addition of harmful substances (bacteria-laced water, paint, floor wax, boric acid, powdered cement, and antifreeze), incorrect active ingredient in the product, and wrong concentration or dose.15-18 Internet pharmacies are the primary source of counterfeit medications, and many patients do not know the dangers.19 Many companies claim that the medications are being manufactured in Canada, but this has been proven to be false. They often provide medications that are not approved by the FDA or Canadian government. Sadly, there have even been links to terror organizations.15
The FDA and ASHP have excellent resources available on their websites that display current drug shortages, reasons for shortage, expected availability and available products.20,21
Patient Approaches and Opportunities
Pharmacists are uniquely positioned to identify medication safety issues, decrease patients’ risk for adverse drug events, and improve the patient experience and outcomes. Community pharmacists often encounter patients with physical impairments and can provide resources to overcome medication-related issues and nonadherence. For patients with osteoarthritis, rheumatoid arthritis, lupus, or other conditions that challenge the use of hands and fingers, the following items may be suggested: prefilled blister packs, easy-open caps, easy-open pill extractors, bottle openers, spacer for inhalers, and eye drop guides. For patients who have trouble seeing, pharmacists may provide medication guides or educational pamphlets in larger print, have instructions/counseling spoken aloud, use color coding, or use talking devices. Patients who have trouble hearing instructions can use hearing aids, visual/written aids, or a TeleTYpe (TTY) device.
As the medication experts, pharmacists are also positioned to regularly conduct medication reconciliation to ensure accurate medication lists and work within an interprofessional team to ensure safe and effective use of medications.22
Related chapters of interest
- Safe opioid use in the community setting: reverse the curse?
- Saying what you mean doesn’t always mean what you say: cross-cultural communication
- More than just diet and exercise: social determinants of health and well-being
- FDA Drug Shortages. https://www.fda.gov/drugs/drugsafety/drugshortages/default.htm
- ASHP Drug Shortages. https://www.ashp.org/drug-shortages/current-shortages
- Institute for Safe Medication Practices – https://www.ismp.org/
- Consumer Med Safety – http://www.consumermedsafety.org/
- Patient reporting of suspicious internet pharmacies – https://nabp.pharmacy/programs/vipps/vipps-accredited-pharmacies-list/.
- Journal Articles
- Beers Criteria: American Geriatrics Society 2015 Beers Criteria Update Expert Panel. American Geriatrics Society 2015 updated Beers criteria for potentially inappropriate medication use in older adults. J Am Geriatr Soc. 2015;63(11):2227-46.
- START/STOPP Criteria: O’Mahony D; O’Sullivan D ; Byrne S; et al. STOPP/START criteria for potentially inappropriate prescribing in older people: version 2. Age Ageing. 2015; 44: 213-218.
- Medication Appropriateness Index: Hanlon et al. A method for assessing drug therapy appropriateness. J Clin Epidemiol. 1992,45:1045-51.
- Shehab N, Lovegrove MC, Geller AI, Rose KO, Weidle NJ, Budnitz DS. US emergency department visits for outpatient adverse drug events, 2013-2014. JAMA 2016;316:2115-25.
- Institute of Medicine. Committee on Identifying and Preventing Medication Errors. Preventing Medication Errors, Washington, DC: The National Academies Press 2006.
- Hajjar E, Hanlon JT, Artz MB, et al. Adverse drug reaction risk factors in older outpatients. Am J Geriatr Pharmacother. 2003; 1:82-89.
- Field TS, Gurwitz JH, Harrold LR, et al. Risk Factors for Adverse Drug Events Among Older Adults in the Ambulatory Setting. J Am Geriatr Soc. 2004; 52:1349–1354.
- Chia L, Schlenk EA, Dunbar-Jacob J. Effect of personal and cultural beliefs on medication adherence in the elderly. Drugs Aging. 2006;23(30: 191-202
- Pretorius RW, Gataric G, Swedlund SK, Miller JR. Reducing the Risk of Adverse Drug Events in Older Adults. Am Fam Physician. 2013;87(5):331-336.
- American Geriatrics Society 2015 Beers Criteria Update Expert Panel. American Geriatrics Society 2015 updated Beers criteria for potentially inappropriate medication use in older adults. J Am Geriatr Soc. 2015;63(11):2227-46.
- O’Mahony D, O’Sullivan D, Byrne S, O’Connor MN, Ryan C, Gallagher P. STOPP/START criteria for potentially inappropriate prescribing in older people: version 2. Age Ageing. 2015; 44: 213-218.
- Hanlon JT, Schmader KE, Samsa GP, et al. A method for assessing drug therapy appropriateness. J Clin Epidemiol. 1992,45:1045-51.
- Edelberg HK, Shallenberger E, Wei JY. Medication management capacity in highly functioning community-living older adults: detection of early deficits. J Am Geriatr Soc. 1999 May;47(5):592-
- Orwig D, Brandt N, Gruber Baldini A. Medication management assessment for older adults in the community. Gerontologist, The. 2006;46(5):661-8.
- Manias E, Beanland CJ, Riley RG, Hutchison AM. Development and Validation of the Self-Administration of Medication Tool. The Annals of Pharmacotherapy: 2006; June; 40,6:1064-1073.
- Ventola CL. The Drug Shortage Crisis in the United States Causes, Impact, and Management Strategies. P T. 2011 Nov; 36(11): 740-742, 749-757.
- McLaughlin M, Kotis D, Thomson K, et al. Effects on patient care caused by drug shortages: a survey. J Manag Care Pharm. 2013 Nov-Dec;19(9):783-8.
- Blackstone EA, Fuhr JP, Pociask S. The Health and Economic Effects of Counterfeit Drugs. Am Health Drug Benefits. 2014 Jun; 7(4): 216–224.
- Liang BA. Fade to black: importation and counterfeit drugs. Am J Law Med. 2006; 32:279-323.
- Chachere V. Attorney General sues Tampa couple over fake cystic fibrosis drug. Florida Times-Union. April 7, 2005.
- US Food and Drug Administration. FDA warns consumers about counterfeit Alli: the counterfeit products contain controlled substance sibutramine. Press release. January 18, 2010. https://web.archive.org/web/20170214233909/http://www.fda.gov:80/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm198519.htm. Accessed 3 May 2018.
- National Association of Boards of Pharmacy. Internet Drug Outlet Identification program: progress report for state and federal regulators: August 2017. https://nabp.pharmacy/wp-content/uploads/2016/08/Internet-Drug-Outlet-Report-August-2017.pdf. Accessed 3 May 2018.
- Drug Shortages. U.S. Food and Drug Administration. https://www.fda.gov/drugs/drugsafety/drugshortages/default.htm. Updated July 24, 2018. Accessed May 3, 2018.
- Drug Shortages. American Society of Health-system Pharmacists. https://www.ashp.org/Drug-Shortages. Accessed May 3, 2018.
- Zegers M, Hesselink G, Geense W, Vincent C, Wollersheim H. Evidence-based interventions to reduce adverse events in hospitals: a systematic review of systematic reviews. BMJ Open. 2016; 6(9): e012555.