3 Medication safety: to ‘error’ is human

Introduction

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.⁸ The 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

Case

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

FH:

• Mother: T2DM, breast cancer
• Father: MI at age 57

Medications:

• 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

Labs:

• 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 mg/dL
• HDL 41 mg/dL
• Triglycerides 137 mg/dL
• Total cholesterol 166 mg/dL
• Alk phos 64 U/L
• AST 25 U/L
• ALT 32 U/L

VS:

• BP 138/72 mmHg
• 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.

Case Questions

1. Identify and describe the areas of increased medication safety concern for this patient.

2. Based on the MAI, which medication is least appropriate for this patient? How should this be addressed?

3. How would you address her statement about her nephew’s beliefs in the use of turmeric and cinnamon instead of her prescription medications?

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?

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.

Author Commentary

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