Prescription & OTC Medication Record Integration;
A Holistic Patient-Centered Approach

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Nonprescription or over-the-counter (OTC) medications play a crucial role in a patient’s ability to make choices to manage their own healthcare. Often these nonprescription choices are unknown to health care practitioners, and thus are often not included as part of patients’ health records. The exclusion of these therapies can pose risks to patient safety. There is a clear need to address the capture of OTC medication use in both the physician and pharmacy electronic health records (EHRs) and during the practitioner-patient medication history and reconciliation process.

The purpose of this publication is to provide a summary of insights and suggestions by key community pharmacy industry stakeholders who were asked to evaluate the technological capability and opportunities to incorporate OTC medications into comprehensive EHRs. For the purposes of this document, EHRs, as defined by Centers for Medicare and Medicaid Services, are an electronic version of a patient’s medical history that are maintained by the provider over time and may include all the key administrative clinical data relevant to that person’s care under a particular provider.1 EHR interoperability where distinct EHRs communicate relevant patient information remains a challenge. Currently, community pharmacy dispensing systems often don’t collect OTC information nor do they communicate with physician office EHRs. In late 2017, the National Council for Prescription Drug Programs (NCPDP) and Health Level Seven International (HL7) will jointly launch an interoperable “Pharmacist eCare Plan” that can be utilized by many pharmacies dispensing systems nationwide. This is the first step in interoperability between community pharmacies and physician EHRs, yet doesn’t directly address the issue of capturing OTC utilization by the patient.

On October 26, 2016, the National Association of Chain Drug Stores (NACDS) Foundation hosted a forum for a select group of healthcare industry professionals to be able to work on a series of recommendations to improve the documentation of OTC use by patients.

This diverse group of more than a dozen stakeholders included community pharmacy leaders from multiple chain pharmacies, pharmacy system vendors, e-prescribing vendors, health information technology experts, and multiple industry representatives, including individuals from the public sector. A list of stakeholders is summarized in Appendix 1. What follows is a consensus of the participants’ insights and suggestions.

Overview of Nonprescription Drug Use

OTC medications play a crucial role in our nation’s healthcare system by increasing access to effective medications and empowering individuals to make healthcare choices for themselves and their families. The vast array of OTC drug products that are available to consumers serve to treat many common ailments, from simple aches and pains to dental care. A recent consumer survey found that 89 percent of consumers value OTC medications as part of their healthcare and 80 percent of consumers indicated that they use OTC medications as first line treatment for various ailments.2 Further, in a survey of over 500 healthcare practitioners, including primary care physicians, nurse practitioners, pediatricians, and pharmacists, more than 90 percent of health care professionals indicated that OTC medications are safe and effective for their intended use and 87 percent agreed they are a crucial part of healthcare.3

Goals of the Forum

  • Provide an environmental assessment of opportunities where OTC medication information can be collected beginning with point of sale;
  • Explain the role of technology in instances where OTC medications are documented/omitted in the normal process of care, including at the pharmacy;
  • Discuss the feasibility of OTC medications being included in patient’s’ EHR through interoperability between physician and pharmacy record systems; and
  • Provide system-level recommendations to begin collaboratively incorporating OTC medications into electronic health records.

OTC Medications and FDA

Since 1972, the U.S. Food and Drug Administration (FDA) has been responsible for the regulatory review of OTC medications, ensuring that the drug products are safe and effective for their intended, labeled use. The FDA requires nonprescription drugs to comply with multiple parameters to ensure that every OTC medication can be safely consumed without the supervision of a health care provider.

Enhanced access to these medications empowers patients to take an active role in their health, and improves the viability of the healthcare system overall. Taken correctly, OTC medications are safe, affordable, and effective.

Patient Safety/Gaps in Care

While OTC medications promote the health of millions of patients, risks due to inappropriate use can pose a substantial risk to patient safety including complications from drug/drug interactions, accidental drug duplication, and unforeseen drug/disease complications. The high prevalence of OTC medication use means these risks are not insignificant. For example,

in a survey of patients diagnosed with heart failure, 88 percent reported OTC medication use.4 The OTC medications included nonsteroidal anti-inflammatory drugs (NSAIDs), proton pump inhibitors (PPIs), magnesium, and acetaminophen, all of which could have serious implications in patients with heart failure.

Patient Scenarios

Patient #1:

A 65-year-old woman who is currently taking alendronate to treat her osteoporosis. She is recently experiencing sleepless nights due to a death in the family. She decides to purchase Unisom Sleepgels (diphenhydramine 50mg) to assist her with sleep. Issues: Likely adverse drug reaction, elevated risk medication for patients over 65 years of age due to a heightened risk of drowsiness and related falls. Combine with her existing condition of osteoporosis, her fall risk and potential for bone fracture upon fall is heightened.

Patient #2:

A 50-year-old male who has been taking Zoloft (sertraline) for the past six months to treat his depression. He has recently been experiencing heartburn and chooses OTC Tagamet (cimetidine) to relieve these symptoms.

Issues: Drug-drug interaction. Cimetidine inhibits the cytochrome P450 3A4 enzyme responsible for metabolizing sertraline. Sertraline concentrations will increase in the patient leading to side effects including nausea, diarrhea, tremor, dizziness – leading to sertraline toxicity.

Patient #3:

A patient taking Tylenol (acetaminophen) for pain uses an app on her phone to capture her OTC medication use and the pharmacist can access this medication list via the EHR. She needs a medication for a cough and the pharmacist can successfully use the integrated OTC-EHR data to identify an appropriate medication that does not also contain acetaminophen. Issues: Drug duplication (avoided)