Over-the-Counter Oversight | AHRQ Patient Safety Network

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Over-the-Counter Oversight
At a preoperative evaluation for skin grafting surgery, a man's prescription medications were reviewed and updated in his medical record. During surgery, the patient experienced profuse bleeding, requiring transfusion with multiple units of blood. Postoperatively, the patient stabilized and the attending surgeon reexamined the patient's medications with him and asked about over-the-counter medications. The patient had been taking one aspirin per day, including the day of surgery. Although the patient was asked about blood-thinning medications at the preoperative visit, he was not asked about over-the-counter medications. In the accompanying commentary, Varalakshmi Janamanchi, MD; Kunjam Modha, MD; and Christopher Whinney, MD, all of Cleveland Clinic Lerner College of Medicine, emphasize the importance of accurate preoperative medication reconciliation and recommend improvement strategies such as physician–pharmacist collaboration and training providers to ask patients specifically about over-the-counter medications.

Cases & Commentaries
Published December 2017

Over-the-Counter Oversight

Commentary by Varalakshmi Janamanchi, MD; Kunjam Modha, MD; and Christopher Whinney, MD

The Case

A 56-year-old man was evaluated in the burn clinic for a second-degree burn on his chest. Although portions of his skin were healing well, the patient was told that he would require skin grafting to ensure a complete recovery. He was scheduled for a preoperative evaluation prior to the date of surgery. During the preoperative visit, the patient's prescription medications were reviewed and updated in his medical record. During the surgery, the patient experienced profuse bleeding and required transfusion of multiple units of blood products. His blood counts and vital signs were closely monitored after surgery and he eventually stabilized. Postoperatively, the attending surgeon reviewed the patient's medications with him in detail and specifically asked about medications purchased over the counter. The patient reported that he purchased aspirin over the counter and had been taking one pill every day, including on the day of surgery. Although the patient had been asked about blood thinning medications at his preoperative visit, he didn't realize that he should have mentioned taking aspirin because he obtained it without a prescription and he was not specifically asked about over-the-counter medications.

The Commentary

by Varalakshmi Janamanchi, MD; Kunjam Modha, MD; and Christopher Whinney, MD

In 2005, the Joint Commission for the Accreditation of Healthcare Organizations made medication reconciliation a National Patient Safety Goal to reduce adverse events arising from medication errors and improve patient safety.(1) The Institute for Healthcare Improvement (IHI) suggests a three-step process for medication reconciliation which includes: (i) verification, or acquiring an updated list of medications; (ii) clarification of medications, frequency, and dosages; and (iii) reconciliation, or making necessary changes in the medical record.(2) Reconciliation should occur in both ambulatory and hospital settings. Opportunities for medication reconciliation in the hospital setting exist at many points of care transition, most commonly at admission and discharge.

Accurate medication reconciliation begins with acquiring an updated medication list, which is challenging in itself. Even in the era of electronic records, patient engagement is paramount. In a study that evaluated the accuracy of medication reconciliation forms completed by patients (using memory, lists, or pill bottles), only 36.3% of patients were able to complete the form without error.(3) Poor health literacy, cognitive impairment, nonavailability of the patient's primary caregiver at the time of medication reconciliation, and transfer from another health care institution with suboptimal transfer of information can all contribute to inaccuracies in medication reconciliation. Thus, primary care physician records, pharmacy prescription fill histories, and other hospital records are more reliable sources. Frequently, the number of care providers interacting with the patient creates confusion regarding who should be primarily responsible for medication reconciliation. Providing interview training and checklists to those obtaining medication histories from patients can be helpful in achieving consistent assessment. AHRQ's Medications at Transitions and Clinical Handoffs (MATCH) toolkit (4) identifies interview techniques that can help providers generate an accurate medication list for their patients.

Given the invasive nature of surgery, the need for anesthesia, the associated risk of bleeding and thrombosis, and the risks of postoperative cardiovascular complications, patients undergoing surgery represent a population that may be particularly vulnerable to adverse drug events from medication errors. Accurate preoperative medication reconciliation is thus essential in this population. One study reported that 27% of patients incorrectly continued or discontinued one or more medications in the preoperative period.(5) Several high-risk categories of medications require special attention during the preoperative visit, including antiplatelet agents, anticoagulants, immunosuppressants, diabetes medications, insulin, and antiarrhythmic agents. Multiple studies have reported increased postoperative bleeding in patients taking aspirin preoperatively.(6-8)

The patient described in this case incorrectly continued to take aspirin preoperatively and developed bleeding complications. Even though he underwent a preoperative assessment during which his prescription medications were reviewed and updated in the medical record and he was correctly and specifically asked about blood thinning medications, he neglected to mention aspirin since he considered it an over-the-counter medication.

Over-the-counter medications that have important implications for surgical patients include aspirin, nonsteroidal anti-inflammatory analgesics, vitamins, supplements, alternative medicines, and herbal products. A 1997 national survey reported that 42.1% and 12.1% of the United States population used alternative medicine and herbal products, respectively.(9) Patients may fail to report the use of these products for various reasons. Patients may not be asked about them directly; patients may assume these products are not medications (as they do not require prescriptions) and therefore are not associated with adverse effects. Or they may assume that these substances simply promote general health and will not have any impact on surgery. The medication reconciliation process should include asking about over-the-counter medications, vitamins, supplements, and alternative medicines and ensure that they are reflected in the medication list. In addition, providing preoperative patients with a complete list of alternative medicines and herbal supplements that may be contraindicated prior to surgery and displaying posters in patient examination rooms with the adverse effects of various supplements and alternative medications may be helpful. Patients should receive both written and verbal instructions to stop medications in a timely manner.

We frequently depend on patients to provide us with an accurate preoperative medication list during preoperative medication reconciliation. Meyer and colleagues looked at medication discrepancies from patient-generated medication lists and compared this with documentation from their pharmacies. Interestingly, they found that patients seem to forget to include medications they take most frequently and often add medications not listed by their pharmacy.(3) Although the electronic health record (EHR) has the potential to improve medication reconciliation and serve as the primary source for an accurate medication list, it too is often inaccurate. When looking at medication lists in the EHR for patients in the emergency department, Monte and colleagues noted that the EHR captured exactly what the patient was taking 21.9% of the time and that over-the-counter medications were a frequent source of error.(10)

There are opportunities to make the EHR more user friendly in order to help improve medication reconciliation accuracy. Schnipper and colleagues tested a postdischarge medication reconciliation tool designed for primary care physicians that was built into the EHR and allowed medications to be grouped by class.(11) Although use of the tool was initially low, providers eventually used it in 41% of applicable visits. In another study of surgical patients in a Spanish hospital system, the implementation of an electronic medication reconciliation tool embedded in the EHR resulted in a reduction in the percentage of medication discrepancies from 10.6% in the preintervention period to 6.6% after the tool was introduced.(12)

A number of small studies have found that the use of pharmacists in the preoperative period can reduce medication errors.(13-15) Moreover, a meta-analysis of 19 studies found that pharmacist review of medications at care transition points such as admission or discharge reduced medication discrepancies.(16) A systematic review also supports the use of medication reconciliation interventions involving pharmacy staff.(17) While pharmacist medication review with patients at a preoperative clinic has demonstrated some success and is a valid approach, the scarcity and expense of pharmacists may limit its use in all patients. Although using pharmacist-led interventions to target higher risk patients identified through a screening tool (18) may be one approach, the patient in this case would not have been identified as high risk and thus would not have received counseling from a pharmacist.

The ideal approach to medication reconciliation in the preoperative period involves the collaboration of physicians and pharmacists, with special attention given to high-risk patients. In addition, training should be provided to those obtaining a medication history, and processes must be in place to ensure careful review of high-risk medications, over-the-counter medications, vitamins, and supplements. Patients should receive both verbal and written instructions regarding which medications—including nonprescription ones—to stop prior to surgery, how far in advance of surgery to stop those medications, and when to resume them.

Take-Home Points

Several high-risk medications need special attention during medication reconciliation at a patient's preoperative visit. These include antiplatelet agents, anticoagulants, immunosuppressants, diabetes medications, insulin, and antiarrhythmic agents.
Providers performing medication reconciliation should specifically ask about over-the-counter medications when taking a medication history and inform patients about potential risks associated with these medications.
Evidence suggests that involving pharmacists in the medication reconciliation process is helpful and may be especially so for high-risk patients.

Varalakshmi Janamanchi, MD
Clinical Assistant Professor of Medicine
Cleveland Clinic Lerner College of Medicine and Case Western Reserve University
Cleveland Clinic Foundation

Kunjam Modha, MD
Assistant Professor of Medicine
Cleveland Clinic Lerner College of Medicine and Case Western Reserve University
Cleveland Clinic Foundation

Christopher Whinney, MD
Chairman, Department of Hospital Medicine
Clinical Assistant Professor of Medicine
Cleveland Clinic Lerner College of Medicine and Case Western Reserve University
Cleveland Clinic Foundation

References

1. National Patient Safety Goals Effective January 2017. Oakbrook Terrace, IL: The Joint Commission; 2017. [Available at]

2. Accuracy at every step: the challenge of medication reconciliation. Institute for Healthcare Improvement Web site. March 20, 2006. [Available at]

3. Meyer C, Stern M, Woolley W, Jeanmonod R, Jeanmonod D. How reliable are patient-completed medication reconciliation forms compared with pharmacy lists? Am J Emerg Med. 2012;30:1048-1054. [go to PubMed]

4. Medications at Transitions and Clinical Handoffs (MATCH) Toolkit for Medication Reconciliation. Gleason KM, Brake H, Agramonte V, Perfetti C. Rockville, MD: Agency for Healthcare Research and Quality; Revised August 2012. AHRQ Publication No. 11(12)-0059. [Available at]

5. Van Waes JAR, de Graaff JC, Egberts ACG, van Klei WA. Medication discontinuity errors in the perioperative period. Acta Anaesthesiol Scand. 2010;54:1185-1191. [go to PubMed]

6. Devereaux PJ, Mrkobrada M, Sessler DI, et al; POISE-2 Investigators. Aspirin in patients undergoing noncardiac surgery. N Engl J Med. 2014;370:1494-1503. [go to PubMed]

7. Ghaffarinejad MH, Fazelifar AF, Shirvani SM, et al. The effect of preoperative aspirin use on postoperative bleeding and perioperative myocardial infarction in patients undergoing coronary artery bypass surgery. Cardiol J. 2007;14:453-457. [go to PubMed]

8. Park HJ, Kwon KY, Woo JH. Comparison of blood loss according to use of aspirin in lumbar fusion patients. Eur Spine J. 2014;23:1777-1782. [go to PubMed]

9. Eisenberg DM, Davis RB, Ettner SL, et al. Trends in alternative medicine use in the United States, 1990–1997: results of a follow-up survey. JAMA. 1998;280:1569-1575. [go to PubMed]

10. Monte AA, Anderson P, Hoppe JA, Weinshilboum RM, Vasiliou V, Heard KJ. Accuracy of electronic medical record medication reconciliation in emergency department patients. J Emerg Med. 2015;49:78-84. [go to PubMed]

11. Schnipper JL, Liang CL, Hamann C, et al. Development of a tool within the electronic medical record to facilitate medication reconciliation after hospital discharge. J Am Med Inform Assoc. 2011;18:309-313. [go to PubMed]

12. Giménez-Manzorro Á, Romero-Jiménez RM, Calleja-Hernández MÁ, Pla-Mestre R, Muñoz-Calero A, Sanjurjo-Sáez M. Effectiveness of an electronic tool for medication reconciliation in a general surgery department. Int J Clin Pharm. 2015;37:159-167. [go to PubMed]

13. Kwan Y, Fernandes OA, Nagge JJ, et al. Pharmacist medication assessments in a surgical preadmission clinic. Arch Intern Med. 2007;28;167:1034-1040. [go to PubMed]

14. van den Bemt PM, van den Broek S, van Nunen AK, Harbers JB, Lenderink AW. Medication reconciliation performed by pharmacy technicians at the time of preoperative screening. Ann Pharmacother. 2009;43:868-874. [go to PubMed]

15. Marotti SB, Kerridge RK, Grimer MD. A randomised controlled trial of pharmacist medication histories and supplementary prescribing on medication errors in postoperative medications. Anaesth Intensive Care. 2011;39:1064-1070. [go to PubMed]

16. Mekkonen AB, McLachlan AJ, Brien JA. Pharmacy-led medication reconciliation programmes at hospital transitions: a systematic review and meta-analysis. J Clin Pharm Ther. 2016;41:128-144. [go to PubMed]

17. Mueller SK, Sponsler KC, Kripalani S, Schnipper JL. Hospital-based medication reconciliation practices: a systematic review. Arch Intern Med. 2012;172:1057-1069. [go to PubMed]

18. Makowsky MJ, Cor K, Wong T. Exploring electronic medical record and self-administered medication risk screening tools in a primary care clinic. J Manag Care Spec Pharm. 2017;23:566-572. [go to PubMed]