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Safety in the Retail Pharmacy

Michelle A. Chui, PharmD, PhD | October 1, 2018 
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Chui MA. Safety in the Retail Pharmacy. PSNet [internet]. Rockville (MD): Agency for Healthcare Research and Quality, US Department of Health and Human Services. 2018.

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Chui MA. Safety in the Retail Pharmacy. PSNet [internet]. Rockville (MD): Agency for Healthcare Research and Quality, US Department of Health and Human Services. 2018.

Perspective

There are approximately 67,000 retail/community pharmacies dispensing 4.4 billion prescriptions each year.(1) Many patients interact with community pharmacists every month when refilling their prescriptions, significantly more often than patients see their physicians or other primary health care providers. In addition to verifying the accuracy of written and dispensed prescriptions and assuring patients' understanding of how to take their medication, community pharmacists serve an invaluable role to patients as the triage point when seeking over-the-counter (OTC) products.

However, community pharmacies are chaotic environments where most community pharmacists struggle to manage the day-to-day activities of taking care of their patients and filling prescriptions. Despite pharmacists' best efforts, evidence suggests that medication errors occur at a rate of 1.7%–22%.(2-4) Of these errors, 6.5% are clinically significant.(2) Using the most conservative estimate, for a single typical community pharmacy dispensing 250 prescriptions per day, this translates to approximately 4 errors per day, including 2 clinically significant errors per week—or 51.5 million errors dispensed each year across the United States. Costs associated with preventable adverse drug events involving older patients in the ambulatory setting were estimated at $877 million per year in 2000. Even though only a fraction of these adverse events relate to the community pharmacy, this estimate gives a sense of the cost of medication errors in the outpatient environment.(5)

Unique Characteristics of Community Pharmacies

Community pharmacies have limited access to patients' electronic medical records

Unbeknownst to many patients and prescribers, most community pharmacists do not have access to patients' diagnoses, laboratory values, or even their entire prescription history through the electronic medical record. Yet, they are tasked with assessing the appropriateness of a medication before dispensing it to a patient. To overcome this barrier, community pharmacists must rely on very limited information on the prescription itself and/or the patient's knowledge of his or her condition. Additionally, if a patient fills prescriptions at multiple pharmacies, the pharmacist may also lack access to the patient's complete medication profile.

Pharmacists have limited ability to control the rate of work

Unlike physician offices, patients do not make appointments at community pharmacies to fill their prescriptions. Patients may call or walk into the pharmacy at any time and request new or refill prescriptions. Many pharmacies also have a drive-through window for prescription drop-off and pick-up. Patients have an expectation that they will not have to wait very long to get their prescriptions filled. Similarly, physicians or physician representatives who call the pharmacist to prescribe medications or ask a question expect to be able to speak with the pharmacist right away. As a result, pharmacists are generally unable to predict the volume and complexity of their work. This leaves limited time to adequately address patient health or drug-related problems, and a limited ability to adjust staffing for patient or clinician needs.

Third-party payment issues

Pharmacists spend considerable time addressing third-party payment issues: More than 93% of all prescriptions are paid for by third-party insurers.(6) These prescriptions are adjudicated online and in real time prior to the prescription being dispensed. During the adjudication process, pharmacists engage with third-party insurers' guidelines on required formulary selections and prior authorization protocols. When the third-party insurer denies a prescription claim, pharmacists must stop their workflow, identify the reason for the denial, and contact the physician's office to get the prescription changed and dispensed. Pharmacists can spend up to 20% of their time addressing insurance problems for their patients.(7)

Most community pharmacies are for-profit organizations, making them unique health care settings

With the exception of community pharmacies affiliated with integrated health care systems, almost all community pharmacies are for-profit organizations. Because there is substantial competition in the marketplace, particularly for publicly traded companies, there is significant emphasis on improving profitability and market share. High-level decisions about policies and procedures, tools and technology, and hiring practices are viewed as proprietary. There is very little sharing of information regarding performance measures and medication errors, information that could help others learn from and prevent similar mistakes. This is inconsistent with the recommendation for health care organizations to improve patient safety through transparency.(8)

Expanding Our Understanding of Medication Safety Risks and Preventive Strategies in the Community Pharmacy

Over the past decade, considerable attention has been directed at determining the extent and scope of medication errors. However, the causes and factors that contribute to medication errors in the community setting have received little attention, despite the critical role that community pharmacists play in safeguarding their patients' medications.(9-10)

Researchers interested in improving medication safety in the community pharmacies should look to their colleagues who have studied safety in other health care settings such as intensive care units, emergency departments, surgery, and anesthesia. One key lesson from these fields is the importance of partnering with human factors engineers to redesign tools, technologies, and work environments to improve safety, effectiveness, and ease of use. A human factors engineer is uniquely skilled at examining a particular activity (such as safely dispensing a medication to a patient), breaking it down to its component tasks, and then assessing the physical and cognitive demands and tools necessary to complete the task optimally.(11) The ability to focus on how a complex community pharmacy work system functions and how components interact with each other in actual practice facilitates a deep understanding of factors that contribute to medication errors.

There are a few examples of research in which partnering with human factors engineers has elucidated community pharmacy work system factors that positively and/or negatively impact the work of pharmacists—which in turn could influence medication safety. Similar to findings related to technology implementation in other health care settings, a work system framework has been used to demonstrate how implementation of electronic prescribing in community pharmacies has negatively impacted pharmacists' work and medication safety.(12) Our most recent research found that barriers to improving OTC medication safety in older adults are multifaceted and include several work system components.(13) We are currently testing a system redesign in community pharmacies in order to support the collaborative work that pharmacists and older adults do together when selecting an OTC medication in the pharmacy.(14)

Conclusion

The vast majority of prescription and nonprescription (OTC) medications are prescribed, dispensed, and administered in the outpatient setting. Community pharmacists, the most accessible medication experts, can play a major role in ensuring safe and appropriate medication use in community-dwelling patients. However, unsafe medication use represents a major public health concern, especially for older adults (15), and preventing medication errors was identified as a priority area for national action by the National Academy of Medicine.(16) Compared to the numerous patient safety studies conducted in inpatient settings, community pharmacies have been all but ignored, and no significant policy or payment levers have been used to provide the incentives or transparency to support significant practice or system changes. Therefore, there is a critical need to increase research efforts to understand the underlying causes of medication errors, to design interactive systems that optimize safety and minimize the risk of error in community pharmacies, and to implement policies that promote a greater focus on this important work.

Michelle A. Chui, PharmD, PhD Vice Chair, Social & Administrative Sciences Division Associate Professor School of Pharmacy University of Wisconsin—Madison Madison, WI

References

1. Medicines Use and Spending in the U.S.: A Review of 2016 and Outlook to 2021. IQVIA Institute for Human Data Science: May 4, 2017. [Available at]

2. Flynn EA, Barker KN, Carnahan BJ. National observational study of prescription dispensing accuracy and safety in 50 pharmacies. J Am Pharm Assoc (Wash). 2003;43:191-200. [go to PubMed]

3. Allan EL, Barker KN, Malloy MJ, Heller WM. Dispensing errors and counseling in community practice. Am Pharm. 1995;NS35:25-33. [go to PubMed]

4. Kessler DO, Arteaga G, Ching K, et al. Interns' success with clinical procedures in infants after simulation training. Pediatrics. 2013;131:e811-e820. [go to PubMed]

5. Field TS, Gilman BH, Subramanian S, Fuller JC, Bates DW, Gurwitz JH. The costs associated with adverse drug events among older adults in the ambulatory setting. Med Care. 2005;43:1171-1176. [go to PubMed]

6. State Health Facts: Number of Retail Prescription Drugs Filled at Pharmacies by Payer. Kaiser Family Foundation; 2018. [Available at]

7. Anderson A. Pharmacy Activity Cost and Productivity Study. National Association of Chain Drug Stores: Alexandria, VA; November 1999.

8. Kachalia A. Improving patient safety through transparency. N Engl J Med. 2013;369:1677-1679. [go to PubMed]

9. Flynn EA, Barker KN. Effect of an automated dispensing system on errors in two pharmacies. J Am Pharm Assoc (2003). 2006;46:613-615. [go to PubMed]

10. Angelo LB, Christensen DB, Ferreri SP. Impact of community pharmacy automation on workflow, workload, and patient interaction. J Am Pharm Assoc (2003). 2005;45:138-144. [go to PubMed]

11. Wickens CD, Gordon SE, Liu Y. Introduction to Human Factors Engineering. Upper Saddle River, NJ: Pearson Prentice Hall; 2004. ISBN: 0131229176.

12. Odukoya O, Chui MA. e-Prescribing: characterisation of patient safety hazards in community pharmacies using a sociotechnical systems approach. BMJ Qual Saf. 2013;22:816-825. [go to PubMed]

13. Stone JA, Lester CA, Aboneh EA, Phelan CH, Welch LL, Chui MA. A preliminary examination of over-the-counter medication misuse rates in older adults. Res Social Adm Pharm. 2017;13:187-192. [go to PubMed]

14. Chui MA, Stone JA, Holden RJ. Improving over-the-counter medication safety for older adults: a study protocol for a demonstration and dissemination study. Res Social Adm Pharm. 2017;13:930-937. [go to PubMed]

15. Zhan C, Sangl J, Bierman AS, et al. Potentially inappropriate medication use in the community-dwelling elderly: findings from the 1996 Medical Expenditure Panel Survey. JAMA. 2001;286:2823-2829. [go to PubMed]

16. Priority Areas for National Action: Transforming Health Care Quality, 2003. Washington, DC: National Academies Press; 2003.

This project was funded under contract number 75Q80119C00004 from the Agency for Healthcare Research and Quality (AHRQ), U.S. Department of Health and Human Services. The authors are solely responsible for this report’s contents, findings, and conclusions, which do not necessarily represent the views of AHRQ. Readers should not interpret any statement in this report as an official position of AHRQ or of the U.S. Department of Health and Human Services. None of the authors has any affiliation or financial involvement that conflicts with the material presented in this report. View AHRQ Disclaimers
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Chui MA. Safety in the Retail Pharmacy. PSNet [internet]. Rockville (MD): Agency for Healthcare Research and Quality, US Department of Health and Human Services. 2018.