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P T. 2012;37(5): 261, 263
Medication Errors

Managing Visits From Pharmaceutical Sales Representatives

Matthew Grissinger RPh, FASCP

Problem: Each year, the pharmaceutical industry spends billions of dollars marketing its products to prescribers. These efforts involve advertising in professional journals and other media as well as direct marketing of medications to prescribers by the pharmaceutical sales force. Although much of the direct marketing to prescribers by sales representatives takes place in physicians’ offices, a fair amount also occurs in hospitals. Hospitals that do not tightly control the process by which pharmaceutical products and related information are brought into their organizations risk, either directly or indirectly, causing serious adverse drug events (AEs). Two such occurrences are described.

Case 1

A pharmaceutical sales representative visited a behavioral health unit of a hospital to market an analgesic that contained acetaminophen. After speaking to the physician director of the unit, the sales representative left a substantial supply of sample tablets on the counter at the nurses’ station. A patient noticed the tablets, confiscated them from the counter, and took all the tablets at the same time. When the problem was discovered, the patient was sent to the emergency department and treated with gastric lavage. Fortunately, the patient had no ill effects from the overdose.

Case 2

In an incident depicted in the film Beyond Blame,1 several patients mistakenly received mivacurium (Mivacron, Glaxo Wellcome/Abbott), a neuromuscular blocker, instead of metronidazole (Flagyl, Pfizer). Three patients experienced respiratory arrest and were rescued, but another patient died. The error occurred after the anesthesia department had ordered mivacurium following a sales visit by a pharmaceutical representative. The carton of mivacurium was delivered to the pharmacy and was placed in stock next to metronidazole. Both products were packaged in foil overwraps.

Before the error occurred, metronidazole had been the only foil-wrapped, pre-mixed solution in the pharmacy; mivacurium was not on the formulary. Neither the technician nor the pharmacist who prepared and dispensed the erroneous drug was aware that a trial carton of mivacurium had been delivered to the pharmacy. Thus, they failed to notice that the foil-wrapped bags contained mivacurium, not metronidazole.

At the time of the error, the drug name was not on the foil overwrap and was not easily visible through a clear plastic window. Thinking that the drug was light-sensitive, nurses who administered the drug did not remove the foil overwrap entirely and therefore also failed to notice the error.

Safe Practice Recommendations: Hospitals can reduce the risk of medication errors by establishing and enforcing a policy that requires advance screening and approval before a pharmaceutical sales representative can approach prescribers and other health care practitioners in the organization. Some hospitals prohibit all on-site visits to clinical areas by pharmaceutical representatives. When hospitals allow these visits—to provide staff education or to market products—the following guidelines should help to ensure safety-centered policies:

  • The pharmacy should maintain oversight of the sales representative’s visit by scheduling all hospital appointments. If employees in another department schedule appointments, pharmacy managers must be informed before the visit. The date, time, and areas that the representative plans to visit, along with a list of products to be discussed, should be provided.
  • When scheduling appointments, sales representatives should provide the pharmacy with their name, company, address, phone number, products to be discussed, and departments and personnel to be visited.
  • Sales representatives should sign in when entering the facility. They should wear an identification badge that includes their name, company, date, and approved destination in the facility.2 They should be escorted to their destination and, if possible, should be accompanied by a member of the pharmacy staff.
  • Representatives should be instructed on the rules governing their visits and the policies about drug samples. They should sign an agreement to abide by the rules during each visit. If possible, they should complete an education module to ensure that they understand the policies.
  • If the hospital has previously developed guidelines, policies, procedures, or formulary limitations for the targeted medications, the representative must clearly communicate the hospital’s approved use and current specific standards during all communication about the drugs with the hospital staff.
  • Sales representatives should not be allowed in physicians’ lounges; they may contact only personnel and departments for which authority has been granted.
  • The representative may distribute drug reference materials only in authorized areas and only if the pharmacy or P&T committee has approved them.
  • The representative may market only those medications that are already on the hospital formulary.
  • The representative may distribute samples (if hospital policy permits) of only those medications that are on the hospital formulary. Samples should be limited to outpatient areas and stored in the pharmacy. Prescribers can be given vouchers to order drugs from sample supplies at no cost to the patient.
  • The representative must leave an area if asked to do so by any hospital staff member.
  • If the representative provides education about a drug to the hospital staff, a pharmacy or nurse educator should also present information about the drug to ensure a balanced perspective. The hospital’s educator pharmacist or nurse should also inform staff members about related policies, procedures, and hospital-defined precautions to take when prescribing, dispensing, or administering the drug.
  • Some medical schools and hospitals have begun reinforcing prescribers’ natural skepticism and have encouraged them to raise challenging questions during sales pitches from pharmaceutical salespeople.24 A few medical schools and affiliated hospitals, including Stanford, Yale, and the University of Pennsylvania, have banned prescribers from accepting gifts from pharmaceutical representatives.3,4 A report by the Association of American Medical Colleges endorses these strategies and calls for additional restrictions to limit drug and medical device company interactions and influence at medical schools and teaching hospitals.35

    Even though most prescribers believe that they can avoid being affected by a sales pitch or a gift,36 robust processes to mitigate undue influence in academic and clinical arenas will help prevent and halt potentially harmful influences on prescribing habits.

    References

    1. ISMP Online Store. Beyond Blame: Solutions to America’s Other Drug Problem Horsham, Pa: Institute for Safe Medication Practices (ISMP). 10-minute documentary, DVD. Available at: https://www.ismp.org/resources.
    2. ECRI Institute. Sales representatives and other outsiders in the OR. Healthcare Risk Control 1999;4:1–10.(Surgery Anesthesia series 24).
    3. Caruso DB. Med schools warn of drug sales pitches. Associated Press. November 22006;Available at: and www.insur-anceheadlines.com/pdf/3016.html. Accessed April 3, 2012.
    4. Caruso DB. Medical schools train doctors to resist marketers’ siren songs. Associated Press. November 12006;Available at: www.commercialalert.org/news/archive/2006/11/medical-schools-train-doctors-to-resist-marketers-siren-songs. Accessed April 3, 2012.
    5. Industry Funding of Medical Education: Report of an AAMC Task Force Washington, D.C: Association of American Medical Colleges. June 2008;Available at: https://www.aamc.org/download/157370/data/industry_funding_report.pdf. Accessed April 2, 2012.
    6. AAMC Calls for Strict Limits on Industry Support of Medical Education Washington, D.C: Association of American Medical Colleges. June 192008;Available at: https://www.aamc.org/newsroom/newsreleases/2008/82614/080619.html. Accessed April 2, 2012.