Managing visits from pharmaceutical sales representatives
From the May 22, 2008 issue
Problem: The pharmaceutical industry spends billions of dollars each year marketing products to prescribers. These efforts involve advertising in professional journals and other media as well as direct marketing to prescribers by the pharmaceutical sales force. While much of the direct marketing to prescribers by sales representatives occurs in physicians’ offices, a fair amount also occurs in hospitals. Hospitals that do not tightly control the process by which pharmaceutical products and related education are brought into their organizations risk serious adverse drug events. Two examples are described below.
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.
In an older case (known to many from our film, Beyond Blame), mivacurium (MIVA-CRON) was accidentally dispensed and administered to several patients instead of metronidazole. Three patients suffered respiratory arrests and were rescued, but another patient died. The error occurred after mivacurium was ordered by the anesthesia department following a sales visit by a pharmaceutical representative. The carton of mivacurium was delivered to the pharmacy and placed in stock next to metronidazole. Both products were packaged in foil overwraps. Prior to the error, the only foil-wrapped, premixed solution in the pharmacy was metronidazole; mivacurium was not on the formulary. Neither the technician nor the pharmacist who prepared and dispensed the erroneous drug were 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 name of the drug was not on the foil overwrap or 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, thus, 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 prescribers and other healthcare providers in the organization can be approached by pharmaceutical representatives. Some hospitals prohibit all on-site visits to clinical areas by pharmaceutical representatives. When hospitals allow these visits—to provide staff education or market products—the following guidelines will help ensure safety-centered policies.
- The pharmacy should maintain oversight of pharmaceutical representatives’ visits by scheduling all appointments hospital-wide. If members of another department (such as materials management) schedule appointments, pharmacy leadership must be informed prior to the visits. The date, time, and areas that representatives plan to visit, along with a list of products that will be discussed, should be provided.
- When scheduling appointments, pharmaceutical representatives should provide the pharmacy with their name, company, address, phone number, products to be discussed, and departments and personnel to be visited.
- Pharmaceutical representatives should sign in when entering the facility and wear an identification badge that includes their name, company, date, and approved destination in the facility.(1) They should be escorted to their destinations and, if possible, accompanied by pharmacy staff.
- Pharmaceutical representatives should be instructed on the rules governing their visits and drug samples, and sign an agreement to abide by the rules during each visit. If possible, they should complete an education module to ensure understanding of the policies.
- If the hospital has previously developed guidelines, policies, procedures, and formulary limitations for the targeted medications, pharmaceutical representatives must clearly communicate the hospital-approved use and specific standards in place during all communication about the drugs with the hospital staff.
- Pharmaceutical representatives should not be allowed in physicians’ lounges. Representatives may contact only personnel and departments for which authority has been granted. Drug reference materials may be distributed only in authorized areas if they have been approved by the pharmacy or Pharmacy and Therapeutics Committee.
- Pharmaceutical representatives should only be allowed to market medications already on the hospital formulary.
- Pharmaceutical representatives should only be allowed to distribute samples (if allowed by hospital policy) of medications on the hospital formulary. Samples should be limited to outpatient areas and stored in the pharmacy. Prescribers can be provided with vouchers to order drugs from sample supplies at no cost to the patient.
- Pharmaceutical representatives must leave an area if asked to do so by any hospital staff member.
- If pharmaceutical representatives provide staff education, pharmacy or nurse educators should co-present information about the drug to ensure a balanced perspective, and inform staff about related policies, procedures, and hospital-defined precautions to take when prescribing, dispensing, or administering the drug.
Some medical schools and hospitals are now reinforcing prescribers’ natural skepticism and encouraging them to raise challenging questions during sales pitches from pharmaceutical representatives.(1,2) A few medical schools and affiliated hospitals, including Stanford, Yale, and the University of Pennsylvania, have banned prescribers from accepting gifts from pharmaceutical representatives.(2) 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 (www.aamc.org/research/coi/industryfunding.pdf). Even though most prescribers believe they can avoid being affected by a sales pitch,(2) robust processes to mitigate undue influence in academic and clinical arenas will help prevent and halt potentially harmful influences on prescribing habits.
References: 1) ECRI Institute. Sales representatives and other outsiders in the OR. Healthcare Risk Control 1999;4(Surgery and Anesthesia 24):1-10. 2) Associated Press. Medical schools warn doctors of drug sales pitches. MSNBC, November 2, 2006. Accessed on May 19, 2008, at: www.msnbc.msn.com/id/15535918/.