Although selection of the proper anesthetic medications is critical to anesthesia patient safety, another vital component of anesthesia care is proper use and administration of the medication selected. Innovative pharmaceutical manufacturers reinvest a sizable fraction of their product-sale revenue into research and development and also, importantly, make significant investments in educational training programs and materials for anesthesia practitioners on the safe use of the medications.
Clearly, patient safety is a paramount concern to both the physician and the drug manufacturer. For anesthesiologists, the potency and unique pharmacological nature of most anesthetic drugs make practitioner education an important component in assuring quality patient care. This is equally appreciated from the pharmaceutical manufacturer’s perspective. We recognize that during an anesthetic, there is very little time for anesthesiologists to react to unanticipated patient responses to drugs before the patient could be endangered. Therefore, it is vital that anesthesiologists are knowledgeable about a product in advance of its use. Pharmaceutical manufacturers can play an important role in this safety strategy by assisting anesthesiologists in obtaining this critical knowledge.
Pharmaceutical Manufacturers Enhance Anesthesiologists’ Education
Pharmaceutical manufacturers can effectively communicate product information in a number of ways. The most comprehensive and readily available information on a drug is provided in the Physician Information Brochure (PIB or “package insert”) included in the product package. Active FDA involvement before a new drug is launched and thereafter helps to ensure that the package insert contains the important, relevant, up-to-date information a physician needs to know to use the drug safely and effectively. While the PIB is no substitute for medical training and practice, the package insert builds upon this existing base of knowledge.
The pharmaceutical sales representative can help introduce and then reinforce the information in the PIB. A physician should view a drug manufacturer’s sales representative as a knowledgeable, easily accessible source of information about that company’s products. Many physicians find that a few minutes of quality “face time” with a knowledgeable sales representative is an efficient way to learn the characteristics of a product. Indeed, a well-trained sales representative can save a physician time and money by helping him or her evaluate and select a drug on the basis of certain clinical advantages over other drugs for the best performance in specific situations.
When a drug manufacturer must disseminate new product warnings or prescribing information quickly and comprehensively, a “Dear Doctor” letter is an excellent means of reaching physicians and other healthcare professionals and supplementing information in the PIB.
Pharmaceutical companies usually receive more requests to support research studies than they can possibly fund and thereby have the opportunity to select those studies which can provide the most useful medical information concerning new developments or uses regarding their products. When these study results are published, they often help improve both the effectiveness of a physician’s practice and the safety of the patient. In addition, other avenues exist through which pharmaceutical manufacturers can disseminate (or facilitate the dissemination of) information, including: symposia; scientific meeting booth exhibits and related activities; roundtable, consensus, or “expert panel” sessions with subsequent publication of the proceedings; videos; direct mail campaigns; teleconferences; and dinner meetings in a city or even for one department’s staff, particularly involving a guest speaker who has done research on a specific medication. Selecting the right “mix” of information-dissemination vehicles is often a challenge and can constitute a major expense in the marketing of, or stewardship for the drug. However, such expenses help to ensure a drug’s safe use.
Educational Efforts Related to Propofol Diprivan (propofol) was approved by the FDA in 1989 and as its use grew, reports of postoperative infections associated with propofol use were received. As noted in the recent New England Journal of Medicine article (July 20, 1995; 333:147-154), the Centers for Disease Control and Prevention (CDC) investigated reports that occurred between June 1990 and February 1993. The CDC reported that breaks in aseptic technique by a small number of healthcare professionals were responsible for the sequence of events in the cases investigated.
When the first reports were received in mid-1990, Zeneca Pharmaceuticals immediately responded by sending out a “Dear Doctor” letter, enhancing the warnings and adding information provided in the PIB to promotional and other materials. Further, our sales representatives were instrumental in highlighting the warnings to individual practitioners and emphasizing the importance of adhering to appropriate aseptic technique when handling this medication.
Unfortunately, even after the above efforts, the number of reports did not decline to zero, so further efforts were continued to enhance, reinforce, and strengthen the propofol warnings. An additional “Dear Doctor” letter was sent to appropriate healthcare professionals. Mailgrams were sent. Information on the importance of using the appropriate aseptic technique was placed on every package and label in red printing. This message also was repeated four times in bold type in the package insert. In our advertising, more prominence has been given to the need for aseptic technique.
Most recently, through an unrestricted educational grant to the Anesthesia Patient Safety Foundation (APSF), Zeneca funded the development and publication of a booklet titled “Recommendations for Handling Parenteral Medications Used for Anesthesia or Sedation.” A wall poster, designed to reinforce the information in this booklet, was also created. Distribution of both began in early June 1995, concluding a year-long effort to provide maximally effective information dissemination.
Since the time of the initial reports investigated by the CDC, the number of incidents reported has declined overall, even as the use of propofol has continued to grow dramatically (propofol is now used in over 50% of all general anesthesia inductions and in approximately 12% of the anesthetic procedures for maintenance).
While our communication efforts may appear to be unnecessary, or only “common sense,” to those who do follow proper aseptic technique and handle the product appropriately, our company believes these efforts are justified in order to reach the few who do not always comply with these practices.
Patient Safety is a Partnership
Pharmaceutical companies recognize that physicians will readily use products that are found to be both safe and effective. Efficacy is “engineered in” through drug discovery and tested in the development phase and clinical trial activities. Safety has two distinct components: first, testing the drug for adverse side effects and toxicity; and, second, helping the health care professionals determine appropriate dosing and how to handle and administer the drug safely.
Pharmaceutical manufacturers can play an important role in helping educate anesthesiologists in the safe and effective use of their drugs. By working together to assure that drugs are fully understood and properly handled and administered, pharmaceutical manufacturers and anesthesiologists can continue to facilitate optimum patient safety and the highest quality patient care.
Mr. Black is Vice President of Zeneca Inc. and President of Zeneca Pharmaceuticals, a business unit of Zeneca Inc., as well as a member of the APSF Executive Committee.