The Patient Package Insert — Rhetoric versus Logic

SINCE THE KEFAUVER HEARINGS INTO THE CONDUCT of t h e pharmaceutical industry in the early 1960s, the public has been treated to virtually a nonstop melodrama revolving around prescription drugs. Leading actors have been incumbent senators, Naderites, and officials of the FDA, FTC, AMA, PMA, various pharmaceutical associations, and consumer groups. Major sequels have been inspired by generic prescribing, bioavailability, therapeutic equivalence, maximum allowable cost, prescription price advertising, drug lag, and now — the PPI ! This saga is undoubtedly a symptom of some underlying pathology in our drug marketing and prescribing system. Unfortunately, the primary diagnoses have been confounded with second and third opinions, and no pragmatic therapeutic plan has yet been undertaken. If health professionals and government experts seem confused by the disagreements among the FDA, FTC, PMA, AMA, APhA, and others, imagine the difficulty the public encounters in following these never-ending arguments. The controversy with patient package inserts involves several issues. The most fundamental is whether or not PPIs are needed. There is also much concern over the depth and quality of the information that may be included, and some envision more harm than good resulting. Generally, physicians and pharmacists prefer optional PPIs rather than mandatory ones, and they greatly fear and resent an FDA-imposed program. There is also contention between physicians and pharmacists concerning responsibility for PPI dispensing and further patient instruction. Significantly, the cost estimates of the program vary greatly; the FDA estimates a five-year cost of $270 million, while the APhA states that it will cost at least $1.8 billion. There is considerable experience and evidence to support the use of written patient-medication instruction beyond that contained on the typical pharmacist-prepared label. The medical and pharmaceutical literature abounds with documentation of widespread problems with patient noncompliance in prescribed drug regimens. Furthermore, there is evidence that noncompliance contributes significantly to morbidity and mortality. It is known that a lack of therapeutic knowledge by the patient contributes, in many cases, to noncompliance. And in turn, noncompliance leads both to wasted physician time and to increased morbidity, with attendant physician and hospital costs. Cole and Immanuel have shown that a hospital-discharge drug-consultation program increased patient compliance from 24 to 92 percent. The authors concluded that the program taught the patient how to manage minor side effects and to better understand his drug therapy. Clinte and Kabat, as well as other investigators, have demonstrated that verbal and written instruction together are better than either one alone in terms of improving compliance. The PPI for oral contraceptives may serve as a possible prototype brochure. Fleckenstein et al. found that 90 percent of surveyed women using the pill had read the PPI, and that 86 percent had found the information useful. There was a positive correlation between the reading of the PPI and both total knowledge score and knowledge of the association of clotting with use of the pill. In summary, the PPI was widely read, accepted, and had a positive impact on patient education. From this and other evidence, it seems clear that PPIs can be beneficial and are definitely needed for selected patients and disease conditions. Furthermore, current medicolegal opinion states unequivocally that the patient has a right to know about his diagnosis and therapy. So the only real professional issue is how to implement a successful PPI program. No controversy would now exist if physicians and pharmacists had, in the past, been more conscientious and effective in basic patient education and attitude development — education and attitudes needed for patients to simply understand and be motivated to follow therapy advice. The FDA is not in a leadership role with the PPI. There are several textbooks and drug counseling guides commercially available, and several firms, in addition to pharmaceutical companies, have a large number of drug brochures now available to physicians and pharmacists. More significantly, the USP will soon release its Dispensing Information (USP-DI) program. This information has been developed by expert professional panels, and a review of sample monographs reveals carefully prepared data that should be a great aid in pharmacistor physician-conducted patient counseling. The FDA will not likely improve this voluntary data significantly. The patient needs to be educated about prescribed drugs, but great sensitivity and personal insight must be exhibited by those undertaking patient counseling. Some patients are well educated and could even tolerate information straight from the Physicians' Desk Reference or "physician package insert. " Others, however, could not handle well even a rudimentary PPI. Generally, there must be a happy medium of information which is instructive but not necessarily alarming to the majority of patients. Much more experience and experimentation are needed before standard PPIs are mandated. Perhaps the government, of which the FDA is a part, should merely promote the idea that citizens have a right to prescription-drug information, and that it is the duty of the physician and pharmacist to supply it. The public should also be advised to actively seek practitioners who will enlighten them about prescribed drugs. The "busy" physician and "remote" pharmacist may respond to patient pressure; but they are not likely to react well to a governmentally mandated program. Professionally developed PPIs should routinely be available upon patient request, and pharmacists should actively promote their appropriate use and provide ancillary verbal reinforcement and clarification. Any action less than this will be a detriment both to patient care and the profession. Service fees must be calculated to include this activity as a professional, reimbursable function.