Patient Package Inserts
The time is always right to do what is right.
–Martin Luther King Jr.
Printed information for patients about a drug that is included in a package or dispensed simultaneously with a drug is defined as a patient package insert. This material differs from official package inserts written for healthcare professionals in that the language is targeted to a different audience. The development of patient package inserts for most or all drugs was discussed in numerous forums within the United States in the late 1970s, but was dropped from consideration because of widespread opposition from both physicians and pharmaceutical companies. Since the early 1990s, the momentum for creating and dispensing these documents is growing. In Europe, the impetus was supplied by the European Union’s decision to require them (i.e., regulations driving companies to supply patients with information). In the United States, pressure from the public is building (i.e., active consumers are pressuring companies to supply them with more information). The Food and Drug Administration is also expected to be influenced (eventually) by European regulatory changes and to promote the practice of supplying patient package inserts in the United States.
THE RATIONALE FOR PATIENT PACKAGE INSERTS
Customers in all countries receive detailed instructions on how to use each new electronic piece of equipment they purchase, whether it is a simple hair dryer or a sophisticated computer. These instruction manuals are often written in four or more languages and present great detail, even covering what the customer should do in case of problems with simple machines. Yet when patients are given drugs that have a major effect on their health, and which do not yield as consistent and reproducible results as electronic goods, the only information patients usually receive are some verbal comments by an often rushed physician or nurse who may or may not remember to mention important information about the drugs. Even under the best conditions and with a conscientious physician or nurse, patients often find it difficult to remember accurately everything they have been told. Moreover, patients rarely ask all the relevant questions that will occur to them over the next day, week, or month and many relevant questions are unknown to them.
Patients Desire More Information about Their Drugs
Numerous surveys, as well as common sense, indicate that many patients desire much more information than they receive (typically only the physician’s recommendation and basic instructions). Thus, it seems important to provide written information that interested patients will use, and which those without interest may ignore. Strull, Lo, and Charles (1984) report that there is often a major difference between patients’ desire for information and their desire to make medical decisions. Physicians have tended to underestimate the former and overestimate the latter. This supports the view that patients desire far more information than they currently receive. In addition, physicians believe they spend much more time informing patients about their drugs than they truly do (Joossens 1991). A major means of addressing these problems is to provide patients with package inserts.
Why Patients Have a Right to Receive Written Information
There are a number of important reasons why the information that would be included in a patient package insert is both a patient right and a moral requirement for prescription drugs.
Physicians and other healthcare professionals often fail to provide relevant and important information to their patients about drugs. Whether physicians forget to present the information, are too rushed to present the information, or believe the patient should not have the information, the end result is the same—patients who want information do not receive it.
Patients have a right to know relevant information about the drugs they are prescribed. Patients also often forget important information they have been told or remember facts incorrectly at a later date. Patients also have a right to consent to treatment in general practice, and patient package inserts are one means of ensuring informed consent, by presenting relevant information about any drugs that may be prescribed.
Patients may misinterpret important information at the time they hear it because of stress, denial, fatigue, failure to hear, or lack of understanding of one or more aspects of the information presented. Patients who are receiving information about their drugs often have difficulty hearing it and remembering it accurately because they are often in an environment that they consider unfriendly or have negative associations about—no matter how cheerful and friendly the staff or how gaily painted the walls.
Physicians may provide too little or too much information about a drug for a particular patient. Having a package insert written in language that can be clearly understood by patients ensures that a prespecified minimum amount of data are available for each patient. Physicians often present information to patients using jargon or in complex terminology. Physicians may be unaware of doing this, but patients frequently do not understand or misinterpret the physicians’ statements.
Physicians almost never truly assess whether their instructions and information are appropriately understood. Sometimes they ask a patient “Do you understand?” This is a totally inadequate means of assessing patient comprehension because patients who do not fully understand what they have heard are often too embarrassed to admit this and would rather avoid this admission. Other patients think they understand what they have heard, but would be unable to repeat what they have heard, and will soon forget the details, or understand something different than what they were told.
Patients may be on vacation or on a trip when they have questions about their drug and they may not have any means of obtaining a rapid answer to an important question.
There is a great difference in patients’ willingness to ask questions and many patients accept their physician’s advice unquestioningly.
OBJECTIVES OF PROVIDING PATIENT PACKAGE INSERTS
The assumption underlying this chapter is that patients have a basic right to be informed about their drugs, and that this requires that they receive more information than is usually provided by physicians. Even if a patient is given a totally perfect and complete explanation about a drug, he or she is likely to forget or misinterpret some of the specific details heard.
Ethical standards require that information provided must be given honestly, responsibly, and truthfully, and using language that will be understandable by patients. The specific objectives of providing information are to:
Inform patients of benefits and risks associated with the drug
Inform patients how to use the drug properly [this is not just for “unusual” delivery systems (e.g., nasal insufflation, constant infusion pump) but also for basic issues such as whether to take a drug before or after meals and how much water to use when taking the drug]
Inform patients about possible interactions the drug may have with other treatments
Promote patient compliance through improved understanding about the drug, including awareness of the consequences of poor compliance
Provide information about potential problems or common questions that may arise
Provide information on how to respond to problems that may arise
MAJOR ISSUES IN PREPARING A MEANINGFUL PATIENT PACKAGE INSERT
Specific issues that must be considered when package inserts are prepared include the following:
Categories of information and specific topics to be discussed
Amount of information to be presented on each topic and the total length of the insert
Style and tone to be used (e.g., conversational, formal, humorous) in the written document, as well as format of the document and technical details (e.g., size of type)
Educational (i.e., reading) level of language to be used (e.g., length of sentences, number of syllables, word choice)
Organization of the document to ensure a logical flow with clear topic headings and sufficient white space between paragraphs
Layout and illustration, which should be clear and contain easy-to-read type without many variations in type, with ragged
right margins and line drawings that do not interfere with text
Manner that information is to be presented (e.g., should the statements made be explained), particularly for statements that are often misinterpreted (e.g., use as directed, take with meals)
Table 39.1 Selected issues and questions to consider in preparing patient package inserts | ||||||||||||||||||||||||
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A number of other issues to consider are listed in Table 39.1.
Medical Literacy
The amount of information published on medical literacy has grown exponentially over the past few years. A decade ago, there was (and still is) significant interest in ensuring that informed consents were readable at the correct grade level and that the material was understandable. In more recent years, this has expanded to evaluating how well information is presented and understood that is in websites, direct-to-consumer advertising, health surveys, and in direct communication with physicians and other healthcare providers.
This area is of great importance in both clinical trials and marketing. Drug development often includes a variety of instruments that must be understood by subjects if the data obtained are to be accurate and reliable. Even a validated instrument used in a partially illiterate population will not provide the data expected. This relates to almost all types of clinical trials but particularly those where patients are asked to complete paper or electronic forms (e.g., patient reported outcome studies, pharmacoeconomic studies, diaries). Readers are referred to the literature such as the Harvard School of Public Health’s Annotated Bibliography, which is available on their website (see Additional Readings). This area must be of great importance when patient package inserts are being developed and field tested in different populations.
Current Examples of Information Directed toward Patients
Public bookstores contain a wide variety of books that discuss both prescription and over-the-counter drugs from a patient’s perspective. Many of these are excellent sources of useful information. Many people that desire this information, however, do not have access to such books because they cannot afford them, they have an “anti-book” attitude, they are unaware of their existence, or for other reasons.
Patient package inserts have been prepared in various countries for different groups of drugs (Anonymous 1990). Patient package inserts are required in several European countries. In the United States, patient package inserts are currently mandated for oral contraceptives (21CFR 310.501), progestational agents (21CFR 310.516), estrogens (21CFR 310.515), isoproterenol inhalation products (21CFR 201.305), and intrauterine devices (21CFR 310.502). A well-written, detailed legal discussion of this subject is presented by Hutt and Merrill (1991). Literature and brochures from various associations, companies, compendia, and other groups are currently serving the purpose of patient package inserts for many drugs. Blattmann (1992) discusses current issues of patient package inserts in Europe.
Who Should Prepare Patient Package Inserts?
It is likely that pharmaceutical companies would prepare drafts of patient package inserts, just as they generally prepare the drafts of professional package inserts. Guidelines for the preparation of these documents (e.g., categories to cover, reading level, degree of completeness) should be issued by national regulatory authorities to standardize the approach. Whether those regulatory authorities would also have to approve each patient package insert will probably vary from country to country. A preferable approach would be for companies to prepare package inserts and submit them to the regulatory authority. If a company did not receive a rejection or a request for change within 30 days, then the document would be deemed “approved.” This is similar to the current approach to processing Investigational New Drug Applications at the Food and Drug Administration.
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