Communicating About Safety
“Information is ultimately what permits people to make meaningful choices about whether or not to take new drugs” (Greenberg, 2003).
“1962—Consumer Bill of Rights is proclaimed by President John F. Kennedy in a message to Congress. Included are the right to safety, the right to be informed, the right to choose, and the right to be heard” (FDA Milestones).1
Patients use the medications approved by the Food and Drug Administration (FDA) and prescribed by health care providers. Despite that, patients historically have been left out of the loop in much of the communication that has occurred among the biomedical research, health care, and pharmaceutical enterprises and government regulators. As described in Chapter 1, social and technological changes have transformed the practice of medicine, the role of patients, and the information environment that surrounds patients and physicians and influences their interactions (Henwood et al., 2003). Public interest in and knowledge about drugs have also evolved greatly due to direct-to-consumer (DTC) prescription drug advertising, ever wider Internet and e-mail access and breadth of information, a shift in the formerly passive role of patient, and the emergence of a powerful patient advocacy movement (Atkin and Wallack, 1990; Dupuits, 2002; Pew Internet and American Life Project, 2003, 2004, 2005). Finally, the recent safety concerns about widely used, well-known drugs and drug classes, from antidepressants to anti-inflammatory drugs, have further mobilized public interest in drug safety issues. As noted earlier, FDA, the pharmaceutical industry, the health care delivery system, and other stakeholders have begun to grapple with serious questions about when to inform patients and consumers about risk, how to communicate effectively, and what information is needed for personal health, health care system, and regulatory decision making.
This chapter is intended not to provide a comprehensive assessment of communication issues in the drug system but rather to describe briefly major
communication efforts at FDA, discuss some of the challenges that have complicated those activities, and to suggest two specific areas for improvement and makes appropriate recommendations.
Pharmaceutical products constitute 11 percent of the health care dollar (Smith et al., 2005). They are characterized by complex risk-benefit profiles, long and complicated research processes, and high visibility. They have the potential to provide important health benefits, from reducing risk of death to improving quality of life, and they are subject to extensive regulatory oversight. Those are some of the reasons why effective and timely risk communication about drugs is essential.
Roles and Needs of Providers and Patients
Despite the greater role patients play in their own health care, and the health care delivery system’s recognition of that role, most of the communication “transactions” in the drug safety system occur among regulators, sponsors, providers, and payors. There are two types of information that may be communicated: information directed outward from stakeholders in the drug safety system (such as education, risk communication, promotional information), and information directed toward the drug safety system from those who experience drug safety problems directly or indirectly (including drug event reporting by patients or providers).
Communication Between the Public and the Drug Safety System
The Committee on the Assessment of the Drug Safety System did not endeavor to conduct a comprehensive examination of the communication needs of patients and the general public. Another IOM committee addressed these issues extensively in their report, Preventing Medication Errors (2007). That report recommended specific steps the health care delivery system, FDA, and other federal agencies could take to improve the availability, accessibility, quality, and quantity of patient and consumer information about drugs and their risks and benefits (see Box 6-1 and Appendix A). The present chapter focuses only on two areas where the committee believes FDA could strengthen its programs targeting patients’ and consumers’ communication needs.
Consumers and patients seek to access the information they need about the drugs they use through an incomplete and imperfect patchwork of sources (Brann and Anderson, 2002). These sources are of varying reliability and usefulness, and they include health care providers and pharmacists, DTC advertising, printed information made available by pharmacies, FDA-required patient package inserts for a limited number of drugs, information from a wide variety of sources made available on the Internet, and so
on. Providers develop their knowledge about prescription drugs through a variety of means, including journal articles, interactions with company sales representatives, continuing education, professional associations, communication or education provided by their practice, hospital, or health system, and communiqués from FDA (either direct for those who request FDA electronic communications, or through professional associations that subscribe to or relay FDA’s public health advisories).
FDA communicates to the public and to providers about drug safety concerns through public health advisories and warning. Some components of FDA’s risk communication are under development, as described in Appendix A. For example, the agency has established a Drug Watch Web site intended for timely communication of safety issues to the public, but concerns arose about communicating complex issues of scientific uncertainty, explaining complex data clearly and in a way that is useful to patients (FDA, 2005). At the time of this writing, the committee had not yet learned of a resolution of these issues.
FDA has historically focused most of its communication activities on health care providers who prescribe FDA-approved drugs and serve as the “learned intermediary” between drug production and regulation and patients. That is evident in the dense, technical language of prescription drug labeling rules. In recent years, FDA has acknowledged the importance of communicating with and to patients and the general public by including them in its mission, which calls for “advancing the public health by … helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.” FDA has also reoriented some of its information and communication toward patients and the public, and has held several public hearings on issues related to communication and DTC advertising.
At least three types of the Center for Drug Evaluation and Research (CDER) regulatory activities involve communication-related activities pertinent to patients and the public. First, FDA has authority over prescription drug advertising developed and published or broadcast by sponsors, and CDER’s Division of Drug Marketing and Communication sends untitled letters2 and warning letters to sponsors whose advertisements do not convey a fair balance of risk and benefit information. Second, all of FDA’s advisory committees include consumer representatives. Those committees’ meetings are open to the public and routinely include opportunity for public comment on the issues under discussion. Some committee meetings may address risk communication issues. Third, FDA provides information about prescription drugs and other FDA-approved therapies on its Web site, and in print information about prescription drugs in general on a very small scale.
See Chapter 5 for explanation.
Recommendations Pertaining to Consumers from Preventing Medication Errors
Recommendation 1: To improve the quality and safety of the medication-use process, specific measures should be instituted to strengthen patients’ capacities for sound medication self-management. Specifically:
Recommendation 2: Government agencies (i.e., the Agency for Healthcare Research and Quality [AHRQ], the Centers for Medicare and Medicaid Services [CMS], FDA, and the National Library of Medicine [NLM]) should enhance the resource base for consumer-oriented drug information and
The Role of Other Government Agencies
Other agencies in the Department of Health and Human Services (DHHS), such as the Agency for Healthcare Research and Quality (AHRQ), the National Institutes of Health (NIH), and the Centers for Medicare and Medicaid Services play a role in public communication about drug risk and benefit. For example, AHRQ’s Effective Health Care Program develops consumer summaries of reports prepared by its DEcIDE (Developing Evidence to Inform Decisions about Effectiveness) network—prescription drug outcomes are one focus of the network—and other material on evidence-based practice. NIH conducts or sponsors clinical trials and does make
medication self-management support. Such efforts require standardization of pharmacy medication information leaflets, improvement of online medication resources, establishment of a national drug information telephone helpline, the development of personal health records, and the development of a national medication safety dissemination plan.
SOURCE: IOM (2007).
public announcements about major health findings from them, good and bad. Recent studies from the Women’s Health Initiative have generated such communications (e.g., about the benefits and risks of Hormone Replacement Therapy) in postmenopausal women. Through NLM, NIH also operates the clinicaltrials.gov trial registration Web site (discussed in Chapter 4).
Communicating Between Providers and the Drug Safety System
Although the present report acknowledges general areas of opportunity and challenges, it does not discuss the communication roles and needs of
providers in great detail. The IOM report Preventing Medication Errors (2007) describes challenges in this area, including barriers to implementing and perfecting the use of information technology. That report also recommends several measures to improve communication to providers by government agencies and health systems (see Box 6-2 and Appendix C).
In the health care delivery system, information about drug safety, and particularly risk management, is integrated into drug prescribing and distribution systems (e.g., claims databases that issue alerts when two drugs with potential interactions are prescribed for the same patient). In its work,
Recommendations Pertaining to Providers (and Patients) from Preventing Medication Errors
Recommendation 3: All health care organizations should immediately make complete patient-information and decision-support tools available to clinicians and patients. Health care systems should capture information on medication safety and use this information to improve the safety of their care delivery systems. Health care organizations should implement the appropriate systems to enable providers to:
Recommendation 5: Industry and government should collaborate to establish standards affecting drug-related health information technologies, specifically:
the committee learned about a wide variety of communication opportunities and challenges related to involving the general public and disease groups (such as online support groups) in reporting drug-related adverse events, about a movement to counteract commercial pharmaceutical company “detailing” with neutral “academic detailing” (Avorn, 2005), about First Amendment-based opposition to calls for increased FDA regulation (including banning) of DTC advertising, etc.
Providers, including physicians and pharmacists, are encouraged to report adverse drug reactions experienced by their patients to the manufac-
Recommendation 7: Oversight and regulatory organizations and payers should use legislation, regulation, accreditation, and payment mechanisms and the media to motivate the adoption of practices and technologies that can reduce medication errors, and to ensure that professionals have the competencies required to deliver medications safely.
turer or to FDA’s Adverse Event Reporting System (providers may report through the MedWatch portal). Although proposals have been made in the United States and Europe to mandate provider reporting, there is little evidence that such attempts would be successful. Furthermore, spontaneous reporting is only one component of an effective drug safety surveillance program, and should not be relied on as the sole or primary source of information. Finally, the quality of spontaneous reports is an important concern; a large quantity of incomplete and poorly executed reports would be unhelpful.
How Industry Communicates to the Public and Patients
The frequently dangerous patent medicines that led to the Pure Food and Drugs Act of 1906 and the Food, Drug, and Cosmetic Act of 1938 were advertised directly to consumers with their colorful labels and claims, but modern prescription drugs, as products of biomedical science are promoted largely to health care providers, mostly to physicians. About 86 percent of industry promotional budgets still pay for “sampling” (providing free samples to providers), detailing (drug promotion to individual providers), and advertising in professional journals (Kaiser Family Foundation, 2004). However, the 1980s were a period of increased advertising directed at patients, known in some contexts as consumers—the term intended to reflect the changing role of patients to more active engagement with the health care system and involvement in their own health care.3 In 2005, pharmaceutical manufacturers spent an estimated $4.2 billion on DTC advertising (and $7.2 billion on professional promotion through journal advertising and sales representative contacts) (IMS Health, 2006). A more recent development in pharmaceutical promotion is relationship marketing, in which companies customize their promotional and informational efforts to target patients who have specific diseases, such as diabetics who use a specific product (Ahearne et al., 2005).
FDA’s Challenges in Communicating to the Public and Patients
FDA faces a number of challenges in improving its internal and external communication. As noted in Chapters 1 and 3, CDER has recognized that its credibility can be compromised by adverse publicity with respect to drug
FDA Response to the December 2005 Public Meeting Input
In December 2005, FDA held a public hearing on communication of drug safety information. The hearing was intended to facilitate discussion on FDA’s risk communication with health care providers and patients/ consumers. The following topics presented to FDA at the meeting were noted as needing improvement and attention:
safety, and it has made efforts to improve transparency and communication, including establishing the Drug Watch Web site (currently under discussion by the agency), charging its recently constituted Drug Safety Oversight Board (DSB, discussed in Chapter 3) with (among other things) oversight of external communication, and creating a new Office of Safety Policy and Communication. However, the guidance document on the purpose and functioning of the Drug Watch Web site is being reconsidered because of concerns about needlessly alarming the public and about releasing safety data without proper context and analysis (DHHS et al., 2005a,b; personal communication, S. Cummins, FDA, 2006). Representatives of consumer organizations that participated in the December 2005 hearing on drug safety communication told the agency about their concerns and criticisms of the FDA Web site and offered specific suggestions for improving it and making it more user-friendly and broadly accessible (see Box 6-3).
Consumer Medication Information
It may surprise many Americans to know that most prescription drugs have only a physician package insert and lack patient package inserts (also known as patient information leaflets), which provide information about a drug’s use, risks, and benefits in clearer, more accessible language appropriate for a lay reader (IOM, 2007). The types of patient package information required by FDA to accompany dispensed drugs include information on oral contraceptives and estrogens (required since 1968 by regulation, 21 CFR
310.501 and 310.515, respectively) and medication guides (MedGuides), which are developed by sponsors (and approved by FDA) from the label text for several hundred drugs that “pose serious and significant public health concern” (CDER, 2006). When patients receive what FDA calls consumer medication information it is in the form of a leaflet developed by health care organizations, or more likely, content included by pharmaceutical software providers with the software that they sell to pharmacies. Sponsors may also choose to prepare patient package inserts, which requires FDA approval. Until 1996, there were no standards and no requirements for the minimal useful information to be provided in patient leaflets.
In 1979 and 1980, FDA published in the Federal Register the draft, and then the final rule requiring written patient information for prescription drugs (CDER and CBER, 2006). The draft rule addressed all prescription drugs, but the final focused only on a limited number of prescription drugs. In 1982, FDA revoked those regulations, partly in response to assurances by the pharmaceutical industry, by health care professional organizations, and private-sector developers of medication information that the objectives of the final rule would be better achieved without regulation.
The absence of FDA-approved literature on some drugs that are on the market has been criticized by consumer advocates and other parties, and it seems to be a result of legislative obstacles due to private-sector resistance, long-standing claims that regulation in this regard might interfere with the practice of medicine and pharmacy, and finally, FDA’s lack of resources. According to the current deputy commissioner for operations, “the Agency [in 1980] published a rule requiring FDA approved patient labeling4 for ten drugs/drug classes,” with the expectation that this would be extended to all prescription drugs. In 1982, “the rule was revoked in favor of private sector efforts to provide patient information that FDA would monitor” (Woodcock, 2002). In 1996, Congress opted to leave consumer medication information in the hands of private-sector content providers and instead tasked FDA with oversight to ensure that 95 percent of consumer medication information meets quality standards by 2006. The quality standards were defined by a broad consortium, the Steering Committee for the Collaborative Development of a Long-Range Action Plan for the Provision of Useful Prescription Medicine Information, which was established to develop an action plan for the secretary of DHHS in 1996.5 FDA expects to complete its review of the quality of consumer medication information in 2007 (see Box 6-4).
FDA uses the term labeling to refer to any FDA-approved materials based on the formal label on which FDA and the sponsor agree at the time on approval or to change in the label after marketing.
The action plan is available online at http://www.fda.gov/cder/offices/ods/keystone.pdf.
Criteria for Useful Consumer Medication Information
Written prescription medicine information should be
SOURCE: Steering Committee for the Collaborative Development of a Long-Range Action Plan for the Provision of Useful Prescription Medicine Information (1996).
One function of the DSB (described in more detail in Chapter 3), now located in the Office of Safety Policy and Communication, is to produce patient information sheets for every drug, to be posted on the FDA/CDER Web site. The sheets are intended to provide safety alerts and other emerging information to consumers about specific drugs. However, a footnote to the Drug Watch guidance developed by CDER seems to suggest that the center’s long-term goal is to develop patient information sheets (and provider sheets) for every drug on the market (FDA, 2005; Galson, 2005; confirmed by S. Galson, personal communication, February 22, 2006).
Improving Communication with the Public
CDER uses the expertise of 17 advisory committees (and the Drug Safety and Risk Management advisory committee) charged with advising FDA and the center on issues related to broad classes of drugs (such as oncologic, cardiovascular, and renal). Although communication issues related to specific drugs may emerge in the committees’ work, the existing committees are chartered to review and evaluate safety and efficacy data (on marketed or investigational human drug products) and to make recommendations to the agency.6 The committee has found a 1996 reference to an FDA Committee on Patient Education (1996). To our knowledge, there is no advisory
committee devoted to advising the agency (and CDER specifically) on public communication issues that arise during the lifecycle of drugs.
The committee remains perplexed about the tasks of the new DSB, and how they relate to the center’s other plans for improving communication. The DSB, discussed in Chapter 3, has the dual purpose of addressing disagreements among CDER offices or divisions and assisting the center in communicating about drug safety issues to patients (Meadows, 2006; Throckmorton, 2006). As the committee noted in Chapter 3, assigning the two functions to the same internal body may not be effective. Both sets of activities require substantial expertise and resources, and from a management point of view, it seemed unusual that the two functions would be assigned to the same group. Although the committee realizes that the appearance of internal CDER conflict over how drug safety issues are identified, defined, and addressed became associated in the press with poor and delayed communication to the public about those drug safety issues, the committee believes that these two areas should be managed separately. Also, the DSB does not possess substantial expertise in the area of risk communication and consumer or patient behavior. For these reasons, the committee believes that a separate, external entity is needed to advise the agency on the diverse communication needs of the public and patients and on the best evidence on risk communication tools and strategies.
Several FDA centers, including CDER, the Center for Biologics Evaluation and Research (CBER), and the Center for Devices and Radiological Health (CDRH), share similar communication challenges. An advisory committee on consumer and patient communication issues could have a dual function, serving as a conduit for public input into FDA’s decision making (for example, through surveys), and an advisor to the agency on a range of communication issues. Other government agencies have advisory committees that involve consumers and patients (see Box 6-5).
The presence of consumer representatives in FDA’s advisory committee process is limited to one member per committee, and communication issues understandably constitute just a small component of advisory committees’ work. We believe that the agency, and especially CDER, would benefit from having a new advisory committee focused entirely on communication with the public, including risk communication. Public communication issues cut across CDER, CBER, and CDRH such as when and how to warn, how and what to communicate, so the proposed committee should serve all relevant centers.
6.1: The committee recommends that Congress enact legislation establishing a new FDA advisory committee on communication with patients and consumers. The committee would be composed of members who represent consumer and patient perspectives and
organizations. The advisory committee would advise CDER and other centers on communication issues related to efficacy, safety, and use during the lifecycle of drugs and other medical products, and it would support the centers in their mission to “help the public get the accurate, science-based information they need to use medicines and foods to improve their health.”
The proposed advisory committee should also have the role of developing and implementing a comprehensive consumer information program at FDA. The expertise needed on the advisory committee may include consumer and patient perspectives (adult, children, chronic conditions, new reader, consumer organizations, disease specific advocacy groups, and patient safety advocacy groups), risk communication, health literacy, social marketing expertise, public relations expertise, social sciences expertise with an emphasis on qualitative research and survey science, journalism, and ethics. The advisory committee could develop standards for effective communication of risk and benefit information, patient-provider communication, and patient participation in the generation of drug safety information and data, and apply available expertise and evidence to refine the structure and content of public health advisories, develop more robust standards for FDA’s assessment of DTC advertising. It would, like all other advisory committees, be based in the Office of the Commissioner, but it would work closely with the new CDER Office of Safety Policy and Communication.7
The scope of work for the new CDER Office of Safety Policy and Communication is still under development. Given the reactive, fragmentary, and short-lived nature of previous CDER initiatives and organizational changes, the committee believes that special attention and commitment will be required to allow the new office to succeed. It will be essential to have its scope and goals clearly defined, and for its work to be given a high priority in CDER.
6.2: The committee recommends that the new Office of Drug Safety Policy and Communication should develop a cohesive risk communication plan that includes, at a minimum, a review of all center risk communication activities, evaluation and revision of communication tools for clarity and consistency, and priority-setting to ensure efficient use of resources. The work of the office should be evaluated after one year.
Examples of Federal Advisory Committees on Consumer Issues
Two DHHS agencies have successfully used consumer advisory committees to obtain input from consumers. The NIH Director’s Council of Public Representatives (COPR) advises the NIH director on “matters related to medical research, NIH policies and programs, and public participation in agency activities.” The COPR has held workshops and issued reports on enhancing public input in research priority-setting, on strengthening public trust in the research enterprise, and on the organizational structure and management of NIH. The COPR Web site also provides information about the cost of running the council: $222,351 for operations and member expenses and $124,118 for 1.30 full-time equivalents of staff. NIH sponsors a public lecture series at which NIH scientists discuss their work in a manner appropriate for a lay audience (NIH, 2006); this series is another example of reaching out to understand consumer concerns.
The National Cancer Institute (NCI) Office of Liaison Activities launched the Director’s Consumer Liaison Group (DCLG) in 1997; it is NCI’s first and only consumer advisory group. The DCLG makes recommendations to the director of NCI from the consumer advocate perspective on a wide variety of issues, programs, and research priorities. The 15 members include advocates, survivors, family members, and health care professionals and are chosen by the NCI director from a pool of applicants. The DCLG complies with the provisions of the Federal Advisory Committee Act. (NCI, 2006a,b). It also provides a forum for the cancer advocacy community. At the time of this writing, plans were being made for a summit titled “Listening and Learning Together: Building a Bridge of Trust” to bring together many segments of the cancer community to give them a voice in shaping the interaction and collaboration between NCI and consumers (NCI, 2006c). In 2003, NCI contracted with a consulting firm to conduct a survey of the cancer advocacy community and, among other things, to measure and track advocacy organizations’ perceptions of the DCLG. The survey found that DCLG was known in the cancer advocacy community, and 69% percent of respondents thought that the group would be more effective if it worked strategically with NCI rather than monitoring or participating in the implementation of NCI’s strategic plan. Respondents also wanted to see the DCLG more involved in research, clinical trials, survivorship, health disparities, and communication.
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