HRG Comments on Prescription Drug Product Labeling; Medical Guide Requirements (HRG Publication #1382)
Dockets Management Branch (HFA-305)
Food and Drug Administration, Rm. 1-23,
12420 Parklawn Drive
Rockville MD 20857
Public Citizen’s Health Research Group Comments on
Prescription Drug Product Labeling; Medication Guide Requirements
Public Citizen representing 90,000 consumers, urges the FDA to enact long over due regulations requiring the distribution of agency approved written information to prescription drug consumers. Revoking the simple, sensible mandatory patient package insert (PPI) program in 1982 has left millions of prescription drug consumers dangerously ignorant about their medications. The FDA’s medication guide proposal only perpetuates the misguided hope that there can be a voluntary private sector solution to the public’s drug information needs and will only deny access to vital information that the public needs to protect themselves from drug induced injury or death for at least four more years.
“Inadequate access to appropriate patient information is a major cause of inappropriate use of prescription medications, resulting in serious personal injury and related costs to the health care system.” Notice of proposed rule-making on Prescription drug product labeling; medication guide requirements. 1
“The Food and Drug Administration (FDA) estimates that the annual cost of hospitalizations due to inappropriate prescription drug use is $20 billion.” 2
The above statements summarize the consequences of a federal agency responsible for the public’s health yielding in 1982 to the pressure of a pharmaceutical industry that claims to operate for the public’s good and to national organizations representing doctors and pharmacists who are sworn to help and protect the public before all else.
The value of consumer drug information has been debated and studied to “death.” The evidence is in, and it is clear; consumers benefit when given access to well-written drug information, and consumers can comprehend the information. Assertions from drug company and professional trade groups opposing the distribution of consumer drug information have been paternalistic, fallacious and self-serving. 3 Informing patients about drugs. Santa Monica, CA: The Rand Corporation, R-2800-FDA, August 1981. Consumers and consumer groups support the distribution of comprehensive written drug information as does the FDA. Yet, American prescription drug consumers are still denied access to information that can be used prevent possible drug induced injury or death.
A well-documented review of the history, research and issues surrounding consumer drug information was presented by the FDA in the proposed rule announcing the Medication Guide requirements.1 Only if history and evidence are ignored can any but the following conclusions be reached:
I. Inadequate access to appropriate drug information is a major cause of inappropriate use of prescription drugs.
II. The inappropriate use of prescription drugs is a serious preventable public health problem.
III. Voluntary private sector solutions to provide adequate access to appropriate drug information have failed.
IV. To reach most of the public, distribution of consumer drug information must be mandatory.
V. To be accurate, consistent and noncommercial, the content of consumer drug information must reflect the current legal requirements for a drug’s use.
Prescription drug consumers have the same right to information as those persons undergoing the simplest of surgical procedures. The disclosure of risks and benefits before surgery is an accepted part of our health care system guided by the principle of informed consent. This principle recognizes the individual’s right to information that is essential in making a personal judgement about accepting or rejecting the possibility of injury from a surgical procedure. Consumers of prescription drugs and surgical procedures share a common prospect; both assume individual risks of possible irreparable injury or death from their respective therapeutic interventions. In contrast to those undergoing surgical procedures prescription drug consumers face unknown risks when prescribed powerful therapeutic agents, perhaps for a lifetime, with no more information than the name of the drug, a sentence on the prescription label and “sticky-reminders” on the bottle.
THE MYTH OF A PRIVATE SECTOR SOLUTION
In 1979, after spending years studying the information needs of prescription drug consumers, the FDA proposed a simple and sensible plan that would have given the public accurate, thorough and understandable written information about prescription drugs. The plan required mandatory distribution of FDA approved drug information with each new and refilled prescription through patient package inserts or PPIs. The FDA’s own research showed broad public support for the plan and that opponents’ arguments to PPIs were groundless. Tragically, in 1982 an agency whose primary responsibility is the public’s health capitulated to political pressure from industry and professional trade groups and canceled a program designed to prevent serious drug induced injury to consumers.
During the 1982 hearings that disemboweled the PPI plan promises were made by representatives of the pharmaceutical industry and pharmacy and medicine trade groups that if the FDA withdrew their mandatory PPI plan the private sector would develop systems to meet the drug information needs of the public. This promise was never kept. It is time that the FDA acknowledges that private sector promises are made to protect private sector interests, not the public’s health.
The FDA’s new medication guide proposal would extend the private sector’s opportunity to voluntarily exercise its initiative until the year 2000. This will only deny the public access to vital drug information for at least four more years. The outcome of allowing another four years of a voluntary private sector solution should be patently obvious to the FDA. In 1982, Public Citizen commenting on this issue made the following prediction that is as true today as it was when written:
“The flurry of voluntary activities that FDA hopes will replace PPI’s will simply never materialize. As soon as FDA withdraws the PPI program, these proposals will fade out of sight, leaving patients as much in the dark about their medications as they were before FDA proposed the PPI program. Patient drug information will be no more than a sensible idea destroyed by industry pressure, honored only by the lip service of a toothless committee.”
In the decade between 1982 and 1992 the percentage of patients receiving written information has increased from 5 to 14 percent in physicians’ offices and from 16 to 32 percent in pharmacies. However, only 25 percent received more than brief “sticker-labels” on their prescription containers at the pharmacy.4
This is an example of how the private sector has responded to the serious public health problem of preventable drug induced injury. Credit for this meager increase in written drug information may have to go to government regulation, including FDA pressure, and state Boards of Pharmacy, not to private sector initiative. The 1990 Omnibus Budget Reconciliation Act (OBRA 90) requires pharmacists to counsel Medicaid recipients about their medications. Since this law went into effect at least forty states have extended the OBRA 90 mandate to cover all prescription drug consumers, not only Medicaid recipients.5 The distribution of written information is less time consuming than pharmacists counselling the public about their drugs.
THE ELDERLY – THE HUMAN COST OF IGNORANCE
Inappropriate use of prescription drugs is a problem that is particularly acute for the elderly. The older age groups use more prescription drugs than their younger counterparts and are more likely to be taking multiple medications, which increases the probability of adverse drug reactions. The United States General Accounting Office report on Prescription Drugs and the Elderly cites research that estimates the percentage of hospitalizations of elderly patients due to adverse drug reactions to be 17 percent, almost six times greater than the percentage of hospitalizations due to adverse drug reactions for the general population.2
A recent, carefully controlled study examined the details of prescriptions of people using three or more drugs to treat chronic illnesses being discharged from a community hospital. The major results of this study listed below are evidence of the preventable risks faced daily by older prescription drug consumers.6
– 88% had one or more prescribing problems with prescriptions they were given.
– 22% of these had at least one potentially serious, life-threatening problem that could have occurred from the prescriptions as written.
– 59% of the patients had been given one or more prescriptions in which the drug was an inappropriate choice.
– 28% were given an overdose.
– 48% were given drugs with one or more harmful interactions.
– 20% were given drugs that unnecessarily duplicated the therapeutic effect of another drug they were taking.
Life and injury is the cost that elderly Americans are paying because neither they nor their care givers routinely have access to clear, accurate and complete information about prescription drugs. The evidence shows that the current “system” of safeguards are not protecting this vulnerable group from preventable adverse drug effects. Before continuing to oppose the mandatory distribution of consumer drug information professional trade lobbies must explain to the public this damning evidence and the performances of the professions they represent in protecting the public from preventable adverse drug reactions.
INADEQUATE AND INCONSISTENT INFORMATION
The FDA evaluated drug information produced by eight different private sector sources that provide information on electronic media designed for use by retail pharmacists as an aid to consumer counseling at the time of drug dispensing. Consistency with current approved product labeling for three drugs was used to measure the accuracy and completeness of the private sector information sources. Only four of the eight sources produced drug specific information for the three drugs chosen and the other four produced only general therapeutic class information. The information communicated to consumers was judged on whether the directions for use were clear and whether risk information conveyed the significance of the risk, how to recognize adverse effects, and the proper response that a consumer should take if an adverse effect were to occur. Substantial differences in the private sector sources were found and the lack of detail and background information explaining risks in information from some of the sources was described as a special concern by the FDA.1
Below are examples of serious and needless omissions found in some the commercially available drug information sources reviewed by the FDA:
“None of the eight sources mentioned the contraindications for the use of enalapril [Vasotec–a common drug used for heart problems and high blood pressure], i.e., allergic reactions or swelling (angioedema) on previous treatment with similar drugs. Two the sources failed to warn the patient about symptoms of angioedema, a potentially deadly allergic reaction. Of the six including such symptoms (i.e., swelling of face, extremities, eyes, lips, tongue or difficulty in swallowing or breathing), only one advised the patient experiencing such symptoms to take no more drug and to seek medical attention immediately.”
Inconsistent and incomplete communication of potentially life saving drug information to consumers is unacceptable. For the public’s safety consumers need a clear, accurate and complete reflection of a product’s approved labeling and this must be the minimum standard by which consumer drug information is judged. Appropriate and safe use of prescription drugs also demands that important product labeling changes are accurately, completely and consistently communicated to the public. The private sector, with a myriad of competing vendors, cannot approach the simplicity and safety of a uniform mandatory system of distributing consumer drug information based on a drug’s current legal labeling requirements.
THE CURIOUS CALL FOR MORE RESEARCH
The goal of improving drug compliance is to ensure that consumers understand the importance of taking their medications and taking them all correctly. Professional trade groups that have long opposed the mandatory distribution of consumer drug information are now making a curious call for basic research into finding ways to improve compliance before giving the public access to drug information. 7 Calling for more compliance studies is side stepping the important public health issue of preventable adverse drug effects that these groups have not addressed, and is only a way to continue to obstruct access to vital drug information.
It would be hard to imagine a successful intervention to improve compliance that would not include comprehensive drug information written for consumers. This fact makes the continued obstruction by some trade groups of consumer drug information pointless. Weighing the published evidence of harm from preventable adverse drug reactions against a purported need for compliance research and deciding that compliance must come first is simply indefensible.
THE EUROPEAN PARADOX
A baffling paradox is the comparison between the failed attempts in the US to provide consumers with written prescription drug information and the response within the European Community (EC) to this important public health issue. The EC adopted legislation in 1992 requiring that consumer drug information approved by a member country’s drug regulatory authority be distributed with all prescriptions by December 1998. Beginning January 1, 1994 European consumers were mandated to receive written drug information leaflets with every prescription for newly marketed drugs.8 The EC’s rational for the regulation was simple:
“. . . the information supplied to users should provide a high degree of consumer protection, in order that medicinal products may be used correctly on the basis of full and comprehensible information.”
Following the requirements mandated by the EC, in the United Kingdom (UK) all new drugs approved for sale after January 1, 1995 were distributed with consumer drug information leaflets. Drugs already on the market, both brand name and generic products, will be dispensed with written information for consumers by September 1998. For those persons confined to a hospital the drug information would be provided on request. At this time, information requirements for nursing home residents have not been decided.9 A practical solution would be to provide the drug information to those helping with the medication management of a nursing home resident such as a spouse, family member or friend on request.
Regulation prevents consumer drug information from becoming another advertising platform for pharmaceutical manufacturers by requiring that the content of consumer drug information leaflets be consistent with the current legal requirements for the drug’s use in the UK. To ensure that leaflets meet these legal requirements, and do not contain advertising, the wording must first be approved by the Medicines Control Agency (MCA), the British equivalent of the FDA, before distribution to the public.8,9
In Appendix I are examples of consumer drug information leaflets produced in the UK by multi-national pharmaceutical manufacturers that operate in both the UK and the US. The leaflets were field tested in groups of consumers for clarity by at least one manufacturer before being sent to the MCA for final approval. A senior marketing official for one of the world’s largest pharmaceutical manufacturers described the process of writing these leaflets as relatively “painless” from the company perspective. The hard work has already been done. The information in the approved product labeling only needs to be put in language that can be used by consumers. Judging by the British experience the “complexities” of mandatory consumer drug information are largely in the minds of their US opponents.
The European approach to consumer drug information is reminiscent of the FDA’s 1979 PPI proposal; simple, comprehensive and mandatory. Our European cousins may have addressed the consumer’s right to prescription drug information later than in the US, but European consumers are already receiving vital prescription drug information.
The distribution of clear, accurate and complete information based on a drug’s approved labeling with all prescriptions is a simple and sensible idea that should have been finalized and put into practice in the US sixteen years ago. This 1979 idea is now becoming a reality in the EC. The FDA’s proposal for medication guides will only further delay consumer access to vital drug information for at least four more years, but if history is the guide, it will be for much longer if the FDA does not find the determination to resist the pressure of drug company and professional trade groups. All that has ever stood between US consumers and access to potentially life saving drug information has been the FDA’s resolve to resist these pressures.
1 Federal Register August 24, 1995;60:44182-44252.
2 Prescription drugs and the elderly. Washington, DC:United States General Accounting Office; 1995.
3 Kanouse DE et al.
4 Morris LA, et al. Counseling patients about prescribed medication: ten year trends. Food and Drug Administration, Rockville, MD, 1993.
5 Consumer patient counseling survey. National Association of Boards of Pharmacy; 1994.
6 Lipton HL, Bero LA, Bird JA, McPhee SJ. The impact of clinical pharmacists’ consultations of physicians’ geriatric drug prescribing. Med Care 1992;30:646-658.
7 Written medication info standard is “inferior goal,” drug trade coalition maintains; FDA “Medguide” may stifle private sector innovations, firms say. F-D-C Reports; December 4, 1995:10-11
8 Council Directive 92/27/EEC of 31 March 1992 on the labeling of medicinal products for human use and on package leaflets. Official Journal of the European Communities1992; 35:8-12.
9 Collier J ed. Patient pack prescribing and the provision of patient information leaflets. Drug and Therapeutics Bulletin. 1995; 33:86-88.