It is a basic tenet of medicine that patients are entitled to make an informed judgment about their own health care. "Informed consent" describes the process by which physicians educate their patients about a proposed course of treatment and gain the consent of the patient for medical care. The difficulty in this process lies in its implementation. There is far too little guidance on this topic from the Food and Drug Administration (FDA), the pharmaceutical and device industry, or organized medicine. This article will offer an overview of this issue and practical suggestions for implementing an effective informed consent process for prescriptions drugs and medical devices.
The nature of the problem
Physicians face a daunting task in the use of prescription drugs and devices. There are hundreds of FDA-approved drugs on the market and a similarly large number of medical devices. Physicians prescribe drugs and devices every day, and these products are essential tools in the delivery of medical care.
While drug and device manufacturers are regulated by the FDA, physicians are governed only by their ethical code, state regulatory authorities, and the nebulous "standard of care" applicable to all medical professionals. This "standard" is evolving, geographically unique, and can sometimes be a traitorous guide for even the most attentive physicians. How, then, do you fulfill your obligation to educate patients and also afford yourself legal protection?
The primary goal: patient education
The foremost goal of the informed consent process is to convey significant safety information so the patient can decide whether or not to undergo medical treatment. Gone are the days in which patients routinely accept the advice of their trusted practitioner without question; it is the savvy physician who has implemented a more diligent process of educating patients and documenting this event.
Nothing can replace the personal informed consent discussion between physician and patient. Prescribers need not engage in a tedious or lengthy colloquy with every patient. However, a short, personal explanation of the proposed treatment, alternatives, benefits and risks, and suggested follow-up care is important. It is beneficial to ask patients if they have any questions and to respond to queries briefly but thoroughly. In most instances, the crux of the informed consent process — and of the physician-patient relationship — is this personal interaction.
Physicians must also remember that they practice in a legal and regulatory setting. It is alarming how many physicians feel that their informed consent discussions can be guided exclusively by their own personal experience with a drug or device. This is an unreliable compass, and personal experience should serve as only one source of medical information. If a physician is provided with significant benefit and risk information about a product, that physician normally has an obligation to pass along this information to the patient. For example, if a drug label is revised to include a black box warning or significant information about a potential adverse event, physicians are well advised to include this information in the informed consent discussion. The goal is not to alarm the patient or to discourage compliance with medical advice, but to pass along safety information deemed important by the government and the product manufacturer. Simply put — important product information cannot be ignored because the physician has never confronted the issue in personal practice.
Tools for the busy physician
Physicians have their own resources by which they inform themselves about drug and device risks and benefits. It is wise to obtain information on devices and pharmaceuticals from many sources: the product supplier, product or package labeling, continuing medical education, information from colleagues, journal articles, and personal experience. Once the physician has a foundation of knowledge, the next step is to effectively convey that information to the patient.
For prescription drugs and some products, the dispensing pharmacist routinely provides information to patients. Patients should be instructed to review this information and to contact their physician or pharmacist with questions. While this information is frequently accurate and informative, pharmacy patient information handouts are not screened by the FDA or industry. Therefore, physicians are advised to focus on FDA-approved product information.
When sample medications are given, patients should be told that the product information (such as the FDA-approved product label) is available for their review and to contact their physician with any questions. A chart note documenting this conversation is beneficial. There is no harm in following this protocol, and it is potentially beneficial to the patient and legally advantageous for the physician.
The package insert
Package inserts are legal and regulatory documents that play a critical role in the health care system. Our drug and device regulatory system focuses on the package insert as the primary tool by which information is conveyed to physicians. The system also relies on the package insert as a valid means of educating patients. In actuality, many package inserts are a confusing mass of scientific jibberish, legal jargon interspersed with epidemiologically unsound "adverse event" data, and meaningless lists of potential health problems. For these reasons, many observers believe that package inserts are an ineffective way to inform physicians and patients about the risks and benefits of prescription drugs and medical devices.
In spite of the inadequacies in the labeling system and until much-needed improvements are implemented, physicians have no choice but to proceed under the rules imposed by our legal and regulatory system. That means it is permissible, and even necessary, for physicians to give package inserts to patients, to suggest that patients review them, and to tell them to notify their physicians if any questions arise.
In 2006, the FDA announced that it was instituting new labeling format requirements for all drugs. These new guidelines were intended to make the product label easier to use and give health care professionals prescribing information that is clearer and more concise. This is an admirable goal, but the new format does little to alleviate the problems it was supposed to fix. While the new format provides an outline for the physician and patient — an improvement over the old format — the mass of irrelevant information remains. The new format also maintains the anachronistic practice of attempting to dictate what information the physician should pass along to the patient.
The package insert should be accepted for what it is: a detailed, scientific dissertation on the drug or device. Just like the owner's manual for an automobile, it contains minutiae that exceed the needs or interests of most physicians and patients; but those who ignore this instrument do so at their own peril.
Counseling and educational resources
Physicians can also consider using available "FDA approved" consumer information sources. One such source is Patient Package Inserts (PPIs). Although the original requirement to include PPIs with drugs has been abandoned, some drugs continue to be accompanied by PPIs. When available, PPIs are usually found at the end of the official product labeling.
"Consumer medication information sheets" also accompany some drugs. These documents are also a viable source of product information for patients, yet they are different from the PPIs. Both documents are subject to FDA scrutiny, and can therefore be considered credible sources for consumer information.
A more recent positive development has been the creation of "Medication Guides" for selected drugs. Medication Guides are currently available for approximately 200 FDA-approved drugs. (For a list of drugs with medication guides, please see http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) The FDA requires that Medication Guides be issued with certain prescribed drugs when the FDA determines that:
- "certain information is necessary to prevent serious adverse effects,
- patient decision-making should be informed by information about a known serious side effect with a product, or
- patient adherence to directions for the use of a product are essential to its effectiveness." (1)
According to the FDA, medication guides "address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events." (1)
Medication Guides are short, written in plain language, and are subject to FDA approval, which offers some degree of legal protection to physicians. While not perfect, Medication Guides are a much better source of information than package inserts for conveying meaningful information .
The moving target
The ongoing challenge for physicians is the need to provide accurate information to patients in a dynamic, scientific environment. Most physicians would be shocked to learn how often drug and device labels are changed by the manufacturer. Physicians receive "Dear Doctor" letters almost daily, usually with little meaningful notice of the significance of the information enclosed. Physicians are thereby faced with the insurmountable task of staying informed about scientific developments and then passing along important safety information to patients.
One practical way physicians can help keep patients informed is by delegating this task to the patients themselves. Given the widespread access to the Internet, it is fair and reasonable for prescribers to ask patients to take responsibility for their own well being. Patients can be told to periodically consult the web site for the drug or device and to consult their physicians if they have a product safety concern. It is good practice to document these instructions in the patient's chart.
Many physicians may argue that this approach will cause patients to burden themselves (and their physicians) with unfounded health and product-safety paranoia. While this is a possibility, most patients should be able to discern when an issue warrants a call or visit to their physicians as opposed to a quick tap of the "delete" button on their computers.
We also suggest that drug and device status be reassessed periodically. This proposal does not require the physicians to revisit their informed consent during each office visit. Rather, physicians should be encouraged to ask each patient about possible side effects or product concerns and to remind each patient to consult with available resources or to call their physician with any questions.
Conclusion
Establishing a uniform system of patient counseling that provides significant safety information to the patient can be advantageous for both physicians and patients. Such a system can enhance patient safety and may reduce the likelihood of litigation related to the use of prescription drugs or medical devices.
Source
- U.S. Food and Drug Administration. Medication Guides. Available at http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm. Accessed July 28, 2009.
Jay Henderson, JD is a partner in the law firm of Cruse, Scott, Henderson and Allen in Houston. He can be reached at jhenderson@crusescott.com.
Risk alerts — Cordarone and TNF inhibitors
To demonstrate the importance of obtaining informed consent when prescribing medications, we are providing the following "risk alert" information on two classes of drugs that have made headlines recently. The new warnings for these drugs may change the risk-benefit profile for their use, depending on the medical facts and the physician's informed judgment.
Cordarone (amiodarone HCl)
The following black box warning has been added to Cordarone (amiodarone HCl), a drug currently approved for use in adults with ventricular arrhythmias for which other treatments did not work or were not tolerated. This warning is located on page 6 of the 27-page package insert.
"Cordarone is intended for use only in patients with the indicated life-threatening arrhythmias because its use is accompanied by substantial toxicity. Cordarone has several potentially fatal toxicities, the most important of which is pulmonary toxicity (hypersensitivity pneumonitis or interstitial/alveolar pneumonitis) that has resulted in clinically manifest disease at rates as high as 10 to 17% in some series of patients with ventricular arrhythmias given doses around 400 mg/day, and as abnormal diffusion capacity without symptoms in a much higher percentage of patients. Pulmonary toxicity has been fatal about 10% of the time. Liver injury is common with Cordarone, but is usually mild and evidenced only by abnormal liver enzymes. Overt liver disease can occur, however, and has been fatal in a few cases. Like other antiarrhythmics, Cordarone can exacerbate the arrhythmia, e.g., by making the arrhythmia less well tolerated or more difficult to reverse. This has occurred in 2 to 5% of patients in various series, and significant heart block or sinus bradycardia has been seen in 2 to 5%. All of these events should be manageable in the proper clinical setting in most cases. Although the frequency of such proarrhythmic events does not appear greater with Cordarone than with many other agents used in this population, the effects are prolonged when they occur.
Even in patients at high risk of arrhythmic death, in whom the toxicity of Cordarone is an acceptable risk, Cordarone poses major management problems that could be life-threatening in a population at risk of sudden death, so that every effort should be made to utilize alternative agents first.
The difficulty of using Cordarone effectively and safely itself poses a significant risk to patients. Patients with the indicated arrhythmias must be hospitalized while the loading dose of Cordarone is given, and a response generally requires at least one week, usually two or more. Because absorption and elimination are variable, maintenance-dose selection is difficult, and it is not unusual to require dosage decrease or discontinuation of treatment. In a retrospective survey of 192 patients with ventricular tachyarrhythmias, 84 required dose reduction and 18 required at least temporary discontinuation because of adverse effects, and several series have reported 15 to 20% overall frequencies of discontinuation due to adverse reactions. The time at which a previously controlled life-threatening arrhythmia will recur after discontinuation or dose adjustment is unpredictable, ranging from weeks to months. The patient is obviously at great risk during this time and may need prolonged hospitalization. Attempts to substitute other antiarrhythmic agents when Cordarone must be stopped will be made difficult by the gradually, but unpredictably, changing amiodarone body burden. A similar problem exists when Cordarone is not effective; it still poses the risk of an interaction with whatever subsequent treatment is tried." (1)
More information on Cordarone, can be found at:
TNF inhibitors (Cimzia, Enbrel, Humira, Remicade, Simponi
The FDA has recently added stronger black box warnings to a group of drugs known as tumor necrosis factor (TNF) blockers. The drugs — which suppress the immune system — are approved to treat a variety of conditions including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, and Crohn's disease. The FDA also recently concluded that there is an increased risk of lymphoma and other cancers associated with the use of these drugs in children and adolescents. The FDA is requiring updates to the current Medication Guide to help patients understand the risks associated with TNF blocker therapy. Additional warning information was added in 2008 regarding an increased risk of developing opportunistic infections while taking the drugs.
"In addition to the updated Boxed Warning, FDA is requiring several other changes to the prescribing information for TNF blockers to warn of and mitigate the risks associated with these drugs. These changes are based on additional safety reviews and include a(n):
- Update to the Warnings section describing reported cases of leukemia in adults, adolescents, and children. Changes to the Warnings section of the labeling will also include additional information on malignancies in children and adolescents.
- Update to the Adverse Events section to include information on reported cases of new-onset psoriasis.
- Revised Medication Guide to reflect this new safety information." (2)
More information on TNF drugs can be found at the following web sites:
Sources
- Cordarone (amiodarone HCl) tablets package insert. Available at
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018972s038s039lbl.pdf. Accessed August 11, 2009.
- Food and Drug Administration. Postmarket drug safety information for patients and providers. Available at http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders /DrugSafetyInformationforHeathcareProfessionals/ucm174474.htm. Accessed August 11, 2009.
