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Physician Education of Their Patients About Prescription Medicines

Note: This report, written in response to Resolution 501 (I-97),  represents the medical/scientific literature on this subject as of December 1998.

Full text

This Council on Scientific Affairs (CSA) report addresses the topic of physician education of their patients about prescription medicines. The report: 1) provides a brief overview of medication compliance, including problems associated with chronic multi-drug therapy; 2) reviews Food and Drug Administration (FDA) and AMA surveys of consumers on receipt of oral and written prescription medicine information from physicians; 3) briefly describes past AMA efforts and current AMA policies regarding patient medication information; 4) discusses the development and AMA Board of Trustees' approval of Guidelines for Physicians for Counseling Patients About Prescription Medications in the Ambulatory Setting; 5) evaluates the role of patient medication cards in routine medication reviews; and 6) offers recommendations for practicing physicians and the AMA.

Methodology

Literature reviews. Articles on medication compliance were obtained as follows. Two on-line literature searches were done to survey the research on this topic. A general overview of the literature was secured by a search of the MEDLINE database (1993-1998) for all English-language articles on patient compliance and drug therapy. This search retrieved 84 citations. The second more specific search of the MEDLINE and HealthSTAR databases (1990-1998) was on the topic of the effect of physician-patient oral and written communication on patient compliance with drug therapy. The search strategy used the key words: (physician patient relations or communication or patient participation or decision-making) and patient compliance and (prescriptions, drug or drug therapy). Retrieval was limited to English-language articles. Over 100 references were retrieved. In addition, articles on medication compliance published prior to 1995 were obtained primarily from a Topical Bibliography on Prescription Medicine Compliance, a list of over 500 references compiled and published by the National Council on Patient Information and Education (NCPIE),1 and from the bibliography (95 references) in the FDA's 1995 Proposed Rule entitled, "Prescription Drug Product Labeling; Medication Guide Requirements."2 The reference lists from articles that were obtained also were perused to identify additional articles of interest. Ultimately, 185 articles were selected and reviewed by the CSA based on their perceived relevance to the topic of interest.

Articles on patient medication cards were obtained from a search of the MEDLINE database (1988-1998) using the phrase, medication card. This search retrieved 71 citations. However, only two English-language articles were related directly to the use of medication cards given to patients as a method of providing them with written information or to facilitate medication review.

Development of Guidelines for Physicians for Counseling Patients About Prescription Medications in the Ambulatory Setting. In 1996, the AMA convened a working group to address the issue of physician communication with and education of patients about their prescription medications. In addition to the AMA, physicians representing various medical specialty societies, including the American Academy of Family Physicians, the American Society of Internal Medicine, the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, and the American Psychiatric Association, were included. Representatives from NCPIE, the United States Pharmacopeia (USP), and selected national pharmacy associations also participated. 

Over a period of four months, this Working Group developed basic guidelines to help physicians provide useful oral counseling and, when appropriate, written information about prescription medications that are prescribed for their patients in the ambulatory setting. Recommendations on the medication record, the treatment plan, oral counseling, written information, and follow-up were included in the guidelines. In September 1996, the AMA Board of Trustees approved the Guidelines for Physicians for Counseling Patients About Prescription Medications in the Ambulatory Setting. These guidelines were released at the AMA's National Leadership Conference in March 1998.

AMA Policies. All AMA policies were obtained from the 1998 edition of the AMA Policy Compendium.


Overview of medical compliance

Definition. Medication compliance traditionally has been defined as the extent to which a person's use of medications coincides with medical or health advice.3 However, some now prefer the term "adherence," which suggests a more active patient collaboration with the physician on medication decisions.4 While the term compliance will be used throughout this report, it is intended to encompass the concepts of patient-centered treatment with two-way communication.

Extent and nature of medication noncompliance. Approximately 2.5 billion prescriptions were dispensed from retail pharmacies in 1996,5 and it is estimated that two of every three physician office visits result in a prescription for medication.6 Unfortunately, many studies have shown that patient compliance with physician recommendations is well below 100 percent for all patient populations (e.g., adults, elderly, children, adolescents).3,4,6-9 Large differences in rates of noncompliance have been reported in individual studies, but it is difficult to compare studies because of differences in methodology. For example, various indirect methods (patient interview, physician estimate, pill count, refill record, electronic monitoring) and direct methods (monitoring of drug levels in blood, urine assays for drug or marker compound) have been used to measure compliance.3,4,7 However, most reviews estimate noncompliance to range from 30 percent to 50 percent.3,4,6,7

Noncompliance has been reported as a problem for a wide range of diseases, both acute and chronic, including diseases that are life-threatening.3,4 Specific diseases or conditions for which noncompliance has been a significant problem include:

  • hypertension;10,11   
  • epilepsy;12   
  • diabetes mellitus;13   
  • asthma;14   
  • psychiatric disorders;15,16   
  • peptic ulcers;17   
  • rheumatoid arthritis;18   
  • hyperlipidemia;19   
  • estrogen replacement for postmenopausal women;20   
  • congestive heart failure;21   
  • penicillin prophylaxis for sickle cell disease;22   
  • human immunodeficiency virus (HIV) infection;23   
  • tuberculosis;24,25   
  • cancer;26 and  
  • immunosuppressive treatment for renal transplant patients.27

A variety of patient behaviors, including both unintended errors and intentional decisions, can lead to noncompliance. These include: failure to have a new prescription filled; failure to have a prescription refilled; taking too low or too high a dose of medication; taking the medication less often or more frequently than recommended; stopping the medication too soon; or knowingly taking the medication with other drugs or foods that can result in an adverse event.4,28 However, it should be noted that not all noncompliance is necessarily bad, and patients may adjust their dose or schedule resulting in a beneficial result; this has been termed "intelligent noncompliance."29

More than 200 variables have been examined as potential factors underlying medication noncompliance.3 Unfortunately, there is little consistent information on factors that can clearly be correlated with noncompliant behavior.3,4,6 The following information has been derived from five review articles that address the subject.3,4,6,28,30 There is general agreement that patient demographic factors, such as age, sex, marital status, income, and education, are inconsistently correlated with compliance. Unresolved patient concerns that may be associated with noncompliance include: perception that the illness is not severe or the patient's susceptibility is low; disagreement with the diagnosis; belief that the medication will not be helpful; presence of an asymptomatic disease that requires long-term therapy; persistence of symptoms that are not relieved by the medication; and fear of adverse effects from the medication. Factors related to the physician/patient relationship that may be associated with noncompliance include: poor communication of information and instructions by the physician leading to misunderstanding by the patient; and general patient dissatisfaction with his or her physician. Factors related to the medication regimen that may be associated with noncompliance include: multiple medications; complex dosage regimen; increased duration of treatment; the regimen interferes with daily lifestyle; and increased cost of the medication. Factors that may affect compliance in certain individuals include: increased forgetfulness in the elderly; cultural conflicts; and language barriers or illiteracy.

Health and economic consequences of medication noncompliance. Various types of adverse health consequences due to medication noncompliance have been reported.4 A number of studies have shown that noncompliance can result in increased hospitalization.31-35 Depending on the study, from 2.9 percent to 11.4 percent of admissions to hospitals resulted from failure to comply with prescribed drug therapy.35

Studies also have shown that patients with various diseases have died, failed to recover, or had their conditions worsen due to noncompliance.4,10,23,24,36-39 For example, an increased risk of death after myocardial infarction has been observed in patients with poor compliance with beta blocker therapy.36,37 Increased risk of death also has been reported in hypertensive patients who abruptly stopped beta blocker therapy38 and in asthmatic patients who failed to take theophylline.39 Failure to comply with antiepileptic therapy has resulted in increased seizures,10  and poor compliance with asthma therapy has caused worsening of the condition.40 Noncompliance with infectious disease therapy can result in treatment failure, increased antimicrobial resistance, and transmission of the infection.23-25,41 Patients requiring special attention are those with HIV infection23 and tuberculosis.24,25

Medication noncompliance in patients with chronic diseases can result in uncontrolled disease and progression of disease.4 For example, this has been observed in hypertension.10 Another health consequence of poor medication compliance is that the prescribing physician may incorrectly evaluate the effectiveness of the treatment regimen. This could lead to an inappropriate increase in dosage or a switch to a less effective treatment regimen.4,42

Noncompliance also is associated with increased costs, both direct and indirect. Increased direct costs can range from the added expense of an unused prescription to additional physician office visits to increased hospitalizations.4 For example, Col et al  31 determined that 11.4 percent of hospital admissions were due to medication noncompliance with an average cost of admission of $2,150. 

Indirect costs can result from lost productivity, absenteeism, and lost earnings.4

Improving medication compliance and outcomes. A number of studies and reviews have addressed the issue of improving medication compliance, and various interventions and models have been proposed.3,4,6,8,9,29,42,43 Unfortunately, there are very few well-controlled trials that assess interventions to improve compliance and outcomes. In 1996, Haynes et al  44 screened more than 1,500 published articles and found only 13 randomized controlled trials that assessed compliance interventions. Seven of 15 interventions were associated with improvements in compliance, six interventions were associated with improved outcomes, and only four interventions were associated with both improved compliance and outcomes. Because of differences across studies (e.g., diseases, types of interventions, methods of measuring compliance), it was not possible to compare the studies. Haynes et al  44 did note that for one short-term treatment, counseling and written information improved both compliance and outcome. On the other hand, interventions for long-term care were complex, involving combinations of interventions. Despite the intensity of these interventions, compliance was not always improved.

Despite the lack of good outcome studies, most experts concur on a series of educational and behavioral strategies that physicians can use to improve patient compliance with therapy. The following information has been derived from seven review articles that address this subject.3,4,6,8,28,29,43 Effective communication with the patient or caregiver is essential; communication should be bi-directional to involve and reinforce the responsibility of the patient. Physicians should present as sincere and caring professionals who provide encouragement to their patients. When possible, treatment regimens should be simplified and fit into the daily routine of the patient. One-on-one oral counseling of the patient with the provision of specific instructions about the treatment regimen is recommended. This should be supplemented by written medication information and instructions. Additional supplementation with reminder aids (e.g., reminder chart) and special medication containers also is recommended, especially for long-term therapy. Patients should be assessed for their ability to understand and carry out the instructions. On follow-up, patients should be asked about their outcome, problems, and compliance. Compliance needs to be reinforced, and patients involvement in self-monitoring their therapy and providing feedback should be encouraged.

Survey data on ora counseling and provision of written information about prescription medications to patients by physicians

Providing education, including oral counseling and written information, about prescription medicines is probably the most basic element of compliance promotion. Patients cannot take their medications appropriately if they do not know how.4 Moreover, consumers and patients want to be better informed about their prescription medications.2,45,46

Do physicians tell patients enough about their prescription medicines? The FDA conducted four cross-sectional national telephone surveys of consumers in 1982, 1984, 1992, and 1994 to address this question.47,48 Telephone households were chosen by random-digit dialing, and approximately 1,000 interviews were completed in each of the four surveys. To be included in the survey, the consumers had to have obtained a new prescription for themselves or for a family member at a retail pharmacy during the previous four weeks. To measure the nature and amount of oral information provided by physicians about that prescription, respondents were asked to signify whether they were told about five specific prescription drug counseling topics. The topics were how much of the medicine to take or use; how often to take or use the medicine; whether or not the medicine could be refilled; any precautions to take while using the medication; and any possible side effects. Respondents who had obtained the prescription at the physician's office also were questioned about whether they received any written information. Results are shown in Table 1.  

The FDA surveys suggest that physicians fail to counsel their patients about new prescriptions 35 percent of the time. Counseling about refills, precautions, and side effects is provided to only about one third of patients. According to the FDA surveys, most physicians did not provide written information to their patients with new prescriptions.

In 1984, the Wisconsin Division of Health included questions about patients' receipt of oral consultation from physicians about prescription drugs in the Wisconsin Health Status telephone survey of 2,135 randomly selected consumers. Consistent with the results observed by the FDA, 66 percent of respondents remembered receiving oral consultation about new (or new and refill) prescriptions from their prescribing physician. The least information was provided about precautions and side effects.49

In 1997, the AMA surveyed 1,500 randomly selected consumers who had seen a physician within the last two years. Receipt of prescription medicine information was just one of many issues covered in this annual survey of "Public Opinions on Health Care Issues."50 At least two thirds of respondents stated that their physician or another health professional in the office discussed aspects of new prescriptions with them. Eighty-four percent of respondents said they were told how to take the medicine; 76 percent were told about precautions; 68 percent were told about side effects; and 66 percent were told about refills. Twenty-seven percent claimed to have received written information directly from the physician and another 18 percent said that someone else in the physician's office provided written information.50 Differences between the AMA and FDA surveys, such as the overall purpose of the survey, the consumer population surveyed, the specific questions asked, and the length of respondents' recall time, may explain why the AMA data are more encouraging.

Regardless of the survey, some patients who are prescribed new medications are receiving no information from their physician about the medication. Moreover, it appears that when information is provided, it often is incomplete (e.g., information about precautions and side effects is not included). This raises the question of how patients who are inadequately informed about their prescription medicines will possess the knowledge to take them appropriately.


AMA activities and policies

AMA activities. The AMA has long held the view that patients should be provided with sufficient and balanced information about their prescription medications to encourage compliance and improve health outcomes. The AMA has been involved in various activities to help physicians achieve this goal.

In 1982, the AMA initiated its "Patient Medication Instruction (PMI)" program to encourage physicians to distribute written patient medication information to their patients. Done in collaboration with the United States Pharmacopeia (USP), PMIs were paper leaflets containing information about specific drugs or drug classes. PMIs for over 100 drugs and drug classes were produced; they were sold, at cost, as pads with 50 leaflets per pad. Because of diminished sales, the PMI program was terminated in 1994. In 1997, the AMA held discussions with two other organizations regarding a CD ROM-based patient medication instruction program whereby semi-customized leaflets could be printed at the point of prescribing. However, to date, the AMA has not entered into an agreement on such an initiative.

In 1982, the National Council on Patient Information and Education (NCPIE) was founded and the AMA has served on its Board of Directors since then. NCPIE is a voluntary coalition of physician, pharmacy, nursing, consumer, pharmaceutical industry, managed care, and other organizations (including the FDA) that is committed to better medication use through improved communication between health care practitioners and patients. Currently, NCPIE has approximately 250 member organizations and offers a wide variety of programs and products to improve medication. communications and compliance. For example, NCPIE holds a "Talk About Prescriptions Month" each October, sponsors a national conference on prescription medicine information and education every other year, runs various media campaigns to promote better medication use, and publishes topical reports and numerous patient education brochures. In 1998, NCPIE collaborated with the AMA to offer a session at the AMA's National Leadership Conference entitled, "Physician Counseling of Patients on Prescription Medicines."

In 1991, the AMA convened an expert panel on polypharmacy issues and a number of intervention strategies were discussed. It was agreed that successful interventions would require the participation and buy-in of the entire health care team, the patient, and the caregivers. The nature of the intervention also would need to focus on improving communication between the patient (and/or caregivers) and the physician within the setting of the physician office.

At its 1992 National Leadership Conference, the AMA presented a program on polypharmacy to help promote the concept of routine medication review. Medical society leaders from New York and Michigan shared their experiences with programs designed to help prevent the misuse of medication by older patients. These programs support the Healthy People 2000 objective to increase to at least 75 percent the proportion of primary care providers who routinely review with their patients aged 65 and older all prescribed and over-the-counter medicines taken by their patients each time a new medication is prescribed.45

In 1995, the AMA established a Medication Error Reduction Initiative, bringing together a coalition of stakeholders and experts in drug therapy. Through a consensus process, the coalition identified priority areas in the practice of medicine to improve medication management. Three of four priority areas were medication review, patient education, and medication monitoring; each is related to improving medication compliance. As part of this initiative, the AMA also conducted research related to these areas to assess physician needs and current medication management practices. 

In 1996, the AMA established the "National Patient Safety Foundation (NPSF)." The NPSF is a broad-based initiative dedicated to supporting research, communications, education, and implementation efforts that promote the goal of ensuring that all patients, in all settings, receive health care services safely. Included in this mission is the concern that patients receive and use medications safely.

Current AMA Policies. A number of AMA policies are relevant to physician education of their patients about prescription medicines. Policy H-165.896 (7) (AMA Policy Compendium, 1998) encourages physicians to counsel their patients about their medicines and reaffirms support of the AMA Patient Medication Instruction (PMI) program (AMA Policy H-115.991); and supports the physician's role as the "learned intermediary" about prescription drugs. As discussed above, the PMI program has been discontinued.

Policy H-115.995 addresses "Patient Instructional Leaflets (PIL)" generally. This policy states: (1) That the AMA advocates the following basic principles in any program for supplying drug information to patients: (a) Not all prescription drugs require PILs. Only special classes of agents need expanded patient information. (b) The PIL is not and should not be considered the basic vehicle for drug information to the patient; this is a function which must be retained by the prescribing physician. Instead, the PIL should be considered an educational adjunct to reinforce the physician's discussion and instruction to the patient. (c) PILs should not be mandatory for all patients. (d) The physician must have the prerogative to determine whether the PIL is in the patient s best interest. (e) PILs should present a fair balance of benefits and risks without undue emphasis on adverse effects that could be alarming to the patient. (f) The PIL should enumerate only selected, significant, documented side effects and adverse reactions. It should not contain a long list of possible, suspected, rare or undocumented side effects as is done in the package insert for physicians. (g) PILs should be dispensed by the physician or by the pharmacist as directed by the physician. (h) PILs should not be developed unilaterally by the federal government but should represent a cooperative effort by major organizations of medicine and pharmacy. (2) The impact of PILs on the quality of medical care should be evaluated in carefully controlled studies.

Policy H-115.997 states that the AMA continues to oppose mandatory patient package inserts for all drugs approved for marketing by the FDA. In this regard, the AMA has opposed FDA-proposed regulations in 1979 and 1995 for mandatory patient package inserts (PPIs) and for Medication Guides, respectively. Furthermore, in 1996, the AMA opposed The Keystone Center's "Action Plan for the Provision of Useful Prescription Medicine Information,"51 which resulted from Section 601 of P.L. 104-180.

Included in Policy H-120.967, "Dispensing of Computer Generated Drug Information," is the statement that "the AMA continues to cooperate with NCPIE, USP, the FDA and others to establish standards for patient information."

Included in Policy H-140.975 (also an AMA Ethical Opinion), "Fundamental Elements of the Patient-Physician Relationship," is the statement that "the patient has the right to receive information from physicians and to discuss the benefits, risks, and costs of appropriate treatment alternatives."

Finally, with specific reference to the first resolve in referred Resolution 501 regarding the provision of concise written instructions specifying dosages and dosage frequency, the following statements from AMA policies H-120.968 and H-115.974 are relevant. Included in Policy H-120.968, "Medication (Drug) Errors in Hospitals," is the statement that "medication orders should be complete and should include patient name; drug name (generic drug name or trademarked name if a product is required); route and site of administration; dosage form (if applicable); dose; strength; quantity; frequency of administration; and prescriber's name." This policy also contains the statement that "physicians should not use vague instructions, such as 'take as directed' ." Included in Policy H-115.974, "Prescription Labeling," is the statement that "the pharmacist include the following information on the label affixed to the container in which a prescription drug is dispensed: a) the brand or generic name of the drug dispensed; b) the strength, if more than one strength of drug is marketed; c) the quantity dispensed." If physicians and pharmacists follow these current AMA recommendations, then the dose and frequency of administration will be on the label affixed to the container in which the prescription drug is dispensed.


Guidelines for Physicians for Counseling Patients About Prescription Medications in the Ambulatory Setting

The Guidelines for Physicians for Counseling Patients About Prescription Medications in the Ambulatory Setting  (counseling guidelines) are included in Table 2.    As discussed under the Methodology, these counseling guidelines were developed by a working group convened by the AMA and subsequently approved by the AMA s Board of Trustees in September 1996.

Physicians who prescribe medicines have the primary responsibility to adequately educate and counsel their patients about them. Thus, the counseling guidelines were prepared to help physicians provide useful oral counseling and, when appropriate, written information about prescription medications that are prescribed for their patients in the ambulatory setting. The counseling guidelines were deliberately kept concise and provide the basic elements to help physicians counsel their patients. As discussed in the preamble, the counseling guidelines are intended to offer suggestions to physicians on the content of information that will likely be most useful to patients who are using prescription medications. The counseling guidelines clearly are not substitutes for best professional judgment, and they should not be construed as standards of medical practice. Physicians are encouraged to customize medication counseling and information to best meet the needs of the individual patient.

The counseling guidelines provide recommendations in five key areas: the medication record, the treatment plan, oral counseling about the medication, written information about the medication, and follow-up (see Table 2). 

The  medication record allows the physician to readily review what medications (prescription and nonprescription) the patient is on and to ask questions and make changes in drug therapies as appropriate.

Developing a  treatment plan in collaboration with the patient provides the opportunity for bi-directional communication to actively involve patients in their therapeutic decisions and to reinforce patient responsibility.

Oral counseling about specific aspects of the prescription medication should provide the patient with the necessary knowledge to take the medication appropriately and to ask relevant questions. Provision of information about side effects has been of concern to some physicians because of the perception that this information will both increase the incidence of reported side effects by patients and lower compliance. However, patients have indicated that they want to receive information about side effects,2,45,46  and available data suggest that provision of information about side effects does not increase the reporting of side effects or lower compliance.52-54

The provision of  written information as a supplement to oral counseling improves patients' knowledge about their prescription medicines.2,55 The counseling guidelines list elements of written information that are consistent with those from the AMA's former PMI program and from the USP s "USP-DI Patient Education Leaflets" program. However, an estimated 40 to 44 million Americans are functionally illiterate, and another 50 million have only marginal literacy skills, suggesting that many patients may not benefit from written information.56

It should be noted that most retail pharmacies currently provide written medication information with dispensed prescriptions, but there is considerable variation in the content and format of the written information. However, as a consequence of The Keystone Center's "Action Plan for the Provision of Useful Prescription Medicine Information"51 (and the acceptance of this plan by the Secretary, Department of Health and Human Services), pharmacies will be required to meet certain "usefulness criteria" described in the Keystone Action Plan by the year 2000. By law (Section 601 of P.L. 104-180), if this requirement is not met, then the FDA will be allowed to regulate written information dispensed with prescription medicines.

Physicians are encouraged to inquire about compliance, as well as beneficial or adverse effects of drug therapy during  follow-up office visits. This is of particular importance with long-term therapy where compliance needs to be reinforced and patients' involvement in self-monitoring their therapy and providing feedback should be encouraged.

Potential role of medication cards

Based on a physician survey conducted under the AMA's Medication Error Reduction Initiative, most physicians routinely review prescription medications with their patients (AMA, unpublished data). To facilitate medication reviews and to enhance compliance, some physicians have given medication cards to their patients to list all medications being taken. Medication cards also have been provided by outside organizations, such as NCPIE and the Office of Women's Health at the FDA, to help consumers keep track of the medications they are taking, to encourage sharing of medication information with multiple prescribers, and to improve compliance. Personal medication cards typically list the names of the medications that the patient is taking, and may include information on how much and how often to take each medication and the medication's purpose.

However, published data on the value of medication cards are very limited. One report from Scotland suggests that providing a medication card upon discharge from the hospital helps older patients recall information related to the name, purpose, and special instructions (e.g., drug-drug interactions) about their medications.57  Another prospective study from Australia, however, suggests that patient compliance with use of the card can be problematic.58  In this latter study, the proportion of elderly patients who presented the medication card to their physician dropped from 61 percent at four months to 23 percent at 12 months. Furthermore, less than 20 percent of the cards contained accurately recorded information. Because the card had been issued by a "third party," i.e., the investigators, it is unclear if medication cards issued by physicians directly to their patients would be used more effectively.

Based on limited published information, medication cards should not be viewed as a substitute for oral counseling or other written information provided by the physician, but as an adjunctive resource that is available to support compliance improvement.

Recommendations

The following statements, recommended by the Council on Scientific Affairs, were adopted by the AMA House of Delegates as AMA policy at the 1998 AMA Interim Meeting:

  1. AMA Policy H-165.896 (7) is modified to read as follows: "The AMA encourages physicians to counsel their patients about their prescription medicines and, when appropriate, to supplement with written information; and supports the physician's role as the 'learned intermediary' about prescription drugs." AMA Policy H-115.991, regarding the discontinued Patient Medication Instruction (PMI) program, is rescinded.  
  2. The AMA supports and will widely disseminate the Guidelines for Physicians for Counseling Patients About Prescription Medications in the Ambulatory Setting.  
  3. The AMA encourages physicians to incorporate medication reviews, including discussions about drug interactions and side effects, as part of routine office-based practice, which may include the use of medication cards to facilitate this process. Medication cards should be regarded as a supplement, and not a replacement, for other information provided by the physician to the patient via oral counseling and, as appropriate, other written information.  
  4. The AMA will continue to participate on the National Council on Patient Information and Education (NCPIE) to foster better medication use through improved communication between physicians and their patients, and the AMA encourages state and specialty medical societies to become members of NCPIE.

Reports by topic

References

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  36. Horwitz RI, Viscoli CM, Berkman L, et al. Treatment adherence and risk of death after a myocardial infarction. Lancet. 1990;336:542-545.  
  37. Gallagher EJ, Viscoli CM, Horwitz RI. The relationship of treatment adherence to the risk of death after myocardial infarction in women. JAMA. 1993;270:742-744.  
  38. Psaty BM, Koepsell TD, Wagner EH, et al. The relative risk of incident coronary heart disease associated with recently stopping the use of beta-blockers. JAMA. 1990;263:1653-1657.  
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Table 1. Percentage of oral information supplied at the physicians' offices

Survey year

Type of information

1982

1984

1992

1994

How much to take

56

55

55

59

How often to take

58

56

56

61

Refills

29

26

32

35

Precautions

26

32

33

35

Side effects

23

23

29

33

Any (oral) information

53

61

61

65

"Written" information received

5

9

14

15

Adapted from reference 46. In 1996, the FDA conducted a fifth telephone survey of consumers;
the results of this survey were essentially unchanged from those obtained in 1994
(FDA, unpublished data).
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Table 2. Guidelines for physicians for counseling patients about prescription medications in the ambulatory setting

Preamble

Prescription medications are among the most useful and cost-effective treatment options available in the health care system. Care often may be improved when physicians provide useful counseling and information about prescription medications to their patients.

The following guidelines were prepared to help physicians provide useful oral counseling and, when appropriate, written information about prescription medications that are prescribed for their patients in the ambulatory setting. These guidelines are intended to provide suggestions to physicians on the content of information that will likely be most useful to patients who are using prescription medications. 

These guidelines are not substitutes for the best professional judgment of physicians in providing high quality care to their patients, and they should not be construed as standards of medical practice. Physicians are encouraged to customize prescription medication counseling and information to best meet the needs of individual patients.

Guidelines for physicians for counseling patients1 about prescription medications in the ambulatory setting2

  1. Medication record. As part of the medical record, the physician should attempt to maintain and update, as necessary, a record (chart) of all medications (prescription and nonprescription) that the patient is taking currently.  
  2. Treatment plan. Decisions regarding the use of prescription medications are best accomplished out of a collaboration between the physician and the patient. This requires that the patient be aware of relevant information regarding the prescribed medication, as well as available alternatives. Therefore, the physician should discuss with the patient expectations of treatment and appropriate information regarding risks, benefits and appropriate alternatives of all medications that may be prescribed, prior to deciding on a treatment plan.  
  3. Oral counseling. Physicians should counsel patients on their medications, emphasizing what is medically significant. Such information may include: 
  • The name of the medication and what it is supposed to do. 
  • How and when to take the medication and for how long. 
  • Appropriate foods, drinks, other prescription or nonprescription medications, or activities that the patient should avoid while taking this medication. 
  • The relevant side effects that should be reported to the physician if they occur. 
  • If applicable, whether anything is unusual about the use of the medication being prescribed (eg, for an off-label indication; prescribing larger than the usual dose). 
  • Whether the prescription can be refilled and how often. 
  • What written information the patient can take with them (if available) or instructions to obtain written information from their pharmacist. 

After counseling the patient, the physician should encourage the patient to ask questions and should ask the patient whether he or she has any concerns about obtaining the medication or about using it in the way it was prescribed.

  1. Written information. It may be helpful for physicians to provide patients with written information about their medications. This information should include the elements outlined below.  
  2. Followup. During subsequent office visits, the physician should question the patient about compliance and any beneficial or adverse effects of the medication. 

Elements of written information 

  • Name of the medication 
  • Use of the medication 
  • Patient instructions before using the medication 
  • Instructions for proper use of the medication 
  • Precautions while using the medication 
  • Side effects of the medication that are serious or occur frequently 

It is important that written information be scientifically accurate and nonpromotional for a particular product. It should provide sufficient information so the patient can use the medication properly, be legible, and written in understandable language.

1The term patient, ie, the person for whom the medication was prescribed and dispensed, is used throughout these guidelines. However, for some patients, other individuals (eg, parents, guardians, caregivers) may also receive the counseling and information.

2These guidelines are not substitutes for the best professional judgment of physicians in providing high quality care to their patients, and they should not be construed as standards of medical practice.
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Resolution 501 (I-97)

Resolution 501, introduced at the 1997 Interim Meeting by the Medical Student Section and referred to the Board of Trustees by the House of Delegates, asks:

That the American Medical Association (AMA) encourage health professionals to provide patients on chronic, multi-drug therapy with concise written instructions regarding their medications, specifying dosages, dosage frequency, and possible interactions; and 

That the AMA support the dissemination of medication cards to patients on chronic multi-drug therapy, and these cards should list the medications that the patient is taking, as well as dosages and dosing frequency of each medication.

This resolution was introduced because of concerns about prescription medication noncompliance and inadequate communication between physicians and patients, especially the elderly who are often on chronic, multi-drug therapy. 

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Last updated: Sep 24, 2007
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