Dr. Howland is Associate Professor of Psychiatry, University of Pittsburgh School of Medicine, Western Psychiatric Institute and Clinic, Pittsburgh, Pennsylvania.
The author discloses that he has no significant financial interests in any product or class of products discussed directly or indirectly in this activity, including research support.
Address correspondence to Robert H. Howland, MD, Associate Professor of Psychiatry, University of Pittsburgh School of Medicine, Western Psychiatric Institute and Clinic, 3811 O’Hara Street, Pittsburgh, PA 15213; e-mail: HowlandRH@upmc.edu.
Patients can obtain a tremendous amount of information about their medications from many sources, including other people (family, friends, and other patients), various media (publications, television, radio, and the Internet), and their health care providers (physicians, nurses, pharmacists, and other professionals). The U.S. Food and Drug Administration (FDA) (2008) has defined three different kinds of written information for patients about prescription medication: Patient Package Inserts (PPIs), Medication Guides (MGs), and Consumer Medication Information (CMI). In this article, I briefly describe these information sources and then discuss in more detail what I believe patients should know about their medications.
Patient Package Insert Information
A PPI gives specific written information about the safe and effective use of a medication. The FDA requires that PPIs be prepared for oral contraceptive medications and for prescription medications that contain estrogen, and pharmacies are required to give this information to patients as part of the drug package. The FDA does not require that PPIs be prepared for other medications; however, manufacturers may do so, and these are often used as part of print advertising for a medication. Drug manufacturers write PPIs, which must be reviewed and approved by the FDA and are part of the drug’s labeling. When given to patients, PPI information is usually identified in the heading as “Patient Information,” “Information for the Patient,” or “Patient Package Insert.” This information is also written verbatim in the product labeling, where clinicians can review it (e.g., in the Physicians’ Desk Reference [PDR]).
An MG addresses issues specific to particular drugs and drug classes. The FDA requires that MGs be written for particular drugs if it is determined that certain information is necessary to prevent serious adverse effects (SAEs), that patient decision making should be informed by details about a known serious side effect with a drug, or that patient adherence to directions for the use of a product are essential to its effectiveness. When an MG exists for a medication, the pharmacy is required to give it to the patient when the drug is dispensed. An example of an MG is the specific written information about antidepressant drugs and suicide risks, which must be given by pharmacies when these drugs are first dispensed. Manufacturers write MGs, but they are developed only when mandated by the FDA. They must be reviewed and approved by the FDA and become part of the drug’s labeling. When given to patients, this information is identified in the heading as “Medication Guide.” Similar to PPIs, MG information is written verbatim in the product labeling and can be reviewed by clinicians in the PDR.
Consumer Medication Information
Compared with PPIs or MGs, CMI provides broader written information about a medication and how to use it. Also, CMI is required for all prescription medications, and a CMI sheet should be given to patients when the drug is dispensed for the first time. The CMI is neither written by the manufacturer or reviewed or approved by the FDA, but it must be drafted according to certain FDA guidelines. Pharmacies or outside companies usually develop CMI using information derived from FDA-approved information for health care professionals or from product labeling. According to the FDA guidelines, CMI should consist of the following elements:
- Drug names (generic and brand), approved uses, and what to watch for to see if patients are getting better.
- Contraindications (situations when the medication should not be used).
- Specific directions about how to use and store the medication and what to do if too much medication is taken (overdose).
- Specific warnings about the medication and things to watch for.
- Symptoms of serious or frequent adverse reactions (unwanted or unexpected side effects) and what to do if they occur.
- General information (e.g., when to talk to the physician or pharmacist).
- Information that is scientifically accurate, unbiased in tone and content, and up to date.
- Information written and arranged so it is easy to read and can be understood by consumers.
When given to patients, CMI is often identified in the heading as “Patient Education” or “About Your Prescription.” Unlike PPIs or MGs, CMI usually varies from pharmacy to pharmacy and is not written verbatim in the product labeling.
Recently, the FDA published the results of a study (Kimberlin & Winterstein, 2008) that was designed as a follow up to a previous study (Svarstad & Mount, 2001) evaluating the quality of CMI dispensed in community pharmacies. The primary research questions were:
- What percentage of individuals getting prescriptions filled in community pharmacy settings was given any written CMI beyond label directions?
- What percentage of these individuals was provided with CMI that adhered to quality criteria as judged by experts and consumers?
- How did expert and consumer evaluations of the quality of CMI differ in the 2001 and 2008 studies?
The study found that the percentage of content criteria met by CMI leaflets in 2008 increased compared with that from 2001, but that information was lacking about the use of medications and how effectiveness and safety should be monitored. In addition, although the CMI examined came from only a few publishers, there was considerable variability in the amount of information included and the formatting of information presented, which is crucial for making information comprehensible and readable. Comparison of 2001 and 2008 data on adherence to formatting criteria demonstrated no improvement in meeting these quality criteria. Because the FDA guidelines emphasize the importance of legibility and comprehensibility to the usefulness of CMI provided to patients, the findings from this study indicate the need for more uniform, user-friendly, concise, and clinically relevant written medication information.
What Medication Information Should Clinicians Share?
Patients should be told what the medication is being used for and what to expect. What are the drug’s generic and brand names? Is the medication being used for an FDA-labeled indication? If it is being used off label, is the use based on clinical studies or well-established clinical experience, or being used for other justifiable clinical reasons? If alternative treatments are available, why is this particular medication being used rather than another drug or another therapy? How long will it take to work? What is the likelihood of a partial response or a full remission? What might be done if the medication does not work or causes intolerable side effects? If it helps, how long should it be taken?
Patients should be told how the medication should be stored, secured, and used. Should the medication be stored in a certain way? Are there children or other people at home who might have access to the medication? What is the starting dosage and usual dosage range of the medication? Are higher-than-recommended dosages ever used? If so, what is the rationale? Are blood levels ever needed for the medication? When should the medication be taken and why? What if the pill or capsule cannot be easily swallowed? Are liquid, chewable, or dissolvable forms available? What should be done if a dosage is missed? If the medication is to be taken as needed (p.r.n.), how should this actually be done? Under what circumstances should the medication be taken p.r.n.? How often does p.r.n. mean? What is the maximum amount that should be used p.r.n. within a 24-hour period?
Patients should be told about possible AEs of medications, how long they might last, and how they might be treated. Which AEs should be specifically discussed with patients? As a general rule, four kinds of AEs should be considered for discussion:
- Those most common and most likely to occur.
- Those that might be considered especially noxious, but not necessarily common or serious (e.g., sexual dysfunction, weight gain).
- Potential SAEs (e.g., dependence, seizures, allergic reactions).
- Those related to abrupt medication discontinuation.
Patients should be given some guidance about what to do if they develop AEs. When should patients call their health care provider? Should they ever stop the medication immediately because of an AE? Is blood work needed routinely or periodically to monitor for AEs?
Patients should be given information about potential interactions with food, other prescription and nonprescription medications, other drug products (vitamins, supplements, and herbal products), alcohol, nicotine, and illicit drugs. Will food affect the absorption of the medication? Can pills or capsules be crushed and mixed with foods or liquids? Should the medication be taken separately from other medications? Will other medications affect the absorption, metabolism, or clearance of the medication? Will other medications blunt the effectiveness or enhance the AEs of the medication? Are any medication combinations especially problematic, potentially dangerous, or contraindicated? Patients should be encouraged to be open about their use of alcohol, marijuana, and other illicit drugs, and they should be instructed to call before taking any new prescription or nonprescription medication, including any kind of vitamin, supplement, or herbal product.
Different sources can provide a wealth of information about medications, but the information may be too much or too little; too complex or incomprehensible; or biased, inaccurate, or contradictory. The problems with written CMI are demonstrated by the results of the FDA-commissioned study described above. Because CMI varies from pharmacy to pharmacy, patients should be asked to show their health care provider the information they have been given. As primary caregivers, physicians and nurses have the responsibility to talk to patients about their medication and to provide information that enhances, clarifies, rectifies, and complements whatever written information patients have. The information should be practical, understandable, unbiased, and scientifically accurate, but also tailored to the individual needs of the patient. For patients who are cognitively impaired (e.g., due to severe depression, psychosis, or dementia), suitable medication information should be given to their family or other caregivers. Patients, families, and caregivers should always be encouraged to ask questions about the information they have been given by their health care provider, from the pharmacy, or from other sources.
- Kimberlin, CL & Winterstein, AG2008. Expert and consumer evaluation of consumer medication information—2008. Retrieved January 8, 2009, from the U.S. Food and Drug Administration Web site: http://www.fda.gov/cder/news/CMI/final_report.pdf
- Svarstad, BL & Mount, JK2001. Evaluation of written prescription information provided in community pharmacies—2001. Retrieved January 8, 2009, from the U.S. Food and Drug Administration Web site: http://www.fda.gov/cder/reports/prescriptioninfo/default.htm.
- U.S. Food and Drug Administration. 2008. Consumer medication information (CMI): Questions and answers. Retrieved January 8, 2009, from http://www.fda.gov/cder/news/CMI/QA.htm