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Consumer Medication Information (CMI)
Questions and Answers
There are different types of information that are written for consumers about your prescription medicine that your pharmacist might give you at the pharmacy when you fill a prescription: Consumer Medication Information (CMI), Medication Guides, and Patient Package Inserts (PPI). All of these are meant to help you to use the medicine safely and effectively.
FDA is releasing today the results of a study on CMI.
1. What is Consumer Medication Information (CMI)?
- consumer information about your prescription medicine provided by the pharmacy
- is usually stapled to the bag or put inside the bag with your prescription medicine at the pharmacy
- should be given to you with all new prescriptions
- has information on how to use your prescription medicine
- is information generally bought by the pharmacy from outside companies that use the FDA-approved information for health care professionals (or professional labeling) to make the CMI for consumers
- is not reviewed or approved by the FDA
2. What is a Medication Guide?
- another type of information written for consumers about your prescription medicine
- is required to be handed to you by the pharmacist each time you fill your prescription when there is a Medication Guide written for your medicine
- is made for only certain prescription medicines that have a serious and significant public health concern; FDA decides when it is required and what information it should have
- is about a specific risk and how to avoid it
- is written by the drug company, then reviewed and approved by the FDA
This article about Medication Guides has more information:
http://www.fda.gov/consumer/updates/medguides060607.html. It also has information about how CMI and Medication Guides are different and the same. This site has a list of some of the medications that have a Medication Guide and has links to each Medication Guide: www.fda.gov/cder/Offices/ODS/medication_guides.htm
3. What is a Patient Package Insert (PPI)?
- another type of information written for consumers about your prescription medicine
- may be provided to you by the pharmacist as part of the drug package
- gives you information about the medicine and how to use it
- are required by FDA to be given to you for oral contraceptives (birth control pills) and prescription medicines with estrogen.. FDA doesn’t require that other medicines have PPIs. Drug companies can choose to create PPIs for other medicines. These PPIs can be used as part of the medicine’s print advertising.
- is written by the drug company, and reviewed and approved by the FDA
Chart: Types of Patient Information 
4. What did the study released today show?
The study was done to see if CMI is meeting the goals as required by the law. The goals contained in law said that 75 percent of consumers should receive useful written information with their prescriptions by the year 2000, and 95% by the year 2006.
The study showed that 94% of consumers are receiving some form of CMI. But it also showed that 75% of the CMI met the minimal criteria for usefulness. The year 2006 goal was not been met.
This study showed that some of the information in CMI has improved since the last study done in 2001. But directions for the use of the medicines was often missing or not complete, and the comprehensibility and legibility of the information was generally poor. The information is not easy-to-read, easy-to-understand, and easy for consumers to use. For more information on the study, see this FDA Consumer article about the study, Prescription Drug Leaflets Need Improvement.
5. How does FDA decide if CMI is useful for consumers?
The 1996 law, Public Law 104-180, required that a thorough plan be developed to make sure that consumers receive useful information with their prescriptions and set goals for CMI. FDA published a guidance to help those who write CMI to meet the goals for CMI and to make sure it is useful for consumers.
The guidance says that each of these should be included for CMI to be useful:
- Drug names (generic and brand), approved uses, and what to watch for to see if you are getting better
- Contraindications (situations when the medicine should not be used)
- Specific directions about how to use and store the medicine and what to do if too much medicine is used (overdose)
- Specific warnings and things to watch for about the medicine
- Symptoms of serious or frequent adverse reactions (unwanted or unexpected side effects) and what to do
- General information, such as when to talk to your doctor or pharmacist,
- Information that is scientifically accurate, unbiased in tone and content, and up-to-date
- Information is written and arranged so it is easy to read and can be understood by consumers
For more on this, see the guidance, Guidance Useful Written Consumer Medication Information (CMI) at: http://www.fda.gov/cder/guidance/7139fnl.htm
6. What will FDA do with the results of this study?
The results of the study say that the goals for CMI haven’t been met. The law says that if the goals aren’t met, FDA should ask the public for feedback on ways they think CMI can be improved so consumers will get useful information with their prescriptions.
One way FDA can do this is to ask the public to send in written comments on how the information given out at pharmacies could be more helpful for consumers. For the next step, FDA will hold a public meeting of its Risk Communication Advisory Committee to discuss the study results, receive advice on ways to improve consumer medication information, and to get public feedback.
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Consumer Medication Information
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Date created: December 16, 2008 |
