From: Hobson,Gerry [ghobson@multum.com] Sent: Monday, June 30, 2003 7:04 PM To: Bechtel, Christine Subject: Request for Oral Presentation Christine Bechtel Center for Drug Evaluation and Research (HFD-006) Food and Drug Administration 5600 Fishers Lane Rockville, MD 20857 Ms. Bechtel, Please accept this electronic mail as notice that I plan to make an oral presentation of approximately 15 minutes duration at the public meeting on Current Status of Useful Written Prescription Drug Information for Consumers. Here is my written statement addressing questions 1, 2, and 3. 1. What steps is the private sector taking to improve the usefulness of the written information patients receive with prescription drugs and to meet the Year 2006 goal? Cerner Multum, Inc. has been producing patient education leaflets (PEL) since 1998, designed to be compliant with MedGuide 1996. The leaflets created by Cerner Multum are created by pharmacists, reviewed by outside experts in clinical practice, and are continuously updated using resources such as new package information and MedWatch alerts. PBMs, hospital systems, retail pharmacies, and Internet sites use the Cerner Multum leaflets. The key features included in the Cerner Multum leaflets are: * All FDA approved indications, * Full Text - comprehensive descriptions of medicines and their effects subdivided into specific sections with distinct section headers, * Easy to read - formatted to include distinct sections, minimum 10 pt. Text, adequate spacing between sections, use of limited bold text, minimum 6th grade comprehension, include the phonetic pronunciation of the drug entity * The use of pictograms/illustrative patient instructions * Age-specific (pediatric/geriatric) information and precautions * Renal and liver precautions * Gender-specific precautions * English and Spanish versions The leaflets are available in multiple formats including print and web-enabled. They are generally one to two legal size pages in length. Detailed systems have been developed to assure that the leaflets fully comply with the template, guidelines, and format of the MedGuide recommendations. The creation of the leaflets adheres to explicit writing guidelines. The leaflet layout sample: Generic Drug Pronunciation Brand Names What is the most important information I should know about _____? (name of drug) A summary section containing critical aspects of proper use, significant warnings, precautions, and/or contraindications, serious adverse reactions, and potential safety hazards. What is (name of drug)? A section that identifies a drug product's indications for use, what class the drug is in and how the drug works. Off-label used (FDA unapproved indications) are tagged separately to allow the institution to decide whether these should be printed). Also, a statement that "Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide" is included. Who should not take (name of drug) Information on circumstances under which the drug product should not be used for its labeled indication (its contraindications), and information from the package insert regarding precautions (conditions or circumstances that may require cautious use of the medication, dosage adjustment or special monitoring). Information related to use of the medication during pregnancy or breast-feeding is also included in this section. Specific warnings or concerns regarding use of the medication in geriatric or pediatric populations also appears in this section. How should I take (name of drug) Information on the proper use of the drug product, including: A statement stressing the importance of adhering to the dosing instructions. A statement or statements describing special instructions on how to prepare and/or administer the drug product. A description of the recommended storage of the drug. What should I do if I miss a dose of (name of drug)? A statement of what the patient should do if he/she misses taking a scheduled dose of the drug product. What should I do if I overdose? Information on what the patient should do in case of an overdose of the drug product and the possible symptoms of an overdose. What should I avoid while taking (name of drug) A statement or statements that identify activities (such as driving or sunbathing), and drugs, foods, or other substances (such as tobacco or alcohol) that the patient should avoid, including why they should be avoided. What are the possible side effects of (name of drug)? A statement of the possible serious side effects that require immediate medical attention followed by a list of those side effects. A statements indicating less serious side effects that may occur (generally, those that occur frequently) and that the patient should discuss them with their provider at a convenient time, followed by a list of those side effects. A statement that tolerance to or dependence on the drug product may occur (if applicable). Also included is a statement that side effects other than the ones listed may occur and patient should contact their healthcare provider with questions. What other drugs will interact with this drug? Statements describing other drugs that will interact with the index drug and how this may affect the prescribed treatment. Also included is a statement that side effects other than the ones listed may occur and patient should contact their healthcare provider with questions. Where can I get more information? Example: Your pharmacist has additional information about (this drug) written for health professionals that you may read. What do the pills look like? Statements describing how the medication is available (i.e., over-the-counter or prescription) and common brand names for the drug. We include a description of shape, color, and dose form for each strength of the medication available (for the most common brand products). A statement such as "Formulations other than those listed may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you." Final (optional) A statement that the drug product not be used for other conditions or given to other persons and should be kept out of the reach of children.. Date The date of the most recent revision of the Medication guide placed immediately after the last section. Disclaimer Reviewed by outside experts. The leaflets are continuously updated using resources such as new package information and MedWatch alerts. 2. What barriers exist for the private sector to meet the Year 2006 goal, and what plans exist to overcome these barriers? Cerner Multum has the resources in intellectual property and technology to meet the Year 2006 goal. Where we see the greatest challenge is in meeting the demands of the different dispensing pharmacies, since not all have the technology resources to retrieve electronically the latest published PEL on a timely manner. Other costly challenges will occur in trying to incorporate the leaflets into the IT systems/workflow used in the dispensing of prescriptions at each pharmacy. The increase in costs will occur at both sides, the vendor (here, Cerner Multum) of the patient medication leaflet modifying the final document to the specific requirements of each particular pharmacy and at the dispensing pharmacy as mentioned above. Workflow issues must be addressed. Even the most useful presentation of patient medical information will only meet the goal if the workflow processes provide for an efficient mechanism of delivery. 3. What should the role of FDA be in assuring full implementation of the Action Plan to meet the Year 2006 goal? FDA should encourage independent entities, e.g., publishers of healthcare information having no conflict of interest to provide unbiased, well-researched, informative, and complete patient education information. Independent publishers of medical information will provide a mechanism for consistent presentation and format of patient medication information across multiple therapeutic classes of drugs. FDA should encourage pharmacy providers to implement the technology and resources necessary for fulfillment of the Year 2006 goal. Regards, Gerry Gerry Hobson, RPh Research Manager Cerner Multum 3200 Cherry Creek Drive Suite 300 Denver, CO 80209 phone: 303.282.2057 fax: 816.936.9057 ghobson@cerner.com