7572 Ch.Teja et al./ Elixir Pharmacy 44 (2012) 7572-7575 Available online at www.elixirpublishers.com (Elixir International Journal) Pharmacy Elixir Pharmacy 44 (2012) 7572-7575 NEW ERA IN US PRESCRIPTION DRUG LABELING Ch.Teja *, Ch. Dheeraj Reddy and G. Krishna Chaitanya, Balamuralidhar.V, T.M. Pramod Kumar, Department of Pharmaceutics, JSS College of Pharmacy, JSS University, Sri Shivarathreeshwara Nagar, Mysore- 570 015. ARTICLE INFO ABSTRACT Article history: The overview of the paper is to give an idea of prescription drug labeling in United States. Received: 15 January 2012; Prescription drug labeling helps in making labels more user friendly and which is an Received in revised form: immediate and important source of medication information for patients. Although patients 15 March 2012; may obtain useful information from prescription drug labeling, its main purpose is to give Accepted: 29 March 2012; healthcare professionals the information they need to prescribe drugs appropriately to the patients. FDA focused its effort on making labeling more informative and easy-to-read and Keywords minimize patient confusion and promote patient awareness on how to use a prescribed Prescription drug label, medicine safely and effectively, thereby reducing risk of medication error. The new drug United States, labeling requirements was initially applied to recently approved prescription drugs and the Labeling Preference, drugs that received approval for new use, and later it was applied in gradually to other drugs. Boxed Warning. As per the new format, the prescription information for newly approved products must meet specific graphical requirements, including the reorganization of critical information so that physicians can find the information quickly. It may conclude in outlining the new format, which is helpful to understand exactly what a prescription drug labeling is in U.S. © 201 2 Elixir all rights reserved. INTRODUCTION • Made locating and using information difficult. Pharmaceutical labeling/Drug labeling: It refers to all the • Did not facilitate finding answers to specific questions. printed information that accompanies a drug including the label, • Eventually, in many cases, labeling lost its user focus. the wrapping and the packaging insert. It became a document to assure completeness for possible Drug labelling is regulated by the food and drug litigation instead of a source of easy-to-use medical information. administration's division of drug marketing, advertising and Generally a label should contain the following information communications. about the following things 1,4 : These regulations apply to prescription drugs, over the counter • A summary of essential scientific information for the safe and drugs, and dietary supplements. effective use of the drug. The term "labeling" according to the united states code • Must be informative and accurate. 321(m) means all labels and other written, printed, or graphic • Use language that is not promotional in tone, false, or matters(1) upon any article or any of its containers and wrappers misleading. or, (2) accompanying such article. • Not to make claims or suggest uses for drugs when there is no Prescription drug labeling information is also known as 1: sufficient evidence of safety and a substantial evidence of • Prescribing information. effectiveness. • Package inserts. • Must contain information based on whenever possible data • Professional labeling. derived from human experience. • Direction circular. • The labelling must also be updated when new information • Package circular. becomes available. Importance of us prescription drug labeling: And Hence the Patient’s Preference was In the Following According to the Institute of Medicine (IOM) 2006 report 4, Manner 1: more than half a million adverse drug events (ADE’s) occur in • Directions – Avoid vague terminology. the United States each year. Problems with prescription drug • Benefits of the medication (Indication). (Rx) labeling were cited as the cause of a large proportion of • Warnings and possible side effects. patient medication errors and ADE’s, as patients may • Suggested responses to side effects (e.g., when to call doctor unintentionally misuse a prescribed medicine due to improper or stop taking medication). understanding of instructions. The elderly, those with limited • Duration of therapy. literacy skills, and individuals managing multiple medication FDA's goal for the prescription drug labelling 4 was to create regimens were found to be at greater risk for making errors in a more useful risk-safety communication tool and to reduce interpreting container label instructions. errors caused by misunderstanding or incorrectly applied drug Why more emphasis on the labeling??????? information. Over the years, prescription drug labeling was complex: FDA focused its effort on making labelling more informative • Did not identify the approval date. and easy-to-read • Did not indicate whether there were any recent changes to the labeling. Tele: E-mail addresses: [email protected] © 2012 Elixir All rights reserved 7573 Ch.Teja et al./ Elixir Pharmacy 44 (2012) 7572-7575 In 1992 FDA conducted focus-group research to learn more Adverse Reactions (listing of most common ARs) about the problems with the old labelling. Drug Interactions Between 1993 and 1994, the agency conducted a national Use in Specific Populations. survey of physicians to gather additional information about how Patient Counseling Information Statement. prescribers used labelling and what problems they had with it. One which are highlighted and in bold are Newly added section Emphasis on the problem associated with the labelling issues. and one which is in italics and underlined contains critical In order to implement a new regulation or change an existing prescribing information. one, FDA must obtain public comments and input on proposals. AN EXAMPLE FOR HIGHLIGHTS OF PRESCRIBING Also must obtain the comments of the prescribers and seek the INFORMATION: suggestions. These highlights do not include all the information needed to In 1995, FDA held a public meeting to discuss the prototype use Imdicon safely and effectively. and received comments to the Federal Register notice See full prescribing information for Imdicon. announcing the meeting. IMDICON (cholinasol) CAPSULES FDA analysed the comments and over the years worked with Initial U.S.Approval: 2000 the pharmaceutical industry and others to revise the prototype and develop what would become the new labelling. WARNING: LIFE THREATENING On December 22, 2000, the Proposed Rule for the labelling HEAMATOLOGICAL ADVERSE change was published in the Federal Register. REACTIONS On January 24, 2006, the "Final Rule: Requirements on the See full prescribing information for complete Content and Format of Labelling for Human Prescription Drug boxed warning . Monitor for hematological and Biological Products" was issued. adverse reactions every 2 weeks for first 3 The products affected by the rule include applications for months of treatment (5.2). Discontinue Imdicon prescription drugs and biologics: Immediately if any of the following occur: Submitted to FDA on or after June 30, 2006 • Neutropenia(5.1) Approved by FDA 5 years prior to June 30, 2006 • Thrombotic thrombocytopenic With major changes in the prescribing information approved five years prior to, on, or after June 30, 2006. purpura(5.1) The above said products shall follow the rules for the labeling • Aplastic anaemia(5.1) requirements abide the labeling requirements. New labeling format: Basing the changes implemented by the FDA a new labeling ------------RECENT MAJOR CHANGES------------ format has been designed 1. Indications and Usage, Coronary Stenting (1.2) 2/200X A. Adds Highlights section Dosage and Administration, Coronary Stenting (2.2) 2/200X B. Adds Contents section ------------INDICATIONS AND USAGE-------------Imdicon is C. Reorders and reorganizes sections an adenosine diphosphate(ADP) antagonist platelet D. Makes additional improvements aggregation inhibitor indicated for: • Reducing the risk of thrombotic stroke in patients who A. HIGHLIGHTS SECTION: have experienced stroke precursors or who have had a This is perhaps the most significant change in the new completed thrombotic stroke(1.1) labeling rule. • The very above said purpose was solved by incorporating the Reducing the incidence of sub acute coronary stent highlights. thrombosis, when used with aspirin(1.2) The Highlights section was created because prescribers said Important Limitations: they would use labeling more if it included a short, half-page • For stroke, Imdicon should be reserved for patients who synopsis. are intolerant of or allergic to aspirin or who have It provides the overview of a drug’s benefits and risks that failed aspirin therapy(1.1) healthcare professionals said was most important to them. Highlight’s section consists of information which is not --------DOSAGE AND ADMINISTRATION-------- repetitive but contains the concise summary of crucial • prescribing information. Stroke: 50 mg once daily with food (2.1) Essentially, the Highlights section is a brief one-half page • Coronary stenting: 50 mg once daily with food, with summary of the more descriptive product labeling. antiplatelet doses of aspirin, for up to 30 days following The highlight section consists mainly of the following parts 4:- stent implantation (2.2) Limitations Statement Product Names and Date of Initial U.S. Approval Discontinue in renally impaired