Health Literacy and Prescription Container Labeling Update from USP Advisory Panel Co-chairs: McEvoy and Schwartzberg
Charge to the Panel Determine optimal prescription label content and format to promote safe medication se by critically reviewing factors that promote or distract from patient nderstanding of prescription medication instrctions Create niversal prescription label standards for format/appearance and content/langage Sponsoring USP Expert Committee: Safe Medication Use (SMU) Co-chairs: Gerald McEvoy, Pharm D; Joanne Schwartzberg, MD, SMU members
Members of Advisory Panel Cynthia Brach (AHRQ Health Policy Researcher) Sandra Leal, Pharm.D., CDE (Commnity Pharmacy Practitioner/IOM Bilingal Advisor) Linda Lloyd M.Ed. (HRSA Health Literacy Expert) Melissa Madigan, Pharm.D., J.D. (Policy - NABP) Dan Morrow, Ph.D. (Academia/Researcher) Rth Parker, M.D. (Health Literacy Expert/Practitioner) Cynthia Raehl, Pharm.D., FASHP, FCCP (Practitioner/Academia) William Shrank, M.D., MSHS (Practitioner/Academia) Patricia Sokol, RN, J.D., (AMA Medication Safety Expert) Darren Townzen, R.Ph., MBA (Commnity Pharmacy/NCPDP ) Jeanne Tttle, R.Ph. (Health System Practitioner/Researcher) Joan E. Kapsnik-Uner, Pharm.D., FCSHP (Data Indstry) Michelle Weist, Pharm.D., BCPS (Health System Practitioner/CPOE Expert) Michael Wolf, Ph.D., MPH (Health Literacy Researcher)
Smmary of the Isse Medication misse reslts in over 1 million ADE/yr (IOM 2007) The patient s best sorce (and often only sorce) of information is the Rx container label. While written information and oral consltations may sometimes be available, the Rx container label mst be able to flfill the professional obligations of physicians and pharmacists to give the patient all the information needed to nderstand how to safely se the medication.
Recommendations for Universal Standards Advisory panel with for sbcommittees stdied isses for over a year. Safe Medication Use Expert Panel adopted report and recommendations in November 2009 Crrently preparing General Chapter for USP-NF.
Universal Standards: Principles Organize the Prescription Label in a Patientcentered Manner Patient-directed information mst be organized in a way that best reflects how most patients seek ot and nderstand medication instrctions. Prescription container labeling shold featre only the most important patient information needed for safe and effective nderstanding and se.
Universal Standards: Format/Readability Patient-directed Instrctional Content Will be at the top of the label; the patient s name, drg name and directions for se (i.e., specific dosage/sage/administration instrctions) shold be displayed with greatest prominence. Other less critical bt important content (e.g., pharmacy name and phone nmber, prescriber name, fill date, refill information, expiration date, prescription nmber, drg qantity, prodct description, and evidence-based axiliary information) shold not spersede critical patient information..
Universal standards: Format/Readability Improve Readability Critical information for patients mst appear on the prescription label in an ncondensed, simple, familiar, minimm 12-point font that is in sentence case. Use nmeric rather than alphabetical characters Use horizontal text Minimize need to trn container
Universal Standards: Format/Readability Optimize Typography Use high contrast print (black print on white backgrond), Use simple, familiar fonts with sfficient space within letters and between letters, se effective fonts sch as serif (e.g., Times Roman) or sans serif (e.g., Arial), Use large print 12-14 point font for critical information and do not se smaller than 10 point font for important information). Bolding, highlighting with light color only, reserve for critical information.
Universal Standards: Format/Readability Optimize White Space Use adeqate space between lines of text (25-30%); Use white space to distingish sections on the label sch as directions for se vs pharmacy information)
Universal Standards: Langage/Content Simplify Langage Langage on the label shold be clear, simplified, concise, familiar and sed in a standardized manner. Only common terms and sentences shold be sed. Use of nfamiliar words (inclding Latin terms) and nclarified medical jargon shold be avoided. Whenever available and appropriate to the patient context, standardized patient-centered translations of common prescribing directions to patients (SIG) shold be sed.
Universal Standards: Langage/Content Use Explicit Text to Describe Dosage/Interval Instrctions Instrctions for se mst clearly separate the dose from the dosage interval, so as to explicitly convey the nmber of dosage nits to be taken and the timing of sch. Instrctions for se shold contain nmeric rather than alphabetic characters for nmbers (For example, Take 2 tablets in the morning and 2 tablets in the evening rather than Take two tablets by moth twice daily ).
Universal Standards: Langage/Content Limited English Proficiency Prescription container labeling shold be provided in an individal s preferred langage, if a high-qality translation process has been sed, inclding: Initial translation by a trained and competent translator Review of the translation by another trained and competent translator and reconciliation of differences Review of the translation by a pharmacist or other medical professional who is a native speaker of the target langage and reconciliation of differences Testing of comprehension with target adiences If a high-qality translation process (as described above) cannot be provided, labels shold be printed in English.
Universal Standards: Langage/Content Inclde Prpose for Use Patient preferences in sharing sch information on the label mst be the paramont consideration. Confidentiality and FDA approval for intended se (e.g., labeled vs off-label se) will limit inclsion of indications on prescription container labels. Crrent evidence spports inclsion of prpose-forse langage in clear, simple terms (e.g. for high blood pressre verss hypertension).
Universal Standards: Langage/Content Axiliary information Axiliary information on the prescription container label shold be minimized and shold be limited to evidence-based critical information regarding safe se. The information shold be presented in a standardized manner and shold be essential for patient nderstanding (e.g., warnings and critical administration alerts). Use of icons shold be limited to those for which evidence demonstrates enhancement of interpretation and clarity abot se.