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Creating a Standard for Medication Prescription Labels Flipbook PDF
Creating a Standard for Medication Prescription Labels Gerald McEvoy, Pharm.D. Assistant Vice President Drug Information
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Creating a Standard for Medication Prescription Labels Gerald McEvoy, Pharm.D. Assistant Vice President Drug Information IOM Roundtable on Health Literacy Health Literacy Past, Present, and Future: Workshop Washington, DC 2014 Nov 6
Developing a Standard for Prescription Container Labels in the US
HISTORY
The problem: Prescription confusion
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Journey to a patient centered label
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Improving Prescription Container Labeling in the US 10‐12‐2007 American College of Physicians Foundation White Paper key findings Inadequate understanding of Rx instructions & warnings is prevalent
and important safety concern Lack of universal standards for labeling is root cause of medication error Evidence‐based practices should guide label content & format Prescription instructions are important for patients and should be clear and concise Patient medication information should be an integrated system that extends beyond the container Healthcare providers are not communicating adequately to patients Research is needed to identify best practices
Changing Prescription Medication Use Container Instructions to Improve Health Literacy & Medication Safety 10‐12‐2007 IOM Roundtable on Health Literacy Workshop Container label is the patient’s most tangible source of
information about prescribed drugs and how to take them Container label is a crucial line of defense against medication errors and adverse drug effects 46% of patients across all levels of literacy misunderstood 1 or 2 dosing instructions* 54% misunderstood one or more auxiliary warning* Workshop convened to address how prescription labels affect patient safety and how to address identified problems
*Michael Wolf
Standardizing Medication Labels: Confusing Patients Less 2008 IOM report on 10‐2007 Workshop ACP White Paper, research, expert opinions, and thought leader
reactions at the Workshop set the foundation for the report Health literacy, public health, regulatory, pharmacy and medical practice, patient advocacy, and standards developers represented Focus was on developing patient‐centered prescription labels that were clear, simple, unambiguous, comprehensibile across literacy levels, and standardized Concept of universal medication schedule (UMS) was proposed* USP offered to serve as neutral multidisciplinary convening organization for developing prescription container labeling standards Participants endorsed USP’s offer *Alastair J. J. Wood
Lack of universal standards for labeling May 18, 2008: The USP Safe Medication Use Expert Committee authorized creation of an Advisory Panel to: • Determine optimal prescription label content and format to promote safe medication use by critically reviewing factors that promote or distract from patient understanding of prescription medication instructions • Create universal prescription label standards for format/appearance and content/language
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USP Expert Panel formed Dec 2008 • • • • • • • • • • • • • • • •
Co-chair Gerald McEvoy, Pharm.D. Co-chair Joanne G. Schwartzberg, MD Cynthia Brach (AHRQ Health Policy Researcher) Sandra Leal, Pharm.D., CDE (Community Pharmacy Practitioner/IOM Bilingual Advisor) Linda Lloyd M.Ed. (HRSA Health Literacy Expert) Melissa Madigan, Pharm.D., J.D. (Policy - NABP) Dan Morrow, Ph.D. (Academia/Researcher) Ruth Parker, M.D. (Health Literacy Expert/Practitioner) Cynthia Raehl, Pharm.D., FASHP, FCCP (Academia/Practitioner) William Shrank, M.D., MSHS (Academia/Practitioner) Patricia Sokol, RN, J.D., (AMA - Medication Safety Expert) Darren Townzen, R.Ph., MBA (Community Pharmacy/NCPDP) Jeanne Tuttle, R.Ph. (Health System Practitioner/Researcher) Joan E. Kapusnik-Uner, Pharm.D., FCSHP (Data Industry) Michelle Weist, Pharm.D., BCPS (Health System Practitioner/CPOE Expert) Michael Wolf, Ph.D., MPH (Health Literacy Researcher)
Lack of universal standards for labeling
December 2008 - Formation of original USP Health Literacy and Prescription Container Labeling Ad-hoc Advisory Panel
January 2011 – proposed General Chapter Prescription Container Labeling appeared in Pharmacopeial Forum 37(1) [Jan-Feb 2011]
February 2011 - Formation of USP Prescription Container Labeling Expert Panel (Formerly: Health Literacy and Prescription Container Labeling Advisory Panel)
October 2011- February 2012 – Review of public comments and draft revisions by the Expert Panel
February 2012- Revision of GCpresented to NSL EC for approval
May 2012 through May 1, 2013: Communication, Education Programs
June 2012: NSL EC ballots on General Chapter Prescription Container Labeling
November 2012: General Chapter was published in USP 36-NF 31
May 2013: General Chapter becomes official
2014: Revisions proposed for visual impairment and patient-centered dosing
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Lack of universal standards for labeling
Organize the prescription in a patient-centered manner
Emphasize instructions and other information important to patients
Improve readability
Optimize typography
Optimize white space
Simplify language
Use explicit text to distinguish dose/interval instructions
Address limited English proficiency
Include purpose for use
Limit auxiliary information to what is essential and evidencebased
Address visual impairment
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DZB1
Which interpretation is right?
Prescription
Examples of Pharmacy “Sig” Interpretations
Lipitor 10 mg tablets
“Take one tablet daily.”
Take one tab QD Dispense #30 No refills
“Take 1 tablet by mouth for high cholesterol.” “Take one (1) tablet(s) by mouth once a day.” “Take one tablet orally every day for high cholesterol.”
Indication: for high cholesterol
Fosamax 5 mg tabs
“Take 1 tablet orally daily.”
Take one tablet QD Dispense #30 Do not lie down for at least 30 min
“Take one tablet by mouth every day for osteoporosis prevention. Do not lie down for at least 30 minutes after taking.”
Indication: Osteoporosis prevention
“Take 1 tablet every day, 30 minutes before breakfast with a glass of water. Do not lie down.” “Take one tablet every day.”
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Slide 12 DZB1
Joanne I have removed the last exampke and added an "oral" example for each one Donna Bohannon, 9/22/2014
Standardization of Prescription Container Information
PRESENT
General Chapter Prescription Container Labeling published November 2012 official May 2013 http://www.usp.org/usp-nf/key-issues/usp-nf-general-chapter-prescription-container-labeling/downloadusp-nf-general-chapter-prescription-container
Prescription Label Organization (Patient-centered Manner)
• Patient-directed information must be organized in a way that best reflects how most patients seek out and understand medication instructions • Prescription container labeling should feature only the most important patient information needed for safe and effective understanding and use
Simplify language Language
on the label should be:
– Clear – Simplified – Concise – Familiar No
medical jargon
Use
the language in a standardized manner
Sentence Do
case (Take 1 tablet by mouth every day)
NOT use all capital letters:
– Such as TAKE 1 TABLET BY MOUTH EVERY DAY 16
Give explicit instructions Instructions
for use (i.e., the SIG or signature) should clearly:
– separate the dose itself from the timing of each dose – to convey the number of dosage units to be taken and the timing Use
specific time periods each day such as
– Morning – Noon – Evening – Bedtime Use
numerals not alphabetic characters for numbers
– Example: “Take 1 tablet in the morning and 1 tablet in the evening.” Dosing
by precise hours of the day makes it harder for a patient to
follow 17
Purpose for use
If the purpose of the medication is indicated on the prescription, it should be included on the prescription container label
Confidentiality and patient preference may limit inclusion of the purpose on labels
Use language that is clear and simple
Use purpose-for-use language in clear, simple terms: E.g., “for high blood pressure” rather than “for hypertension”
http://healthliteracy.com/dictionary.asp
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Limit Auxiliary Information
Auxiliary information on the prescription container label should be: – Evidence-based: • Evidence-based auxiliary information, both text and icons, should be standardized • Should be applied consistently such that it does not depend on individual practitioner choice
– In simple explicit language: • Be minimized to avoid distracting patients with nonessential information • Most patients (specially the ones with low literacy), pay little attention to auxiliary information
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Improve Readability
Labels should be designed and formatted so they are easy to read
Minimize the need to turn the container in order to read lines of text
Never truncate or abbreviate critical information
Reserve highlighting, bolding, and other typographical cues to preserve readability
Limit the number of colors used for highlighting (e.g., no more than one or two)
Use separate lines to distinguish when each dose should be taken 20
Optimize Typography
High-contrast print (e.g., black print on white background)
Simple, uncondensed familiar fonts with sufficient space within letters and between letters (e.g., Times Roman or Arial)
Sentence case (i.e., punctuated like a sentence in English: initial capital followed by lower-case words except proper nouns with capital first letter)
Large font size (e.g., minimum 12-point Times Roman or 11-point Arial) for critical information
Adequate white space between lines of text (25%–30% of the point size)
White space to distinguish sections on the label such as directions for use vs. pharmacy information
Horizontal text only 21
Standards Adoption • Prescription label standards are regulated by states – States would need to enforce USP standard – Standards of practice also can apply when state regulations do not specifically endorse or preclude
• California was first state to require patient-centered labels in 2011 • National Association of Boards of Pharmacy (NABP) adopted USP prescription container standard in 2012 resolution encouraging individual states to adopt • Utah and New York have adopted some supportive language • Some national chains have pre-empted state adoption to the extent permitted • Institute for Safe Medication Practice (ISMP), NCPDP, and other groups have supported 22
Standardization of Prescription Container Information
FUTURE
Proposed Revisions to General Chapter
Address June 2014 US Access Board best practices for making prescription container label information accessible to visually impaired patients
Address standardized patient-centered instructions such as the universal medication schedule (UMS)
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Visual Impairment • Follow patient-centered prescription container label standards • Provide alternative access to label information such as tactile (braille), audible, and enhanced visual systems • Enhance communications on available options • Provide service or direct patient to alternative access • Follow best practices for alternative access format • Best practices recommended by the United States Access Board
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Methodology for Patient-Centered Instructions
Schedule medication-taking into 4 standardized time periods (e.g., morning, noon, evening, bedtime)
Particularly useful for simplifying daily medication regimens that include multiple oral therapies
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An Enhanced Label with “UMS”
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Patient-Centered Label Can Improve Understanding/Adherence
State Board of Pharmacy in CA passed legislation for this label 28
NCPDP Acetaminophen Label Best Practices Complete spelling of active ingredients in acetaminophen‐ containing prescription medicines in addition to brand name Adopt one standard concomitant use and liver warning that aligns with OTC acetaminophen warnings on Drug Facts labels Prioritize standard warning label to print in top 3 warning labels to increase probability of routine inclusion on container Support introduction of evidence‐based icons that improve consumer and patient understanding beyond explicit text alone Employ general health literacy and plain language principles on warning labels that are patient‐centered and promote readability and understanding
NCPDP Acetaminophen Label Best Practices
Eliminate use of “APAP”
Adoption of NCPDP Acetaminophen Best Practices Almost 90% of US pharmacies have adopted NCPDP recommendations and provide full spell‐out for 2‐ ingredient combos Major national pharmacies have implemented (e.g., RiteAid, Walgreens,
CVS, WalMart, Target, Costco, K‐Mart, Safeway, Publix, Giant Eagle) Pharmacy software vendors (e.g., McKesson, QS1, PDX, Rx30) serving independents have implemented
APAP abbreviation eliminated from databases of all major publishers (FDB, Wolters Kluwer, Gold Standard) Standardized acetaminophen warning label is printed in top 3 labels for 98% of prescriptions http://ncpdp.org/education/fileform.aspx?fn=/NCPDP/media/pdf/wp/NCPDPacetaminophenWPv1.1_31jan2013.pdf&WP=true
NCPDP Standardized Oral Liquid Dosing Use mL as standard unit of measure Discontinue usage of household units of measure (e.g., tsp) Convert dosing instructions to mL when non‐standard units
are prescribed (e.g., mg, tsp)
Always use leading zeros before decimal point and never use trailing zeros Provide dosing device with numeric graduations that correspond to labeled dose Educate patients and caregivers Educate pharmacy staff about importance of using mL as unit of measure for all oral liquids
NCPDP Standardized Oral Liquid Dosing Widespread support by professional practice groups, CDC, FDA, USP, and others Widespread national press coverage Pharmacy database producers are facilitating easy adoption (e.g., conversion of household units to mL) Several chain pharmacies already have endorsed (e.g., Walgreens, WalMart, Kroger, Publix) Communication with other pharmacy CEOs under way Schools of Pharmacy are being asked to advocate the recommendations http://www.ncpdp.org/ncpdp/media/pdf/wp/dosingdesignations‐oralliquid‐medicationlabels.pdf
NCPDP Universal Medication Schedule
NCPDP Universal Medication Schedule April 2013 White Paper advocates industry adoption of UMS NCPDP recommends UMS as a best practice for simplifying medication instructions for patients and their caregivers and thus potentially improving care and outcomes Prescribers and dispensers are highly encouraged to begin incorporating UMS into their practices Industry transition to NCPDP’s SCRIPT version 10.6 standard for e‐prescribing will facilitate implementation UMS potential benefits include: Increased consistent patient understanding of & adherence to medication regimens Simplification of dosing regimens when multiple medications are taken Standardization of dosing regimens likely will enhance pharmacist and prescriber
productivity, accuracy, and workflow efficiencies Simply translation to other regimens because of English standardization http://www.ncpdp.org/members/pdf/201304.UMS.WhitePaper.pdf