NCPIE, Copyright 2007 Written Drug Information: Now & into the Future A look at where things now...

NCPIE, Copyright 2007

Written Drug Information: Now & into the Future

A look at where things now stand with the provision of useful written information to consumers, along with some conjecture as

to how the future of drug information might evolve.

Ray Bullman

Executive Vice President

National Council on Patient Information and Education

April 24, 2007


ABOUT NCPIE

• Produces messages & /materials to promote better consumer – patient – provider dialogue about medicines

• Sample Activities: National Brown Bag Medicine Review, “Talk About Rx” Month, Be MedWise about OTCs, Consumer Medicine Information (CMI) Initiative

Written Drug Information: Now & into the Future


Written Drug Information: Now and Into the Future

NCPIE’s Role = Catalyst & Convener

– Encourage committed stakeholders to meet long-range CMI goals established in Public Law 104-180, outlined in Action Plan for Provision of Useful Prescription Medicine Information

– CMI Initiative formed March 2003


Written Information: Recent Regulatory History

• 1995: FDA proposed MedGuide Rule

• 1996: Public Law 104-180; private sector charged with developing criteria for “useful” written medicine information (CMI)

• 1997: HHS Secretary accepts Action Plan; Targets set for 2000 & 2006; FDA = “judge”

• FDA’s interim evaluation released June 2002


CMI Targets

• 95% - Distribution with new Rxs at retail pharmacies

• 95% - CMI leaflets that meet Agency’s interpretation of Action Plan criteria as

delineated in FDA’s Guidance on Useful Written Consumer Medicine Information (July 2006)


NCPIE Involvement in Written Medicine Information

1996: NCPIE represented on Keystone Action Plan Committee (“useful” CMI)

‘97-’00: NCPIE stakeholder conferences

include Action Plan topics

2002: FDA encourages NCPIE to act as convener/catalyst to stimulate stakeholder activity to achieve Action Plan goals



July ‘02: NCPIE presents @ FDA mid-course assessment public hearing

March ‘03: 1st meeting of NCPIE CMI Initiative stakeholders, FDA, & Svarstad team

March ’04: NCPIE convenes “all-hands” stakeholder meeting w/FDA



June ‘04: NCPIE CMI Criteria Cmtee meets with FDA team & Svarstad

Aug. ‘04: NCPIE Criteria Cmtee completes Guide for Assessing Usefulness of

CMI Sept. ’04: NCPIE submits Assessment Guide

(above) to FDA for input.

Oct. ’04 – No Agency response on AssessmentMay ’05: Guide



April ’05: NCPIE organizes session on CMI, PhRMA Paperless Labeling Initiative

& FDA’s Daily Med & Medication Guide programs @ FDLI annual mtg.

May ‘05: FDA publishes draft guidance on CMI



July ’05: NCPIE submits comments to FDA docket on draft CMI guidance; re-submits CMI Assessment Guide

Aug. ’05: NCPIE submits comments to FDA docket on draft Guidance for Industry on FDA’s “Drug Watch” for Emerging Drug Safety Information



July ‘06: FDA releases final Guidance on Useful Written CMI (14 months after release of draft guidance)

July ’06: NCPIE organizes telecon with FDA & three dozen stakeholder groups to provide opportunity for Q & A about final CMI guidance



MedGuides / e- MedGuides

Jan. ’05: FDA invites NCPIE to organize stakeholder discussions about Medication Guide dissemination;

NCPIE helps organize 3 meetings:

July ‘05 Oct. ‘05 Sept. ‘06


NCPIE: Catalyst for Stakeholder Meetings with FDA on MedGuides

Sept. 2006 Meeting with FDA: • Key issues / recommendations from pharmacy

supply chain paper presented

• Summary of NCPIE focus groups to assess consumers' views on CMI and MedGuides presented.


NCPIE Focus Groups -- Medication Guides --

- Focus group members appreciated formatted MedGuide more than unformatted CMI

- MedGuide information should be provided by prescriber:

* Best time for questions; too late at the pharmacy;

* Can ask for alternative medicine


Key Issues

• Paper distribution = poor distribution process

• Pharmacists don’t know about MedGuides• Compliance with regulation (model pharmacy

act)• Content of MedGuides: variability; confusion due

to quantity of information• Integration of MG content into CMI• Cost shift to pharmacy ?


Written Information: Questions to Ponder

What impact will introduction of FDA’s Patient Information Sheets (PIS) have:

On stakeholders: publishers, systems vendors, printers, packagers, pharmacies, pharmacists, prescribers?

On patients and caregivers?



• What impact will introduction of more and more Medication Guides have on CMI?

- On stakeholders (publishers, systems vendors, pharmacies, pharmacists)?

- On patients and caregivers?



• What do we know about consumers’:

– Reaction to CMI? (apart from what FDA says)

– Use of CMI?

– Expectations about or preferences for CMI?


Consumer Medicine Information (circa March 2004)


Action PlanAction Plan Compliant CMI(circa 2006)


2007 CMI Assessment

Goal # 1 95% Distribution

• Very obtainable

• “Low hanging fruit” -- 11% of pharmacies that did not provide CMI @ mid-point have had ample notification of deficiency

• Preference: include other dispensing sites as well as community pharmacies (e.g., mail order)


2007 CMI Assessment

Goal # 2 95% “Useful” CMI (per Action Plan and FDA’s interpretive Final Guidance

on criteria for content, design, layout, and readability)

• Full goal attainment much more challenging;

• At retail level – requires universal systems changes by 60,000+ community pharmacies in collaboration with 3rd party system vendors (from large chains to single pharmacy)


2007 CMI Assessment



• Publishers - content is compliant (self report);

• Publishers – content available in multiple formats (text, xml)

• Publishers - encouraging FDA to review / comment on monographs prior to dissemination (What role might state pharmacy boards play in CMI feedback / oversight?)


2007 CMI Assessment



• At the retail level –requires universal systems changes

by 60,000+ pharmacies in collaboration with 3rd party

system vendors (from large chains to single pharmacy)

• If publishers’ content revisions are indeed Action Plan

compliant, challenge becomes roll-out / implementation,

populating marketplace with “new” CMI


State of Flux / What’s in Play



• Reluctance to commit $ / change in part due to state of flux related to dissemination of medicine information.

What’s in play:

– CMI (as we now know it)– Medication Guides (as we now know them)


What’s in Play?

– Medication Guides( pdf format, capacity to produce e-

version, in conjunction with CMI or stand-alone)

– Package Insert (PI) - paper

– e-Package Insert (PhRMA Paperless Labeling )

– Patient Package Insert (PPI) - paper

– DailyMed (FDA & Library of Medicine)


What’s In Play?

ALL OF THE ABOVE ?


What’s In Play?

VARIATIONS OF THE ABOVE?


Are We Overlooking Something?


(Code: Webdings, Wingdings, Bookshelf Symbol 7, Arial)



Telling consumers to “read it & heed it” and to ask questions ensures communication of useful medicine information …

Right?

What if you can’t read, or can’t read with understanding or don’t speak the language of your health care provider?


Low Health Literacy

• “Half of all adults are unable to understand much of what they need to know to take care of themselves and to follow their doctor’s instructions.” (Dr. Harvey V. Fineberg, President, IOM)

• 90 million adults (1 in 3) may lack the functional reading and math skills to effectively use the U.S. health system; most are native born, English speakers. (Health Literacy: A Prescription to End Confusion, IOM)


Low Health Literacy

• Most likely to face limited health literacy:

– Elderly;– Poor; – New Immigrants.

• System problem not a patient characteristic.


Three Approaches Showing Promise

1. Culturally appropriate health education

2. Patient advocacy

3. Medical education recognizing the critical importance of patient communication in the training of hcps at all levels.

(IOM: Health Literacy: A Prescription to End Confusion, 2004)


Healthy People 2010 – Chapter 17

Federal goals for ensuring better (more useful) medicine communication:

FDA is lead agency for monitoring progress to meet objectives in Chapter 17: Medical Product Safety.

Objectives 17.3 17.5 of relevance here:



17-3. Increase the proportion of primary care providers, pharmacists, and other hcps who routinely review with their patients aged 65 years & older and patients with chronic illnesses or disabilities all new prescribed & OTC medicines.

DELETED from HP 2010 @ mid-course review!


Healthy People 2010 - Chapter17

17.4: Increase the proportion of patients receiving, at the time their new prescriptions are dispensed, written information that conforms to the “Action Plan for the Provision of Prescription Medicine Information.”



17.5: Increase the proportion of patients receiving from prescribers, pharmacists, and other hcps oral counseling information that conveys directions for use and risk information (precautions and warnings).


Important – but Under-spoken - Aspect of Medicine Communication

Medication counseling by:

• Prescribers and

• Pharmacists


Consumers’ Reported Receipt of Rx Information@ the Physician’s Office (told selected info)

1992 2000 2004How much to take: 55% 62% 64%How often to take: 56% 64% 66%Refills: 32% 37% 37% Precautions: 33% 36% 37% Side Effects: 29% 35% 35%Any information: 61% 68% 70%All information: n/a 24% 26%

(source: FDA; Dec. 2006)


Consumers’ Reported Receipt of Rx Information@ the Pharmacy (told selected info)

1992 2000 2004How much to take: 28% 34% 29%How often to take: 27% 34% 31%Refills: 16% 17% 16% Precautions: 18% 24% 21% Side Effects: 11% 20% 17%Any information: 37% 37% 38%All information: n/a 12% 6%

(source: FDA; Dec. 2006)


What’s Likely to Change

The Status Quo


In the (very) Near Future

• FDA Public Hearings:– Electronic dissemination of Package Insert

(PI) April 27 in DC

– Medication Guides (electronic dissemination, integration of content with CMI, etc)

June 12-13 in DC


What We’re All Seeking

• Provision of the most useful information for all consumers to promote safe and appropriate medicine use.


QuestionsQuestions


Contact Information

Wm. Ray BullmanExecutive Vice President

National Council on Patient Information and Education4915 Saint Elmo Ave., Suite 505

Bethesda, MD [email protected] – email

(301) 656-8565 – phone(301) 656-4464 – faxwww.talkaboutrx.orgwww.bemedwise.org

NCPIE, Copyright 2007 Written Drug Information: Now & into the Future A look at where things now...

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