It’s Your Choice for Delivering Useful CMI – Either You Do It or

the Government Will

ASAP 2005 Midyear Industry & Technology Issues

ConferenceJune 16 -18, 2005

Galloway, NJ

Contact Information

Ray BullmanExecutive Vice President

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

Bethesda, MD 20814-6082bullman@ncpie.info

(301) 656- 8565, ext. 14 – phone

www.talkaboutrx.org (click CMI Section)

About NCPIE

• Nonprofit; coalition; Formed in 1982

• Over 120 member organizations (diverse)

• Mission: Stimulate / improve communication of information on appropriate medicine use to consumers and healthcare providers

About NCPIE

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

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

NCPIE CMI Initiative

• NCPIE’s Role = Catalyst & Convener

• Objective: Encourage key players to meet

long-range CMI quality-improvement goal required by Congress

• CMI Initiative formed March 2003; sunsets Dec. 31, 2006

CMI: 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 first evaluation released June 2002.

Today’s CMI Challenge

• 89%: CMI distribution with new Rx per FDA (2002)

• 55%: CMI leaflets that met “Action Plan” criteria for usefulness per FDA assessment (2002)

==================================• 95%: distribution with new Rxs (2007)

• 95%: CMI leaflets that meet “Action Plan” criteriafor usefulness per FDA final assessment (2007)

Keystone Action Plan Criteria

• Drug names, indication for use

• Contraindications, what to do

• How to use, monitor• Precautions, how to

avoid harm• Serious or frequent

ADRs; what do do

• General info, encouragement to ask questions

• Scientifically accurate, not promotional

• Written at 6th-8th grade reading level; legible

FDA’s Consumer Rating Process

• Recruited 154 consumer raters in 11 states

• Each rater independently rated ~ 10 leaflets

• Leaflet rated on 12 items (1-5 pts. Each)

Consumer Rating Process (on a scale of 1 to 5)

1. Poor print size good print size2. Poor print quality good print

quality3. Poor spacing between lines good

spacing between lines4. Poorly organized Well organized5. Poor length Good length 6. Unattractive Attractive **

Consumer Rating Process (on a scale of 1 to 5)

7. Unclear Clear

8. UnhelpfulHelpful

9. Incomplete Complete

10. Scary Reassuring **

11. Hard to find impt. Info. Easy to find impt. information

12. Hard to remember Easy to remember**** = not included in calculation of adherence score

Consumer Rating Process Scale (on a scale of 1 to 5)

Overall, what is our opinion about this sheet. Circle one number that best describes how you would feel if you received this information sheet:

1. Hard to read easy to read

2. Hard to understand easy to understand

3. Not useful Useful

Consumer Ratings

Lowest ratings:

• print size

• print quality

• spacing

• overall readability

CMI Initiative is Caught in a Tornado

• One intent of Action Plan for many was to keep Medication Guide rule from being implemented:

1. Action Plan drives content & design improvements;

2. Consumers receive “useful” CMI– FDA precluded from full implementation of

MedGuide rule (one for every drug product)

CMI Initiative is Caught in a Tornado

Following 1997 acceptance of Action Plan by HHS:

- 1999: FDA gains limited MedGuide authority (up to 10 drugs per year) if they meet certain criteria [21 CFR 208]

- 2002: FDA assesses Progress – Distribution target met; – Content /readability target not met.

CMI Initiative is Caught in a Tornado

- 2004: Antidepressant & NSAID safety issues unleash firestorm of criticism (congress, media, & public) on FDA

- 2005: Class MedGuide for Antidepressants

- 2005: MedGuide for Elidel & several others

- 2005: Class MedGuide for Rx NSAIDs

-2005: FDA releases Drug Safety Initiative plan; intent for more MedGuides

FDA’s Drug Safety Initiative

• “To make drug safety information available to you in an easily accessible format”

• Establishes Drug Safety Oversight Board

• Drug safety information in new web location – “Drug Watch” The Drug Watch is intended to identify drugs for which FDA is actively evaluating early safety signals

FDA’s Drug Safety Initiative

The purpose of the Drug Watch Web page is to communicate significant emerging safety information about specific drug products or classes of drug products.

FDA’s Drug Safety Initiative

Factors to determine if a drug will appear on Drug Watch

• Whether new and emerging safety information could significantly affect prescribing decisions or how patients should be monitored (e.g., a drug that has been identified with a possible association with renal failure should not be prescribed to patients with renal disease; a new possible drug-drug interaction has been identified and needs to be considered in prescribing)

FDA’s Drug Safety Initiative

• Whether measures can be taken as a result of providing information that could help to prevent or mitigate harm (e.g., limit prescribing to patients most likely to benefit from the drug, conduct special monitoring of patients on the drug, be alert for signs of serious adverse reactions)

• Whether an unapproved (off-label) use of the drug appears to pose a significant risk to patients

The Fine Print

We also have decided to intensify our current program to provide the public with the most important information for the safe and effective use of drugs in patient friendly language. 

As part of this continuing effort, we are developing Patient Information Sheets intended to convey critical facets of a product's approved labeling in lay terms.  These sheets will include a section for "emerging safety information" in those instances when we determine that there is information on the Drug Watch that a patient should consider. 

The Fine Print

Our ultimate objective is to develop Patient Information Sheets for all approved drugs, most of which will not have an emerging safety section. 

Latest NEWS….CMI Guidance from FDA

• Draft Guidance – Useful Written Consumer Medicine Information – released May 26, 2005

• Comments due to FDA by July 25, 2005

• All urged to submit comments & concerns

Initial Concerns: CMI Guidance from FDA

• Initial concerns relate to need to include:– All indications to be compliant– All contraindications to be compliant

• Isn’t this creating a mirror image of the brief summary? How useful is that?

• Implications? Costs? Other burdens?

CMI Guidance from FDA

To find draft CMI guidance document:

http://www.fda.gov/cder/guidance/6520dft.htm

To find Fed. Register Notice (comments):http://www.fda.gov/OHRMS/DOCKETS/98fr/05-10445.htm

CMI – Questions to Ponder

• FDA, through delegation of authority, is required to conduct final assessment of CMI after Dec. 2006.

• Is this a conflict? Should FDA have this authority? If not, who else should assess CMI?

CMI – Questions to Ponder

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

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

- On patients and caregivers?

CMI – Questions to Ponder

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

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

- On patients and caregivers?

CMI – Questions to Ponder

• What do we know about consumers’:

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

– Use of CMI?

– Expectations about or preferences for CMI?

Private Sector Consumer Medicine Information (CMI)

(circa March 2004)

“Action Plan” Compliant CMI(circa 1997)

Patient Information Sheets (PIS)from FDA (circa 2005)

FORMAT -- Patient Information Sheets from the FDA

• FDA Alert• What is [name of drug]?• Who should not take [name of drug]?• What are the risks?• Are there any interactions with drugs or

foods?• How do I take [name of drug]?• Is there anything else I need to know?

FORMAT – Medication GuidesManufacturer-prepared / FDA Approved

(1) The brand name (e.g., the trademark or proprietary name), if any, and established or proper name.

(2) The heading, “What is the most important information I should know about (name of drug)?” followed by a statement describing the particular serious and significant public health concern that has created the need for the Medication Guide.

(3) The heading, “What is (name of drug)?” followed by a section that identifies a drug product's indications for use

4) The heading, “Who should not take (name of drug)?” followed by information on circumstances under which the drug product should not be used for its labeled indication (its contraindications).

(5) The heading, “How should I take (name of drug)?”

FORMAT – Medication GuidesManufacturer-prepared / FDA Approved

6) The heading “What should I avoid while taking (name of drug)?” followed by a statement or statements of specific, important precautions patients should take to ensure proper use of the drug

(7) The heading, “What are the possible or reasonably likely side effects of (name of drug)?”

(8) General information about the safe and effective use of prescription drug products, including the verbatim statement that “Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide”

9) Additional headings and subheadings may be interspersed throughout the Medication Guide, if appropriate

Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) (See the end of this Medication Guide for a list of prescription NSAID medicines.) (JUNE 15, 2005)

What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

NSAID medicines may increase the chance of a heart attack or stroke that can lead to death. This chance increases:

• with longer use of NSAID medicines • in people who have heart disease

NSAID medicines should never be used right before or after a heart surgery called a “coronary artery bypass graft (CABG)." NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding:

• can happen without warning symptoms • may cause death

The chance of a person getting an ulcer or bleeding increases with: • taking medicines called “corticosteroids” and “anticoagulants” • longer use • smoking • drinking alcohol • older age • having poor health

NSAID medicines should only be used: • exactly as prescribed • at the lowest dose possible for your treatment • for the shortest time needed

What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)? NSAID medicines are use to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as:

• different types of arthritis • menstrual cramps and other types of short-term pain

Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)? Do not take an NSAID medicine:

• if you had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID medicine • for pain right before or after heart bypass surgery

Tell your healthcare provider: • about all of your medical conditions. • about all of the medicines you take. NSAIDs and some other medicines can interact with each other and cause serious side effects. Keep a list of your medicines to show to your healthcare provider and pharmacist. • if you are pregnant. NSAID medicines should not be used by pregnant women late in their pregnancy. • if you are breastfeeding. Talk to your doctor.

What are the possible side effects of (NSAIDs? Serious side effects include: • heart attack • stroke • high blood pressure • heart failure from body swelling (fluid retention) • kidney problems including kidney failure • bleeding and ulcers in the stomach and intestine • low red blood cells (anemia) • life-threatening skin reactions • life-threatening allergic reactions • liver problems including liver failure • asthma attacks in people who have asthma

Other side effects include: • stomach pain • constipation • diarrhea • gas • heartburn • nausea • vomiting • dizziness

Get emergency help right away if you have any of the following symptoms:

• shortness of breath or trouble breathing • chest pain • weakness in one part or side of your body • slurred speech • swelling of the face or throat

Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms: • nausea • more tired or weaker than usual

• itching • your skin or eyes look yellow • stomach pain • flu-like symptoms • vomit blood • there is blood in your bowel movement or it is black and sticky like tar • unusual weight gain • skin rash or blisters with fever • swelling of the arms and legs, hands and feet

These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines.

Other information about NSAIDs:

• Aspirin is an NSAID medicine but it does not increase the chance of a heart attack. Aspirin can cause bleeding in the brain, stomach, and intestines. Aspirin can also cause ulcers in the stomach and intestines.

• Some of these NSAID medicines are sold in lower doses without a prescription (over –the –counter). Talk to your healthcare provider before using over –the –counter NSAIDs for more than 10 days.

NSAID medicines that need a prescription Generic Name Tradename Celecoxib Celebrex Diclofenac Cataflam, Voltaren, Arthrotec (combined with misoprostol)Diflunisal Dolobid Etodolac Lodine, Lodine XL Fenoprofen Nalfon, Nalfon 200 Flurbirofen Ansaid Ibuprofen Motrin, Tab-Profen, Vicoprofen (combined with ydrocodone),

Combunox (combined with oxycodone) Indomethacin Indocin, Indocin SR, Indo-Lemmon, Indomethagan Ketoprofen Oruvail Ketorolac Toradol Mefenamic Acid Ponstel Meloxicam Mobic Nabumetone Relafen Naproxen Naprosyn, Anaprox, Anaprox DS, EC-Naproxyn, Naprelan,

Naprapac (copackaged with lansoprazole) Oxaprozin Daypro Piroxicam Feldene Sulindac Clinoril Tolmetin Tolectin, Tolectin DS, Tolectin 600