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

It’s Your Choice for Delivering
Useful CMI – Either You Do It or the
Government Will
ASAP 2005 Midyear
Industry & Technology Issues
Conference
June 16 -18, 2005
Galloway, NJ
Contact Information
Ray Bullman
Executive Vice President
National Council on Patient Information and Education
4915 Saint Elmo Ave., Suite 505
Bethesda, MD 20814-6082
[email protected]
(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” criteria
for 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.
2.
3.
4.
5.
6.
Poor print size  good print size
Poor print quality good print
quality
Poor spacing between lines good
spacing between lines
Poorly organized   Well organized
Poor length  Good length
Unattractive  Attractive **
Consumer Rating Process
(on a scale of 1 to 5)
7.
8.
9.
10.
11.
12.
Unclear  Clear
UnhelpfulHelpful
Incomplete  Complete
Scary  Reassuring **
Hard to find impt. Info.  Easy to find
impt. information
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/0510445.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 Guides
Manufacturer-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 Guides
Manufacturer-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