CH - 1 Linda Suydam, DPA CHPA Overview and Approach

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1 CH - 1 Linda Suydam, DPA CHPA Overview and Approach President Consumer Healthcare Products Association

2 CHPA Acetaminophen Task Group CH - 2 Bayer Healthcare LLC GlaxoSmithKline McNeil Consumer Healthcare Novartis Consumer Health, Inc. Perrigo Company The Procter & Gamble Company Schering-Plough Health Care Products, Inc. Wyeth Consumer Healthcare

3 Today s Agenda CH - 3 CHPA Acetaminophen Task Group Overview and Approach Safety of OTC Combination Products Linda Suydam, DPA President Consumer Healthcare Products Association James H. Lewis, MD, FACP, FACG Professor of Medicine Division of Gastroenterology Director of Hepatology Georgetown University Medical Center Research and Education Initiatives and Commitments Linda Suydam, DPA President Consumer Healthcare Products Association

4 Categories of Acetaminophen Misuse CH - 4 OTC Single Ingredient OTC Combination Rx Narcotic/APAP Combination

5 Categories of Acetaminophen Misuse CH - 5 OTC Single Ingredient Suicide Unintentional Unknown OTC Combination Suicide Unintentional Unknown Rx Narcotic/APAP Combination Suicide Unintentional Unknown

6 Categories of Acetaminophen Misuse CH - 6 OTC Single Ingredient Suicide Unintentional Unknown OTC Combination Suicide Unintentional Unknown Rx Narcotic/APAP Combination Suicide Unintentional Unknown

7 Interventions Must Involve OTC and Rx Acetaminophen Manufacturers CH - 7 % of Overall Dosage Units (2008) 52% OTC Products 48% Rx Products IMS Health, MIDAS May 2009; 24 billion Dosage Units of Acetaminophen Containing Medicines Sold (2008)

8 OTC and Rx Acetaminophen CH - 8 % of Overall Dosage Units (2008) 27% 25% OTC Products w/o McNeil 25% 27% McNeil Products 48% 48% 48% Rx Products IMS Health, MIDAS May 2009; 24 billion Dosage Units of Acetaminophen Containing Medicines Sold (2008)

9 CHPA Position CH - 9 Continued OTC availability of combination medicines containing acetaminophen Pediatric dosing devices and dosing directions on label for < 2 years Supports 1000mg single dose / 4000mg maximum daily dose Comprehensive OTC and Rx research and education program

10 Acetaminophen-Related Deaths CH % Rx medicines 40% OTC medicines Of all cases 82% suicide and intentional misuse 6% OTC combination products FDA Briefing Book, 2009; AERS 2005

11 Voluntary Label Enhancements Since 2002 CH - 11 Listing acetaminophen ingredient on principal display panel (front) Highlighting active ingredients on Drug Facts label for acetaminophen Adding a liver damage warning Adding concomitant use warning

12 Additional Industry Actions CH - 12 Strengthened liver warning Implementing FDA s final rule CDC Pediatric Program 2008-Present

13 OTC Combination Medicines Provide Meaningful Health Benefits CH - 13 Two types of combination products More effective treatment of same symptom pain Concurrent treatment of multiple symptoms including pain or fever

14 Increase in Pain Relief with Combination Analgesics CH - 14 Proportion with 50% pain relief (%) Aspirin 500mg/acetaminophen 400mg/caffeine 100mg Acetaminophen 1000mg Aspirin 1000mg Placebo :00 0:30 1:00 1:30 2:00 2:30 3:00 3:30 4:00 Diener et al Time (hours)

15 Frequency of Cold Symptoms in Adults (%) CH - 15 Symptoms Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 Day 7 Nasal Congestion Runny Nose Sore Throat Cough Sneeze Headache adapted from Witek et al. 1992

16 Prescription Combination Products Reduce Risk of Dosing Errors CH - 16 Proper dosing Reduced pill burden and costs Improved outcomes 9 trials including 20,000 people meta-analysis Reduced risk of non-compliance by 25% Bangalore, Messerli 2007

17 CHPA Task Group Recommendations CH - 17 Supports continued OTC availability of combination medicines containing acetaminophen Supports pediatric dosing devices and dosing directions on label for < 2 years Supports 1000mg single dose / 4000mg maximum daily dose Supports a comprehensive OTC and Rx research and education program

18 Additional External Experts CH - 18 Franz H. Messerli, MD Medical Director Division of Research St. Luke's-Roosevelt Hospital Center Stephen Silberstein, MD Director Jefferson Headache Center Thomas Jefferson University Hospital Saul Shiffman, PhD Professor of Psychology Psychiatry, Pharmaceutical Sciences University of Pittsburgh

19 CH - 19 Safety of OTC Acetaminophen Combination Products James H. Lewis, MD, FACP, FACG, AGAF Professor of Medicine Director of Hepatology Georgetown University Medical Center Washington, D.C.

20 Databases Reviewed for Fatalities Associated with Acetaminophen CH - 20 Toxic Exposure Surveillance System (TESS) Adverse Event Reporting System (AERS) 2005

21 TESS Fatalities (2005 and 2007) OTC Combination/OTC Single/Rx Combination CH - 21 Bronstein et al 2006 Bronstein et al 2008

22 AERS Fatalities (2005) (Sample of 72 cases analyzed) CH % cause of death unknown 51% cause of death known 25% hepatic events 26% cardiac respiratory event FDA Briefing Book 2009

23 AERS Fatalities (2005) Associated with OTC Combination/ OTC Single/Rx Combination % Fatalities CH % 33% 6% FDA Briefing Book 2009

24 TESS 2005 & 2007 and AERS 2005 Unintentional vs. Intentional CH - 24 All 3 Product Categories OTC Combinations Suicide 62% (n=117) 70% (n=14) TESS 2005 Unintentional 18% (n=34) 5% (n=1) Unknown 20% (n=37) 25% (n=5) Suicide 59% (n=131) 78% (n=18) TESS 2007 Unintentional 19% (n=42) 13% (n=3) Unknown 22% (n=49) 9% (n=2) AERS 2005 Suicide and Intentional Misuse 82% (n=59) 80% (n=4) Unintentional 6% (n=4) 20% (n=1) Unknown 12% (n=9) 0% (n=0)

25 Disproportionately Low Rate of Fatal Events Associated with OTC Combination Products CH - 25 % Fatalities/Units Sold TESS 2005 AERS 2005 IMS % 51% 38% 33% 34% 39% 27% 11% 6%

26 CH - 26 Conclusions Overall low incidence of cases OTC combination products disproportionately lower Data do not support removing acetaminophen from OTC combination products

27 CH - 27 Linda Suydam, DPA Research and Education Program President Consumer Healthcare Products Association

28 New Research and Education Program CH - 28 Industry-wide, industry-supported Specifically focused on acetaminophen Include Rx partners Program reinforces new labels Partnerships through healthcare consortium

29 Multiplying Our Efforts through a Healthcare Consortium CH - 29 Alliance for Aging Research American Association of Family Physicians American Pharmacists Association Consumer Healthcare Products Association National Association of Boards of Pharmacy National Association of Chain Drug Stores National Council on Patient Information and Education U.S. Food and Drug Administration

30 Step-Wise Research and Education Program CH - 30 Step 1: Conduct Qualitative and Quantitative Research Step 2: Develop Research-Based Education and Measurement Objectives Step 3: Test Messages and Tactics Step 4: Execute Program Step 5: Measure Impact and Refine

31 Step 1: Conduct Qualitative and Quantitative Research CH - 31 Identify cognitive, behavioral factors Identify potential target populations Qualitative research complete Heavy drinkers Chronic pain sufferers Information will serve as a baseline

32 Gather Quantitative Data for Further Information CH - 32 Reduce number who don t follow label Exceeding daily maximum dose Exceeding single dose Speeding up dosing interval Concomitant use Heavy drinking and use Target user populations Baseline of 2000 adults

33 Step 2: Develop Research-Based Education and Measurement Objectives CH - 33 Change how adults take and use acetaminophen Assess and change attitudes Assess and change reported behaviors Measure impact against objectives

34 Step 3: Test Messages and Tactics CH - 34 Test and validate all program elements Messages Communications tactics, e.g. icon

35 Step 4: Execute Program CH - 35 Online In Store Patient Care Partners Labeling Media

36 Step 4: Execute Program CH - 36 Online In Store Patient Care Partners Labeling Media

37 Step 4: Execute Program CH - 37 Online Acetaminophen: Tips for Safe Use In Store Patient Care Partners Labeling Media To learn more, please visit OTCsafety.org Facts about the Safe Use of Children s Acetaminophen Containing Products

38 Step 4: Execute Program CH - 38 Online In Store Patient Care Partners Labeling Media

39 Step 4: Execute Program CH - 39 Online In Store Patient Care Partners Labeling Media

40 Step 4: Execute Program CH - 40 Online In Store Patient Care Partners Labeling Media

41 CHPA Research and Education Timeline CH - 41 June: Conduct Qualitative Research August: Evaluate Research Nov/Dec: Rollout Program Dec 2010: Field Research July: Hold Consortium Meeting Conduct Quantitative Research Sept/Oct: Test Messages/ Tactics June 2010: Semi- Annual Research

42 CHPA Stop Cough Medicine Abuse Campaign CH - 42

43 CHPA Stop Cough Medicine Abuse Campaign CH - 43 Efforts starting to build awareness Shaping perception of risk Increasing parent-teen conversations on dangers of drug abuse

44 CHPA s Position and Commitment CH - 44 Supports continued OTC availability of combination medicines containing acetaminophen Supports pediatric dosing devices and dosing directions on label for < 2 years Supports 1000mg single dose / 4000mg maximum daily dose Supports a comprehensive OTC and Rx research and education program