Y. W. Francis Lam, Pharm.D. FCCP University of North Texas Health Science Center Grand Round Rx to OTC Switch: Potentials, Challenges, and Initiatives

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1 1 Rx to OTC Switch Potentials, Challenges, and Initiatives Y. W. Francis Lam, Pharm.D., FCCP Professor of Pharmacology Educational Goal Attendees will have an overall understanding of Origin of OTC drug category Brief history of past and current drug laws relevant to OTC drugs Rx to OTC switch process Push for self-care. Regulatory perspectives Decision-making and recommendation NSURE Initiative Benefits versus risks Issues for switch consideration Safety, efficacy, use pattern Label comprehension and actual use What to do professionally Disclosures Y. W. Francis Lam, Pharm.D., FCCP served on the FDA NDAC Y. W. Francis Lam, Pharm.D., FCCP has no relevant financial relationships with commercial interests to disclose.

2 2 Crossroads of Pharmaceuticals & Toxicology 1937: Elixir of sulfanilamide 1961: Thalidomide 1906: Pure Food and Drug Act 1938: Food, Drug, & Cosmetic Act 1962: Kefauver- Harris Amendment 1972: Net benefit: Reasonable expectation OTC are safe and effective when used according to the label OTC Drugs Review and Classification Safety, efficacy of OTC marketed before 5/11/1972 >400,000 OTCs marketed at that time Tough, long regulation process Three-phase public rule-making process of reviewing active ingredients I (GRASE), II (not GRASE), III (cannot determine) Drug monograph for OTC approval Standards of acceptable active ingredients, doses, formulations, indications, warnings, directions for use Legal pathways for marketing OTC drug post 1938 Compliant with drug monograph Through the NDA process Rx to OTC Switch Marketing of a drug product that was once a Rx Same indication Same strength, dosage form Same dose, duration of use Same administration route Same population Rx drugs should be classified as OTC as long as they can be effectively and safely used as directed Case by case, evidence-based Consumer versus the drug Label comprehension studies Self-selection studies Actual use studies

3 3 Consumer Belief and Behavior OTC medications are rigorously monitored Nobody wants to call PCP every time s(he) has a cold, headache, or fever The Self-Care Movement Consumer Health Product Association Nov 2014 The Rx to OTC Switch Status Self-care philosophy a major driving force 73% Americans would rather treat themselves at home than to see a physician Consumer Health Product Association Rx medication treatment gap Number of people with a condition or disease who need treatment but do not get it Managed care Pharmaceutical companies OTC status as a component in product life cycle planning >700 switch over the last 35+ years, 8 since 2010

4 4 Benefits Consumer treatment access convenience HCPs Fewer patients with minor complaints More time for seriously ill patients counseling opportunities Payers Lower Rx reimbursement Fewer HCP visits for minor complaints Industry product life-cycle, brand awareness Expand target populations Risks Abuse/Misue Masking of disease. Delayed diagnosis $$$, possible utilization Concerns about risk of unnecessary use Difficult to track OTC use ( lost control ) medical care from mis-diagnosis medical care from mis-use OTC regulations demand for improved safety, efficacy data New Initiative for Rx to OTC Switch Non-prescription Safe Use Regulatory Expansion (NSURE) Task Force in 2012 Expansion of Conditions of Safe Use Ensure proper self-selection and self-care NOT establishing a third class of drug NOT changing the switch approval process NOT changing current rules governing Rx-only drugs Potential outcomes Bring untreated patients into healthcare system role of pharmacists and other HCPs Expanded portfolio of potential Rx to OTC switch NSURE Evaluate new strategies (technologies) Enabling self-care Smart phone- or tablet-based apps In-store kiosks Enabling healthcare professionals participation Electronically integrated system tracking test results and patient records for diagnosis, monitoring, and sharing Technology integration to patient access to OTC drugs AND healthcare professional involvement

5 5 Nobody wants to call PCP every time s(he) has a cold, headache, or fever Flexible access and appropriate self-care Who decide diagnostic criteria, appropriate tx? Impact on cost and reimbursement Practical issues Multi-lingual capability User skill and literacy level Internet connection availability Variable patient engagement eotc candidates for technology-enabled switches? The Guiding Principles Can condition be adequately self-diagnosed and successfully self-treated? Need for physician evaluation? Adverse consequences from misdiagnosis and delay in diagnosis Safety and efficacy of self-treatment for consumer use, under conditions of actual use Understanding of product directions for safe use Safety expectation. Ability to identify adverse effects, and determine when to seek professional help Ability to access treatment effect Understanding of expected benefit, and what to do if product not working

6 6 Nonprescription Drugs Advisory Committee (NDAC) One of > 50 FDA Advisory Committees that make recommendations Approval of drugs (Rx and OTC), biologic devices Regulations for governing process of drug approval Public forum included NDAC + 2 nd FDA Advisory Committee Introduction (COI of SGE). Public hearing Interested individuals can submit request to present opinion and information Presentations by sponsor and FDA Q&A. Discussion Advisory Committee Recommendations Committee members to consider Safety, efficacy Self-diagnosis and self-medication appropriate? Cholestyramine, acyclovir, anti-asthmatic Rx Discussion and recommendations Interpretation and deliberations of draft questions Questions for presenters Patient self-selection, label comprehension, potential intervention by study personnel or HCP, study reimbursement Broader issue of management of chronic disease Voting by members. Recommendation Considerations for Rx Switch to OTCs Safety (a RELATIVE matter) Benefits outweigh risks? - phenylpropanolamine Low potential for misuse (aspirin and NSAIDs) and abuse (dextromethorphan) Ease of diagnosis and treatment MI versus typical heartburn Proper labelling The law requires all OTC drug labels to have information in a standard format designed to give the user easy-to-find information Can the drug be labeled in a way that can be used safely by the public Patient education and counseling. Potential DDI

7 7 The Other Side of the Coin Disadvantage are not the OTC drugs themselves It s the people! If 1 pill is good then 2 pills should be twice as good Ibuprofen 200 mg 1938 Act: Directions likely versus must be understood Special populations Non-English speaking Blind Learning disability Companies not held responsible for every possible situation of use Five deaths from abuse of DM sold over the internet J Anal Toxicol 2009;33:99-103

8 8 incidence of MRSA skin infections following OTC availability of topical antibiotic 5 years after initial introduction for clinical use in % rate in first year of use (1991 to 1992) 16% rate from 1996 to 1997, 28% reported in % community versus 19.8% hospital (p < 0.05) resistance after OTC switched back to Rx only 18% in 1993 to 0.3% in Australia The Other Side of the Coin Is adequate directions for use sufficient? Can consumer read the label? 90 to 95% of consumers read the Drug Facts label Only 16% read the entire label! Can they understand the label? Extent of comprehension about label? Most read the label selectively Often pay insufficient attention to the active ingredients and the safety information Amount of acetaminophen

9 9 The Other Side of the Coin Do they follow the label? 50% of respondents who reported taking an OTC pain reliever in 2009 Not concerned about potential side effects Do they achieve desirable outcome? The Statin examples Static on Statin Statins manufacturers have petitioned FDA for Rx-to-OTC status Lovastatin 2000, 2005, 2007; pravastatin 2000, 2005 Atorvastatin Phase 3 actual use trial to simulate OTC use Take appropriate dose, self-monitor, and appropriate, necessary medical action Requires proper diagnosis, careful monitoring Safety AND misuse Missed opportunity for counselling of possible lifestyle therapies Exercise, diet Gut Wall Efflux ABC transporter (Pglycoprotein Liver To Systemic Circulation Feces CYP3A4-mediated metabolism Hepatic First Vein Pass Effect

10 10 Ways to Improve Safety Recognition of at-risk patients OTC = risk-free believer, elderly, children Multiple Rx and/or OTC regimens Chronic medical conditions Role of healthcare professionals Help to make proper OTC choices and/or referrals Current medication regimens and co-morbidities Role of pharmacy education Refresher course or CE on OTC? Is OTC selection part of clinical practice? Medication Therapy Management Program BTC option? Roles of HCPs Improve communication skills Encourage patients to seek guidance from HCPs Encourage and support appropriate self-care Help patient select safe and effective product(s) Appropriateness of self-treatment versus seeking further medical care Treatment protocol/guidance prn Review all medications taken by patient Educate patients, community, friends, and family about OTC products Plan B as an emergency contraceptive. The sooner it is taken, the better it works. Specifics on Patient Education Emphasize on READING label THOROUGHLY Emphasize on ADHERING to recommended DIRECTIONS Encourage on ASKING questions Selection and use Counsel against PERCEIVED need/advantage of multiple-ingredient combination Check active ingredients Counsel on DDI OTC intranasal corticosteroid inhalers Triamcinolone, fluticasone, budesonide

11 11 EDUCATING Consumers Plan B CARE educational program Beyond 2016? Drug information on available OTC for self-care Selection via iterative algorithm (BEYOND Drug Facts) Mandatory HCP counseling for chronic and/or asymptomatic health condition? Comprehension of appropriate use Type of verification needed (initial and refill)? Decision algorithm for inappropriate use/ineligibility? Q&A? Available alternatives? Ensuring F/U for appropriate care? Assessment of outcome, adherence, ongoing use? More Points to Consider idevice and idata What will (should) happen to the unique consumer data collected? What should be shared? When? How? Who will control this information?

12 12 Thank you!