1. Self-Care & OTC medications

2. Self-care

3. Self-medication

4. Brain-Storming! Self-care, Self-treatment or Self- medication? Smoking cessation Regular exercise Healthy eating Hot-water bottle A hot drink to sooth a sore throat 2 tablets of paracetamol bought from the pharmacy without a prescription 1 tablet of diazepam already available at home Taking antihypertensive medication regularly to control BP

9. Characteristics of OTC drugs: OTC drugs have to meet ALL of the characteristics to be eligible for OTC approval: Their benefits outweigh their risks The potential for misuse and abuse is low Consumer can use them for self-diagnosed conditions They can be adequately labeled Health practitioners are not needed for the safe and effective use of the product 9

10. The Self-Care Revolution >100,000 OTC products are available to consumers in the US to treat > 400 ailments. OTC drugs account for ~ 60% of all the medications in the US. > 100 classes (therapeutic categories) of OTC drugs

12. Why the pharmacist? The community pharmacist is uniquely qualified The pharmacist is the most accessible health professional and the only health professional who receives formal- university-based education and training in non-prescription drug pharmacotherapy and is perceived very favourably by the public. !

13. Pharmacist-patient interaction is vital for optimal OTC pharmacotherapy: big variety of product choices and misleading marketing message unclear, limited and difficult-to-read package labelling comorbidity polypharmacy

15. Health problems most likely to be treated with OTC drugs = minor ailments Headache Common cold Muscle aches and pains (including sprains & strains) Dermatological conditions (acne, cold sores, dandruff, dry skin, athlete's foot Minor wounds (e.g. cuts and scratches) Premenstrual and menstrual symptoms Upset stomach Sleeping problems

16. Patients should be viewed as individuals with unique backgrounds and needs

17. Initial encounter with a patient seeking assistance with OTC drug use: Pharmacist should: Assess, by interview and observation, the patient’s physical complaint/symptoms and medical condition Differentiate self-treatable conditions from those requiring medical attention Advise and counsel the patient on the proper course of action (i.e. no treatment with drug therapy, self-treatment with OTC products, or a referral).

18. If self-treatment with one or more of OTC drugs is appropriate: 1. Assist in OTC product selection 2. Assess patient risk factors: (contraindications, warnings, precautions, age, organ function) 3. Counsel the patient regarding proper drug use: (e.g. dosage, administration, monitoring parameters) 4. Maintain a patient drug profile that includes OTC as well as Rx drugs.

19. If self-treatment with one or more of OTC drugs is appropriate: 5. Monitor drug therapy for: allergies or hypersensitivities, ADR, D-D, an appropriate response to therapy, signs and symptoms of drug use and/or dependency 6. Discourage the use of fraudulent and “quack” remedies 7. Assess the potential of OTC drugs to mask the symptoms of a more serious condition 8. Prevent delays in seeking appropriate medical attention

20. What does FDA do with regard to OTC drugs? 1. Reviews OTC products for safety and effectiveness 2. Responsible for establishment of regulations of OTC drugs labeling 3. Responsible for the reclassifying process of OTC drugs from prescription status

21. Food, Drug, and Cosmetic (FD&C) Act of 1938 The most important piece of legislation in pharmaceutical history Created the FDA Required pharmaceutical manufacturers to file a new drug application (NDA) with each new drug before marketing Gave FDA the power to conduct inspections of manufacturing plants to ensure compliance Required only that drugs be safe for human consumption NOT that they be effective or useful for the purpose for which they were sold. 21

22. FDA Regulation of Drugs: 1951: an amendment to the FD&C Act established two classes of drugs: prescription and non-prescription (OTC) Prior to that time, manufacturers were free to determine to which category their drug product belonged Drugs that could be used safely without medical supervision/adequate labeling for use  marketed without Rx

23. In 1962: a major amendment to the FD&C Act required that drug products be proven not only safe but also effective for their intended uses. FDA Regulation of Drugs: As a result: FDA undertook a review of the effectiveness of the 4500 new drug products, including the 512 OTC drugs that had been approved for safety since 1938.

24. FDA Regulation of Drugs: 1972: FDA initiated a massive scientific review of 700 active ingredients in 300,000 OTC drug formulations to ensure that they were: safe & effective & bore fully informative labeling  This “ OTC Drug Review ” is still underway. The aim of the 1972 review is to establish OTC monographs

25. Why Drug Reclassification? Shift some of the responsibility and cost of healthcare to consumers Save GPs’ time for more serious conditions Increase patients’ empowerment Extend the role of community pharmacists

26. Drug Reclassification: RxOTC

27. (cont’d)

28. Selected List of reclassified drug ingredients (USA):

29. Why clinicians must be familiar with OTC products? 1. Many OTC products are effective in treating common ailments and at less cost, 2. Many active ingredients contained in OTC drugs may worsen existing medical conditions or interact with prescription medication. E.g. antacids bind many drugs, thus reduce absorption. Cimetidine inhibits hepatic microsomal drug-metabolizing enzymes. 3. Misuse or abuse of OTC products may actually produce significant medical complications

30. Note: Many of the more potent OTC ingredients are hidden in products where their presence would not ordinarily be expected: Examples: 1. Alcohol (% ethanol) in cough syrups, cold preparations, and mouthwashes 2. Antihistamines in analgesics, menstrual products, sleep aids, 3. Aspirin & other salicylates: in antidiarrheals, cough/allregy preparations 4. Caffeine in analgesics, menstrual products and stimulants

31. Cont’d 5. Benzocaine in antitussives/lozenges, dermatologic preparations, hemorrhoidal products, toothache, cold sore and teething products 6. Sodium in analgesics, antacids and laxatives 7. Sympathomimetics in analgesics, asthma products, cough, cold and allergy preparations, hemorrhoidal products and sore throat products

32. Homework Drug interactions with OTC (Table 1- 3, page 12) Adverse effects of some inactive ingredients (Table 1-4, page 13)