1. Self-Care M. Wazaify, PhD Fall 2016

2. 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

3. The Self-Care Revolution Self-care: the type of self- intervention during which patients are responsible for their own health care without referral to the doctor (Hughes et al., 2001).

4. 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. !

5. 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

6. OTC DRUGS OTC drug products are those drugs that are available to consumers without a prescription. There are more than 80 therapeutic categories of OTC drugs, ranging from acne drug products to weight control drug products. 6

7. Characteristics OTC drugs generally have these characteristics:(They 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 7

8. 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

9. 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).

10. 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.

11. 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

13. What does FDA do with regard to OTC drugs? 1. Review 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

14. Drug Reclassification: Classes of drugs limited to Rx: Certain habit-forming drugs listed by name; Drugs not safe for use except under the supervision of a licensed practitioner because of toxicity or other potential for harmful effect, the method of use etc; Drugs limited to prescription under an NDA

15. Drug Reclassification: RxOTC Reclassification Criteria: The indication(s) for which the drug to be used on an OTC basis should be similar to those on Rx and must permit easy diagnosis and monitoring by the patient. A favourable adverse-event and drug interaction profiles, relatively low toxicity and a low potential for abuse. The drug should not have properties that make it impractical for OTC use, e.g. narrow therapeutic index.

16. 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

17. Selected List of reclassified drug ingredients (USA): IngredientUse Chlorpheniramine maleate Antihistamine CimetidineHeartburn Ephedrine sulphateBronchodilator IbuprofenAnalgesic PhenylpropanolamineDecongestant MiconazoleAntifungal Source: Handbook of Nonprescription Drugs, APhA. Table 3, page 11, Chapter 1.

18. Selected agents reclassified POM  OTC (USA) YearIngredientYearIngredient 1989Clotrimazole (topical)1976Chlorpheniramine 1979Hydrocortisone1995Cimetidine 1996Minoxidil1981Diphenhydramine 1994Naphazoline/antazo- line 1984Ibuprofen 1990Permethrin1995Ketoprofen 1981*phenylpropanolamin e 1996Nicotine polacrilex (gum) 1976Xylometazoline2003Omeprazole Reference: Basic and Clinical Pharmacology, Katzung (2004). Chapter 64

19. Selected agents reclassified POM  OTC (UK) Year of switch OTC productsDrug 1983Various (e.g. Nurofen ® ) Ibuprofen 1989Coughcaps ® Dextromethorphan (controlled release) 1991Nicorette ® Nicotine gum 2mg 1993Zovirax ® Acyclovir 1993Zirtek ® Cetirizine 1994Zantac 75 ® Ranitidine 1995Diflucan One ® Fluconazole (oral) 2001Levonelle ® Levonorgestrel adapted from Blenkinsopp and Bradley (1996); Bond, (2001)

20. Labeling & Packaging Issues

21. The need for NEW labeling? “switch” from Rx  OTC: the need for more sophisticated self-diagnostic and self-monitoring evaluation; The older population is increasing in the USA The new format helps pharmacists to readily find information on the label and point it to the patient

22. OTC “ Drug Facts” box Starting May 2002: Most OTC medicines manufactured after this date carried the new Drug Facts label However, certain products e.g. sunscreens were not required until 2006 Many manufacturers voluntarily used the new OTC label before the effective date

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28. The new Drug Facts labeling requirements do not apply to dietary supplements, which are regulated as food products, and are labeled with a Supplement Facts panel. 28

29. OTC Drug Labelling 1. Comprehensibility 2. Readability 3. Comprehensiveness

30. OTC Drug Labelling Comprehensibility: FDA regulations require that OTC drug labelling contain terms likely to be read and understood by the average consumer Counselling consumers on how to interpret product labels properly

31. OTC Drug Labelling Readability: 1. Provision of essential information in the same order and area 2. Uniformity in print size, pictograms, icons, colours, numbering, margins etc. 3. Special populations: a threshold print size of 4.5, has been suggested as minimum,while not optimal.

32. OTC Drug Labelling Essential Information (In order): 1. The product’s active ingredients including amounts 2. Purpose of the active ingredient 3. The uses (indications) for the drug 4. Specific warnings including when the product should not be used under any circumstances, and when it is appropriate to consult with a doctor or pharmacist. The warnings section also describes side effects that could occur and substances or activities to avoid. 5. Dosage instructions: when, how and how often 6. The product inactive ingredients

33. Limitations of package labelling: A package label can never address the infinite management issues associated with drug use,particularly in the comorbidity or polypharmacy. Thus, package labelling should acknowledge and encourage dialogue with health professionals (pharmacist, doctor).

34. Expiration Date Labeling 1 Expiration Date: is the date beyond which the product should not be used because the stability, potency, strength, or quality may have been affected over time FDA regulations govern how this date is determined and tested Most OTC products are required to include an expiration date on the labeling

35. OTC drug products that do not have a dosage limit and are stable for at least 3 years are exempt from the requirement to include the expiration date on the label e.g. topical drugs, skin protectants, lotions, and astringents

36. “Can I use it if expired?” Safety: Rarely does a safety issue arise Effectiveness: You should advise patients that the product probably has lost some of its ability to work as effectively as possible of the particular symptom or medical problem and it should be discarded !

37. The Tylenol Cyanide crisis! In 1982, Johnson and Johnson experienced a major crisis when it discovered that numerous bottles of its Extra-Strength Tylenol capsules had been laced with cyanide. By the end of this major crisis, seven people had passed away from the use of the laced Extra-Strength Tylenol!

38. Tamper-evident Packaging The FDA defines a tamper- resistant (?) package as: “one having an indicator or barrier to entry which, if breached or missing, can reasonably be expected to provide visible evidence to consumers that tampering has occurred”

39. Tamper-evident Packaging OTC drug products must have one or more barriers to entry that, if breached or missing from package, provide consumers with evidence that tampering may have occurred Packages must have unique designs or characteristics that can not be duplicated A statement that alerts consumers to this tamper-evident feature

40. e.g. “ For your protection, this bottle has an imprinted seal around the neck” You should encourage patients to look for tamper-evident features and if missing or breached to return the product to the pharmacy or store.

41. Tamper-evident Packaging The agency stresses that “tamper- proof” OR “tamper resistant” packaging is not possible. A labeling statement suggesting that the package is tamper-proof, as contrasted with tamper-resistant will be considered false and misleading.

42. Tamper-evident Packaging Examples Examples of acceptable packaging include but are not limited to: Film Wrappers- The film is wrapped around the entire product and must be cut or torn to open the package. Blister or strip packs- The individual compartment must be torn or broken to obtain the product. Bubble packs- The product and container is sealed in plastic and mounted in or on a display card. The plastic must be torn or broken to remove the package

43. Tamper-evident Packaging Examples Heat Shrink bands or wrappers-The bands, applied at the juncture of the cap and the container, must be torn or broken to open the package. Cellulose wet shrink seals are not considered an effective tamper-resistant mechanism. Foil, paper or plastic pouches-The product is enclosed in an individual pouch that must be torn or broken to obtain the product.

44. Tamper-evident Packaging Examples Bottle seals-Paper, foil or thermal plastic is sealed to the mouth of a container under the cap. The seal must be torn or broken to remove the product. Bottle seals applied with a pressure sensitive adhesive are no longer considered an effective tamper-resistant mechanism. Breakable caps-The container is sealed by a plastic or metal cap that either breaks away completely when removed from the container or leaves part of the cap attached to the container. The cap must be broken to open the container.

45. Tamper-evident Packaging Examples Sealed tubes-The mouth of a tube is sealed and the seal must be punctured to obtain the product. Aerosol containers -Aerosol containers are inherently tamper-resistant. All Metal and Composite Cans-The container cannot be pulled apart without visible evidence of entry. Note: Barriers made from readily obtainable material such as plain tape, saran wrap, aluminum foil, etc. must be printed to distinguish themselves from a substitute available from a retail product. Vitamins are currently excluded from tamper-resistant requirements because of their classification by the FDA as a food.

46. Marketing Issues Product Line Extensions Nonprescription Drug Advertising (HOME WORK+ quiz)

47. Product Line Extensions To capitalize on the loyalty created by consumer recognition and trust of a brand name New doses, formulations, combinations of ingredients or even a totally different therapeutic entity (e.g. device) of a brand name product that has been originally marketed as single ingredient at a specific dose to treat specific symptom