1. Self-Care and OTC Pharmacotherapy
Self care: the action taken by the individuals to optimise their health and wellbeing both physical and mental.
The Self-Care Revolution
20th and 21st century:
higher education, health help books, magazines, radio and TV programmes, internet etc.
M. Wazaify, PhD
Spring 2017

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
This term (self care) embraces both the prevention of illness, and the self-treatment of minor ailments as well as long-term conditions that have been diagnosed by a doctor.
What is the difference between:
Drug vs. Medicine
Self-Care and Self Medication

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).
In the twenty first century, consumers desire and are taking a much more informed and active role in managing their own health. People are trusted to use dangerous electrical appliances and toxic household chemicals at home. Is dealing with drugs that much different?
Websites:
Everything you want to know about self-medication and health maintenance at your fingertips
What is the difference between: self-care and self-medication?
Drug and Medicine?
Example:
Self treatment: home remedy, OTC drug or Rx drug already at home.

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.
The pharmacist should differentiate him/herself from other providers of the commodity by offering value-added informational services.
The community pharmacist is uniquely qualified:
In-depth knowledge of pathophysiology, pharmacology, medicinal chemistry, pharmacokinetics and pharmaceutics
Access to electronic and printed databases
Accessibility to the public

5. big variety of product choices and misleading marketing message
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
There is a difference between providing information to and educating patients. Validation of understanding is critical. Patients should be strongly encouraged to comment and ask questions.
Package labelling are often limited in their depth of the message it communicates. It can never address all the informational needs of the patient for all clinical circumstances and it can be difficult to read.
Comorbidity and polypharmacy create infinite special considerations in ensuring the safe, appropriate and effective use of OTC drugs.

6. OTC DRUGS
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.  
Over-the-counter (OTC) drugs play an increasingly vital role in most health care systems.

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
Please provide examples for each characteristic: (i.e. narcotics would never be eligible for OTC approval since the potential for misuse and abuse will never be low)

8. 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

9. Drug Reclassification: Rx OTC
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.

10. 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
“ I can treat my headache for a dime. When I go to my doctor, my co-payment for the office visit is $15 and my co-payment on prescription drugs is 5 for generics and $15 for brand-name drugs. I try to take care of myself when I can”
Self-medication with OTC drugs is usually the initial level of care in a tiered system of health care.

11. Selected List of reclassified drug ingredients (USA):
Use
Chlorpheniramine maleate
Antihistamine
Cimetidine
Heartburn
Ephedrine sulphate
Bronchodilator
Ibuprofen
Analgesic
Phenylpropanolamine
Decongestant
Miconazole
Antifungal
Source: Handbook of Nonprescription Drugs, APhA. Table 3, page 11, Chapter 1.

12. Selected agents reclassified POM OTC (USA)
Year
Ingredient
1989
Clotrimazole (topical)
1976
Chlorpheniramine
1979
Hydrocortisone
1995
Cimetidine
1996
Minoxidil
1981
Diphenhydramine
1994
Naphazoline/antazo-line
1984
Ibuprofen
1990
Permethrin
Ketoprofen
1981*
phenylpropanolamine
Nicotine polacrilex (gum)
Xylometazoline
2003
Omeprazole
Reference: Basic and Clinical Pharmacology, Katzung (2004). Chapter 64

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

14. 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

15. 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).

16. If self-treatment with one or more of OTC drugs is appropriate:
Assist in OTC product selection
Assess patient risk factors: (contraindications, warnings, precautions, age, organ function)
Counsel the patient regarding proper drug use: (e.g. dosage, administration, monitoring parameters)
Maintain a patient drug profile that includes OTC as well as Rx drugs.
If self-treatment with one or more of OTC drugs is appropriate, the pharmacist is positioned and intellectually equipped to perform the following patient care services:

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

18. Labeling & Packaging Issues

19. 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
Before simplifying the OTC label, The FDA conducted extensive research on how consumers use OTC drug labels. One major problem has been the readability of OTC drug labels, especially for older Americans, who purchase almost 30 percent of the nonprescription drugs sold in the US.
The FDA also found that consumers thought words like “indications”, “precautions” and “contraindications” were too technical and confusing.
The FDA established an implementation plan, dependent on the monograph and the approval status of the product, most OTC labels must use the Drug Facts format by 2006;
An OTC product that lacks the labeling after its required implementation plan date may be considered misbranded and subject to the same enforcement approach that FDA can take with other misbranded drugs: issuance of a warning letter, product seizures and injunctions

20. Previously, information about product directions, warnings and approved uses has appeared in different places on the label depending on the OTC product and brand. Finding information about inactive ingredients has also been a challenge for those who may be allergic to an ingredient in a drug product.
Patterned after the Nutrition Facts food label, the new Drug Facts label uses simple language and an easy-to-read format to help people compare and select OTC medicines and follow dosage instructions

24. 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.

25. OTC Drug Labelling Comprehensibility Readability Comprehensiveness
During the design of the label, special effort should be directed to ensure adequate comprehensibility, readability and comprehensiveness

26. 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
Labels on OTC drug containers and packaging should provide detailed information, so that consumers can properly select and use the drugs. The message should not be constrained by the size of the container or package.
To standardize labelling information for the average consumer is challenging: significant percentage of the population are “below average” in its ability to read, comprehend, discern and act properly on label information.I.e. 20% of the US adult population functionally illiterate (e.g. reading is below fifth grade level, expressing difficulty in reading and accurately comprehending a food package label or restaurant menu)

27. OTC Drug Labelling Readability:
Provision of essential information in the same order and area
Uniformity in print size, pictograms, icons, colours, numbering, margins etc.
Special populations: a threshold print size of 4.5, has been suggested as minimum,while not optimal.
Readability= how easy it is to read the text.
To increase the readability of the drug labelling:
Essential information should be provided in the same order and in the same area of every drug label.
Uniformity in the print size, pictograms, icons, colour, type size, type spacing, margins, paragraphs, upper vs. lower case lettering, bulleting, numbering and language simplification.
Special populations with impaired vision. E.g. a 45 year old needs 50% more light than a 20 year old and a 75 year old needs three times as much light as a 20 year old. We cannot control light! But we can compensate for low light and poor visual acuity by using large print for the most critical messages.

28. OTC Drug Labelling Essential Information (In order):
The product’s active ingredients including amounts
Purpose of the active ingredient
The uses (indications) for the drug
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.
Dosage instructions: when, how and how often
The product inactive ingredients
Including inactive ingredients including the amount in each dosage unit
Only the FDA approved indication, linking the ingredient with its specific indication
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.
Proper way to take the medication: when, how and how often to take the medication
Caution pregnant or breast feeding women to check with the health professional before taking the medication. Paediatric and geriatric populations may have special info needs (e.g. dosing and safety closures)- removal from reach of children, what to do in case of accidental OD?, S.E, D-D,
If symptoms persist or worsen within a relatively short period of time, you should consult with a health professional
Name, address, toll-free telephone number
Should remain distinguishable over time
Label Flags: when significant changes are made in a product (e.g. formulation) or its label information >> in prominent type, apparent in package.

29. 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).
“ If you still have any questions about this product, talk to your doctor, pharmacist, or other health-care professional”

30. 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

31. e.g. topical drugs, skin protectants, lotions, and astringents
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
Labels must also include any special storage conditions or requirements for the product
Pharmacist should remind patients to check their OTC product labels periodically for expiration date

32. “Can I use it if expired?”!!
“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

33. 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!
In response to the September 1982 cyanide poisonings in Chicago, the Food and Drug Administration (FDA) has issued tamper-resistant packaging requirements for all over-the-counter (OTC) drug products and certain cosmetic products, excluding dermatologics (products applied to the skin), dentifrices and insulin.

34. 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”
Tamper-resistant packaging may involve immediate container/closure systems or secondary container carton systems.
The OTC drug products that are covered by these regulations include oral, nasal, otic, ophthalmic, rectal, and vaginal drug products.
Cosmetic products covered include liquid oral hygiene products (mouthwash), and vaginal products.

35. 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

36. 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.
It is not acceptable to have the tamper-resistant labeling solely on package inserts and
all tamper-resistant features must be referenced in the labeling statement.
If the tamper-evident system is an outer container, the inner container must bear a statement that it should be in the outer container at the time of purchase.

37. 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.

38. 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

39. 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.

40. 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.

41. 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.
Saran polyvinylidene chloride or Saran resins and films (called PVDC) have been wrapping products for more than 50 years. Saran works by polymerizing vinylide chloride with monomers such as acrylic esters and unsaturated carboxyl groups, forming long chains of vinylide chloride. The copolymerization results in a film with molecules bound so tightly together that very little gas or water can get through. The result is a barrier against oxygen, moisture, chemicals and heat-qualities used to protect food, consumer and industrial products. PVDC is resistant to oxygen, water, acids, bases, and solvents.

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

43. 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
Such extensions can create consumer confusion and inappropriate selection and use
Pharmacists must be familiar with the range of products within a brand name to recommend safely and correctly and to counsel patients on these products
Some product line extensions that carry the original brand name as prefix retain the active ingredient of the original product, but strengths may vary (e.g. Nytol and Nytol-one-a-night)
Some manufacturers may continue to use the brand name as the prefix but use none of the active ingredients of the original product and attach a suffix for differentiation (e.g. cold & flu, Extra, non-drowsy, sinus, Day/Night, and Plus)