OTC DRUGS Flashcards by Hanabi San

Over-the-Counter Drugs

Nonprescription drugs

Use for short-term treatment of common minor illnesses.

More than 300 000 over-the-counter (OTC) drugs available

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OTC drugs regulated by Health Canada’s Food and Drug Regulations

Safety and efficacy

Appropriate labelling standards

Reclassification

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Nonprescription drugs

More than 80% of Canadians use OTCs

Most are unscheduled drugs that can be sold without professional supervision

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Schedule

III

Schedule I (prescription)

Schedule II (restricted access such as behind counter)

Schedule III (pharmacy only, nonprescription, pharmacist must be available for assistance)

Schedule IV (those that may be prescribed by a pharmacist)

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Criteria for OTC Status

III

I: Indications for use (diagnose condition and monitor effectiveness)

II: Safety Profile (Ae profile, limited interaction with other drugs, kow potential for misuse, high therapeutic index)

III: Practicality for OTC use (easy to use and monitor)

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I: Indications for use

Consumers must be able to

diagnose conditions
Monitor effectiveness

The benefits of correct usage must outweigh risks

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II: Safety Profile

Drugs must have:

Favourable adverse event profile

Limited interactions with other drugs

Lowe potential for misuse

High therapeutic Index

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III: Practicality for OTC use

Drugs must be:

Easy to use and monitor

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Process for Reclassification

Submission of a “switch” application to National Drug Scheduling Advisory Committee (NDSAC)

Review of clinical-trial results and safety data submitted to Health Canada

Approval of active ingredient for nonprescription status

Removal from Schedule F of the Food and Drug Regulations

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Reclassified OTC Drugs

Analgesics

Analgesics
1. acetaminophen, codeine 8 mg, caffeine (Tylenol No.1®)

acetylsalicylic acid, codeine 8 mg, caffeine (222®, AC&C®)
ibuprofen (Advil®, Motrin®)
naproxen sodium (Aleve®, Anaprox®, Naprelan®, Naproxen®)

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Reclassified OTC Drugs

Histamine blockers

H1-receptors

cetirizine (Aller-Relief®, Reactine®)

2.chlorpheniramine maleate (Chlor-Tripolon®)

3.diphenhydramine hydrochloride (Benadryl®)

loratadine (Claritin®)

H2-receptors

famotidine (Pepsid®)
ranitidine (Zantac®)

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Reclassified OTC Drugs

Smoking Deterrents

nicotine gum (Nicorette®)

nicotine transdermal patch (Nicoderm®, Habitrol®)

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Reclassified OTC Drugs

Topical Medications

clotrimazole (Canesten®)

miconazole nitrate (Micazole®, Monistat®)

minoxidil (Minox®, Rogaine®)

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Advantages of OTC

Convenience of self treatment of minor ailments

Decreased health care costs when drug is paid out of pocket

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Disadvantages
of OTC

May postpone effective treatment of serious or life-threatening disorders

May delay treatment of serious or life-threatening disorders

May relieve symptoms of a disorder but not the cause

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Use of OTC Drugs: Potential Hazards

Toxicity
**May have their own toxicity profiles

Possible interactions with current prescription medications

Misuse

Use should be for short-term treatment of common minor illnesses

Interactions with current prescription medications may occur

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*Patient Education is still helpful!

I.E. Hepatotoxicity is associated with excessive acetaminophen use

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Consumer Use of Natural Health Products

Therapeutic agents for treatment and prevention of diseases

Proactively to preserve health and wellness and “boost” one’s immune system

Adjunct therapy to support conventional pharmaceutical therapies

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Natural Health Products Examples

Dietary Supplements: Vitamin and mineral supplements – health food bars, shakes

Herbs – teas, oils, ointments, dried extract

Homeopathy – microdose of substance thought to cause disease

Traditional Chinese, Ayurvedic, and other traditional medicines

Probiotics

Other products like amino acids and essential fatty acids

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Natural Health Products

Require a product licence from Health Canada

Regulated by the Natural Health Products Directorate (recent new name Natural and Non-prescription Health Products Directorate NNHPD)

Homeopathic Meds receive a DIN – HM followed by a product number

Classified according to level of risk (see next slide)

Also have labelling requirements: product name, amount of product, conditions for use or purpose, dose amount, warnings, cautionary statements, contraindications, possible adverse reactions

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Natural Health Products:Consumer Use

71% of Canadians regularly take vitamins and minerals, herbal products, and homeopathic medicines

Natural health products treat minor conditions and illnesses (e.g., coughs, colds, stomach upset)

Little is known about potential safety concerns

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National Center for Complementary and Alternative Medicine (NCCAM)

Complementary medicine (integrative medicine): simultaneous use of both conventional and alternative medicine

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NCCAM classifies complementary and alternative medicine

Alternative medical systems

Mind–body interventions

Biologically based therapies

Manipulative and body-based methods

Energy therapies

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Homeopathy

Popular form of alternative medicine

Based on belief that a disease can be treated by the administration of a microdose of a substance thought to cause the physical signs of that disease

Thought to stimulate the body’s immune defences

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Commonly Used Herbal Products

Aloe Feverfew Gingko biloba Goldenseal St. John’s wort Valerian Chamomile Echinacea Garlic Ginseng Hawthorn Saw palmetto Black cohosh Ginger

Conditions Treated with Herbal Products

Anxiety Colds and cough Depression Headache Insomnia Ulcers Premenstrual syndrome Arthritis Constipation Fever Infection Stress Weakness Intestinal disorders

Safety

Caution for allergic reactions, toxic reactions, and adverse effects Drug interactions Under-reporting of natural health products (NHPs) to health care providers NHP Canada’s Vigilance Program Indiscriminate or excessive use of NHPs potentially dangerous

Chamomile: Increased potential for bleeding with?

anticoagulants

What causes decreased elimination of many drugs excreted by the kidneys

Cranberry

Possible interference with or counteraction to immunosuppressant drugs and antivirals

Echinacea

Possible interaction with antipsychotic drugs

Evening primrose

Possible interference with hypoglycemic therapy and the anticoagulant warfarin sodium (Coumadin®)

Garlic

May increase risk of bleeding with use of anticoagulants (warfarin sodium, heparin sodium) and antiplatelets (aspirin, clopidrogrel)

Gingko biloba

At high dosages, possible interference with cardiac, antidiabetic, or anticoagulant drugs

Ginger root

Grapefruit 4

Decreases metabolism of drugs used for erectile dysfunction Decreases metabolism of estrogens and some psychotherapeutic drugs (benzodiazepines, sertraline) Increases risk of toxicity of immunosuppressants, HMG-CoA reductase inhibitors, and of some psychotherapeutic drugs (pimozide, escitalopram) Increases intensity and duration of effects of caffeine

May lead to toxic levels of cardiac glycosides (e.g., digitalis)

Hawthorn

May increase the effect of barbiturates and alcohol

Kava

May change the effects of hormones in oral contraceptive drugs, patches, or hormonal replacement therapies

Saw palmetto

May lead to serotonin syndrome if used with other serotonergic drugs; Strong CYP 3A4 inducer, resulting in decreased concentrations of many drugs

St. John’s wort

Increases central nervous system depression if used with sedatives

Valerian

Medical Use of Marihuana

Herb with a long history of use Health Canada Marihuana Medical Access Regulations (MMAR) in 2003 to allow access to and possession of marihuana for individuals suffering from specific grave and debilitating illnesses, while protecting public safety MMAR was repealed in 2014, and the Marihuana for Medical Purposes Regulations became law. Health Canada transferred access decisions to health care providers who provide medical documentation confirming diagnosis and submits to a licensed supplier.

In 2015, the Supreme Court of Canada ruled against the federal government to expand the definition of medical marihuana beyond the “dried” form and allow the consumption of

medical marihuana as well as the use of other extracts and derivatives.

Nursing Implications

Obtain thorough medication history, documenting all medications used (prescription, OTC, natural health products). Assess level of education and understanding. Assess for information specific to various products. Assess system functions (especially renal, liver, and cardiac). Assess for conditions that are contraindications. Assess for potential drug–drug and drug–food interactions. Provide thorough and individualized patient education. Ensure that patients recognize that manufacturers of herbal products and dietary supplements are not required to prove safety and effectiveness. Teach patients to monitor themselves for unusual or adverse reactions as well as therapeutic responses.

Herbal products may not be safe for ____, ______, or _____ or _____ women. “Natural” does not mean ____.

Herbal products may not be safe for infants, children, or pregnant or lactating women. “Natural” does not mean safe.

Canadian legislation re: NHPs

The natural and non-prescription health products directorate (NNHPD) regulates the safety. efficacy. and quality of NHPs

NHPs (natural health products) information that is important to communicate to pts

Labelling is not 100% reliable for the provision of proper instructions or warnings, and the products should be taken with caution

"Oh, I frequently take something for my headaches, but I didn't mention it because aspirin is nonprescription"

Response: Although aspirin is OTC, it is still important to know why you take it, how much you take, and how often

Small pack over her chest with a strong odour- "My grandmother never used medicines from the doctor. She told me that this plaster and tea were all I would need to fix things." Also drinks herbal tea

"What's in the plaster and the tea? When do you usually use them?

Pt takes an herbal supplement that contains cava- develops a yellow tinge on skin and sclera

Report the incident to Medeffect (established by Health Canada)

Why are some drugs ITC and some are not?

the benefits of correct usage of the drug outweigh risks the drug has limited interaction with other drugs the drug is easy to use

Alternative medicine

herbal, natural health, chiropractic, massage

Complementary medicine

alternative medicine used simultaneously with conventional medicine

Conventional medicine

the practice of medicine by doctors and allied health providers to treat symptoms and diseases

Homeopathy

a popular form of alternative medicine that uses microdoses of active ingredients (plants, minerals)

Iatrogenic effects

unintentional AE caused by actions of the prescriber, HCP, or other alternative medicine

Integrative medicine

simultaneous use of both conventional and and alternative medicine

Phytochemicals

The pharmacological active ingredients in herbal remedies

Phytomedicine

application of scientific research to the practice of herbal medicine

High risk of AEs of OTCs

pediatric OAs multiple chronic diseases frail/ poor health suppressed immune system debilitated poor diet contraindicated in pts with liver, kidney, heart/ vascular dysfuction

OTC and NHP nursing intervention

PT education These drugs are not completely safe and are not without toxicity NHP does not mean that it can be safely administered to children, pregnant/ lactating women....

effects of OTC and NHPs

therapeutic responses will vary

common problem of OTC

delay treatment of actual problem

Misuse of: Pseudoephedrine Nasal spray symphatomimetics antacids

used in cough and cold products & street drugs cause rebound congestion cause AE in pts with type 1 diabetes- elevated PG can cause constipation/ impaction

kava root

liver toxicity

ephedera

cardiovascular and stroke risks

herbal products can

increase bleeding risk with warfarin potentiate digoxin toxicity increase effects of HTN drugs cause heart block/ dysrhythmias

OTC DRUGS Flashcards

(66 cards)