OTC DRUGS Flashcards
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
OTC drugs regulated by Health Canada’s Food and Drug Regulations
Safety and efficacy
Appropriate labelling standards
Reclassification
Nonprescription drugs
More than 80% of Canadians use OTCs
Most are unscheduled drugs that can be sold without professional supervision
Schedule
I
II
III
IV
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)
Criteria for OTC Status
I
II
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)
I: Indications for use
Consumers must be able to
- diagnose conditions
- Monitor effectiveness
The benefits of correct usage must outweigh risks
II: Safety Profile
Drugs must have:
Favourable adverse event profile
Limited interactions with other drugs
Lowe potential for misuse
High therapeutic Index
III: Practicality for OTC use
Drugs must be:
Easy to use and monitor
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
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®)
Reclassified OTC Drugs
Histamine blockers
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®)
Reclassified OTC Drugs
Smoking Deterrents
nicotine gum (Nicorette®)
nicotine transdermal patch (Nicoderm®, Habitrol®)
Reclassified OTC Drugs
Topical Medications
clotrimazole (Canesten®)
miconazole nitrate (Micazole®, Monistat®)
minoxidil (Minox®, Rogaine®)
Advantages of OTC
Convenience of self treatment of minor ailments
Decreased health care costs when drug is paid out of pocket
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
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
*Patient Education is still helpful!
I.E. Hepatotoxicity is associated with excessive acetaminophen use
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
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
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
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
National Center for Complementary and Alternative Medicine (NCCAM)
Complementary medicine (integrative medicine): simultaneous use of both conventional and alternative medicine
NCCAM classifies complementary and alternative medicine
Alternative medical systems
Mind–body interventions
Biologically based therapies
Manipulative and body-based methods
Energy therapies
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
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
