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STUDY CARDS > OTC DRUGS > Flashcards

OTC DRUGS Flashcards

1
Q

Over-the-Counter Drugs

A

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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2
Q

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

A

Safety and efficacy

Appropriate labelling standards

Reclassification

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3
Q

Nonprescription drugs

A

More than 80% of Canadians use OTCs

Most are unscheduled drugs that can be sold without professional supervision

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4
Q

Schedule

I

II

III

IV

A

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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5
Q

Criteria for OTC Status

I

II

III

A

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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6
Q

I: Indications for use

A

Consumers must be able to

  1. diagnose conditions
  2. Monitor effectiveness

The benefits of correct usage must outweigh risks

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7
Q

II: Safety Profile

A

Drugs must have:

Favourable adverse event profile

Limited interactions with other drugs

Lowe potential for misuse

High therapeutic Index

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8
Q

III: Practicality for OTC use

A

Drugs must be:

Easy to use and monitor

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9
Q

Process for Reclassification

A

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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10
Q

Reclassified OTC Drugs

Analgesics

A

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

  1. acetylsalicylic acid, codeine 8 mg, caffeine (222®, AC&C®)
  2. ibuprofen (Advil®, Motrin®)
  3. naproxen sodium (Aleve®, Anaprox®, Naprelan®, Naproxen®)
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11
Q

Reclassified OTC Drugs

Histamine blockers

A

Histamine blockers

H1-receptors

  1. cetirizine (Aller-Relief®, Reactine®)

2.chlorpheniramine maleate (Chlor-Tripolon®)

3.diphenhydramine hydrochloride (Benadryl®)

  1. loratadine (Claritin®)

H2-receptors

  1. famotidine (Pepsid®)
  2. ranitidine (Zantac®)
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12
Q

Reclassified OTC Drugs

Smoking Deterrents

A

nicotine gum (Nicorette®)

nicotine transdermal patch (Nicoderm®, Habitrol®)

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13
Q

Reclassified OTC Drugs

Topical Medications

A

clotrimazole (Canesten®)

miconazole nitrate (Micazole®, Monistat®)

minoxidil (Minox®, Rogaine®)

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14
Q

Advantages of OTC

A

Convenience of self treatment of minor ailments

Decreased health care costs when drug is paid out of pocket

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15
Q

Disadvantages
of OTC

A

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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16
Q

Use of OTC Drugs: Potential Hazards

A

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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17
Q

*Patient Education is still helpful!

A

I.E. Hepatotoxicity is associated with excessive acetaminophen use

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18
Q

Consumer Use of Natural Health Products

A

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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19
Q

Natural Health Products Examples

A

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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20
Q

Natural Health Products

A

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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21
Q

Natural Health Products:Consumer Use

A

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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22
Q

National Center for Complementary and Alternative Medicine (NCCAM)

A

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

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23
Q

NCCAM classifies complementary and alternative medicine

A

Alternative medical systems

Mind–body interventions

Biologically based therapies

Manipulative and body-based methods

Energy therapies

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24
Q

Homeopathy

A

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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25
Q

Commonly Used Herbal Products

A

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

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26
Q

Conditions Treated with Herbal Products

A

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

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27
Q

Safety

A

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

28
Q

Chamomile: Increased potential for bleeding with?

A

anticoagulants

29
Q

What causes decreased elimination of many drugs excreted by the kidneys

A

Cranberry

30
Q

Possible interference with or counteraction to immunosuppressant drugs and antivirals

A

Echinacea

31
Q

Possible interaction with antipsychotic drugs

A

Evening primrose

32
Q

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

A

Garlic

33
Q

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

A

Gingko biloba

34
Q

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

A

Ginger root

35
Q

Grapefruit 4

A

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

36
Q

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

A

Hawthorn

37
Q

May increase the effect of barbiturates and alcohol

A

Kava

38
Q

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

A

Saw palmetto

39
Q

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

A

St. John’s wort

40
Q

Increases central nervous system depression if used with sedatives

A

Valerian

41
Q

Medical Use of Marihuana

A

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.

42
Q

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

A

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

43
Q

Nursing Implications

A

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.

44
Q

Herbal products may not be safe for ____, ______, or _____ or _____ women.

“Natural” does not mean ____.

A

Herbal products may not be safe for infants, children, or pregnant or lactating women.

“Natural” does not mean safe.

45
Q

Canadian legislation re: NHPs

A

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

46
Q

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

A

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

47
Q

“Oh, I frequently take something for my headaches, but I didn’t mention it because aspirin is nonprescription”

A

Response:

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

48
Q

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

A

“What’s in the plaster and the tea? When do you usually use them?

49
Q

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

A

Report the incident to Medeffect (established by Health Canada)

50
Q

Why are some drugs ITC and some are not?

A

the benefits of correct usage of the drug outweigh risks

the drug has limited interaction with other drugs

the drug is easy to use

51
Q

Alternative medicine

A

herbal, natural health, chiropractic, massage

52
Q

Complementary medicine

A

alternative medicine used simultaneously with conventional medicine

53
Q

Conventional medicine

A

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

54
Q

Homeopathy

A

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

55
Q

Iatrogenic effects

A

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

56
Q

Integrative medicine

A

simultaneous use of both conventional and and alternative medicine

57
Q

Phytochemicals

A

The pharmacological active ingredients in herbal remedies

58
Q

Phytomedicine

A

application of scientific research to the practice of herbal medicine

59
Q

High risk of AEs of OTCs

A

pediatric
OAs
multiple chronic diseases
frail/ poor health
suppressed immune system
debilitated
poor diet

contraindicated in pts with liver, kidney, heart/ vascular dysfuction

60
Q

OTC and NHP nursing intervention

A

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….

61
Q

effects of OTC and NHPs

A

therapeutic responses will vary

62
Q

common problem of OTC

A

delay treatment of actual problem

63
Q

Misuse of:

Pseudoephedrine

Nasal spray

symphatomimetics

antacids

A

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

64
Q

kava root

A

liver toxicity

65
Q

ephedera

A

cardiovascular and stroke risks

66
Q

herbal products can

A

increase bleeding risk with warfarin

potentiate digoxin toxicity

increase effects of HTN drugs

cause heart block/ dysrhythmias

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