2 laws related to drug standards and controls in Canada (enforced by the Health Protection
Branch of the Department of National Health & Welfare) -
The Food & Drug Act
The Narcotics Control Act
Purpose of the laws -
1. To protect the consumer from health hazards and fraud or deception in the sale
and use of foods, drugs, cosmetics and medical devices.
2. To monitor the potency, purity and safety of Canadian Drug products.
This is achieved by outlining provisions for: -
Conditions of drug sale
Labeling and advertising of drugs
Manufacturing standards
Procedure for new drugs
Inspection
Importation
Food and Drug Act -
Provides controls:
Food additives, cosmetics, medical devices and all drugs (over the counter, OTC, as well as
prescription).
EXCEPTION : Narcotics
Schedule F -
List drugs that require a prescription, such as most antibiotics, corticosteroids,
cardiovascular drugs, antipsychotics
Schedule G -
Prescription drugs which because of recognized abuse potential are subject to
additional requirements
Symbol C (meaning controlled substance) must appear on the label.
Amphetamines and barbiturates. Highly addictive
Narcotic Control Act/Regulation -
as "a derivative of opium or synthetic chemicals that produce the same
pharmacological effects as opium.
Ex. Heroin, morphine, codeine, Demerol, cocaine.
The letter N must appear on all labels.
Codeine is the only narcotic that may be purchased without a prescription and then only if: -
It is combined with at least 2 other drugs
Each tablet contains no more than 8 mg of codeine or an oral solution only contains 20mg per
30ml preparation.
It is combined with at least 2 other drugs
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,Each tablet contains no more than 8 mg of codeine or an oral solution only contains 20mg per
30ml preparation. -
is a signed legal document that must include:
The patient's name, address and age (if significant)
The prescriber's name, address, and identification
The date
The name and amount of the drug
Permission for additional quantities if necessary
The drug's generic or brand name is utilized
Heading -
Name, address and telephone number of the prescriber
Name, address and telephone number of the patient (written)
Date of the prescription (not a legal prescription unless filled in with date
Body -
The symbol Rx
Name and dosage size or concentration (for liquids) of the drug
Amount to be dispensed
Directions to the patient
Closing -
Prescriber's signature
Refill instructions
Prescription Label -
Name of drug being dispensed
Dosage
How often it has to be taken
Warnings (ex. Do not take with alcohol)
Doctor's name
Patient's name
Other (how it should be taken)
Refills
Date
Pharmacy location
Routes of Drug Administration -
Topical
Transdermal
Oral route (PO)
Sublingual Route (S.L.)
Parenteral Route
Inhalation
Other routes of drug administration
Why Are Drugs Administered Differently? -
Route will affect the onset and duration of response
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, Onset -
The time it takes for the drug to take effect
Duration -
The length of a drug's effect
Topical -
Application to body surfaces: skin or oral mucosa
What type of drug effect (i.e. systemic or local) may be achieved by using topical route of
administration? -
Local
Identify examples of drugs that are administered topically -
Ex. benzocaine (Orajel), local topical anesthetic, polymyxin (Polysporin),
sunscreens
Transdermal -
Provides continuous, controlled systemic absorption of medication through a
semipermeable membrane by application of medication to intact skin.
Identify several examples of specific drugs that are administered transdermally -
Birth control patch (estrogen)
Nicotine patch
Nitrates (nitroglycerin)
What is meant by sublingual? -
Under the tongue
What is the approximate onset of action for sublingual medications? -
Immediate. 1-3 mins.
Directly into the blood, little loss of the drug
Avoids GI acid and enzymes and first pass effect
Identify examples of drugs that are administered sublingually? -
Nitroglycerin
From what portion of the gastrointestinal tract are drugs absorbed? -
In the walls of the intestine; in the duodenum
What is the average onset of drug action for medications administered orally? -
30-60 minutes. Not good for emergencies
Slower onset and less predictable
Depends on food, passage through hepatic portal circulation, gastric acids and enzymes.
Identify factors that could both accelerate and decrease this time -
The form in which the drug is given (liquid vs. pill)
Whether taken with food or on an empty stomach
If taken with other drugs
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