Drug Regulations & Standards Flashcards
Test I Review
The Department in Canada that is responsible for monitoring the potency, purity and safety of Canadian drug products.
The Department of Health and Welfare in federal ministry Health Canada.
2 main regulations governing the potency, purity and safety of drugs in Canada.
- The Food and Drug Act (1953) and its revisions.
2. The Controlled Drug and Substances Act 1996.
The Primary Regulation which includes all food and drugs.
The Food and Drug Act (1953) and its revisions.
The 4 Canadian Drug Legislations
- Food and drugs Act, 1927
- Food and drug Regulation 1953,1954, Revised1979 and Periodic Amendments
- Controlled Drugs and Substance Act, 1997
- Non-prescription drugs
i. This Act includes legislation about prescription, non-prescription and controlled substances
ii. The primary legislation concerned with food and drugs
iii. This ACT and REGULATION empower the Department of National Health and Welfare of Canada to protect the public from foreseeable risks relating to the manufacture and sale of drugs.
iv. The legislation provides for a review of the safety and efficacy of drugs before their clearance for marketing in Canada and determines whether the medicine is prescription or non-prescription. The current Act has evolved over the years and is reviewed from time to time.
FOOD and DRUGS ACT1927, FOOD and DRUG REGULATIONS1953, 1954, REVISED 1979
7 sections of The Food and Drug Regulations
Part A - Administration
Part C - Drugs
Part D - Vitamins, Minerals and Amino Acids
Part E - Cyclamide and Saccharin Sweeteners
Schedule F
Part G - Controlled Drugs
Part J – Restricted Drugs
- To protect the consumer from drugs which are contaminated, adulterated, or unsafe for use.
- To address drugs that are labeled falsely and those with misleading or deceptive labeling.
Purpose of the Food and Drug Act.
How many schedules does the act include to fulfill the purpose of the law?
8
With regards to Purpose (1), which schedule is related?
With regards to Purpose (1), Schedule B contains a list of pharmacopoeias and formularies to be used as reference: USP, NF, BP, PI, CF. EP, etc.
With regards to Purpose (2), which schedule is related?
With regards to Purpose (2), Schedule A, stipulates no food, drug, cosmetic or devices is to be advertised as cure for certain diseases. Schedules F, G and H deal with drug classification for distribution to the public
Which schedules deal with drug classification for distribution to the public?
Schedules F, G and H.
Which schedule lists diseases for which no food, drug, cosmetic or device may be offered as cure?
Schedule A.
Which schedule list pharmacopoeia or formulary that have prescribed standard for drug, which must be met before a drug is approved for sale?
Schedule B
What must be seen in the label to know that the drug met the requirements for Purpose 1?
The Canadian standard drug (CSD)
What schedules list drugs such as injectable liver extract, all insulin preparation, injectable antibiotic, etc. whose manufacturing is prohibited unless on premises unless the Minister of National Health and Welfare approves. These schedules also prohibit the distribution of drug samples except to licensed individuals, e.g., MD, dentist, pharmacist?
Schedules C & D
Which schedule deals with Cyclamide and Saccharin Sweeteners?
Schedule E
Which schedule are federally regulated drugs and the Controlled Drugs and Substances Act. outlined?
- Lists drugs that can be sold or refilled only by prescription. Refills for some drugs are allowed not exceeding 6 months. Drugs listed here include antibiotic, hormones, and tranquilizers. Provinces use this schedule to determine which drugs should be sold as OTCs.
Schedule F
What symbol does the Schedule F bear?
Pr
3 divisions of Schedule F drugs.
- Schedule l - drugs requiring prescription
- Schedule ll - drugs not requiring prescription (OTC drugs) but require Pharmacist control
- Schedule lll - OTC available in Pharmacy
What are drugs sold in in or out of a pharmacy?
- Provinces use this schedule to determine which drugs should be sold as OTCs. Drugs in one
- Province may be in Schedule l while in another Province the same drug may be under in schedule lll regulation.
• Unscheduled drugs
This schedule contains lists of drugs that are controlled drugs. These drugs affect the central nervous system (stimulants or sedatives).
Schedule G
Schedule G drugs bear the symbol?
C
Schedule G drugs are dispensed on by prescription and the labelling must show? (6)
Name and address of pharmacy or pharmacist
Date and number of the prescription
Recipient name
Practitioner’s name
Direction for use
Refills are only allowed by written or from the practitioner.
The main legislations that are important to nurses administering medication.
Schedule F, Part of Schedule G and the Controlled Drugs and the Substances Act.
The committee that advises provincial drug regulatory authorities on placement of drugs within the National model.
The National Drug Scheduling Committee
Advise on each Schedule so drug sells in Canada vary in provinces.
Provincial advisory bodies
They have their own legislation that is different from the National Legislation
Provinces
Proposed a scheduling model which embraces all medicines in Canada.
The National Association of Pharmacy Regulatory
The National Association of Pharmacy Regulatorys’ scheduling model which embraces all medicines in Canada. (5)
- Schedule l:All prescription drugs, including narcotics
- Schedule ll:Restricted Access Non-prescription Drugs (see Non-prescription Drugs below).
- Schedule lll:Pharmacy Only Non-prescription Drugs (see Non-prescription Drugs below).
- Unscheduled Drugs:Those drugs not assigned to the above categories
- Schedule F:Drugs requiring a prescription, except for controlled drugs. Drugs in this Schedule may be prescribed by MDs, dentists, vets.
Schedule that handles all prescription drugs, including narcotics. (NAPR)
Schedule I
Schedule that handles restricted access to Non-prescription Drugs. (NAPR)
Schedule II
Schedule that handles pharmacy only non-prescription drugs. (NAPR)
Schedule III
Schedule that are not assigned tp schedule I, II, & III. (NAPR)
Unscheduled Drugs
Schedule that handles drugs that reuires prescriptions, except for controlled drugs. Drugs in this Schedule may be prescribed by MDs, dentists, vets. (NAPR)
Schedule F
Advises provincial regulatory authorities on matters relating to the placement of drugs within the national scheduling model.
The National Drug Scheduling Advisory Committee
- Establishes the requirements for the control and sale of narcotics and substances of abuse in Canada.
- This Act described substances that are more heavily regulated than other therapeutic agents because they are more frequently misused, abuse and/or addictive.
- Substances falling under this Act generally require special prescriptions and more stringent record-keeping than other medications.
CONTROLLED DRUG AND SUBSTANCE ACT (CDSA), 1997
- Provides legal control of addictive and habituating drugs
- Controls possession, distribution, sale and production, import, export of certain drug, drug precursors, etc. of addictive and habit-forming drugs.
CONTROLLED DRUG AND SUBSTANCE ACT (CDSA), 1997
The CDSA 1997 is comprised of four Regulations:
A. The Narcotic and Control Regulations
B. Precursor Control Regulation
C. Benzodiazepine and other Targeted Substances
D. Marijuana Medical Access Regulations
Regulation of CDSA that governs the sell, distribution and use of narcotics and control drugs.
A. The Narcotic and Control Regulations
Drugs controlled under the Narcotic and Control Regulations are clearly identifiable by the symbol?
N
The provisions of The Narcotic and Control Regulations include: (3)
- Narcotics drugs, e.g., codeine
- Narcotic preparation, e.g. verbal preparations
- Control drugs, e.g., amphetamine, anabolic steroids
Outlines the regulations to prevent misuse and abuse of diazepines and other mind altering drugs There are stringent and comprehensive rules and documental surrounding these drugs. Example: If a nurse injects only a portion of an ampoule of a benzodiazepine, the remainder is wasted but cannot be disposed of unless another licensed nurse witnesses it
The benzodiazepine and other Targeted Substances Regulation
Outline the provisions for sell, possession and use of medical marijuana. It also regulates conditions that qualify for this drug.
The Marijuana Medical Access Regulations
The Act sets out eight Schedules of controlled substances. Assignment to each schedule is based on potential for abuse and ease with which illicit substances can be manufactured in illegal laboratories.
The CDSA 1997
The eight(8) Schedules of controlled substances (CDSA1997)
- Schedule l through lV are defined below, schedules V to VIII are not yet finalized.
1. Schedule l: Opium poppy and its derivatives (e.g., heroin); coca and its derivative
2. Schedule ll. Cannabis and its derivatives (e.g., marijuana, hashish)
3. Schedule lll. Amphetamines, methylphenidate, lysergic acid diethylamide (LSD), methaqualone, psilocybin and mescaline.
4. Schedule lV. Sedative/hypnotic agents (e.g., barbiturates, benzodiazepines); anabolic steroids
The schedule that handles opium poppy and its derivatives (e.g., heroin); coca and its derivative. (CDSA 1997)
Schedule I
The schedule that handles cannabis and its derivatives (e.g., marijuana, hashish) (CDSA1997)
Schedule II
The schedule that handles Amphetamines, methylphenidate, lysergic acid diethylamide (LSD), methaqualone, psilocybin and mescaline. (CDSA1997)
Schedule III
The schedule that handles Sedative/hypnotic agents (e.g., barbiturates, benzodiazepines); anabolic steroids. (CDSA1997)
Schedule IV
Provincial health authorities acknowledge three(3) categories of non-prescription drugs;
l.Restricted Access Non-prescription drugs that are available for sale directly from the pharmacists and are “kept behind the counter”.
Example: insulin, glucagons, nitro-glycerine
ll.Pharmacy Only Non-prescription Drugs, i.e., can be sold only through pharmacies. Example: antihistamines
lll. ‘Unscheduled’ Medication e.g. aspirin, nicotine gums and patches, ibuprofen, some cough and cold preparations which can be sold at retail outlets.
Drugs that are available for sale directly from the pharmacists and are “kept behind the counter”.
Example: insulin, glucagons, nitro-glycerine
l.Restricted Access Non-prescription drugs
Drugs that can be sold only through pharmacies.
Example: antihistamines
ll.Pharmacy Only Non-prescription Drugs
Drugs that can be sold at retail outlets.
e.g. aspirin, nicotine gums and patches, ibuprofen, some cough and cold preparations
III. ‘Unscheduled’ Medication
The regulation governs botanical products used either as food or as traditional Herbal medicines (THMs).
COMPLEMENTARY/ALTERNATIVE MEDICINE (CAM) REGUALTIONS
Produce that do not require labelling, caution, contraindication or adverse effects.
Botanical produces used as food
These are intended for self-medication and so require labelling.
Traditional Herbal medicines (THMs).
- This regulation deals with labelling, distribution and sells of NHP.
The Natural Health Products (NHP) Regulations (2004)
Under the regulation of NHP 2004, each product has a?
Drug Identification Number (DIN) or a National Product Number (NPN) and is usually marked as HM- Homeopathic Medicine.
The Natural Health Products (NHP) Regulations (2004) require that lebelling include? (5)
Use, recommended dose, length of time to be taken, ingredients, and risks
- Nurses must be aware of the nursing practice regarding these drugs and the requirements for documentation and storage. Consult Hospital Rules
- The Act describes substances that are more heavily regulated than general prescription medication, be familiar with the dispensing rules.
- Substances under this ACT require specific prescription and stringent record keeping.
- Any drug which is wasted (e.g., left-over part of ampoule) must be witnessed by another practitioner and carefully documented before it’s disposed of.
NURSING IMPLICATIONS CONTROLSUBSTANCES ACT
The Nine Rights of Medication Administration include:
- Right patient • Right drug
- Right route • Right time
- Right dose
Patients Rights (2)
- Informed Consent
2. Information about all medication, their indication and adverse effect
Nurses administer medications in accordance with the physician’s order. Essential components of the medical order include: (7)
- Date on an outpatient prescription; date and time on an inpatient order
- Patient name for an outpatient; patient identification number, etc. for an inpatient.
- Drug name (generic or trade) and strength of dose
- Frequency of dose and duration of therapy
- Prescription should show info similar to medical order
- Physician’s full name; outpatient prescription could have other physicians identifier
- Refills, where required, on outpatients prescription
These are needed to ensure that drug products made by different manufacturers or in different batches by the same manufacturer, will be uniformly pure and potent.
Standardization
The act that recognizes the standards described by international authoritative sources to be acceptable as official drugs in Canada.
The Food and Drugs Act 1953
The Food and Drugs Act 1953, recognizes the standards described by international authoritative sources to be acceptable as official drugs in Canada. The acceptable standards are: (7)
United States Pharmacopeia (USP) National Formulary (NF) European Pharmacopoeia(EP) International Pharmacopoeia (IP) British Pharmaceutical Codex (BPC) British Pharmacopoeia (BP), Canadian Formulary (CF).
In Canada the standardizing body is the?
Canadian Formulary (CF).
Provides a comprehensive list of pharmaceutical products distributed in Canada as well as other information of practical value to health care professionals.
Compendium of Pharmaceuticals and Specialties (CPS)
Provides comprehensive information for health professionals and consumers about the non-prescription drug products available in Canada.
Patient Self-Care; Helping Patient Make Therapeutic Choices
It is a non-prescription companion of CPS and Patient-Self –Care
Compendium of Self-Care Products
The electronic database that gives nurses access to a wealth of information from sources in U.S.A. and other countries.
The National Library of Medicine (NLM)
Sources of Drug Information (6)
- Compendium of Pharmaceuticals and Specialties (CPS)
- Patient Self-Care; Helping Patient Make Therapeutic Choices
- Compendium of Self-Care Products
- Electronic Databases – The National Library of Medicine (NLM
- Textbooks
- Drug reference and inserts
N means?
Narcotics
A law which has been promulgated (or “enacted”) by a legislature or other governing body, or the process of making it.
Legislation
It is an instrument that records a fact or something that has been said, done, or agreed.
Act
