LO 1-3 Flashcards
(32 cards)
Define Pharmacology
- The science of drugs - pharmacon = drug (Greek), logos = science
- The study of how drugs interact with living organisms to produce a change in function
Define Drug
- Therapeutic agent other than food, used in the prevention, diagnosis, alleviation, treatment, or cure of disease.
- Synthetic, semisynthetic or natural substance
- Medication, medicine: a licenced drug used to treat a medical condition
- Preventive medicine : has future benefits, does not treat any existing disease or symptoms
What do drugs do in the body?
- alter some functions or produce some effects (affecting mind, body or both)
What are the 2 major classifications of drugs with examples?
- Over the counter (OTC): no prescription (e.g. ibuprofen( Advil, Motrin), acetaminophen( Tylenol))
- Prescription drugs: prescription from MD, DDS, optometrists (e.g. antibiotics, narcotics)
Why is it important for dental professionals to understand pharmacology
- Obtaining adequate health history.
- Administering drugs in a dental setting: topical anesthetic, local anesthetic, F, nitrous oxide
- Handling emergency situation
- Planning appointments and pre-medication
- Choosing medication for self and family
- Discussing drugs with patient and other health care professional
- Continuing education
- Recognizing the clinical symptoms of drug interactions/discussing drug interactions
What 2 laws are related to drug standards and control in Canada?
- Food and Drugs Act - controls drugs (otc and prescription, except controlled drugs), food additives, cosmetics, medical devices
- Controlled Drugs and Substances Act
What is the purpose of drug laws?
- To protect the consumer from
health hazards and fraud or deception in the sale and use of foods, drugs, cosmetics and medical devices. - To monitor the potency, purity and safety of drug products on the Canadian market
What do drug laws outline regulations for?
- Procedure for new drugs
- Manufacturing standards
- Labeling and advertising of drugs
- Conditions of drug sale
- Inspection
- Importation
What does the Therapeutic Products Directorate(TPD) apply to?
- The Food and Drug Regulations under the authority of The Food and Drugs Act to ensure that the pharmaceutical drugs offered for sale in Canada are safe, effective and of high quality.
- The TPD also administers the fee regulations for drugs under the authority of The Financial Administration Act.
Before drug products are authorized for sale in Canada, Health Canada reviews them to assess their __________
safety, efficacy and quality
In addition to prescription and non-prescription pharmaceuticals, drug products include ____________
Disinfectants and sanitizers with disinfectant claims
Prior to being given market authorization, a manufacturer must present proper ____________ of a product’s safety, efficacy and quality as required by the Food and Drugs Act and Regulations
scientific evidence
When a product is offered for sale in Canada to treat or prevent diseases or symptoms, it is regulated as a drug under ____________
the Food and Drugs Act
Define controlled substances
- Any type of drug that the federal government has categorized as having a higher-than-average potential for abuse or addiction.
- There are 6 Schedules for controlled substances.
Concerning drugs, what is Health Canada’s role?
- to regulate the import, export, production, distribution, possession, and sale of controlled drugs
- To administer legislation/ activities through the Office of Controlled Substances
- Collaborate with Canadian/ international stakeholders to ensure effective handling and legal distribution of controlled drugs.
- Analyze, through the Drug Analysis Service, suspected illegal drugs that are seized by Canadian police forces (RCMP, provincial, regional and municipal) and Canada Customs
Describe the drug approval process at a high level
Drugs must pass through many steps before being approved (e.g. preclinical studies such as animal trials, clinical trials)
What is a drug identification number?
- A computer-generated eight-digit number assigned by Health Canada to a drug product before being marketed in Canada.
- A DIN uniquely identifies the following product characteristics: manufacturer; product name; active ingredient(s); strength(s) of active ingredient(s); pharmaceutical form; route of administration.
What is the chemical name of a drug?
Identifies the exact chemical structure while the drug is being tested or developed.
What is the generic name of a drug?
Each drug has only one generic name. Public, common name, not owned (e.g. acetaminophen)
What is the trade name of a drug?
- Brand, Commercial, Proprietary name (e.g. Tylenol)
- Registered trademark
What is the numbering system in trade names?
It refers to the amount of one component to differentiate it from an almost identical product. (e.g.Tylenol 1, 2, 3 - denotes the amount of codeine)
Describe the types of drug substitutions
- Chemically equivalent: same chemical and physical standards
- Biologically equivalent: produce same concentrations in blood and tissues
- Therapeutically equivalent: equal therapeutic effect in clinical trials
- Before generic drugs are marketed they must be shown to be biologically and therapeutically equivalent.
What should an RDH understand about medications?
- Understand patient’s medication
- Understand patient’s medical history
- Understand drug interaction
Prescription writing - Ordering supplies: generic substitution gives equivalent therapeutic results at a fraction of the cost of proprietary drugs.
What drug reference publications should you be aware of?
- Compendium of Pharmaceuticals and Specialties (CPS) - for Canadian health professionals, comes out yearly
- Dental Drug Reference - internet database through ODA, CDA, Medline, CDHA, ODHA