Flashcards in Professional Practice and Its Boundaries Deck (52):
What conditions are required in the sale of pseudoephedrine?
Photo ID is required
A record of the buyer must be made
What is a potential consequence of illegal practice?
You can go to jail for the most serious offences.
What is the Department of Health's description of the National Health Policy?
“Australia’s health system is world class, supporting universal and affordable access to high quality medical, pharmaceutical and hospital services, while helping people to stay healthy through health promotion and disease prevention activities.”
What is the purpose of the Health Practitioner Regulation National Law Act (2009)
Protection of health and safety of the public.
What are the essential assessment factors for Pharmacist Only Medicines?
Don't require close medical management
Easily recognised with assistance from a pharmacist
Amenable to short-term treatment or capable of being monitored by the consumer with assistance from a pharmacist
Low abuse potential
Low potential for harm
Low incidence of severe adverse effects
Only interactions that can be managed by a pharmacist
Medium/wide Therapeutic Index
The risk of masking a serious disease or compromising medical
management can be managed by a pharmacist
Only contra-indications that can be dealt with by a pharmacist
Safety in use with counselling by a pharmacist
What conditions have AUST-R medicines met?
They have undergone and passed safety and efficacy assessment.
What is a Therapeutic Index?
The ratio between the effect concentration and the toxic concentration of a drug. If it's wide, it's hard to accidentally overdose.
What are the four components of the National Medicines Policy?
Access to affordable medicines (PBS)
Quality use of medicines (QUM)
Medicines of appropriate
standards of quality safety
and efficacy (Regulatory – TGA)
Maintaining a responsible
and viable medicines
What does the term "Prescribed S3 Poison" refer to?
Dihydrocodeine in cough preparations;
Doxylamine in preparations also containing codeine;
Promethazine in preparations also containing
What schedule number are Prescription Only medicines
Who administers the Health Practitioner Regulation National Law Act (2009)
The Pharmacy Board of Australia.
What schedule number are Pharmacy Only medicines?
Describe Controlled Drugs
Are dependence producing
Are likely to be abused or misused
Require restriction of manufacture, supply,
distribution, possession and use
What is a fiduciary relationship?
A trusting relationship.
Where someone (particularly a professional) can be trusted with people's information and may know secrets about customers.
What are the essential assessment factors for Pharmacy Only Medicines?
Not require medical diagnosis or management
Can be self-managed
Suitable for self treatment of minor problems
Extremely low abuse potential
Low potential for harm
Only minor interactions with commonly used substances or food
Wide Therapeutic Index
Low risk of masking a serious disease
Low risk of compromising medical management of a disease
What are Uniform Poisons Standards?
Uniform Poisons Standards cover many things, mostly things such as schedules and things required on product labels.
What factors determine a schedule of a medicine?
Toxicity and safety
Purpose for which the medicine is to be used
Need for access to the medicine
Risks, benefits and potential hazards associated with use
Extent and pattern of use
Dosage and formulation
Potential for misuse
Any other matter necessary to protect public health
What is the role of State Governments in the regulation of medicines?
Laws around storage and
Funding of public hospitals - PBS + State funded medications
Name 2 Practice Legislations on a State level.
Controlled Substances Act 1984
Controlled Substances Regulations 2011
Describe Pharmacist Only Medicines
Are substantially safe but require professional advice or counselling
by a pharmacist
• Use requires pharmacist advice, management or monitoring
• Are for ailments or symptoms which:
• Can be identified by the consumer and verified by a pharmacist
• Do not require medical diagnosis or only require initial medical
diagnosis, and do not require close medical management
Describe the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP1)
Contains the decisions of the National Drugs and Poisons Schedule Committee
It promotes ‘uniform scheduling of substances and uniform labelling and packaging requirements throughout Australia’
It is adopted in South Australia under the Controlled Substances Regulations 1996
What does a profession generally embody?
1. Service above self interest
2. Application of specialised knowledge
3. Skills in the service of humanity
4. An ethical code
5. A fiduciary practitioner-client relationship
6. Registration which embodies standards of training and practice in some statutory form
7. Regulation of advertising services
8. Independence from external control (within the law) - competent enough to give an opinion or suggestion to a government agency
What schedule number are Pharmacist Only medicines?
What can drugs also be considered?
Poisons, because too much of any drug is poisonous
What does the R in AUST-R stand for?
What is the name for Schedule 2 medicines?
What is a particular characteristic of S2 medicines regarding their misuse?
Usually S2 Medicines need you to go out of your way to abuse them. For example, having 4 tablets instead of 2 won't kill you, but having 400 will.
What characterises a professional?
Professionals have knowledge that not everyone has.
What is the main purpose of Pharmacist Only Medicines?
Purpose: Access (via pharmacist) to effective medicines that require
Put simply, what are professional standards?
The expected daily practice standard.
What is the main purpose of Pharmacy Only Medicines?
Easy access (via pharmacy) to effective medicines
Who is the Therapeutic Goods act administered by?
The Commonwealth Therapeutic Goods
What does the L in AUST-L stand for?
What type of drugs are available in retail outlets?
What is the name for Schedule 3 medicines?
What are two definitions of a profession?
A vocation requiring training in
the arts or sciences and advanced
studies in a specialised field
A body of qualified persons in a
specific occupation or field
What is AHPRA a commonly-used abbreviation for?
The Australian Health Practitioner Regulatory Agency (2007)
What percentage of drugs are subsidised by the PBS?
Put simply, what are legal requirements?
The minimum practice standard.
What conditions have AUST-L medicines met?
They have undergone and passed a safety assessment.
Describe Prescription Only Medicines
Require specified management or monitoring
Are for conditions that require specified diagnosis or management, the safety and efficacy of which may require further evaluation
Are new therapeutic substances
What is the Department of Health's description of the National Medicines Policy?
“A cooperative endeavour to bring about better health outcomes for all Australians, focusing especially on people's access to, and wise use of, medicines.”
What schedule number are Controlled Drugs?
What type of drugs are commonly S4 scheduled?
We need them to be less accessible until we can find out more about them - particularly regarding safety.
What is the role of the Federal Government in the regulation of medicines?
Funding and laws around PBS
Funding of public and private hospitals
PBS = >90% of dispensed drugs
Describe Pharmacy Only Medicines
Substantially safe in use but where advice or counselling is available if necessary.
For minor ailments or symptoms which can be easily recognised by the consumer and do not require medical diagnosis or management
Name 2 Practice Legislations on a National level.
Health Practitioner Regulation National Law Act 2009
Australian Health Practitioner Regulatory Agency 2007
What is the Regulatory Agency (2007) responsible for?
The maintenance of high standards of competence and conduct by persons providing services
Registration of health professionals including pharmacists and pharmacy students
What is the name for Schedule 4 medicines?
How much methamphetamine can be made by 30 mg of pseudoephedrine?
Between 10 and 20 mg
What four things influence medicine schedules?
Therapeutic Goods Act (1989) and its regulations (1990)
National Drugs and Poisons Schedule Committee
Standard for the Uniform Scheduling of Drugs and Poisons
Controlled Substances Act (1984) and its Regulations (2011)