Module one: Community pharmacy in Australia and regulating medicines
Products and services provided by the community pharmacy sector include:
Over-the-counter medicines
Prescription medicines
Health aids and equipment
Flu immunisations
Health screening programs e.g. blood pressure and blood glucose monitoring
Medicine review and management services
Advice and management services for conditions such as: diabetes, blood pressure, diet and wound care
The pharmacy industry in Australia:
Government agencies, the government and Industry bodies and professional organisation.
The Commonwealth Government and state governments
Both the Commonwealth Government and state and territory governments set laws and implement guidelines and legislation in relation to the supply of medicines to the community. These rules ensure that people have access to the medicines that they require to make them well, and that these medicines are provided in a safe and responsible manner.
What are the laws that influence a pharmacy's operations?
National health act, quality use of medicines(QUM), stae/territory laws and regulations and therapeutic goods act.
The national health act- 1953
The Department of Health administers many of the rules that pharmacies need to follow. For example, the Department assists pharmacies to provide quality health care information, advice and service to customers. The National Health Act also covers the prevention and treatment of disease, national health benefits and scientific research.
Quality use of medicines(QUM)
It promotes the responsible supply of medicines to the public and is relevant to your role as pharmacy assistant.
What are the QUM principles?
Wise, suitable, safe and effective
State and territory laws and regulation
State and territory laws and regulations support our national laws in regulating the manufacture, possession and supply of medicines and poisons. State and territory laws impact on the way that pharmacies supply medicines to the public, with particular reference to the storage, sale and labelling of medicines.
The Therapeutic Goods Act - 1989
sets out the legal requirements for the import, export, manufacture and supply of therapeutic goods in Australia.
Other laws
Australian consumer Law, equal opportunity and anti - discrimination laws, environmental Laws, and privacy Laws.
government agencies
There are a number of government agencies or bodies that assist pharmacies to implement and follow the range of laws that guide a pharmacy's operations.
Therapeutic goods
refers to products such as medicines and medical devices.
The Therapeutic Goods Administration (TGA) is a division of the Department of Health. It provides a national system of controls for regulating therapeutic goods in relation to:
Supply
Import
Export
Manufacturing
Advertising
The TGA is supported by two committees in making decisions about the public's access to particular medicines. These committees are:
The Advisory Committee on Medicines Scheduling(ACMS) and The Advisory Committee on Chemicals Scheduling(ACCS)
What is ACMS
The Advisory Committee on Medicines Scheduling advises and makes recommendations on scheduling of medicines.
What is ACCS
The Advisory Committee on Chemicals Scheduling advises and makes recommendations on the scheduling of chemicals.
What is ARTG
The Australian Register of Therapeutic Goods (ARTG) lists all medicines and medical devices approved for supply, import or export.
Aust (L) and Aust (R) medicines
In Australia, medicines are categorised as either 'Registered' or 'Listed' on the Australian Register of Therapeutic Goods (ARTG), according to the safety of the ingredients they contain. Lower-risk medicines are 'Listed', while medicines that have a higher risk of side effects and are used to treat more serious illnesses are 'Registered'. You can easily identify whether medicines are 'Listed' or 'Registered' by checking the code printed on the medicine label or packaging.
Whomakes scheduling desicions?
These expert committees are: 1. The Advisory Committee on Medicines Scheduling (ACMS), 2. The Advisory Committee on Chemicals Scheduling (ACCS).
What factors determine a medicine's schedule?
Safety of the medicine
Concentration of active ingredients
Pack size
Seriousness of the condition it has been approved to treat
Effects of the medicine when correctly used
Potential side effects
Effects if taken accidentally by children
Effects of taking an overdose
Potential for people to become dependent on it
Benefits of making it easily available
What is antihistamines?
Antihistamine medications help ease allergy symptoms.
S2
Pharmacy medicines
S6
poison
S3
Pharmacist Only medicine
Examples of products within the Pharmacist Only Medicine (S3) range include:
Some asthma medicine e.g. salbutamol
Some proton pump inhibitors (acid suppressing medicine)
Some stronger analgesics (pain relievers)
Examples of Pharmacy Medicines (S2) include:
Some diarrhoea medicines
Some antihistamines
S4
Prescription Only Medicine
Examples of Prescription Only Medicines include:
The contraceptive pill.
Antibiotics.
Heart and cholesterol medicine.
S5
Caution - These products contain substances with some potential for causing harm. The packaging must contain the warning: 'CAUTION'
S7
Dangerous poison - These are substances with a high potential for causing harm. They often fall within the industrial and agricultural product area and are not generally sold in pharmacies.
S8
controlled drug - Substances with a high potential for abuse and addiction. They are regulated by strict controls regarding storage and dispensing
S9
Prohibited substance- Sale, distribution, use and manufacture of these drugs is strictly prohibited by law.
Unscheduled medicines - can be sold in other retail outlets such as supermarkets and convenience stores.
Examples of unscheduled medicines include:
Antacids
Paracetamol (in packs containing less than 20 tablets)
Complementary medicines (e.g. vitamins and minerals)
Lubricant eye drops
Some laxatives
Most nicotine replacement therapies
Coughs, colds and influenza (flu) are common ailments that bring many customers into the pharmacy, particularly over winter months. While medicines cannot cure a cough or cold, they do provide temporary relief from symptoms such as a blocked nose and minor aches and pains. The range of cough and cold products includes:
Decongestants and antihistamines to clear up a blocked or runny nose
Cough suppressants and expectorants for coughs
Analgesics to relieve pain and reduce fever
Gastrointestinal medicines are used to treat gastrointestinal conditions including indigestion, constipation and diarrhoea. Medicines include:
Acid neutralisers (antacids)
Barrier medicines (alginates)
Proton pump inhibitors
Laxatives
Anti-diarrhoeals
Allergies medicine
Allergy medicines are used to treat symptoms of allergies. Examples of allergy medicines are antihistamines which work by blocking the chemical (histamine) that is released by your immune system during an allergic reaction causing symptoms such as watery eyes, runny nose, hives etc. they are in a range of forms including tablets, liquids, inhalers, nasal sprays, eye drops and skin creams.
Antifungal treatments are used to treat fungal infections, which most commonly affect the skin, hair and nails. The main antifungal products supplied in pharmacies are:
Topical antifungals which are applied directly to the skin, hair or nails.
Oral antifungals e.g. capsules and tablets.
Antifungal pessaries which are small soft tablets inserted into the vagina to treat conditions such as vaginal thrush.
Analgesics are medicines designed to relieve the symptoms of pain. There are a number of different groups of analgesics which include:
Simple analgesics e.g. Panadol®
Non steroidal anti-inflammatory drugs (NSAIDs) e.g. Nurofen®
Babies's and children's medicine
As children’s small bodies are very sensitive to medicine, they require specifically formulated medicines designed for their size and needs. Lower doses of most adult formulas are not advisable and can have serious consequences.Your pharmacy will stock a large range of babies' and children's medicines located within other medicine categories and in a variety of forms such as liquids, tablets, inhalers, eye and ear drops.