Legal + Ethics Flashcards
(574 cards)
What body is the legislation covered in the Controlled Substances Act 1984 and the Controlled Substances (Poisons) Regulations 2011 administered by?
This legislation is administered by the Drugs of Dependence Unit, SA Health.
Describe the requirements of pharmacists as outlined in the Controlled Substances Act 1984?
The Act provides pharmacists with certain privileges not available to the general public. In exchange for these privileges, it expects pharmacists to be aware of the requirements of the Act, to act lawfully and act responsibly at all times.
What 2 legal documents is the prescription and supply of drugs of dependence in South Australia is regulated under?
- The Controlled Substances Act 1984
- Controlled Substances (Poisons) Regulations 2011.
These privileges may be withdrawn by order of the Minister responsible for the Act if a conviction is obtained or an opinion is formed that the pharmacist has acted irresponsibly in handling prescription drugs (Section 57 of the Act).
What 2 legal documents is the prescription and supply of drugs of dependence in South Australia is regulated under?
- The Controlled Substances Act 1984
- Controlled Substances (Poisons) Regulations 2011.
What are 4 instances in which a prescriber must not (unless an emergency exists) prescribe or supply a drug of dependence?
- having not first examined the patient or animal and determined that it is clinically necessary
- for self- treatment
- for the treatment of their spouse or other family member unless authorised by the Minister
- for the purpose maintaining or treating drug dependence unless authorised by the Minister
Prescriptions for drugs of dependence are valid for how long from the date of prescribing?
Prescriptions for drugs of dependence are valid for a maximum period of six months from the date of prescribing.
What 6 things should be included on the prescription for a drug of dependence?
- prescriber name, address, telephone number and signature
- date on which the prescription is written
- patients full name and address
- patient’s date of birth
- the quantity to be supplied in words and numerals
- in the case of veterinary prescriptions to treat an animal; the species of animal, name if applicable, and the name and address of the owner of the animal
In addition to standard requirements, Medication Assisted Treatment for Opioid Dependence (MATOD) prescriptions should include what 5 things?
- dose in milligrams, and for methADONe, millilitres as well to minimise error,
- doses to be administered under supervision
- number of take away doses that may be provided each week
- expiry date of the prescription. This date is the date after which no more drug can be supplied and should coincide with the date that the patient is to be reviewed
- name of the pharmacy that can dispense the prescription
What is a drug of dependence authority?
An authority is a legal document granted by the Minister allowing prescribers to treat a particular patient with specified drugs of dependence; it is not intended to provide clinical endorsement of the treatment being prescribed, this is the responsibility of the prescriber.
What is the purpose of a drug of dependence authority?
An authority issued under section 18A of the Act stipulates the conditions under which prescribing of a drug of dependence must occur, including dosage and quantity. It is not the same as an authority issued by Medicare Australia for PBS purposes.
For what period of time may a prescriber prescribe a drug of dependence to a patient without an authority?
It is an offence to prescribe or supply (including administering from the prescribers’ own supply), drugs of dependence for a patient for regular treatment exceeding two months without authority from the Minister. Treatment provided by other prescribers must be considered when calculating the two-month period.
Are veterinary surgeons required to hold drug of dependence authorities to treat animal patients?
Veterinary surgeons are not required to hold authorities to treat animal patients.
How may a prescriber obtain a drug of dependence authority?
Applications must be made to the Minister via the Drugs of Dependence Unit. Applications are to be made in writing only and signed by the applying prescriber.
Can a prescriber prescribe a drug of dependence for the purpose of treating drug dependence?
Treating drug dependence, be it illicit, licit or iatrogenic dependence, requires an authority from the Minister in the first instance; it is an offence to prescribe for this purpose without an authority for any period.
Are there circumstances in which a prescriber may be exempt from requiring a drug of dependence authority?
Yes. An authority is not required when prescribing or supplying a drug of dependence in the following circumstances:
1. a patient aged 70 years or more and the drug involved is not pethidine
2. a patient whose life expectancy is less than 12 months if the drug is not pethidine and the prescriber has informed the Minister of the patient’s name, address, date of birth and the nature of the condition for which the drug is prescribed. In these cases, the prescriber must endorse the prescription either “Notified Palliative Care Patient” or “NPCP”
3. an inpatient in a hospital or correctional institution where the duration of treatment with a drug of dependence does not exceed 14 days
4. a patient discharged from a hospital following an inpatient stay and the duration of treatment after discharge does not exceed 14 days
What does the term “Controlled Drugs” refer to?
Drugs of dependence and other drugs that have no medical use and a high abuse potential.
Describe the 3 primary controls on prescription drugs.
- Possession, prescribing, supply and administration of Schedule 4 and Schedule 8 drugs are prohibited. (Section 18, 31 and 32)
- Pharmacists and other health workers are exempted only while acting in the ordinary course of their profession or in accordance with the Regulations.
- Patients are exempted where the drug has been lawfully prescribed or supplied.
Describe the legal obligations of pharmacists relating to the manufacture of drugs
Pharmacists may manufacture, produce, pack, sell or supply scheduled poisons where such activity is part of ordinary pharmacy practice. Mass production is considered to be manufacturing and requires a licence.
What are 5 regulations on the purchasing of drugs by pharmacists?
- Persons authorised to possess or persons licensed to possess may purchase Schedule 4 and Schedule 8 drugs by written and signed order from a pharmacy.
- Drugs must be purchased in the name of the authorised person and he or she takes responsibility for them.
- If purchasing as a licensed person, the licence should be viewed before the sale.
- If drugs are to be purchased in the name of the practice, the practice must obtain a license to possess such drugs.
- The cancelled Order for a drug of dependence must be forwarded to the Drugs of Dependence Unit by the 7th day of the following month.
Describe the legal obligations of the sale or supply of drugs by pharmacists.
Pharmacists are authorised to sell or supply all classes of drugs and poisons but must be satisfied the supply is lawful.
Describe the legal obligations of the sale or supply of Schedule 3 medicines (pharmacist only)
Regulation 13: A Pharmacist must personally (not through an assistant) give oral directions, supplemented where practicable with written directions, for the safe and proper use of a schedule 3 medicine to the person who is being supplied the medicine.
Describe the legal requirements regarding the labelling of Schedule 3 medications.
Certain S3 medicines must be labelled according to the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) (Regulation 26). These medicines are:
1. Dihydrocodeine in cough preparations
2. Doxylamine in preparations also containing codeine
3. Promethazine in preparations also containing codeine
4. Pseudoephedrine.
Describe the legal obligations of pharmacists relating to the sale or supply of pseudoephedrine
Regulation 14: Pharmacists must not sell or supply pseudoephedrine (either as Schedule 3 or Schedule 4) unless the person presenting for the supply provides a specified form of photo-identification or his or her birth certificate. Accepted forms of photo-identification include a current:
1. driver’s licence
2. firearms licence
3. non-Australian passport
4. proof of age card
5. student identification card.
The records of sale or supply must be made in an electronic form that is accessible via the internet to the Chief Executive of the Department for Health and Wellbeing and the Commissioner of Police.
Describe the legal obligations of pharmacists relating to the sale or supply of Schedule 7 poisons.
Section 16, Regulation 12 and 21: Schedule 7 poisons must not be sold to a person under 18 years of age, a person not known to the pharmacist (unless evidence of identity is produced) or for domestic or garden use. A record of the sale must be kept including the intended use of the poison and the licence number is applicable.