Legal + Ethics Flashcards
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These privileges may be withdrawn by order of the Minister responsible for the Act if a conviction is obtained or an opinion is formed that the pharmacist has acted irresponsibly in handling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.
Describe the legal obligations of pharmacists relating to the supply of needles and syringes.
Regulation 8A: The Controlled Substances (Controlled Drugs, Precursors and Plants) Regulations 2000 permits a pharmacist to supply needles, syringes and advice regarding their safe use to drug users.
Describe the legal obligation of pharmacists relating to medication containers
Section 24, Regulation 26: Prescribed medicines (medicines listed in Schedule 1 to Therapeutic Goods Order No. 80) must be provided in child resistant packaging or containers except where the pharmacist believes that the person would suffer undue hardship through difficulty in opening a container that complies with that Order.
Describe the legal obligation of pharmacists relating to the labelling of drugs.
Section 24, Regulation 26: All poisons must be labelled with the original manufacturers label or labelled with the name (trade and approved), form and strength of the medicine, directions for safe use including route of administration, name of patient, date dispensed, reference number linking to the prescription record if dispensed, name and address of pharmacy. Drugs for patient use must be labelled according to the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP). Warning labels such as a drowsiness warning label may also be required.
Describe the legal obligation of pharmacists relating to the storage of drugs
Section 25, Regulation 27, Code of Practice for the Storage and Transport of Drugs of Dependence: S4 drugs must be stored to prevent public access.
No poison can be stored:
1. in a container that is normally used for food or beverages or is similar to a container that is normally used for food or beverages,
2. if Schedule 3, where the public has access, or
3. if Schedule 2, 5 or 6, where public has access unless
a. it is a Schedule 6 hair colouring preparation, or
b. it is above 1.2 metres from the floor, or
c. it is in a blister pack or a child resistant package or container, or
d. it is in a container over 5 litres or is over 5 kilograms in weight
Describe the legal obligation of pharmacists relating to the storage of Schedule 8 medications.
Schedule 8 drugs must be stored to prevent unauthorised access, for instance generally in a locked safe or vault.
Describe the legal obligation of pharmacists relating to the specifications of Schedule 8 safes.
Minimum specifications depend on the number of doses stored. The standard 10mm steel pharmacy safe is sufficient if 500 or less doses, or 1000 or less doses if there is 24 hour alarm monitoring. Larger quantities, or where there is less monitoring, require greater security. For further information refer to the Code of Practice for the Storage and Transport of Drugs of Dependence
Describe the legal obligation of pharmacists relating to the transportation of drugs
Section 25, Regulation 28 and 239: Schedule 8 drugs must be transported in a manner consistent with the Code of Practice for the Storage and Transport of Drugs of Dependence. Using Australia Post to transport Schedule 8 drugs is prohibited, unless the particular distribution program is exempted under the Crimes Act 1914 . Where it is necessary to transport Schedule 8 drugs, for example to remote locations, this must be arranged through a courier service and comply with relevant provisions of the Code of Practice for the Storage and Transport of Drugs of Dependence.
Describe the legal obligation of pharmacists relating to the record keeping (in relation to supply of Schedule 8 medications)
Schedule 8 drugs must maintain a drug of dependence register and record all transactions. (Regulation 41) All records must be kept a minimum of two years from date of last entry on the record. (Regulation 49)
Describe the legal obligation of pharmacists relating to the advertising of drugs
A pharmacist may not advertise a Schedule 3, 4 or 8 medicine except where the following applies:
1. the advertisement appears in a journal circulated predominantly among health professionals
2. it is a Schedule 3 poison listed in Appendix H of the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP)
3. advertisements for Schedule 3,4 or 8 medicine that consist of a price list that complies with the Price Information Code of Practice published by the Therapeutic Goods Administration.
Is adapalene under Appendix H of the SUSMP, meaning it can be advertised?
Yes
Is tretinoin under Appendix H of the SUSMP, meaning it can be advertised?
No
Is trifarotene under Appendix H of the SUSMP, meaning it can be advertised?
No
Is adrenaline under Appendix H of the SUSMP, meaning it can be advertised?
Yes
Is astodrimer sodium under Appendix H of the SUSMP, meaning it can be advertised?
Yes (for the treatment and relief of bacterial vaginosis and for the prevention of recurrent bacterial vaginosis)
Is levonorgestrel under Appendix H of the SUSMP, meaning it can be advertised?
Yes
Is ulipristal under Appendix H of the SUSMP, meaning it can be advertised?
Yes
Is bifonazole under Appendix H of the SUSMP, meaning it can be advertised?
No
Is butoconazole under Appendix H of the SUSMP, meaning it can be advertised?
Yes
Is clotrimazole under Appendix H of the SUSMP, meaning it can be advertised?
Yes
Is econazole under Appendix H of the SUSMP, meaning it can be advertised?
Yes
Is fluconazole under Appendix H of the SUSMP, meaning it can be advertised?
Yes
Is isoconazole under Appendix H of the SUSMP, meaning it can be advertised?
Yes
Is ketoconazole under Appendix H of the SUSMP, meaning it can be advertised?
No
Is miconazole under Appendix H of the SUSMP, meaning it can be advertised?
Yes
Is oxiconazole under Appendix H of the SUSMP, meaning it can be advertised?
Yes
Is tioconazole under Appendix H of the SUSMP, meaning it can be advertised?
Yes
Is nystatin under Appendix H of the SUSMP, meaning it can be advertised?
Yes
Is alimemazine under Appendix H of the SUSMP, meaning it can be advertised?
No
Is bilastine under Appendix H of the SUSMP, meaning it can be advertised?
Yes
Is brompheniramine under Appendix H of the SUSMP, meaning it can be advertised?
No
Is cetirizine under Appendix H of the SUSMP, meaning it can be advertised?
No
Is chlorphenamine under Appendix H of the SUSMP, meaning it can be advertised?
No
Is cyclizine under Appendix H of the SUSMP, meaning it can be advertised?
No
Is cyproheptadine under Appendix H of the SUSMP, meaning it can be advertised?
No
Is desloratadine under Appendix H of the SUSMP, meaning it can be advertised?
No
Is dexchlorphenamine under Appendix H of the SUSMP, meaning it can be advertised?
No
Is dimenhydrinate under Appendix H of the SUSMP, meaning it can be advertised?
Yes
Is diphenhydramine under Appendix H of the SUSMP, meaning it can be advertised?
No
Is doxylamine under Appendix H of the SUSMP, meaning it can be advertised?
No
Is fexofenadine under Appendix H of the SUSMP, meaning it can be advertised?
No
Is loratadine under Appendix H of the SUSMP, meaning it can be advertised?
No
Is proMETHazine under Appendix H of the SUSMP, meaning it can be advertised?
No
Is amorolfine under Appendix H of the SUSMP, meaning it can be advertised?
No
Is ciclopirox under Appendix H of the SUSMP, meaning it can be advertised?
Yes
Is terbinafine Is ciclopirox under Appendix H of the SUSMP, meaning it can be advertised?
No
Is tolnaftate under Appendix H of the SUSMP, meaning it can be advertised?
No
Is betamethasone under Appendix H of the SUSMP, meaning it can be advertised?
No
Is clobetasol under Appendix H of the SUSMP, meaning it can be advertised?
No
Is clobetasone under Appendix H of the SUSMP, meaning it can be advertised?
Yes
Is desonide under Appendix H of the SUSMP, meaning it can be advertised?
No
Is hydrocortisone under Appendix H of the SUSMP, meaning it can be advertised?
Yes
Is mometasone under Appendix H of the SUSMP, meaning it can be advertised?
No
Is triamcinolone under Appendix H of the SUSMP, meaning it can be advertised?
Yes
Is celecoxib under Appendix H of the SUSMP, meaning it can be advertised?
No
Is diclofenac under Appendix H of the SUSMP, meaning it can be advertised?
Yes
Is etoricoxib under Appendix H of the SUSMP, meaning it can be advertised?
No
Is ibuprofen under Appendix H of the SUSMP, meaning it can be advertised?
Yes
Is indometacin under Appendix H of the SUSMP, meaning it can be advertised?
No
Is ketoprofen under Appendix H of the SUSMP, meaning it can be advertised?
Yes
Is mefenamic acid under Appendix H of the SUSMP, meaning it can be advertised?
No
Is meloxicam under Appendix H of the SUSMP, meaning it can be advertised?
No
Is naproxen under Appendix H of the SUSMP, meaning it can be advertised?
Yes
Is parecoxib under Appendix H of the SUSMP, meaning it can be advertised?
No
Is piroxicam under Appendix H of the SUSMP, meaning it can be advertised?
No
Is diphenoxylate under Appendix H of the SUSMP, meaning it can be advertised?
Yes
Is loperamide under Appendix H of the SUSMP, meaning it can be advertised?
No
Is eletriptan under Appendix H of the SUSMP, meaning it can be advertised?
Yes
Is naratriptan under Appendix H of the SUSMP, meaning it can be advertised?
No
Is rizatriptan under Appendix H of the SUSMP, meaning it can be advertised?
Yes
Is sUMATRIPTAn under Appendix H of the SUSMP, meaning it can be advertised?
Yes
Is zolmitriptan under Appendix H of the SUSMP, meaning it can be advertised?
Yes
Is esomeprazole under Appendix H of the SUSMP, meaning it can be advertised?
Yes
Is lansoprazole under Appendix H of the SUSMP, meaning it can be advertised?
Yes
Is omeprazole under Appendix H of the SUSMP, meaning it can be advertised?
Yes
Is pantoprazole under Appendix H of the SUSMP, meaning it can be advertised?
Yes
Is RABEprazole under Appendix H of the SUSMP, meaning it can be advertised?
No
Is aciclovir under Appendix H of the SUSMP, meaning it can be advertised?
No
is famciclovir under Appendix H of the SUSMP, meaning it can be advertised?
Yes
Is ganciclovir under Appendix H of the SUSMP, meaning it can be advertised?
No
Is valAciclovir under Appendix H of the SUSMP, meaning it can be advertised?
No
Is valGANciclovir under Appendix H of the SUSMP, meaning it can be advertised?
No
Is fluoride under Appendix H of the SUSMP, meaning it can be advertised?
Yes
Is acetylcysteine under Appendix H of the SUSMP, meaning it can be advertised?
No
Is atropine under Appendix H of the SUSMP, meaning it can be advertised?
No
Is calcium gluconate under Appendix H of the SUSMP, meaning it can be advertised?
No
Is digoxin-specific antibody under Appendix H of the SUSMP, meaning it can be advertised?
No
Is flumazenil under Appendix H of the SUSMP, meaning it can be advertised?
No
Is Fuller’s earth under Appendix H of the SUSMP, meaning it can be advertised?
No
Is glucagon under Appendix H of the SUSMP, meaning it can be advertised?
Yes
Is naloxone under Appendix H of the SUSMP, meaning it can be advertised?
Yes
Is pralidoxime under Appendix H of the SUSMP, meaning it can be advertised?
No
Is pyridoxine under Appendix H of the SUSMP, meaning it can be advertised?
No
Is thiamine under Appendix H of the SUSMP, meaning it can be advertised?
No
Is glyceryl trinitrate under Appendix H of the SUSMP, meaning it can be advertised?
Yes
Is isosorbide dinitrate under Appendix H of the SUSMP, meaning it can be advertised?
No
Is isosorbide mononitrate under Appendix H of the SUSMP, meaning it can be advertised?
No
Is cisapride under Appendix H of the SUSMP, meaning it can be advertised?
No
Is hyoscine butylbromide under Appendix H of the SUSMP, meaning it can be advertised?
Yes
Is mebeverine under Appendix H of the SUSMP, meaning it can be advertised?
No
Is peppermint oil under Appendix H of the SUSMP, meaning it can be advertised?
No
Is buspirone under Appendix H of the SUSMP, meaning it can be advertised?
No
Is melatonin under Appendix H of the SUSMP, meaning it can be advertised?
Yes
Is zolpidem under Appendix H of the SUSMP, meaning it can be advertised?
No
Is zopiclone under Appendix H of the SUSMP, meaning it can be advertised?
No
Is aspirin under Appendix H of the SUSMP, meaning it can be advertised?
No
Is paracetamol under Appendix H of the SUSMP, meaning it can be advertised?
Yes
Is imiquimod under Appendix H of the SUSMP, meaning it can be advertised?
No
Is podophyllotoxin under Appendix H of the SUSMP, meaning it can be advertised?
Yes
Is podophyllum under Appendix H of the SUSMP, meaning it can be advertised?
Yes
Is dithranol under Appendix H of the SUSMP, meaning it can be advertised?
No
Is methoxsalen under Appendix H of the SUSMP, meaning it can be advertised?
No
Is salicylic acid under Appendix H of the SUSMP, meaning it can be advertised?
Yes
Is Vitamin D under Appendix H of the SUSMP, meaning it can be advertised?
Yes
What does “vicarious liability” refer to in the legal and ethical obligations of a pharmacist?
An employer may be held responsible for the actions of an employee.
Can prescription medications be accessed without a prescription from a pharmacy?
Section 18, Regulation 35 and 37: Persons authorised to possess or persons licensed to possess (such as medical practitioners, nurse practitioners, dentists, veterinarians) may purchase S4 and S8 drugs by written and signed order (not prescription) from a pharmacy.
Can a medical practitioner self-prescribe drugs of dependence?
A medical practitioner must not (unless an emergency exists) prescribe or supply a drug of dependence for self- treatment or for the treatment of his or her spouse or other family member unless authorised by the Minister.
Can an agent collect prescription medications for a patient?
Section 18, Regulation 35 and 37: Yes, but drugs are purchased in the name of the authorised person and he or she takes responsibility for them.
Can prescription medications be purchased from a pharmacy as a licensed person?
Section 18, Regulation 35 and 37: Yes, but if purchasing as a licensed person, the licence should be viewed by the pharmacist before the sale.
Can prescription medications be purchased from a pharmacy on behalf of a medical practice?
Section 18, Regulation 35 and 37: Yes, but if drugs are to be purchased in the name of the practice, the practice must obtain a license to possess such drugs.
Can orders for drugs of dependence be cancelled?
Section 18, Regulation 35 and 37: Yes, but 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.
May pharmacists supply Schedule 4 drugs on receipt of a written order (i.e. not a prescription)?
Regulation 21: Pharmacists are permitted to supply Schedule 4 drugs on receipt of a written order to:
1. a council or health service for use in an immunisation program,
2. a health professional authorised to supply or administer the drug such as a medical practitioner, nurse practitioner or dentist,
3. the owner of animals for mass treatment of those animals, where the owner
a. has an order from a veterinary surgeon for the drug or
b. the drug is an antibiotic ordered from an inspector under the Livestock Act 1997 (SA) and the order is countersigned by the Chief Inspector,
4. a Master or Medical Officer of a ship where the drugs are required to be carried by law.
May pharmacists supply Schedule 8 drugs on receipt of a written order (i.e. not a prescription)?
Regulation 40:
1. A drug of dependence may be supplied on receipt of an order.
2. The pharmacist must not supply unless:
a. satisfied the person ordering is lawfully authorised to possess the drug, (this includes medical practitioners, dentists, veterinary surgeons and licence holders)
b. if not known to the pharmacist, provides satisfactory identification
o a receipt is provided.
3. Cancelled orders (unless supplying to a health service) must be forwarded to Drugs of Dependence Unit each month with the prescription returns.
Can other health professionals (i.e. besides medical professionals) purchase and possess Schedule 4 medications?
Section 18, Regulation 18: Other professions are permitted to administer (and thus purchase and possess), prescribe or supply a limited range of Schedule 4 medicines.
What does Regulation 18 state about the provision of Schedule 4 medications to health professionals?
Section 18, Regulation 18: Podiatrists, dental therapists, dental hygienists, oral health therapists and optometrists are able to administer the Schedule 4 medicines listed in regulation 18.
Describe the regulations around prescribing relating to optometrists and podiatrists.
Section 18, Regulation 18: Optometrists and podiatrists whose registration is endorsed with a scheduled medicines endorsement are authorised to prescribe, supply or administer scheduled medicines in accordance with that endorsement.
Describe the regulations around prescribing relating to optometrists and podiatrists.
Section 18, Regulation 18: Eligible midwives acting in the ordinary course of their profession whose registration is endorsed with a scheduled medicines endorsement are authorised to prescribe Schedule 4 and Schedule 8 drugs, in accordance with that endorsement (Section 18 and 18A).
What are the legal requirements Prescription requirements for a Schedule 4 prescription?
Regulation 33 and 34: Prescriptions for Schedule 4 drugs must be legible, written in ink and include the following**:
1. name, address and telephone number of the prescriber
2. date the prescription was written
3. full name and address of the patient
4. name of the drug and if necessary, the strength and form of the drug
5. dosage instructions for the safe use of the drug
6. quantity to be dispensed
7. number of repeats if applicable
8. prescriber’s personal signature.
** Does not apply to a medication chart for a Schedule 4 medicine that may be supplied under the Medication Charts Program (when that Program comes into operation).
What are the legal requirements Prescription requirements for a Schedule 8 prescription?
Regulation 33 and 34: Prescriptions for Schedule 8 drugs must be legible, written in ink and include the following**:
1. name, address and telephone number of the prescriber
2. date the prescription was written
3. full name and address of the patient
4. name of the drug and if necessary, the strength and form of the drug
5. dosage instructions for the safe use of the drug
6. quantity to be dispensed
7. number of repeats if applicable
8. prescriber’s personal signature.
For drugs of dependence (Schedule 8 drugs), prescriptions must also include:
9. date of birth of the patient
10. quantity in words and numerals.
How long are prescriptions valid for after writing?
Regulation 33 and 34: Prescriptions are valid for a period of 12 months from the date of prescribing and 6 months in the case Schedule 8 drugs.
What is the core statement of Regulation 35?
Regulation 35: Only valid prescriptions may be dispensed.
Can a pharmacist dispense from a repeat authorisation?
Regulation 35: The pharmacist must dispense from an original or a copy attached to an original repeat authorisation (do not dispense from a repeat authorisation as this may contain an error).
What must a pharmacist legally do when finalising every prescription?
Regulation 35: The pharmacist must endorse the prescription (or copy if dispensing from a copy) with his or her name, business name and address, date dispensed and a unique prescription number.
May pharmacists retrospectively enter details into a prescription record?
Regulation 35: The pharmacist must enter details of the prescription into a prescription record on the same day as it is dispensed.
What must a pharmacist do when a prescription is dispensed for the last time?
Regulation 35: The pharmacist must cancel the prescription when it is dispensed for the last time. The pharmacist must retain the original unless not cancelled.
What must a pharmacist do if dispensing a drug of dependence?
Regulation 35: The pharmacist must, if for a drug of dependence, forward the original, (or a true copy if the original is to be forwarded to Medicare Australia, or in the case of a repeat still to be dispensed) to the Drugs of Dependence Unit by the 7th day of the following month. If no drugs of dependence sales or dispensing occurred, a nil return must be forwarded.
Can a pharmacist dispense a repeat earlier than is stipulated?
Regulation 35: Repeats cannot be dispensed earlier than stipulated unless the pharmacist is satisfied the patient will be out of the state, has lost the previous supply and the pharmacist notifies the prescriber. If intervals are not stipulated, dispensing must not occur earlier than needed based on the prescribed dose.
What must a pharmacist do if they believe a prescription has been forged?
Regulation 35: Where there is reasonable cause to believe the prescription has been altered, forged or obtained by false pretences, the prescription must not be dispensed and in the case of forgery, forwarded to the Police and a copy to the Drugs of Dependence Unit.
What should a pharmacist do if they are presented with a forged for fraudulently altered prescription or document?
- contact SA Police on 131 444 to report the incident and seek police attendance
- complete the Notification to police of a prescription suspected of being forged or fraudulently altered (RF 1661) (PDF 154KB)
- provide the completed form plus the forged/fraudulently altered prescription/document to the police when they attend
- fax a copy of the form and forged/fraudulently altered prescription/document to the Drugs of Dependence Unit
- retain a copy for your records.
What must a pharmacist do if presented for a prescription for a drug of dependence in which either the patient is not known or the prescriber’s signature is not known?
Regulation 35: If the patient is not known or the prescriber’s signature is not known, no more than two days’ supply may be dispensed until the prescription is verified with the prescriber.
What are the regulations around the handing over of drugs of dependence?
Regulation 35: A pharmacist must not hand over drugs until the prescription (or copy) is signed and dated by the person collecting the drugs and if the person is not known, produced satisfactory evidence of his or her identity.
What is a regulation around who a prescriber may prescribe schedule 8 medications for?
A medical practitioner must not (unless an emergency exists) prescribe or supply a drug of dependence for self-treatment or for the treatment of his or her spouse or other family member unless authorised by the Minister.
What does Regulation 35 (12) state?
The requirements under regulation 35 in relation to dispensing prescriptions do NOT apply if a pharmacist or medical practitioner dispenses a medicine supplied under the Medication Charts Program on a medication chart prescription, and the supply is in accordance with the National Health (Residential Medication Chart) Determination.
What are the requirements of supply for a pharmacist or medical practitioner who dispenses a medicine under the Medication Charts Program?
Regulation 35 (12):
1. Record specified details about the prescriber, the resident and the drug when he or she dispenses a drug on a medication chart prescription
2. Not dispense a drug if the prescription is out of date (more than 12 months old), has been cancelled, is partly/wholly illegible, does not comply with the Act or Regulations or if there is reasonable grounds to suspect the prescription has been forged or fraudulently altered. See also ‘Fraudulent and forged prescriptions’.
May a pharmacist sell or supply a Schedule 4 drug without dispensing a prescription?
Regulation 21: A pharmacist may sell or supply a Schedule 4 drug without dispensing a prescription if the drug is a pharmaceutical benefit that may be supplied under the Continued Dispensing Program. The sale or supply of the drug must comply with the National Health (Continued Dispensing) Determination.
What is the maximum quantity permitted for a pharmacist to provide under the National Health (Continued Dispensing) Determination?
Regulation 21: Where supply is made under this program, the maximum quantity permitted under the Pharmaceutical Benefits Scheme for that medicine may be supplied.
How frequently may a patient access Schedule 4 medications on the National Health (Continued Dispensing) Determination?
Regulation 21: Under the Continued Dispensing Program, the medicine may only be supplied to the person once in a 12 month period.
What conditions must be met for a pharmacist to supply a medicine under the Continued Dispensing Program?
Regulation 21: A pharmacist must not supply a medicine under the Continued Dispensing Program unless the person has previously had a valid prescription and the person’s therapy is stable, and information about the supply is provided to the most recent prescriber.
Can a prescriber give a verbal order for a medication?
Regulation 33: A prescriber may, where there is a good reason, give a prescription by telephone, facsimile, or other electronic means.
What information is required on a verbal order from a prescriber?
Regulation 33: The same information as required for a written prescription must be provided. Unless the prescription was faxed and endorsed with the name of the single pharmacy to dispense the prescription, the prescriber must forward a written prescription as confirmation as soon as practical or if a drug of dependence, within 24 hours.
Can a prescriber prescribe drugs of dependence to a drug dependent person?
An authority under South Australian controlled substances legislation (granted by the DDU) is required prior to prescribing or supplying a drug of dependence to a drug dependent person.
Describe the regulations around what MATOD therapy prescribers can prescribe.
In South Australia, all medical practitioners and nurse practitioners (within their scope of practice) can prescribe sublingual buprenorphine with naloxone film (Suboxone®) to treat opioid drug dependence for up to ten patients, without completing specialised MATOD training. With the recognised greater safety of buprenorphine/naloxone use in the treatment of opioid dependence, this may provide better access for patients to receive both MATOD and other medical treatment from their usual prescriber. A medical practitioner must become accredited to: prescribe methADONe liquid or buprenorphine as a single agent or prescribe Suboxone treat more than ten patients.
Describe the legislation around prescribing buprenorphine (Subutex) for accredited MATOD prescribers
Accredited MATOD prescribers must notify the DDU in writing prior to prescribing buprenorphine as Subutex® for patients who are:
1. allergic to naloxone
2. on a low dose short-term withdrawal regime
Describe the legislation around prescribing buprenorphine (Subutex) for non-accredited MATOD prescribers
Non-accredited MATOD prescribers can apply to the DDU to prescribe buprenorphine for patients:
1. if treatment has been initiated and stabilised by an accredited prescriber
2. on a low dose (≤2mg) short term withdrawal regime
What are non-accredited MATOD prescribers with patients who become pregnant recommended to do?
Seek advice regarding management from an accredited prescriber or Drug and Alcohol Services South Australia (DASSA).
Can non-accredited MATOD prescribers prescribe buprenorphine depots?
No
Describe the rules around provision of buprenorphine depots by pharmacists.
Pharmacists must not provide the injection to the patient. They must be provided to an authorised health professional.
What are 3 instances in which twice per day dosing (split dosing) of methADONe may be considered for MATOD patients?
- patients who rapidly metabolise methADONe
- vomiting and/or rapid metabolising during pregnancy
- patients with acute pain (short term treatment with split dosing)
What is a legal implication related to split dosing of methADONe for MATOD therapy?
Accredited prescribers must notify the DDU in writing prior to prescribing split dosing of methADONe.
What are 4 actions that may result in MATOD authority restrictions or termination of treatment
- suspected, attempted or confirmed diversion
- unsanctioned drug use, intravenous drug use
- continued drug seeking, prescription forgery/tampering
- inappropriate storage of take away doses potentially resulting in theft or accidental death
May a pharmacist provide a Schedule 8 medication on receipt of an order?
Regulation 40: a drug of dependence may be supplied on receipt of an order where the pharmacist is satisfied the person ordering is lawfully authorised to possess the drug, (this includes patients, medical practitioners, dentists, veterinary surgeons and licence holders).
What is a legal requirement if the person collecting a drug of dependence is not known to the pharmacist?
If the person is not known to the pharmacist he or she must provide satisfactory identification before the drug is supplied, and provide the pharmacist with a signed and dated receipt for the drug.
What is a requirement around recording of drugs of dependence by pharmacists?
Regulation 41: Pharmacists must maintain a drug of dependence register and record all drug transactions.
How long must records of drugs of dependence be kept for?
Regulation 35: All records must be retained, protected and available for inspection for a period of two years from date of last entry on the record.
What details of supply must be recorded with drugs of dependence?
Regulation 35: The supply must be recorded with the following details and the pharmacist must sign the record:
1. his or her name and business address
2. the name and address of the person to whom the drug was supplied
3. the date on which the drug was supplied
4. the name or ingredients of the drug
5. the amount, and if applicable the strength of the drug
6. if the drug was sold or supplied on order, the invoice number (if any) for the sale or supply of the drug
7. the total amount of the drug now in stock on the premises
What must pharmacists do when cancelling orders of drugs of dependence?
Regulation 35: Cancelled orders (unless supplying to a health service) must be forwarded to Drugs of Dependence Unit each month with the prescription returns.
Can a drug of dependence be supplied on Emergency Supply provisions?
Regulation 35 and 40: A drug of dependence must not be supplied without prior receipt of a lawful order or prescription (written, verbal, fax or by other permitted electronic transmission)
Can a drug of dependence be supplied on Emergency Supply provisions?
Regulation 35 and 40: A Schedule 4 drug may be supplied to a person by a pharmacist without an order or prescription provided
1. the person is currently under treatment with the drug
2. the continued supply is essential for health reasons
3. there is good reason why the person cannot supply a prescription
4. the drug is not one listed in the table in regulation 19(1) and
5. the supply does not exceed three (3) days or the smallest standard pack if a mixture, cream or ointment.
What are 4 classes of drugs which cannot be provided without an order or prescription?
- Ovulatory stimulants
- Retinoids
- Thalidomide and lenalidomide
- Endothelin receptor antagonists
May a pharmacist destroy drugs of dependence independently?
No. Destruction and disposal must be witnessed by another appropriate person (ie. pharmacist, registered health practitioner, an authorised officer, police officer, registered veterinary surgeon or a person who has been authorised in writing by the Chief Executive of the SA Ambulance Service to administer drugs of dependence).
What documentation is required when destroying drugs of dependence?
A record including the full names and signatures of the person and the witness to the destruction, name, strength and amount of drug; and the date and time of destruction must be made immediately after the drug is destroyed.
When is a drug of dependence considered to be adequately destroyed?
Drugs must be rendered unusable (damage that is so severe that the drug is unrecoverable), disposed of in an environmentally responsible way and so there is no risk to the public of them being reused or diverted.Destruction and disposal of drugs of dependence must not pose a risk to public health or safety (Regulation 48).
What is an agency to contact for advice on how to appropriately destroy drugs of dependence?
The Pharmacy Regulation Authority SA (PRASA)
What is the role of pharmacists in preventing drug-seeking behaviours?
Section 30: Pharmacists should take all reasonable actions to ensure they are treating a genuine medical condition and treatment does not contribute to the induction of drug dependence, maintenance of drug dependence without a proper treatment plan or add to the pool of drugs available for illicit drug trafficking.
What is a potential consequence for pharmacists found guilty of supply of drugs of dependence without due diligence?
Section 57: Supply without due diligence may be considered to be “irresponsible” and result in the serving of an Order which effectively removes privileges granted to a pharmacist to handle prescription drugs.
What should a pharmacist do if they are suspicious a person is seeking prescription drugs?
Pharmacists may contact the Drugs of Dependence Unit if suspicious of a person seeking prescription drugs.
May unit officers acting for the Minister for Mental Health and Substance Abuse disclose personal information about a patient to a medical practitioner?
Unit officers, acting for the Minister for Mental Health and Substance Abuse, are empowered to provide information regarding medical history to a Medical Practitioner where an opinion is formed the person is drug dependent and acting illegally.
What is the “Privileged Circular”?
Section 58: The Minister publishes a “Privileged Circular” periodically listing major drug seekers at the time with the aim to restrict or stop further supplies of drugs to those persons
What are the 4 requirements of pharmacists in regard to forged or fraudulently altered prescriptions?
Pharmacists must :
1. not dispense a prescription they have reasonable cause to believe has been forged or obtained fraudulently and
2. if forged, retain the prescription and forward it together with the Notification Form for Forged or Fraudulently Altered Prescriptions to the police (available from DDU website)
3. a copy of the prescription and form is to be forwarded to the Drugs of Dependence Unit also.
4. Retain a copy for your records
Describe the special provision requirements relating to ovulatory stimulants
Regulation 19: Clomiphene, cyclofenil, follitropin-alpha, follitropin-beta, luteinisinghormone, or urofollitrophinmay only be supplied if prescribed or ordered by a specialist in endocrinology, obstetrics and gynaecology or a medical practitioner providing services to a fertility unit, an endocrinology unit, or an obstetric and gynaecological unit in a teaching hospital.
Describe the special provision requirements relating to retinoids
Regulation 19: Acitretin, bexarotene and etretinate (for human use) and isotretinoin (for human internal use) and may only be supplied if prescribed or ordered by a specialist in dermatology, oncology or haematology (or a medical registrar working under such a specialist), or such other specialist individually authorised by the Minister. Tretinoin (for human internal use) may only be supplied if prescribed or ordered by a specialist in oncology or haematology (or a medical registrar working under such a specialist) or such other specialist individually authorised by the Minister.
Describe the special provision requirements relating to Thalidomide and lenalidomide
Regulation 19: Thalidomide or lenalidomide for human use may only be supplied if prescribed or ordered by a specialist in oncology or haematology (or a medical registrar working under such a specialist), or a medical practitioner individually authorised by the Minister.
Describe the special provision requirements relating to Endothelin Receptor Antagonists
Regulation 19: Ambrisentan, bosentan, and sitaxentan may only be prescribed or ordered by a relevant specialist (or a medical registrar working under such a specialist) or a medical practitioner individually authorised by the Minister.
Describe the special provision requirements relating to Dronabinol (delta-9-tetrahydrocannabinol), which is a Schedule 8 drug.
Prescribers must be authorised by the Secretary of the Commonwealth Department of Health and Ageing to prescribe or order dronabinol (contact the TGA). Authority to prescribe will not be granted by the South Australian Minister for Mental Health and Substance Abuse unless the applying prescriber can demonstrate he or she is in possession of a Commonwealth authority.
What should pharmacists do if they require guidance in a scenario related to a drug of dependence?
Pharmacists are encouraged to telephone the Drugs of Dependence Unit to discuss cases where guidance or advice is required.
May a pharmacist supply pharmaceutical benefits at any site?
An approved pharmacist may only supply pharmaceutical benefits at or from premises for which they have been approved.
As part of their approval under section 90 of the Act, all approved pharmacists are subject to certain conditions. These include that the approved pharmacist will do what 3 things?
- not supply to anyone any pharmaceutical benefit that attracts a Commonwealth contribution for free, or for a price that is less than the relevant patient contribution;
- clearly advertise that any offer for free or cut-price medicines does not include pharmaceutical benefits which have a Commonwealth contribution; and
- not pay rebates or refunds of patient contributions.
The Conditions of Approval require that an approved pharmacist must, amongst other requirements, satisfy what 4 obligations?
- comply with all legal requirements for the practice of pharmacy;
- comply with the Pharmaceutical Society of Australia’s Code of Ethics and Professional Practice Standards in their dealings with each individual patient;
- maintain the currency of his or her pharmaceutical knowledge in accordance with the Pharmaceutical Society of Australia’s Competency Standards for Pharmacists in Australia; and
- not make a claim for payment for the supply of a pharmaceutical benefit unless it was supplied at or from approved premises for the pharmacist.
If you have concerns about a potential breach of the Conditions of Approval for approved pharmacists, or any other compliance matter, who can you report your concerns to?
The Provider Benefits Integrity Hotline
What are 5 requirements of a pharmacist approved to supply medicines under the PBS?
The pharmacist:
1. will publicly display a notice setting out the pharmacy’s normal trading hours;
2. is obliged to supply pharmaceutical benefits at the pharmacy at any hour if a PBS prescription is marked ‘urgent’ and initialled by the prescriber;
3. will keep adequate stocks for the supply of pharmaceutical benefits;
4. may be called on by Services Australia to provide details of stocks of pharmaceutical benefits or preparations for pharmaceutical benefits; and
5. must keep copies of all paper-based and electronic PBS prescriptions, with a for at least two years from the date of supply. This includes PBS prescriptions ordering repeats when it is the final supply, and order forms for prescriber bag supplies. Please note that some State/Territory laws require these copies to be kept for longer periods.
What 2 steps must be taken before a pharmaceutical benefit is supplied?
- A pharmacist must endorse the PBS prescription and duplicate with his/her name and approved supplier number.
- A PBS prescription identifying number must be given to the PBS prescription item on both the PBS prescription and duplicate. Any recognised series of numbers may be used.
What must be done before a pharmaceutical benefit is supplied if there is more than one item on a PBS prescription?
If more than one item is on a PBS prescription, a separate identifying number should be allocated to each item.
What must be done before a pharmaceutical benefit is supplied in the case of a repeat authorisation?
The same PBS prescription identifying number(s) must be carried through for each item. A pharmacist must also allocate his/her own identifying number on the repeat authorisation. It must be written alongside the date and place of supply.
Pharmacists are authorised to supply pharmaceutical benefits only after they receive one of which 3 types of prescription?
Except in urgent cases
1. the pharmacist/patient and Medicare/DVA copies of a valid PBS prescription which is not more than 12 months old; or
2. the pharmacist/patient and Medicare/DVA copies of an approved authority PBS prescription or an authority to prescribe which is not more than 12 months old; or
3. a repeat authorisation attached to a patient/pharmacist PBS prescription not more than 12 months after the date of the original PBS prescription.
Describe the regulations around pharmaceutical benefit in urgent cases.
In urgent cases and where State/Territory law allows, pharmacists can supply a pharmaceutical benefit to a person without a PBS prescription, provided details of the prescription are given by the prescriber via telephone or other means. The prescriber must then forward the written PBS prescription and duplicate to the pharmacist within seven days of the date of supply.
Describe the regulations around pharmaceutical benefit in urgent cases where prior approval from Services Australia of the DVA is required.
Where a pharmaceutical benefit needs prior approval from Services Australia or the DVA, the prescriber must obtain approval and then advise the pharmacist of the PBS prescription and approval details. Only an original supply can be provided in this manner, not repeats.
Describe the regulations around providing Authority required (STREAMLINED) items.
A pharmacist must not supply an Authority required (STREAMLINED) item unless the prescriber has written the four digit streamlined authority code on an authority PBS/RPBS prescription.
Describe the regulations around the number of supplies of a pharmaceutical benefit
A pharmaceutical benefit cannot be supplied more times than specified in the PBS prescription.
May pharmacists alter prescriptions to allow them to conform to PBS requirements?
A pharmacist cannot add to, delete from, or alter a PBS prescription in any other way. However, there may be circumstances where after contacting a prescriber, the pharmacist can clarify the prescriber’s intentions and endorse the PBS prescription accordingly.
How frequently can patients access pharmaceutical benefit?
A pharmaceutical benefit may not be supplied if the same or an equivalent pharmaceutical benefit (any brand) has already been supplied for the patient within the period specified by legislative instrument for early supply purposes.
How frequently can patients access pharmaceutical benefit if there is no specified period?
Either:
1. on the same day or within the previous 20 days, if it is a pharmaceutical benefit (other than an eye preparation) that has five or more repeats allowed in the PBS Schedule, (e.g., if a pharmaceutical benefit is supplied on Tuesday 4 June, it cannot be supplied again for that patient until Tuesday 25 June) or otherwise;
2. on the same day or within the previous four days for all other items (e.g., if a pharmaceutical benefit is supplied on a Monday, it cannot be supplied again for that patient until the next Saturday).
What are 2 instances where it is appropriate to disregard specified durations between pharmaceutical benefit?
- the repeated supply is prescribed on a PBS prescription endorsed with the words ‘one supply’ or ‘1 supply’ (it is still valid if the prescription is endorsed ‘Regulation 24’ or ‘Reg 24’) or on an RPBS prescription endorsed ‘hardship conditions apply’ (see below under ‘Regulation 49 ‘); or
- if the pharmacist believes a repeat supply is needed without delay for the treatment of the person, or a previous supply has been destroyed, lost or stolen. In this case, the pharmacist can provide another supply but must write ‘immediate supply necessary’ and sign the PBS prescription.
Can a pharmacist can supply an alternative pharmaceutical benefit without reference to the prescriber?
Yes, provided that:
1. the PBS prescription does not indicate that only the pharmaceutical benefit prescribed is to be supplied (ie substitution is not permitted); and
2. the Schedule states that the prescribed benefit and the substitute benefits are equivalent; and
3. supply of the substitute benefit does not contravene relevant State/Territory law; and
4. the substitute benefit is a listed brand in the Schedule.
How does a change in schedule of a medication affect pharmaceutical benefit?
If an item or brand is deleted from the Schedule, it cannot be supplied as a pharmaceutical benefit from the date the deletion takes effect – regardless of whether the PBS prescription was written before this date. This includes repeat authorisations. (Special conditions applying to RPBS prescriptions are detailed in the RPBS Explanatory Notes.)
What are the implications if an item or brand is Supply Only on the schedule?
If an item or brand is Supply Only on the Schedule, it can be supplied as a pharmaceutical benefit. PBS Prescriptions written prior to the Supply Only period are able to be dispensed using either the Supply Only product where available, or an equivalent product as specified on the PBS schedule.
If restrictions on the prescribing of a pharmaceutical benefit change, or the maximum quantity or number of repeats is altered in the Schedule, can valid PBS prescriptions written before the date of effect of the change be supplied as pharmaceutical benefits?
Yes, but only under the conditions applying at the date of prescribing.
