Pharmacy Regulations & Medication Labeling

• Valid script requirements for prescriptions in WA:
• Prescriber's name, address, and telephone number
• Patient's or animal species' name and address
• If for veterinary prescriptions, include the caretaker's information
• For non-veterinary S4 medicines: patient's date of birth, unless the pharmacist has a valid reason why not
• Medicine name, strength, and formulation
• Precise directions for use, including dosage and frequency
• Quantity to be dispensed
• Number of repeats permitted
• Date the prescription was issued
• Prescriber's signature in ink

S4 Prescriptions

• Patient's date of birth must be present
• Must be less than 12 months old from the date of issue

S8 Prescriptions

• Patient's date of birth verified
• Minimum repeat dispensing interval must be specified
• Cannot include any S4 medicines
• Must be less than 6 months old from the date of issue
• Prescribers are strongly discouraged from prescribing S8 medications for themselves or family members

S4 Specified Drugs

• Includes anabolic steroids and other androgenic substances like prasterone and human growth hormone
• A miscellaneous group of drugs, including barbiturates, dextropropoxyphene, anorectics, ephedrine, pseudoephedrine, erythropoietins, darbepoetin, and diazepam

S8 Community Program for Opioid Pharmacotherapy (CPOP)

• Covers treatments for opioid dependence
• Dispensing requires approval for community pharmacies from the Health Department

S8 Stimulant Medicines

• Dexamfetamine, lisdexamfetamine, and methylphenidate prescriptions require prior authorization

• Shared care model applies

• Forged prescriptions must be retained and cancelled by the pharmacist

• Advise the Department of Health immediately

• All cases must reported ASAP

Interstate Prescriptions

• Prescriptions issued by interstate prescribers can be dispensed in WA if the prescriber is registered nationally via AHPRA
• May be authorized to prescribe stimulants if:
  • The patient is a WA resident, with address on the script
  • The prescriber has had a telehealth consultation with a specialist
• Must include information required by WA Medicines and Poisons legislation
• The patient's date of birth, exact repeat intervals, and precise directions for use are needed for S8 prescriptions
• Authenticity of paper-based prescriptions (handwritten and computer-generated) must be verified, even for repeats
• Repeats must not be given back to the patient but can be transferred if needed

Dispensing Genuineness Verification

• Reasonable steps should include identity and authority of the prescriber
• Identity of the person presenting the prescription
• Authenticity of the prescription itself
• If unfamiliar with the patient or it has not been previously dispensed at the pharmacy, steps should be taken to verify the prescription
• Verify by speaking to the prescriber in person, via phone, or equivalent means, unless it is an eScript
• PBS authority approval numbers are not a substitute for personal verification with the prescriber

S3 Restricted Substances

• The purchaser's identity must be known to the pharmacist; ID is required if not known
• Therepeutic need must be established
• Amount sold must be reasonable
• Must be labelled and the sale recorded.
• Recording in Project Stop:
• Date of sale
• Name and address of purchaser
• Name and address of the person intended for
• Name and quantity of medicine supplied
• Unique identification number or alpha-numeric code
• Must be labelled with:
• Name and address of pharmacy
• Unique identification number or alpha-numeric code

S4 Monitored Medicines

• Must adhere to ScriptCheckWA requirements
• Staged supply and limited quantities must be upheld
• No early prescriptions
• Clear directions of use with max daily dose
• Limit supply from a single pharmacy
• Consult with the doctor for dependance management

S4 Structured Administration and Supply Arrangement

• Allows a health practitioner - who is NOT the prescriber - to administer medicine beyond circumstances listed in Medicines and Poisons Regulations provided reference is made to SASA

S8

• The requirements for S8 prescriptions
• Must include the patient's date of birth and repeat intervals
• If a prescription does not state repeat interval, it is invalid, but you can clarify
• S4 and S8 substances cannot be on the same script
• The same S8 drug can be on the same script
• If verification cannot be obtained, a pharmacist can supply up to 2 days of treatment if the prescription is otherwise valid
• Retain the prescription or with the approval of the CEO, transfer the script to another pharmacist

Emergency S4 or S8 Supply

• A prescriber can direct a pharmacist to supply an S4 or S8 medicine in an emergency

• The prescriber must prepare a valid prescription to cover the emergency supply and post it to the pharmacist within 24 hours

• An emailed script is not valid

• The script should not be given to the patient, and no e-Script should be issued

• A pharmacist may provide up to a three-day emergency supply of an S4 medicine without a prescription if:

• The person or animal is under regular treatment with the medicine

• It is not practical to obtain a prescription in sufficient time

• Interruption of treatment is likely to cause harm

• Schedule 8 are not permitted and can only give 2 days supply if unable to verify but not if script is invalid

• Pharmacists must label these medicines and record the supply

• For non-divisible packs, one standard pack can be supplied

• To provide more than a three-day emergency supply of an S4 or S8 medicine, a pharmacist needs a verbal or electronic direction from a prescriber or a prescription faxed from a medical practice

• Should a prescription not be received within 5 working days, the pharmacist should inform the Department of Health

Continued Dispensing Rules

• Applies to S4 medications exclusively
• Under Schedule 1 of the National Health (Continued Dispensing) Determination 2022
• Follow the Department of Human Services PBS Continued Dispensing Arrangements
• Adhere to Guidelines for the Continued Dispensing of Eligible Prescribed Medicines by Pharmacists
• Only available once in any 12-month period
• The pharmacist must inform the patient's usual prescriber that the supply has occurred within 24 hours
• Pharmacists must label the medicine & make a record of the supply
• For medicines not covered otherwise, a pharmacist may supply in an emergency:
• 3-day treatment of a Schedule 4 medicine
• According to the verbal instructions of a prescriber

Regulation of Medicines & Poisons – SUSMP

• Labelling by pharmacists must follow Appendix L of the SUSMP

• Labels must be in English with

• “KEEP OUT OF REACH OF CHILDREN” in red on a white background

• generic or brand name of the medicine

• strength and form of the medicine

• directions for use

• total quantity in the container

• patient name

• name, address, and telephone number of the supplying pharmacy/prescriber

• date of supply

• Pharmacists label must also include the prescription reference number corresponding to the electronic record they made.

Topical Use Labels

• Must say: "FOR EXTERNAL USE ONLY" and "POISON"

• Check schedule requirements

• For Appendix k (legal requirement)

• SEDATION WARNING – reinforce again somewhere on label

• Schedule 4 Monitored Medicines:

• Higher risk of patient abuse, misuse and physical or psychological dependence

• All benzodiazepines in S4

• Codeine-based preparations in S4

• Gabapentin

• Pregabalin

• Quetiapine

• Tramadol

• Zolpidem

• Zopiclone

• Capture on ScriptCheck WA

• Record prescriber's name and address & patient DOB

Storage Conditions

• Schedule 2 Pharmacy Medicines

• Must be stored to prevent physical access by the public

• Safe use of which requires pharmacists advice

• Pharmacy – behind counter or licensed retailer – closed display counter

• Permit or license holders must store the product so it cannot be visible or accessible

• Schedule 3 Pharmacist Only

• Only by retail sale from a pharmacy

• Must be stored to prevent public access – behind counter

• Retail sale must be done only by a pharmacist, intern or technician under a pharmacist supervision.

• Must be stored so that they are not visible and prevent physical access for permit holders/authorized health practitioners

• S3 Restricted:

• Pharmacist only, stored in the dispenary, away from any retail area (pseudoephedrine)

• The identity of the purchaser must be known to the pharmacist, with ID required if no known

• Schedule 4 Prescription Only

• Written, computer generated or electronic

• Must be less than 12 months of date of issue

• Stored in dispensary to prevent physical access by the public

• Storage by health practitioners:

• Store S4 meds at their usual practice place is in a container, cabinet, or locked room accessible by authorized health professionals

• Authorized health practitioners limited tp reasonable amounts in transportation

• Authorized health practitioners must keep S8 at all times and implement reasonable steps to avoid loss or theft

• Schedule 8 Controlled Prescription:

• Must be stored in a secure cabinet access which is supervised or a safe with detection device

• Must be written within 6 months to be valid

Advertising Regulation

• S2 medicines can be advertised
• S3 medicines cannot be advertised unless for health professionals licensed to manufacture or supply
• S4 and S8 medicines must not be advertised except to health professionals
• Advertising for S9 & 10 is illegal
• Ads may specify the condition, disease or ailment pending on the approval from the Department of Health
• Price info cannot promote the sale or use of a medicine

Record Keeping

• S4 records to be kept for 2 years, with DOB recorded
• S8 records to be kept for 5 years

Medicine Categories

• Labelled medicines (L) are tested for safety but unsure of efficacy
• Labelled medicines (R) are tested for safety and efficacy

Dentist Prescriptions For S8

• May prescribe up to 14 days supply for acute dental treatment

S4 Medicines: Prescription Requirements

• Prescriber name, address, & phone
• Prescriber number
• Patient name and address
• Type of benefit, PBS or RPBS
• Formulation/strength information
• Dising instructions
• Amount
• Authority
• Doctor details
• Scripts are typically valid for 12 months from the date issued.