Prescription record keeping requirements for pharmacists

Pharmacists must mark prescriptions to show they have been dispensed. This must include the prescription reference number, the amount dispensed, the date of dispensing and the name and address of the pharmacy.

Once all supplies and repeats authorised are fully dispensed, prescriptions must be marked as cancelled. Expired prescriptions must also be cancelled. Prescriptions expire 12 months after issue for Schedule 4 items and 6 months for Schedule 8 items.

Where a Schedule 8 prescription has been authenticated with the prescriber, the pharmacist should annotate the document to indicate how it was verified.

A separate record of what was dispensed on each occasion must be kept in the patient clinical record. In a pharmacy, the clinical record will be the dispensing software. For each medicine dispensed, the pharmacist must record the:

• name and address of patient (and owner of animal for veterinary prescriptions)
• patients date of birth for Schedule 8 medicines
• name of medicine supplied and quantity supplied
• prescription date and dispensing date
• prescription reference number generated by the dispensing software; and
• name and address of the prescriber.

These records must also be made for 3 day emergency supplies, emergency supplies authorised by a prescriber, and continued dispensing supplies. Doctor’s bag or other similar supply to an authorised health practitioner requires equivalent records to be made.

For Schedule 8 medicines dispensed, a record must also be made in the Schedule 8 Register at the time of supply.

The original prescription must be kept while the document is still in use. This includes Schedule 8 prescriptions, with repeats remaining and within the 6 month expiration date.

Once no longer in use,documents must be retained for the required duration. This includes prescriptions, repeat forms, duplicates, doctors’ bag requests, faxes for emergency supply, supply requisitions, or other document used to authorise supply. Other records to keep include any dispensing information required by legislation, such as supply endorsements, script cancellations, etc.

Copies of the original prescription can be kept in original hard copy form, or as an electronic copy or scanned image archived in a secure electronic format. These records these should not be provided to patients, transmitted, disseminated or used for any other purpose.

Copies/images of supply documents are also necessary where the pharmacy is not dispensing from the original document, such as an order to supply a medicine on a Residential Medication Chart.

Copies and images are not legal prescriptions and cannot be used to dispense medicines. Pharmacists must not accept scanned images in lieu of an original hard copy prescription. Electronic images do not qualify as an approved electronic prescribing system.

Under Pharmaceutical Benefits Scheme (PBS) legislation hard copy prescriptions are no longer required to be sent to Medicare as part of the claiming process.

There are still requirements to retain copies of the prescription / repeats and be able to produce records to Medicare. More information on Commonwealth requirements can be found at the Department of Human Services (external site).

How long to keep records

All dispensing, supply and prescription records must be retained for:

• two years for Schedule 4 medicines
• five years for Schedule 8 medicines.

This applies to original documents, copies or scans, computer records and Schedule 8 Registers.

Pharmacists should take adequate steps to secure the all records and documents held, and to protect the information against data loss or corruption.

Producing records on demand

Any record that the Medicines and Poisons Regulations require a pharmacist to make and keep, must be able to be produced when requested by an authorised officer of the Department of Health. Original documents must be surrendered or copies, data and reports produced as instructed, within a reasonable time frame.

When storing or archiving records and data, pharmacies should ensure they are able to locate and retrieve individual document or information when needed, according to:

• patient or medicine
• date of supply or range of dates
• prescription reference number(s).

Storing hardcopy records

Hardcopy originals in use must be kept on site, at the pharmacy and remain under the control of the pharmacist with overall responsibility.

Once no longer in use, hardcopy records may be securely stored elsewhere so long as the records can be produced when required. Storage at residential properties or the pharmacist’s home is not suitable. Off-site storage is recommended through a commercial operator with expertise to manage:

• privacy and security
• prevent unauthorised access, alteration, theft or loss
• protect from damage due to fire, water or other disaster; and
• retrieval on demand.

Where copies or scans of documents are stored, the records must meet the requirements of the legislation and be suitable for later reproduction.

An electronically stored copy must be a true and accurate image of the original document, as the legal authorisation to supply a medicine. No part of the document should be obscured or illegible. Image quality should be sufficient for this purpose, including image resolution, contrast, colour and size. It is recommended that a fit-for-purpose, commercial document archiving system, be employed.

The electronic storage method should not allow the modification, alteration or deletion of an image. The system must be appropriately backed up, protected from disaster, and resistant to loss of data, according to industry standards. The system should maintain the privacy and security of the information to the same degree as the original documents. Electronic records must remain under the control and/or possession of the authorised person.

The system must be able to retrieve or reproduce images for viewing, printing or electronic transfer to the Department of Health as requested.

A hard copy original record must not be destroyed while still in use for the purposes of supply. Where the hard copy is the only available record, it must not be destroyed inside the required record keeping duration.

Where an equivalent electronic copy or image has been made and can be produced, the hard copy original that is not in use may be destroyed.

Both hard copies and electronic records may be destroyed once the required time frame has expired. The method of destruction of paper records is a matter for individual pharmacies, however it is recommended that a licensed, confidential waste operator be used.