- The department does not approve software for use by registered health practitioners because there is no legislative provision to do so.
- Any claims by a software supplier that the department has approved its software for use in Victoria are not correct.
- It is the responsibility of the registered health practitioner to comply with the provisions of the Act and Regulations, and to ensure that selected software enables them to do so.
- It is advisable to seek confirmation from prospective software suppliers that the software will enable the health practitioner to comply with the legislation and that following the provided operating instructions will ensure compliance with the legislation.
Note: This following information does not address all aspects of legislative requirements. It merely clarifies issues and provides examples to illustrate the issues that software suppliers should address.
Computer records for Schedule 8 medicines
The Guide to the Drugs Poisons and Controlled Substances Regulations 2006 explains that compliance with r. 41 can be achieved by using a bound volume with consecutively numbered pages and that, before introducing an alternative form of records, a person must ensure that the alternative form of records will comply with the requirements of r. 41.
Accordingly, pharmacists and other registered health practitioners wishing to use electronic records for Schedule 8 medicines in Victoria must satisfy the criteria by which the records are to be retained and retrieved (r. 41). This includes the requirement that the records cannot be altered, obliterated, deleted or removed without detection.
Looking ahead to the Controlled Drug Electronic Register (CDER)
The Electronic Recording and Reporting of Controlled Drugs (ERRCD) initiative, a component of the Fifth Community Pharmacy Agreement between the Australian Government and the Pharmacy Guild of Australia, will see the development and implementation of software programs that will provide a nationally consistent Controlled Drug Electronic Register (CDER) that interfaces with existing pharmacy dispensing software. This function will assist pharmacists to meet their statutory obligations to maintain records of controlled medicines.
Although there are no national uniform regulations in place specifying the requirements for a CDER, the Australian Government and the Pharmacy Guild of Australia have undertaken to work closely with state and territory regulators to ensure the CDER meets jurisdictional requirements and can be used in place of a paper-based controlled medicines register. That said, the department will not be approving any software programs emanating from this initiative for reasons already stated.
Medical practitioners and other registered health practitioners wishing to issue computer-generated prescriptions must do so in a manner that has been approved by the Secretary of the department (r. 26), which means that the computer-generated prescriptions must satisfy the ‘criteria for computer-generated prescriptions’ (see ‘Secretary-approved lists’).
The Guide to the Drugs Poisons and Controlled Substances Regulations 2006 explains that, as the criteria for computer-generated prescriptions may vary in different states, medical practitioners and other authorised prescribers are strongly advised to seek, prior to purchase, verification from the software supplier that their software enables compliance with the specified criteria in Victoria.
Examples have been identified in which medical practitioners have contravened the Drugs Poisons and Controlled Substances Regulations 2006 by using software that is in common use in other states but does not satisfy Victorian requirements.
Forged and fraudulent computer-generated prescriptions
To address the growing problem of forged or fraudulently altered computer-generated prescriptions, it should be noted that the ‘criteria for computer-generated prescriptions’ includes the following:
- Alterations must not be made to computer-generated prescriptions. Where an alteration is required, a new prescription must be generated and the other prescription immediately destroyed.
- In addition to the computer-generated particulars on a prescription, computer-generated prescriptions for drugs of dependence must also include specified particulars in the prescriber’s own handwriting and that the software program must automatically indicate that such handwriting is required.
Note: Unlike other states, the requirement for handwriting particulars of a computer-generated prescription applies to Schedule 4 drugs of dependence in addition to Schedule 8 medicines. Schedule 4 drugs of dependence include benzodiazepines, pseudoephedrine, phentermine (Duromine®), testosterone and other anabolic steroids.