INSIGHTS: Pharmacy alert: maintaining script certifications

April 8, 2014


Pharmacists in Victoria are governed by a number of different pieces of legislation and associated regulations. This article warns pharmacists not to overlook their obligations under section 32(4)(c) of the Pharmacy Regulation Act 2010 (Vic).

Section 32 of the Act relates to a pharmacist’s obligation to keep accurate records of dispensed prescriptions (and details the information to be recorded). Generally speaking, most pharmacy dispensing programs require the pharmacist to input this information when dispensing. However, sub-section 32(4)(c) requires the pharmacist who dispensed a prescription to certify the record created under section 32 with his or her handwritten signature within 24 hours of dispensing. If the prescription record is made in a manner which precludes handwritten endorsement (i.e. the pharmacist maintains electronic records), the pharmacist is obligated to create a separate record for that purpose.

As most pharmacists utilise electronic record keeping software the requirement of sub-section 32(4)(c) is sometimes overlooked. This separate record (described in some dispensing programs as the “Script Certification”) must state that the pharmacist dispensed the prescription(s) listed on the certificate, and it must be endorsed with a handwritten signature of the dispensing pharmacist. This can only be achieved by creating a hardcopy document. The certificate must be kept as part of the pharmacist’s prescription records.

The records created under section 32 of the Act must be retained securely in the pharmacy for at least three years, in a format that allows for ready retrieval by reference to the name and address of the person to whom the medication was dispensed, the date of dispensing, and from information on the container’s label. The hardcopy certificates may be stored electronically pursuant to the provisions of the Electronic Transactions (Victoria) Act 2000 (so long as they are compliant with its requirements), however, they must first be created.

Meridian Lawyers has found that when a pharmacist is subject to a notification of complaint that is investigated by the Australian Health Practitioner Regulation Agency, one of the first documents requested by AHPRA is this certificate. This is because it identifies which pharmacist dispensed any particular prescription on any given day. Unfortunately, in some cases, the pharmacist has failed to maintain proper certificates, which can expose them to further disciplinary action. A breach of the Act can also expose a pharmacist to separate action from the Victorian Pharmacy Authority.

Meridian Lawyers encourages pharmacists to take the time to reacquaint themselves with their obligations under section 32, and to ensure their practices are compliant with its requirements.

If you wish to discuss this requirement further, please contact Kellie Dell’Oro.