Regulations and rail gauge problems holding up ERRCD roll-out

A host of legal and practical impediments are behind the slow roll-out of the promised Electronic Recording and Reporting of Controlled Drugs (ERRCD) system, which aims to provide real-time surveillance and reporting of schedule 8 drugs.

Last week, the Victorian branch of the AMA called on its state government to implement the system as a matter of urgency, citing calls by the Coroners Court and public health authorities to roll ERRCD out to help prevent deaths from prescription drug misuse.

The South Australian branch of the AMA has also lobbied its government to implement the system without delay, citing recent deaths from the misuse of the painkiller fentanyl.

However, despite the federal Department of Health having purchased software licences for each state and territory and establishing a national database hosted on a secure server, each state still needs to implement the system individually, as the regulation of the prescribing and dispensing of controlled drugs is a jurisdictional responsibility.

While it was designed in Tasmania and has been implemented there, the other states are still grappling with how to go about implementing ERRCD.

A spokesperson for the NSW Ministry of Health told Pulse+IT this week that it was continuing to work through the financial and practical implications of the implementation, with a full roll out likely to take three years.

“There may need to be changes to legislation to require the provision of pharmacy dispensing records of controlled drugs and to enable access to records by medical practitioners and pharmacists,” the spokesperson said. “These factors will be considered as the Ministry of Health progresses the implementation.”

AMA Victoria president Stephen Parnis said the AMA understood that laws must be changed in Victoria to enact the replacement of the current manual and paper-based reporting of controlled drugs.

“We acknowledge the Victorian government’s previous discussions with the Commonwealth with respect to funding the system,” Dr Parnis said. “However, we request that the funding issues for the conversion and upgrade of current Victorian data systems be revisited as a matter of urgency.

“The Victorian Department of Health informed us in October 2013 that the development of the ERRCD system is a ‘complex undertaking’ and that they are working closely with the Commonwealth and other states to determine the parameters for an effective system.

“As far as we know, there has been no movement to change state legislation.”

Dr Parnis also said the department had informed the AMA that it was finalising its advice on the business case analysis for introduction of the ERRCD system. “We have had no further information as to the state of this analysis: we understand that a number of options have been proposed [and] analysed, but at this stage we are not privy to the preferred option.”

Western Australia has made some progress with the required legislative changes to support an ERRCD system through its Medicines Poisons and Therapeutic Goods Bill 2013, which is currently before state parliament.

A spokesperson for WA Health said this legislation is required to allow the collection, sharing and the protection of personal data.

“WA is strongly in support of the ERRCD system but there is a lot of technical and administrative work that still needs to be done before software can be rolled out,” the spokesperson said. “WA Health will continue to contribute to national level discussions on ERRCD implementation to ensure the system meets local needs.”

The spokesperson said moving to a national system for controlled drug recording and reporting was a complex task that extends beyond the initial development of new software. “An administrative infrastructure is required to ensure sustainability of the system and protect confidential patient information,” the spokesperson said.

“Agreements are required on matters such as hosting, database and system administration, change management, business continuity, data custodianship and security, data sharing, high level user support and ongoing system financing."

Queensland faces its own challenges. It runs a database known as the Monitoring of Drugs of Dependence System (MODDS), which is maintained by the Medicines Regulation and Quality (MRQ) section of Queensland Health's Health Protection Unit.

MRQ director Susan Ballantyne said schedule 8 prescription information is required to be reported by pharmacists on a monthly basis under the Health (Drugs and Poisons) Regulation 1996, data which is collected by the MRQ.

Dr Ballantyne said she anticipated that only minor legislative changes would be needed to change the regulation to require pharmacists to submit their dispensed controlled drug records to the department in real time, but that the ERRCD system had been developed “as a generic system structure and will require significant modification for functional use in each jurisdiction”.

She said MODDS collates all of the controlled drugs dispensed prescription information in Queensland for purposes of monitoring and surveillance of activities such as doctor shopping, drug dependent patients and appropriate prescribing by medical practitioners.

“As the data is entered retrospectively, there is a time lag in any intervention or response by the MRQ,” she said. “However, currently all doctors and pharmacists have full access to this information through a 24/7 telephone enquiry service.

“A real-time reporting system would feed the necessary information directly to MRQ and potentially to relevant health practitioners, facilitating much more timely intervention and possible prevention of inappropriate prescribing and dispensing.

“The Queensland Department of Health is in the process of assessing appropriate due diligence on the ERRCD program to assess if it will be able to appropriately meet the business and regulatory needs of the department and improve health outcomes, prior to considering full implementation or whether the existing system (MODDS) should be amended to achieve equivalent functionality.

“Once a real-time reporting system is implemented the department would engage in appropriate communication with all relevant stakeholders such as general practitioners and community pharmacists.”

In addition to state-based services like Queensland's telephone enquiry service, the federal Department of Human Services (DHS) also runs a Prescription Shopping Information Service (PSIS) for prescribers, which is accurate up to the last 24 hours.

Doctors can call a hotline to query the patient's recent history and can ask for a PBS patient summary to be sent to them or to access it through HPOS. However, this service is not available to pharmacists.

AMA Victoria has asked for $55 million to be allocated over four years on preventing harm from misuse of prescription drugs in its pre-budget submission. Dr Parnis said the government's business analysis of ERRCD, when it is released, will detail what actions need to occur to roll it out, including software development, training and implementation.

“The Commonwealth’s funding will not be enough for Victoria to implement this system and that is why we are urging the Victorian government to direct funds to this area,” he said.

Posted in Australian eHealth

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