Labor MP and pharmacist Emma McBride has spoken in support of the Therapeutic Goods Amendment Bill… with some caveats
In speaking on the Therapeutic Goods Amendment (2016 Measures No.1) Bill 2016 in Parliament on Monday, Ms McBride said she supports the Bill as it will ultimately result in improved access to medicines, “a change which is better for all of us”.
“Labor supports the bill and I am pleased to speak this bill, though with some reservations,” she said.
She highlighted recommendation 24 of the Sansom review, relating to category A and category B Special Access Scheme medications, “which are handed out on a daily basis to outpatients of Wyong Hospital”.
“The bill supports recommendation 24 of the review, which stipulates that the current criteria and processes for category A SAS patients remain unchanged. However, it proposes that certain low-risk category B medicines should receive automatic approval, subject to a number of safeguards.
“As a hospital pharmacist and former member of the Central Coast Local Health District Drug and Therapeutic Committee, I understand the importance of robust decision-making processes and approval pathways for medicines and medical devices. I am also aware of the necessity for the regulations, protocols, policies, procedures and guidelines that safeguard their use,” Ms McBride said.
“However, I am acutely aware of the unnecessary delays, treatment interruptions and distress to patients and their families that can and do occur because of the administrative burden to access these medications—the paperwork, the lengthy phone calls and the extensive consultation and liaison required for drugs which in many cases are low risk—medication such as Midodrine, used in the treatment of orthostatic hypotension.
“The delay in commencing this medication due to current SAS processes can delay effective treatment and increase the patient’s hospital stay. That outcome is not in the best interests of the patient or our health service.”
Only 0.3% of roughly 20,000 SAS category B applications received by the TGA are rejected each year, she said.
“Regularly submitting and resubmitting paper-based SAS category B forms for medications that have an established history of use for a given indication and do not risk public safety only increases the administrative burden for clinicians and, as I have pointed out, can delay or interrupt necessary treatment.
“I welcome this common sense change for certain low-risk category B medications. I would also welcome a move away from the current paper-based system and the development of an online system for SAS applications and notifications.”
Ms McBride also discussed support in the Bill for recommendation 27 of the Sansom Review, “which proposes that the government develop a more comprehensive postmarketing monitoring scheme for medicines and medical devices, including better integration and analysis of information from datasets including the medical benefits scheme; the establishment of registries for high-risk implantable devices; the implementation of an alert scheme for newly registered medicines to encourage reporting of adverse events; allowing the electronic reporting of adverse events; and improving collaboration with overseas regulators”.
“Central to this is better integration and timely analysis of available datasets, including analysis of matched, de-identified data from the PBS, MBS, eHealth, hospital records, private health insurance and other available datasets,” she said.
Ms McBride said she supports PSA assertions that Australia has the ability to lead the world in the collection of accurate and timely information on new medicines.
“Twelve per cent of all medical admissions and 20 to 30% of all hospital admissions in the population aged 65 years and over are estimated to be directly attributable to medication misadventure.
“Everyone wants the doctor who sees them in the ED to have the most up-to-date information. Everyone wants the pharmacist who reviews their medication to have the most up-to-date information.
“I particularly welcome changes that will encourage the reporting of adverse events for newly registered medicines, whilst noting that the government has proposed strengthened postmarketing monitoring and surveillance.”
But she cautioned that,“we have not seen all the details, so it is not possible to determine if those enhanced measures will be adequate. We also do not know how the Australian notified bodies will be chosen or how they will be monitored”.
She highlighted the importance of fast access to medicines in changing the lives of patients, including the cases of two children she had met in the course of her duties as a politician; as well as the potential for pre-exposure prophylaxis (PrEP) to change the lives of people living with HIV and their partners.
“While the PBS will likely make a decision on including PrEP this year, Australians are already accessing the drug,” Ms McBride said.
“GPs across Australia are assisting their patients with access to medication through the personal importation scheme. But this does not treat all Australians equally. We should be ensuring that people at high risk of HIV have access and that existing state-based trials are expanded with additional trial spaces.
“Fast access to new medicines is critical for people whose health and wellbeing worsens each day they wait for access.
“As a pharmacist working in community and hospital pharmacy over the last 20 years, I know that medicines are important, I know that medical treatments can change lives and I know that fast access for people who have conditions that worsen each day is critical.
“Labor will be supporting this bill; however, we do so with some reservations.”