Latest system for medicines shortages reporting has had ‘major failings,’ says NPS MedicineWise’s new CEO, but recent legislation is set to improve the situation
Medicine shortages are not a new problem but the extent and scope has worsened over recent years, writes Steve Morris in Australian Prescriber.
Mr Morris became CEO of NPS MedicineWise in September, taking over the role from Dr Lynne Weekes who was in the role for 20 years.
He has previously held the roles of Executive Director, SA Pharmacy and Chief Pharmacist, SA Health.
In an article about medicine shortages in Australia, Mr Morris explains that Australia is potentially more vulnerable than bigger markets because it accounts for only 2% of the global market and imports over 90% of its medicines.
A 2017 survey of Australian hospitals found the five most common medicines in short supply were antibiotics, anaesthetics, cardiology drugs, endocrinology drugs and chemotherapy.
“Such shortages can have a significant impact on patient care with little or no notice,” says Mr Morris, who also points out that this year supply issues have significantly impacted EpiPens, vaccines and even water for injections.
Meanwhile he says the TGA’s Medicines Shortage Information Initiative, a voluntary sponsor reporting scheme, has had “major failings” with some critical shortages not being reported and few clinicians being aware of the initiative.
“The current system leads to duplication of effort, inconsistency and creates a vicious cycle of local stockpiling leading to shortages of therapeutic alternatives within the wider health system, and potential inequity of access to critical drugs across Australia,” he argues.
“The lack of inclusive, robust and timely information prevents effective system-wide strategies from being put in place.”
Mr Morris applauds the recent introduction of the Therapeutic Goods Amendment (2018 Measures No. 1) Bill 2018 which will come into effect on 1 January 2019.
Under this legislation, medicine companies will be mandated to report shortages of important medicines as soon as they occur, with tough penalties to apply to companies that do not comply.
The reporting will be made public for those drugs with the potential for extreme impacts on patients.
This legislation was based on proposals on which the TGA consulted, and aligns with principles of transparency, coordination and communication articulated by the World Health Organization.
“Systematic, timely and transparent reporting is the foundation of a patient-centred approach to medicines shortages,” Mr Morris urges.
“Medicines shortages will continue to impact on patient care for the foreseeable future. It is simplistic to believe that there are straightforward solutions.
“Successful implementation [of the legislation] will require all stakeholders to embrace the principles of transparency, coordination and communication.”
Read the full article here