The federal government has no plans to make millions of doses of an experimental drug being used in clinical trials on Covid-19 patients available to people who rely on the medicine to treat severe autoimmune conditions, despite Australia’s low number of Covid-19 cases.
The former politician Clive Palmer was granted permission by Australia’s drugs regulator to import the drug, hydroxychloroquine, and the materials required to produce it, so that doses could be added to the national medical stockpile. The drug is used overseas to prevent and treat malaria, and is mostly prescribed in Australia to treat painful symptoms of autoimmune conditions including rheumatoid arthritis and lupus.
However, it is being used only in clinical trials to treat and prevent Covid-19. In newspaper advertisements, Palmer said enough supplies to provide 33m doses of the drug had been imported and made available to the stockpile. The US president, Donald Trump, also promoted the unproven drug as being the best hope for treating Covid-19, which led to Australian doctors prescribing the drug to themselves and their family members. This sparked national shortages of the drug for autoimmune patients, and strict new prescribing restrictions were introduced by the Therapeutic Goods Administration.
The president of the Pharmaceutical Society of Australia, Prof Chris Freeman, said abuse of prescribing had greatly reduced, but “unfortunately our members are still citing cases of individual prescribers trying to source this medicine for themselves, which is disappointing”.
Pharmacists have been told to hold medicine supply for those who have conditions that hydroxychloroquine has been proven to treat.
Despite this, people who rely on the drug have been told to contact pharmacies two weeks before they require a repeat script to allow adequate time for supply to be organised. Consumers are still reporting delays and difficulties accessing the drug.
In his latest ads, Palmer stresses: “It is important that Australians that have been using the drug to treat malaria, lupus and autoimmune diseases over the last 40 years will not have any difficulty in acquiring the drug.”
Even though studies are increasingly finding that hydroxychloroquine is not effective to treat Covid-19, and despite low case numbers of the virus in Australia, the stockpile of hydroxychloroquine could not be made available to consumers struggling to source it for autoimmune diseases, a TGA spokesman said. However, the TGA acknowledged the drug was out of stock at some pharmacies, and that there was a national shortage of a generic hydroxychloroquine brand.
“In most cases, medicines used in clinical trials and included in the national medicines stockpile for the purposes of Covid trials or therapy are not Australian-registered medicines and the TGA has not evaluated their quality, safety and effectiveness,” the spokesman said. “They are supplied under specific exemptions in the Therapeutic Goods Act 1989 and are not approved for general use in Australia and cannot be lawfully released for general use.”
The spokesman could not confirm whether Palmer’s claims that 33m doses had been imported were accurate. “The process to receive donations to the national medical stockpile is under way and the department is not currently in a position to confirm numbers received from individual donors,” he said. The drug has a shelf life of about three years. It is unclear what the government will do with the excess drug if the doses are not all used.
A professor of infectious diseases, Dr Peter Collignon, said the government should make excess supplies of hydroxychloroquine available to countries with high rates of malaria and to those who could use it.
“If Palmer has truly donated this quantity to the stockpile, and it’s sitting there while the evidence is showing there’s not much chop for it treating Covid-19, the sensible thing to do would be to see what else can we use this supply for,” he said.
The national medical stockpile was established in 2002 as a strategic reserve of medicines, vaccines, antidotes and protective equipment to use in a public health emergency or disaster, such as pandemics, cyclones and terrorist attacks. The secret warehouses throughout Australia that contain the stockpile include items that may not otherwise be available in the quantities required during an emergency, or that may take months to ordinarily import.
An audit of the stockpile conducted in 2014 found it contained 42 products and more than 110m items, dominated by products associated with influenza pandemic preparedness.
“Key challenges in planning for and administering the stockpile include effective stock selection and procurement; warehousing to maintain the efficacy of items; stock‑control to account for and locate items; and dealing with items as they reach their expiry dates,” the Australian National Audit Office found.
“Unlike other inventories which are continually being recycled, an emergency stockpile is infrequently deployed and significant volumes of unused goods need to be disposed of on expiry. The limited shelf life of medicines and equipment and the long‑term maintenance of emergency stockpiles constitute a significant cost for government.”
A NSW Health spokesman said while there were adequate stocks of hydroxychloroquine tablets in hospital pharmacies, “we cannot comment on what supply private pharmacies may have nor what requests they may have made to the commonwealth government by them”.
