Australia experiencing critical shortage of antidepressants, contraceptives and HRT
Australia is experiencing a critical shortage of key drugs including antidepressants, contraceptives and hormone replacement therapies, a situation that experts say highlights systemic problems with medicine supply in the country.
Most of the shortages appear unrelated to coronavirus disruptions, although in the case of the popular antidepressant Prozac, the manufacturer, Eli Lilly, cites “unexpected increase in demand” during the crisis. Other manufacturers refuse to detail reasons for the supply problems.
Records and medical professionals suggest most of these shortages are about money and highlight difficulties of holding big pharmaceutical companies to account.
Some brands of contraceptive and hormone replacement therapy have been subject to mysterious worldwide shortages, as previously reported by the Guardian. Since those reports, the expected length of the supply shortages in Australia has blown out, by more than a year in the case of the popular HRT patch Estradot.
Other current critical shortages include injectable adrenaline used in cardiac arrest and for severe allergic reactions, and Sinemet, used to treat the symptoms of Parkinson’s disease. The reasons given for the shortages by the importers are “manufacturing” and “other” respectively.
To address the most urgent shortages, the national regulatory body, the Therapeutic Goods Administration, has authorised the import of products not normally approved for Australia under special access arrangements. However, these drugs cannot be subsidised under the Pharmaceutical Benefits Scheme, meaning costs can become prohibitive for patients.
Since the beginning of last year, drug companies have been obliged to report impending supply issues to the TGA, but the reasons given for the shortages are often monosyllabic and opaque. Sometimes the single word “other” is given as the rationale for a shortage that can have devastating impacts on patients.
The dates on which supply is likely to be resumed must be declared, but can be changed by the drug companies at any time without further explanation.
The oral contraceptives Norimin and Brevinor are both made by the multinational firm Pfizer. When they became unavailable earlier this year, Pfizer said normal supply was expected to be resumed by August. Now that has moved to November and December respectively.
Asked for the reason, a spokesperson for Pfizer said the shortage had been caused by “the manufacturing site upgrading engineering on packaging lines, and implementing additional packaging lines”.
Asked for the location of the manufacturing plant, and whether the company was concerned about its inability to maintain supply during upgrades, the spokesperson responded that the company had no further comment, other than to say it was “focused on providing a consistent supply … and committed to actively resolving this matter”.
Replacement products for the contraceptives are available and women affected are being advised to see their doctors.
According to a spokesman for the Australian and New Zealand College of Psychiatrists, Dr Malcolm Hopwood, one of the most worrying current supply issues concerns the antidepressant drug Nardil. Its active ingredient is phenelzine, which is now completely unavailable.
Hopwood said Nardil was an older medicine used by a small number of patients, usually because it was the only drug that had worked for them. He said the lack of availability was causing enormous anxiety and distress.
The TGA allowed doctors to import other unregistered phenelzine products under special arrangements, but these had not been subsidised under the PBS and cost hundreds of dollars a month, taking them out of the reach of many patients, Hopwood said.
Now, even these substitutes are unavailable. The sponsor of the drug, Link Pharmaceuticals, has told the TGA that Nardil is being discontinued.
The TGA said it had approved other providers under special access arrangements but now they too had reported they could no longer obtain phenelzine. “Supply problems with phenelzine are a global issue,” the TGA said.
But information on why, where the drug is manufactured and why supplies have ceased is not available.
A joint statement by the TGA, Australian and New Zealand College of Psychiatrists and the Society of Hospital Pharmacists of Australia warned that patients should be gradually weaned off the drug before they ran out of supply. Withdrawal could cause nightmares, headaches, disorientation, jerks and psychosis.
The distributor of Nardil, Link Medical Products, was contacted for comment and said the product had been discontinued because of “manufacturing problems”. Requests for more information on the nature and location of these problems were not responded to by deadline.
Hopwood said: “My reading is it boils down to money.” He said the amount used in Australia meant that it wasn’t profitable for the company to keep supplying it.
He said he would like to see the TGA support the cost. “The money involved in the grand scheme of things wouldn’t be that much.
“It’s an interesting discussion about where the TGA’s responsibility begins and ends in pressuring the drug companies to continue to provide drugs. They don’t have that role. So who does?”
Meanwhile menopausal women are suffering distress due to shortages in key hormone replacement therapies, including the popular Estradot hormonal patches.
With the predicted period of the shortage blowing out, the TGA has allowed the import of replacement medicines, but again without PBS subsidy.
An examination of the records of the TGA’s advisory panels reveals that the manufacturer, Sandoz, earlier this year applied for Estradot to be permanently removed from the PBS, and then withdrew the application without explanation.
The TGA was unable to shed any light on the reason for this, but it seems, once again, to come down to money.
The general manager of Sandoz, Guy Strong, said “the decision to request delisting was not related to the supply issues, but on the feasibility of continuing to supply the product at a viable price”.
The company cites the catch-all “manufacturing” as the reason for the shortage.
The hormone replacement patches are a complicated product, involving not only the active ingredient, the hormone estradiol, but also the patch and the adhesive.
“We are working to re-establish supply and will let the market know when we are confident of a supply date,” Strong said.
That is expected to be in July next year but this could change at any time.
The president of the Australian Menopause Society, Dr Sonia Davison, has said that women who use hormone replacement therapy usually do so because of very debilitating symptoms.
It is also used to treat complaints such as bone thinning. Some women could become suicidal without appropriate medication, she said, and the products in short supply were among the market leaders.
A TGA spokesperson said: “Pharmaceutical companies are … private entities that make their own decisions regarding their products, and cannot be compelled by the government to list a product on the PBS.”
The TGA does not have the power to obligate drug companies to manage global distribution to avoid shortfalls.
The TGA spokesperson said shortages could occur for a number of reasons, “such as the moving or closing of manufacturing plants, raw material shortages, natural disasters, logistical difficulties, batches of the medicine not meeting applicable specifications or increased demand. The problem of medicine shortages is not unique to Australia.”
Patients who use any of the medications in short supply should consult their doctors about accessing replacements, the TGA said.