More needs to be done so situations mirroring last year’s metformin shortages don’t happen again, they say
Medicines shortages are rife and the current processes don’t seem to be helping, according to pharmacists interviewed by the AJP.
Some shortages have been worse than others – for example, metformin was in extremely short supply last year, with pharmacists left in the lurch wondering when the critical medicine would become available.
Dr Gregory Kossena (PhD), managing partner of Cowes Pharmacy in Victoria, says the metformin shortages were “perhaps the worst I have ever seen”.
“This was compounded by the fact that metformin is without a doubt the most common of all prescribed diabetic medication,” says Dr Kossena.
“To not have any formulation in any brand was just crazy, things should have not been able to get to such a stage.”
He says the TGA told him a supply of some brands was still available, however after contacting the manufacturers directly he discovered this was not the case and supply was not expected for many weeks.
Being unable to “convert a prescription” for metformin to another formulation or a different medication, Dr Kossena was forced to send patients back to their doctor.
“The fact that many of the patients who had run out of metformin XR could simply been converted onto metformin IR formulation was obvious, yet by law we had to send each and every patient back to their doctor to get a new prescription,” says Dr Kossena, “thereby costing the patient and Medicare an unnecessary astronomical amount for nothing!”
A poll on our website revealed the majority (76%) of respondents reported having to contact the initial prescriber to arrange a therapeutic alternative.
And under half (47%) reported being “usually able” to provide the generic alternative or substitute brands.
“Pharmacy should have the ability to ‘convert a prescription’ using professional judgment in such scenarios where possible,” Dr Kossena argues.
Dr Kossena had contacted then Health Minister Sussan Ley with his concerns, who responded that a new prescription is typically required – however in emergency circumstances, a pharmacist may supply the medicine without a paper prescription following the confirmation of details from the relevant prescriber, with the script sent to the pharmacist within seven days.
Regarding the metformin shortages, Minister Ley had also stated that new batches of the drug had been released but “in some instances, it can take time for products to make their way through the supply chain”.
Another pharmacist tells AJP that the current processes are not good enough.
“My experience, like most pharmacists, was that the metformin shortage went on longer than it should have and the TGA website was useless because it relied on the voluntary notification of the sponsor,” says the pharmacist, who prefers not to be named.
“Pharmacists never refer to the TGA website because we know that it’s unavailable, because we see it’s short on the websites of Symbion, API or Sigma – and they usually have a date expected that never turns out to be true.
“What the TGA needs to do is get its information from the three main wholesalers on a weekly basis, then they could follow up with the manufacturer.”
“My concern is that the TGA are not focused enough on the ‘continuity of supply’ issue,” says Dr Kossena, adding that its Medicine Shortages Initiative (MSI) website does not address the issue but simply highlights it, and is often weeks off the real-time stock scenario.
Similar scenarios to the metformin shortage that have occurred recently include HRT (Estradot, Estalis) patches, Fasigyn/Simplotan tablets, Sofradex/Otodex ear drops, Viscotears eye gel.
“The list goes on”, says Dr Kossena. “Whilst these are not as critical as a key diabetic medication, the premise is the same.”
Hospital pharmacists are also experiencing shortages: according to a recent SHPA survey, information about current or impending shortages was found to be “highly unreliable”, with shortages flagged by pharmaceutical suppliers only 15% of the time.
“When we cross-referenced the responses with warnings and alerts available that day through government websites, including the TGA’s MSI portal, 85% of reported shortages were not listed by their respective companies,” said SHPA president Professor Michael Dooley.
“Just over 32% of shortages were reported to have a direct impact on patient care through swapping in a less effective medicine, changing the administration due to a different form, or in many cases a lack of suitable alternatives.”
The TGA has reassured pharmacists that it is looking at strategies to improve information about, and management of, medicines shortages.
This process is currently occurring through the establishment of a Medicines Shortages Working Group, which includes members from the Commonwealth and state health departments, as well as industry, wholesale, pharmacy and medical associations.
According to a spokeswoman for the TGA, the working group has had a number of meetings in order to:
- Confirm the roles and responsibilities of all major stakeholders in the management of medicines shortages;
- Review whether or not these roles and responsibilities have been effective in managing shortages;
- Provide more analysis from stakeholder perspectives on what the causes of shortages are in the Australian setting; and
- Identify what additional strategies could be considered to improve the management of medicine shortages (including vaccines).
The TGA has also been in contact with the National Pharmaceutical Services Association (NPSA) regarding the possibility of working with wholesalers and accessing information regarding medicines shortages.
However these discussions are “still ongoing”, the spokeswoman tells AJP.