The use of expired medicine is often shrouded in controversy, misinformation and occasional political spin. The last thing patients in intensive care and their families need is to go through a bout of anxiety as they discover that expired drugs are being used by the hospital medical staff.
When the Times of Malta questioned Health Minister Chris Fearne on whether the use of expired medicine in our hospitals was an isolated case, he replied that there have been cases, both in Malta and abroad, where the use of expired medicines was authorised.
The minister was technically correct. In 2009, for instance, the respected and conservative Food and Drug Administration, which is the food and drug safety watchdog in the US, authorised the use of Tamiflu in suspension and in capsule form that had exceeded its shelf life in response to the then H1N1 influenza public health emergency. The FDA said it had evaluated each lot of Tamiflu medicine that had expired to assure the equality and stability of the product before giving its authorisation to healthcare professionals to use the product.
But the FDA did not stop there. It insisted with healthcare professionals that its authorisation was given after it had determined that data supported the use of certain lots of Tamiflu beyond their expiration date. It also advised that medical staff should consider discussing this information with patients to help them understand such information and address any concerns they might have.
In its communication strategy within the context of a national medical emergency, the US watchdog felt that patients, families and caregivers should be informed about the benefits of taking antiviral medications in relation to the potential risks of untreated illness.
It is a tough reality that the demand and supply of certain types of medicinal products can at times be mismatched with the result that when an epidemic, like that of H1N1, strikes hospitals may not have enough medicine available to treat or prevent the spread of the disease. The Harvard Medical School health publication points out that, since 1979, drug manufacturers are required to stamp an expiration date on their products.
This is the date at which the manufacturer can still guarantee the full potency and safety of the drug. However, most drugs still remain effective for years after their expiry date.
Mr Fearne has ordered an inquiry into reports that expired medicine was used to treat patients in critical condition in intensive care at Mater Dei Hospital. The inquiry should, of course, be left to do its work and come up with the recommendations it deems fit.
Still, the lack of transparency on the part of the Ministry of Health in informing patients, their families, and the public on the use of expired medicine is a political issue that needs to be addressed at the political level.
When first approach about the matter, a ministry spokeswoman said the authorities were not aware that expired medication was being used at Mater Dei.
That sounded very much like ‘kicking the can’ and trying to point fingers elsewhere for what was a communication blunder. The use of expired medicine may be legitimate if it passes rigorous scientific tests by an autonomous medical safety regulator.
What is not legitimate, or, at least, morally acceptable, is that patients or their families are kept in the dark on the use of such products.
Transparency should be the cornerstone of any public health service.