Pharmacists expose risks posed by medicines with no English information

Mary, an 80-year-old woman, has been receiving treatment for osteoporosis through the free government medicine scheme for some years.

She was prescribed by her doctor a twice-daily dose of 500mg calcium pills, which she obtained from her local pharmacy through the Pharmacy Of Your Choice (POYC) scheme.

A few months ago, POYC changed the brand of calcium medicine and started supplying tablets of 1g, which would mean that Mary only needed to take one pill a day instead of two.

However, the new brand, Calcioral D3, only had a patient information leaflet in Greek, making it next to impossible for Mary to understand that the new brand came in a different dosage.

Calcium overdose

It was the local pharmacist who realised that the new medicine had a different dosage and informed Mary accordingly. “Had I not realised, she would have kept on taking two pills a day, overshooting the recommended daily dose by a full 1g,” the pharmacist, who asked to remain anonymous, told MaltaToday.

Mary’s story is symptomatic of a much wider problem within the POYC scheme. The pharmacist approached this newspaper after seeing MaltaToday’s story about the medicine Mefeda, used to treat ADHD, that comes with no English-language patient information leaflet.

“It’s already a problem that the POYC frequently changes the brands of calcium medicine, something that can confuse elderly people like Mary, but it is even more concerning that the products they supply do not come with patient information leaflets that are in English,” the pharmacist said.

To make matters worse, the same medicine is sold in pharmacies with the English-language leaflet as required by law.

The loophole

The law states that medicines are required by law to have product information in either English or Maltese, and when this is not available, the agent is required to provide an additional leaflet containing a professional translation in English that is stuck to the outside of the box.

“But POYC use a legal loophole to import medicines in languages other than English because they are probably cheaper, without adhering to the requirement to fix an additional leaflet on the outside of the box,” the pharmacist said.

The health ministry has blamed Brexit for the difficulty to source medicines with patient information in English but told MaltaToday last week that an English translation is sent as an email attachment to pharmacists and patients who ask for it. But many are unconvinced by the POYC’s strategy.

Asthma medicine’s side effects… in Spanish

Another pharmacist pointed out that the inhaler Flixotide, normally prescribed to children who suffer from asthma is widely available in pharmacies with English-language labelling. However, the same product supplied by POYC is imported from Spain and contains a Spanish-only leaflet.

“The patient leaflet of the English Flixotide found in all pharmacies in Malta contains important information on how to prevent serious oral side effects in children because of the chronic corticosteroid use but this information cannot be accessed in the non-English Flixotide given by POYC,” the pharmacist said.

This creates an unjust system, where people with means know what they are being given, while those who depend on the free medicine are left to their own devices, they added.

“The truth is that we are cutting too many corners in healthcare and it is the patients that suffer,” the pharmacist said.

Meanwhile, the Nationalist Party said it expected government to stop skimping on medicines following MaltaToday’s initial report revealing concerns over free ADHD drugs.

“It is a well-known fact that in recent years the government has tried to economise on medicines by distributing generic drugs which are often less effective than the specific ones that used to be given previously,” PN spokespersons Adrian Delia and Ian Vassallo said.

They insisted Maltese law requires that medicines distributed to patients must include all instructions and information in English.

They accused the regulatory authorities of failing to clamp down on the government over patient leaflets that cannot be read.