The hospital pharmacy technician who discovered counterfeit medicines “most certainly” helped to keep children safe, says TGA investigator

Ann Stubley, a pharmacy technician from the Sydney Children’s Hospital at Randwick, NSW, has been applauded for the “vigilance” and “great professionalism” with which she handled her discovery of counterfeit Viagra tablets while compounding them for use in children with pulmonary arterial hypertension.

A TGA senior investigator wrote to the director of the pharmacy department in which Ms Stubley works praising her for her assistance and vigilance which, he said, “most certainly avoided a child’s welfare being placed in jeopardy”.

“Additionally, her initial actions and handling of the counterfeit product showed great professionalism and certainly made the job of investigators far easier,” he said.

Meanwhile the pharmacy owner and wholesaler who introduced the counterfeit Viagra into the Sydney pharmaceutical market has had his registration cancelled.

Previous reports including the official tribunal decision mistakenly referred to a ‘pharmacist’ making the discovery rather than a ‘pharmacy technician’.

AJP has spoken with Ms Stubley about her experiences that day and the warning signs all compounders, pharmacists and pharmacy techs need to look out for…

What happened the day you discovered the counterfeit tablets?

I was making a batch of sildenafil mixture for our patients, and the mixture did not seem right.

The tablets were easy to grind in mortar and the end result was gritty.

I failed the batch, notified other staff including the Senior Pharmacist, and then rang Pfizer to see if they had exchanged excipients etc. as companies do reformulate and change packaging all the time.

Pfizer said that the batch number I supplied was not theirs.

I then rang Westmead Children’s Hospital [in Westmead, NSW] to see if they had any of the same batch of tablets and to isolate if they did as something was not right.

I then rang Symbion to query where they sourced it from and told them to isolate the stock – something was wrong.

It then mushroomed, the TGA became involved and started an investigation. In the meantime Pfizer started a recall, and the rest is on public record.

I had to go to court from someone involved and they pled guilty the day before the trial.

I am glad that I found it.

What should compounders look out for?

When you compound medicines very frequently as I do at Sydney Children’s Hospital, you do pick up when things are not right.

I have worked in pharmacy since leaving school in 1983 and I absolutely love it. I have been at the Randwick campus since 1989.

I suppose experience helps, and if you are unsure always ask.

All the products that we make have batch sheets with methods, so following them should be easy.

As companies change packs and formulations regularly it does not hurt to call the manufacturer if they are in Australia.

If you haven’t compounded anything before you probably would not notice it not being right.

We commonly compound about 10 to 15 regular mixtures but have many more formulas available for some less common to be made. Of course we have to ensure we have stability data etc. for what we make also. Most of them only have a 30-day expiry, so we are regularly making them.

The most common [mixtures] would be sodium bicarbonate mixture, sugar-free potassium citrate mixture for our ketogenic patients, Omeprazole suspension, etc.

What tasks do you do in your role other than compounding?

Other than compounding, I also order stock and maintain stock levels, maintain SAS records and order the SAS drugs, dispense and attend to patients and their parents that come to the pharmacy.

As I have been there quite a while I have seen so many little ones grow up then graduate to the adult clinics at other hospitals, as well as the usual clerical and telephoning duties that are required in the day-to-day running of the department.

I think it is important that the role of a technician is a varied one and a responsible one.

I love my job and the small team we have at Sydney Children’s Hospital. I love how all departments work together for the benefit of our patients.