Local study finds it safe to store dabigatran in medicine sachets for eight weeks

ESSENTIALS 

• A University of Auckland School of Pharmacy study has found it is safe to keep dabigatran capsules in dose administration aids for up to eight weeks.
• The researchers stored the repackaged medicines in conditions mimicking real-life settings at the school for 16 weeks and at various times during this period the capsules were evaluated for drug content and dissolution profile.
• While similar studies have been done overseas, this is the first to be done in New Zealand conditions.

Most of our [dabigatran] patients had Praxada on the side of their pack, which was easy for us but not great for patients

University of Auckland researchers have found it is safe to repackage dabigatran capsules in medicine sachets or pill boxes to improve medicines adherence in New Zealand.

Dabigatran is an anticoagulant used to treat and prevent blood clots. Its capsules are moisture sensitive, and because of this New Zealand regulations specify it must be dispensed only in its original packaging.

West Auckland pharmacist Dale Griffiths, the owner of Westview Pharmacy, thought being able to dispense dabigatran in dose administration aids (DAAs), such as medicine sachets, instead of the original packaging would be a great way to improve medicines adherence.

“Most of our [dabigatran] patients had Praxada on the side of their pack, which was easy for us but not great for patients.”

Overseas studies have shown it is safe and effective to store dabigatran capsules in DAAs, but no research had been done under New Zealand climate conditions.

Mr Griffiths approached the Auckland pharmacy school and asked them to study the situation here.

Dabigatran stored in conditions mimicking real life 

A research team of five students headed by lead author Zainab Noori, took Pradaxa 110mg dabigatran capsules repackaged in DAA using Mr Griffiths’ pharmacy dispensing robot. Auckland Cancer Society Research Centre senior research fellow Jagdish Jaiswal also provided a lot of assistance during the project.

Mr Griffiths says Ms Noori “really did see this home”. He gives her a huge amount of credit for doing the work while she was also doing her internship and raising three children.

The researchers stored the repackaged medicines in conditions mimicking real-life settings at the school (room temperature, bedroom and fridge) for 16 weeks.

At predetermined times, the capsules were evaluated for drug content and dissolution profile.

The researchers found that capsules repackaged in DAA demonstrated stability for up to eight weeks in all New Zealand storage conditions, confirming the safety of repackaging dabigatran into a DAA.

From eight until 16 weeks, the capsules stored in DAA at the room temperature and bedroom conditions met New Zealand drug content requirements. But the capsules stored in fridge conditions did not.

Samples demonstrated similarity in dissolution profile until eight weeks, with release rate decreased at 16 weeks under all storage conditions.

Patients benefit from convenience 

Mr Griffiths says his pharmacy has now begun putting dabigatran in medicines sachets because they have New Zealand research saying it is safe to do so.

The study: “Improving adherence by investigating the stability of dabigatran outside of the manufacturer’s original packaging: a New Zealand perspective” was published in the online journal Expert Opinion on Drug Delivery on 24 December.

Auckland School of Pharmacy senior lecturer Manisha Sharma says patients often prefer using DAAs for convenience and this study shows it is safe to use them with dabigatran for up to eight weeks.

DAAs especially benefit patients who are taking multiple medicines at once, as they make it easier to remember when to take the pills, Dr Sharma says.

They also provide assurance to families taking care of elderly patients that their family member is taking the correct dose of medicine at the right times.

“If they have everything bagged in one thing, that will help them.”

The research was funded by the University of Auckland and Westview Pharmacy.