Accuretic (quinapril and hydrochlorothiazide) tablets: Supply issue
People using Accuretic must get a new prescription to change to an alternative high blood pressure medicine.
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Updated 17 August 2022: details about funding to support the change updated.
What is happening to Accuretic?
Recent batches of Accuretic, quinapril with hydrochlorothiazide, have been found to have small amounts of two impurities, called N-nitroso-quinapril and N-nitroso-hydrochlorothiazide. Medicine safety regulators have determined that exposure to these types of substances over a long time may increase a person’s risk of getting cancer.
The risks of nitrosamines are low, it is a greater risk if people stop taking this medicine. People should keep taking Accuretic until they have spoken to a medical professional.
This is a global issue. Pfizer, the supplier of Accuretic, has been undertaking voluntary recalls of the medicine around the world, including in Australia, Europe, the United States of America, and Canada.
What are N-nitroso-quinapril and N-nitroso-hydrochlorothizide?
N-nitroso-quinapril and N-nitroso-hydrochlorothizide are unintended by-products of the manufacturing process for Accuretic. These impurities belong to a group of chemicals known as nitrosamines. These are commonly found in water and foods, including cured and grilled meats, dairy products and vegetables.
Everyone is exposed to some level of nitrosamines, which may increase the risk of cancer if you are exposed to them above acceptable levels over long periods of time.
Based on the relative risks posed by the nitrosamine impurity and the real potential for patients to miss therapy if an abrupt change is made, Medsafe has accepted that, on balance, it will not object to Pfizer continuing to supply Accuretic while urgent arrangements are made to replace it.
Accuretic stock situation
From August 2022, supplies of Accuretic will begin to be disrupted. As such, we are asking people to be changed to an alternative treatment when they are due to fill their repeat or get a new prescription.
Pfizer has not provided a timeframe for the availability of stock of quinapril with hydrochlorothiazide without impurities for the New Zealand market. They have indicated that it could be more than 12 months.
Pharmac and Pfizer have been investigating several avenues since March 2022 to secure an alternative quinapril with hydrochlorothiazide product. Due to the global issues, no alternative brand can be sourced in sufficient volumes for New Zealand that can be verified as being free from impurities. As such, an acceptable chemical substitute cannot be sourced for the New Zealand market.
The impurity issue does not affect other quinapril products. Arrow-Quinapril is the funded brand of quinapril (without hydrochlorothiazide). There is ample stock of Arrow-Quinapril.
Alternative treatment options
People taking Accuretic must talk to their prescriber about alternative treatment options. We know that the health sector is stretched at this time of year, and we apologise for the added the pressure this situation creates.
We have received clinical advice that losartan with hydrochlorothiazide is a suitable alternative treatment. Teva, the supplier of this product, has assured us that there is ample stock of this product for everyone who needs it.
We are also advised that any of the other funded ACEi and ARBs medicines (such as, candesartan) can be used with another funded thiazide or thiazide-like diuretic if required. This option would require patients to take two separate medicines rather than one combination medicine.
He Ako Hiringa has created a resource to support clinicians(external link), including a dose conversion chart.
Thank you for your assistance with the management of this issue.
Additional costs to be covered
To support the required change, Pharmac is funding primary care for the initial consultation for patients transitioning from Accuretic to an alternative treatment.
Funding for the initial consultation fee is available for any patient who:
- is currently using the Accuretic brand of medication
- is transitioning to a suitable alternative treatment
- requires an additional appointment with a prescriber in primary care to support a change from Accuretic to an alternative medicine(s).
Primary care providers should talk to their PHO about how to claim the reimbursement. We have provided bulk funding to PHOs to cover these costs. If you are not a member of a PHO, email firstname.lastname@example.org
Patients should not be charged the usual prescription co-payment for the first dispensing of their new medicine or medicines.
A one-off payment has been made to community pharmacies to reimburse them for their dispensing work and associated costs.
What to do if you take Accuretic
When you are next due a repeat, you need to talk to your healthcare professional to get a prescription for a new high blood pressure medicine.
You should keep taking Accuretic as prescribed until you have your new treatment. Nitrosamines pose a low risk, there are greater risks to your health if you stop taking Accuretic.
We are covering the cost of the change including a free initial consultation with your primary care prescriber.
General practices should not charge you for this appointment. They will be reimbursed through their primary health organisation (PHO).
We acknowledge that changing medicines can be disruptive. We appreciate your patience.
- Te Reo Māori [PDF](external link)
- Samoan [PDF](external link)
- Tongan [PDF](external link)
- Chinese (Simplified) [PDF](external link)
- Hindi [PDF](external link)
Unused stock of Accuretic
Pfizer has advised that pharmacies and wholesalers will be able to return any unused stock of Accuretic at the end of the transition period.
Pharmacies should discuss the returns process with their wholesaler.
Who to contact?
If you have questions about the funding of alternative treatments, or the funding of Accuretic, email email@example.com
If you have questions or concerns about the safety of Accuretic, you should talk to your healthcare professional. You can also email Medsafe at firstname.lastname@example.org
If you have questions about Accuretic or its availability, contact Pfizer(external link)
If you are a medical centre seeking reimbursement, talk to your PHO.