HPRA Recall of a number of Valsartan-containing film coated tablet products
UPDATES AVAILABLE AT BOTTOM OF PAGE
What is the issue?
The HPRA has issued an immediate pharmacy-level recall of certain batches of valsartan-containing medicines due to fears of contamination with a potentially carcinogenic impurity, N-nitrosodimethylamine. There is no evidence that this impurity has caused any harm to patients; however, the recall is being undertaken as a precautionary measure while the investigation is ongoing.
What advice has been given to patients?
The HPRA position, as set out in their letter, is that patients should not stop taking their valsartan medicine abruptly, as the health risk of abruptly discontinuing this medicine is higher than any potential risk presented by the impurity, and that patients should return to their pharmacist to seek an alternative.
What should pharmacists do?
- Dispense a suitable alternative valsartan-containing medicine or, if none is available (or the patient is reluctant to keep taking valsartan),
- Refer patient back to their doctor to have an alternative medicine prescribed (patient to keep taking valsartan in the interim).
- GMS patients will need a new prescription if the pharmacy is to be reimbursed for replacing one pack of valsartan with another.
What is the HSE doing?
We contacted the HSE seeking the following assurances as a matter of urgency:
- that the HSE have sought confirmation from the wholesalers and manufacturers that alternative valsartan-containing products are available;
- that, in circumstances where the only valsartan-containing medicines available to pharmacists are originator Diovan® products, the HSE will reimburse pharmacists for the medicines at full reimbursement price without the requirement for the GP to write ‘Do Not Substitute’; and
- that the Medicines Management Programme will urgently issue clinical guidance to GP’s on managing the transition to therapeutic alternatives.
In their response the HSE said that they are awaiting responses from the remaining four suppliers of reference priced valsartan products and that, when the other suppliers have confirmed their position, “a decision in relation to cover an increased cost of the proprietary product will be made after lunch”.
What other valsartan products are available?
We have been in touch with suppliers of other valsartan-containing products to establish the stock situation.
Teva have said that any stock they had with wholesalers yesterday is all gone. Furthermore, the rest of their stock has been quarantined at distribution level while they satisfy themselves that their stock is not affected by this. As that examination concludes, they may be able to release stock over the next few days and will let us know.
Any stock that becomes available at the wholesalers will be on allocation to avoid bulk buying.
Krka have informed us that their valsartan products are out of stock at wholesaler level. They have not quarantined any stock at this time. They are trying to get an emergency order out of distribution and into the wholesalers and will update us when they have managed to do so.
Stocks, when available, will be on allocation.
What about credit for medicines which are returned?
We have contacted Actavis, Clonmel and Rowex to clarify their returns procedures and to ensure that credit is given for all opened/partial returned packs, not just full packs. Their responses are as follows:
Clonmel: Any stock (partial packs & unopened) purchased from the wholesaler are to be returned to the wholesaler who will organise credit. Wholesalers will not accept any stock purchased directly from the manufacturer.
Stock (partial packs & unopened) purchased from Clonmel must be returned in a prepaid envelope to Clonmel who will organise credit. Clonmel does not have adequate stock to provide replacements. A letter is being sent to pharmacies today.
Actavis: Stock should be returned to wholesaler within seven days. The wholesaler will organise credit according to their own policies.
Other suppliers: Although we have not received official confirmation, it is likely that the returns/credit process will be similar for the other companies involved. We will update you on the wholesalers’ position when we have that information.
UPDATES: (last updated 11 July 2018)
4.00pm, Friday 6 July: The HSE has advised that they will not reimburse Diovan® unless the GP has written ‘Do Not Substitute’ on the prescription. They are keeping matters ‘under review.’ We will update you if this changes.
5.00pm, Friday 6 July:The HSE MMP has advised that if prescribers are switching from Valsartan to another ARB then Candesartan is the preferred ARB.
5.00pm, Friday 6 July: Mylan has advised that the wholesalers are out of stock and awaiting deliveries on Monday. Mylan are trying to access more stock but as this a pan European issue it will be some days before they know the situation. Stocks, when available, will be on allocation. They have not quarantined any stock at this time.
2.00pm, Saturday 7 July: Additional stocks of unaffected valsartan-containing medicines became available for wholesalers on Friday July 6th. Further supplies to that mentioned yesterday will also be available on Monday morning July 9th for ordering by pharmacies. While the stock situation will remain constrained there should be adequate supplies next week to meet immediate patient needs.
5.00pm, Monday 10 July: The PSI has sent an update email to all pharmacists in relation to a further letter from the HPRA about the recall of more valsartan-containing medicines. Please check your email for details.
3.00pm, Wednesday 11 July: The HPRA has asked that pharmacists manage current stocks of unaffected valsartan products by not dispensing more than one month at a time to a patient, where at all possible, as there will likely be constraints on supplies experienced over the coming weeks and months.
HPRA Update Wednesday 11 July 2018
The HPRA is today proceeding with the precautionary recall of certain parallel imported valsartan products. This is a targeted recall – only those pharmacies that received stock of the products in question from the parallel importer companies – Eurodrug/Imbat, iMed Healthcare and PCO – are directly impacted by this recall action. As a result, the volume of packs that will be recalled on this occasion is significantly lower than in the earlier recall of 5 July 2018.
Copies of the three recall letters are available for information below:
- Eurodrug/Imbat Valsartan PPA Recall Letter
- iMed Healthcare Valsartan PPA Recall Letter
- PCO Valsartan PPA Recall Letter
For ease of reference, the HPRA has published a complete list of all valsartan-containing medicines impacted by this recall. Please click here for the list.
Click here for the HPRA letters, HPRA list of Valsartan products being recalled, the HSE MMP letter, and the recall letters sent to Eurodrug, iMed and PCO