BRUCE CHARLESWORTH, head of medical affairs at Pfizer UK, responds:

As one of several manufacturers of methotrexate, Pfizer can only comment on its own packaging practice which differs from the “multiples of seven” approach under scrutiny here. On the whole we agree that the potential for confusion exists when a weekly medication is packaged in multiples of seven — this is one of the reasons Pfizer only packages methotrexate in quantities of 100.

This does not simply mean we disregard the need for further improvements to our medicines — on the contrary, we continually review and agree the nature of our packaging and our labelling alongside regulatory bodies such as the Medicines and Healthcare products Regulatory Agency, health care professionals and patients as necessary, in order to ensure effective and safe administration. To this end, Pfizer is actively working with the National Patient Safety Agency (NPSA) to find optimal packaging for this particular medicine by addressing opportunities beyond simply the number of tablets per pack. As an example of our commitment, Pfizer has already opted to change the shape of the 10mg tablet in line with recommendations to clearly differentiate the 10mg and 2.5mg tablets. Evidence from the NPSA also suggests that methotrexate should be available in packs of one, two or three months’ supply depending on the individual patient, and this is in hand.

A change in packaging is an involved undertaking and cannot be addressed with a short-term solution. Any change implemented must address public needs such as the shelf life, the usability and convenience as well as maximising patient safety wherever possible. With this in mind, any further changes to the packaging in light of our collaboration with the NPSA, will be addressed in tandem with ensuring it is also acceptable to rheumatoid arthritis patients. We have made sure that research into the suitability and safety of all packaging is undertaken wherever necessary.

MIKE REARDON, group executive director, Goldshield Group Plc, responds:

Although Goldshield is not currently the marketing authorisation holder for this product, the company has made a full contribution to the National Patient Safety Agency initiative on improving patient safety, with respect to methotrexate use.

When Goldshield takes over responsibility for the supply of this product from Wyeth Pharmaceuticals, we are committed to introducing (as quickly as possible) a 24-tablet pack with revised labelling, designed to reduce the risk of daily dosing and equivalent to a one-, two- or three-month supply depending upon individual dose. The pack designs have already been agreed with the manufacturer and the revised labelling is currently with the MHRA for approval.

We would hope that the new pack initiative will have been fully implemented by all suppliers within a few months.

GERAINT MORGAN, manager of medical information, Mayne Pharma Plc, responds:

Mayne supplies methotrexate tablets (2.5mg and 10mg) in a bulk pack containing 100 tablets, as opposed to the packs of 28 described. This minimises the potential for inadvertent daily dosing as a result of being supplied in a multiple of seven tablets.

Mayne has been working with the National Patient Safety Agency as part of the Pharmaceutical Industry Reference Group to reduce the potential for harm caused by oral methotrexate. This has resulted in several positive changes that minimise the risk of inappropriate dosage including:

· A shape change to the 10mg tablets to make it easier to distinguish between the Mayne Pharma/DBL 10mg and 2.5mg methotrexate tablets

· A change in the packaging of both the 2.5mg and 10mg tablets to highlight clearly the tablet strength, dosage warning, and the tablet shape