Serious concerns could delay Zocor switch
pharmafile | March 17, 2004 | News story | |Â Â Â
Serious concerns have been expressed about plans to sell statins over the counter, and could hold up the POM to P switch, despite it having the backing of the government.
Johnson & Johnson MSD plans to launch the OTC version of simvastatin, to be known as Zocor Heart Pro this summer, but there is little sign of progress despite the consultation ending in mid-January.
When asked about the progress of the consultation, a Department of Health spokesman said larger consultations could generate 250 responses and that if "Only half of those are positive, it will take some time to address all the concerns expressed," but declined to say whether this was the case for Zocor Heart Pro.
Many consultees have been happy to make public their responses while some groups such as the British Heart Foundation welcome the plans with few provisos, others such as the Royal College of General Practitioners (RCGPs) have expressed a number of serious reservations.
A group of the College's leading doctors responded to the consultation listing 11 objections, including the fundamental point that evidence of simvastatin effectiveness relates to higher doses than the proposed 10mg dose for OTC sale.
"We take issue with the inference [in the MHRA consultation document] of the benefits of low-dose statins in low-risk populations as the studies alluded to, which show a reduction in risk of 27%, are an extrapolation of data using higher doses," the RCGP commented.
A number of other concerns, including the readiness of pharmacists to take on the complex role of treating coronary heart disease have been raised by the RCGPs and others.
For example, pharmacists do not currently have access to patient records, making it difficult for them to make informed clinical decisions or systems to inform doctors about which patients were taking the OTC drug.
Independent prescribing advisor Noel Staunton voiced widely held views when he told the recent Prescriber conference that the 10mg OTC drug would have knock-on effects for other services.
"Simvastatin will "go P" because the Department of Health and the BMA have said yes to it. But what happens when it goes P? It doesn cannibalise the prescription market, it feeds the prescription market.
"The patient who buys the OTC version will become more interested in his cholesterol and will go into the doctor to get a higher dose than his 10mg."
While this may be good news for the industry, doctors are concerned it could put further pressure on prescribing budgets. But Pfizer, manufacturer of the UK biggest selling statin treatment Lipitor has opposed the move.
In a detailed response, Pfizer UK's Medical Director Dr Kate Lloyd said the company believed a number of issues have been underestimated within the proposal, in particular "the failure to recognise the need for a formal, comprehensive assessment of cardiovascular risk before initiation of therapy, minimum monitoring requirements and the structuring of communication involving the patient GP.
"This model of care is not currently consistently available within the UK OTC environment."
Dr Lloyd concluded that 'considerable challenges' remained in achieving the standards of care necessary to support the switch, and said a pilot programme would be needed to gauge what could be achieved in practice.
Despite such reservations, the government is determined to increase OTC access to major drugs as part of plans to make pharmacists truly front-line clinicians.
Gul Root, Principal Pharmacist at the Department of Health told the Prescriber conference the plans would help transform the role of pharmacists.
"I think it will be a really exciting opportunity for pharmacists because that will be a first in chronic disease management." She added: "We also need to be sure that pharmacists are able to take on these roles and are trained."
Training and professional issues and pay levels are all currently centre stage as the professions representative body the NSPC negotiate a new contract for community pharmacists, which the government expects to agree on this summer.
The deal will redefine the responsibilities, roles and rewards for pharmacist in much the same way as the new GMS contract has for GPs, with similarly hard bargaining expected before agreement is reached.
This means a host of concurrent reforms including the Zocor Heart Pro consultation will be tied-up in the negotiations, and will probably be held back until the bigger issues have been resolved.
