Zocor Brand For Pharmacy Access Drug May Create Confusion – Galpharm

Use of the Zocor brand name for the nonprescription version of Merck's prescription statin "has the massive potential to cause confusion with [prescription] products which could have serious ramifications," Galpharm Healthcare says in comments to the UK's Medicines & Healthcare products Regulatory Agency.

"The OTC indication is different to the POM [prescription only medicine] indication, although patients/customers will not appreciate this," the firm asserts in a Jan. 16 letter.

Galpharm's comments and those submitted to MHRA by other firms, associations and individuals recently were made public following the agency's May 12 decision to switch the drug in a 10 mg strength from POM to pharmacy status (¹ (Also see "Non-Rx Zocor Will Be Available In UK Without Cholesterol Screen Requirement" - Pink Sheet, 17 May, 2004.), p. 5).

The MHRA approved the name Zocor Heart-Pro for the behind-the-counter version.

Galpharm points to patients who are currently prescribed Zocor in 20, 40 and 80 mg doses and states, "if the same patient is then made aware that a product called Zocor has become available from their pharmacist, it is again reasonable to assume that the patient would find this more convenient than having to visit their doctor" and thus would purchase the nonprescription version.

"If this error occurs, there is the added risk of patients using the OTC product 'off label,'" the company asserts, noting it is "surprised that the proposed name has even reached the stage of public consideration."

Galpharm is involved in another major switch in the UK involving omeprazole. Following the government's approval of the drug for pharmacy status in January, Galpharm announced its plans to launch Galpharm Heartburn Relief and an out-licensing agreement with GlaxoSmithKline for Zanprol (² (Also see "GSK, Galpharm Pioneer UK Nonprescription Omeprazole Market" - Pink Sheet, 29 Mar, 2004.), p. 6).

Finally, Galpharm notes that at an estimated cost of $14.67 to $18.34 ($=€.82) for a 28-tablet pack, Zocor Heart-Pro is more expensive for consumers than Rx Zocor, which may "drive more patients to their [general practitioner] demanding simvastatin."

As a result, the firm continues, the physician "will potentially be placed in an invidious position since the GP would not normally prescribe simvastatin for the proposed OTC indication."

Several other comments from pharmacy and professional groups express similar concerns over the long-term cost of the drug as a nonprescription product.

"The proposal will exacerbate the inverse care law where the more affluent will buy the drug, leaving the marginalized and disadvantaged unable to," writes the Royal College of General Practitioners, which also agreed that a switch would not lessen patient visits to doctors.

"GPs already have to resist pressure from patients who have been advised in the private sector to take statins, but not meeting the coronary risk criteria of local and national guidelines. Pressure on prescribing budgets is already immense," the RCGP points out.

The role played by the pharmacist in follow-up evaluations of consumers taking Zocor was noted by the Royal Pharmaceutical Society of Great Britain. Although the group welcomed the switch, "we would further expect that the ongoing monitoring of the customer would be performed by the pharmacist," the group states.

The Royal College of Physicians submitted comments stating there is "no rationale" for choosing a 10 mg dose of Zocor. "For simvastatin, this is unlikely to be beneficial in most individuals. There is no study to show that this is efficacious. We feel the lowest dose has been chosen as the least risky...it is not clear how many people would get any benefit from this dose."

Comments from several groups expressed concern over a lack of data demonstrating 10 mg simvastatin's efficacy in reducing the risk of a first major coronary event in the target audience.

However, comments from PharmacyHealthLink note the organization "accepts that there are no studies directly on the role of simvastatin 10 mg in reducing the risk of a first major coronary event in this group of people, but would argue that data from existing studies would support a CHD risk reduction in these patient groups."