Potential Impact on Cardiovascular Public Health of Over-the-Counter Statin Availability

Improving the Decision-Making Process for Nonprescription Drugs: A Framework for Benefit–Risk Assessment

“…Statins are proven to decrease mortality and serious cardiovascular morbidity 15 . In this case, improved access to statins may increase the use of these drugs among consumers who meet the guideline indications 16 , 17 . For this reason, simvastatin has been approved for nonprescription sales in the United Kingdom.…”

“…In this scenario, the consumer is at lower risk than while taking no statin at all, but at greater risk than if the higher, more appropriate dose had been prescribed. When considering moving statins to nonprescription status, regulators and health‐care providers must balance the advantage of increased access to eligible consumers against the disadvantage of risk of misuse by those for whom the drug is inappropriate as well as underdosing by those who would be likely to benefit from higher prescription doses 17 …”

“…14 15 In this case, improved access to statins may increase the use of these drugs among consumers who meet the guideline indications. 16,17 For this reason, simvastatin has been approved for nonprescription sales in the United Kingdom. Despite the established efficacy of drugs approved for nonprescription sale and the intuitive value of the improved access described, very little quantitative data are available to estimate the magnitude of improved clinical outcomes due to enhanced drug availability.…”

“…When considering moving statins to nonprescription status, regulators and health-care providers must balance the advantage of increased access to eligible consumers against the disadvantage of risk of misuse by those for whom the drug is inappropriate as well as underdosing by those who would be likely to benefit from higher prescription doses. 17 If a serious condition requiring medical attention is the cause of the symptoms being self-treated, a delay in definitive management due to inadequate self-directed care may lead to worsened outcomes. The likelihood and severity of any hypothesized worsened outcomes need to be carefully evaluated based on the proposed indication for a nonprescription drug.…”

Potential Effects of Introducing Behind the Counter Drugs

“…After 26 weeks, only 2 percent of purchasers exhibited behaviors that were contraindicated by the label. In a follow-on study, Brass et al (2006) used the results of CUSTOM to analyze the cost-effectiveness of moving lovastatin to OTC status. Given the risk profile of the CUSTOM patients, Brass et al estimated that the use of 20-mg lovastatin for 10 years could reduce the number of coronary heart-disease events by up to 33,100 per 1 million users.…”