Consumers' Association voices concern at over the counter statinsBMJ 2004; 329 doi: https://doi.org/10.1136/bmj.329.7461.310-e (Published 05 August 2004) Cite this as: BMJ 2004;329:310
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Studies show that statin effficacy in primary prevention in moderate
risk patients is limited. There is a great deal of evidence to suggest
that their role is best served in secondary prevention. This group of
patients are underprescribed. More effort should be channeled here into
increasing availability whilst retaining affordability.
It is notable that the FDA did not allow OTC statins in the US.
Although the side effects from 10mg lovastatin would be low, patients may
take a greater dose that would normally require observations of LFTs when
given by the doctor under prescription. Also, the FDA felt the clinical
benefits were unproven.
What should be done for primary prevention then?
In primary prevention, the role of a healthy lifestyle and awareness
of hypercholesterolaemia's assymptomatic nature ahould not be
underestimated. By providing a magical pill to people that will supposedly
rid them of their clogged arteries will ultimately reduce their motivation
to take matters into their own hands.
A greater emphasis should also be made on a universal protocol for
statin therapy. With there being numerous guidelines that are available,
it is not surprising that statin therapy can be non uniform amongst
Competing interests: No competing interests
Now that statins are made available as O.T.C. drugs at least it should be ensured that these products contain a product insert mentioning specifically the risk involved in sudden stoppage of these drugs.This is known to have a bad rebound and the resultant rise in lipids may even precipitate an acute MI or a stroke.
Competing interests: No competing interests
Willingness to purchase over-the-counter (OTC) simvastatin 10mg is not related to coronary heart disease risk
The governments inexorable march on the road towards POM (Prescription-Only-Medicine) to P (Pharmacy Medicine) changes reached arguably its most significant milestone with the deregulation of simvastatin in August 2004. One of the most widely used statins, it is the first to be approved for over-the-counter sale by pharmacists and is now being sold as the lower 10mg dose (Brand name: Zocor Heart-Pro) by Johnson & Johnson MSD. Zocor Heart-Pro is indicated for people at “moderate” risk of a major coronary event, defined as a 10-15 per cent risk of an event in the next 10 years. Patients wanting to buy the product in a pharmacy use a tick-box questionnaire supplied by the drug company that determines whether or not the drug is suitable for them with respect to risk factors, family history, medical and drug history, co-morbidity, contraindications and potential drug interactions. Males over 45 and females over 55 are deemed suitable if they have one or more of the following risk factors; smoker (or quit in the last 5 years), family history of coronary heart disease (CHD), of south Asian ethnicity and obesity1. There has been much debate in medical and pharmaceutical literature regarding this move and depending on whom you listen to, this is either another ill-conceived example of the “creeping privatisation” of the NHS, or a reasonable attempt to empower the patient to take control of his own healthcare2, 3, 4.
We investigated the characteristics of people who expressed a willingness to buy Zocor Heart-Pro. JQ, also a locum pharmacist, selected subjects who appeared likely to be amongst the target population for this medication as they entered one of three pharmacies in the Bristol area over a 10-day period soon after Zocor Heart-Pro became available for OTC sale. Subjects were excluded if they were already receiving a statin. Responses to a self-completed “tick-box” questionnaire were analysed. Four weeks after the drug had been deregulated there was only one purchase in the three pharmacies. During the study period, there were 102 respondents to the self-completed questionnaire (51 male). The mean age of all respondents was 56.8 (SD +/- 10.6) years, ranging from 37-82 years. Overall 45% of respondents would have been willing to purchase the medication (47% of the males and 43% of the females). There was no statistical evidence of any difference in willingness to buy by any of the parameters investigated (Table 1). 94% of those who were willing to buy would only do so having consulted with their GP first. There was no evidence that willingness to buy varied by age (p=0.4). The respondents were also asked about where they had first heard about Zocor Heart-Pro, if at all. 65% had never heard of it before; 17% had heard about it on the TV or radio; 10% first learned of it from their GP; 4% read about it in a magazine or newspaper; and 3% had heard about it from a friend.
We found that Zocor Heart-Pro is as likely to be used by those who are at low risk of CHD as those who are at higher risk. If this translates into actual purchasing patterns then OTC statins may have a limited impact on population health. The fact that most of those who would consider buying Zocor Heart-Pro would only do so after having consulted with their GP first may underline a lack of faith on behalf of the patient in their own ability to manage their own cholesterol status.
1. Practice guidance: OTC simvastatin 10mg. p169-170, The Pharmacy Journal, 31st July 2004.
2. OTC statins: a bad decision for public health. Lancet 2004;363:1659
3. UK public to be used as guinea pigs, warns Consumers’ Association. Consumers’ Association Press Release, 12 May 2004. Available at www.which.net (accessed July 22, 2004).
4. Over-the-counter simvastatin – is it hype or a genuine hope for the future? Hird, M. p156-160, The Pharmacy Journal, 31st July, 2004.
Competing interests: Table 1: Characteristics of subjects who were willing to buy simvastatin 10 mg, Bristol, August 2004 Willing to buy? No. Yes No ÷2 p-valueSex Male 51 47% 53% - -Female 51 45% 55% 0.04 (1df) 0.8Smoker? Yes 24 50% 50% - -No 78 45% 55% 0.19 (1df) 0.7Ex-smoker? Yes 32 44% 56% - -No 50 48% 52% 0.15(2df) 0.91st degree relative with CHD? Yes 48 46% 54% - -No 54 46% 54% 0.002 (1df) 0.9Pay for your prescriptions? Yes 48 52% 48% - -No 54 41% 59% 1.32 (1df) 0.3On medication for CHD? Yes 16 56% 44% - -No 86 46% 54% 0.79 (1df) 0.4Have, or have had, diabetes? Yes 7 57% 43% - -No 95 45% 55% 0.37 (1df) 0.5On medication for high BP? Yes 22 41% 59% - -No 80 48% 52% 0.30 (1df) 0.6Have irregular heartbeat? Yes 8 75% 25% - -No 94 44% 56% 2.92 (1df) 0.09Have thyroid problems? Yes 11 55% 45% - -No 91 45% 55% 0.36 (1df) 0.6