Consumers' Association voices concern at over the counter statins

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.

Table 1: Characteristics of subjects who were willing to buy simvastatin 10 mg, Bristol, August 2004

		Willing to buy?		
	No.	Yes	No	÷2 	p-value
Sex					
Male	51	47%	53%	-	-
Female	51	45%	55%	0.04 (1df)	0.8
Smoker?					
Yes	24	50%	50%	-	-
No	78	45%	55%	0.19 (1df)	0.7
Ex-smoker?					
Yes	32	44%	56%	-	-
No	50	48%	52%	0.15(2df)	0.9
1st degree relative with CHD? 			
Yes	48	46%	54%	-	-
No	54	46%	54%	0.002 (1df)	0.9
Pay for your prescriptions?			
Yes	48	52%	48%	-	-
No	54	41%	59%	1.32 (1df)	0.3
On medication for CHD?			
Yes	16	56%	44%	-	-
No	86	46%	54%	0.79 (1df)	0.4
Have, or have had, diabetes?			
Yes	7	57%	43%	-	-
No	95	45%	55%	0.37 (1df)	0.5
On medication for high BP?			
Yes	22	41%	59%	-	-
No	80	48%	52%	0.30 (1df)	0.6
Have irregular heartbeat?			
Yes	8	75%	25%	-	-
No	94	44%	56%	2.92 (1df)	0.09
Have thyroid problems?			
Yes	11	55%	45%	-	-
No	91	45%	55%	0.36 (1df)	0.6

References

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:
None declared