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The Pharmaceutical Journal Vol 267 No 7173 676-680
10 November 2001

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Letters to the Editor

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The industry (2 letters)

"Same but different" drugs

From Ms C. L. Huckerby, MRPharmS

I write with both frustration and despair at the recent decision to discontinue Cardura (doxazosin) 4mg tablets. According to the drug company, this decision was made due to the availability of the 4mg XL "new improved version". Reasons include to reduce the potential for error stemming from confusion between the two tablets, and that research suggests that most people taking Cardura, do so at doses lower than 8mg, and thus the standard preparation is surplus to requirements.

From my experience as both a community and primary care pharmacist I feel confident in saying that pharmacists are more than capable of minimising dispensing errors by employing good dispensing operating procedures; after all we are likely to have Adalat LA 20mg and Adalat Retard 20mg in the dispensary.

After looking closely at the new prescribing information for Cardura XL and comparing it to that for standard Cardura (also a once daily preparation), the dosage instructions are in fact different. The maximum daily dose with the XL version is 8mg daily, considerably less than for the standard preparation. Arguably, the majority of the people in the drug companies research took less than 8mg daily. However there is still that forgotten group of people who take larger doses of doxazosin for many reasons, most of which are due to their suffering from a chronic condition, resulting in hypertension and taking multiple medication, for which only an alpha-blocker is suitable.

As our role as pharmacists is changing and improving, we play an increasingly more important one as mediators of health care, ensuring that patients get the most from their medication. When asking the drug company what my patient taking 12mg doxazosin daily (three 4mg tablets) would do, I was told that the choice would be either six 2mg tablets or to review drug therapy. Surely this polypharmacy is exactly what we are trying to discourage. This same patient has a chronic kidney condition and already takes eight tablets a day. Notwithstanding the inherent costs for the practice, this change to 2mg tablets is going to cost the practice an extra £380 per year. When I presented this problem to the drug company I was told that the XL is cheaper than the standard preparation, and so the money saved on switching other patients over, could be used for this patient and others in the same position.

I believe this to be just another example of drug companies' growing greed and has little regard for patient compliance and management of their condition. The changeover will not only raise issues around patient compliance, but will also result in added practice and pharmacist costs, with respect to time spent on counselling and updating and amending patient medication records. My time in practice is increasingly being spent dealing with changes made by drug companies that discontinue drugs just before the patent is due to expire, only to introduce a "same but different" drug which is proven to be more useful.

Primary care pharmacy is necessary and important to aid the implementation of the national service frameworks and to reduce both clinical and financial risk. How can we facilitate this when drug companies do not work to the same ethos?

Clair Huckerby
Birmingham

Are clinical decisions driven by the industry?

From Mrs E. Lamerton, MRPharmS

It was with interest that I read the recent communication from Pfizer regarding withdrawal of standard Cardura 4mg tablets from the market. Naturally, I welcome advances in dosage design to enable "improved compliance" and increased cost-effectiveness, even if once again, I have to explain a change in tablet appearance to my patients.

It was with dismay however, that I noted the advice from the company, that patients requiring 16mg a day (a not insignificant proportion of patients with renal failure) should be prescribed eight 2mg Cardura standard strength or prescribed an alternative antihypertensive class.

Patient adherence with antihypertensive medication is often found to be poor and doubling the number of tablets from four to eight of only one medicine will certainly not enhance concordance.

Is this yet another example of profit over patients and clinical decisions being driven by industry?

Elizabeth Lamerton
Renal Pharmacist
Hope Hospital,
Salford

 
 

Dr Kate Lloyd (medical director, Pfizer) replies:

The decision to withdraw the 4mg standard dose of Cardura (doxazosin) was made as an improved formulation, Cardura XL 4mg was launched earlier this year. It is not in the company's or patients' best interests to provide two formulations of the same dose of doxazosin when there are clinical benefits associated with Cardura XL over standard Cardura. In addition, there is the potential for confusion, so standard Cardura 4mg will be withdrawn from 20 December 2001.

To minimise any disruption, Pfizer has notified doctors and pharmacists of this decision three months in advance of the withdrawal date and the Medicines Control Agency is also aware of this decision.

The patent for standard Cardura does expire in 2002 but this is not the rationale for the withdrawal of Cardura standard 4mg as demonstrated by the fact that both Cardura standard 1mg and 2mg will continue to be available. These are in fact the most widely used dosage forms of Cardura.

We are aware that the withdrawal of the standard 4mg dose does have particular implications for a small proportion of patients receiving high doses of doxazosin therapy who as a result will need to take multiple tablets in order to maintain their existing dose. We apologise for any inconvenience that this may cause this group of patients, their pharmacists and clinicians, and recommend that multiples of 2mg standard Cardura or an alternative antihypertensive class are used in these individuals.

Finally, in a further move to minimise the disruption that the withdrawal of the 4mg standard formulation will have on pharmacists, physicians and patients, Pfizer has developed information leaflets and other supporting materials to help clinicians explain the transition to their patients. Copies of these can be obtained from Pfizer by telephoning 01304 645210.

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