Rapid Responses to:
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Rapid Responses: Rapid Responses published:
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![[Read Rapid Response]](/icons/misc/sectionDOWN.gif)
What about Oseltamivir?
- Gary D Lum (31 December 2004)
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Motives differ between nations
- Matthew Robinson (1 January 2005)
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Chicken or Egg?
- Magnus I Hird (2 January 2005)
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The link between over the counter licensing and Direct to consumer advertising
- Robert G Bunney (4 January 2005)
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Ulterior
- Dominic McDermott (6 January 2005)
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Switching Drugs to OTC Status May Benefit Patients Financially
- Patrick W. Sullivan (11 January 2005)
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Changes to approved names of drugs
- David R Hadden (21 April 2005)
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Gary D Lum, Director Northern Territory Government Pathology Service
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I wonder how readers of this article feel about making Oseltamivir over the counter (OTC)? Influenza outbreaks can have devastating consequences. Trying to get an appointment to see a primary care doctor can be difficult. Provided pharmacists ask the correct questions to filter patients, should Oseltamivir be OTC? Competing interests: None declared |
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Matthew Robinson, Pharmacist PR3 1RY
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The authors of this paper suggest that Omeprazole has only been deregulated in the USA and Sweden. This is incorrect as Zanprol (Omeprazole 10mg) has been available in Britain for several months. It is also suggested that Simvastatin does not fit the deregulation model for three reasons: 1. It's not for an acute condition 2. It's for something that isn't easy to diagnose 3. It could cause harm from abuse if more widely available While I agree with point 1, I think we already sell medication OTC that is not for acute conditions - aspirin 75mg for example. Risk of CHD is not easy to diagnose, but with risk prediction charts it is not hard. Deregulation of Simvastatin in the UK means that it is sold by or under the supervision of a pharmacist who should be capable of assessing the patients' risk therefore this really isn't a problem (as perhaps it would be in the USA). The third point confuses me somewhat though, simvastatin is not a drug of abuse, are the authors referring to effects of the liver? Surely these are unlikely at 10mg and easily dealt with by pre-warning the patient to stop taking the tablets if they get muscle pain. On a final note the authors point out the there are no trials of simvastatin in OTC situations. Are there trials of any drugs in OTC situations? Most RCTs are closely controlled and the patients are intensively monitored. Were there RCTs published when other drugs have been deregulated - if there were I haven't seen them. Competing interests: None declared |
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Magnus I Hird, Pharmacist Practitioner Bloomfield Medical Centre, FY1 6JW
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Cohen et al suggest that prescription drugs become candidates for OTC switching if they meet 3 criteria: use for non-chronic and easy to self diagnose conditions and having low potential for abuse. Whether this is actual policy of drug regulators or not is unclear. Perhaps these statements are drawn from examination of the current scope of the OTC market? In other words the products available OTC generally meet these criteria, therefore these must be the basis on which OTC switches are selected. If so there would appear to be a potential here for a chicken and egg scenario. The vast majority of switches are instigated in applications made by the manufacturers, and often for reasons for commercial profits. This requires that there is a potential market for the switched drug. This in turn relies on consumers recognising the need for the drug and being sufficiently motivated to purchase it. Thus it could be argued that a population that was less involved in their own health would not be expected to see the need for preventative drugs and therefore would make switching of them likely to fail as sales would be poor. So the manufacturers never apply for such a switch in the first place. So, are the three "conditions" "chickens" that create the switched "egg", or does the "egg" of what would succeed in the marketplace create the "chicken" "conditions"? Today the public are better informed about their health than in the past and are exposed on a daily basis to messages about how to improve it. The huge growth in stanol margerines and other products, for example, shows that they are open to accepting new interventions to reduce surrogate markers of coronary risk. So why not a statin? Is this the reason behind such a switch? Not a change in the regulatory "conditions" but a change in the commerical marketplace and consumer behaviours? In terms of evidence of efficacy, there are no trials of statins in an OTC population, but when evidence does not exist we can examine what is available and judge whether it could be extrapolated. In terms of the level of risk, there are trials at 10-year CHD risk levels around 6% over 10 years that showed significant benefits (albeit not in terms of mortality) with statin treatment. This is below the risk level for OTC use. The other differences are primarily whether the disease (or risk of it) is different in an OTC group compared to the traditional patient group, and whether they would take the medicine differently. The former seems highly unlikely: risk is risk. The latter is more complex and involves a recognition that real life and clinical trials are also different. We know that huge proportions of patients do not take statin drugs long term, yet we prescribe them at healthcare provider (eg NHS) expense, based on the results in clinical trial populations. There will undoubtedly be people that take OTC simvastatin intermittently or short term, and they would be extremely unlikely to benefit from it. But those that take it properly should stand to benefit in proportionally similar ways to those we prescribe for. Competing interests: I was paid to write professional guidance on OTC Simvastatin by the RPSGB |
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Robert G Bunney, General Practioner Brannam Medical Centre,Barnstaple,EX328GP
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I believe the main reason the manufacturers of Simvastatin have lobbied (successfully) for permission to sell a 10 mg dose over the counter in the UK is to enable direct to consumer advertising of this previously prescription only drug. People with a 10 year risk of IHD of 15% or greater (28.4% of men and 6.7% of women in the 1988 Health Survey for England) who approach their pharmacist in response to the advertising will be directed to their GP for an NHS prescription even though due to budgetary restrictions many primary care trusts only advise treating those with a 10 year risk of 30% or greater. Anyone with a 10 year risk of 10-15% will be offered the chance to buy the drug at full cost from the pharmacist but of course are likely to approach their general practitioner to ask why if the drug is as effective as the advertising has led them to believe they cannot obtain it on the NHS. Robert Bunney Competing interests: None declared |
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Dominic McDermott, Pharmaceutical Adviser Newcastle PCT
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I agree with Dr Bunney. Would it be ludicrously fanciful to suggest that moves to increase OTC availability of patent expired drugs for which there are prescription only alternatives might, in some instances, be a spoiling tactic? What is it that, according to the addage, familiarity breeds? Even more fanciful, perhaps, to speculate about collusion between pharmaceutical companies? In the UK (and EU, possibly) OTC availability of any drug in a class (e.g. statins) removes restrictions on DTC advertising for the condition to be treated (provided only the de-regulated drug is named). How many GPs have already been visited by people who have seen the adverts, visited a pharmacy, been told they qualify by virtue of being at "moderately increased risk" of CHD and then decided that they don't like the idea of paying £12.99 per month (c.f. £6.40 per prescription item - in many cases 2 months supply)? Possibly a not so subtle way of precipitating the change to a 15% risk threshold for intervention with statins anticipated in the NHS National Service Framework for CHD? Competing interests: NHS employee |
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Patrick W. Sullivan, Assistant Professor University of Colorado School of Pharmacy Pharmaceutical Outcomes Research Program Denver CO 80012
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EDITOR – Cohen et al., state that switching drugs to over the counter availability increases costs for most insured patients in the United States due to resultant changes in drug benefits. As noted, most health plans restrict drug coverage and increase copayments for the entire class when one member of the class is made available OTC. However, evidence from recent Rx-to-OTC switches suggests that patients benefit financially from OTC availability despite health plans’ restrictions and increasing copayments in the U.S. Sullivan et al., have shown that the Rx-to-OTC switch of loratadine was cost-effective for consumers, insurers and society as a whole.1, 2 In addition, a simple examination of the average out-of-pocket cost for second generation antihistamines demonstrates that health plan members pay less for loratadine after OTC availability. Prior to the OTC introduction of loratadine, at least one SGA was available through most health plans as a preferred brand product with a co-payment of approximately $17 per month supply in the U.S. in 2002.3 Recent pricing for OTC loratadine (generic OTC loratadine 10mg once per day = $8.50/month)4 shows that OTC loratadine is significantly less expensive for health plan members than the average copayment prior to the OTC switch. In addition, the price of OTC omeprazole (20mg Prilosec OTC once per day = $19/month)4 is equivalent to the average copayment in 2003 for preferred branded drugs ($19).5 However, as previous research has noted, the opportunity cost of obtaining a prescription drug must include the time cost of waiting to see the physician, the physician visit and pharmacy waiting time (approximately 2-3 hours of lost time @$20 per hour).2 Cohen et al. correctly pointed out that the uninsured benefit financially from OTC switches because they no longer have to pay the higher retail price for a prescription drug. Although some insured patients may suffer from loss of coverage or higher out-of-pocket costs, evidence from the most recent Rx-to-OTC switches in the United States demonstrates that the majority of insured patients benefit financially from OTC availability. 1. Sullivan PW, Follin SL, Nichol MB. Transitioning The Second- Generation Antihistamines To Over-The-Counter Status: A Cost- Effectiveness Analysis. Medical Care. December 2003;41(12):1382-1395. 2. Sullivan PW, Nichol MB. The economic impact of payer policies after the Rx-to-OTC switch of second-generation antihistamines. Value Health. Jul- Aug 2004;7(4):402-412. 3. Kaiser Family Foundation. 2002 Employer Health Benefits Survey. Menlo Park: Kaiser Family Foundation; 2002. 4. Drugstore.com. Available at: www.drugstore.com. Accessed January 10, 2005, 2005. 5. Kaiser Family Foundation. Employer Health Benefits 2003 Annual Survey. Menlo Park: Kaiser Family Foundation; 2003. Competing interests: Dr. Sullivan is currently involved in research supported by Schering Plough, Inc. |
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David R Hadden, hon professor of endocrinology Royal Victoria Hospital, Belfast BT12 6BA
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Changes to approved names of drugs: EDITOR - If you read the recent British National Formulary (BNF 47) and the explanation about changes to approved names of drugs, you may be confused. Whose language are we speaking – is it English, or European, or American? I asked the hospital pharmacist to identify why the approved name for the sulphonylurea (?sulfonilurea!), glibenclamide in the U.K and Europe, is gliburide in the USA. I still do not know the answer to this question, and it is causing considerable confusion now that this substance is being prescribed in gestational diabetes based on U.S evidence only, although not authorised in the BNF for pregnancy. But she has opened up a whole Pandora’s box of problems of derivation, as well as pronunciation. What is the accepted European pharmacological language, and is it based on any rational process? It looks more as though it adopts USA usage irregularly, without giving reason. Is there any concern about Latin and Greek in Europe? · If ph is to become f (alphadolone – alfadolone) what then of the
pharmacists (farmacists?).
I respect the UK academic and clinical concern about adrenaline/epinephrine – why does the European pharmacopaeia (?farmacopeia) give in on this? They should at least be fighting for epinefrine! This is a major Europe/US conflict of usage, but the European pharmacists have sold the pass on all these other points. As an endocrinologist these names do matter, and the present situation is that biochemical and scientific usage is at variance with pharmacological. What do we use in clinical medicine? Is there somewhere in Brussels an unknown committee, following Bernard Shaw’s goal of a completely new spelling of English - or of all the European languages! iours fatfulli, David Hadden Competing interests: None declared. 1. Department of Health: Medicines Control Agency. Changes to the names of certain medicinal substances. 1 Dec 1997. Competing interests: None declared |
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