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Return to PJ Online Home Page The Pharmaceutical Journal Vol 266 No 7139 p356-359
March 17, 2001

Letters

Emergency contraception
Flaxseed oil
Community pharmacy
Pharmacy practice
Patient packs
Schizophrenia
Industrial pharmacists
Parallel imports
The Journal


Emergency contraception

» Proceed with great care  / Antiemetics are impractical

Proceed with great care

From Dr P. J. Brown, FRPharmS

I must take issue with some of the remarks made in your editorial “Hot potato” dealing with the matter of emergency hormonal contraception (PJ, March 3, p269).

First, you dismiss as “side issues” concerns about the supply of EHC which include conscientious objection to the whole principle. I am sure that those pharmacists who hold such views would not regard them as side issues. Those who hold the view that chemical abortion is wrong do so very sincerely and should not be marginalised. Since when, in a free country where free speech is encouraged, has discussing moral issues become unacceptable?

Second, you say that the main reason for the introduction of emergency contraception is to tackle the high rate of teenage pregnancy prevalent in the UK. Although this may be the case, I believe that, however good its intentions, it is another misguided Government policy. Do policy makers really believe that teenage girls will go to their local pharmacy to ask for such a product? In many cases, these children express amazement at the state in which they find themselves. It is important to remember that the teenage girls for whom the emergency contraception is intended are actually frightened children who need the support of their families and the confidentiality of the doctor's surgery. If these are not available, the next best place is probably their schools where, at least, they are known and, it is to be hoped, understood. The open pharmacy is not the place for this kind of business to be transacted.

You did not raise the matter of safety in your editorial and this is my third concern. It seems that the safety of emergency contraception has yet to be studied extensively. Yet, there are no requirements for pharmacists to keep records of the over-the-counter purchases and there is no follow-up. It must be remembered that we are providing girls, who may not have taken oral contraceptives, with a large dose of a progestogen, with all its immunosuppressive properties. Some gynaecologists are concerned that this immunosuppression could occur at a time when sexually transmitted infections could be present with very serious consequences. I understand that one such case may have occurred and is currently being followed up and could result in a yellow card warning being sent to the Committee on Safety of Medicines.

If pharmacists are to be involved in the provision of emergency contraception to girls and young women, they must approach it from a strictly medical point of view, and not see themselves as being players in a social experiment aimed at ridding society of an ill, as your editorial suggests. Although there is a strong case to be made for pharmacists to become involved in the treatment of minor illnesses, I do not think that morning after contraception comes into this bracket, and hence that pharmacists must proceed with great care.

Philip Brown
Kingston-upon-Thames, Surrey

Antiemetics are impractical

From Mr N. Shah, MRPharmS

With reference to the vomiting experienced with progestogen only emergency hormonal contraception, the “Information guide on emergency hormonal contraception” produced by the Centre for Pharmacy Postgraduate Education states that “consideration should be given to whether an antiemetic might be useful”.

However, in the absence of a licensed over-the-counter antiemetic, this consideration, in my view, would not be manageable.

Nitin Shah
London SW6

Dr PETER WILSON (director, Centre for Pharmacy Postgraduate Education) replies:

The full text from our information guide is as follows — “If a woman has taken EHC in the past and has had a problem with vomiting, consideration should be given to whether an antiemetic might be useful. Where previous use has been of Schering PC4 the likelihood of vomiting will be much lower with Levonelle. The clinical trial results with Levonelle-2 suggest that vomiting is only likely to be a problem in 5–6 per cent of women with Levonelle. Family planning doctors often prescribe domperidone where an antiemetic is needed. However there is not a currently licensed OTC indication for domperidone.”

If a woman requesting emergency hormonal contraception from a pharmacy has had problems with vomiting in the past then it would be appropriate to consider referral to her GP or a family planning clinic so that the provision of EHC can include the management of possible vomiting. If this proves impractical, eg, because of the delay it may cause, the pharmacist needs to consider how to meet the best interests of the woman. There are at least three options: supply EHC, supply EHC with an over the counter antiemetic, or suggest that the woman could attend a family planning clinic within five days of unprotected sex to have an IUD fitted. It would help in decision making if the pharmacist is aware of how EHC-induced vomiting is managed by family planning practitioners locally. Which, if any, of these options is chosen would depend on the circumstances and the pharmacist’s professional judgment.

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Flaxseed oil

Evidence-based or commercial hype?

From Mr R. J. Schmidt, MRPharmS

I read with interest the article by Rapport and Lockwood entitled “Flaxseed and flaxseed oil” (PJ, March 3, p287). Over the years, I have recognised that the complementary health food and health care industry promotes one or two new “wonder products” every year, some of which stand the test of time while others fall by the wayside. This year appears to be the year of the flaxseed — otherwise known as linseed.

Although there is clearly an evidence base underpinning the renewed interest in flaxseed and its oil — Rapport and Lockwood provide 24 medico-scientific literature references from the period 1991 to 2000 — we have to be alert to the promotional activities of the industry which are for obvious reasons designed to hype products. I fear that Rapport and Lockwood may have muddled the commercial hype in with the evidence base.

So, I would challenge Rapport and Lockwood to explain why no literature reference is provided to support their assertion that “the modern, western diet contains a much greater quantity of omega-6 than omega-3 fatty acids, in a ratio of 20–30 to one, although ideally the ratio should be almost equal”. I have a suspicion that omega-6/omega-3 fatty acid ratios of old western diets were no different from those found in modern western diets and that no hard evidence for an ideal ratio actually exists. (We can, I suppose, assume that the authors do realise that our diets do not normally contain any significant quantity of free fatty acids, but rather the glycerides of the fatty acids. Their assertion that flaxseed contains more than 50 per cent a-linolenic acid is also similarly flawed.) They make a further assertion that, because of modern industrial and agricultural practice, the omega-3 content of many foods, including meat, fish, eggs and vegetables, is much lower than before. And, as a result many people are deficient in omega-3 ALA, which may lead to degenerative disease. This assertion should be supported by references to the primary literature. Again, I have a suspicion that assays of omega-3 fatty acids in food materials produced before the period of modern industrial and agricultural practice have never been performed. I would be happy to have my suspicions allayed.

Richard J. Schmidt
Barnoldswick, Lancashire

Dr G. B. LOCKWOOD replies:

Dr Schmidt's intimation that we have any connection whatsoever with the health food industry is incorrect. Our interest in the field of nutraceuticals is academic, and Dr Schmidt will see that this is not the only nutraceutical we have covered to date in our articles, which incidentally, have all been published within one year.

The sentence in our article concerning the ratio of omega-6 to omega-3 fatty acids in our diets is taken from reference 3,1 and evidence is quoted therein that the ratio has decreased due to a reduction in fish consumption coupled with modern agricultural practices of feeding animals with nutrients high in omega-6 fatty acids.

The whole subject of evolutionary changes in fatty acid composition of food animals, although fascinating, did not fall within the scope of our article. However, to indulge in an academically interesting topic for just a little longer, fatty acid ratios of “old” western diets have been calculated from the fatty acids of wild species of African animals, and then compared with those of domestic cattle, even including comparison of the same animal species in the different environments. Research of this type has even been used to describe the diet of Palaeolithic man, and it is in this work that the ratio of omega-6 to omega-3 fatty acids is reported as being almost equal. References relating to this work can be found in our reference 3 in the article.1 In most literature dealing with fixed oils and their sources, it is common to assume the author is referring to fatty acid content of the triglycerides, as opposed to free fatty acids. The linolenic acid content of flaxseed oil is thus quoted as approximately 60 per cent (59.8 per cent) in 'The lipid handbook'.2

Reference
1. Simopoulos AP. Essential fatty acids in health and chronic disease. Am J Clin Nutr 1999;70:560S-9S.
2. Gunstone FD, Harwood JL, Padley FB (editors). The lipid handbook. London: Chapman & Hall; 1986.

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Community pharmacy

 

Long hours

From Mr M. G. J. Cooper, MRPharmS

I was amazed to find in the March 3 edition of The Pharmaceutical Journal (pA16) an advertisement for a pharmacist to work from 9am to 11pm on Thursdays, Fridays and Saturdays.

If the Ministry of Transport decrees that lorry drivers can only drive for 10 hours in a 24-hour period to prevent accidents, a similar decree should be made regarding pharmacists. With more and more supermarkets opening in-store pharmacies with long opening hours, the problem is increasing and requires urgent attention from the Royal Pharmaceutical Society.

M. G. J. Cooper
Manningtree, Essex

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Pharmacy practice

 

Where was our representation?

From Miss L. A. Holden, MRPharmS and Mr A. Plumridge, MRPharmS

Once again pharmacists have been portrayed as money-grabbing, rather than as health professionals. On a recent edition of Watchdog Healthcheck the item on parallel imports and drug price differences between Britain, Australia and the rest of Europe, implied that all pharmacists were cheating the National Health Service out of millions of pounds in revenue. Where was our representation from either the National Pharmaceutical Association or the Royal Pharmaceutical Society? No pharmacist was interviewed as to why this practice occurs.

In comparison, in another item the dentists had a very eloquent practitioner and a national representative who gave a more balanced view of their current situation within the NHS.

If pharmacists as a whole want to gain the professional respect which we deserve, it is essential that we have a proactive voice within the media. Surely the recent adverse publicity surrounding emergency hormonal contraception should have given the Society the incentive it needs to solve this ongoing problem.

Louise Holden
Adam Plumridge

Cheltenham, Gloucestershire

Mr JEAN-PIERRE MOSER (head of public relations, Royal Pharmaceutical Society) states:

The Watchdog programme in question included a report on parallel imports comparing the price of medicines in Britain with the price of those in Europe and Australia. It did not explicitly criticise pharmacists for supplying parallel imports but did explain how the current system worked and highlighted implications of the practice.

The general thrust of the report concerned why medicines are cheaper in some countries compared with Britain. This is clearly a question for the pharmaceutical industry and relevant spokespeople from that sector offered comment on the programme.

The Society's public relations unit is always seeking opportunities to promote the work of the members and offer comment and correct inaccuracies where appropriate.

On the issue of emergency hormonal contraception, proactive media briefing by the Society led to positive and balanced coverage in the majority of the national newspapers, with the exception of the Daily Mail. However, with background information supplied by the PR unit, this newspaper carried a feature entitled “The good pharmacist”, highlighting the developing role of community pharmacy, on Tuesday, March 6.

With an estimated six million visits paid to pharmacies each day, then the best ambassadors for the profession will always be members. At the same time, the PR unit will continue to look at ways to promote the service provided and if necessary address unfair criticism.

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Patient packs

 

Riding two horses

From Mr S. Lyftingsmo

After visiting Britain to learn about medicine labelling, one of my strongest remaining impressions is that pharmacists do not dispense patient packs; they dispense from patient packs.

Coming from Norway, where there is no dispensing from bulk, my idea of a patient pack is a medicine package that is sold to the patient in its original size. Making a 28-pack to be 30, or vice versa, is unheard of. In rare cases a small package is “borrowed” from a larger one, for instance, 30 tablets can be taken from a 100-pack. It is not permitted to “refill” the broken package with tablets with a different batch number.

Combining the breaking of patient packs with small-scale dispensing from bulk, leaves British pharmacists with the disadvantages of both systems. In order to get the advantages of patient packs dispensing from bulk and breaking patient packs must cease. That is possible to do. To ignore patient packs and only dispense from bulk is not possible any more.

There are three things that I believe are important for moving over to patient packs:

(i) a strong professional, ethical and maybe legal standard against the breaking of patient packs

(ii) a legal permission to dispense or sell the nearest package size

(iii) making the dispensing period the same both for hospital and for community pharmacies.

Stein Lyftingsmo
Elverum, Norway

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Schizophrenia

 

Antipsychotics guidance needed

From Mrs S. J. Otter, MRPharmS

On January 10, 2001, Janssen-Cilag announced that it had voluntarily chosen to discontinue droperidol (Droleptan) from March 31. The Medicines Control Agency had raised concems about the potential effect of droperidol on the cardiac QTc interval.1 This followed the restrictions placed on thioridazine (Melleril) from the Committee on Safety of Medicines for the same reasons in December, 2000.2 Psychiatric pharmacists commonly see prescriptions for droperidol and thioridazine in the UK and these warnings raise important concerns and implications for the professions involved in mental health care.

The CSM warning on thioridazine recommends that alternative agents are prescribed in place of thioridazine, but does not suggest which antipsychotics would be suitable replacements. It would make sense to ensure that the large numbers of prescriptions for both thioridazine and droperidol are replaced by antipsychotics that have not been associated with similar QTc problems.

Other antipsychotics have at some time also been associated with significant QTc prolongation. The European Society of Cardiologists lists the following antipsychotics as significantly prolonging the QTc interval: chlorpromazine, mesoridazine, droperidol, perphenazine, haloperidol, pimozide, sertindole, thioridazine and trifluoperazine.3

There are other risk factors involved in the issue of QTc prolongation and schizophrenia. Many patients have pre-existing cardiac conditions and are more likely to have predisposing risk factors for prolonged QTc interval than the general population.4 Other factors have also been shown to raise the risk, including high doses, polypharmacy, substance abuse, exhaustive mania and psychological stress. In combination with antipsychotics these risk factors can put patients at an even greater risk of cardiac events and sudden death.3,5 However, it is important to realise that this is not a class effect and to recognise that some antipsychotics are safer than others. Consequently antipsychotics that do not significantly prolong the QTC interval do not require special monitoring such as ECGs or electrolyte testing.

In conclusion, QTc prolongation is a complex issue of growing concern for all those involved in the care and treatment of patients with schizophrenia. Psychiatric pharmacists need to be provided with more guidance in minimising the multiple risks involved in this issue in order to effectively advise formulary committees and psychiatrists when addressing the needs of individual patients.

References
1. Droperidol to be discontinued to prevent chronic use. Pharm J 2001;266:73.
2 Thioridazine — new restrictions on use. Pharm J 2000;265:877.
3. Haverkamp W, Breithardt A, Camm J et al. The potential for QTc prolongation and proarrhythmia by non-antiarrhythmic drugs: clinical and regulatory implications. Report on a policy conference of the European Society of Cardiology. Eur Heart J 2000;21: 1216-31. (Published simultaneously in Cardiovasc Res 2000;47:219-33.)
4. Reilly JG, Ayis SA, Ferrier IN et al. QTc interval abnormalities and psychotropic drug therapy in psychiatric patients. Lancet 2000;355:1048.
5. Working Group of the Royal College of Psychiatrists' Psychopharmacology Subgroup. The association between antipsychotic drugs and sudden death. (Council Report CR57). London: Royal College of Psychiatrists; 1997. p7 & p9.

Sylvia Otter
Glenfield, Leicestershire

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Industrial pharmacists

» How to keep journal going  / Make important contribution

How to keep journal going

From Mr M. M. V. Shah, MRPharmS

It is sad to learn that the Royal Pharmaceutical Society is unable to fund the Industrial Pharmacist. Perhaps a solution would be for all the pharmaceutical companies to become members of the Industrial Pharmacists Group and thereby pay an annual subscription which would keep the Industrial Pharmacist going.

Mahesh Shah
Nairobi, Kenya

Make important contribution

From Dr M. H. Jepson, FRPharmS

David Taylor’s “Broad Spectrum” contribution on pharmacy and national policy on pharmaceuticals (PJ, February 17, p226) succinctly expressed a balanced perspective of pharmacy’s crucial relationship with the pharmaceutical industry.

Too often, pharmacists seem to be put into or find themselves in a position whereby the short-term, uncritical economics of drug cost savings are paramount and insensitive to a wider perspective and even the true interests of some patients.

Pharmacists who have made their careers in the pharmaceutical industry ought not to feel isolated from the profession at large as some undoubtedly do. Their contribution, in relation to both human and veterinary pharmaceutical research and development, regulatory affairs, manufacture, as well as many other aspects of the industry, yes, including marketing and sales, have played a vitally important part in the strength of the industry. This has greatly benefited us all in so many diverse ways, and spreads way beyond these shores.

That apart, I would commend Professor Taylor’s thought provoking article to all pharmacists interested in the “future of pharmacy” debate.

Michael Jepson
Birmingham

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Parallel imports

 

What is the effect on patients?

From Mr J. Sharp, Hon MRPharmS

A few years ago I started taking a daily dose of amlodipine 5mg for the control of mild to moderate hypertension. The tablets were regularly dispensed in the manufacturer's (Pfizer’s) original pack, which prominently displayed the proprietary name Istin, with the addition of the pharmacy, amlodipine label. A few months ago the format of the pack changed to the standard plain white card carton, with pharmacy label, containing blister strips, boldly printed “NORVASC” (Pfizer) and with other wording in Spanish, each with a small sticker giving the generic name and the “licence holder” as Medihealth of London. The shape of the tablets was also different. The Istin tablets were plain white and round. The Norvasc tablets are plain white and rectangular, with rounded corners.

Recently, my doctor, apparently on the instruction or suggestion of some “higher authority”, has changed my medication to felodipine. This has been dispensed in the manufacturer's (clearly indicated as Astra Zeneca) original pack. The text on this pack is in Italian. It is, however, largely obscured by a sticker, in English, applied by the repackager and licence holder (Dowelhurst Ltd, of Warwick). This sticker indicates, inter alia that the product is Plendil and was manufactured by “Officina Consortile di Comazza, Italy” (cf, “AstraZeneca” printed on the pack itself). The blister-strips inside the carton are prominently printed “Plendil 5” and “Astra Zeneca”. The tablets are round, pink, and modified release coated.

If I, who am not entirely unaware of the workings of the pharmaceutical industry, nor of such matters as generic prescribing and parallel importing, am just a little bewildered by all this, what effect can it have on the generality of patients? What can it do for their confidence in the medical and other health care professions, which is already at an all-time low?

John Sharp
Woodley, Berkshire

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The Journal

 

Blowing trumpets

From Mr M. R. Hickey, MRPharmS

I was curious to read the letters congratulating you on your recent appointment as editor of The Pharmaceutical Journal, particularly the six letters after the headline “Independent, objective, analytical” (PJ, March 10, pp313–314).

It would appear to me, although I could be wrong, that some of these letters were extremely personal in tone and were not really intended for publication in a professional journal. I do not doubt your ability as a journalist but, given the present furore at your appointment, the inclusion of all these letters might be seen as inappropriate, might be thought to display a lack of balance — a case, may I suggest, of blowing one's own trumpet.

Maurice Hickey
Forres, Morayshire

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