Not to be taken as directed

BMJ 2003; 326 doi: http://dx.doi.org/10.1136/bmj.326.7385.348 (Published 15 February 2003)
Cite this as: BMJ 2003;326:348

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Displaying 1-6 out of 6 published

Overhaul required of licensing rules for medication

A vigilant pharmacist made me aware on 10th July that AstraZeneca had announced the discontinuation of Mysoline affecting tens of thousands of patients in the UK. Supplies would dry up from December 2003. Imagine the shock when you’ve used it for over 20 years and learnt numerous patients have been unable to wean off it in over 40 years.

AstraZeneca PLC

The directors of AstraZeneca(Global) deemed Mysoline a low volume usage product so suddenly, epilepsy control for many is in jeopardy. AstraZeneca have a mission statement which refers to global responsibility for consistently high standards of behaviour worldwide:-

Yet, no measures were taken to mitigate the impact of this decision by ensuring:
Continuity of supply by another firm,
All affected patients had seen a specialist with a way forward in place
Recognising it takes upto 18 months to wean off

Medicines and Healthcare Regulatory Authority

The MHRA sanction the discontinuation of medication in an ‘Ivory Tower’ with none of the aforementioned measures implemented. They state “companies cannot be forced to produce medication”.

Summary

The Terms and Conditions behind licensing companies to produce and sell medication in the UK need tightening up. They can’t just stop supplying for economic reasons when it is so life-affecting and takes so long to come off. They must carry a ‘behavioural responsibility’ to ensure all those using their products have consulted a specialist and a way forward is in place.

It is impossible to measure the cumulative stress caused and time taken up of so many people's lives. An holistic approach is required to ensure patients don't get subjected to this sort of situation again. Next time, it might be something life saving, not life-affecting.

Competing interests:   None declared

Competing interests: None declared

Mark G Handley, Patient (Victim)

KT3 4LH

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Editor –

The editorial of 15 February, 2003 (1), discussed the concept of concordance - "the creation of an agreement that respects the beliefs and wishes of the patient" and also stated that "when the medicines that doctors prescribe fail to produce benefit they expect, they often respond by…selecting an alternative medicine".

On May 1, 2003, a report entitled "Complementary and Alternative Medicine: the consumer perspective) was published by the Prince of Wale’s Foundation for Integrated Health within its occasional papers series(2). This report was funded by the UK Department of Health and demonstrates just how widespread the current choice by the British public for complementary and alternative medicine (CAM) is.

The report summarised the findings from the three main British based surveys on CAM use (3,4,5).Additionally, a seven month search was launched to uncover formerly unpublished material about consumer preference for CAM from all over the UK. Over 50 additional theses, internal reports, unpublished papers and World-Wide-Web based publications were added to the report. This material spanned the years from 1988 to 2001.

The results of this report might be briefly summarised as follows(2):

Eight types of CAM were indicated as the most commonly utilised. These were: acupuncture, aromatherapy, chiropractic, homeopathy, hypnotherapy, herbal medicine, osteopathy and reflexology. The survey of most commonly utilised therapies also highlighted a need to distinguish between practitioner based therapies, over the counter medication and self practised therapies such as yoga and meditation.

The major presenting conditions for CAM use were found to be musculo-skeletal problems especially of the neck and back , injuries, bowel problems, indigestion, mental health problems (specifically, stress, anxiety and depression), migraine and asthma. In addition, life-style use (such as for the purposes of the maintenance of well being) was also found to be a significant reason for CAM use. Poor outcomes from conventional allopathic medical treatment, experiences of adverse effects from pharmaceuticals, negative experiences of the patient-doctor relationship and health beliefs which were not in keeping with the allopathic medical models were also reasons for CAM choice.

Women were found to be greater users of CAM than men, both in terms of practitioner interventions and over the counter purchases of homeopathic and herbal remedies. This was found to be broadly similar to the pattern of female use of GP and outpatient services. CAM users were also most likely to fall within the 35-44 age group. In terms of social class, those from groups AB (professional and white collar workers) and C1 (clerical, junior managerial and administrative workers) are more likely to be users of CAM while those from groups C2 (skilled working class) and DE (unskilled and manual workers) were more likely to be non-users. This profile applies in a setting where the majority of CAM use is paid for out of pocket and are therefore more likely to be utilised by people with sufficient disposable income.

Stringent estimates of use suggested that between 6.6% and 20% of the population has utilised CAM in the previous 12 months. The average number of visits to a practitioner ranged from 2.8 to 5.3 per year, leading to an extrapolation that around 5.3 million people aged over 18 made 31.7 million visits to practitioners of the eight most popular CAM therapies in the previous 12 months. There were also indications that the use of CAM had risen between 1993 and 1998. Excluding over the counter use of CAM products, lifetime use of any of the eight most popular CAM therapies was estimated to be 32.1%. This estimate rose to a figure of 46.6% if over the counter products were included in the equation.

Currently 79% of CAM is paid for directly by the patient with a mean expenditure calculated at approximately £13.62 a month. The NHS accounts for around 10% of consultations at an estimated cost of £50-55 million in 2001. Total expenditure for consultations with CAM practitioners was estimated at £580 million. However, other estimates suggested that with the inclusion of over the counter products, expenditure could be as high £1.47 billion per annum.

Clearly the use of CAM is neither peripheral nor "fringe" within the UK today. The high levels of consumer investment and interest in CAM suggest that the evidence base for CAM needs to be urgently addressed and expanded, in the interest of patient safety. Therefore, more investment in CAM clinical and basic scientific research is required. This report also deserves attention because it voices a consumer opinion of modern health care and highlights a vote for a diverse system of health care which promotes greater human contact between patient and healer. This will have implications for the way in which a responsible consumer of healthcare interacts with their GPs to appraise options and alternatives which appear to be here to stay. Putting concordance into practice does indeed appear to be key for the future of a modern pluralistic system of healthcare.

Chi-Keong Ong, MSc., PhD. Mansfield College, University of Oxford

Michael Fox The Prince of Wale’s Foundation for Integrated Health

1. Marinker M and Shaw J. Editorial: Not to be taken as directed. BMJ 2003, 326:348-349.

2. Ong CK and Banks B. Complementary and Alternative Medicine: the consumer perspective. Occasional Papers No. 2 (2003). The Prince of Wales’s Foundation for Integrated Health: London.

3. Thomas KJ et al. Use and expenditure on complementary medicine in England: a population based survey. Complementary Therapies in Medicine (2001) 9: 2-11

4. Ernst E and White A. The BBC survey of complementary medicine use in the UK. Complementary Therapies in Medicine 2000. 8: 32-36

5. Ong CK et al. Use of complementary and alternative medical services in England: A population survey of four counties 1997. American Journal of Public Health (2002), 92:1653-1656.

Competing interests:   None declared

Competing interests: None declared

Chi-Keong Ong, Research Fellow in Community and Complementary Medicine

Michael Fox

Mansfield College, University of Oxford, Oxford OX1 3TF

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Sir: Whether at any time doctors' orders have been followed is open to debate. The very term suggests a degree of contempt. With political correctness having moved the term from this to compliance, then adherence and now concordance, may reflect the seriousness, or lack thereof, with which our instructions are taken. More basic than how much patients value the instructions given to them by medical practitioners, may be the belief patients' attribute to the physicians directions. Coming at the problem from another angle one might wish to consider to what extent patients believe how much the disease that doctors label a patients illness with accords with their own perceptions of their problem.

Certainly, in psychiatry particularly, this element of 'insight' is a major determinant of so called lack of concordance. Were more time spent in trying to explain to patients the nature of their problems, as seen through a doctors eyes, a more reliable uptake of advice might be expected. To anticipate an improvement in this area, within the shortsighted government encouragement of doctor bashing, internet misinformation overload and sensationalisation of medication side-effects, is probably overoptimistic, but still worth trying.

Competing interests:   None declared

Competing interests: None declared

Andrew A Al-Adwani, Consultant Psychiatrist

Depatment of Psychitry, Scunthorpe General Hospital, Church Lane, North Lincolnshire

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15 February 2003

Concordance is the key word for successful treatment nowadays. Most of our patients today are health-educated, health-concious and enlightened. For prescriptions to be followed, the patients have to be taken into confidence first. If the confidence is won, concordance will follow. It has been rightly said, 'Medicine is Science, but treatment is an Art". If we can master this art properly, then concordance should be well managed and emphasized, thereby resulting in better compliance.Placing one self in the patient's position, thinking of whatever queries can creep into the mind of the person on the other side of the table and trying to answer them in a truthful manner should see us through.

Best regards.

Dr. M. Mukherjee, MD.

Competing interests:   None declared

Competing interests: None declared

Mainak Mukherjee, Consultant General Psychiatrist

West Bengal, India - 713101

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15 February 2003

Dear Editor,

The issue of concordance is an important one.The authors state:"...we must learn to create robust therapeutic alliances with mutual respect for the both the doctors professional opinion and the patients personal decisions..." As is fairly usual in medicine, we are given hints about what to do and why to do it. What is left out is HOW TO - the process.

The field of Neuro-linguistic Programming (NLP) is the study of HOW people do what they do - the structure of subjective experience. In the book Consulting with NLP (1) I detail not only how patient's structure their health beliefs and expectations, but also how to communicate effectively using their own decision making strategies.

Utilising just how this particular patient consulting today convinces himself to actually take action we can formulate our communication in such a way that it makes complete sense to the unique individual sitting in front of us. If we do it wrong they may not "see what we are saying", it may not "sound right" nor even "feel right".

Our job as effective communicators is to get the message across respectfully and with empathy so that it fits their own decision strategies like a glove. NLP will give you lots of helpful hints.

Sincerely,

Lewis Walker FRCP

Ref (1)Walker, L (2002) Consulting with NLP: neuro-linguistic programming in the medical consultation. Radcliffe Medical Press

Competing interests:   I am the author of the quoted book

Competing interests: None declared

Lewis Walker, General Practitioner

Ardach Health Centre, Buckie, Scotland

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14 February 2003

one frustating feature of medical practice if poor patient compliance.i find many reasons for these:

1.large number of tablets: if the number is large, compliance is going to be poor. under the circumstances, one should select longer acting drugs and fewer dosing and also combinations may be resorted too. for instance a combined preparation of atenolol with amlodipine will give better compliance than prescribing them separately. a good test is ask " can i take so many tablets myself?" if the answer is no, improvise the prescription.anti-tubercular drugs also produce poor compliance, but the kit preparation are more successful.

2.unnecessary drugs: cut down on multivitamins, anti-allergics for common cold, fish oils and anti-oxidants, vit c, cough syrups etc.

3.side effects: the doctor may be required to change the family of drugs. for instance enalapril produce cough and amlodipine pedal edema. both these may produce poor compliance. losartan is almost free of cough, and lercanidipine less of edema.

4.poor patient awareness: another cause of discontinuation is patient's beleif that treatment is temporary. most patients discontinue anti- hypertensives or anti-diabetics because they feel better. it is necessary to educate them that there is no cure for many of the so called modern diseases and a life long commitment is required by the patient.

5.aversion to allopathy: some patients have either genuine or misguided aversion to allopathic grugs. they prefer herbal or homeopathic drugs. here you cannot do much except request the patient to do the necessary. there is little to be gained in belittling other alternative forms of therapy, including acupuncture, faith healing etc. it is said that a doctor's prescription tells more about the doctor rather than what his patient is suffering from.we must remind ourselves not to make the treatment worse than the disease.

Competing interests:   None declared

Competing interests: None declared

dr.manan vasenwala md,mrcp, consultant-cardiologist (non-invasive)

k.k.heart center, aligarh.202002,INDIA

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