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rational psychotropic prescribing for children
- andrew f clark (23 June 2006)
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Licensing a drug for children should include the evaluation of the potential increased toxicological risk in overdose as well as the risk of suicide itself
- Reza Afshari (26 June 2006)
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Irrational prescription is common in paediatric tuberculosis cases
- Sangeeta Sharma (27 June 2006)
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Please do not ignore the child !
- Arnob Chakraborti (27 June 2006)
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Off-label Prescribing - an Ethical Quagmire?
- HELEN M PEARS (17 July 2006)
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Open Letter to the US FDA
- Stefan P. Kruszewski, M.D., Steven G. Klotz (12 June 2007)
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andrew f clark, consultant & honorary senior lecturer in adolescent psychiatry bolton salford trafford mental health services, m25 3bl
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Sutcliffe & Wong highlight the paucity of high quality research regarding the beneficial and adverse effects of prescribing psychotropic medication to children and caution that practitioners need to remain wary of both industry influence and societal pressures. Training influences and therapeutic belief systems also play a powerful part in treatment decision making. In a prospective study of prescribing of psychotropic medication to children by UK child and adolescent psychiatrists (Clark, 2004) the inception rate (ie commenced of a child on psychotropic medication which they were not already prescribed) was one new prescription a year per 1000 children in the general population. Stimulants and antidepressant drugs were most commonly prescribed but in total 48 different drugs were prescribed for 25 different diagnoses. There was marked variation between services in amount of prescribing with significant correlation between prescription of stimulants and prescription of SSRI antidepressants. These two classes of drug have little overlap in clinical indications which suggests that some clinicians or services are inherently more likely to prescribe than others. The marked variability between services in their levels of prescribing must raise some questions about differing clinical practices. Development of treatment protocols for the commoner disorders and treatments may be helpful here although successfully integrating these into routine clinical practice remains a challenge. Clark AF (2004) Incidences of new prescribing by British child and adolescent psychiatrists: a prospective study over twelve months. Journal of Psychopharmacology, 18, 115-120. Competing interests: None declared |
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Reza Afshari, M.D., M.PH., Ph.D., Assistant Professor of Clinical Toxicology Medical Toxicology Centre, Imam Reza University Hospital, Ibn-e-Sina St., Mashhad, 91735-348, Iran
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Alastair G Sutcliffe in his article “Rational prescribing for children” quite rightly pointed out that practitioners should only prescribe drugs to children with clear evidence of favourable ratio of benefit to risk. He also discussed the potential increased risk of suicide in relation to the use of some psychotropic agents in adolescence. It is also true that we should be ensured that good clinical studies can be practically achieved in relation to the Medicines for Children. Another important risk, however, he did not discuss is the possibility of increased toxicological risk in accidental or suicidal drug overdoses in children or adolescence as well as the frequency of overdose itself. Some complications can be seen in overdoses but not in clinical studies with therapeutic doses. I previously have shown that for example co-proxamol was 10 times more fatal in overdose in comparison to other combination of paracetamol and opioids, while their hospital admissions were similar 1,2. Co-proxamol in overdose was a rapid killer. Therefore victims were susceptible to be directly referred to the forensic medicine departments before being admitted to the hospitals and therefore were not being picked up by the health authorities 3, 4. This may have hidden its important complications after decades of being in the market, as admissions in the hospitals for co-proxamol, co-codamol and co-dydramol were similar. This may also happen with the use of medications in children. Any license extension of drugs to children or the structure of "paediatric use marketing authorisation" as a whole should have the capabilities to focus on not only potential increase in risk of suicide, but also any potential increased toxicological risk of overdose with drugs. As children might be different from adults, a separate toxicological folded for children should also be opened. References 1.R Afshari, AM Good, SRJ Maxwell, DN Bateman. Co-proxamol overdose is associated with a 10-fold excess in mortality compared with other paracetamol combination analgesics, BJCP, 2005 Oct;60(4):444-7. 2.Bateman DN, Afshari R (2003) Co-proxamol and suicide: Licence needs to be changed. BMJ. Aug 2;327(7409):287. 3.Afshari, R. Maxwell, S. Dawson, AH. Bateman, DN. ECG abnormalities in co-proxamol (paracetamol/dextropropoxyphene) poisoning. Clin Toxicol (Phila), 2005, 43 (4):255-259. 4.Afshari R, The cardiovascular effects of opioid analgesics: Studies on the role of opioid and non-opioid receptors in man, PhD thesis, The University of Edinburgh, 2005. Competing interests: None declared |
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Sangeeta Sharma, Specialist & Head Deptt of Peadiatrics LRS Institute of Tuberculosis & Respiratory Diseases, New Delhi 110030
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The article by Sutcliffe and Wong regarding irrational prescription in paediatric practice is very timely and appropriate. The irrational prescription is not limited to antipsychiatric medication or antibiotics. It is seen very commonly in children with diarrhoea where private practioners very commonly prescribe antibiotics in absence of scientific indication. In cases with paediatric tuberculosis, the practioners often prescribe irrational drug combinations using outdated medicines in suboptimal dosage or use second line drugs in absence of indication. This can be very dangerous and can lead on to multi drug resistant tuberculosis which is far more difficult to treat. The treatment is more expensive, needs longer duration of therapy and is toxic with very high rate of morbidity and high mortality which is more common in paediatric patients. Hence all the paediatric tuberculosis patients( both pulmonary and extrapulmonary )should be treated by specialists with special interest in respiratory diseases under Revised National Tuberculosis Control Programme using Directly Observed Treatment Shortcourse (DOTS) which is proven to be most cost effective treatment available for tuberculosis with very high success rate. Competing interests: None declared |
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Arnob Chakraborti, senior house officer, CAMHS Evergreen Place, Walsall PCT, WS2 9XH
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It was reassuring to read Sutcliffe & Wong's arguement about the dearth of evidence base regarding pediatric prescriptions and the influence of the industry and society.1. The article features mainly psychotrophic prescriptions, which also brings to mind the fact that whilst in general pediatrics doses are commonly calculated according to body weight or surface area, it is usual in psychopharmacological practise to titrate the dose against symptom control or functioning and dose- related adverse effects, and an optimal balance aspired for. Stimulants and SSRIs happen to be the most prescribed psychotrophic medications for kids although anti-psychotics, mood stabilisers, other antidepressants and hypnotics also figure in the list of routine CAMHS practice. Given 1 in 10 children in GB aged 5-16 suffers from a clinically recognisable mental disorder.2.we can only but expect further prescriptions. Most pharmacokinetic and pharmacodynamic research has been carried out on adults, presumably due to consent related issues, but what needs to be borne in mind is that children are physiologically not scaled- down adults. While the difference in their physiology is important, the distinction in their psychology should also be recognised - family, siblings, friends, peer groups, classrooms and school, all play a role in their developing identities. This should only make the clinical decision of prescription only harder, weighing the pros and cons on a scale which is already tipped with a developing brain and a developing mind. And the tradition of 'Primum Non Nocere - First, do no harm' needs to be maintained. Grading of the degree of harm in terms of potential side-effects, psychological challenges, evaluating favourable benefit to risk ratio and attempting the child client's involvement into the decision making process might yeild benefits; but as with the rest its still "an evidence based desert".1. Seldom do we come acros a child who relishes the task of taking regular and daily medications. And strong evidence from follow up studies (Rutter et al 1975).3. showing that 40% of childhood disorders persisted into adolescence we are entering an area where long term treatment adherance and compliance are critical issues. .1.Alastair G Sutcliffe and Ian Chi Kei Wong ;Rational prescribing for children; BMJ 2006; 332: 1464-1465 .2.Survey of the mental health of children and young people in GB; Office of National Statistics; 2004 .3.Rutter M, Yule B, Quinton D et al; Attainment and adjustment in two geographical areas; BJPsych 126:520-533 Competing interests: None declared |
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HELEN M PEARS, SpR Psychiatry Oak House, University Hospital Aintree, Lower Lane, Liverpool L9 7AL
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I read with interest Alistair Sutcliffe and Ian Wong's comments on rational off-label prescribing in children. They wisely advise practitioners to remain wary of industry and societal influences. I would venture that one must also also closely consider the ethical issues at play in off-label prescribing. As an SpR in Psychiatry, I encounter similar issues to those in Paediatrics with a dearth of evidence for many treatments and drug labelling restricted in many areas. It seems fair to say that there is often a lack of incentive to widen licensed indications for medications used in our population. Research in the specialty is frequently complex, with outcomes poorly defined and recruitment fraught with ethical diffiulty. It is, thus, expensive and application for wide labelling indications time consuming. For many medications then labelled indications remain limited. There are frequent difficult choices to for Psychiatrists to make then with regard to off-label prescribing. In addition to the above we are often left without the guidance of patients' own insight or informed wishes to guide us. Advocates for our patients, equivalent perhaps to parents in Paediatrics, are frequently lacking. Capacity to understand the reason for treatment with medication is often lacking in the first place and discussion around the meaning of 'off-label' unfeasible. Thus, we must weigh up the twin moral duties of beneficence and non- malificence in off-label prescribing based only upon scant evidence and our own judgement as to what is in the patient's best interests. In the absence of advocates for many patients, must we, as representatives of their best interests, push for a fairer system of labelling medications in order to access for them better regulation of their treatment choices? I wonder whether, in fact, we have a ethical responsibility to 'campaign' for a system, independent of the pharmaceutical industry and market forces, in order to ensure that we make medications available to our patients based soley upon robust evidence of clinical efficacy and safety and not upon profitability. Competing interests: None declared |
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Stefan P. Kruszewski, M.D., Psychiatrist, addictionologist Harrisburg, Pennsylvania 17112 USA, Steven G. Klotz
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Open Letter to the FDA US Senate Finance Committee
Andrew C. von Eschenbach, M.D.
Max Baucus, Chairman
Dear Commissioner Eschenbach: As reported in Bloomberg News by Rapaport, Pettypiece and Waters on 24 May 2007, several manufacturers of atypical antipsychotic medications have discussed pending applications/approvals from, and/or plans to submit such ‘new indication’ applications to, the US Food and Drug Administration(FDA). According to the article, the manufacturers would seek to obtain FDA approval for the specific ‘indication’ to use atypical antipsychotics in teenagers. Already approved in the US adult population, marketing for atypical antipsychotic drugs from Eli Lilly (makers of Zyprexa), Janssen, a division of Johnson and Johnson (makers of Risperdal) and Bristol Myers Squibb/Otsuka (makers of Abilify) would be affected. Dr. R. Findling mentions that these new ‘indications’ would be able to enhance the confidence level of providers and parents when they, respectively, prescribe or permit these potent psychotropic agents to be used in a younger population. Schizophrenia and Bipolar Disorders are painful mental illnesses, often with varying courses of stability/instability and unpredictable functional disabilities. We agree that all available therapies should be sought to minimize the emotional damages and maximize the return to health for individuals and their families affected by the symptoms categorized under these diagnoses. However, second-generation atypical antipsychotic medications have not clearly proven to be safer, more efficacious or more effective than older agents. Furthermore, some of the atypicals medications may have risks (significant weight gain, pancreatitis, diabetes, cardiovascular complications, hyperprolactinemia, or infections) that may outweigh their benefits when compared to other first-generation agents. Studies already suggest that younger patients may be more prone to suffer from severe side effects for longer periods of time. We are unaware of any evidence suggesting that an indication will make prescribing habits safer. We see no compelling reason for the drug manufacturers to seek specific FDA approval of atypical antipsychotics in the teenage population. Our reasons are not complex. They include: 1. All of these drugs are already available in the marketplace.
We strongly recommend that the FDA re-consider and delay administrative reviews and approvals for indications that have little merit other than for ostensible marketing purposes. That delay does not compromise patient care. Doctors who assess young patients with diagnostic accuracy and treat them carefully and compassionately will not increase their personal liability if they apply informed consent to use off-label medications correctly. Furthermore, delaying the administrative FDA approval for this ‘new’ indication (but current practice) may prevent the escalation of excessive use of atypical antipsychotic medications whose occasional and predictable serious side-effects can compromise both medical and psychiatric care. Sincerely, Steven G Klotz, MD; Stefan P. Kruszewski, M.D. 31 May 2007 1. Rapaport L, Pettypiece S. Bristol seeks U.S. approval for antipsychotic Abilify in teens [Online]. Bloomberg News 2007 May 24 [cited 2007 May 30]; [3 screens]. Available from: URL:http://www.bloomberg.com/apps/news?pid=newsarchive&sid=aiVGsv0rwml4. 2. Rapaport L, Pettypiece S. Bristol seeks U.S. approval for antipsychotic Abilify in teens [Online]. Bloomberg News 2007 May 24 [cited 2007 May 30]; [screen 2] Available from: URL:http://www.bloomberg.com/apps/news?pid=newsarchive&sid=aiVGsv0rwml4. Competing interests: Dr. Klotz is an academically trained child, adolescent and adult psychiatrist now in private practice in central Pennsylvania. Dr. Kruszewski is an adult, geriatric, adolescent and addiction psychiatrist practicing in Harrisburg, Pennsylvania. Both Drs. Klotz and Kruszewski have previously consulted for and spoken on behalf of multiple pharmaceutical companies. |
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