红参的吃法大全Commentary
has not been optimized for reporting by physicians and others,and has also left the capture of qualitative information and the concerns of patients woefully lacking.This includes a lack of dialogue and uful individual feedback to reporters.It is not surprising that reporting rates remain low.
Following the detection of a signal that something could be wrong with a drug,more active measures to asss that risk further are necessary for evaluation of its effect on public health,in other words whether the problem is going to affect many people.Becau of the rarity of rious adver events,obrvational studies are normally ud,although some suggest that large prospec-tive studies are necessary,even if they are expensive.In either ca,the reasons for decisions to take further action are not usually made public.Few have addresd this matter,but some have madefirm proposals for decision making[5–10].At the heart of the matter is how one deter-mines a primary probability(notional)of a causal link between a drug and an adver event,the riousness of the perceived public health risk and the availability of resources to investigate it.The judgement to take things further is heavily weighted by the frequent comment that ICHRs are‘only anecdotal’and‘poor qua
lity evidence’.
书法家字体This is a dangerous catch22.ICHRs are the chief means by which new hypothes about rare events are brought to our attention,so we need to have a clear,open procedure to determine what signals should be further investigated and when.The causality guidelines offered by Bradford Hill in1965[11,12]and the EIDOS and DoTS proposals[7,9] form a strong basis for the considerations and should be transparently ud and evaluated for their merits.More-over,causality logic should be a basic subject in all medical schools,since it is at the root of successful diagnosis.In addition to this logic,I believe that three other factors are esntial in pharmacovigilance and in medicine in general:•to be preci about the ways in which data are prepared and transformed into databas;
•to be able to recognize condary effects,which may be more obvious than the primary effect,but not so easy to link causally;
•to be cognizant of interactions,not only between drugs but between drugs and dias and even environmental factors.Non-drug interactions may be written off as con-founders when they are actually co-precipitating factors, such as tho that are important determinants of medi-cation errors.
Pharmacovigilance currently forms a sort of sociologi-cal experiment that operates,as far as health-c
are profes-sionals and the public are concerned,without clear objectives in relation to individual decisions,with no pro-tocol(although risk management plans are a great step forward),with obscure materials and methods ud for making decisions,with very limited reasoning and discus-sion,and little or no follow-up and audit of the results.
半透明图片The general way forward ems clear:a rigorous way of documenting all the steps,from getting ICHRs into regula-tory databas to asssing the effects on public health,is esntial and should be publicly reviewed for weakness. In turn,matters would be much improved if patient groups were to have an input,by giving their benefit/harm per-ceptions,and therefore influencing decisions about what should be the true targets for regulatory and pharma-covigilance activities,so avoiding cond guessing by regulators.
Developing some specific areas of pharmacovigilance
There have been many advances in tools that have been propod to aid the overall tasks of pharmacovigilance, and here I shall critically review some of them. Pharmacoepidemiology
Advances in pharmacoepidemiology have been dramatic over the last two decades,particularly in obrvational epi-demiology and meta-analysis.Together the two areas have partially addresd a
major challenge for epidemiolo-gists:many adver reactions are too rare to be en as statistically significant until considerable exposure has taken place,and such exposure is uncontrolled in day-to-day clinical practice.On the other hand,a major advantage of obrvational epidemiology is that it does tackle the u of drugs in unlected populations.However,a consider-able danger aris in assuming that even a large study can determine lack of causality in a few patients.Importantly, what it can do is to asss the relative probabilities below which any risk merges into the background,and occasion-ally a study may provide uful information about low risk groups with shared characteristics.It is the low-risk groups that should be studied further,for instance by genotyping and examining other aspects,such as medica-tion errors.Such studies should also form part of our inves-tigation of similar patients collected via ICHRs.
Tofind sufficient patient exposure,longitudinal health-care data are ud.While overall data quality testing is done on databas,for each investigation different quality issues are relevant,and in each specific area of quality problems may ari.Transparency in how quality is exam-ined should be an important part of obrvational studies, as should the potential for bias.
Since epidemiology is considered elwhere in this issue of the Journal,I shall comment on only one further matter.Obssion with one kind of tool(for example, obrvational vs.prospective studies)sho
uld befirmly resisted.It is the right tool for the job that is important and different methods should not be considered as competi-tive.Reasons for differences infindings need to be consid-ered carefully.Two recent studies of the hypothesis that bisphosphonates may be associated with oesophageal
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980/73:6/Br J Clin Pharmacol
knowledge goes intofinding out about how drugs work for good and ill,the very limited results on improving the individual patient’s benefit to harm balance em to suggest lf-gratification rather than a productive exerci. There can be only one answer to this paradox(that what we know is not what the patient should know),and that is a concentrated effort to improve our communications and educational methods,using and developing all the media and technological supports that are available to us (Figure1).This also implies more widespread u of social media.
Serious rearch into and audit of communications science may be much more fruitful than providing more data that are irrelevant,in that they are not ud to best effect,or at all.
Competing Interests
There are no competing interests to declare.
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佛的四字词语
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RECEIVED
18January2012家长意见20字
ACCEPTED
30January2012
ACCEPTED ARTICLE PUBLISHED ONLINE
23February2012
CORRESPONDENCE
Professor Ivor Ralph Edwards,74597Enköping,Sweden.
E-mail:*************************
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982/73:6/Br J Clin Pharmacol
