Welcome to PhytoNET
A personal message to all those interested in herbal medicine.
The following pages will provide a reliable source of quality information about herbal medicines (or phytomedicines). If you would like to be kept updated on the work of the leading representatives of phytomedicine in Europe, and in particular the European Scientific Co-operative on Phytotherapy (ESCOP) please log in with your e-mail address and we will provide you with newsletters and other opportunities for contact.
You will find a number of services on these pages. In particular we have set up a new adverse drug reporting scheme which we would like you to use. Let us consider therefore the answer to a key question:
Why should I use the PhytoNET adverse drug pages?
In recent years, especially in the UK, there have been increasing numbers of accounts of adverse effects following the consumption of herbal remedies. There have been a few alarming cases of serious damage reported in medical journals but also an intense media coverage which has cast wider doubts about herbal safety. Safety is now likely to be the first potential problem expressed by those looking at herbal or phytomedicine from the outside.
There are data available on routine adverse effects from taking herbs, most of it in fact reassuring, at least as far as responsible practice is concerned. However the main conclusion drawn by everyone who has looked at the matter is that THE INFORMATION ON HERBAL SAFETY IS EXTREMELY INADEQUATE. In particular, regulators, responsible for maintaining public health, are likely to point out that REPORTING MECHANISMS (pharmacovigilance procedures) for monitoring adverse effects of herbs are notably poor. Without information, they ask, how can a proper evaluation of public risk be conducted? In a vacuum of hard data, even a theoretical risk or the occasional report of problems can persuade regulators to withdraw herbs from sale to the public. This has already happened in Europe: the EC Committee for Proprietary Medicinal Products has produced a list of herbs withdrawn for safety reasons on the basis of their containing potentially toxic constituents, even though many have a traditional usage.
Under the terms of the EC BIOMED project, a major pharmacovigilance project has begun. Hopefully this will be extended in the future. It will involve all those with a professional interest in monitoring safety in an effort to improve on the data available about the experience of using herbs. Everyone involved is on the same side when it comes to the public interest - WE ALL NEED MORE INFORMATION. Those of us who use herbal medicine are likely to be reassured that what we do is largely safe and we will in any case all profit from identifying where the main risks lie.
Currently there are a number of established pharmacovigilance schemes for reporting adverse effects to drugs. These mostly involve physicians who may not understand herbal medicines very well. There are many other users of herbal medicines who are not covered by these schemes - pharmacists, phytotherapists, herbalists, other health professionals, and the patients or users themselves. ANYONE WHO HAS EVER USED HERBAL MEDICINES AND WHO HAS NOTICED ANY ADVERSE EVENT IS ENCOURAGED TO USE THE YELLOW FORMS ON THIS WEB PAGE. You will have to log in an e-mail address to do so. This will be a reassurance to you. We will keep all notifiers fully informed about the progress of each report and they will also be part of a regular mailing programme.
Confidentiality
You will not be able to access other ADRs directly. In the first instance PhytoNET retains a confidential relationship with our notifiers - the information they provide is their intellectual property donated to a restricted audience in the wider interest. They may not want to pass it directly to the authorities without a filter mechanism provided by PhytoNET. Where such information is judged to have a wider relevance we go back to the notifier to propose that we pass it on to the relevant authorities and/or we use it to prepare an expert review of the issue concerned for possible publication.
Criteria for such further action are one or more of the following:
1) a serious adverse event: death, damage to, or change in function of, vital organs, incapacity or extended disability and any long-term consequences;
2) an adverse event that resembles one already recorded for the herb in question (in PhytoNET or elsewhere);
3) any suggestion of contamination, adulteration or substitution of a product with toxic materials.
In any such case account will also be taken of the degree of association of the adverse event with the herb in relation to other possible influences (such as other drug consumption). However, it is notoriously difficult to establish causality in initial reports so that a link with the herb reported will be assumed in applying the criteria above unless there is clear evidence to the contrary.
Many reports are likely to be occasional incidents involving transient adverse events. Where they do not comply with the criteria above they will be logged within the PhytoNET database as a non-ascribed resource of ADR's. Access to this material is generally restricted to the ESCOP Toxicology Panel (made up of independent European academics with relevant knowledge), whose brief is to provide the expert review service as outlined earlier. From time to time the Panel will produce bulletins on the state of the PhytoNET database for publication in the European Phytojournal available free on http://www.escop.com/epj
It is anticipated that notifiers will be cooperative in a
considered approach to divulge their information under the circumstances above provided
they are fully involved in the decision. It is on these terms that we offer the
PhytoNET facility.
PLEASE REPORT. If you have any worries whatsoever please e-mail me directly on S.Y.Mills@exeter.ac.uk. I personally use herbs professionally and want to see herbal medicines remain available for all those who wish to use them. We all need to ensure that herbal medicine is based on the most responsible practice.
Simon Y. Mills MA FNIMH MCPP
Practicing Medical Herbalist
Chairman, British Herbal Medicine Association
Hon Secretary, ESCOP
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