Guest guest Posted September 24, 2004 Report Share Posted September 24, 2004 Hi Micheál, > Phil, I read with interest what I think was the tail-end of a > discussion on hiding behind the 'cascade' derogation to prescribe > homeopathic products. You seek opinions on the interpretation, > which I think emanates from a colleague. My opinion is that it has > glaring omissions and is therefore fatally flawed. ... Many thanks, Micheál, for correcting my fatal error in relation to the application of the different applications between food animals and non-food animals. The position of the EU Legislation vis a vis homeopathy, herbal medicine and eclectic prescribing is even worse than I suspected. Your very thorough exposition suggests that we are heading for all- out war between the vested interests of the adherents of mainstream allopathic medicine and those of CAM. That war is not only about vested interests, but also about the issue of freedom of choice in therapy for clients and practitioners The war has begun now in earnest in EU. IMO, it would appear that CAM professionals in EU will face sanctions, right up to prison sentences, as happened with chiropractors in the USA. A colleague on another List wrote yesterday: " During the first 75 years of its existence, chiropractic doctors were jailed >15,000 times due to anti-chiropractic campaigns organized by state medical societies and the AMA. The last chiropractor to be thrown in jail for practicing was in 1974, in Louisiana -- *after* the bill legislating the practice of chiropractic was passed. It wasn't until Federal Judge Susan Getzendammer found the AMA and other medical societies guilty of anti-trust violations that they stopped telling our patients that we are quacks. Then they just went underground, using fronts like NCAHF and other to continue trashing us " . The gloves are off in EU now. It may take an anti-trust case in the EU Courts to resolve the impasse. Many thanks, Phil >>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>> Micheál O Manhony wrote: Phil, I read with interest what I think was the tail-end of a discussion on hiding behind the 'cascade' derogation to prescribe homeopathic products. You seek opinions on the interpretation, which I think emanates from a colleague. My opinion is that it has glaring omissions and is therefore fatally flawed. Omission 1: At the end of this email I have given the link to the cascade system in the Irish Animal Remedies Regulation. Read the first paragraph of this regulation. Two conditions MUST be met in order to invoke the cascade " where there is no authorised animal remedy for the treatment of a condition in a particular species AND where it is necessary in order to avoid causing unacceptable suffering to the animal or animals concerned. " So if a licensed product exists, then we cannot hide behind cascade to prescribe unlicensed drugs Its very simple. Then, and only then, can we invoke the cascade. Is this the case for the bulk of homeopathic products???? I have never prescribed these products, but I'm willing to bet that it is not Omission 2: Please read the full cascade system. It is called the cascade because it involves a progression of the leniency of the derogation. If the above conditions are met the veterinarian may INITIALLy CASCADE to an " animal remedy [authoriseed] in another animal species or for another condition in the same species " If that doesn't exist the veterinarian may THEN CASCADE to " a medical preparation authorised for human use " If neither of these three alternatives are available the veterinarian may THEN CASCADE to " an animal remedy prepared extemporaneously " In short, in order to cascade as far as unlicensed made-up homeopathic products the first three alternatives must not exist. Is this the case for the bulk of homeopathic prescriptions???? While I am at it, the purest notion of homeopathy is the extemporaneous make-up of product for a certain condition in a certain individual The use of pre-prepared product does not sit well with either the 'extemporaeous' rung of the cascade, or the art of homeopathy. Omission 3: In the case of Food animals, even when invoking the cascade, the provisions of that paragraph shall only apply to the administration or prescription of substances which are to be found in animal remedies authorised by the Competent Authority or licensed by the Minister for administration to food producing animals. This again is very clear. Whatever rung of the cascade system we stand on we can only give products to food animals which are licensed in SOME food animal in this country. As there are no homeopathic products licensed in any food animals in this country, the cascade system cannot be used to warrant their use in these species. Homeopathic products are specifically defined as animal remedies by the Irish Medicines Board. See article 6 on page 15 here: http://tinyurl.com/53arv While provision is laid for a 'simplified registration' for homeopathic animal remedies this does not apply to homeopathic products for food animals. Does anyone know of any homeopathic product that is actually licensed by the IMB? The cascade system protects the meagre access which our profession has for 'minor-use' and 'minor-products' (MUPs) Flagrant misuse of the cascade system by suggesting that we can invoke it at will to justify the use of whatever product we like is unlikely to protect our access to MUPs in the long term. Micheál O' Mahony >>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>> The cascade system, copied and pasted from SI179 1996 http://tinyurl.com/5e8uj ADMINISTRATION OF ANIMAL REMEDIES 40. (1) Notwithstanding Regulation 38 and subject to the subsequent provisions of this Regulation, where there is no authorised animal remedy for the treatment of a condition in a particular species and, where it is necessary in order to avoid causing unacceptable suffering to the animal or animals concerned, a registered veterinary surgeon may administer, sell, supply or prescribe the use of— (a) an animal remedy in respect of which there is for the time being in force an animal remedies authorisation authorising the use of such animal remedy in another animal species or for another condition in the same species, or (b) if there is no animal remedy such as referred to in subparagraph (a), a medical preparation authorised for human use in accordance with the provisions of the Medical Preparations (Licensing, Advertisement and Sale) Regulations, 1984 and 1989 and the Medical Preparations (Licensing, Advertisement and Sale) (Amendment) Regulations, 1993 (S.I. No. 70 of 1993), or © if there is no animal remedy or medical preparation as referred to at subparagraphs (a) or (b), an animal remedy prepared extemporaneously by — (i) a pharmacist in accordance with the prescription of a registered veterinary surgeon, or (ii) a registered veterinary surgeon, in respect of animals under his or her care concerning which he or she has been consulted in a professional capacity, or (iii) a person licensed to manufacture such class of animal remedy in accordance with Regulation 21. (2) Where it is necessary to treat a food producing animal in accordance with paragraph (1), the provisions of that paragraph shall only apply to the administration or prescription of substances which are to be found in animal remedies authorised by the Competent Authority or licensed by the Minister for administration to food producing animals. (3) Where a registered veterinary surgeon administers or prescribes an animal remedy in accordance with paragraph (1) for administration to food producing animals such registered veterinary surgeon shall specify an appropriate withdrawal period so as to ensure that food produced from the treated animal does not contain residues which may be harmful for consumers of produce derived from treated animals. (4) Where an animal remedy or medical preparation administered or prescribed in accordance with paragraph (1) does not indicate a withdrawal period for the species to be treated, the following withdrawal periods shall be mandatory unless a longer withdrawal period is specified in accordance with paragraph (3):— - eggs from treated animals - 7 days - milk from treated animals - 7 days - meat, including fat & offal from poultry and mammals - 28 days - meat from fish - 500 degree days. (5) Where a registered veterinary surgeon administers or prescribes an animal remedy in accordance with paragraph (1) a record shall be kept detailing (a) date of examination of animals, (b) identification of animals, © number of animals treated, (d) name and address of owner or person in charge of the animals, (e) diagnosis, (f) details of the animal remedy or medicinal product administered or prescribed and reasons for such choice, (g) the dosage administered or prescribed, (h) the duration of treatment, (i) the withdrawal period, if any, specified. (6) The records specified in paragraph (5) shall be maintained for three years and be furnished on request for examination by an authorised officer. (7) This Regulation applies to the treatment of an individual animal or a small number of animals on a particular holding or premises and shall not be construed so as to provide for the general manufacture, sale, supply or use as an animal remedy of a medical preparation or an animal remedy to which subparagraph (1)(b) or subparagraph (1)© applies. (8) A registered veterinary surgeon who prescribes, sells or supplies an animal remedy under this Regulation (or a pharmacist who sells or supplies an animal remedy in accordance with the prescription of a registered veterinary surgeon) shall label the animal remedy with a notice in the form prescribed and containing the information specified by Regulation 33 (3). (9) This Regulation shall not apply to the administration of an animal remedy to an animal or class of animal where the administration of such animal remedy to such animal or class of animal is specifically prohibited by the animal remedies authorisation or where the animal remedy consists of, or contains, a substance the administration of which to such an animal or class of animal is prohibited by the law of the State or any provision of Community Law. (10) An animal remedy administered in accordance with, and for the purposes provided for by, this Regulation, shall for the purposes of such administration be deemed to be an authorised animal remedy. On 23 Sep 2004, at 08:16, wrote: >>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>> Phil Wrote: Hi Carvel, Jan, Susan, & Vet Ireland Colleagues, Susan asked: So exactly what implications follow from the letter below? If homeopathics are approved for people, then they can still be used under the 'cascade'? I have forwarded the letter to the Vet Ireland List for comment. Gaels, I would value your comments on my interpretation, below. My interpretation is: EU is moving towards total regulation of vet medicines. Registration will specify the species and the indications. EU Legislation will force vets to use only registered medicines as animal remedies; use of unregistered products could leave them liable to litigation if cases do not respond, or adverse outcomes occur. Exceptions will include the cascade system if a registered remedy does not exist for a specific condition. 3. To qualify as a registered medicine, each product must prove safety, efficacy and quality control for indicated species and conditions in an expensive registration process. 4. For many reasons, if current rules of registration apply, it is unlikely that homeopathics will be registered as medicines for humans or animals. 5. Ergo, vets or doctors who use them as remedies will be using " unregistered " (unapproved) products. Best regards, Phil >>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>> Vet Times Volume 34, no. 36, 20th September 2004, page 39: Use of medicines under the cascade Dear Editor, I would like to thank Simon Baker (23rd August issue) for providing a further opportunity for me to comment on the use of veterinary medicines under the cascade. In his letter, he raises the important issue of how veterinarians may try new modes of medical treatment. New medicinal treatments should be thoroughly researched, documented and then assessed and authorised by the regulatory authority before veterinarians are able to use them legally. Selected veterinary practices may play a part in clinical trials of new medicines before they are fully authorised, but such a trial wil be conducted under an Animal Test Certificate (ATC) issued by the regulatory authority. The ATC will restrict the extent of the trials conducted and the data produced will be used in the assessment of the veterinary medicine prior to its authorisation. Veterinary surgeons conducting trials outside these rules are clearly taking considerable risks [as] their actions could be more correctly described as research and, therefore, may require an ASPA licence from the Home 0ffice, even if the animal owners have given their consent to the treatment being used. On an entirely different front, Simon Baker asks for some guidance as to where homoeopathic remedies sit within the cascade. Homoeopathic remedies should be authorised in a similar manner to other forms of veterinary medicine. Thus, assuming a homoeopathic remedy is authorised either as a veterinary or human medicine, it may be used under the cascade using exactly the same rules as any other veterinary medicine. If, however, the homoeopathic remedy is not authorised for use as a human or animal remedy, then it may not be used under the cascade provision. Veterinary surgeons may like to know that there are currently no homoeopathic remedies authorised for use as veterinary medicines in the UK. Yours faithfully, STEVE DEAN, BVetMed, DVR, MRCVS, Chief Executive, Veterinary Medicines Directorate, Woodham Lane, New Haw, Addlestone, Surrey KT15 3LS. >>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>> Best regards, Email: < WORK : Teagasc Research Management, Sandymount Ave., Dublin 4, Ireland Mobile: 353-; [in the Republic: 0] HOME : 1 Esker Lawns, Lucan, Dublin, Ireland Tel : 353-; [in the Republic: 0] WWW : http://homepage.eircom.net/~progers/searchap.htm Chinese Proverb: " Man who says it can't be done, should not interrupt man doing it " Quote Link to comment Share on other sites More sharing options...
Guest guest Posted September 24, 2004 Report Share Posted September 24, 2004 Hi Micheál, > Phil, I read with interest what I think was the tail-end of a > discussion on hiding behind the 'cascade' derogation to prescribe > homeopathic products. You seek opinions on the interpretation, > which I think emanates from a colleague. My opinion is that it has > glaring omissions and is therefore fatally flawed. ... Many thanks, Micheál, for correcting my fatal error in relation to the application of the different applications between food animals and non-food animals. The position of the EU Legislation vis a vis homeopathy, herbal medicine and eclectic prescribing is even worse than I suspected. Your very thorough exposition suggests that we are heading for all- out war between the vested interests of the adherents of mainstream allopathic medicine and those of CAM. That war is not only about vested interests, but also about the issue of freedom of choice in therapy for clients and practitioners The war has begun now in earnest in EU. IMO, it would appear that CAM professionals in EU will face sanctions, right up to prison sentences, as happened with chiropractors in the USA. A colleague on another List wrote yesterday: " During the first 75 years of its existence, chiropractic doctors were jailed >15,000 times due to anti-chiropractic campaigns organized by state medical societies and the AMA. The last chiropractor to be thrown in jail for practicing was in 1974, in Louisiana -- *after* the bill legislating the practice of chiropractic was passed. It wasn't until Federal Judge Susan Getzendammer found the AMA and other medical societies guilty of anti-trust violations that they stopped telling our patients that we are quacks. Then they just went underground, using fronts like NCAHF and other to continue trashing us " . The gloves are off in EU now. It may take an anti-trust case in the EU Courts to resolve the impasse. Many thanks, Phil >>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>> Micheál O Manhony wrote: Phil, I read with interest what I think was the tail-end of a discussion on hiding behind the 'cascade' derogation to prescribe homeopathic products. You seek opinions on the interpretation, which I think emanates from a colleague. My opinion is that it has glaring omissions and is therefore fatally flawed. Omission 1: At the end of this email I have given the link to the cascade system in the Irish Animal Remedies Regulation. Read the first paragraph of this regulation. Two conditions MUST be met in order to invoke the cascade " where there is no authorised animal remedy for the treatment of a condition in a particular species AND where it is necessary in order to avoid causing unacceptable suffering to the animal or animals concerned. " So if a licensed product exists, then we cannot hide behind cascade to prescribe unlicensed drugs Its very simple. Then, and only then, can we invoke the cascade. Is this the case for the bulk of homeopathic products???? I have never prescribed these products, but I'm willing to bet that it is not Omission 2: Please read the full cascade system. It is called the cascade because it involves a progression of the leniency of the derogation. If the above conditions are met the veterinarian may INITIALLy CASCADE to an " animal remedy [authoriseed] in another animal species or for another condition in the same species " If that doesn't exist the veterinarian may THEN CASCADE to " a medical preparation authorised for human use " If neither of these three alternatives are available the veterinarian may THEN CASCADE to " an animal remedy prepared extemporaneously " In short, in order to cascade as far as unlicensed made-up homeopathic products the first three alternatives must not exist. Is this the case for the bulk of homeopathic prescriptions???? While I am at it, the purest notion of homeopathy is the extemporaneous make-up of product for a certain condition in a certain individual The use of pre-prepared product does not sit well with either the 'extemporaeous' rung of the cascade, or the art of homeopathy. Omission 3: In the case of Food animals, even when invoking the cascade, the provisions of that paragraph shall only apply to the administration or prescription of substances which are to be found in animal remedies authorised by the Competent Authority or licensed by the Minister for administration to food producing animals. This again is very clear. Whatever rung of the cascade system we stand on we can only give products to food animals which are licensed in SOME food animal in this country. As there are no homeopathic products licensed in any food animals in this country, the cascade system cannot be used to warrant their use in these species. Homeopathic products are specifically defined as animal remedies by the Irish Medicines Board. See article 6 on page 15 here: http://tinyurl.com/53arv While provision is laid for a 'simplified registration' for homeopathic animal remedies this does not apply to homeopathic products for food animals. Does anyone know of any homeopathic product that is actually licensed by the IMB? The cascade system protects the meagre access which our profession has for 'minor-use' and 'minor-products' (MUPs) Flagrant misuse of the cascade system by suggesting that we can invoke it at will to justify the use of whatever product we like is unlikely to protect our access to MUPs in the long term. Micheál O' Mahony >>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>> The cascade system, copied and pasted from SI179 1996 http://tinyurl.com/5e8uj ADMINISTRATION OF ANIMAL REMEDIES 40. (1) Notwithstanding Regulation 38 and subject to the subsequent provisions of this Regulation, where there is no authorised animal remedy for the treatment of a condition in a particular species and, where it is necessary in order to avoid causing unacceptable suffering to the animal or animals concerned, a registered veterinary surgeon may administer, sell, supply or prescribe the use of— (a) an animal remedy in respect of which there is for the time being in force an animal remedies authorisation authorising the use of such animal remedy in another animal species or for another condition in the same species, or (b) if there is no animal remedy such as referred to in subparagraph (a), a medical preparation authorised for human use in accordance with the provisions of the Medical Preparations (Licensing, Advertisement and Sale) Regulations, 1984 and 1989 and the Medical Preparations (Licensing, Advertisement and Sale) (Amendment) Regulations, 1993 (S.I. No. 70 of 1993), or © if there is no animal remedy or medical preparation as referred to at subparagraphs (a) or (b), an animal remedy prepared extemporaneously by — (i) a pharmacist in accordance with the prescription of a registered veterinary surgeon, or (ii) a registered veterinary surgeon, in respect of animals under his or her care concerning which he or she has been consulted in a professional capacity, or (iii) a person licensed to manufacture such class of animal remedy in accordance with Regulation 21. (2) Where it is necessary to treat a food producing animal in accordance with paragraph (1), the provisions of that paragraph shall only apply to the administration or prescription of substances which are to be found in animal remedies authorised by the Competent Authority or licensed by the Minister for administration to food producing animals. (3) Where a registered veterinary surgeon administers or prescribes an animal remedy in accordance with paragraph (1) for administration to food producing animals such registered veterinary surgeon shall specify an appropriate withdrawal period so as to ensure that food produced from the treated animal does not contain residues which may be harmful for consumers of produce derived from treated animals. (4) Where an animal remedy or medical preparation administered or prescribed in accordance with paragraph (1) does not indicate a withdrawal period for the species to be treated, the following withdrawal periods shall be mandatory unless a longer withdrawal period is specified in accordance with paragraph (3):— - eggs from treated animals - 7 days - milk from treated animals - 7 days - meat, including fat & offal from poultry and mammals - 28 days - meat from fish - 500 degree days. (5) Where a registered veterinary surgeon administers or prescribes an animal remedy in accordance with paragraph (1) a record shall be kept detailing (a) date of examination of animals, (b) identification of animals, © number of animals treated, (d) name and address of owner or person in charge of the animals, (e) diagnosis, (f) details of the animal remedy or medicinal product administered or prescribed and reasons for such choice, (g) the dosage administered or prescribed, (h) the duration of treatment, (i) the withdrawal period, if any, specified. (6) The records specified in paragraph (5) shall be maintained for three years and be furnished on request for examination by an authorised officer. (7) This Regulation applies to the treatment of an individual animal or a small number of animals on a particular holding or premises and shall not be construed so as to provide for the general manufacture, sale, supply or use as an animal remedy of a medical preparation or an animal remedy to which subparagraph (1)(b) or subparagraph (1)© applies. (8) A registered veterinary surgeon who prescribes, sells or supplies an animal remedy under this Regulation (or a pharmacist who sells or supplies an animal remedy in accordance with the prescription of a registered veterinary surgeon) shall label the animal remedy with a notice in the form prescribed and containing the information specified by Regulation 33 (3). (9) This Regulation shall not apply to the administration of an animal remedy to an animal or class of animal where the administration of such animal remedy to such animal or class of animal is specifically prohibited by the animal remedies authorisation or where the animal remedy consists of, or contains, a substance the administration of which to such an animal or class of animal is prohibited by the law of the State or any provision of Community Law. (10) An animal remedy administered in accordance with, and for the purposes provided for by, this Regulation, shall for the purposes of such administration be deemed to be an authorised animal remedy. On 23 Sep 2004, at 08:16, wrote: >>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>> Phil Wrote: Hi Carvel, Jan, Susan, & Vet Ireland Colleagues, Susan asked: So exactly what implications follow from the letter below? If homeopathics are approved for people, then they can still be used under the 'cascade'? I have forwarded the letter to the Vet Ireland List for comment. Gaels, I would value your comments on my interpretation, below. My interpretation is: EU is moving towards total regulation of vet medicines. Registration will specify the species and the indications. EU Legislation will force vets to use only registered medicines as animal remedies; use of unregistered products could leave them liable to litigation if cases do not respond, or adverse outcomes occur. Exceptions will include the cascade system if a registered remedy does not exist for a specific condition. 3. To qualify as a registered medicine, each product must prove safety, efficacy and quality control for indicated species and conditions in an expensive registration process. 4. For many reasons, if current rules of registration apply, it is unlikely that homeopathics will be registered as medicines for humans or animals. 5. Ergo, vets or doctors who use them as remedies will be using " unregistered " (unapproved) products. Best regards, Phil >>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>> Vet Times Volume 34, no. 36, 20th September 2004, page 39: Use of medicines under the cascade Dear Editor, I would like to thank Simon Baker (23rd August issue) for providing a further opportunity for me to comment on the use of veterinary medicines under the cascade. In his letter, he raises the important issue of how veterinarians may try new modes of medical treatment. New medicinal treatments should be thoroughly researched, documented and then assessed and authorised by the regulatory authority before veterinarians are able to use them legally. Selected veterinary practices may play a part in clinical trials of new medicines before they are fully authorised, but such a trial wil be conducted under an Animal Test Certificate (ATC) issued by the regulatory authority. The ATC will restrict the extent of the trials conducted and the data produced will be used in the assessment of the veterinary medicine prior to its authorisation. Veterinary surgeons conducting trials outside these rules are clearly taking considerable risks [as] their actions could be more correctly described as research and, therefore, may require an ASPA licence from the Home 0ffice, even if the animal owners have given their consent to the treatment being used. On an entirely different front, Simon Baker asks for some guidance as to where homoeopathic remedies sit within the cascade. Homoeopathic remedies should be authorised in a similar manner to other forms of veterinary medicine. Thus, assuming a homoeopathic remedy is authorised either as a veterinary or human medicine, it may be used under the cascade using exactly the same rules as any other veterinary medicine. If, however, the homoeopathic remedy is not authorised for use as a human or animal remedy, then it may not be used under the cascade provision. Veterinary surgeons may like to know that there are currently no homoeopathic remedies authorised for use as veterinary medicines in the UK. Yours faithfully, STEVE DEAN, BVetMed, DVR, MRCVS, Chief Executive, Veterinary Medicines Directorate, Woodham Lane, New Haw, Addlestone, Surrey KT15 3LS. >>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>> Best regards, Email: < WORK : Teagasc Research Management, Sandymount Ave., Dublin 4, Ireland Mobile: 353-; [in the Republic: 0] HOME : 1 Esker Lawns, Lucan, Dublin, Ireland Tel : 353-; [in the Republic: 0] WWW : http://homepage.eircom.net/~progers/searchap.htm Chinese Proverb: " Man who says it can't be done, should not interrupt man doing it " Quote Link to comment Share on other sites More sharing options...
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