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The liability of the radiopharmacist and the nuclear physician in the use of radiopharmaceuticals
0883-2897/86 $3.00+0.00 Pergamon Journals Ltd
Nucl. Med. Biol. Vol. 13, No. 2, pp.227-230, 1986 Int. J. Radiat. Appl. Instrum. Part B Printed in Great Britain
THE
LIABILITY PHYSICIAN
OF THE IN
RADIOPHARMACIST
THE
Franck Universite
de
AND
THE
NUCLEAR
USE OF RADIOPHARMACEUTICALS
Bordeaux
COUSTOU II,
Bordeaux,
France
INTRODUCTION Radioactive products used for the physician who applies them or liability is not basically different from tional products. Nevertheless, we will ceuticals can result in aspects that in who handle them. TRADITIONAL
ASPECTS
for therapy or diagnosis entail a professional liability the pharmacist who prepares them. The nature of this the liability assumed by practitioners using convensee that the inherent characteristics of radiopharmathemselves determine the liability assumed by those
OF THE
PHYSICIAN’S
AND
PHARMACIST’S
LIABILITY
Traditionally, jurisprudence assumes that there is a contractual character to the physician’s liability. A verbal contract between the physician and the patient comes into existence the moment the patient asks for the physician’s help and the physician grants it. This contract is based on the overall principle of the patient’s free choice of the physician, and the possibility for the physician, except in an emergency, to refuse to give treatment insofar as he considers that he is not qualified. In reality, it has to be admitted that the principles of free choice are tending to become more and more relative in the hospital system and in certain areas of mutual insurance. The consequence of the contractual nature of medical liability is first of all that it has a 30-year statute of limitations, which means that during this time the patient can always put in a claim against his physician or surgeon for compensation for damages he feels he has sustained. Consequently, it is up to the patient to offer proof of a relationship existing between the treatment received and the damages observed. On the other hand, the doctor is obliged to prove that even if this relationship exists, he fulfilled the terms of the contract under conditions providing all the guarantees that could be expected. For this reason, medical liability is also considered to be a liability of resources. In other words, the physician must apply all the resources of modern science and technology at his disposal, to give relief or try to heal the patient. The physician who does not have these resources at his disposal because of a lack of qualifications or a lack of equipment, must solicit the required help, and either continue his own treatment, or withdraw from the case. For some time now, it has appeared that jurisprudence, in order to obtain compensation for the victim as often as possible, has acknowledged the liability of the physician under very debatable circumstances, and introduced a true presumption of causality (J.C. P, 1973, I, 2541, CHABAS note). Another circumstance that now increases the physician’s liability in a certain number of areas, is that the judge is no longer satisfied by the concept of resources, but in an authoritarian way demands that the result of medical act be that which the patient has a right to expect. This is true, for instance, in the case of medical acts of diagnosis, such where the practitioner’s error is no longer accepted, even if as radiology, biology, etc., all the available resources were used. The liability of the pharmacist, according to a constant jurisprudence, is either criminal or quasi-criminal. In other words, a pharmacist can only be held responsible for until the passage of the law of Decema prejudicial act if the act was erroneous. Moreover, ber 31, 1980, the compensation action against the pharmacist causing the damages had a 3year statute of limitations. Under the new law, there is still a 3-year statute of limitations for the penal action, but the civil action for compensation can be initiated within 30 years, Moreover, in a more than negligible number of cases, as in the case of contractual liability. jurisprudence has tended to contest the criminal nature of pharmaceutical liability and tried to demonstrate the existence of a contract in the relationship between the pharmacist and the patient. However, the distinction has lost much of its interest since the law of Dec. 31,
1980. 227
228
Regardless of the solution adopted, it is nevertheless true that until now it has been the patient’s responsability to prove a causal relationship between the damage observed and the administration of the medicine. A recent directive of the European Community Council (85/374 CEE) will clearly increase the extent of pharmaceutical liability. The manufacturer of a defective product will now be held responsible for the damage caused, whether or not there was an error. This directive is soon to be introduced into the legislations of the member states, and even thought its implications are general, it will directly concern pharmaceutical activities. RADIOPHARMACEUTICALS
-
LIABILITY
OF THE
PHYSICIAN
AND
THE
PHARMACIST
The problems of liability in nuclear medicine occur on two levels. First of all, and distribution of medicines containing radioactive the preparation, packaging, storage, substances are all subject to a set of legislative and statutory texts related either to general legislation concerning industrial establishments in which these products are handled, or to specific provisions directed at the medicines themselves and at artificial radioelements used for analysis and diagnosis. These provisions, which originated in the order of January 6, 1959, have been the subject of several laws and many application texts. They concern classified installations, the protection and inspection of nuthe disposal of waste products, clear materials, etc. . member countries of the European Council, including France, have decided Ten to institute an international system for supervising radiopharmaceuticals, and have defined general principles for coordinating the international legislations and statutes in this domain June 1973, p. 815). In France, the pharmaceutical applications (“Bull. Ordre Pharmaciens”, of artificial radioelements are governed by a set of texts in the legislative portion of the Code of Public Health (art. L 631 to 640) and also in the statutory portion (art. 5230 to 5238). It should be noted that certain of these provisions are applicable even if the products involved are not for use in medicine or biology. With regard to radiopharmaceuticals and radioelements for use in nuclear medicine aror in biology in general, a decree of January 13, 1986, which modifies and complements ticles R 5134 and those following it in the Health Code, provides important details concerning The principles are stated in articles L 631 to L 640. the supervision of these substances. In general, no individual or legal entities other than the Atomic Energy Commission are allowed to prepare, import, or export artificial radioelements without obtaining a permit issued by the President of the Commission, provided for in article L 633 of the Health Code. If these substances are intended for use in medicine and biology, the permit is granted by the Minister of Health, after the opinion of the first section of the abovementioned commission. it is combined with that required by If this concerns a pharmaceutical company, article L 598 in the Health Code. The permit is granted to an individual and specifies the establishment where the radioactive substances are handled. The recipient of the permit must have a level of qualification defined by departmental order. At the moment, there are several different educational programs that lead to a certificate of studies or a certificate of specialized studies complying with the decree of June 17, 1962. The decree to be issued will probably define and coordinate these methods of qualification. The permit application must be accompanied by a file providing all the necessary information about the places of preparation and storage, the nature of the products, the kind of source, and the guarantees for supervision and safety at the establishment’s disposal. The permit is issued for a period of 5 years, and is renewable. the official bulletin of the Ministry of With respect to the products themselves, Social Affairs and National Solidarity (“Sante” no. 8422 of June 21, 1984) has published a relative to the preparation of application notice to manufacturers of radiopharmaceuticals, Radioactive medicines must comply files for the marketing permit related to these products. to which specific requirements are added. The marwith general norms for patent medicines, keting permit is only granted upon presentation of a technical file describing the structure and characteristics of both the raw materials used as a vehicle and the radioactive material and assay of all the components itself. The details of inspection, purity, characterization, of the medicine must be brought to the attention of the competent authorities. Different provisions are applicable depending on whether the product is supplied in a ready-to-use form or in the form of a generator for preparing an extemporaneous solution. It can easily be seen that this set of rules constitutes a source of different kinds of liability for the radiopharmacist who is personally responsible for the application of the rules in his establishment, and who guarantees the quality of the preparations that are evenIn other words, in addition to the liability incumbent upon tually made available to the users. there is also the specific liability resulting the manufacturer of pharmaceutical products, from the competence required for handling radioactive substances. Aside from this guarantee of quality, there is no doubt that the radiopharmacistmanufacturer, considered as a contractor, also assumes responsibility for the safety of the Moreover, the same sources of liability are personnel and the protection of the environment. found on the hospital department level or the laboratory in which the radioactive products are stored before being delivered to the radiophysicians or biologists. Here, there is of
229
course the question of the supervision of extemporaneous preparations, as well as the disposal of waste products, be they unused medicines or reagents discarded after use. The holder of the special permit is clearly responsible for compliance with the existing legislation on the subject. Nevertheless, it is doubtful whether we have become fully aware of the exact quantities of radioactive substances discarded in effluents as a result of the developeven though the quantities used in each operament of techniques using labeled products, tion are often very small. Mr. Gerard Renon, the Director General of C.E.A., was right that these scattered sources perhaps repreto emphasize at a news conference last year, In this area, the “Agence Nationale pour la gestion sent the greatest risk of an accident. des dechets radio-actifs” (ANDRA, the National Agency for the Handling of Radioactive Wastes) has a very important role to play. All of this amply justifies the existence of a well-defined statute for the radiopharmacist and a detailed description of his duties and liability. THE
NUCLEAR
PHYSICIAN
As mentioned above, the nuclear physician assumes a contractual liability with respect to his patients, which coincides exactly with his liability as a physician in general. However, it is unquestionable that the medical act of applying a radiopharmaceutical treatment has a highly specific aspect. The decision to use these products constitutes an act that is almost as serious as that of the surgeon deciding to operate. It is not an ordinary therapy, but rather a treatment requiring special competence that is officially recognized. Whoever takes this responsibility must guarantee the safety of the patient, insofar as this is possible, both with respect to the choice of the methods and to the immediate and future supervision of the patient’s development. The need to obtain the patient’s consent, while informing him of the risks involved and giving him as much information as possible about the different aspects of the treatment, is here even more of a basic obligation than in general practice. Similarly, the personal physician who may subsequently be in charge of the patient, should also be very carefully informed. The responsibility of the nuclear physician also extends to the assistants he involves in the treatment. He is accountable for their qualifications and he must be careful that they only act within the limits of their competence. There is another question related to the medicine itself : should responsibility and liability be shared between the nuclear physician and radiopharmacist ? Certain treatments require the extemporaneous preparation of a medicine practically at the patient’s bedside, and in this case the physician and his assistants carry out the operation with components supplied by the radiopharmacist. In the absence of the radiopharmacist, there is no doubt that the physician is reponsible for the conformity of the medicine prepared, and even though this is often a very easy task, it is still worth asking whether it would be preferable to have the radiopharmacist participate in person. It can also be asked whether the physician who uses radioactive products for diagnosis, rather than treatment, should be considered separately. The obligations of this practitioner are strictly the same with respect to the patient, the personnel, and the envi ronment. But is the liability the same as in the preceding case ? As seen above, jurisprudence tends to consider that medical liability in the case of diagnosis is no longer contractual, but has the character of a liability of the result. In other words, if the diagnosis is erroneous, in spite of the methods applied, there is still some question as to whether the doctor’s error can be invoked. In our opinion, the methods of diagnosis using radioactive substances are not comparable to a simple radiographic technique. Considering the difficulties involved (and excluding the hypothetical case of a serious mistake), error or absence of diagnosis in such cases does not appear to have been invoked until now in terms of the practitioner’s error. THE
NUCLEAR
BIOLOGIST
As we come to the end of this survey of nuclear practices, we should not forget The responsibility of this practitioner the biologist who uses radioactive products in vitro. is basically similar to that of the biologist in general. Nevertheless, there should be some reminder in his locality of the special care that has to taken in handling and disposing of the substances used, to protect his coworkers and his environment. CONCLUSION The result of the above considerations is that the use of radioactive substances in general, and radiopharmaceuticals in particular, poses serious problems, and that the liabilities involved go well beyond the scope of traditional medicine and pharmacy. Moreover, physicians, pharmacists, and their collaborators are not the only ones concerned. The directors of the establishments themselves cannot ignore the risks involved in handling radioactive substances in the different departments they administer. They must listen attentively to the observations expressed by the practitioners and take a personal interest in compliance with safety rules and equipment conformity. I should perhaps end by referring to the use of labeled products in pharmaco-
230
kinetic studies, specifically in metabolite research. Although this technique is common in France for studies involving animals, its use is forbidden in humans, which is, incidentally, not the case in other countries, specifically the United States. This is both an ethical and a judicial problem, but it is perhaps too soon to go into the problem in detail. In any case, it will probably be discussed in the near future in the National Committee on Ethics and the Regional Hospital Committees which were created in the context of pharmaceutical supervision.
Nucl. Med. Biol. Vol. 13, No. 2, pp.227-230, 1986 Int. J. Radiat. Appl. Instrum. Part B Printed in Great Britain
THE
LIABILITY PHYSICIAN
OF THE IN
RADIOPHARMACIST
THE
Franck Universite
de
AND
THE
NUCLEAR
USE OF RADIOPHARMACEUTICALS
Bordeaux
COUSTOU II,
Bordeaux,
France
INTRODUCTION Radioactive products used for the physician who applies them or liability is not basically different from tional products. Nevertheless, we will ceuticals can result in aspects that in who handle them. TRADITIONAL
ASPECTS
for therapy or diagnosis entail a professional liability the pharmacist who prepares them. The nature of this the liability assumed by practitioners using convensee that the inherent characteristics of radiopharmathemselves determine the liability assumed by those
OF THE
PHYSICIAN’S
AND
PHARMACIST’S
LIABILITY
Traditionally, jurisprudence assumes that there is a contractual character to the physician’s liability. A verbal contract between the physician and the patient comes into existence the moment the patient asks for the physician’s help and the physician grants it. This contract is based on the overall principle of the patient’s free choice of the physician, and the possibility for the physician, except in an emergency, to refuse to give treatment insofar as he considers that he is not qualified. In reality, it has to be admitted that the principles of free choice are tending to become more and more relative in the hospital system and in certain areas of mutual insurance. The consequence of the contractual nature of medical liability is first of all that it has a 30-year statute of limitations, which means that during this time the patient can always put in a claim against his physician or surgeon for compensation for damages he feels he has sustained. Consequently, it is up to the patient to offer proof of a relationship existing between the treatment received and the damages observed. On the other hand, the doctor is obliged to prove that even if this relationship exists, he fulfilled the terms of the contract under conditions providing all the guarantees that could be expected. For this reason, medical liability is also considered to be a liability of resources. In other words, the physician must apply all the resources of modern science and technology at his disposal, to give relief or try to heal the patient. The physician who does not have these resources at his disposal because of a lack of qualifications or a lack of equipment, must solicit the required help, and either continue his own treatment, or withdraw from the case. For some time now, it has appeared that jurisprudence, in order to obtain compensation for the victim as often as possible, has acknowledged the liability of the physician under very debatable circumstances, and introduced a true presumption of causality (J.C. P, 1973, I, 2541, CHABAS note). Another circumstance that now increases the physician’s liability in a certain number of areas, is that the judge is no longer satisfied by the concept of resources, but in an authoritarian way demands that the result of medical act be that which the patient has a right to expect. This is true, for instance, in the case of medical acts of diagnosis, such where the practitioner’s error is no longer accepted, even if as radiology, biology, etc., all the available resources were used. The liability of the pharmacist, according to a constant jurisprudence, is either criminal or quasi-criminal. In other words, a pharmacist can only be held responsible for until the passage of the law of Decema prejudicial act if the act was erroneous. Moreover, ber 31, 1980, the compensation action against the pharmacist causing the damages had a 3year statute of limitations. Under the new law, there is still a 3-year statute of limitations for the penal action, but the civil action for compensation can be initiated within 30 years, Moreover, in a more than negligible number of cases, as in the case of contractual liability. jurisprudence has tended to contest the criminal nature of pharmaceutical liability and tried to demonstrate the existence of a contract in the relationship between the pharmacist and the patient. However, the distinction has lost much of its interest since the law of Dec. 31,
1980. 227
228
Regardless of the solution adopted, it is nevertheless true that until now it has been the patient’s responsability to prove a causal relationship between the damage observed and the administration of the medicine. A recent directive of the European Community Council (85/374 CEE) will clearly increase the extent of pharmaceutical liability. The manufacturer of a defective product will now be held responsible for the damage caused, whether or not there was an error. This directive is soon to be introduced into the legislations of the member states, and even thought its implications are general, it will directly concern pharmaceutical activities. RADIOPHARMACEUTICALS
-
LIABILITY
OF THE
PHYSICIAN
AND
THE
PHARMACIST
The problems of liability in nuclear medicine occur on two levels. First of all, and distribution of medicines containing radioactive the preparation, packaging, storage, substances are all subject to a set of legislative and statutory texts related either to general legislation concerning industrial establishments in which these products are handled, or to specific provisions directed at the medicines themselves and at artificial radioelements used for analysis and diagnosis. These provisions, which originated in the order of January 6, 1959, have been the subject of several laws and many application texts. They concern classified installations, the protection and inspection of nuthe disposal of waste products, clear materials, etc. . member countries of the European Council, including France, have decided Ten to institute an international system for supervising radiopharmaceuticals, and have defined general principles for coordinating the international legislations and statutes in this domain June 1973, p. 815). In France, the pharmaceutical applications (“Bull. Ordre Pharmaciens”, of artificial radioelements are governed by a set of texts in the legislative portion of the Code of Public Health (art. L 631 to 640) and also in the statutory portion (art. 5230 to 5238). It should be noted that certain of these provisions are applicable even if the products involved are not for use in medicine or biology. With regard to radiopharmaceuticals and radioelements for use in nuclear medicine aror in biology in general, a decree of January 13, 1986, which modifies and complements ticles R 5134 and those following it in the Health Code, provides important details concerning The principles are stated in articles L 631 to L 640. the supervision of these substances. In general, no individual or legal entities other than the Atomic Energy Commission are allowed to prepare, import, or export artificial radioelements without obtaining a permit issued by the President of the Commission, provided for in article L 633 of the Health Code. If these substances are intended for use in medicine and biology, the permit is granted by the Minister of Health, after the opinion of the first section of the abovementioned commission. it is combined with that required by If this concerns a pharmaceutical company, article L 598 in the Health Code. The permit is granted to an individual and specifies the establishment where the radioactive substances are handled. The recipient of the permit must have a level of qualification defined by departmental order. At the moment, there are several different educational programs that lead to a certificate of studies or a certificate of specialized studies complying with the decree of June 17, 1962. The decree to be issued will probably define and coordinate these methods of qualification. The permit application must be accompanied by a file providing all the necessary information about the places of preparation and storage, the nature of the products, the kind of source, and the guarantees for supervision and safety at the establishment’s disposal. The permit is issued for a period of 5 years, and is renewable. the official bulletin of the Ministry of With respect to the products themselves, Social Affairs and National Solidarity (“Sante” no. 8422 of June 21, 1984) has published a relative to the preparation of application notice to manufacturers of radiopharmaceuticals, Radioactive medicines must comply files for the marketing permit related to these products. to which specific requirements are added. The marwith general norms for patent medicines, keting permit is only granted upon presentation of a technical file describing the structure and characteristics of both the raw materials used as a vehicle and the radioactive material and assay of all the components itself. The details of inspection, purity, characterization, of the medicine must be brought to the attention of the competent authorities. Different provisions are applicable depending on whether the product is supplied in a ready-to-use form or in the form of a generator for preparing an extemporaneous solution. It can easily be seen that this set of rules constitutes a source of different kinds of liability for the radiopharmacist who is personally responsible for the application of the rules in his establishment, and who guarantees the quality of the preparations that are evenIn other words, in addition to the liability incumbent upon tually made available to the users. there is also the specific liability resulting the manufacturer of pharmaceutical products, from the competence required for handling radioactive substances. Aside from this guarantee of quality, there is no doubt that the radiopharmacistmanufacturer, considered as a contractor, also assumes responsibility for the safety of the Moreover, the same sources of liability are personnel and the protection of the environment. found on the hospital department level or the laboratory in which the radioactive products are stored before being delivered to the radiophysicians or biologists. Here, there is of
229
course the question of the supervision of extemporaneous preparations, as well as the disposal of waste products, be they unused medicines or reagents discarded after use. The holder of the special permit is clearly responsible for compliance with the existing legislation on the subject. Nevertheless, it is doubtful whether we have become fully aware of the exact quantities of radioactive substances discarded in effluents as a result of the developeven though the quantities used in each operament of techniques using labeled products, tion are often very small. Mr. Gerard Renon, the Director General of C.E.A., was right that these scattered sources perhaps repreto emphasize at a news conference last year, In this area, the “Agence Nationale pour la gestion sent the greatest risk of an accident. des dechets radio-actifs” (ANDRA, the National Agency for the Handling of Radioactive Wastes) has a very important role to play. All of this amply justifies the existence of a well-defined statute for the radiopharmacist and a detailed description of his duties and liability. THE
NUCLEAR
PHYSICIAN
As mentioned above, the nuclear physician assumes a contractual liability with respect to his patients, which coincides exactly with his liability as a physician in general. However, it is unquestionable that the medical act of applying a radiopharmaceutical treatment has a highly specific aspect. The decision to use these products constitutes an act that is almost as serious as that of the surgeon deciding to operate. It is not an ordinary therapy, but rather a treatment requiring special competence that is officially recognized. Whoever takes this responsibility must guarantee the safety of the patient, insofar as this is possible, both with respect to the choice of the methods and to the immediate and future supervision of the patient’s development. The need to obtain the patient’s consent, while informing him of the risks involved and giving him as much information as possible about the different aspects of the treatment, is here even more of a basic obligation than in general practice. Similarly, the personal physician who may subsequently be in charge of the patient, should also be very carefully informed. The responsibility of the nuclear physician also extends to the assistants he involves in the treatment. He is accountable for their qualifications and he must be careful that they only act within the limits of their competence. There is another question related to the medicine itself : should responsibility and liability be shared between the nuclear physician and radiopharmacist ? Certain treatments require the extemporaneous preparation of a medicine practically at the patient’s bedside, and in this case the physician and his assistants carry out the operation with components supplied by the radiopharmacist. In the absence of the radiopharmacist, there is no doubt that the physician is reponsible for the conformity of the medicine prepared, and even though this is often a very easy task, it is still worth asking whether it would be preferable to have the radiopharmacist participate in person. It can also be asked whether the physician who uses radioactive products for diagnosis, rather than treatment, should be considered separately. The obligations of this practitioner are strictly the same with respect to the patient, the personnel, and the envi ronment. But is the liability the same as in the preceding case ? As seen above, jurisprudence tends to consider that medical liability in the case of diagnosis is no longer contractual, but has the character of a liability of the result. In other words, if the diagnosis is erroneous, in spite of the methods applied, there is still some question as to whether the doctor’s error can be invoked. In our opinion, the methods of diagnosis using radioactive substances are not comparable to a simple radiographic technique. Considering the difficulties involved (and excluding the hypothetical case of a serious mistake), error or absence of diagnosis in such cases does not appear to have been invoked until now in terms of the practitioner’s error. THE
NUCLEAR
BIOLOGIST
As we come to the end of this survey of nuclear practices, we should not forget The responsibility of this practitioner the biologist who uses radioactive products in vitro. is basically similar to that of the biologist in general. Nevertheless, there should be some reminder in his locality of the special care that has to taken in handling and disposing of the substances used, to protect his coworkers and his environment. CONCLUSION The result of the above considerations is that the use of radioactive substances in general, and radiopharmaceuticals in particular, poses serious problems, and that the liabilities involved go well beyond the scope of traditional medicine and pharmacy. Moreover, physicians, pharmacists, and their collaborators are not the only ones concerned. The directors of the establishments themselves cannot ignore the risks involved in handling radioactive substances in the different departments they administer. They must listen attentively to the observations expressed by the practitioners and take a personal interest in compliance with safety rules and equipment conformity. I should perhaps end by referring to the use of labeled products in pharmaco-
230
kinetic studies, specifically in metabolite research. Although this technique is common in France for studies involving animals, its use is forbidden in humans, which is, incidentally, not the case in other countries, specifically the United States. This is both an ethical and a judicial problem, but it is perhaps too soon to go into the problem in detail. In any case, it will probably be discussed in the near future in the National Committee on Ethics and the Regional Hospital Committees which were created in the context of pharmaceutical supervision.