2 Case Number 001: Petition of Complaint Research Research Report

2 Case Number 001: Petition of Complaint Research Research Report Contents 1 Petition of complaint research 2 Process and content of research 3 Judgment on the complaint 4 Recommendation to the other party of hospital 1 Petition of complaint research On April 20, 2000, a petitioner (male, born on February 19, 1937) presented his petition for research to NPO Patients Rights Ombudsman and Ombudsman meeting on the following complaint to the other party hospital (located in Fukuoka city): The petitioner had continued to visit the other party hospital for taking medical care for his cerebral infarction. In the middle of April 1999, he caught a cold so he was prescribed a medicine for cold from the other party hospital on April 17. After taking the medicine, his hair suddenly began to fall out from his head and alopecia symptom spread to his whole body. At that time, <1> A doctor in charge of the other party of hospital (Doctor A) did not admit that the cause of such alopecia was the medicine prescribed to the petitioner for cold by the other party of hospital. <2> The other party of hospital did not provide any medical treatment for alopecia. <3> Doctor A introduced the petitioner to University hospital B (dermatology) for medical treatment of the alopecia. However, Doctor A gave no explanation about a content of a letter of introduction issued at that time to the petitioner. After that, Doctor A also gave no explanation about a content of an answer from University hospital B when Doctor A changed a content of prescription for medical treatment of the petitioner s cerebral infarction after being suggested by University hospital B. The above three points were presented by the petitioner as complaints. He required Patients Rights Ombudsman to judge if these three points of complaint were reasonable or not. In addition, the petitioner and his wife requested NPO Patients Rights Ombudsman to 1

consult his complaints prior to their petition of this complaint research. They got consultation support (including research of medicine damage) by consultants. According to the consultation, the petitioner discussed with the other party of hospital, but his complaints were not solved. As the result the petitioner presented the petition of this complaint research to NPO Patients Rights Ombudsman for requiring a judgment on this complaint from the point of view of third party. 2 Process and content of research <1> Process of the research *On May 7, 2000, the regular management committee of Ombudsman meeting decided to commence the research for this petition. A research subcommittee consists of four members including a pharmacist and a lawyer specially committed to this case. *On June 4, 2000, the research subcommittee reported its research process in Ombudsman meeting. A doctor out of Ombudsman meeting members was decided to be additionally committed as a member of the research subcommittee. *On May 22, June 9, 20 and 28 and July 25 of 2000, the research subcommittee meetings were held five times. In these periods, two hearing sessions from the petitioner himself and the other persons involved in the case and one hearing session from the other party of hospital were held. At the same time, the research subcommittee reviewed materials that were provided from the petitioner and referred at the stage of consultation support research. Finally, the research subcommittee made a research report. *On August 6, 2000, Ombudsman meeting basically approved the research report of the research subcommittee. Regular management committee was assigned to make a final document after discussing about the subcommittee s research report in Ombudsman meeting. On the same day, regular management committee discussed and decided how to organize a final document. Finally this research report was made. <2> Process of medical practice that is indisputable (including the result of hearing from the petitioner and materials provided by the other party hospital) *On June 1994, the petitioner fell resulted from cerebral infarction. *On January 1995, the petitioner started visiting to the other party of hospital (in order 2

to take medical treatment and rehabilitation of his cerebral infarction). *On March 18, 1998, Doctor A, against whom the petitioner presented his complaint, succeeded as a doctor in charge of the petitioner. The petitioner visited the hospital every four weeks. The prescription given to the petitioner was as follows: 1) Nivadil (2) 1T 1 14T 2) Sermion 3T 3 14T Dantrium 3T 3 14T 3) MS warm pack 4) Mevalotin 2T 2 14T 5) Bisolvon 2T 2 14T Mucotron 2T 2 14T *On April 7, 1999, Saturday, the petitioner took diagnosis because of fever and upper respiratory tract infections. Doctor A prescribed the medicines for cold as follows. The petitioner asked the doctor if he could take these medicines together with the medicines he had been taking till then. Doctor A answered that it was no problem. 1) PL granule 3.0 3 5T 2) Loxonin 3T 3 5T 3) Mucosta 3T 3 5T *On the same day, he took the medicines for cold twice, in the afternoon and evening. In the evening, alopecia symptom of the petitioner s head has emerged, so he stopped taking medicines after that. *On April 19, Monday, he claimed his alopecia symptom to take diagnosis. He asked Doctor A if the alopecia occurred because of the prescribed medicine but Doctor A said that it might not be the cause. *On April 23, Wednesday, the petitioner took diagnosis since his alopecia symptom spread to his whole body. Doctor A issued a letter of introduction to University hospital B (dermatology) for the petitioner. However, no explanation about the content of the letter of introduction was given to the petitioner. *On April 26, the petitioner took diagnosis at University hospital B. The petitioner was diagnosed as diffuse alopecia and orally explained that it was not caused by the medicines prescribed by Doctor A. After that, the petitioner started taking medical 3

treatment in University hospital B for his alopecia symptom (the medical treatment had continued when this complaint petition was presented by the petitioner). *A doctor of University hospital B issued an answer sheet to Doctor A dated the same day (April 26), which described that an examination would be performed whether any other disease except for the medicine could cause the patient s alopecia. *A doctor of University hospital B issued a letter of introduction dated July 29 (diagnosis information sheet) to Doctor A, the title of which was Request for stopping or changing of the internal medicine of the petitioner. The description of the letter was as follows: The name of the disease of the petitioner is to be generalized alopecia. (The examination for the cause of disease resulted in that the first diagnosis for the petitioner had no problem) but there is a probability that the cause of disease might be somewhat related with the internal medicine the petitioner is taking at present. As the patient is quite anxious about the medicine he is taking, so we suggest you to stop or change the medicine prescribed to the patient at present if you can. *According to the above document from University hospital B, Doctor A of the other party of hospital changed the prescription of the medicine of the petitioner, who continued to take medical treatment for his cerebral infarction at the other party of hospital after his alopecia symptom occurred, that is, Doctor A changed the prescription to stop prescribing Mevalotin and also to decrease other medicines for the petitioner. However, Doctor A explained to the petitioner nothing about the content of the answer sheet etc. provided from University hospital B. *Around December of 1999, the alopecia symptom of the petitioner started recovering and his hair grew again gradually but not completely yet at the time of this petition of complaint research. <3> Results of hearings from the other party of hospital # Summary of an explanation by a doctor in charge (Doctor A) when this complaint was presented *On April 19, the patient claimed that his alopecia symptom was resulted from the medicine prescribed. But I did not think that the medicine prescribed must be the cause of the symptom since the patient took only twice the medicine for cold before his alopecia symptom appeared and there was no description on a statement of virtues that the medicines might induce alopecia symptom. However, I told the patient to stop 4

taking the medicine for cold tentatively. *At the time of medical examination on April 23, the alopecia symptom proceeded and the patient strongly claimed that, so I thought it was better to let him consult a special doctor immediately. I wrote a letter of introduction addressed to dermatology department of University hospital B and handed it to the patient. As referring to Drugs in Japan which describes the effects of medicine, I thought that the possibility of the harmful after-effects was low. However, considering the strong claim of the patient, I wrote that the alopecia symptom might be induced by the medicine prescribed on a letter of introduction and asked for technical examination and also I put the content of the medicine prescribed to the patient till then just in case. To prevent the patient from feeling anxiety, I did not explain to the patient about the content of the letter of introduction. *As for alopecia symptom, I left all of medical treatments to a special medical institute, because I introduced the patient to it. So I neither used any steroid for medical treatment of the patient nor I gave any explanation about the content of diagnosis and medical treatment for alopecia symptom. After that, University hospital B suggested the change of the patient s prescription, so I changed the prescription as University hospital B had suggested. *However, as for the content of medical treatment, and the answer etc. from University hospital B, I did not explain it. The patient must be confused if I explain about it to him when the medical treatment for his alopecia symptom is remitted to University hospital B. Once I introduce the patient to a special medical provider, it is hard for me to have a doubt about the result of diagnosis by the special medical provider. # Summary of an explanation by the director of the other party of hospital *The doctor of university hospital B thinks that the alopecia symptom of the patient must be caused by infectious disease. The reason is that CRP of the patient does not rise when he has a slight fever. There are many examples of infectious diseases to induce alopecia symptom and medicine might be a load for alopecia. The medicine itself is not the cause of alopecia. But the medicine might be a trigger of inducing alopecia since the patient might have any virus infectious disease, that is, the load of medicine might be a problem. The purpose for that University hospital B gave a suggestion of decreasing medicine etc. to Doctor A would probably be to reduce the 5

load of medicine. Under present conditions it is impossible that the load of medicine might result in the same alopecia symptom if Doctor A prescribes the same amount of medicine to the patient. *It may be sure for us to give the patient much trouble by insufficient exchanging of information of the patient condition between University hospital B and our hospital. We should have discussed with University hospital B how to give explanation to the patient in detail and deal with him properly and faithfully. We should have reflect the point that we had left everything about the patient to University hospital B too much, which caused the patient being much confused and in trouble. We have not explained to the patient about the view of University hospital B that the patient s alopecia was basically due to virus infectious disease. After discussing with University hospital B to get consensus we are going to inform him as it is about possibility that his alopecia was caused by virus infectious disease or gave induced by medicine. *These processes gave the patient stress to result in gastrointestinal bleeding. After that, I received his previous doctor in charge and continued to examine the petitioner and continue to have an interview in the presence of his wife. At present, the petitioner becomes quite calm mentally so I am going to tell him the cause of his alopecia symptom and medical process so far when it is most convenient. <4> Results of research for side effect of drugs performed during consultation support stage # According to the result of medicine damage research performed by medicine damage Ombudsperson Tie-up meeting Fukuoka, Mevalotin that the petitioner has been taking hitherto is described to have side-effect of alopecia with the probability of more than 5 percent. As for Nivadil and Loxonin, antiphlogistics and analgesics, prescribed for cold this time, they are also reported to have side effect of alopecia. For these reasons, the possibility that duplicated administration of these medicines might cause the patient s alopecia symptom cannot be denied. <5> Materials collected to be used as evidence of judgment *Memo of hearing from the petitioner and his wife done by research subcommittee <2 pieces>. *Recording report of hearing from the petitioner and his wife <2 pieces>. 6

*Recording report of hearing from the other party of hospital <1 piece>. *A letter of introduction addressed to University hospital B from the other party of hospital (copy) <1 piece> *An answer sheet addressed to the other party of hospital from University hospital B (copy) <2 pieces> *Materials provided by the petitioner at the stage of consultation support <1 set> (A medical certificate of the other party of hospital to the patient in which the content of the prescription was described, a research report from medicine damage Ombudsperson tie-up meeting Fukuoka attached by the statement of effect of medicines, copy of memo of side effect report, etc.) <1 piece for each material> 3 Judgment on the complaint <1> The first complaint of the petitioner is about the fact that the doctor in charge (Doctor A) of the other party of hospital did not admit that his alopecia symptom was ascribed to the medicine that the doctor had prescribed. (1) The petitioner suffered from sudden loss of hair from every part of body that he had never experienced before. (2) In the face of such abnormal condition that the petitioner doubted strongly that it must be caused by side effect of the medicines that were newly prescribed and he took just before this symptom emerged. It is quite natural action as a patient that he required Doctor A to confirm the side effect of the medicine. It is also understandable that the petitioner was disappointed and doubtful because Doctor A did not accept the petitioner s request and did not deal faithfully with his complaint. Furthermore, according to the review of each material collected for research of this case by Ombudsman meeting, the possibility that sudden general alopecia was caused by side effect of the medicine prescribed to the petitioner does not seem to be small. Although University hospital B tried to clarify the cause of this alopecia symptom on the basis of its technical point of view immediate after this alopecia symptom emerged, it could not be asserted that the alopecia is due to damage from medicine. At present, It is methodologically difficult to review if the point of view is right or wrong, and to have enough evidence which makes it possible to present a judgment regardless of the point of view, and to keep on researching further in order to define the cause of the alopecia. 7

Therefore, as a conclusion, we can only say that we cannot approve the petitioner s first complaint that was presented on the assumption that the cause of his alopecia symptom lies in the side effect of the medicine prescribed. <2> We cannot support the petitioner s complaint that the other party hospital provided no medical treatment for his alopecia symptom. Indeed, the other party hospital did not provide medical treatment for his alopecia symptom directly as the petitioner said. Generally in medical institute, it is necessary to recommend or introduce a patient to transfer to other medical institute where an appropriate medical treatment and necessary examination are expected to be available if the symptom of a patient s disease seems to be emerged by disease other than disease that the doctor professed to examine and treat or if a doctor judges that more technical examination, etc. should be necessary for a patient s disease, except for taking emergency measures. And if such substitutive measure is taken, an original medical institute is considered to accomplish its obligation of muster specified in Medical Practitioners Law. As for this case, several days after the petitioner claimed his alopecia symptom, Doctor A of the other party of hospital introduced the petitioner to University hospital B to promote his taking medical treatment where an appropriate technical examination and medical treatment for the petitioner s symptom are expected to be available. Doctor A remitted wholly the patient s medical treatment to Universal hospital B since then. As explained below, no proper explanation about the process of introduction, etc. was given to the petitioner. However, except for the complaint from the petitioner that he felt as if he was thought troublesome and the other party of hospital gave up taking care of him, objectively speaking, the other party of hospital is considered to have taken substitutive measure for the patient s medical treatment by introducing him to other technical medical institute, and such action of the other party of hospital is appreciated. So far as this point is concerned, the complaint of the petitioner that the other party of hospital did nothing for his alopecia symptom is not relevant. <3> As for the facts constituting the third complaint of the petitioner, the other party of hospital did not present any objection to what the petitioner claimed as follows: Doctor A introduced me University hospital B (dermatology) for the treatment of my alopecia 8

symptom. However, Doctor A did not give me any explanation about the content of a letter of introduction issued at that time and also about the content of the answer from University hospital B when Doctor A changed the content of prescription for my cerebral infarction treatment according to the suggestion from University hospital B. Besides, Doctor A of the other party of hospital shows the recognition that as far as introducing a patient to a technical medical institute, it is a proper measure that any explanation about the content of diagnosis for a patient s disease and so on covered by medical treatment of a introduced technical medical institute should not be given to a patient at all in order not to let a patient be confused by such explanation. However, when a medical institute suggests a patient to take other new medical practice (examination intervention), the information about the reason and necessity for it should be essentially provided to a patient in advance. The content of a letter of introduction addressed to other technical medical institute for recommending a patient to take examination there should be included in said information. (The patient had suspected that the cause of his alopecia symptom might be damage by medicines. No matter how the letter of introduction was actually described from patient s point of view, no explanation was given to the patient and adversely led the patient to distrust strongly Doctor A of the other party of hospital. The same thing can be said for the explanation about the answer from a medical institute to be introduced. The case is exceptional one if in which a patient is completely transferred to such introduced medical institute and is continuously taken entire medical treatment there, there is no opportunity and necessity to explain about the answer from such technical medical institute to the patient individually. However, not only if the relationship between a patient and a hospital by medical treatment for other chronic disease is maintained just as this case, but also if the content of the answer from introduced medical institute may influence to the medical treatment of the patient, it is necessary to explain about the content to the patient and also the consent to changing the policy of the patient s own medical treatment should be obtained from the patient. It essentially should be done from the viewpoint of patients rights to informed consent. Therefore, such attitude of Doctor A of the other party of hospital violated rights to informed consent of the petitioner. The complaint of the petitioner at this point has entirely relevant reason so we can support the third complaint of the petitioner. 9

4 Recommendation to the other party hospital In medical institutes in Japan, usually a letter of introduction and an answer sheet which a patient brings to and from other medical institute are sealed so that a patient cannot check the content of the information although the information is regarding a patient him or herself. Many medical institutes exchange their information in such a curious manner. As for this case, University hospital B did not explain the content of answer sheet addressed to the other party hospital to the petitioner in detail. Therefore, only the patient was not informed anything about the content of his medical treatment and was neglected. Such exchange of information only between medical institutes and neglecting patients are evil customs from the period of paternalism. Such custom should be removed immediately today when establishing medical practice based on informed consent from patients is strongly required. This case reflected such bad effect of today s medical practice with reality. We strongly recommend to the other party of hospital that from now on, it should establish the system where patient s information should be basically provided to the patients themselves through discussing with medical institute to which the patient is introduced, when it will require to introduce its patients to a technical medical institute in the cause of clinical symptoms. In addition, as a result of giving no proper explanation about the information to the patient, that is the reason of this complaint, patient s confidence to Doctor A has been ruined. Moreover, University hospital B which the petitioner was introduced to and which provided technical medical treatment to the petitioner neither disclosed the content of answer sheet addressed to the other party of hospital to the petitioner, nor gave direct and accurate explanation about the result of examination, etc. was given to the petitioner in order to convince the petitioner. The petitioner was broken in health by uneasiness and stress in these circumstances. However, the director of the other party of hospital exactly comprehended the fact ex post facto and has been making every effort in order to maintain the sound relationship on medical treatments as a medical institute and to recover the patient s trust. As for this complaint research, the other party of hospital got agreement of University hospital B to disclose two pieces of answer sheet from University hospital B to the patient and is making efforts to share 10

information with the patient. Therefore, NPO Patients Rights Ombudsman expects the other party of hospital as a medical institute to take appropriate measures immediately in order to realize the following purposes from now on: to recover from violating the patient s right by such as giving sufficient explanation to the petitioner even though it is on ex post facto basis and to prevent the recurrence of similar complaints at the same time. (That s all for above) <Answer from the other party of hospital> After that, a polite letter of thanks was sent from the director of the other party hospital to Patients Rights Ombudsman office as follows (the content is summarized): We are really grateful to you for sending us a detailed report of complaint research. Through reading this report, we could comprehend feeling and condition of the patient more objectively and at the same time, we strongly recognize the importance of informed consent in medical practice from now on. We are going to communicate well and share information of medical practice with the patient and to cooperate with University hospital B to provide appropriate medical practice to the patient. Moreover, we are going to make every effort in order to prevent recurrence of such complaint petition with keeping the results of hearings and instructions in the report of complaint research in mind. (That s all for above) 11