Thursday, June 23, 2016

Home> …> Breast Cancer – patient choice of alternative treatment … – Board of Health

Exempt from public disclosure pursuant to offline a. § 13 cf. PAA. § 13 first paragraph. 1

Norwegian Board determines each year a significant number of supervisory issues facing healthcare professionals and businesses in the health service based on information on individual events. Some of these will be published on this website anonymously. The cases are intended as such matters for enterprises and personnel to benefit from them and to inform them about our business, and not as an aid to identification of individual cases and individual personnel.

The public demands for transparency in individual cases are handled through that anyone can request access to individual documents, based on publicly available mailing lists.

Procedural process

The subject matter

Legal basis for the assessment

Norwegian Board of Health review

Conclusion

Norwegian Board of Health has completed supervision case against you without administrative sanction. We have determined that you have violated acceptability requirements of the Health § 4, but you should not be given a warning.

Procedural process

Norwegian Board of Health received the letter XXXXXX from County of XXXXXX sent a supervision about your business as a doctor. Audit case concerns your monitoring of a patient in XXXXXX XXXXXX was diagnosed breast cancer.

We oriented you by letter XXXXXX that we would consider giving you a warning. You said you this by letter XXXXXX.



The subject matter

You are a graduate of the University of Oslo and became certified physician on XXXXXX, HPR no. XXXXXX. You are a specialist in family medicine and works as a general practitioner at Løkketangen GP centers. You have been the specific patient’s general practitioner since XXXXXX.

Norwegian Board has considered the matter on the basis of the documents you’ve got submitted earlier in the proceedings. Below is a discussion of the factors that has been important for our assessment.

XXXXXX HF (hereinafter XXXXXX) sent the XXXXXX a concern to the County of XXXXXX, which in turn forwarded it to the County of XXXXXX as the appropriate authority the XXXXXX. This report was your monitoring XXXXXX f XXXXXX ( “patient”) after she XXXXXX was diagnosed with breast cancer.

It appears the collated record documents that you referred the patient to a specialist in XXXXXX, after she had discovered a cool left breast. Finnålsbiopsi showed when no malignancy.

The patient wanted in XXXXXX consideration of a new bump on the lateral side of the right breast. The patient had had the ball for several months without that she had sought you as her GP. You referred the patient to the surgical department XXXXXX same day. From there she was referred to the XXXXXX XXXXXX HF, where it was performed mammography. Mammography showed a large masses laterally in the right breast and a pathological lymph node in the right axilla. The patient did not want to take a biopsy of the ball and was referred to a surgeon for evaluation and further processing. By surgical outpatient clinic at XXXXXX XXXXXX it gave ultrasound bullet suspect a huge malignant tumor. Because of bad experience previously wished basically patient not to take the biopsy. This was nevertheless conducted two days later. In journal note, it appears that you encouraged the patient to take the test and stressed that it was important to get examined the bullet properly. The biopsy showed high-grade carcinoma.

In the journal the XXXXXX have noted the following: XXXXXX bullet in h.bryst is malignant. Offered first chemotherapy, then removal of the breast and eventually radiotherapy. She did not want this then becomes too great a burden, which I agree in due XXXXXX . Want an alternative treatment XXXXXX , to get started in the summer. XXXXXX New contact if necessary. “

The XXXXXX is noted in the journal that it ” [g] years in general much better, the ball has shrunk somewhat and shape are soaring. “ from medical record XXXXXX: ” waiting for cancer drugs from XXXXXX , to the treatment stay on XXXXXX when these are received. “ From medical record XXXXXX: “Is i XXXXXX for cancer treatment. Much nauseated and in pain, asking for Rp.på antiemetic and larger pack of Tylenol. “

The XXXXXX is the following listed in the patient file: ” Coming to KTR. Not wanted recommended follow-up / treatment of breast cancer XXXXXX have more faith in alternative therapies, XXXXXX . The bullet is still large and tender, but liquids are not. Doctors XXXXXX informed her that biopsy of the tumor could lead to the spread and gave her rough told that she will die of the disease. XXXXXX Upon inspection we see a big bump on the lateral side of h. Chest sticking out, the skin is bluish discoloration, but dry. She looks less healthy than before. Breast cancer treated alternatively, opportunities for improvement, but uncertain prognosis. XXXXXX New contact if necessary. “

Of journal notes the XXXXXX and XXXXXX stated that the patient had severe pain due to blasting in cancer bullet, and the bullet liquids. Tylenol and Codeine did not give satisfactory pain relief, and the patient received prescribed OxyContin 20 mg x 2. Patients received advice that she as well as OxyContin can take Tylenol.

The XXXXXX took the patient in touch with you. This time because she wanted to initiate traditional medical treatment of the tumor. In the journal, it is noted: “[...] bullet in h.bryst has grown even more. She wants me contacts

XXXXXX for review. I have today consulted oncologist at XXXXXX , recommended to refer the patient to the hospital XXXXXX for further investigation (metastasis screening) and treatment (chemotherapy and hormone therapy?), Released today . A photocopy of f. Discharge summaries. The patient thinks this is a good solution. Not capacity to contradict her at XXXXXX . “

Of the documents appearing on the patient met for consultation by XXXXXX XXXXXX it. The patient had at the consultation by XXXXXX an unusually large locally advanced breast cancer located in upper lateral part of the right breast and right armpit. According to description measured tumor XXXXXX. The tumor was so large that it was considered inoperable and had to be treated with chemotherapy to be shrunk prior to the operation. As also discussed in the journal notes, the patient was offered chemotherapy in XXXXXX already in XXXXXX, but she refused this because she was very concerned that such treatment could lead to recurrence of XXXXXX.

After consultation at XXXXXX on XXXXXX expressed hospital in concern of XXXXXX to the County that they were uncertain whether you’ve been supportive by encouraging the patient to use alternative treatment for her cancer. Furthermore, they believe disease severity does not appear on your journal notes, and that they therefore are unsure whether you have been aware of the severity of the disease and that this is potentially life threatening. The hospital writes concern message: “Especially statements such as” opportunity for improvement “the XXXXXX arouses concern of yours.” it make the hospital questioned whether you have overestimated the effects of alternative treatments for patient cancer, and whether the patient as a result now has developed an unusually large locally advanced breast cancer.

the patient has been submitted to the relevant documents, including your statement to the case, but did not leave a comment. In telephone conversation with the County of XXXXXX XXXXXX the expressed patient that she thinks it is a pity that it has opened a supervision against you. She trusts you, and that’s why she kept you as her doctor XXXXXX. She feel understood by you, which takes into account her XXXXXX.

Excerpts from your statements

You’ve stated you to the case by letter of XXXXXX and XXXXXX.

from the statements stated inter alia that quickly referred the patient to the specialist services in XXXXXX and XXXXXX when she told of bullets in the chest. Furthermore you that the XXXXXX stated in the record that you had encouraged the patient to meet to review the hospital because it was important to clarify what the bullet in the right breast consisted of. You also shows the patient the XXXXXX when examined by a surgeon / oncologist in XXXXXX said she would not take new biopsy, surgery or receiving chemotherapy, if the bullet would prove to be malignant. This reasoned patient with her XXXXXX, who would make sure she would not tolerate any form of cancer treatment or biopsy.

You also notes that in the journal memorandum of XXXXXX was so precise in your statement then you had noted that you agreed that offered cancer treatment would be a great strain. There you had meant was that such tough treatment combined with known XXXXXX and XXXXXX in general would be expected to reduce the patient’s general condition even more. In your statement of XXXXXX sorry that journal note was imprecisely worded and has created confusion. What you meant was that you could understand why she thought so and that it made a choice difficult, but you had thus the same opinion regarding cancer treatment that colleagues in XXXXXX. You sorry also that you note the XXXXXX wrote that there were opportunities for improvement. It was the patient’s own experience and observations, and not yours. As shown by the note XXXXXX tried you in getting the patient to change his mind. This time she wanted to receive traditional treatment and was quickly referred to this. Of medical records from XXXXXX XXXXXX it emerges once more that the patient took up the fear that her XXXXXX would worsen after cancer treatment. She was again urged to accept such treatment.

You also states that the process has been delayed because the patient wanted time to think about and have had great faith in alternative therapies. You write that this choice is made on the patient’s own responsibility, and you have been agreed that she must choose the treatment itself and you could not force her into anything. Your impression is that the patient does not quite have understood how serious the situation was.

You are very clear that you have not backed that she would not accept the traditional cancer treatment, and that you have understood that the condition has been fatal . However, no patient about to receive such treatment. She got good information specialist at an early stage and you thought that she then had received the necessary information from qualified individuals to make an informed decision. You do not mean it’s your job to say something about this, then the specialists are those who have the right expertise to provide patients with necessary and correct information. You do not think that by the understanding that she meant cancer treatment would aggravate her XXXXXX, has made that the consequences were different.

You refer to the minutes of the telephone conversation between the County and the patient the XXXXXX where the patient said she was happy with you, which took into account her XXXXXX. You point out again that you had the understanding that cancer treatment in combination with XXXXXX could aggravate the latter, but that you are not advised not to accept offers of traditional cancer treatment.

Former supervision

the State Board of Health has previously dealt with a supervision toward you (XXXXXX). Audit case concerned whether your diagnosis and monitoring of a patient with XXXXXX was professionally acceptable according to the Health § 4 Board of Health concluded that you had misdiagnosed the patient and given XXXXXX inadequate monitoring. There was thus one breach of the Health § 4 and you were imposed a warning under the Health § 56.



Legal basis for the assessment

The information in supervision by the case to consider whether you has acted contrary to the requirement of sound management in the health § 4. Including we will consider whether the patient was given the necessary information so that she could make an informed decision on whether she would accept the offered health care or not, see. patient and user rights Act §§ 3-1, 3-2 and 4-1, ref. the Health § 10 sections outline the relevant provisions.

The Health § 4 subsections:

Health personnel shall conduct their work in accordance with the requirements to professional responsibility and diligent care that can be expected based on their qualifications, work character and situation in general.

Health professionals should abide by their professional qualifications, and shall obtain assistance or refer patients further where necessary and possible. If the patient needs dictate, the profession shall be by collaboration and cooperation with other qualified personnel. Health professionals have an obligation to participate in work with individual plan when a patient or user is entitled to such a plan after patient and user Rights Act § 2-5.

the health § 10 first paragraph:

the health health services, should provide information to the person entitled to it under the rules of patient and user rights Act §§ 3 -2 3-4. In health institutions information under the first sentence given by the person whom the institution designates.

Health & Rights Act § 3-1 first paragraph:

Patient and user have right to participate in the implementation of health services. This includes the patient’s right to participate in choosing between available and appropriate examinations and treatment. The form should be adapted to the individual’s ability to give and receive information.

Health & Rights Act § 3-2, first paragraph:

Patients should have the information necessary to gain insight into their health status and contents health care. Patients should also be informed of possible risks and side effects.

Health & Rights Act 4-1 first paragraph:

Health care may be granted only with the patient’s consent, unless there is a legal basis or other valid legal basis to provide health care without consent. For the consent to be valid, the patient must have received the necessary information about their health status and content of health care.

The Health § 4 is a central provision. The provision requires professional responsibility and diligent care and to health professionals’ professional practice. What is justifiable is determined by an assessment of each case, and how health workers ideally should have acted.



Norwegian Board of Health review

Norwegian Board has considered whether your patient follow-up after that she had breast cancer diagnosed in XXXXXX has been prudent, ref. the Health § 4. in this connection, we assessed whether the patient received the necessary information and guidance so that she could make an informed decision that she did not want to accept the recommended cancer treatment.

good practice for handling and monitoring of patients referred to a specialist for suspected breast cancer

It is known practice that any woman with recent onset, well-defined tumor in the breast, regardless of age, should be referred to a surgeon or breast clinic for diagnostic assessment. The report from there and implementation of treatment is a task for the specialist. When controls finishing transferred from the specialist to the GP, it is after the specified program.

A general practitioner must rely on specialist health assessment and advice on further action. However, it is also necessary that the family doctor, through his relationship with the patient, will provide information and guidance. The Health § 10; see. Patient and user Rights Act § 3-2, first paragraph requires health professionals to give the patient the information necessary to gain insight into their health status and contents of the health care provided. The purpose is to ensure that the patient receives the information necessary to give informed consent for health care and to assist in the implementation of treatment, cf. Patient and user Rights Act §§ 3-1 first paragraph and 4-1, first paragraph. Participation court gives the patient a right to participate in choosing between available and justifiable treatment, cf. Patient and user Rights Act § 3-1 first paragraph.

What kind of advice and information provided and the main content of this shall documented. It is not sufficient that the information only be given orally during the consultation.

There are specialist health that is responsible for further investigation, diagnosis and treatment of breast cancer. However, it should be known to all GPs that alternative treatment under no circumstances should be chosen instead of traditional cancer treatment.

Primary treatment of breast cancer is surgery at unresectable tumor. The options are breast-conserving surgery (BCT) or mastectomy (mastectomy). Participants also receive any adjuvant therapy (endocrine, chemotherapy, radiation therapy) to eliminate remaining micrometastases. Endocrine therapy, chemotherapy and radiotherapy can be given both in adherence to primary curative interventions or metastatic disease.

Assessing Your dealings

on the basis of the subject matter as described above, adding Norwegian Board assumed that the patient was to consultation with you on XXXXXX and that the same day referring the patient for examination at XXXXXX for consideration. Mammography showed a large masses and a pathological lymph node. XXXXXX accepted patient biopsies, which showed high-grade carcinoma. The patient did not want traditional treatment. First the XXXXXX accepted patient a new referral from you. The bullet in the right breast had then grown even more.

You had telephone consultation with the patient the XXXXXX and XXXXXX and XXXXXX. and XXXXXX. The XXXXXX had to patient consultation. You journaled when including doctors in XXXXXX had given her “rough told that she will die of the disease” . Furthermore, you wrote that the patient was “positive and optimistic for the future” and that it was “opportunities for improvement, but uncertain prognosis” . Regarding inspection of breast noted that you could see a big bump on the lateral side of the right chest sticking out. His skin was bluish discolored but dry. The patient looked less healthy than before.

Norwegian Board considers that you initially quickly referred the patient to a specialist. On subsequent telephone consultations and by the consultation the XXXXXX stated it is not the record that you urged her to accept traditional cancer treatment. Nor does it appear that you confirmed specialist health information that the initiation of treatment was urgent and that it could go very wrong if she did not accept the advice she was given. On the contrary journaled you that it was “opportunities for improvement” by alternative treatment .

Norwegian Board of Health has no information that you really supported the alternative treatment other than that you recognized the patient’s right to be consulted (complicity). However, patient and user Rights Act § 3-1 first paragraph, only the patient a right of codetermination of available and appropriate treatment methods. It is not until the matter is that you adequately informed the patient that the only proper method of treatment was the treatment specialist health services offered.

Although the hospital is responsible for the treatment of patients with breast cancer, the elementary knowledge for a general practitioner that alternative therapies are not an acceptable alternative. Norwegian Board considering that you had many occasions to explicitly in the journal strongly urge the patient to follow the treatment method proposed by the hospital.

Norwegian Board of Health is aware that neither the specialist health services managed to persuade the patient to consent to health care before after several months. Yet had you as the patient’s general practitioner, a physician patient trusted and had known over time, unique. This also because the patient’s skepticism to receive treatment primarily due fear of worsening her XXXXXX -sykdom which you were responsible treats of. In your statement you write that you had the impression that the patient had not quite realized how serious the situation was. Norwegian Board of Health believes that you, the patient’s general practitioner had a duty as far as possible to make sure the patient understood the serious situation she was in. Although cancer treatment in combination with XXXXXX could aggravate the latter, it is of minor importance if the patient, without treatment, are in danger of dying from the former.

in a situation like this, where the patient sat in mortal danger by denying health care, more stringent requirements for information and documentation. Norwegian Board is of the opinion that you should have made sure it was apparent in the journal what information you had given to the patient so that the Journal is hardly conducive to any doubts about what was your recommendation in the case. You conducted many consultations with the patient during the time period, and thus had several occasions to this.

Norwegian Board has therefore concluded that your monitoring of the patient during the period after she got breast cancer diagnosed in XXXXXX, was unjustifiable, ref. the Health § 4.

Assessment of whether you should be given a warning

Norwegian Board of Health has concluded that you have broken acceptability requirements of the Health § 4. violations of Health Personnel provisions we can give warning pursuant to the Health § 56 which reads:

the board can issue a warning to healthcare professionals who intentionally or negligently violates the obligations under this Act or regulations issued pursuant to it, if the breach of duty is liable to endanger the safety of health and care services, to affix the patients and users with a substantial load or to substantially undermine confidence in healthcare or health and care services.

The board can give a warning to health care professionals who have demonstrated a behavior that is likely to significantly impair confidence in the profession.

Warning are individual decisions under the Public Administration.

To give warning is firstly a condition that you have acted negligently. In this assessment, the Norwegian Board of Health to decide whether you can be blamed. In the assessment, we could focus on whether you had alternatives of action in the current situation. Norwegian Board of Health believes that you had courses of action in that you had many occasions to strongly urge patients to follow treatment hospital suggested, and to explain the serious situation the patient was in, something that the journal appears that you do not have sufficiently done. Norwegian Board of Health has on this basis concluded that you acted negligently.

The second condition that must be met is that the act is likely to endanger the safety of health care services, apply patients or users with a substantial load or to substantially undermine confidence in healthcare or health and care services. It does not matter whether the action in the present case actually received such consequences.

Norwegian Board has considered whether your negligent conduct is likely to cause patients considerable strain. We believe that the family doctor has a responsibility to clearly inform and guide patients when they oppose vital treatment recommended by the specialist services. This applies particularly where the patient is in close contact with the family doctor and where the disease severity and prognosis are known GP. A failure to do this is in our opinion likely to cause patients considerable strain.

The main conditions to give you a warning pursuant to the Health § 56 are met. The Board shall make a judgment on whether you should be given a warning. Such assessments are based on the purpose of giving warning that is responding to serious violations of the Health. The reaction will help to promote quality in health, patient safety and help prevent future breach of duty.

We in this evaluation emphasized that you acted quickly and adequately when the patient first decided to accept treatment. This applies both to references to diagnostic evaluation in XXXXXX and XXXXXX, and when she finally accepted the reference to necessary treatment in XXXXXX. Furthermore there is no information in the case to suggest that you considered alternative treatment as an equal treatment. We have also emphasized that neither the specialist health managed to persuade the patient to receive proper treatment at an earlier stage. After an overall assessment, the Public Health concluded that it is not appropriate to give you warning.



Conclusion

Norwegian Board of Health has concluded that you have breached the requirement of professional responsibility in the Health § 4 but we have not found it necessary to issue a warning.

Audit the thing is with this end.

Sincerely,

XXXXXX
XXXXXX

XXXXXX XXXXXX

The letter is approved electronically and sent therefore without signature

Copy to:
County of XXXXXX XXXXXX

Legal officer: XXXXXX
Health Academic coordinator: XXXXXX

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