The Case
As part of the therapy for rheumatoid arthritis, you decide to prescribe rituximab to one of your patients. Since your office is not offering this infusion on site and she lives several miles away from the infusion center that you usually use, you agree to prescribe the medication and coordinate the rituximab infusion with a colleague in hematology who has been following her for anemia. After your conversation with the hematology colleague, he agrees to infuse rituximab for the patient under your orders. You fax your colleague an order for rituximab 1,000 mg IV on Day 1 and Day 15, and methylprednisolone 100 mg IV with each rituximab infusion, as per rheumatoid arthritis protocol.1 The plan is to repeat rituximab infusions every six months, if effective, after this induction phase. As part of the orders, you request copies of the infusion notes and obtain safety labs, with the results to be sent to you for review and charting. The patient calls your office stating that she is confused, because the hematologist has been infusing her rituximab every three months, which was not indicated by the instructions that you initially gave her. When your office calls the hematologist, they encounter a difficult situation in which the visit notes and lab information are not provided. You call the hematologist to clarify the situation; he becomes upset and decides to refuse infusing your patient anymore. The patient has been doing much better on rituximab, and she does not want to go to the hospital for the infusions. She has already failed infliximab, adalimumab, etanercept, and abatacept. She cannot afford the self-injectable medications and Medicare only covers the infusions.
Ethical Questions
- Is it ethical for the hematologist to change your rituximab prescription? What recourses are available for the continuity of care of the patient?
- Is it ethical for you, as the ordering physician (rheumatologist), to give the patient limited options in terms of how to obtain her treatment, especially in this situation?
- What is the ethical method of action to continue caring for this patient without jeopardizing her safety, if you cannot obtain records for review at the facility where she receives the rituximab infusion you ordered?
- Who is responsible for the safety lab review, the rheumatologist as the ordering physician or the oncologist as the infusion clinic supervisor?
What do you think? see below for the answers.
Infusion Ethics: Answers and Discussion
1. Is it ethical for the hematologist to change your rituximab prescription? What resources are available for the continuity of care of the patient?
This could be a dilemma, since both physicians (rheumatologist and hematologist) are providers for the patient, and are educated in the use of rituximab therapy. However, the ethical question is in which capacity the hematologist is seeing the patient: as a hematologist or as a physician supervising nursing staff at an infusion clinic providing a service to the referring specialist. The definition of a supervisor of nursing staff of the infusion clinic fits best in this clinical scenario, and the ethical way to proceed would be to follow the orders as provided by the rheumatologist, unless there is a clinical question or doubt in the orders. Such doubts would require delay of service and some review and clarification among the ordering physician (rheumatologist) and the nursing staff or acting physician at the facility. If terms of agreement cannot be met, then options to change infusion provider include, 1) finding another infusion center or facility whose sole or main purpose is to comply with outside orders for referring physicians; 2) using the ordering rheumatologist’s office, if feasible; or 3) referring the patient to the hospital-operated infusion service. Another alternative would be to change medications altogether, but there are limited remaining options available for this patient. As another way to resolve the situation, negotiating with the oncologist to continue therapy under the orders as provided by the rheumatologist could be attempted, if the venues of communication remain professional and cordial. It is noteworthy to stress that there is value in following evidence-based therapeutic protocols for the correct diagnosis, and not using a different protocol for the same medication that is meant for a different diagnosis, with the expectation of obtaining the same clinical benefits. The finality of terminating infusions services by the hematologist without providing viable alternatives could be construed as abandonment or denial of care.
2. Is it ethical for you, as the ordering physician (rheumatologist), to give the patient limited options in terms of how to obtain her treatment, especially in this situation?
Yes, especially since your ultimate goal is to continue providing care for this patient’s advantage with an effective therapy. On the other hand, this does not preclude providing the patient with a list of options as part of the commitment of full disclosure. For example, she could either drive to the infusion center of your choice, or go to the hospital of your choice for the infusion, or go to another provider that may be willing to infuse the medication at his or her office. She could altogether discontinue the medication, but this will most likely result in persistent pain and uncontrolled rheumatoid arthritis symptoms. She could change to a different medication altogether. This new medication may be effective, or may be more costly or not effective. Her history already includes several disease-modifying antirheumatic drug failures, which translates to limited therapeutic options for her. She could change rheumatologists altogether to another clinic that could provide rituximab infusions at her convenience. This decision varies depending on the individuals involved, and is part of the expected interactive dynamics of the physician–patient relationship. In this case, the patient makes it clear that she does not want to change rheumatologists.
3. What is the ethical method of action to continue caring for this patient without jeopardizing her safety, if you cannot obtain records for review at the facility where she receives the rituximab infusion you ordered?
The desired outcome is to provide care for your patient and optimize their disease control, best with a treat-to-target approach.2 The ethical issue remains that communication is paramount to be able to provide adequate care in any medical situation. The rheumatologist treating this patient is ultimately responsible for the monitoring of side effects of the medications prescribed, including laboratory monitoring, but the data need to be available for the proper monitoring to occur. Results of laboratory testing and infusions notes are necessary for this monitoring to occur. Each state has laws pertaining prompt release of medical records. For example, the requirement in Texas is that the release of medical records should be within 14 business days.3 If that is not satisfied or corrected, the provider in violation of this statute can be reported to the Texas Medical Board and disciplined accordingly. The rules and regulations that apply may vary from state to state, and it is important that we are all familiar with these statutes. If communications remains poor after attempts to correct these issues, then a change in infusion center would be most appropriate.
4. Who is responsible for the safety lab review, the rheumatologist as the ordering physician or the oncologist as the infusion clinic supervisor?
Ultimately, the ordering physician would be held responsible for the results and the follow up required by the results. However, depending on how the orders were written for the labs to be done, is it is possible that the ordering physician (rheumatologist) is not the actual physician on the orders because of the labs being drawn at the infusion center. In that case, the hematologist is not only responsible for following up on the results, he is also responsible to delegate on reporting the abnormal values to the rheumatologist.
Back to the Case
After the case was presented in a meeting at the Ethics Committee of the ACR, the rheumatologist decided to attempt to resolve the situation. After a cordial dialogue, the hematologist agreed to continue rituximab infusion therapy at his facility, under the rheumatologist’s orders, as stipulated by the rheumatoid arthritis protocol. The laboratory results and notes from the infusion center were eventually provided to the rheumatologist. The patient has done extremely well on therapy and continues to have an excellent relationship with both providers. The salient point of this discussion is that communication between providers and appropriate coordination of care can be the decisive issue in the outcome of your patient.
Dr. Barbosa is director of North Texas Joint Care, PA, in Dallas.
References
- Cohen SB, Emery P, Greenwald MW, et al. Rituximab for rheumatoid arthritis refractory to anti-tumor necrosis factor therapy: Results of a multicenter, randomized, double-blind, placebo-controlled, phase III trial evaluating primary efficacy and safety at twenty-four weeks. Arthritis Rheum. 2006;54:2793-806.
- Schoels M, Knevel R, Aletaha D, et al. Evidence for treating rheumatoid arthritis to target: Results of a systematic literature search. Ann Rheum Dis. 2010;69:638-643.
- Texas Administrative Code. Title 22: Examining Boards, Part 9: Texas Medical Board, Chapter 165: Medical Records, Rule §165.2, Medical Record Release and Charges.