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(Sec.)30l.25(c)...[Controlled Substances Act]

(1) Such dispensing is done in the usual course of his professional practice;

(2) Such individual practitioner is authorized or permitted to do so by the jurisdiction in which he is practicing;

(3) The hospital or other institution by whom he is employed has verified that the individual practitioner is so permitted to dispense, administer, or prescribe drugs within the jurisdiction;

(4) Such individual practitioner is acting only within the scope of his employment in the hospital or institution;

(5) The hospital or other institution authorized the intern, resident, or foreign physician to dispense or prescribe under the hospital registration and designates a specific internal code number for intern, resident, or foreign physician so authorized.

There are two important restrictions in the Controlled Substances Act. First, the state laws must authorize the writing of prescriptions in the hospital setting. The hospital must be careful to verify that this may be done in the state where it is located. The state law must also be checked to determine if this authorization is limited to the hospital setting or if it may be extended to situations where the unlicensed practitioner works with a physician outside the hospital. Even when the state law extends beyond the hospital, the federal law would exclude situations that are not part of the formal training program. This would allow formal training in a physician's office but would not allow moonlighting.

The second restriction is that the prescribing or dispensing of drugs be in the course of employment by the institution. This prevents the unlicensed practitioner from having a private practice, even if the patients were seen in the hospital.

Observance of these drug laws is very important because of the criminal penalties involved. Unlicensed practitioners should be carefully instructed in their responsibilities under the law. They must understand that the drug laws apply irrespective of their understanding of them. the same penalty applies in the case of an illegal prescription whether it is written intentionally or in ignorance.

Once members of the house staff are licensed by the state (which should be a condition for continuing training), they will have their own controlled substances registration number and will be able to write prescriptions legally, regardless of their position with the hospital. Outside of the hospital, they will be fully enfranchised as physicians. Inside the hospital, however, they will not automatically gain any rights be becoming licensed. The status of house staff officers in the hospital must be established by the hospital bylaws and medical section rules. The hospital cannot authorize unlicensed practitioners to act beyond the constraints of state law; but, once the house officers are licensed, they may be granted full privileges. Most hospitals do not grant unlimited privileges to licensed house staff members, but rather maintain for them the limited privileges usually associated with the student role. For this reason, licensed house staff members may operate under the same constraints (except for drugs) as unlicensed practitioners.

The major constraint that follows from limited privileges is the need to have orders cosigned and chart notes annotated by a medical staff member:

When members of the house staff and other specified professional personnel are involved in patient care, sufficient evidence should be documented in the medical record to substantiate the active participation in, and supervision of, the patient's care by the responsible attending physician or dentist. Any entries in the medical record by house staff or other specified professional personnel that require countersigning by supervisory or attending medical staff members shall be defined in the medical staff rules and regulations.

While the hospital must not overreach the applicable state and federal laws when delegating authority to unlicensed house staff, the only legal constraint on licensed house staff is that they be monitored in the same fashion as other members of the active medical staff. The hospital cannot delegate its responsibility for monitoring the house staff to the medical school that is sponsoring the training program. The hospital must ensure that each patient be fully informed of the hospital's policy regarding house staff, and this should be incorporated into the general consent to medical care. Patients cannot be treated by the house staff without permission. If a patient declines to allow treatment by the house staff, there should be a protocol to deal with such a refusal. In this situation, the hospital may require the attending physician to be responsible for 24-hour coverage.

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