Subchapter F. MINIMUM STANDARDS OF PRACTICE


Sec.


16.91.    Identifying information on prescriptions and orders for equipmentand service.
16.92.    Prescribing, administering and dispensing controlled substances.
16.93.    Packaging.
16.94.    Labeling of dispensed drugs.
16.95.    Medical records.
16.96.    [Reserved].
16.97.    Disciplinary guidelines for use of anabolic steroids—statement of policy.

§ 16.91. Identifying information on prescriptions and orders forequipment and service.

 After December 31, 1982, the name and license number of the physician shall be printed or preprinted on a written prescription for drugs and on a written order for services or equipment to be provided to a patient by another provider unless the patient is receiving those drugs or other services or equipment as part of inpatient services.

Cross References

   This section cited in 49 Pa. Code §  18.158 (relating to prescribing and dispensing drugs, pharmaceutical aids and devices).

§ 16.92. Prescribing, administering and dispensing controlled substances.

 (a)  A person licensed to practice medicine and surgery in this Commonwealth or otherwise licensed or regulated by the Board, when prescribing, administering or dispensing controlled substances, shall carry out, or cause to be carried out, the following minimum standards:

   (1)  Initial medical history and physical examination. In a health care facility regulated by the Department of Health, the Department of Public Welfare or the Federal government, an initial medical history shall be taken and an initial physical examination shall be conducted to the extent required by the Department of Health in 28 Pa. Code (relating to health and safety) or Department of Public Welfare in 55 Pa. Code (relating to public welfare) or the Federal government in appropriate Federal regulations, whichever is applicable, and bylaws of the health care facility and its medical staff. In other practice settings, before commencing treatment that involves prescribing, administering or dispensing a controlled substance, an initial medical history shall be taken and an initial physical examination shall be conducted unless emergency circumstances justify otherwise. Alternatively, medical history and physical examination information recorded by another health care provider may be considered if the medical history was taken and the physical examination was conducted within the immediately preceding 30 days. The physical examination shall include an evaluation of the heart, lungs, blood pressure and body functions that relate to the patient’s specific complaint.

   (2)  Reevaluations. Among the factors to be considered in determining the number and frequency of follow-up evaluations that should be recommended to the patient are the condition diagnosed, the controlled substance involved, expected results and possible side effects. For chronic conditions, periodic follow-up evaluations shall be recommended to monitor the effectiveness of the controlled substance in achieving the intended results.

   (3)  Patient counseling. Appropriate counseling shall be given to the patient regarding the condition diagnosed and the controlled substance prescribed, administered or dispensed. Unless the patient is in an inpatient care setting, the patient shall be specifically counseled about dosage levels, instructions for use, frequency and duration of use and possible side effects.

   (4)  Medical records. In a health care facility regulated by the Department of Health, the Department of Public Welfare or the Federal government, information pertaining to the prescription, administration or dispensation of a controlled substance shall be entered in the medical records of the patient and the health care facility under 28 Pa. Code or 55 Pa. Code or appropriate Federal regulations, whichever is applicable, and bylaws of the health care facility and its medical staff. In other practice settings, certain information shall be recorded in the patient’s medical record on each occasion when a controlled substance is prescribed, administered or dispensed. This information shall include the name of the controlled substance, its strength, the quantity and the date it was prescribed, administered or dispensed. On the initial occasion when a controlled substance is prescribed, administered or dispensed to a patient, the medical record shall also include a specification of the symptoms observed and reported, the diagnosis of the condition for which the controlled substance is being given and the directions given to the patient for the use of the controlled substance. If the same controlled substance continues to be prescribed, administered or dispensed, the medical record shall reflect changes in the symptoms observed and reported, in the diagnosis of the condition for which the controlled substance is being given and in the directions given to the patient.

   (5)  Emergency prescriptions. In the case of an emergency phone call by a known patient, a prudent, short-term prescription for a controlled substance may be issued. Neither a refill nor a consecutive issuance of this emergency prescription may be given unless a physical examination and evaluation of the patient are first conducted. The results of this examination and evaluation shall be set forth in the patient’s medical record together with the diagnosis of the condition for which the controlled substance is being prescribed. An emergency oral prescription for a Schedule II controlled substance shall be covered by a written prescription delivered to the pharmacist within 72 hours. In certain health care facilities regulated by the Department of Health, the Department of Public Welfare and the Federal government, orders for the immediate, direct administration of a Schedule II controlled substance to a patient are not considered prescriptions and are, therefore, not subject to the requirements in this paragraph. Further information regarding this exclusion can be found in The Controlled Substance, Drug, Device and Cosmetic Act (35 P. S. § §  780-101—780-144) and 28 Pa. Code Chapter 25 (relating to controlled substances, drugs, devices and cosmetics).

 (b)  This section establishes minimum standards for the prescription, administration and dispensation of controlled substances by persons licensed to practice medicine and surgery in this Commonwealth or otherwise licensed or regulated by the Board. This section does not restrict or limit the application of The Controlled Substance, Drug, Device and Cosmetic Act or of another statute or regulation, and does not relieve a person from complying with more stringent standards that may be imposed by another statute or regulation.

 (c)  Compliance with this section will not be treated as compliance with the standards of acceptable and prevailing medical practice when medical circumstances require that the practitioner exceed the requirements of this section.

Cross References

   This section cited in 49 Pa. Code §  18.6a (relating to prescribing, dispensing and administering drugs); 49 Pa. Code §  18.157 (relating to administration of controlled substances and whole blood and blood components); and 49 Pa. Code §  18.158 (relating to prescribing and dispensing drugs, pharmaceutical aids and devices); and 49 Pa. Code §  21.283 (relating to prescribing and dispensing drugs); .

§ 16.93. Packaging.

 Prescription drugs—that is, drugs which cannot be purchased over the counter—for oral administration shall be dispensed in safety closure packaging, except where exempt by State or Federal statute or regulation or as specifically requested by the patient. For Federal regulations pertaining to packaging, see 16 CFR Part 1700 (relating to poison prevention packaging).

Cross References

   This section cited in 49 Pa. Code §  18.6a (relating to prescribing, dispensing and administering drugs); 49 Pa. Code §  21.283 (relating to prescribing and dispensing drugs); and 49 Pa. Code §  18.158 (relating to prescribing and dispensing drugs, pharmaceutical aids and devices).

§ 16.94. Labeling of dispensed drugs.

 (a)  The label on a dispensed drug container shall include the name of the drug, using abbreviations if necessary; the quantity; and the name of the manufacturer if the drug is a generic drug. If a practitioner specifically indicates that the name of the drug may not appear on the label, the recognized national drug code number shall be placed on the label if the number is available for the product. The label shall also bear the name and address of the practitioner, the date dispensed, the name of the patient and the directions for use of the drug by the patient.

 (b)  Drugs which, at the time of their dispensing, have full potency for less than 1 year, as determined by the expiration date placed on the original label by the manufacturer, may only be dispensed with a label that indicates the expiration date. The label shall include the statement, ‘‘Do not use after manufacturer’s expiration date,’’ or similar wording.

Cross References

   This section cited in 34 Pa. Code §  501.5 (relating to exemptions); 49 Pa. Code §  18.6a (relating to prescribing, dispensing and administering drugs); 49 Pa. Code §  21.283 (relating to prescribing and dispensing drugs); and 49 Pa. Code §  18.158 (relating to prescribing and dispensing drugs, pharmaceutical aids and devices).

§ 16.95. Medical records.

 (a)  A physician shall maintain medical records for patients which accurately, legibly and completely reflect the evaluation and treatment of the patient. The components of the records are not required to be maintained at a single location. Entries in the medical record shall be made in a timely manner.

 (b)  The medical record shall contain information sufficient to clearly identify the patient, the person making the entry if the person is not the physician—such as a physician assistant or a certified registered nurse practitioner—the date of the medical record entry and patient complaints and symptoms.

 (c)  Clinical information pertaining to the patient which has been accumulated by the physician, either by himself or through his agents, shall be incorporated in the patient’s medical record.

 (d)  The medical record shall also include diagnoses, the findings and results of pathologic or clinical laboratory examination, radiology examination, medical and surgical treatment and other diagnostic, corrective or therapeutic procedures.

 (e)  A patient’s medical record shall be retained by a physician for at least 7 years from the date of the last medical service for which a medical record entry is required. The medical record for a minor patient shall be retained until 1 year after the minor patient reaches majority, even if this means that the physician retains the record for a period of more than 7 years.

 (f)  The components of a patient’s medical record, which are prepared by a physician or his agent and which are retained by a health care facility regulated by the Federal government, or by the Department of Health or the Department of Public Welfare are considered to be a part of the patient’s medical record which is required to be maintained by a physician, but are otherwise exempt from the requirements in subsections (a)—(e). These components of a patient’s medical record shall contain information required by applicable Federal regulations, or by 28 Pa. Code (relating to health and safety) or 55 Pa. Code (relating to public welfare)—see for example, Department of Health regulations at 28 Pa. Code § §  115.31—115.34 (relating to policies and procedures for patient medical records)—and health care facility and medical staff bylaws.

Cross References

   This section cited in 49 Pa. Code §  18.15 (relating to practice responsibilities of acupuncturist and practitioner of oriental medicine who is not a medical doctor); 49 Pa. Code §  18.158 (relating to prescribing and dispensing drugs, pharmaceutical aids and devices); and 49 Pa. Code §  18.159 (relating to medical records).

§ 16.96. [Reserved].


Source

   The provisions of this §  16.96 adopted January 16, 1987, effective July 17, 1987, 17 Pa.B. 255; amended October 9, 1987, effective October 1, 1987, 17 Pa.B. 4040; amended October 20, 1989, effective October 21, 1989, 19 Pa.B. 4511; reserved March 13, 1998, effective March 14, 1998, 28 Pa.B. 1316. Immediately preceding text appears at serial pages (209935) to (209936).

Notes of Decisions

   Validity

   Regulations which required an osteopathic physician to obtain a written waiver from the State Board of Medicine or a medical doctor or the State Board of Osteopathic Medicine for treatment of patients with drugs known as ‘‘sympathomimetic amines,’’ beyond a 45-day period, was an unreasonable exercise of bureaucratic authority and the regulations were void and unenforceable. Pennsylvania Medical Society v. State Board of Medicine, 546 A.2d 720 (Pa. Cmwlth. 1988).

§ 16.97. Disciplinary guidelines for use of anabolic steroids—statement of policy.

 Under section 4 of the act of December 22, 1989 (P. L. 702, No. 93) (35 P. S. §  807.4), known as the Anabolic Steriod Law:

   (1)  A medical doctor or other Board regulated practitioner may not prescribe, administer or dispense an anabolic steroid for the purpose of:

     (i)   Increasing muscle mass, strength or weight, without medical necessity.

     (ii)   Improving a person’s performance in an exercise, sport or game.

   (2)  The Board may impose disciplinary sanctions within the following range against the license, certificate or registration to practice in this Commonwealth of a medical doctor or a Board regulated practitioner who violates section 4 of the Anabolic Steriod Law:

     (i)   First violation.

       (A)   Minimum: 3-month suspension.

       (B)   Maximum: revocation.

     (ii)   A subsequent violation.

       (A)   Minimum: 1-year suspension.

       (B)   Maximum: revocation.

Source

   The provisions of this §  16.97 adopted June 12, 1992, effective June 13, 1992, 22 Pa.B. 2996.



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