Subchapter F. MINIMUM STANDARDS OF PRACTICE


Sec.


16.91.    Identifying information on prescriptions and orders for equipmentand service.
16.92.    Prescribing, administering and dispensing.
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.

 (a)  For purposes of this section, ‘‘drug’’ includes the following:

   (1)  Controlled substances under The Controlled Substance, Drug, Device and Cosmetic Act (35 P. S. § §  780-101—780-144) or substances that are controlled substances under Federal law.

   (2)  Carisoprodol or agents in which carisoprodol is an active ingredient.

   (3)  Butalbital or agents in which butalbital is an active ingredient.

   (4)  Tramadol hydrochloride or agents in which tramadol hydrochloride is an active ingredient.

 (b)  When prescribing, administering or dispensing drugs regulated under this section, a person licensed to practice medicine and surgery in this Commonwealth or otherwise licensed or regulated by the Board shall carry out, or cause to be carried out, the following minimum standards:

   (1)  Initial medical history and physical examination. An initial medical history shall be taken and an initial physical examination shall be conducted unless emergency circumstances justify otherwise. Medical history and physical examination information recorded by another licensed 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 objective evaluation of the heart, lungs, blood pressure and body functions that relate to the patient’s specific complaint.

   (2)  Reevaluations. Reevaluations of the patient’s condition and efficacy of the drug therapy shall be made consistent with the condition diagnosed, the drug or drugs involved, expected results and possible side effects.

   (3)  Patient counseling. The patient shall be counseled regarding the condition diagnosed and the drug 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. Accurate and complete medical records must document the evaluation and care received by patients.

     (i)   On the initial occasion when a drug is prescribed, administered or dispensed to a patient, the medical record must include the following:

       (A)   A specification of the symptoms observed by the licensed health care provider and reported by the patient.

       (B)   The diagnosis of the condition for which the drug is being given.

       (C)   The directions given to the patient for the use of the drug.

       (D)   The name, strength and quantity of the drug and the date on which the drug was prescribed, administered or dispensed.

     (ii)   After the initial occasion when a drug is prescribed, administered or dispensed, the medical record must include the information required in subsection (b)(4)(i)(D) and changes or additions to the information recorded under subsection (b)(4)(i)(A)—(C).

   (5)  Emergency prescriptions. In the case of an emergency contact from a known patient, a prudent, short-term prescription for a drug 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 is first conducted by a licensed health care provider. The results of this examination and evaluation shall be recorded in the patient’s medical record together with the diagnosis of the condition for which the drug 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.

   (6)  Compliance with other laws.

     (i)   This section may not be construed as restricting or limiting the application of The Controlled Substance, Drug, Device and Cosmetic Act or statutes or regulations of the Department of Health and the Department of Public Welfare that govern the prescription, administration and dispensation of drugs and medical recordkeeping in certain health care facilities.

     (ii)   This section may not be construed as restricting or limiting the application of Federal laws or regulations that govern the prescription, administration and dispensation of drugs and medical recordkeeping in certain health care facilities.

     (iii)   This section does not relieve a person from complying with more stringent standards that may be imposed by another statute or regulation.

   (7)  Compliance with facility policy. This section does not relieve a person from complying with more stringent standards that may be imposed by the health care facility in which the person practices or by the person’s employer.

   (8)  Adherence to standards of practice. 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 licensed health care provider exceed the requirements of this section.

Authority

   The provisions of this §  16.92 amended under section 8 of the Medical Practice Act of 1985 (63 P. S. §  422.8).

Source

   The provisions of this §  16.92 amended June 21, 2013, effective June 22, 2013, 43 Pa.B. 3347. Immediately preceding text appears at serial pages (342646) to (342648).

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).

§ 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); 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); 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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