RULES AND REGULATIONS
Title 49—PROFESSIONAL AND VOCATIONAL STANDARDS
STATE BOARD OF MEDICINE
[ 49 PA. CODE CH. 16 ]
[43 Pa.B. 3347]
[Saturday, June 22, 2013]
The State Board of Medicine (Board) amends § 16.92 (relating to prescribing, administering and dispensing) to read as set forth in Annex A.
The final-form rulemaking will be effective upon publication in the Pennsylvania Bulletin.
The final-form rulemaking is authorized under section 8 of the Medical Practice Act of 1985 (act) (63 P. S. § 422.8).
Background and Purpose
Poisoning is the leading cause of accidental death in the United States, and nine out of ten poisoning deaths are related to prescription drug overuse or abuse. See Warner M., et al. (2011). ''Drug poisoning deaths in the United States, 1980—2008.'' National Center for Health Statistics data brief, no 81. In this Commonwealth and 29 other states, poisoning is the leading cause of injury death. States must take steps to reverse this preventable cause of death.
While the Board already had in place a regulation to provide safeguards for physicians prescribing, administering and dispensing controlled substances, the Board failed to address and provide similar safeguards related to noncontrolled prescription drugs. Requiring the same safeguards for noncontrolled prescription drugs would be unnecessary and overly burdensome because most noncontrolled prescription drugs, such as antibiotics, are used very safely and are not drugs of abuse themselves or used in association with drugs of abuse. As more fully set forth in the proposed rulemaking published at 42 Pa.B. 1122 (March 3, 2012), the Board identified three noncontrolled drugs with sufficiently similar propensities for abuse or use in combination with drugs of abuse to controlled substances, and for which there are numerous cases reported of fatal overdose, to warrant placing additional requirements on physicians who prescribe, administer and dispense these drugs.
Summary of Comments and Responses to Proposed Rulemaking
Comments from the public
The proposed rulemaking was published at 42 Pa.B. 1122. The Board received comments from the Pennsylvania Pharmacists Association; JNESCO District Council 1, IUOE/AFL-CIO; the Pennsylvania Medical Society; and Kalogredis, Sansweet, Dearden and Burke, Ltd. (KSDB) on behalf of Troy Pharmacy. In addition, the Board received comments from the House Professional Licensure Committee (HPLC) and the Independent Regulatory Review Commission (IRRC).
The Pennsylvania Pharmacists Association stated that it supported the proposed rulemaking as written. JNESCO, on behalf of 5,000 nurses and health care workers, wrote in support of the proposed rulemaking, noting that ''it is vital to monitor those substances that have the potential to be improperly prescribed'' and that health care workers have a ''moral, ethical and legal obligation to ensure the safety and well-being of the patients we serve.'' JNESCO noted that the Commonwealth would be the 17th state to further regulate these drugs. The Board appreciates the support of these groups.
The Pennsylvania Medical Society, representing about 17,000 physicians, residents and medical students, wrote in support of the proposed rulemaking and applauded the Board for tackling prescription drug abuse and diversion. The Pennsylvania Medical Society agreed that butalbital, carisoprodol and tramadol hydrochloride are medications with the potential for overuse or abuse with potential fatal side effects. The Pennsylvania Medical Society also noted with approval the Board's emphasis on ensuring that the doctor-patient relationship is paramount prior to prescribing medications. The Board appreciates the support of the Pennsylvania Medical Society.
KSDB wrote in opposition to the proposed rulemaking. They viewed the proposed rulemaking as an attempt to classify the three drugs as controlled substances, which it viewed as the proper role of the Federal Drug Enforcement Administration (DEA), and stated that the Board was attempting to bypass the DEA drug review system for adding or deleting controlled substances.
This final-form rulemaking does not attempt to reclassify the three drugs. As noted by KSDB, at the Federal level, the DEA is involved in the classification of drugs as controlled substances. In fact, on December 12, 2011, the Administrator of the DEA issued a final rulemaking placing carisoprodol into Schedule IV on the Federal list of controlled substances. See 21 CFR 1308 (relating to schedules of controlled substances).
The Controlled Substance, Drug, Device and Cosmetic Act (Drug Act) (35 P. S. §§ 780-101—780-144) contains the listing of substances controlled in this Commonwealth and vests authority to control substances listed in the statutory schedules with the Secretary of Health. The Board is not seeking to amend the Drug Act. Rather, the Board is regulating the practice of medicine within this Commonwealth.
KSDB also suggested that the Board's proposed rulemaking violated the Commerce Clause of the United States Constitution because it would ''force non PA licensed medical practitioners to follow onerous 'controlled drug' procedures to prescribe these drugs, rather than prescribing them as non controlled drugs which is permitted in their home state'' thereby discriminating ''against out of state licensed physicians prescriptions being dispensed by a PA licensed pharmacy.'' The Board disagrees with KSDB's statement that Board regulations must be followed by physicians who are not licensed in this Commonwealth and who are not practicing in this Commonwealth. Physicians are required to follow the laws and regulations of the state in which they are practicing.
Comments from HPLC and IRRC
The HPLC submitted comments to the Board on April 4, 2012. The HPLC first suggested that § 16.92(b)(2) may need to be clarified as to who does the reevaluation and that the reevaluation should become part of the medical record or that subsection (b)(2) should be moved to subsection (b)(4)(ii) so it becomes part of the written medical record. Reevaluations may be done by the same practitioner that can perform an initial evaluation. As set forth in § 16.92(b), a licensed physician or physician assistant shall carry out or cause to be carried out the functions in § 16.92(b)(1)—(8). Reevaluations shall be recorded in the medical record for several reasons. Section 16.92(b)(4) states that accurate and complete medical records must document the evaluation and care received by patients. Section 16.95(a) (relating to medical records) provides that a physician shall maintain medical records which accurately, legibly and completely reflect the evaluation and treatment of the patient. Reevaluation is, of course, a subset of evaluation. For these reasons, the Board does not believe § 16.92(b)(2) requires clarification.
Similarly, the HPLC suggested that § 16.92(b)(3) may need to be clarified in regard to who does counseling. As previously noted, the provisions of § 16.92(b) shall be carried out by or be caused to be carried out by a licensed physician or physician assistant. The Board does not believe it is necessary to repeat the provisions of subsection (b) in each of the paragraphs under subsection (b).
The HPLC recommended that the Board use ''licensed health care provider'' consistently throughout the regulation. The Board agrees and added ''licensed'' to § 16.92(b)(4)(i)(A) and (8).
IRRC questioned the Board's assertion in the proposed rulemaking that there would not be additional costs or additional recordkeeping associated with the rulemaking, noting that it appeared that the more stringent requirements for evaluations, which necessitate recording evaluations, would likely impact the regulated community in both additional costs and recordkeeping requirements. The Board amended the fiscal costs statement and the regulatory analysis to acknowledge those potential costs to the regulated community as suggested.
IRRC questioned whether ''or cause to be carried out'' might be exploited by unscrupulous practitioners to circumvent the intent of the final-form rulemaking and suggested the Board consider clarifying the phrase. The regulation applies to physicians and physician assistants and only physicians are authorized to delegate the performance of medical services. The Board is confident that physicians know to whom they are permitted to delegate particular tasks and understand that ''or cause to be carried out,'' which has been in the Board's regulation for many years, makes the physician responsible for a task delegated to another. Therefore, the Board declines to add additional language related to the phrase.
IRRC noted that, although an initial medical history and physical examination are required, the medical records are not required to include documentation of the initial medical history and physical examination of a patient. The Board disagrees. The Board's recordkeeping regulation, § 16.95, requires a physician to maintain medical records for patients which accurately, legibly and completely reflect the evaluation and treatment of the patient, which would include the initial medical history and results of a physical examination. In addition, § 16.92(b)(4) states that ''accurate and complete medical records must document the evaluation and care received by patients.'' As amended in the final-form rulemaking, § 16.92(b)(4)(ii) requires documentation of the name, strength and quantity of a drug and the date on which a drug was prescribed, administered or dispensed, as well as any change in the patient's symptoms, diagnosis or directions for drug use.
IRRC also suggested that subsection (b)(4) be amended to require documentation in the medical record of the periodic reevaluations required under subsection (b)(2). The Board believes that §§ 16.92(b)(4) and 16.95 already require documentation of reevaluations. Nevertheless, the Board amended § 16.92(b)(4)(ii)(B) to more specifically require recording information obtained on reevaluation.
IRRC questioned the exemption of a patient in an inpatient care setting from counseling regarding possible side effects. IRRC suggested adding ''possible side effects'' to the counseling requirements in the first sentence of subsection (b)(3) and deleting ''possible side effects'' from the exemption in the second sentence of subsection (b)(3). The first sentence of subsection (b)(3) is a general statement requiring patients to be counseled regarding the condition diagnosed and the drug prescribed, administered or dispensed. This general statement would not benefit from adding one particular aspect of counseling, that is, counseling about possible side effects. The second sentence of subsection (b)(3) serves two purposes: it elaborates on the content of the counseling generally required; and it exempts a patient in an inpatient care setting from the counseling requirement. Generally, patients treated in an outpatient setting are counseled on the drug, dosage, duration and other instructions for use because they are expected to administer the prescribed drugs to themselves. In an inpatient setting, it is usually the medical/nursing staff of the facility that will be administering the drugs and monitoring the patient for possible side effects. Additionally, a patient in an inpatient care setting may be unconscious, under anesthesia or otherwise incapable of counseling. A patient in an inpatient care setting may be in cardiac arrest or other emergent condition, such as in an emergency room or intensive care unit, where delaying the prescription and administration of a drug until the patient can be counseled could cause patient death. The patient counseling provision in this final-form rulemaking is identical to the patient counseling provision in the existing regulation and no problems with the provision have been brought to the Board's attention. The Board therefore declines the suggested edit to subsection (b)(3).
IRRC suggested that the information in subsection (b)(4)(i) and (ii) should be specifically required to be recorded in the medical record on and after the initial occasion when a drug is prescribed. The Board agrees and amended the final-form rulemaking accordingly.
IRRC raised several additional issues related to clarity of the rulemaking. IRRC suggested that the Board consider including a reference to the appropriate section of the act regarding penalties for noncompliance with the proposed rulemaking. None of the other provisions in Subchapter F (relating to minimum standards of practice) include this reference and it is understood that failure to comply may result in disciplinary action. The Board declines to add the reference to the final-form rulemaking.
IRRC suggested that the Board use ''licensed health care provider'' consistently in the regulation. The Board made amendments to do so in this final-form rulemaking.
IRRC asked if a prescription relayed electronically to a pharmacist meets the requirement in subsection (b)(5) that an emergency oral prescription be covered by a written prescription delivered to the pharmacist within 72 hours. This requirement is virtually identical to the Department of Health regulation in 28 Pa. Code § 25.45 (relating to emergency oral prescription). The DEA amended 21 CFR Parts 1300, 1304, 1306 and 1311 at 75 FR 16236 (March 31, 2010) to provide health care practitioners the option of transmitting prescriptions for controlled substances electronically. The Department of Health published a notice concerning electronically transmitted prescriptions at 40 Pa.B. 7160 (December 11, 2010). In this notice, the Department of Health clarified its position on whether the electronic transmission of prescriptions to a pharmacy is an acceptable practice for the medical and pharmaceutical communities under the Drug Act and its regulations. The notice clarified the Department's interpretation that a prescription transmitted electronically or by facsimile constitutes a ''written order on a prescription blank'' and that an electronically-transmitted prescription for a controlled substance is considered to be typewritten, provided that the transmission of the prescription otherwise complies with Federal and State laws and regulations, including the Board's regulations. Additionally, the State Board of Pharmacy amended § 27.201(b)(5) (relating to electronically transmitted prescriptions) to provide that ''the electronic transmission of a prescription . . . is considered a written prescription order.'' The Board believes the regulated community understands that a ''written prescription'' may now be transmitted electronically, so long as the licensed health care practitioner complies with the applicable Federal and State laws and regulations.
Fiscal Impact and Paperwork Requirements
The final-form rulemaking will not have adverse fiscal impact and will not impose additional paperwork requirements on the Commonwealth or its political subdivisions. Physicians prescribing, administering or dispensing the three additional drugs will need to ensure proper examinations of patients to assess the appropriateness of prescribing these three drugs and keep medical records that accurately reflect the care provided to patients. If there are physicians who are not already examining patients to assess the appropriateness of prescribing these three drugs, these physicians will need to conform to the regulation. Because of the high potential for abuse, misuse, dependency and possible death associated with these three drugs, the Board speculates that few physicians are currently prescribing these drugs without first carrying out, or causing to be carried out, an examination of the patient and appropriate documentation in the medical record.
The Board continuously monitors the effectiveness of its regulations. Therefore, a sunset date has not been assigned.
Under section 5(a) of the Regulatory Review Act (71 P. S. § 745.5(a)), on February 22, 2012, the Board submitted a copy of the notice of proposed rulemaking, published at 42 Pa.B. 1122, to IRRC and the Chairpersons of the HPLC and the Senate Consumer Protection and Professional Licensure Committee (SCP/PLC) for review and comment.
Under section 5(c) of the Regulatory Review Act, IRRC, the HPLC and the SCP/PLC were provided with copies of the comments received during the public comment period, as well as other documents when requested. In preparing the final-form rulemaking, the Board has considered all comments from IRRC, the HPLC, the SCP/PLC and the public.
Under section 5.1(j.2) of the Regulatory Review Act (71 P. S. § 745.5a(j.2)), on April 9, 2013, the final-form rulemaking was approved by the HPLC. On May 15, 2013, the final-form rulemaking was deemed approved by the SCP/PLC. Under section 5.1(e) of the Regulatory Review Act, IRRC met on May 16, 2013, and approved the final-form rulemaking.
Interested persons may obtain information regarding the final-form rulemaking by writing to Teresa Lazo, Board Counsel, State Board of Medicine, P. O. Box 2649, Harrisburg, PA 17105-2649, firstname.lastname@example.org.
The Board finds that:
(1) Public notice of proposed rulemaking was given under sections 201 and 202 of the act of July 31, 1968 (P. L. 769, No. 240) (45 P. S. §§ 1201 and 1202) and the regulations promulgated thereunder, 1 Pa. Code §§ 7.1 and 7.2.
(2) A public comment period was provided as required by law and the comments were considered.
(3) The amendments to the final-form rulemaking do not enlarge the purpose of the proposed rulemaking published at 42 Pa.B. 1122.
(4) This final-form rulemaking is necessary and appropriate for administration and enforcement of the authorizing acts identified in this preamble.
The Board orders that:
(a) The regulations of the Board, 49 Pa. Code Chapter 16, are amended by amending § 16.92 to read as set forth in Annex A.
(b) The Board shall submit this order and Annex A to the Office of General Counsel and to the Office of Attorney General as required by law.
(c) The Board shall certify this order and Annex A and deposit them with the Legislative Reference Bureau as required by law.
(d) This order shall take effect on publication in the Pennsylvania Bulletin.
JAMES W. FREEMAN, MD,
(Editor's Note: For the text of the order of the Independent Regulatory Review Commission relating to this document, see 43 Pa.B. 3067 (June 1, 2013).)
Fiscal Note: Fiscal Note 16A-4933 remains valid for the final adoption of the subject regulation.
TITLE 49. PROFESSIONAL AND VOCATIONAL STANDARDS
PART I. DEPARTMENT OF STATE
Subpart A. PROFESSIONAL AND OCCUPATIONAL AFFAIRS
CHAPTER 16. STATE BOARD OF MEDICINE—GENERAL PROVISIONS
Subchapter F. MINIMUM STANDARDS OF PRACTICE
§ 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.
[Pa.B. Doc. No. 13-1116. Filed for public inspection June 21, 2013, 9:00 a.m.]
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