A Guide to State Opioid Prescribing Policies

Pain Policy and Regulation: Pennsylvania

Summary

The Pennsylvania material on using controlled substances is found in an old licensing board newsletter and, at the time of this summary, it is not easy to find the document. Readers should check with their licensing board to find an official copy of the document and to check for any updates. Pennsylvania also has specific requirements relating to physician extenders and their ability to prescribe controlled substances. The detail in these materials is extensive and should be reviewed by the reader.

Pennsylvania Code on Prescribing Controlled Medications

Properly licensed clinicians who prescribe, administer, or dispense controlled substances must "carry out or cause to be carried out" the following minimum standards:

Initial Medical History and Physical Examination. The clinician is responsible for taking an initial medical history and conducting an initial physical examination in a healthcare facility regulated by the federal or state government, as required under the Pennsylvania code (health and safety and public welfare) or federal law, whichever applies to the facility. In other practice settings, before beginning treatment that involves prescribing, administering, or dispensing a controlled substance, the clinician must take an initial medical history and conduct an initial physical examination unless emergency circumstances justify otherwise. Alternatively, medical history and physical examination information recorded by another healthcare 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 must include an evaluation of the heart, lungs, blood pressure, and body functions that relate to the patient's specific complaint.

Reevaluations. Clinicians should consider the following factors, among others, when determining the number and frequency of each patient's follow-up evaluation schedule: (a) the condition diagnosed, (b) the controlled substance involved, (c) expected results, and (d) possible side effects.

For chronic conditions, the clinician should recommend periodic follow-up evaluations to monitor the effectiveness of the controlled substance in achieving the intended results.

Patient Counseling

Informed consent requires patient counseling. The clinician must provide the patient with appropriate counseling regarding the condition diagnosed and the controlled substance prescribed, administered, or dispensed. Unless the patient is in an inpatient care setting, the patient must be specifically counseled about dosage levels, instructions for use, frequency and duration of use, and possible side effects.

Note from the author: The concept of patient counseling is the state's attempt to provide clinicians with minimum standards for informed consent. Unfortunately, the state's attempt leaves out critical elements of a legal informed consent and might mislead a clinician into thinking that if the minimum standard set by the state is achieved, the clinician will be safe if sued. This is not true, and therefore the legal elements of informed consent, as structured by the American Medical Association Code of Ethics and cases nationwide interpreting the same, are provided here. Informed consent should be documented very carefully and clinicians should check with legal counsel for the American Medical Association or local medical association for updates.

Critical elements of informed consent relating to treatment of any kind (language adjusted to reflect treatment involving controlled medications):

1. A discussion of the risks associated with the controlled medication, including the potential for addiction, the concepts of physical dependence and tolerance, and a discussion of possible side effects and how they will be handled;
2. A statement of the anticipated benefits, including the reasonable period for achieving benefit;
3. Alternative and complimentary therapies and how they might contribute to the patient's ability to meet treatment goals and whether there are treatments that are available to the patient in lieu of the controlled medications; and
4. Special issues associated with the use of the controlled medications, such as making important decisions, driving a vehicle, job-related information, and safe handling and storage of controlled medications.

Medical Records

In a healthcare facility regulated by state or federal government, all information relating to the prescription, administration, or dispensation of a controlled substance must be entered in the patient's medical record and in the medical records of the healthcare facility. In other practice settings, the state code requires that certain information be entered each time a controlled substance is prescribed, administered, or dispensed to a patient. The following information must be included: (a) the name of the controlled substance, (b) its strength, (c) the quantity, and (d) the date it was prescribed, administered, or dispensed.

Note on initial prescribing: When initially prescribing, administering, or dispensing a controlled substance to a patient, the practitioner must document in the medical record specific information about (a) the symptoms observed and reported, (b) the diagnosis of the condition for which the controlled substance is being given, and (c) the directions given to the patient for the use of the controlled substance.

If a practitioner continues to prescribe, administer, or dispense the same controlled substance to the patient, the practitioner must document in the medial record (a) changes in the symptoms observed and reported, (b) changes in the diagnosis of the condition for which the controlled substance is being given, and (c) changes in the directions given to the patient.

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 must 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 must be covered by a written prescription delivered to the pharmacist within 72 hours.

In certain healthcare facilities regulated by the state or 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 Pennsylvania Code Chapter 25 (relating to controlled substances, drugs, devices, and cosmetics).

Note on "minimum standards." In the Pennsylvania code provisions relating to prescribing controlled substances, it is important to note that minimum standards do 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.

It is important for practitioners to understand that the Pennsylvania code states that despite state law (regulation/rule) requiring practitioners to, at a minimum, do the things set forth above, the state will not treat doing so as compliance with the standards of acceptable and prevailing medical practice when medical circumstances require that the practitioner exceed the requirements of this section.

The above information can be found in Pennsylvania code chapter 16, section 92, available at: http://www.pacode.com/secure/data/049/chapter16/s16.92.html.

Pennsylvania Code on Medical Records

Physicians must maintain medical records for patients that 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 must be made in a timely manner.

The medical record must 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.

Clinical information pertaining to the patient that has been accumulated by the physician and staff must be incorporated into the medical record. The medical record must also include diagnoses, findings and results of pathologic or clinical laboratory examination or radiology examination, medical and surgical treatment, and other diagnostic, corrective, or therapeutic procedures.

Patient's medical records must be kept 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 must 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.

The above information on medical records is available at: http://www.pacode.com/secure/data/049/chapter16/s16.95.html

Schedule II Controlled Substances

Unless there is an emergency, no controlled substance in schedule II may be dispensed without the written prescription of a properly licensed and registered practitioner. No prescription for a controlled substance in schedule II may be refilled.

Schedule III or IV Controlled Substances

Unless dispensed directly by a properly licensed and registered practitioner, other than a pharmacist, to an ultimate user, no controlled substance in schedule III or IV may be dispensed without a written or oral prescription. Such prescriptions may not be filled or refilled more than 6 months after the date thereof or be refilled more than 5 times after the date of the prescription unless renewed by the practitioner.

Schedule V Controlled Substances

No controlled substance in schedule V may be distributed or dispensed for other than a medicinal purpose.

Substantive Standards for all Controlled Substances

A practitioner may prescribe, administer, or dispense a controlled substance or other drug or device only (i) in good faith in the course of his or her professional practice, (ii) within the scope of the patient relationship, and (iii) in accordance with treatment principles accepted by a responsible segment of the medical profession.

A practitioner may cause a controlled substance, other drug or device, or drug to be administered by a professional assistant under his or her direction and supervision.

General Information Required on Drug Labels

Any drug or device dispensed by a pharmacist pursuant to a prescription order must include a label showing (i) the name and address of the pharmacy and any registration number obtained pursuant to any applicable federal laws, (ii) the name of the patient, or, if the patient is an animal, the name of the owner of the animal and the species of the animal, (iii) the name of the practitioner by whom the prescription order was written, and (iv) the serial number and date of filing of the prescription order. In addition, the following statement is required on the label of a controlled substance: "Transfer of this drug to anyone other than the patient for whom it was prescribed is illegal."

There are many record-keeping requirements for controlled substances in Pennsylvania, and the Controlled Drug Act should be read in its entirety. The Act is available at: http://www.health.state.pa.us/pdf/ddc/ddcAct.pdf

Pennsylvania Position on Issuance of Multiple Prescriptions for Schedule II Controlled Substances

This information is difficult to find on the Medical Board's Website. It can be found under the FAQ section for the Pennsylvania Department of Health by scrolling down to find the question. The regulations regarding the issuance of multiple CII prescriptions for the same controlled substance can be found at: http://app1.health.state.pa.us/ddc/DDCFaqs.asp#0000000052. The information is current as of September 30, 2008:

The Pennsylvania Controlled Substance, Drug, Device, and Cosmetic Act does not address the matter of multiple CII prescriptions and is silent on this issue. The Act, like federal law, does prohibit refills of CII drugs. The federal law is found in the Code of Federal Regulations, section 1306.12 (http://edocket.access.gpo.gov/cfr_2008/aprqtr/21cfr1306.12.htm). A summary is provided here.

1. The refilling of a prescription for a controlled substance listed in schedule II is prohibited.
2. 1. An individual practitioner may issue multiple prescriptions authorizing the patient to receive a total of up to a 90-day supply of a schedule II controlled substance provided the following conditions are met:
      1. Each separate prescription is issued for a legitimate medical purpose by an individual practitioner acting in the usual course of professional practice;
      2. The individual practitioner provides written instructions on each prescription (other than the first prescription, if the prescribing practitioner intends for that prescription to be filled immediately) indicating the earliest date on which a pharmacy may fill each prescription;
      3. The individual practitioner concludes that providing the patient with multiple prescriptions in this manner does not create an undue risk for diversion or abuse;
      4. The issuance of multiple prescriptions as described in this section is permissible under the applicable state laws; and
      5. The individual practitioner complies fully with all other applicable requirements under the Act and these regulations as well as any additional requirements under state law.
   2. Nothing in this paragraph (b) shall be construed as mandating or encouraging individual practitioners to issue multiple prescriptions or to see their patients only once every 90 days when prescribing schedule II controlled substances. Rather, individual practitioners must determine on their own, based on sound medical judgment and in accordance with established medical standards, whether it is appropriate to issue multiple prescriptions and how often to see their patients when doing so.

Section 1306.14, Labeling of substances and filling of prescriptions, has been amended by adding a new paragraph (e) to read as follows:

(e) Where a prescription that has been prepared in accordance with section 1306.12(b) contains instructions from the prescribing practitioner indicating that the prescription shall not be filled until a certain date, no pharmacist may fill the prescription before that date. (Published in the Federal Register November 19, 2007; effective December 19, 2007.)

Note: These regulations do not waive the requirement that the original issuance date be written on each.

Pharmacist Participation in Drug Therapy

A pharmacist is permitted to enter into a written agreement or protocol with a licensed physician authorizing the management of drug therapy in an institutional setting. The licensed physician who is a party to a written agreement or protocol authorizing the management of drug therapy must be in active practice, and the written agreement or protocol must be within the scope of the licensed physician's current practice. Read the specific Pennsylvania law in its entirety on the Pennsylvania Pharmacy Board Website, section 9.1, available at: http://www.dos.state.pa.us/bpoa/lib/bpoa/20/phabd/pharmacyact.pdf.

Pennsylvania and a Prescription Monitoring Program

Pennsylvania collects information on schedule II controlled substance prescriptions, but the state does not allow practitioners access to this information (current through May 2008). Pennsylvania needs to change this law if the state hopes to solve the problem of people from bordering states like Ohio coming to Pennsylvania and abusing and/or diverting schedule III, IV, and V controlled substances. A change is also needed to better protect Pennsylvania's clinician licensees.

[ CLOSE WINDOW ]

Author Information

Jennifer Bolen, JD, Jennifer Bolen, JD, Founder, The Legal Side of Pain, Lenoir City, Tennessee http://www.legalsideofpain.com

Disclosure: Jennifer Bolen, JD, has disclosed no relevant financial relationships.