Clarification of Senate Bill 151

Exerpted from April 2004 Action Report

After the Medical Board ran a February 2004 Action Report article regarding new changes for triplicate prescription forms, the Medical and Pharmacy boards received numerous inquiries requesting clarification of the new law. The changes can be confusing as they affect two groups of physicians-the practitioner who examines a patient and prescribes a Schedule II controlled substance for the patient, and the practitioner who examines a patient, prescribes a Schedule II controlled substance, and also dispenses the prescription for the patient at his or her office.

The following explains the responsibilities of the physician prescriber and the physician dispenser:

For the non-dispensing practitioner, the responsibility is unchanged. A practitioner who prescribes a Schedule II drug must document the following in the record:

1. Name and address of patient
2. Date
3. Name, strength and quantity of the controlled substance

For the dispensing practitioner, there are reporting obligations to the California Department of Justice (DOJ). To clarify, a dispensing practitioner is a physician who not only examines the patient and writes a prescription for treatment, but also fills the prescription onsite at his or her office. The dispensing prescriber's record must show the pathology and purpose for which the controlled substance is prescribed. For each prescription for a Schedule II drug dispensed, the prescriber must record and maintain all of the following:

1. Full name, address, gender, and date of birth of the patient
2. The prescriber's license number, federal controlled substance registration number, and the state medical license number of any prescriber using the federal controlled substance registration number of a government-exempt facility
3. National Drug Code number of the medication dispensed
4. Quantity of the controlled substance dispensed
5. ICD-9 (diagnosis Pharmacy code), if available*
6. Date of dispensing of the prescription

According to Health and Safety Code section 11159.2, physicians who write prescriptions for Schedule II drugs for terminally ill patients are not subject to Health and Safety Code section 11164, which pertains to the execution and contents of prescriptions for Schedule II-V drugs. These prescriptions must indicate that the prescribing physician has certified that the patient is terminally ill by using the words "11159.2 exemption," and can be written on an ordinary prescription form. The following timeline is included to assist you in preparing for these changes to California prescribing laws:

Effective January 1, 2004

• Controlled substance prescriptions (Schedules II-V) are valid for six months.
• All pharmacies are required to report Schedule II drug prescriptions to the CURES program in a time and manner established by the DOJ.
• Schedule II-V drug prescriptions may be printed or written by the prescriber's staff but are required to be signed and dated by the prescriber after the information is filled in.

Effective July 1, 2004

• The DOJ will no longer produce or distribute triplicate prescription forms.
• The existing supply of triplicate prescription forms can continue to be used to prescribe Schedule II drugs through December 31, 2004.
• Prescribers may use the new controlled substance prescription forms for Schedule II drug prescriptions.
• Oral and electronic orders for Schedule II drug prescriptions for patients in skilled nursing facilities, intermediate care facilities, home healthcare programs, and hospice programs are permitted. Such orders must be reduced to hardcopy form and signed by the pharmacist on a form of the pharmacy's design.
• Prescribers dispensing Schedule II drugs are required to begin reporting these prescriptions to the DOJ. (DOJ reporting information will be posted on the board's Web site as soon as it is available.)

Effective January 1, 2005

• Triplicate prescription forms are no longer valid.
• All written controlled substance prescription drugs shall be on the new tamper-resistant prescription forms.
• Oral and fax prescriptions for Schedule III-V are still permitted.
• Pharmacies must report Schedule III drug prescription information to the CURES program.
• Prescribers dispensing Schedule III drugs must report those prescriptions to the DOJ.

Note: Separate regulations for skilled nursing homes, intermediate care, and hospital settings are available on the Board of Pharmacy's Web site at: www.pharmacy.ca.gov.

Note: To avoid a patient keeping a prescription written on an old form and attempting to have it filled after January 1, 2005, the board suggests that physicians transition to using the new forms at least six months in advance.

Note: Any controlled substance classified in Schedule III, IV, or V may be dispensed with an oral, faxed or electronically transmitted prescription, which must be reduced to hard copy by the pharmacist filling the prescription or by any authorized persons per Health and Safety Code section 11150.

See the "Frequently Asked Questions" below for answers to additional questions you may have regarding the new prescription forms.

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Frequently Asked Questions

Q. In reference to the February 2004 article "New State Law Changes Requirements for Triplicate Drug Prescription Forms," can you separate the responsibilities of the physician who writes a Schedule II controlled substance prescription from the responsibilities of the physician who writes and dispenses a Schedule II controlled substance prescription?

A. The February 2004 article was confusing in that it did not distinguish the differences in responsibilities between a physician who prescribes a controlled substance and a physician who prescribes and dispenses a controlled substance (much like a pharmacist). A clear description of the mandated responsibilities for physicians who write prescriptions for Schedule II controlled substances and for physicians who write and dispense prescriptions for Schedule II controlled substances is presented earlier in this article. It is important to review the timelines included in the article to insure that the changes in prescribing of Schedules II-V controlled substances are met. Also, refer to the link on the Board of Pharmacy Web site titled, "Prescribing and Dispensing Controlled Substances," click on "Information for Prescribers and Pharmacists," and review the numerous materials available including the "Flowcharts for Dispensing Process for Controlled Substances." This is valuable information to assist in understanding and preparing for the changes in law. (Due to space restraints, the board is unable to include these charts in this issue.)

Q. I was unable to access Health and Safety Code sections 11159.2 and 11164 through the Web site at www.leginfo.ca.gov. Can you provide another access?

A. Health and Safety Code section 11159.2 is only accessible by requesting 11159 (for some reason the system does not recognize 11159.2). After clicking on section 11150 to 11180, scroll down to 11159.2. Section 11164 also is located within this same group of sections.

Q. Can the new prescription pads be used for all drugs, or just controlled substances?

A. As of January 1, 2005 all controlled substance prescriptions must be written on the new prescription form. However, any prescription can also be written on this form.

Q. Where can a physician obtain the history of a patient's use of Schedule II controlled substances if the physician suspects drug abuse?

A. The request form titled, "Patient Activity Report (PAR)," can be downloaded from the board's Web site under "Services for Licensees." As of January 1, 2003, all licensed healthcare practitioners (who are authorized to obtain triplicate prescription forms) are able to obtain a "patient history" or activity report from DOJ to assist in identifying those patients who may be "doctor shopping." The activity report will provide the practitioner with a list of all Schedule II controlled substances that have been prescribed to the patient and includes the name of the practitioner issuing the prescription and the pharmacy where the prescription was filled. The Activity Report may also assist the practitioner in determining if a patient has altered the quantity of drugs prescribed from the original order or if illegal orders have been made in the practitioner's name by office personnel or others. To request a Patient Activity Report, the request must be made in writing by the practitioner and submitted to DOJ by fax (916) 227-5079 or mail to: California Department of Justice, P.O. Box 160447, Sacramento, CA 95816. (Additional information on the CURES program is available in the February 2003 Action Report located on the Medical Board's Web site under "Publications.")

Q. Is the new prescription form faxable and/or acceptable for photocopy?

A. No, the new prescription forms that replace the triplicate prescribing form are for written prescriptions only that the physician gives to the patient to be filled at a pharmacy. If the physician also dispenses a prescription, he or she must complete the additional requirements listed earlier in this article. If there is an attempt to fax or copy the prescription, the word VOID will automatically appear on the form. In that case, a physician may use a form of his or her own design to fax a prescription to the pharmacy as long as all of the required information is included.

Q. How will physicians know who is certified to provide the new Schedule II controlled substance prescription forms?

A. The Medical Board will provide a Web site link on its home page to the Board of Pharmacy's Web site where a list of approved security printers and contact information for purchasing the new forms will be posted. Check the Medical Board's Web site at www.caldocinfo.ca.gov or www.mbc.ca.gov, or the Board of Pharmacy's Web site at www.pharmacy.ca.gov, after April 30, 2004.

Q. What was the intent of SB 151 and the reasoning behind changing the prescribing law?

A. The intent of the new law is to promote patient access to appropriate pain medications, while concurrently reducing the illegal diversion of prescription drugs.

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* Number 5, above, the ICD-9 diagnosis code, is used by Medicare and must be included on all prescriptions for Medicare patients. A prescriber's staff should have this information available to fill in as it is a pre-existing requirement of Medicare.