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• Prescription Law Changes 2004

Prescription Law Changes 2004

Questions with an asterisk (*) have updated information. New questions-and answers are in a section at the end.

I've heard I can't use a triplicate form anymore to prescribe a controlled substance. What is happening?
A new law, SB 151, will replace the triplicate forms with a new tamper-resistant form. Effective July 1, 2004, prescribers will be required to use a new, tamper-resistant prescription form when providing prescriptions for Schedule II controlled substances to patients. Effective January 1, 2005, written prescriptions for all controlled substances must be on the new forms. Prescribers who dispense Schedule II controlled substances also will be required to submit information monthly to the Department of Justice. Effective January 1, 2005, dispensing of both Schedule II and Schedule III controlled substances must be reported. This is the timeline:

Effective January 1, 2004:

Prescribers have until June 30, 2004 to order new triplicate forms from the Bureau of Narcotics Enforcement, Department of Justice. The triplicate prescription forms may continue to be used until December 31, 2004.

Controlled substance prescriptions (Schedules II-V) are valid for six months. Such prescriptions are required to be signed and dated only by the prescriber.

Effective July 1, 2004:

Prescribers may begin using the new controlled substance prescription form.

Triplicate forms may continue to be used until December 31, 2004.

Prescribers who dispense Schedule II controlled substances must submit prescription information to the Controlled Utilization Review and Evaluation System (CURES) program at the Bureau of Narcotics Enforcement, Department of Justice. See below for the section discussing requirements for dispensing controlled substances.

Effective January 1, 2005:

Triplicate form prescriptions are no longer valid.

Prescribers who dispense Schedule II and/or III controlled substances must submit prescription information to the CURES program. See below for the section discussing requirements for dispensing controlled substances.

All written controlled substances prescriptions must be on the new controlled substance prescription form.

Can I order the new controlled substance prescription forms from any printer?
No. The forms may only be ordered from printers approved by the Board of Pharmacy and Department of Justice. The list of approved printers can be found at http://www.pharmacy.ca.gov/consumers/prescribe_dispense.htm. The Board of Pharmacy anticipates that as many as 20 or more new printers will be approved by the end of 2004. The new forms have several security features including latent void protection to prevent duplication and chemical void protection to prevent chemical alterations.

What makes the new form secure?
The new form has a number of different security features, and a description of each feature is on the back of each form:

• Void appears throughout the form when tampered with, to prevent duplication (i.e. chemical washing to alter).
• Watermark on the backside of the prescription with the text California Security Prescription.
• Thermo-chromic ink that changes color temporarily when exposed to heat
• A description of the security features printed on each prescription form
• Quantity check-off boxes
• The preprinted name, category or licensure, license number, and federal controlled substance registration number of the prescribing practitioner.
  
  

What information is required on the new forms?
The new forms may be ordered in any format you like (including duplicate copy), but the following information is required to be preprinted on the forms:

• Prescribers name or names
• Category of licensure, license number
• Federal controlled substance registration number (DEA number)
• One of two statements must be on the form (prescribers choice):
  (1) Prescription is void if more than one controlled substance is written per blank.
  (2) Prescription is void if the number of controlled substances prescribed is not noted.
  
  

Can more than one dentists name be listed on the new controlled substance prescription form?
Yes, if each listed dentist has a DEA number and all work at the same office.

I have more than one dental officemay I list both offices on the new controlled substance prescription form?
Yes, if it is a single dentist with multiple offices. If there are multiple dentists, the multiple addresses may be listed only if all the listed dentists practice at all the listed addresses.

What do I do with the old triplicate forms?
After December 31, 2004, when the triplicate forms are no longer valid, you can mail the forms to the Bureau of Narcotics Enforcement, Department of Justice, at the address noted on the forms.

I teach at the dental schooldo I have to provide my own forms, or is there an alternative?
Licensed health facilities, such as teaching facilities, are allowed to use institutional forms. Institutional forms have preprinted facility information, and they are ordered by the facilitys designated prescriber. The designated prescribers name, license number and DEA number also are preprinted on the forms. The designated prescriber issues the forms to other prescribers at the facility, and must keep a log of the distribution. The designated prescriber may delegate this task, but will be held accountable. The actual prescriber must add name, license, and DEA number to the forms. The distribution log must include the name, license number, DEA number, and quantity of forms issue, and the log must be maintained for three years.

Can I continue to fax in a prescription for a controlled substance to a pharmacy?
Yes, but only for Schedules III - V drugs. The prescription should be written on a regular prescription form in order for the pharmacy to read the fax. Faxing or photocopying the new controlled substance prescription form will create a copy that has VOID throughout the form. Remember, the new form is intended to be tamper resistant. A prescription communicated directly from prescriber to the dispensing pharmacy is far less likely to be tampered with.

Can I continue to call in a prescription for a controlled substance to a pharmacy?
Yes, but only for Schedules III - V drugs.

I usually dispense one or two tablets of Vicodin to patients when necessary can I continue to do this?
Yes, but there are several things you must do to comply with the law if you dispense Schedule III-V drugs to patients, according to Business & Profession Code Sections 4076, 4170, 4172:

1. Store controlled substances in a locked cabinet or drawer.

2. Maintain a log.

3. Prior to dispensing, offer to give a written prescription to the patient that the patient may elect to have filled by you, the dentist, or by any pharmacy. You must provide the patient with a written disclosure that the patient has a choice between obtaining the prescription from you, the dentist, or obtaining the prescription at a pharmacy of the patients choice.

4. When dispensing controlled substances to a patient, you must:

• Label the container with the prescribers name, patients name, drug name, date, dosage, quantity, directions for use, and expiration date.
• Inform the patient orally or in writing of possible side effects of the drug.

5. Starting July 1, 2004 for Schedule II drugs, and starting January 1, 2005 for Schedule III drugs, report those prescriptions to the CURES program on a monthly basis. This information is aggregated into a statewide database used by law enforcement and regulatory agencies. It is also available for prescribers and pharmacists who wish to obtain a patient drug history for someone under their care. Dispensing prescribers must submit the following information for each prescription filled:

• Full name, address, gender, and date of birth of the patient;
• Prescriber's category of licensure, license number, and federal controlled substance registration number;
• NDC (National Drug Code) number of the controlled substance dispensed;
• Quantity of the controlled substance dispensed;
• ICD-9 (diagnosis code), if available; and
• Date of dispensing of the prescription.

Does the administration of a Schedule II drug need to be reported to the CURES program?
No. However, every prescriber who prescribes or administers a Schedule II drug must make a record of the transaction that includes all of the following:

• Name and address of the patient
• Date of transaction
• Character, including name and strength, and quantity of the control substances involved
• The pathology and purpose for which the Schedule II drug is administered or prescribed

The information can be kept in the patient record; a separate drug log is not required for the administration of Schedule II drugs.

What is is the difference between "administration" and "dispensing" of controlled substances?
"Administration" is the injection, inhalation, or ingestion of a controlled substance into the patient for the patient's immediate needs. "Dispensing" is providing a controlled substance in a container to a patient for later use.

How do I report to the CURES program?
A Direct Dispensing Log and instructions are available on the CURES web site, www.ag.ca.gov/bne/trips.htm. You can print the log, complete it, and mail it to the address below.

Data specifications for creating a log with your own software are available from CURES or, for a limited time, from CDA. If you want to receive these specifications, please send an e-mail to contactcda@cda.org with CURES data specs in the subject field.

CURES is working to develop a secure system for individual prescribers to report electronically. CDA will inform you when the system is available.

California Department of Justice
Bureau of Narcotics Enforcement CURES Program
PO Box 160447
Sacramento, CA 95816
(916) 319-9062

Who do I contact for additional information?
You may contact the Board of Pharmacy, (916) 445-5014, www.pharmacy.ca.gov/consumers/prescribe_dispense.htm, the Bureau of Narcotics Enforcement at the telephone number above, or the CDA Contact Center (866) 232-6362.

Additional Questions & Answers
From the California State Board of Pharmacy

Do prescriptions for all controlled substances have to be entirely in the prescribers handwriting?
No, the prescriber is only required to sign and date controlled substance prescription, with limited exceptions.

Can a prescriber purchase stock prescription blanks for a laser or dot matrix printer that comes with all of the security features except for the preprinted prescriber name, category of licensure, DEA number and state license number?
No, the preprinted prescriber information is one of the security features and therefore, must be provided by an approved security printer. However, an approved security printer could offer for sale tamper-resistant security prescription blanks designed for laser or dot matrix printers as long as they are preprinted with the prescriber information before shipping to the prescriber. The prescriber could then send the patient and prescription information electronically to print on the laser prescription blank. The prescriber must the sign and date the prescription.

Note: Although the prescriber address is not required to be printed on the prescription form by the approved security printer, the pharmacist cannot fill the prescription without the prescriber address on the form. Therefore, the board recommends that prescribers order the new tamper-resistant security prescription forms with the address printed on the form. Multiple addresses are acceptable.

Can a prescribers staff person call in or send a fax for a Schedule III V prescription?
Yes, however, the prescription must include the name of the person calling in or faxing the prescription. A pharmacist or pharmacist intern must receive a telephone order. In addition, the pharmacist must authenticate the validity of the prescription.

What are the quantity check-off boxes on the new tamper-resistant prescription forms?
The quantity check-off boxes are a security feature that ensures the quantity, for which the prescription is written, is not tampered with in any way. The prescriber writes the prescription as usual, including the quantity, in the body of the prescription. In addition, the prescriber checks the box next to the applicable quantity range confirming the quantity for each prescription written. If the prescription is for anything other than tablets or capsules, the prescriber must also designate the units referenced in the quantity range.

How does a prescriber mark the quantity check-off boxes on the new tamper-resistant security prescription form when writing a prescription for multiple drugs on one prescription form?
Some of the new tamper resistant prescription forms provide separate sections for writing multiple drug prescriptions, which include separate quantity check-off boxes for each. However, some form designs include only one set of quantity check-off boxes. Prescribers check the appropriate quantity range confirming the quantity for each prescription written. For example, if a prescriber writes one prescription for 100 tablets and, on the same form, writes another prescription for 25 tablets, the prescriber would check the quantity ranges 75 to 100 and 25 to 49. If the quantity of more than one prescription falls within the same range, simply check the quantity range once. For example, if the prescriber writes three prescriptions and two are for 100 tablets each and one is for 300 tablets, the prescriber would check the quantity ranges 75100 and 151 and over.

Can a prescriber electronically transmit a Schedule III through V controlled substance prescription from a computer or personal digital assistant (PDA) to a pharmacys computer or fax machine?
Yes. Advice from the Drug Enforcement Administration in a letter from Patricia M. Good, Chief of the Liaison and Policy Section, Office of Diversion Control for the U.S. Department of Justice dated September 28, 2001, states that current DEA regulations allow for Schedule III, IV, or V controlled substances that are electronically created or transmitted, which includes PDAs, either directly to a computer or via facsimile machine, be treated as an oral prescription. This means the prescription must be reduced to hard copy form by the pharmacist and retained for at least three years. Additionally, a pharmacist that receives an electronically transmitted prescription via facsimile, or other methods, must ensure the validity of the prescription prior to dispensing the controlled substance (Title 21, Code of Federal Regulations section 1306.21). Electronically transmitted prescriptions, including those sent via PDA, must contain an electronic signature of the prescriber. Pharmacies must ensure the authenticity, integrity, nonrepudiation, and confidentiality of the document. Authentication means ensuring that the prescriber is the person he or she purports to be. Integrity means ensuring that both the document and the signature have not been altered in the course of transmission. Nonrepudiation means ensuring that a party to the transaction cannot later disclaim it. Moreover, a pharmacist has an affirmative obligation to verify a prescription when appropriate to do so. The pharmacy must also ensure that a prescription has been electronically transmitted to the pharmacy of the patients choice. This may be done a number of ways, including, but not limited to, an affirmative statement on the prescription that the prescriber advised the patient of this right.

Additional questions and answers can be found at the Board of Pharamcy web site. (www.pharmacy.ca.gov/consumers/prescribe_dispense.htm)

Updated January 2005