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Counterfeit Proof Prescription Pad Vendors

Counterfeit Proof Prescription Pad Vendors

For Vendors:

Effective July 1, 2018, section 456.44, Florida Statutes, was amended to require health care practitioners who prescribe controlled substance to indicate directly on the prescription pad if the prescription is for the treatment of pain other than acute pain.

Chapter 2018-13, Laws of Florida now requires:

  1. For the treatment of pain other than acute pain, a practitioner must indicate "NONACUTE PAIN" on the prescription.
  2. If claiming an exception to the acute pain prescribing limits, indicate "ACUTE PAIN EXCEPTION".

As an approved Counterfeit-Proof Prescription Pad Vendor you are required to add this indicator to new prescription pads produced for health care practitioners who prescribe control substances in Florida.

A sample prescription pad including new requirements may look like this: [SAMPLE]

NOTICE: Health care practitioners are not required to destroy prescription pads already purchased. They can hand write the words “NONACUTE PAIN” or “ACUTE PAIN EXCEPTION” directly on the prescription pad until they are ready to reorder.

For more information regarding the new requirements please visit: http://www.floridahealth.gov/licensing-and-regulation/counterfeit-proof-prescription-pad-vendors/index.html

Prescribing Practitioners:

Effective July 1, 2018, section 456.44, Florida Statutes, was amended to require health care practitioners who prescribe controlled substance to indicate directly on the prescription pad if the prescription is for the treatment of pain other than acute pain.

  1. For the treatment of pain other than acute pain, a practitioner must indicate "NONACUTE PAIN" on the prescription.
  2. If claiming an exception to the acute pain prescribing limits, indicate "ACUTE PAIN EXCEPTION".

NOTICE: Health care practitioners are not required to destroy prescription pads already purchased. They can hand write the words “NONACUTE PAIN” or “ACUTE PAIN EXCEPTION” directly on the prescription pad until they are ready to reorder.

Frequently Asked Questions

Allopathic prescribing practitioners (MD), osteopathic prescribing practitioners (OS), podiatric prescribing practitioners (PO), Dentists (DMD or DDS), optometrists (DO), physician assistants (PA), and Advanced Practitioner Registered Nurses (APRN).

No. Veterinarians are not regulated by section 456.42, F.S.

Prescriptions for controlled substances must be written on a counterfeit-proof pad produced by an approved vendor or electronically prescribed

The requirements for a written prescription are outlined in section 456.42, F.S.

Per section 893.02(7), F.S., "dispense" means the transfer of possession of one or more doses of a medicinal drug by a pharmacist or other licensed practitioner to the ultimate consumer thereof or to one who represents that it is his or her intention not to consume or use the same but to transfer the same to the ultimate consumer or user for consumption by the ultimate consumer or user.

Per section 893.02(21), F.S., "prescription" means and includes an order for drugs or medicinal supplies written, signed, or transmitted by word of mouth, telephone, telegram, or other means of communication by a duly licensed practitioner licensed by the laws of the state to prescribe such drugs or medicinal supplies, issued in good faith and in the course of professional practice, intended to be filled, compounded, or dispensed by another person licensed by the laws of the state to do so, and meeting the requirements of s. 893.04. … (Please see the statute for the complete definition.)

Per section 893.02(1), F.S., "administer" means the direct application of a controlled substance, whether by injection, inhalation, ingestion, or any other means, to the body of a person or animal.

A prescription may be typed, but must be signed by the prescribing practitioner on the day it is issued.

Section 893.04(1)(f) and (2)(c), F.S. reflect the following regarding oral prescriptions:

  • A prescription for a controlled substance listed in Schedule II may be dispensed only upon a written or electronic prescription of a practitioner, except that in an emergency situation, as defined by regulation of the Department of Health, such controlled substance may be dispensed upon oral prescription but is limited to a 72-hour supply. A prescription for a controlled substance listed in Schedule II may not be refilled.
  • Any controlled substance listed in Schedule III or Schedule IV may be dispensed by a pharmacist upon an oral prescription if, before filling the prescription, the pharmacist reduces it to writing or records the prescription electronically if permitted by federal law. Such prescriptions must contain the date of the oral authorization

 

Section 456.42, F.S. does not change the requirements for non-controlled substance prescription pads. There is no prohibition from using counterfeit-proof prescription pad/blanks for non-controlled substance prescribing.

Please reference section 408.0611, F.S., which defines an electronic prescription and section 465.035, F.S. for requirements for faxing prescriptions.

The paper used to prescribe controlled substances listed in Chapter 893, Florida Statutes, must be produced by a vendor approved by the Department of Health and must have printed on the front the vendors unique tracking identification number. This number will be used by the Pharmacy to confirm/verify the prescription was written on a pad/blank produced by an approved vendor. If the vendor you currently use to produce the paper for your EMR system is not on our list of approved vendors, please suggest they apply to become an approved vendor.

Section 456.42, Florida Statutes, requires written prescriptions for controlled substances listed in section 893.03, F.S., to be written on counterfeit-proof prescription pads. Please review section 893.03, F.S. to make your determination.

No, you are not required to pre-print your license number on the counterfeit-proof prescription pad or blank.

Approved vendors are required to provide a space on the counterfeit-proof prescription pad for the DEA number. The DEA number can be preprinted on the prescription pad or there can be a space for the for the DEA number to be handwritten (see Section 3(b) of Rule 64B-3.005). If a space is provided, it could be shown as DEA#_____________________.

Section 456.43, Florida Statutes, does not appear to address this question. Please consult your attorney and your vendor and use your professional judgment.

The counterfeit-proof prescription pad must have the name/address of the facility/practitioner, space for the practitioners DEA number, a place to indicate if the prescription is for the treatment of pain other than acute pain, and the vendor’s unique tracking identification number. If the practitioner is working at a facility, such as a hospital, the practitioner can use the facility’s counterfeit-proof prescription pads for the prescription by printing and signing their name on the front of the script, along with their DEA number and indicator if the prescription is for the treatment of pain other than acute pain.

Yes, you can provide blank stock to the practitioner for use with controlled substance prescriptions. However, the paper must meet all the security and safety standards required by the Department and the vendor must print their tracking number (three letter ID, date and batch number) on the front of the paper. If the practitioner is going to be printing more than one prescription per blank sheet, the tracking number must be listed multiple times on the sheet to accommodate multiple prescriptions. The practitioner CANNOT print the tracking number themselves.

The Practitioner needs to contact the vendor they are using and make sure the prescription paper meets all the specifications. The practitioner needs to confirm that the vendor is approved by the Florida Department of Health.

Practitioners will not be issued a "code" from the Department of Health. Please refer to the approved vendor list.

To ensure the quality and security of counterfeit-proof prescription pads provided by the vendor, the vendor must agree to produce a counterfeit-proof prescription pad or blank that meets the minimum specifications listed below:

  1. The background color must be blue or green and resist reproduction;
  2. The pad or blank must be printed on artificial watermarked paper;
  3. The pad or blank must resist erasures and alterations;
  4. The word “void” or “illegal” must appear on any photocopy or other reproduction of the pad or blank. This language shall not obstruct or render illegible any portion of the drug name, quantity or directions for use;
  5. The counterfeit-proof prescription pad or blank must contain the following information:
    • The preprinted name, address and category of professional licensure of the prescribing practitioner or the name and address of the healthcare facility;
    • A space for the prescribing practitioner’s name if not preprinted and federal Drug Enforcement Administration registration number for controlled substances;
    • A place to indicate if “NONACUTE PAIN” if the prescription is for the treatment of pain other than acute pain;
    • A place to indicate “ACUTE PAIN EXCEPTION” if the prescription is for the treatment of acute pain with exception as specified in s. 456.44, F.S.
    • A unique tracking identification number for each order on the front of the counterfeit-proof prescription pad or blank. The number must consist of three subsets: (1) a unique alphabetic prefix that readily identifies the vendor, (2) the date of printing, and (3) a batch number. The alpha prefix used to identify the vendor will be assigned by the department and must appear in upper case. The date of printing must immediately follow the vendor’s unique alpha identifier and must be presented in six character numerical field using the format YRMODY. The batch number assigned by the vendor must immediately follow the print date and consist of numerical characters and must not contain spaces or special characters (e.g., dashes, periods, commas, slashes, alpha characters). From left to right, the tracking identification number must appear as alpha prefix, print date, and then batch number, with no blank spaces between subsets. Counterfeit-proof Prescription Pad Sample (pdf)

 

A pharmacist must report to the sheriff or local law enforcement within 24 hours after learning of any instance in which a person fraudulently obtained or attempted to fraudulently obtain a controlled substance.

Yes. If a controlled substance prescription is written outside the State of Florida, it is not subject to Florida law.
Section 465.003(14), F.S. provides:
14) "Prescription" includes any order for drugs or medicinal supplies written or transmitted by any means of communication by a duly licensed practitioner authorized by the laws of the state to prescribe such drugs or medicinal supplies and intended to be dispensed by a pharmacist. The term also includes an orally transmitted order by the lawfully designated agent of such practitioner. The term also includes an order written or transmitted by a practitioner licensed to practice in a jurisdiction other than this state, but only if the pharmacist called upon to dispense such order determines, in the exercise of her or his professional judgment, that the order is valid and necessary for the treatment of a chronic or recurrent illness. The term “prescription” also includes a pharmacist’s order for a product selected from the formulary created pursuant to s. 465.186. Prescriptions may be retained in written form or the pharmacist may cause them to be recorded in a data processing system, provided that such order can be produced in printed form upon lawful request.

Yes. The Department has approved several out-of-state vendors to produce prescription pads/blanks.

No. The Department has approved several out-of-state vendors to produce prescription pads/blanks.

Yes, electronic and digital signatures are acceptable when practitioners and facilities are placing orders online.

No. The unique tracking identification number must be printed on the front of the blank and readily visible (see Section 3(c) of Rule 64B-3.005).

Yes. The licensed facility may be listed instead of the practitioner names if the names will not fit listed on the prescription. The vendor must validate the license number of the facility by referring to www.floridahealthfinder.gov. The hospital, clinic or other medical facility must have the physical address of the location listed on the front of the prescription, under the facility name.

The watermark is an artificial watermark created by the vendor or paper supplier. You can contact the vendor to find out what watermark was used with a specific order. The water mark may be as simple as the type of paper listed on the back of the prescription.

Contact the prescribing practitioner and ask them to verify with their vendor that the supplied paper meets all the requirements.

No. The date must be six digits, but the tracking number can be any length of numbers. The date must appear immediately following the vendor ID in year/month/day format (ABC110929xxxxxxxxx)

To ensure patients are not adversely affected and to address any confusion regarding the specification for printing a unique tracking number on counterfeit-proof prescription pads or blanks produced by approved vendor, the Department authorizes Florida licensed pharmacies to fill prescriptions for controlled substances written on a counterfeit-proof prescriptions with a unique tracking number that is incorrect,as long as the counterfeit-proof prescription pad or blank was produced by an approved vendor on or before November 1, 2011. Pharmacies should confirm the vendor is approved to produce counterfeit-proof prescription pads or blanks by visiting the Approved Vendor List. The pharmacy should also verify the prescription pad or blank was produced on or before November 1, 2011. The second subset of the unique tracking number shows the YRMODY on or before November 1, 2011 (e.g., 111101).

Contact the Division of Medical Quality Assurance, Board of Pharmacy, at (850) 245-4292 or via email at info@floridaspharmacy.gov for information about becoming an approved vendor for the Department of Health.

Section. 456.42, F.S., requires approved vendors submit a monthly report to the Department which, at a minimum, documents the number of prescription pads sold and identifies the purchasers. Such report must be submitted by the approved vendor and received by the Department no later than the 15th day of the following month. The Department is in the process of establishing procedures for vendor reporting. Once procedures are established, we will notify all approved vendors and post information online.

REPORTING

No. The report is based on sales for a specific month (e.g., August 1-31, September 1-30, etc). Vendors are required to submit their monthly report by the 15th of the following month (e.g., September 1st through September 15th).

The system will give you an error message for the following reasons:
A) Error Message: ERROR: Data for this reporting period already exists. This error message appears when trying to submit a report for a month that has already been opened. Once “Create Monthly Report” has been clicked, a report for the month is immediately created. If this error message appears, click the “HOME” link in the top right corner of your screen, then click “Update Monthly Report”. The option to “update report” or “delete report” will be given.
B) Error message: Invalid order date. Month value must be the same as the reporting month. This message appears when trying to submit a report that has two different dates in the “order date” box. The date submitted must correspond to the month showing in the dropdown box. For example, if the dropdown box reads “September”, then the dates entered into the “order date” box must be 09/01/2011,09/02/2011, etc.
C) Error message: Invalid order date. This message appears when the dates have been incorrectly entered the date in the “order date” box. For example, if the date entered is 8/21/11, the above error message will appear in red. The date must be entered as shown in the example, 08/21/2011, above the “order date” box.
Be sure to download the user guide for the vendor reporting (pdf). This guide will walk the user through the online reporting process.

When reporting for a facility, enter the name of the facility, followed by the names of the doctors.

In the “# Blanks/8½ x 11” field, list the number of sheets and then in the “single scripts” column, list the number of times the tracking number was printed. For example, 1000 in the “# Blanks/8½ x 11” box and 4000 in the “single scripts” box.

The “Imprint Scripts” box is for reporting the medications that were printed by the vendor on the prescription pads. If no medication was printed, nothing should be entered into the box

Yes. Upon logging into the reporting system, click on the link “create monthly report” for the month that needs to be reported and check the box directly under the reporting month and year that states “Please check here if you have no data to submit for the selected reporting period.” Be sure to click “OK” to submit for the month.

Once you click “Submit”, the report has been filed with the Department of Health. If more entries will be entered at a later date, save the changes made for that login and exit the system. If the monthly reporting is completed, click “Review” and make sure everything in the report is completed, then click “submit”. The system will prompt the vendor to confirm the monthly report is correct and that nothing will be added. If the report is complete, click “Submit”. The vendor will then have the option of printing the submitted report for their records. If the report is not complete and the vendor needs to make further changes, please contact the Department at 850-245-4063.

It is the vendor's responsibility to correct the error. The vendor will need to contact the Department regarding the incorrectly printed quantity and the correctly printed quantity. The vendor is responsible for working with the practitioner to ensure that the corrected order is without errors.

The prescriptions may be shipped to a medical facility or practitioner home, and the package must have a signature upon delivery. Prescriptions may not be shipped to Post Offices Boxes.

No. We realize the industry offers several pantograph solutions that invalidates a script if copied; however, since s. 456.042(2), Florida Statutes, required the department approve vendors to produce standardized counterfeit-proof prescription pads or blanks, the department adopted specifications that were already approved by the Agency for Health Care Administration, Medicaid Provider Program, and the Department’s Rule 64B-3.005, FAC. Both agencies requires a pantograph that displays the word "VOID" or "ILLEGAL" to appear on the prescription if copied.

To ensure patients are not adversely affected and to address any confusion regarding the specification for printing a unique tracking number on counterfeit-proof prescription pads/blanks produced by the vendor, the Department is notifying Florida Pharmacies that some approved vendors may have produced counterfeit-proof prescription pads/blanks that included spaces or special characters (e.g., dashes, periods, commas, slashes, alpha characters) in the vendor's unique tracking number and authorizing Florida pharmacies to accept prescriptions that included spaces or special characters in the vendor's unique tracking number as long as these prescriptions were produced prior to November 1, 2011 (the second subset with YRMODY, 111101) by an approved vendor. This will allow approved vendors who did not fully understand the requirement for printing the three subsets that make up the unique tracking number to make the appropriate corrections to ensure compliance with Rule 63B-3.005.
However, if the vendor prints an incorrect unique tracking number after November 1, 2011, the vendor must correct the printing error and reprint the order for the prescribing practitioner.

 

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