Tamper-Resistant Prescription Pads/Paper
Due to federal law, the use of tamper-resistant prescription pads/paper is required for all written prescriptions for outpatient drugs, including those for OTC drugs or products, for Medicaid clients.
The following prescriptions are required to be executed on tamper-resistant prescription pads/paper:
- Written prescriptions for outpatient drugs, including controlled and uncontrolled substances and OTC drugs or products, whenever Medicaid could pay for any portion of the cost of the prescription (including when Medicaid is the secondary payer).
- Written prescriptions for outpatient drugs given to Medicaid recipients from an outpatient hospital or independent medical clinic, outpatient psychiatric clinic, outpatient drug and alcohol clinic or psychiatric partial hospitalization clinic, or other situations in which the Medicaid recipient would take the written prescription to an outpatient pharmacy to be filled.
The following prescriptions or situations are exempt from this requirement:
- Prescriptions transmitted by telephone, by fax or electronically as an e-prescription directly to the pharmacy by the prescriber or prescriber's staff who is authorized to act on the prescriber's behalf.
- Prescriptions paid for by a managed care entity.
- When a prescriber administers or provides the drug directly (such as samples) to the patient.
- Written prescriptions prepared in an institutional setting where the prescriber writes the order into the medical record and then the order is given by medical staff directly to the pharmacy, such that the patient never has the opportunity to handle the written order.
- Prescriptions written for any medical item, service or equipment that is not considered an outpatient drug.
The law specifies three different characteristics that must be incorporated into the prescription pads/paper and each state has been charged with defining the specific features required by that state in order to comply with the federal requirement. Colorado has specified the features that are required as follows:
Characteristic #1: One or more industry-recognized features designed to prevent unauthorized copying of completed or blank prescription form. A written prescription shall contain at least one of the following features:
a. Void/Illegal/Copy Pantograph with or without the Reverse Rx feature. The word "Void", "Illegal", or "Copy" appears when the prescription is photocopied. If the paper has the Reverse Rx feature, the Rx symbol must disappear when photocopied at light setting. The Reverse Rx feature is not allowed as a feature by itself.
b. Micro-fine printed security message generated by a computer, electronic medical records system or other electronic means. The message may serve as a signature line or border. This must be printed in 0.5 font or smaller and readable when viewed at 5x magnification or greater and illegible when copied.
c. Coin-reactive ink or security mark. The pad or paper identifies an area on the pad/paper where the ink changes color or reveals wording or a picture when that area is rubbed by a coin. This must be accompanied by a message describing what is necessary to demonstrate authenticity.
d. Security print watermark. Specific wording is printed on the front or back of the prescription paper and can only be seen when viewed at an angle.
e. Paper with a watermark. This is paper that contains a watermark that can be seen when backlit.
Characteristic #2: One or more industry recognized features designed to prevent the erasure or modification of information written on the prescription by the prescriber. A written prescription shall contain at least one of the following features:
a. An erasure-revealing background. This is a background that consists of a non-white solid color or consistent pattern that has been printed onto the paper. If an erasure or modification is attempted, the background will show marks or the color of the underlying paper where the alterations were made.
b. Toner fusing technology for laser-printed prescriptions. This is a treatment that is added to the surface of the paper to create a strong bond between the laser-printed text and the paper. The computer-printed information cannot be lifted from the surface of the paper without damaging the paper.
c. Chemical-reactive paper. This is paper that contains features that show discoloration or reveals a hidden message if solvents are used to attempt to wash the ink from its surface.
d. Plain bond paper combined with inkjet-printing. The inkjet printing is absorbed into the high grade paper stock. Erasures and modifications cannot be made without damaging the paper.
e. Pre-printed quantity check-off boxes indicated in ranges of no more than 25 per range combined with a written quantity. The range box corresponding to the quantity prescribed must be checked by the prescriber for the prescription to be valid.
f. Pre-printed refill indicator where the number of refills allowed is marked or no refills or "NR" is marked when no refills are authorized. Refill information must be completed by the prescriber for the prescription to be valid.
g. Characters surrounding the authorized dispensing quantity and the number of refills. Special characters such as a series of asterisks must be repeated on both sides of the numbers indicating the quantity and the number of refills authorized, e.g., Quantity ***50*** Refill ***3***. This is acceptable only for prescriptions that are generated by a computer, electronic medical records system or other electronic means.
Characteristic #3: One or more industry recognized features designed to prevent the use of counterfeit forms. A written prescription must contain at least one of the following features:
a. Security features listed visibly in a box, band or border on the prescription. This must be a complete listing of all of the security features incorporated into the prescription pad/paper in order to minimize tampering.
b. Security threads. Metal, fluorescent or plastic security threads are embedded into the prescription pad/paper.
c. Thermochromic ink. All or some of the pad is pre-printed with ink that changes color when exposed to heat and then changes back to its original color when cooled. This must be accompanied by a message describing what is necessary to demonstrate authenticity.
It is important to understand that failure to comply with these requirements could result in a withholding of Medicaid reimbursement.
The following list may be useful in locating tamper-resistant pads/paper:
For further information on the federal requirement:
http://www.cms.hhs.gov/center/intergovernmental.asp
Letter from CMS to State Medicaid Directors
Two updates to tamper-resistant pads/paper requirement by CMS
Fact Sheet for Pharmacists by CMS