Tamper-Resistant Prescription Pads

As of October 1, 2008 the second phase of the Centers for Medicare and Medicaid Services tamper-resistant prescription pad requirements takes effect. The law requires that all hand-written and/or computer-generated printed prescriptions for Medicaid outpatient drugs must comply with federal and/or state guidance for tamper resistance.

Currently, a handwritten or computer-generated printed prescription must contain at least one of the following three characteristics to be compliant. By Oct. 1, handwritten or printed prescriptions must contain all three of the following characteristics:

1. One or more industry-recognized features designed to prevent unauthorized copying of a completed or blank prescription form
2. One or more industry-recognized features designed to prevent the erasure or modification of information written on the prescription by the prescriber
3. One or more industry-recognized features designed to prevent the use of counterfeit prescription forms

The National Council for Prescription Drug Programs (NCPDP) suggests the following best practices to meet the tamper-resistant requirements:

Category 1: A) Photocopied “COPY”, “ILLEGAL” or “VOID” Pantograph
Category 2: A) An Erasure revealing background (resists erasures and alterations)
                   B) Quantity check off boxes
                   C) Refill indicator (circle number of refills or “NR”)
Category 3: A) Security features and descriptions listed on the prescription.

Note: While the law specifies “prescription pad,” these requirements also apply to computer-generated prescriptions that are printed using paper inserted into the printer, according to CMS. In addition, the agency has clarified that while special paper may be used to achieve copy resistance, it is not necessary. Computer-generated prescriptions may be printed on plain paper and be fully compliant with the regulations provided they contain at least one feature from each of the three categories.

The tamper-resistant requirement does not apply when a prescription is communicated by the prescriber to the pharmacy electronically, verbally, or by fax; when a managed care entity pays for the prescription; or in most situations when drugs are provided in designated institutional and clinical settings, according to CMS. In addition, emergency fills with a non-compliant written prescription are allowed as long as the prescriber provides a verbal, faxed, electronic or compliant written prescription within 72 hours.

For more information, download the CMS frequently asked questions document. (offsite PDF, 57K)

Related Information

Below are links to the State Medicaid Director Letter and an informational background document for State health policy makers that includes a checklist of questions to ask to begin implementation.

State Medicaid Director Letter (PDF, 81K)

State Health Policymakers Backgrounder (PDF, 42K)