NABP Issues Criteria for "Specified List" of Drugs Susceptible to Diversion

January 7, 2005
Pharmaceutical Technology

NABP Issues Criteria for "Specified List" of Drugs Susceptible to Diversion

On 28 December, the National Association of Boards of Pharmacy (NABP, Mount Prospect, IL, www.nabp.net) issued criteria for adding pharmaceuticals to its "National Specified List of Susceptible Drug Products." NABP created the Specified List to help states "reduce redundancy and confusion as they update and adopt regulations" to reduce drug counterfeiting and diversion.  The NABP policy statement outlined eight conditions that could make a product a candidate for special handling, ranging from theft of a shipment to national shortages (the full NABP policy is reproduced below).

(At the same time, NABP issued an updated Specified List, adding Viagra (sildenafil) as the 32nd product. See the full Specified List below.)

Specified List products are likely to merit special record-keeping (such as Florida already requires), integral tracking devices (such as the radio frequency identification devices), and other measures. NABP designed the list to provide a single point of reference for its Model State Pharmacy Act and Model Rule of the National Association of Boards of Pharmacy.

These measures contribute to the overall effort to reduce fraud and diversion, outlined in the US Food and Drug Administration's February 2004 report, Combating Counterfeit Drugs. That report included an anti-diversion  timetable, in which NABP model acts and rules figure prominently  (see below).


Excerpts from the  National Association of Boards of Pharmacy Criteria for The National Specified List of Susceptible Products

December 28, 2004

Background

On February 20, 2004, the National Association of Boards of Pharmacy(r) (NABP(r)) released the updated Model Rules for the Licensure of Wholesale Distributors. The updated Model Rules, part of the Model State Pharmacy Act and Model Rules of the National Association of Boards of Pharmacy, were provided to assist state boards of pharmacy in maintaining the integrity of the United States medication distribution system through the regulation of wholesale distributors. The updated Model Rules are the result of a concerted effort between NABP and other representatives from pharmacy, government, and the wholesale distributor industry to protect the public from the ill effects of counterfeit drugs and devices.

In addition to stricter licensing requirements such as criminal background checks and due diligence procedures prior to wholesale distribution transactions, the Model Rules mandate specific pedigree requirements for products that are particularly prone to adulteration, counterfeiting, or diversion. These products, as defined in the updated Model Rules, are designated as the "National Specified List of Susceptible Products." In attempts to reduce redundancy and confusion as states update and adopt regulations, it is highly suggested that states adopt the "National Specified List of Susceptible Products" that have been developed in conjunction with NABP, governmental agencies, professional organizations, and other invited industry stakeholders. The original "List," which was adapted from the Florida Statewide Pharmaceutical Services and Drug Wholesaler Advisory Council (Florida Department of Health), represented a starting point for states that had an imminent need for such direction.

Purpose, Membership, and Appointment of the National Drug Advisory Coalition

The National Drug Advisory Coalition's primary purpose is to revise the "National Specified List of Susceptible Products" on no less than an annual basis. The National Drug Advisory Coalition will also be charged with drafting criteria and the ongoing assessment of the criteria that detail the standards and guidance for the revision process. The National Drug Advisory Coalition will consist of no more than 15 members (including ex-officio members) which will be appointed by the NABP Executive Committee. The voting membership of the National Drug Advisory Coalition will consist of representation from NABP, the state boards of pharmacy, American Medical Association, American Society of Health-System Pharmacists, Healthcare Distribution Management Association, National Association of Chain Drug Stores, Pharmaceutical Distributors Association, Pharmaceutical Research and Manufacturers of America, United States Pharmacopeia, and any other entity that the NABP Executive Committee deems appropriate. Ex-officio members, who are non-voting members, will serve as a resource for the National Drug Advisory Coalition including, but not limited to, one representative each from a primary and secondary wholesale distributor. Each voting member shall serve at least a two-year term and the Executive Committee shall stagger appointments. Upon appointment to the Coalition, each member shall provide the Executive Committee with its designated representative. If this designated representative is no longer affiliated with the member organization, then the member shall immediately appoint another designated representative and inform the Executive Committee.

Terminology

For the purposes of this document, the following definitions are applicable:

  • "Adulterated" has the same meaning as set forth at 21 U.S.C. §351 of the US Food, Drug, and Cosmetic Act. However, for purposes of assessing products to be added or removed from the National Specified List of Susceptible Products, the term "adulterated" shall not include situations where the adulteration is linked to manufacturer-related activities that have resulted in a manufacturer-or-agency initiated recall or withdrawal.
  • "Coalition" means the National Drug Advisory Coalition.
  • "Executive Committee" means the NABP Executive Committee.
  • "Manufacturer" means a person engaged in the manufacture of drugs or devices.
  • "National Specified List of Susceptible Products" or "List" means a specific list of prescription drugs to be designated by the National Drug Advisory Coalition; determined to be susceptible to adulteration, counterfeiting, or diversion; and posing the potential for a greater public health risk.
  • "Pedigree" means a document or record in a form, written or electronic, that records each distribution of any given drug, from the sale by a manufacturer through acquisition and sale by any wholesale distributor or repackager and/or pharmacy.
  • "Prescription drug" means a drug which is required under federal law to be labeled with either of the following statements prior to being dispensed or delivered: (i) "Rx Only"; or (ii) a drug which is required by any applicable federal or state law or rule to be dispensed pursuant only to a prescription drug order or is restricted to use by practitioners only.
  • "Single source drug" means a prescription drug that is designated as the only approved product available for that active ingredient, dosage form, and route of administration.
  • "Wholesale distributor" means any person engaged in wholesale distribution of drugs or devices, including but not limited to manufacturers; repackagers; own-label distributors; private-label distributors; jobbers; brokers; warehouses, including manufacturers' and distributors' warehouses, chain drug warehouses, and wholesale drug warehouses; independent wholesale drug traders; and retail pharmacies that conduct wholesale distributions.
Criteria for the National Specified List of Susceptible Products
Section 1.

The Coalition may recommend that a prescription drug be placed on the National Specified List of Susceptible Products if the Coalition receives official notice in writing from the United States Food and Drug Administration, a manufacturer, a wholesale distributor, a state or federal law enforcement agency, or a state or federal government agency responsible for regulating the sale or distribution of prescription drugs that the prescription drug has been adulterated, counterfeited, or diverted from the legal channels of distribution for prescription drugs; and the prescription drug satisfies one of the following criteria:

  • (I) The Coalition receives notice from a law enforcement agency that a significant shipment of a prescription drug has been stolen or missing;
  • (II) The prescription drug is subject to a special, limited distribution process and is not generally sold to wholesale distributors by the manufacturer of the prescription drug because of concerns for counterfeiting or diversion;
  • (III) The Coalition receives notice from a manufacturer, a wholesale distributor, or a law enforcement or government agency responsible for regulating the sale or distribution of prescription drugs, that a falsified pedigree (or other similar documentation) was passed or a legitimate pedigree was not passed by or to a wholesale distributor or pharmacy;
  • (IV) The prescription drug is used extensively for serious and/or life-threatening conditions, where drug non-responsiveness would not be considered to be medically unusual;
  • (V) The prescription drug is a single source injectable drug or immune globulin;
  • (VI) The prescription drug is commonly prescribed and available for normal prescription use in dosages or strengths that have a substantial wholesale cost or appears among the IMS top 50 single source revenue-generating prescription drugs that may encourage counterfeiting or diversion;
  • (VII) The prescription drug is in limited supply due to a national shortage and the shortage is characterized by a time period of no less than nine months; or
  • (VIII) The prescription drug exhibits a similar mechanism of pharmacologic action and/or possesses a similar chemical structure of another prescription drug that is already included on the List.
Section 2.

The Coalition may recommend that a prescription drug may be considered to be placed on the List if the prescription drug satisfies any three of the eight criteria as set forth in Section 1. However, a prescription drug may not be included on the List if the prescription drug is unlikely to be counterfeited or diverted from the legal channels of distribution for prescription drugs.

Section 3.

Prior to recommending the placement of a prescription drug on the List the Coalition shall consider the criteria enumerated in Section 1 and 2 and provide a written recommendation adopted by majority vote to the Executive Committee concerning each such prescription drug.

Section 4.

 When a prescription drug is added to the List, the Executive Committee will notify (via electronic means, facsimile, or US mail and on NABP's web site) all state boards of pharmacy (or other state government agency responsible for regulating the sale or distribution of prescription drugs), the US Food and Drug Administration, the manufacturer of that prescription drug, and various national health professional and industry associations of the inclusion of that prescription drug to the List. Any addition to the List will become effective 90 (ninety) days after the Executive Committee officially releases such information. The Executive Committee will provide notice to all aforementioned entities when a prescription drug is deleted from the List.

Section 5.

If the Coalition or Executive Committee determines that a prescription drug should be added to the List by emergency vote, due to an imminent and significant public health concern, the Coalition and Executive Committee may proceed to add such drug to the List and the emergency addition shall be effective for a period of one year from the date on which the emergency addition is added. Once the Coalition reconvenes the Coalition will determine whether or not the emergency addition should remain on the List. A prescription drug may be placed on the List via an emergency vote when:

  • (I) The prescription drug satisfies any two of the criteria specified in Section 1 or Section 2; or
  • (II) The prescription drug satisfies any one of the criteria specified in Section 1 or Section 2 if the prescription drug has not yet become available for wholesale distribution or has been available for wholesale distribution for not more than 60 days.
Section 6.

Not less than annually, the Coalition shall evaluate whether or not each prescription drug included on the List should remain on the List. In determining whether a prescription drug should remain on the List, the Coalition should consider:

  • (I) Whether the conditions contributing to the placement of the prescription drug on the List still exist and are applicable;
  • (II) The availability of generic forms of the prescription drug; and
  • (III) Pricing actions that may impact the diversion or counterfeiting potential of the prescription drug since it was placed on the List. The Coalition shall provide a written recommendation adopted by majority vote to the secretary of the Executive Committee concerning each prescription drug that the Coalition recommends be removed from the List.

National Association of Boards of Pharmacy National Specified List of Susceptible Products

28 December 2004

The National Association of Boards of Pharmacy Model Rules for the Licensure of Wholesale Distributors defines the "National Specified List of Susceptible Products" as a specific list of drugs or devices to be designated by the state, or a third party approved by the state, determined to be susceptible to adulteration, counterfeiting, or diversion and posing the potential for a greater public health risk.

  • Combivir(r) (lamivudine/zidovudine)
  • Crixivan(r) (indinavir)
  • Diflucan(r) (fluconazole)
  • Epivir(r) (lamivudine)
  • Epogen(r) (epoetin alfa)
  • Gamimune(r) (globulin, immune)
  • Gammagard(r) (globulin, immune)
  • Immune globulin
  • Lamisil(r) (terbinafine)
  • Lipitor(r) (atorvastatin)
  • Lupron(r) (leuprolide)
  • Neupogen(r) (filgrastim)
  • Nutropin AQ(r) (somatropin, E-coli derived)
  • Panglobulin(r) (globulin, immune)
  • Procrit(r) (epoetin alfa)
  • Retrovir(r) (zidovudine)
  • Risperdal(r) (risperidone)
  • Rocephin(r) (ceftriaxone)
  • Serostim(r) (somatropin, mannalian derived)
  • Sustiva(r) (efavirenz)
  • Trizivir(r) (abacavir/lamivudine/zidovudine)
  • Venoglobulin(r) (globulin, immune)
  • Viagra(r) (sildenafil)
  • Videx(r) (didanosine)
  • Viracept(r) (nelfinavir)
  • Viramune(r) (nevirapine)
  • Zerit(r) (stavudine)
  • Ziagen(r) (abacavir)
  • Zocor(r) (simvastatin)
  • Zofran(r) (ondansetron)
  • Zoladex(r) (goserelin)
  • Zyprexa(r) (olanzapine)

FDA Timetable for Combating Counterfeit Drugs

FDA Timetable for Combating Counterfeit Drugs

Now

Next Year

Within Three Years

Authentication (overt, covert, forensic)Higher criminal penaltiesElectronic pedigree

Adapted from Combating Counterfeit Drugs, FDA, February 2004