Narcotic Treatment Programs Best Practice Guideline
Once an NTP is registered by DEA the program will be provided an initial supply of "US Official Order Forms - Schedules I and II" (DEA Form-222). [21 CFR 1305.05(b)]. The forms must be used when ordering any schedule II medications (e.g., methadone, LAAM). [21 CFR 1305.03]. A copy of DEA Form-222 is found in Appendix B.
The following sections outline procedures for executing the order forms and offer recommendations for establishing a systematic ordering system to ensure that an adequate supply of medication is available. Procedures for responding to emergency situations, such as when a supply of the medication is needed and normal ordering procedures cannot be used, are also discussed.
- Completing and Submitting the Order Form
- Establishing and Maintaining an Ordering System
- Emergency Orders
Steps for completing and submitting a DEA Form-222 include the following:
- To order needed medication, a DEA Form-222 must be completed by the NTP.
The following instructions for completing and executing order forms have been compiled from 21 CFR 1305.06, 1305.07, 1305.09, and 1305.11 as well as from the instructions located on the back of Copy 3 of the order form.
- Order forms must be prepared using a typewriter, pen, or indelible pencil.
- No order form shall be filled if it (1) is not complete, legible, or properly prepared, executed, or endorsed, or (2) shows any alteration, erasure, or change of any description. A defective order form may not be corrected; it must be replaced by a new order form.
- However, DEA has acknowledged that some minor changes may be accepted by a supplier. For instance, suppliers may correct order forms that contain minor errors (e.g., forms which are missing inconsequential information, or forms on which a purchaser has unintentionally inserted an incorrect date.
- The name and address of the supplier from whom the medication is being ordered must be entered on the order form.
- Only one supplier may be entered on any order form.
- Only one item must be entered on each numbered line. According to the instructions found on the back of Copy 3 of the order form, an item is any number of units of the same description, i.e., the same kind of medication and the same size container or the same number and size of dosage units.
- The number of lines completed must be noted on the form. A space is provided for the insertion of this information above the "date issued" block.
- Each order form must be signed and dated by the person authorized to sign an application for registration/renewal application, and others designated by a power of attorney.
The power of attorney regulation is presented below. An example of the type of form that can be used as a power of attorney for DEA order forms and a sample notice of revocation of the power of attorney is found in Appendix B.
- According to the instructions found on the back of Copy 3 of the order form, the order form should be dated and signed as of the day it is submitted for filing.
Any purchaser may authorize one or more individuals, whether or not located at the registered location of the purchaser, to obtain and execute order forms on his/her behalf by executing a power of attorney for each such individual. The power of attorney shall be signed by the same person who signed the most recent application for registration or reregistration and by the individual being authorized to obtain and execute order forms. The power of attorney shall be filed with the executed order forms of the purchaser, and shall be retained for the same period as any order form bearing the signature of the attorney. The power of attorney shall be available for inspection together with other order form records. Any power of attorney may be revoked at any time by executing a notice of revocation, signed by the person who signed (or was authorized to sign) the power of attorney or by a successor, whoever signed the most recent application for registration or reregistration, and filing it with the power of attorney being revoked. [21 CFR 1305.07].
- After filling in the information required to submit an order, the NTP sends Copies 1 and 2 of the DEA Form-222 to the supplier. The supplier retains Copy 1 for its records and submits Copy 2 to DEA. [21 CFR 1305.09(a),(d)]. At present, the forms should be mailed, not faxed, to the supplier (except in an emergency).
- Order forms must be maintained separately from all other records. Copy 3 of the executed order forms and any attached statements or other related documents must be retained at the registered location printed on the order form. [21 CFR 1305.13(c)].The NTP should establish and maintain a separate, readily retrievable file containing Copy 3 of all executed order forms.
- The order forms must be retained for two years after the date of execution [21 CFR 1305.13(c)], or for the length of time required by the State Methadone Authority, whichever is the stricter requirement.
- If an order cannot be filled in its entirety, it may be filled in part and the balance supplied by additional shipments within 60 days following the date of the order form. No order form is valid more than 60 days after its execution by the purchasing NTP.[21 CFR 1305.09(b)]
- Whenever a purchaser or supplier discovers that any used or unused order forms are stolen or lost, he/she must, immediately upon this discovery, report the theft or loss to the local DEA diversion field office, stating the serial number of each form. If the circumstances surrounding the theft or loss result in the purchaser (the NTP) being unable to state the serial numbers of the order forms, he/she must report, in lieu of the numbers of the forms, the date or approximate date the forms were issued to the NTP by DEA. [21 CFR 1305.12(b)].
- If any unused order form reported stolen or lost is subsequently recovered or found, the local DEA diversion field office must be immediately notified. [21 CFR 1305.12(b)].
To ensure that an adequate supply of medication is available to meet patient dosing requirements, it is recommended that programs establish and maintain a consistent ordering system. Important elements of such a system include the following:
- One NTP staff member should be designated to monitor medication inventory, complete order forms, and ensure that adequate supplies of medication and order forms are available at the program.
- The point in time at which an order for additional medication should be sent to the supplier should be determined by considering:
- The number of patients in the program,
- The average patient dose,
- The capacity of the safe used by the program to store the medication, and
- The usual length of time between the date an order form is mailed to the supplier and the date that the order is received by the program.
- The NTP's available supply of order forms (DEA Form-222) should be systematically monitored. To maintain an adequate supply, additional order forms may be requested from the local DEA diversion field office (see Appendix D).
The NTP should anticipate a two to three week processing time before it receives the forms.
An emergency order occurs when an NTP does not have an adequate supply of medication in its inventory to meet patient dosing requirements, and would not be able to obtain the needed medication from the supplier in time to meet these requirements if normal ordering procedures were used. To address an emergency order when a DEA Form-222 is available, the NTP should arrange a transfer of medication from another NTP or other DEA registrant (i.e., hospital or pharmacy). If an order form is not available, the NTP should contact the local DEA diversion field office to authorize an emergency shipment and should also contact the supplier. Specific procedures to be used in these situations follow.
- Procedures When an Order Form is Available
- Procedures When an Order Form is Not Available
When an order form is available, the following actions should take place:
- The State Methadone Authority should be notified by the NTP supplying the medication that a transfer is being planned.
- The NTP in need of medication must complete a DEA Form-222. [21 CFR 1305.03].
- On the order form, the NTP supplying the medication must be listed as the supplier. [21 CFR 1305.06(c)].
- There must be adequate security arrangements for the safe transfer of the medication to the receiving NTP. [21 CFR 1301.74(f)]
- The NTP in need of the medication must submit Copies 1 and 2 of DEA Form-222 to the NTP that is supplying the medication. [21 CFR 1305.09(a)].The supplying NTP then transfers the quantity of medication indicated on the order form to the NTP in need of the medication.
- The NTP supplying the medication may wish to notify the local DEA diversion field office if a significant amount of medication is being transferred.
- The NTP supplying the medication must retain Copy 1 for its records and submit Copy 2 to the local DEA diversion field office. [21 CFR 1305.09(d)].
Specific procedures used when an order form is not available include the following:
- The NTP in need of medication should contact the local DEA diversion field office for assistance. The program should be prepared to provide DEA personnel with the name and phone number of a contact at the supplier, the NTP's DEA number, and the quantity of medication needed.
- The NTP should also contact the supplier to request the needed medication, and have the supplier contact the local DEA office to confirm that the emergency order was authorized. At that time, the supplier may ship the needed medication to the NTP.
- Once the NTP receives their supply of DEA Form-222s, the NTP must submit an order form to document the emergency order authorized by DEA. [21 CFR 1305.03].It is recommended that the order form reflect the actual date that the shipment of medication occurred.
- The NTP in need of the medication then submits Copies 1 and 2 of the order form to the supplier, and retains Copy 3 for their records. [21 CFR 1305.09(a)].