Diversion Control Division, US Department of Justice, Drug Enforcement Administration

Narcotic Treatment Programs Best Practice Guideline

PART 4

DISPENSING / ADMINISTERING MEDICATION

The medication may be dispensed or administered manually or by using a computer system. Growing numbers of NTPs are using automated dispensing equipment in conjunction with computer software programs. Part 4 includes recommendations to assist NTPs to achieve maximum efficiency in the operation of these dispensing systems and in the use of computer software for dispensing the medication and/or for related recordkeeping.

At present, there are three forms of medication used in treatment: liquid, solid, and powdered. The NTP is advised to contact the State Methadone Authority to determine whether there are any specific prohibitions regarding the dispensing of any form of medication.

The recommendations presented below focus on procedures for dispensing/administering of liquid and solid medication. Those programs using powdered medication, which is converted to a liquid form prior to its utilization in treatment, should follow the recommendations presented below for liquid medication.


Using Automated Dispensing Pumps for Liquid Medication

The following sections present recommended procedures for maintaining and calibrating automated dispensing pumps.

  • Manufacturer's Instructions and Technical Assistance
    • Read and follow the instructions in the manufacturer's manual prior to beginning operation.
    • After beginning operation, follow the general care and usage instructions in the manufacturer's manual on a day-to-day basis.
    • To prevent loss of the manufacturer's instruction manual and to ensure that it is available whenever it is needed, store the manual in a specific location in the NTP's medication area or administration office. Make an extra copy of the manual and store this back-up copy in a separate location.
    • When questions pertaining to the operation and maintenance of the dispensing system arise, do not hesitate to contact the technical service department of the system manufacturer. The NTP should designate a specific individual to make such contacts.
  • Cleaning and Storing Equipment
    • An automated dispensing system should be flushed with tepid, distilled water each day. (Tepid water is needed because excessively hot water can be corrosive to stainless steel equipment.)
    • To prevent drying out of equipment, after flushing, distilled water should be left in the pump and tubing until the system is ready to be refilled with medication.
    • Only authorized and trained personnel should purge the pump.
  • Calibrating the Equipment
    • Because manufacturers vary in their recommendations related to calibration of automated dispensing pump equipment, NTPs are advised to review the specific recommendations regarding calibration of pumps provided by the manufacturer of their pump. Some manufacturers recommend the use of volumetric flask calibration standards while others recommend the use of gravimetric calibration standards. In addition, some manufacturers recommend that pump equipment be recalibrated at the factory, while others deem on site recalibration to be appropriate. If recalibration is to be implemented at the NTP site, it is recommended that those NTP personnel who have been designated as responsible for recalibration be trained and certified by the pump manufacturer or the manufacturer's designee to ensure accurate calibration.

      Other recommendations regarding calibration include the following:

    • To minimize errors in the pumping of medication, automated dispensing pumps should be calibrated and serviced following the manufacturer's recommendations.
    • Only certified, designated personnel should be involved in recalibrating equipment. These personnel should follow the manufacturer's recommendations and procedures during the recalibration process.
    • The NTP should maintain a log documenting the history of pump recalibration.
    • Pump output should be verified periodically, using either volumetric or gravimetric measures, as recommended by the pump's manufacturer.
    • Graduated cylinders should not be used to verify bottle fill capacity. NTP personnel should not "dump" the contents of the bottles provided by the supplier into other containers in order to check bottle fill.
  • Maintaining and Replacing Tubing
    • Tubing should be flushed and cleaned daily with tepid water.
    • Tubing should be replaced when it begins to leak.
    • Even when tubing appears to be in good condition, it should be replaced quarterly or at the time interval recommended by the manufacturer.
    • Tubing should be replaced each time the NTP begins to use a different narcotic medication or narcotic medication from a different manufacturer in the pump system.
    • The NTP should validate the pump's calibration after the tubing has been replaced.
    • Replacement tubing should be obtained directly from the pump manufacturer or following the manufacturer's specific replacement recommendations.
    • When an NTP purchases replacement tubing not precut to the appropriate length, and if active medication is dosed directly from the tubing (that is, there is no nozzle), it is important to cut the tubing cleanly and squarely (not at an angle) to prevent splashing, dripping, and/or diverting the fluid direction.

Using Computer Software for Dispensing/Related Recordkeeping

When using computer software packages, including software associated with the operation of automated dispensing pump and/or used for recordkeeping related to the dispensing of liquid or solid medication, NTPs should follow the specific recommendations of the companies which provide and install the computer hardware and software. General recommendations regarding the training of program personnel in the use of computer software and actions to be taken in the event of system emergencies follow.

  • Training in the Use of Software
    • Designated NTP personnel should be trained by the software company before the NTP's use of computer equipment begins.
    • Program management should ensure that new staff are trained in the use of the software either by existing program personnel, who have been previously trained by the software company, or by the software company itself.
    • Training should be conducted by the software company for all designated dispensing personnel at least annually or whenever there is a major change in dispensing personnel.
  • Addressing System Emergencies
    • When the automated system goes down, the vendor's software checklist should be consulted to be sure that procedures have been properly followed. NTPs are also advised to contact their software manufacturer.
    • Each NTP should develop operating instructions for manual dispensing to be implemented in the event that the automated system goes down. The operating instructions should be developed before problems arise and NTP personnel should be trained in their use. These instructions should include procedures for bringing the system back on line and for updating the system.
    • Federal regulations require that NTPs maintain complete and accurate records. [21 CFR 1304.21(a) and (d)]. In order to comply with this regulation, NTPs must maintain dispensing information manually when the automated system becomes inoperable. Once the system is again operational, computer records must be updated to include information related to all manual dispensing that occurred while the system was inoperable. This information must be entered into the computer prior to closing.
    • The NTP should maintain an off site back-up of all computer generated program information.
    • The NTP should conduct periodic drills to prepare personnel for system emergencies.

Other Recommendations and Requirements

General procedures related to the dispensing and administering of solid or liquid medication include the following:

  • An NTP must provide effective security controls and procedures to guard against theft and diversion. [21 CFR 1301.71(a)].
  • A log of bottle numbers should be maintained.
  • Medication should be used on a "first in/first out" basis.

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