Dear Administrator - Fentanyl Alert
October 29, 2001
Investigations conducted by the New York State Department of Health, Bureau of Controlled Substances (BCS), have revealed numerous incidences of diversion of the drug fentanyl in hospitals and other healthcare institutions. The purpose of this letter is to alert administrators of these facilities to the growing problem of fentanyl diversion and to recommend security measures that can be taken to prevent it.
Fentanyl is a highly potent narcotic. Doses measured in microgram amounts are ordered and administered in a hospital setting for the relief of pain. The injectable form, as either generic fentanyl or the trade name product Sublimaze, is used primarily as an adjunct to anesthesia in surgical procedures. Fentanyl is also available in transdermal patches, marketed under the name Duragesic. By a continuous release of drug, which is then absorbed through the skin, fentanyl patches provide extended pain relief to those patients who require it . The injectable form of fentanyl - along with the analog products Sufenta (sufentanil), Alfenta (alfentanil), and Ultiva (remifentanil) - is most prone to diversion. However, BCS investigations have revealed that diversion of fentanyl patches is also occurring with increasing frequency.
Fentanyl is most often diverted by those healthcare professionals directly responsible for its administration and safeguarding. The injectable form of the drug is diverted primarily from operating rooms. This is accomplished by substitution, outright theft, the underdosing of surgical patients, and the falsifying of medications administration records. Fentanyl transdermal patches are often stolen from ward stocks or, in some instances, actually removed from the skin of patients. The patch is then punctured or sliced open to extract the fentanyl.
Whatever the method employed, the diversion of fentanyl is a danger to the public health. Impaired healthcare professionals pose enormous potential consequences for patients. A surgical patient's life can be placed in jeopardy. A patient from whom a diverted fentanyl patch is removed is made to suffer unrelieved pain.
The Bureau of Controlled Substances and the Office of Continuing Care recommend that, in healthcare facilities where fentanyl transdermal patches are used, administrators implement the following measures to both detect and prevent their diversion:
- During shift counts of controlled substances, the foil packets containing fentanyl patches should be removed from their boxes and inspected for signs of tampering.
- Each time a fentanyl patch is newly applied to a patient's skin, a pen or magic marker should be used to write the date, time, and initials of the medication nurse on the patch. During the time the patient wears the patch, this documentation should be regularly checked against medication administration records. The patch should also be inspected for cuts, needle holes or other evidence of tampering, such as a dried-out appearance.
- Each time a fentanyl patch is removed from a patient, it should be rendered both unusable and unrecoverable. Even after the 72-hour period during which a fentanyl patch is effective for the patient, it still contains a significant amount of drug. One method of rendering the patch unusable and unrecoverable is to fold it together, adhesive to adhesive, and dispose of it in a container for used sharps. As with any other remaining partial dose of a controlled substance, the used fentanyl patch should be disposed of in the presence of a witness.
- In facilities where an individual medication administration record is issued for each patient receiving fentanyl patches, the remaining blank lines on the record should be crossed out when the patches are discontinued.
Your prompt attention to the matter of fentanyl diversion is requested. You are urged to implement the above recommended security measures as well as additional measures of your own design. As an administrator, you should also be aware that Section 80.6 of the New York Code of Rules and Regulations states that the administrative head of a hospital, nursing home, and health related facility is responsible for the proper safeguarding and handling of controlled substances within that facility. Section 80.6 further states that an administrative head or supervisor is not relieved of his responsibility to detect and correct any diversion or mishandling of controlled substances by a delegation of responsibility.
If you have any questions regarding the diversion of fentanyl or would like to request advice on policy and procedures to bolster its safeguarding, you may contact the Bureau of Controlled Substances at the above address and phone number.
James Giglio, Director
Bureau of Controlled Substances
Anna D. Colello, Director
Division of Quality Assurance and Surveillance
for Nursing Homes and ICF/MRs