Observations
Based on a review of patient records, the facility's physician failed to adhere to the dosing protocol listed on the medication by ordering that single dose Suboxone film be cut in one of five patient records. The medication packaging identifies this as a single dose medication.
The findings include:
The physician prescribed four Suboxone 8 mg/2 mg SL film, to last a period of seven days. This prescription would require that the patient would cut the film into smaller doses.
Suboxone film is not formulated to be cut into smaller doses. Prescriptions need to be for the manufactured quantities of 12 mg/3 mg, 8 mg/2 mg, 4 mg/1 mg or 2 mg/.5 mg doses.
The office manager was interviewed throughout the licensing inspection and confirmed the findings on May 2, 2014.
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Plan of Correction
On 4/11/14 the pharmaceutical company was contacted by Facility Director regarding the cutting of films for decreased dosages. They reported that although it is a common practice, that no clinical trials have been conducted to authorize the cutting of films. They will be sending information regarding FDA approved dosages to our facility. Staff was informed by the Facility Director via email and the Medical Assistants/Administrative staff will review prescriptions prior to leaving the facility to ensure they follow FDA regulations and the Office Manager will review prescriptions weekly. |
Observations
Based on a review of client records, the facility failed to document a complete client record on an individual which included information relative to the client's involvement with the project in five of five client records.
The findings include:
Five client records were reviewed on May 2, 2014. All five records were required to be a complete client record on an individual which included information relative to the client's involvement with the project. Client records #1, 2, 3, 4 and 5 did not include documentation of all of the Suboxone/Zubsolv prescriptions written for each patient.
Client #1 was admitted to treatment on February 8, 2014. The medication log indicated that prescriptions were written; however, there were no Suboxone scripts documented in the client record for February 8 and February 15, 2014.
Client #2 was admitted to treatment on January 18, 2014. The medication log indicated that prescriptions were written; however, there were no Suboxone scripts documented in the client record for January 18 & 25, February 1, 8, 15 & 22, March 17 & 22 and April 6, 2014.
Client #3 was admitted to treatment on February 15, 2014. The medication log indicated that prescriptions were written; however, there were no Suboxone scripts documented in the client record for February 15 and February 22, 2014.
Client #4 was admitted to treatment on January 25, 2014. The medication log indicated that prescriptions were written; however, there were no Zubsolv scripts documented in the client record for January 25, February 1, 8 and 15, 2014.
Client #5 was admitted to treatment on February 8, 2014. The medication log indicated that prescriptions were written; however, there were no Suboxone scripts documented in the client record for February 8, 15 & 22 and April 26, 2014.
The office manager was interviewed throughout the licensing inspection and confirmed the findings on May 2, 2014.
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Plan of Correction
On 5/2/2014, the Office Manager spoke with all personnel involved with Buprenorphine clients and reviewed the need to document all prescriptions. The Office Manager will be reviewing prescriptions weekly and ensuring that the appropriate personnel have documented on the prescription log all presrciptions. |