This report is a result of an on-site inspection conducted for the approval to use a narcotic agent, specifically methadone and buprenorphine, in the treatment of narcotic addiction. This inspection was conducted on October 11-13, 2011 by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the on-site inspection, Net Treatment Services, Inc. - Net Steps was found not to be in compliance with the applicable chapters of 4 PA Code and 28 PA Code which pertain to the facility. The following deficiencies were identified during this inspection.
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Plan of Correction
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Observations
Based on a review of patient records, the facility failed to ensure each medication dose change was written and signed by the treatment physician in four of four patient records.
The findings include:
Thirteen patient records were reviewed October 12-13, 2011. Four patient records were reviewed for initial and subsequent mediation orders and dosage changes.
Patient # 3 was admitted January 25, 2011. The physician documented the initial medication order to start at 30 milligrams and build up to 60 milligrams over 7 days. There was no documentation the physician was consulted during the 7 days prior to each increase.
Patient #10 was admitted August 22, 2011. The physician documented the initial medication order on August 22, 2011 to start at 30 milligrams and build up to 60 milligrams over 7 days. There was no documentation the physician was consulted during the 7 days prior to each increase.
Patient # 11 was admitted September 22, 2011. The physician documented the initial medication order on September 22, 2011 to start at 30 milligrams and build up to 60 milligrams over 7 days. There was no documentation the physician was consulted during the 7 days prior to each increase.
Patient # 12 was admitted August 18, 2011. The physician documented the initial medication order on August 18, 2011 to start at 30 milligrams and build up to 60 milligrams over 7 days. There was no documentation the physician was consulted during the 7 days prior to each increase.
On September 4, 2007, all narcotic treatment programs were issued a letter regarding the use of standard orders, especially during the induction phase, by the Department of Health & Human Services, Substance Abuse and Mental Health Services Administration: (SAMHSA)
In part, the following is excerpted from the letter:
"Because methadone overdose deaths have occurred in early treatment due to the drug's
cumulative effects of the first several days, it is also important to be cautious when
adjusting the dose. According to the drug labeling, the peak respiratory depressant
effects of methadone typically occur later and persist longer than its peak analgesic effects, which can contribute to cases of iatrogenic overdose, particularly during treatment initiation and dose titration. With repeated dosing, "methadone may be retained in the liver and released slowly, prolonging the duration of action despite low plasma concentrations." The drug labeling also states that "steady-state concentrations are not usually attained until 3 to 5 days of dosing," and that doses "will 'hold' for a longer period of time as tissue stores of methadone accumulate." Therefore, patients should be closely monitored during the induction phase, and the increase in dose should be under the close supervision of a physician as stated in 42 CFR 8.12 (h)(4), ' Dosing and administration decisions shall be made by a program physician familiar with the most up-to-date product labeling'. "
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Plan of Correction
All new patients routinely see a physician weekly for the first 21 days of treatment. The physicians' offices are co-located with the dispensing area providing easy access between the new patients and the physicians. While many patients are able to be started on comparable induction regimens, the particulars of their dosage is determined using our physicians best medical judgment for that particular patient and is not based on any computer formula or standing order protocols. While " There is no induction dosing protocol that has proved absolutely safe for all patients and, during the early days of induction, clinical observation of patients after dosing until peak SMLs are reached might be recommended. "
Because the first week of treatment is a time of particular risk of overdose, our patients are routinely evaluated daily by nursing staff, before and after dosing, to ensure that there is no evidence of toxicity from opioids or other drugs. In addition, our physicians are in real-time informed of any medical issues or concerns regarding our patients. Our physician staff is available to evaluate patients at any time during the induction period, if it is deemed medically prudent or necessary based on these assessments prior to their scheduled 5-7 day follow up visit.
Our POC, is to only increase dosage level on the first week with a physicians visit, to have the Nursing staff document their daily dose evaluations and communicate as such to the physicians for oversight and management during induction. We will maintain our weekly physician appointments during induction and our current practice the daily physicians review. Our patient's dose is always determined on an individual basis and not via 'standing orders', and based on best practices. Therefore our patients will continue to be closely monitored during the induction phase, and the increase in dose will be under the close supervision of a physician, well qualified in addiction medicine, as stated in 42CFR 8.12(h)(4).
This plan will be responsibility of the Medical Director and monitored by Director of Nursing. The POC will be effective November 14, 2011.
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