Observations
Based on interviews with the facility director on 1-7-09 and 2-13-09, the facility failed to follow state and federal regulations regarding the redistribution of Suboxone, a prescribed narcotic, to other patients in the facility.
Findings include the following:
During a telephone interview with the facility director on 2/13/09, the facility director confirmed that the prescribed Suboxone of two patients who had decided not to continue with Suboxone treatment was redistributed to other patients who had valid prescriptions for Suboxone but could not afford to fill those prescriptions due to lapses in insurance coverage. The facility director further confirmed that standardized forms had been developed for this purpose, and were utilized to demonstrate that the two patients who decided not to continue with Suboxone treatment had " gifted " the remaining medication to the facility.
Federal regulations at 21 CFR Chapter I, part 290, Controlled Drugs, Subpart A, 290.5 Drugs; statement of required warning.
The label of any drug listed as a ' ' controlled substance ' ' in schedule II, III, or IV of the Federal Controlled Substances Act shall, when dispensed to or for a patient, contain the following warning: ' ' Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed ' .... This prohibition is described in detail within the Federal Controlled Substances Act.
The facility also failed to comply with Pennsylvania law at Act 64 of 1972, public law 233, " The Controlled Substances, Drugs, Device, and Cosmetic Act " section 11 (f), "Section 11. Professional Prescription, Administration, and Dispensing.- (f) Any drug or device dispensed by a pharmacist pursuant to a prescription order shall bear a label showing (i) the name and address of the pharmacy and any registration number obtained pursuant to any applicable Federal laws, (ii) the name of the patient, or, if the patient is an animal, the name of the owner of the animal and the species of the animal, (iii) the name of the practitioner by whom the prescription order was written, and (iv) the serial number and date of filing of the prescription order. In addition, the following statement shall be required on the label of a controlled substance: "Transfer of this drug to anyone other than the patient for whom it was prescribed is illegal." ((f) amended July 2, 1993, P.L.377, No.53).
The facility, in redistributing Suboxone to patients other than those to whom the medication had originally been prescribed, was engaging in practices reserved for licensed pharmacies in the Commonwealth. The facility does not posses a license from the Commonwealth to operate a pharmacy.
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Plan of Correction
The Gifting program referred to ended over four months ago. The facility has been advised by DOH that a technical violation existed because the facility is not currently a pharmacy.
No repetition will occur. |