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Kansas News: Unused Medication Act
Published in the December 2008 Kansas State Board of Pharmacy Newsletter
The 2008 Legislature passed a law creating the Unused Medications Act, a voluntary program through which adult-care homes, mail-service pharmacies, and medical care facilities may donate unused medications to indigent health care clinics, federally qualified health centers, or community mental health clinic center for distribution to medically indigent Kansas residents. The Board of Pharmacy will have a public hearing on December 3, 2008, to adopt rules and regulations related to the transferring, accepting, and recall of unused medications. Each administrator or operator of an adult-care home, pharmacist-in-charge of a mail-service pharmacy, or administrator of a medical care facility shall submit notification to the Board if they intend to participate in the unused medications program. Forms have been developed and will be available on the Board’s Web site at www.kansas.gov/pharmacy under the link for Forms and Applications. As the transfer occurs the entity donating the drug shall determine the quality and suitability of each medication by a pharmacist’s verification that the unused medication can be identified, is in the manufacturer’s sealed container, a pharmacy unit-dose package, or a hermetically sealed tamper-evident package from the pharmacy. It shall not have passed its beyond-use date, cannot be a controlled substance, shall not be adulterated, and shall not be a medication that can be dispensed only to a patient or resident registered with the drug manufacturer.
The identifying name of the patient shall be removed in order to protect confidentiality. There shall be a consultation with the qualifying center or clinic to determine whether the center or clinic is willing to accept the unused medication and to ensure that the center or clinic has a consulting pharmacist and is registered with the Board of Pharmacy to accept unused medications.
The donating entity shall also complete a manifest on a form supplied by the Board of Pharmacy. The manifest copy shall be included with the donated medications. The donating entity shall also maintain a copy of the manifest that was signed and returned by the qualifying center or clinic for at least five years.
The qualifying center or clinic that elects to participate in the unused medication program shall submit written notification to the Board of Pharmacy on forms supplied by the Board of Pharmacy and available on the Board’s Web site. The center or clinic shall maintain all medication in a storage unit with con¬trolled access. After acceptance of the medication, the center or clinic shall determine the quality and suitability of each unused medication by verification of a pharmacist or practitioner that the medication can be identified, is not a medication that can be dispensed only to a patient or resident registered with the drug manufacturer, that the name of the patient has been removed to protect confidentiality, and that each medication has been checked against the manifest to resolve any discrepancies with the donating entity. The manifest must be completed and signed and returned to the donating entity. Each center or clinic shall maintain a copy of the signed manifest for at least five years.
If an unused medication is recalled and the qualifying center or clinic does not have the lot number on the label to differentiate between the recalled medications and the nonrecalled medica¬tions, all of the medication shall be destroyed. If the donating entity has transferred medication that is subsequently recalled and the donating entity has been notified of the recall, the donating entity shall be responsible for notifying the qualifying center or clinic. Each qualifying center or clinic in possession of any unused medication that is expired, adulterated, or recalled shall make a manifest for and destroy the medication. Following the destruction of the unused medications, the manifest shall be signed by the consulting pharmacist and a witness to verify the destruction. Each drug destruction manifest shall be maintained for at least five years.
