Kansas News: 2008 Legislative Changes

June 1, 2008 4:44 pm

Published in the June 2008 Kansas State Board of Pharmacy Newsletter

The Kansas legislature passed several important pharmacy-related bills during the 2008 session. Senate Bill (SB) 491 creates the Prescription Drug Monitoring Program (PMP) recommended by the Prescription Monitoring Task Force that met over the last six months pursuant to a proviso from the 2007 legislative session. The task force was chaired by Barry Sarvis, RPh, and included many stakeholders from the health care community who participated in developing the recommendation. SB 491 requires the Kansas State Board of Pharmacy to establish and maintain a PMP for Schedule II through IV substances. Each dispenser of outpatient drugs is required to electronically submit information for each controlled substance prescription dispensed to the Board of Pharmacy. The Board of Pharmacy is required to develop and maintain a database of controlled substance prescriptions submit¬ted. The database will be confidential and access is limited to certain persons authorized by the statute including pharmacists and prescribers. The PMP will have an advisory committee from various disciplines to advise the Board on its operations. The Board has applied for a grant from the United States Department of Justice to help implement the program. The Board will provide education to the pharmacies once rules and regulations for the program are promulgated and it is operational.
The bill also requires the Board of Pharmacy to assemble a task force to study the feasibility of scheduling pseudoephedrine products as a Schedule III or IV controlled substances. The study is to consider the impact on the consumer and any costs associated with making such a change. The task force is required to report its findings to the 2009 legislature.
SB 549, the bill that creates a continuous quality improvement program (CQI) for retail pharmacy was amended into SB 491 and must be in place no later than July 1, 2009. The purpose of the CQI program is to assess errors in dispensing or furnishing prescription medications so that the pharmacy may take appro¬priate action to prevent a recurrence. Any reports, memoranda, proceedings, findings, or other records generated as part of the CQI program are considered confidential and privileged peer review documents and not subject to discovery, subpoena, or other means of legal compulsion for their release. Such informa¬tion will not be admissible in any civil or administrative action other than an administrative proceeding initiated by the Board of Pharmacy. Nothing in the new statute should be construed to prevent a patient from accessing such patient’s prescription records, nor does confidentiality affect the discoverability of records that are not generated or maintained solely as part of a CQI program. The Board will promulgate rules and regulations that will require the pharmacy to keep records of its CQI meet¬ings. Once a meeting has been held the pharmacy must create a summarization document that contains an analysis of remedial measures that will be undertaken following an event. The intent of the CQI bill is for the pharmacy to prevent future medication-related problems or errors.
The second portion of SB 549 provides an additional remedy to the Board of Pharmacy to assess a civil fine against a nonresident pharmacy not exceeding $5,000 per violation when a nonresident pharmacy fails to supply information requested by the Board or to respond to an inquiry after being noticed by certified mail.
The legislature also placed three substances on the Schedule I controlled substance list in Kansas. These include salvia divino¬rum (salvinorum A), datura stramonium (gypsum weed or jimsom weed), and 3, 4-methylenedioxymethamphetamine (Ecstasy).
House Bill (HB) 2578 creates the Utilization of Unused Medica¬tions 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 centers for distribution to medically indigent Kansas residents. The bill would establish criteria for which medications can be donated including that medications must come from a controlled storage unit of the donating entity, be either in its original sealed unit dose packaging or in a hermetically sealed tamper-evident package, the medication must be nonexpired, and controlled substances cannot be donated. The Board of Pharmacy will establish and implement the Unused Medication program and provide techni¬cal support assistance to entities who wish to participate. The Board will promulgate rules and regulations by December 2008 for program implementation by December 1, 2008.
HB 2618 did not pass this session, but may be introduced again next year. The bill would require the Board of Pharmacy and other state agencies to use the Office of Administrative Hearings for conducting all disputed hearings under the Kansas Administrative Procedure Act. The Office of Administrative Hearings would assign an attorney to hear cases rather than the Board of Pharmacy. The presiding officer would render an ini¬tial order that would become a final order unless reviewed. The bill would have required the licensee or registrant to provide an expert witness for the hearing at their own expense. The legisla¬ture will be reviewing this for all administrative agencies again next year. You may review HB 2618 in its entirety online at www.kslegislature.org. If you oppose any part of HB 2618, you may want to consider contacting your representative and senator to let them know your position.
Issuance of Multiple Prescriptions for Schedule related problems or errors.
The second portion of SB 549 provides an additional remedy to the Board of Pharmacy to assess a civil fine against a nonresident pharmacy not exceeding $5,000 per violation when a nonresident pharmacy fails to supply information requested by the Board or to respond to an inquiry after being noticed by certified mail.
The legislature also placed three substances on the Schedule I controlled substance list in Kansas. These include salvia divino¬rum (salvinorum A), datura stramonium (gypsum weed or jimsom weed), and 3, 4-methylenedioxymethamphetamine (Ecstasy).
House Bill (HB) 2578 creates the Utilization of Unused Medica¬tions 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 centers for distribution to medically indigent Kansas residents. The bill would establish criteria for which medications can be donated including that medications must come from a controlled storage unit of the donating entity, be either in its original sealed unit dose packaging or in a hermetically sealed tamper-evident package, the medication must be nonexpired, and controlled substances cannot be donated. The Board of Pharmacy will establish and implement the Unused Medication program and provide techni¬cal support assistance to entities who wish to participate. The Board will promulgate rules and regulations by December 2008 for program implementation by December 1, 2008.
HB 2618 did not pass this session, but may be introduced again next year. The bill would require the Board of Pharmacy and other state agencies to use the Office of Administrative Hearings for conducting all disputed hearings under the Kansas Administrative Procedure Act. The Office of Administrative Hearings would assign an attorney to hear cases rather than the Board of Pharmacy. The presiding officer would render an ini¬tial order that would become a final order unless reviewed. The bill would have required the licensee or registrant to provide an expert witness for the hearing at their own expense. The legisla¬ture will be reviewing this for all administrative agencies again next year. You may review HB 2618 in its entirety online at www.kslegislature.org. If you oppose any part of HB 2618, you may want to consider contacting your representative and senator to let them know your position.