Brief Summary of Engrossed Substitute Bill

(As Amended by House)

Allows for the prescription and distribution of prepackaged emergency medications at times when a hospital pharmacy is closed and a community pharmacy is not available within 15 miles, or when a practitioner determines that a patient has no reasonable ability to reach a local pharmacy.
Establishes policy standards for the types of emergency medications that may be distributed and the circumstances under which distribution is appropriate.
Allows a hospital pharmacy to engage in intracompany sales as well as the sale, purchase, or trade of a drug for emergency medical reasons, regardless of whether it has a wholesale distributor license.

Background:

Emergency Medications at Hospital Pharmacies.

Under Pharmacy Quality Assurance Commission (Commission) rules, the director of pharmacy at a hospital must develop policies and procedures to provide emergency medications to outpatients for times when community or hospital pharmacy services are not available. Under these policies, designated registered nurses may deliver medications other than controlled substances. The policies must require that an order of a practitioner with prescriptive authority be presented and retained for verification by the pharmacist; the medication be prepackaged and appropriately labeled; no more than a 24-hour supply be provided to the patient; the container be labeled by the designated registered nurse; and the medications be stored in a secure place. The procedures do not apply to controlled substances, except in 10 specified rural hospitals.

Wholesale Pharmacy Licenses.

Any person who engages in the wholesale distribution of drugs must receive a wholesale distributor license from the Commission. Licensed wholesale distributors must meet minimum standards related to facilities; storage; the examination of materials; returned, damaged, and outdated prescription drugs; policies and procedures for the receipt, security, storage, inventory, and distribution of prescription drugs; and lists of persons in charge of distribution, handling, and storage of drugs. Wholesale distribution activities include the distribution of prescription drugs to persons other than a consumer or patient. Wholesale distribution does not include transactions and dispensing pursuant to a prescription; the distribution of drug samples; transactions involving blood and blood components for transfusions; intracompany sales; and transactions related to drugs for emergency medical reasons.

Summary of Amended Bill:

Prepackaged medications.

A hospital may allow prepackaged emergency medications for patients being discharged from the emergency department to be prescribed by practitioners with prescriptive authority and distributed by these practitioners and registered nurses when: (1) community pharmacies and outpatient hospital services are not available within 15 miles by road; or (2) in the judgment of a practitioner and consistent with hospital policies, the patient has no reasonable ability to reach a local community or outpatient pharmacy.

The director of the hospital pharmacy must develop policies and procedures regarding the types of emergency medications to be prepackaged; the preparation of the emergency medications by, or under the supervision of, a pharmacist; the criteria under which prepackaged emergency medications may be prescribed and distributed; the training requirements for staff; the maintenance of prescriptions; the storage of the medications; and patient counseling on the medications. In addition, the policies must establish a limit of a 48-hour supply of the emergency medications, except when a community pharmacy or the hospital pharmacy will not be available within 48 hours, in which case a 96-hour supply may be dispensed. The delivery of a single dose of medication for immediate administration is exempt from the requirements.

The term "emergency medication" is defined as medication commonly prescribed to emergency department patients and includes controlled substances.

Hospital Pharmacies.

Regardless of whether they have a wholesale distributor license, hospital pharmacies may engage in intracompany sales as well as the sale, purchase, or trade of a drug for emergency medical reasons. "Intracompany sale" is defined as a transfer or transaction between any component of a company under common ownership and control of the corporate entity. "Emergency medical reasons" include transfers of a drug to alleviate a temporary shortage, except that the value of the transfers cannot have a gross value that is more than 5 percent of the total annual drug sales revenue of either the transferor or transferee.

Hospitals may receive a pharmacy license that includes any individual practitioner's office or multipractitioner clinic that is owned and operated by the hospital and listed on the hospital's initial or renewal pharmacy application. Hospitals with additional offices or clinics under its pharmacy license must keep those entities on the license through at least one inspection or for 24 months. The Secretary of Health may establish fees for offices or clinics under the hospital's pharmacy license.

Individual practitioners and multipractitioner clinics, whether or not they are hospital-based, are excluded from the definition of "health care entity." Non-hospital-based individual practitioners or multipractitioner clinics may elect to become licensed as health care entities. Residential treatment facilities are added to the definition of "health care entity."

Staff Summary of Public Testimony:

(In support) This bill is intended to put into law what pharmacies currently do. For years patients have had access to prepackaged medications even when community pharmacies were closed, but the Pharmacy Quality Assurance Commission recently narrowed the interpretation of current rules which resulted in a decrease in patient access. Current interpretations of the rules may force patients to go without adequate treatment and possibly have to drive long distances at night to obtain medications. This bill will allow all hospital emergency departments to provide emergency take-home medication when community pharmacy services are unavailable. This bill is critical for providing quality, compassionate care to patients. Without this bill, patient health may be jeopardized.

There has been a title amendment to the bill to allow for further changes related to allowing hospitals to transfer drugs within the hospital system, to clarify the definition of a health care entity, clarify that hospital pharmacies do not need additional licenses to distribute drugs to another entity with common ownership, and allow hospitals to use other clinics owned and operated by the hospital. Hospital pharmacies have provided drugs to facilities under common ownership for years without any safety issues or quality concerns. Having to seek separate licenses ignores long-standing practices and places additional burdens on hospitals and clinics. Without this bill, hospital-owned clinics will be held to unequal standards as compared to freestanding clinics simply due to ownership structure, and will be a financial and administrative burden.

(Opposed) None.