Missouri Senate

Senate Substitute

Current law requires certain documentation relating to the sale of products containing pseudoephedrine. For non-prescription pseudoephedrine products, this act requires that the photo identification that must currently be provided to the pharmacist must be issued by a state or the federal government, or another acceptable document and that such identification must be furnished prior to purchase. The log currently maintained by pharmacists is modified to now include the signature of the purchaser, the name of the product and the time of the purchase. The act also requires that the log be electronic, rather than written. The seller is required to deliver the product directly into the custody of the purchaser.

The act modifies the current gram limits for the sale of pseudoephedrine products. The act provides that the limits do not apply to quantities that must be sold, dispensed or distributed in a pharmacy under a valid prescription or to any purchase by an individual of a single package containing not more than 60 mg of pseudoephedrine. The current 30 day period limit of 9 grams to a person applies without regard to the number of transactions. For mail order or mobile retail sales within a 30 day period, the limit on pseudoephedrine products shall be 7.5 grams without regard to the number of transactions. Within a twenty-four hour period, no person may obtain 3.6 grams without regard to the number of transactions.

The act provides that liquid or liquid-filled gel capsule forms of pseudoephedrine must be in a place where customers do not have direct access to them. The act repeals provisions that exempted the liquid and liquid-filled gel capsule forms of pseudoephedrine from recordkeeping and log maintenance requirements.

The person selling the pseudoephedrine products shall maintain an electronic log of each transaction, including the name and signature of the purchaser, the name of the drug, the date and time of purchase and the name or initials of the person selling the drugs. Pharmacies must submit information regarding sales of certain pseudoephedrine products in accordance with transmission methods and frequencies established by the department of health and senior services. All logs, records and other documents maintained for the dispensing of pseudoephedrine products shall be open for inspection and copying by law enforcement officers whose duty it is to enforce state or federal controlled substance laws.

The act establishes a drug monitoring program in the Department of Health and Senior Services. The program will monitor the prescribing and dispensing of all Schedule II through Schedule V controlled substances by all licensed professionals who prescribe or dispense these substances in Missouri. The dispenser must electronically submit to the department information for each prescription or dispensing. The act specifies the frequency of the submissions. The department may issue a waiver to a dispenser who is unable to submit the required information electronically. If a waiver is obtained, a dispenser may submit the required information in paper format or by other approved means. With certain listed exceptions, all submitted prescription information shall be confidential.

The act authorizes the release of non-personal, general information for statistical, educational, and research purposes. The department may contract with other state agencies or private vendors to implement the provisions of this act. Any person, contractor or entity that knowingly releases information access from the program shall be guilty of a class A misdemeanor for a first violation and a class D felony for subsequent violations as well as a civil monetary penalty of up to $25,000. The department is required to implement certain education courses regarding the prescription monitoring program. The department shall, when appropriate, work with associations for impaired professionals to ensure ongoing monitoring and treatment.

Nothing in the drug monitoring program shall be construed to require a dispenser or prescriber to access or check information from the program prior to dispensing, prescribing or administering medications. Dispensers and prescribers are immune from liability based on any claim of damages as a result of accessing or failing to access the information in the drug monitoring program.

In addition, this act modifies and adds to the current names of scheduled controlled substances. The provisions of this relating to the drug monitoring program shall be effective on January 1, 2009 and the drug monitoring program shall sunset in six years.

This act also modifies provisions relating to advanced practice nurses. Currently, advanced practice registered nurses have the authority to administer, dispense and prescribe certain drugs while operating under a collaborative practice agreement. This act authorizes advanced practice registered nurses who hold a certificate of controlled substance prescriptive authority from the board of nursing to prescribe controlled substances in schedules III, IV, and V while operating under a collaborative practice agreement. Schedule III narcotic controlled substance prescriptions shall be limited to a 120 hour supply without refill. Certified registered nurse anesthetists do not have this authority.

The act contains requirements that must be contained in all collaborative practice agreements including:

a. Names, addresses, and phone numbers of the collaborating individuals.

b. A list of offices where the collaborating physician has authorized the APRN to prescribe.

c. A requirement that notice shall be displayed at all offices where an APRN is prescribing, that informs patients that they may be seen by an APRN.

d. All specialty or board certifications.

e. The details of the collaboration including geographic proximity, and how absences are handled.

f. A description of the prescriptive authority including a list of controlled substances the physician authorizes.

g. A list of all other practice agreements involving the collaborating individuals.

h. The duration of the agreement.

i. A description of the time and manner of the collaborating physician's review of the APRN's prescribing practices

The act modifies requirements for all collaborative arrangements including the following:

2. Physicians shall not collaborate with more than three full time APRNs

3. APRNs shall practice for one month in a setting where the collaborating physician is continuously present.

4. Neither physicians nor APRNs shall be required to enter collaborative practice agreements.

The act defines advanced practice registered nurse, certified advanced registered nurse practitioner, certified clinical nurse specialist, certified nurse midwife, and certified registered nurse anesthetist.

The act includes experience and practice requirements that are prerequisites for the board of nursing to grant a certificate of controlled substance prescriptive authority.

This act establishes the Pharmacy Rebates Fund for the purposes of depositing any revenues received by the state from pharmaceutical manufacturer rebates as required by state or federal law for use in the MO HealthNet pharmacy program.

This act is similar to HCS/SS/SCS/SB 85 (2007), SB 797 (2006), SB 158 (2005) and HB 987 (2004). Provisions of this act are similar to HCS/SCS/SB 724 and to SB 1068 (2008).

JIM ERTLE