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Legislative Update February 2002

Alyson Welsh, Director of Government Affairs

New Continuing Education Rules Effective February 1, 2002 !
The State Board of Pharmacy approved new rules regarding pharmacists’ continuing education requirements. The new rule eliminates the requirement for “patient care” specific continuing education. Previously, a minimum of the 4.5 CEUs (45 contact hours) out of the required 6.0 CEUs (60 contact hours) to be reported every three years were required to be in patient care related programs. However, starting February 1, 2002, this will no longer be a requirement. The requirement for a minimum of 0.3 CEUs (three contact hours) of the 6.0 CEUs in State Board approved jurisprudence remains. The remaining 5.7 CEUs (57 contact hours) can be in topics of your choice.

House Bill 4 Hearings Resume in Ohio Senate
On January 16, 2002, hearings resumed on House Bill 4, Ohio’s attempt at having a state run discount drug card. Under this bill, the Ohio Department of Aging would contract with a Pharmacy Benefits Manager (PBM) to offer a discount card to Ohio’s senior citizens. This card would in someway be linked with the Golden Buckeye Card, which is a free card offered to Ohio’s senior citizens.

Since the bill’s introduction in February 2001, OPA has been expressing concern on the concept of the program, and how retail pharmacy would fund this “discount” 100 percent for seniors. At the January 16 hearing in the Ohio Senate Health and Human Services Committee, a representative from Merck-Medco testified in support of HB 4. After two hours of questioning from the Senators on the committee, the Merck-Medco representative acknowledged that retail pharmacy will fund this program. How they “negotiate” a discount and if that discount is passed on to the retail pharmacy was questioned. The committee also questioned whether PBMs are regulated by any state agencies, and requested that Committee Chair Senator Lynn Wachtmann research the issue and present findings at a future date. Finally they asked questions regarding the benefits of adding another “middleman” into this already complex pharmaceutical program, and questioned in general whether the state should contract with a PBM for this program. The Chairman repeatedly stated that a well-informed consumer who shopped pharmacies would probably be able to find a better price than someone who had a discount card. Hearings are expected to resume on HB 4.

Dangerous Drug Database Legislation Introduced in Ohio General Assembly !
HB 475 will authorize the Ohio State Board of Pharmacy to establish and maintain a dangerous drug database to monitor the use, misuse and diversion of dangerous drugs. State Representative Tom Raga (R-Mason) introduced House Bill 475 on January 16, 2002. State Rep. Raga has been working with the Ohio State Board of Pharmacy and local law enforcement agencies on the creation of a “Dangerous Drug Database.” Under this proposal, pharmacists would be required to electronically submit the following information to the board:

1. Patient Identification
2. Identification of the drug dispensed
3. Quantity of the drug dispensed
4. Date of the Dispensing
5. Directions for Use
6. Serial Number assigned by the terminal distributor
7. Terminal distributor’s license number issued by the Board
8. Identification of the prescriber

The Board would retain the information in the dangerous drug database for two years. Pharmacists or prescribers, along with state, federal, county, township or municipal officers and representatives of government entities who are involved in investigations of a licensed health care professional can obtain information from this dangerous drug database. Pharmacists and prescribers will be required to submit their requests on a form to be developed by the board and must prove that it will be used for the purpose of providing medical or pharmaceutical care to a current patient.

After initial discussions with State Rep. Raga and the State Board of Pharmacy, immunity language was included into the bill for pharmacists. This language states that this bill doesn’t require a pharmacist or prescriber to obtain information about a patient from this database. It also states that a pharmacist or prescriber shall not be held liable in damages to any person in any civil action for injury, death or loss on the basis that the pharmacist or prescriber did not seek or obtain information from the database. OPA will continue to work with the sponsor of the bill as well as the State Board of Pharmacy on this legislation

APhA Files Brief with U.S. Supreme Court for Pharmacists’ Right to Compound
The American Pharmaceutical Association (APhA) filed a “friend of the Court” brief with the U.S. Supreme Court during the week of January 14, 2002, to address the right of pharmacists to compound drug formulations.

APhA submitted the brief to provide the Court with information about the importance of compounding. At issue is litigation from the U.S. Court of Appeals for the Ninth Circuit. In Western States Medical Center, et at. v. Tommy G. Thompson, Secretary of Health and Human Services, et al., the court held that a section of the FDA Modernization Act of 1997 was unconstitutional. The section specified the substantial limits on FDA’s authority to regulate pharmacy compounding. Specifically, the court found that the requirement that compounding pharmacists must refrain from advertising in order to qualify for exception from FDA regulation was unconstitutional. Because that portion could not be separated from the rest of the compounding language, the entire section relating to compounding was invalid.
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