Legislative Update February 2006
Pseudoephedrine Sales, PA Prescribing, Drug Licensing, Drug Repository Program
Kelly Vyzral, Director of Government Affairs
Sub. SB 53: Pseudoephedrine Sales (Carey)
On January 11 the House Civil and Commercial Law Committee unanimously recommended the bill, and it was passed by the full House January 18. The House and Senate will now have to reconcile the bill, meaning that the Senate will have to agree to the changes made by the House.
OPA was able to make some significant changes in the bill from its original form, most important for pharmacists is that we were successful in removing felony penalties from retailers. This could have been disastrous for pharmacists who could have lost their license because of an oversight while looking through 30 days of a log book. As the bill passed:
- All single ingredient products must be placed behind a counter; exempts gel caps, liquids and pediatrics
- Consumer must be 18-years-old to purchase the product
- cSales are restricted to 9 grams per consumer per 30-day period, unless accompanied by a prescription
- Retailers must maintain a log and ask for I.D.
- Log book must be retained for a minimum of one year after the date of the last purchase recorded in the log book
- Retail establishment must post a sign warning customers of the new restrictions on purchasing pseudoephedrine products. Language can be posted on each page of the log book or posted in a conspicuous location in the store
- The log must be made available to law enforcement; however, the law enforcement official must ask for it
- Permit retail employees under the age of 18 to handle/sell sole-ingredient pseudoephed-rine products
- Allows retailers to decide whether they want to keep electronic or paper logs, based on their technological capabilities
- A violation of the law is a misdemeanor of the first degree
SB 154: PA Prescribing (Wachtmann)
On January 12 the House Health Committee unanimously passed SB 154, the measure that gives physician assistants (PAs) the authority to prescribe a limited number of prescription drugs. The bill would also require that PAs obtain a master?s degree to enter the profession.
OPA opposed the legislation on the grounds that it would threaten the health and safety of Ohioans by increasing the number of mistaken prescriptions that can cause adverse drug interactions. As a result of our lobbying efforts, we were able to make some important changes to this bill before it was voted out of committee. The bill originally opened up dispensing for Advanced Practice Nurses (APNs) and PAs to personally furnish complete or partial supplies of drugs when pharmacy services are not reasonably available, when it is in the best interest of the patient, or when it is an emergency. OPA was successful in having the bill amended to put PAs on the same level as APNs, and taking their dispensing ability back to current law which allows them to dispense antibiotics, antifungals, scabicides, contraceptives, prenatal vitamins, and antihyperten-sives. The APNs and PAs are allowed to dispense drugs and devices used to treat diabetes, asthma, and high cholesterol.They are only permitted to dispense these drugs and devices in federally-funded and non-profit health clinics.
Despite the changes, OPA continues to oppose this bill because we feel that the provision to allow PAs to dispense medication is a threat to the health and safety of all Ohio?s citizens. This bill would allow PAs to diagnose, prescribe and dispense. There is no check and balance in this equation. Pharmacists are the only healthcare provider who has the specialized education to identify and correct the many drug interactions that can harm a patient. We want the legislature to know that pharmacists are an integral part of the healthcare continuum. If you subtract the pharmacist from this equation, you are losing a valuable safety net. At the time of writing this column, SB 154 awaits a vote before the full House.
SB 188: Drug Licensing (Grendell)
This bill was introduced to settle an on-going issue between the State Board of Pharmacy and manufacturing interests. It would affect only those compounders who are in the process of applying to, or awaiting approval from, FDA to manufacture. The bill does not alter current requirements for a license to do business as a manufacturer, wholesaler, or terminal distributor of dangerous drugs. This bill would create a license issued by the Board of Pharmacy authorizing a terminal distributor to compound drugs, on a routine basis, and sell those drugs to an authorized prescriber of drugs. It provides that a terminal distributor compounding license is valid for one year and requires the Board to review and renew licenses. The bill also requires a terminal distributor who holds a compounding license to submit an annual report to the Board that demonstrates the distributor?s progress in obtaining approval from the United States Department of Health and Human Services to manufacture drugs. This bill recently hit a snag when opposition began pushing for a definition of compounding to be added to the bill. This bill is currently under redraft. OPA will continue to watch this bill closely and will update you as soon as the new draft is available.
SB 228: Drug Repository Program (Schuring)
This bill would require terminal and wholesale distributors of dangerous drugs to send to the Drug Repository Program unused or unsold prescription drugs that qualify for the program. Sen. Schuring said, in sponsor testimony, that the bill was intended to encourage use of the existing voluntary Ohio Drug Repository Program that he created with legislation in the 124thGeneral Assembly. As envisioned, unused, sealed, tamper-evident medications from nursing homes and pharmacies were to be returned to distributors for use in free clinics.
OPA opposes any legislation that would require pharmacists to send unused medication to the Drug Repository Program on the grounds that such medication would normally be sent back to the wholesaler for refund to the pharmacy. We will be meeting with the sponsor to discuss possible changes in language that would allow pharmacists to participate in the program when it is appropriate, while still allowing them to obtain refunds for unused medication when necessary.
HB 468: Best Rx Program(Hagan/Spada)
Rep. John Hagan (R-Alliance) and Sen. Robert Spada (R-North Royalton) introduced legislation aimed at expanding participation in Ohio?s Best Rx, the state?s prescription drug discount program for the uninsured. The legislation will increase eligibility from 250 percent of poverty to 300 percent. It would also allow the mail order system to disclose, or use the identifying information of the participants to solicit their business.
This legislation is costing jobs in Ohio. Through the first year of the program, it has taken $3 million in salaries and profits from our local pharmacies, while costing the brand name pharmaceutical manufacturers only $301,432.65 in rebates. Meanwhile, manufacturers have increased their prices at least 7 percent since this legislation passed, which means on the average $100 prescription, they have increased prices $7. They have only paid $7.34 ?discount? on the very few prescriptions that they paid rebates, which means they only paid about 34 cents, while pharmacists have lost $15.42 per prescription, on what was CASH business. On top of that, the ?discounts? taken have come from the lower-price generics, where pharmacists were able to make some profit, while the public got lower prices. Now, those prices are at rock-bottom, destroying the profitability of that part of the pharmacy?s business. The government price control program is going to result in a number of pharmacy closures in 2006.
OPA is opposing the expansion of this program to 300 percent of poverty. That makes a government price control program for nearly the entire cash population of the middle class. More affluent people have insurance cards, which leaves no cash business at all where pharmacy?s set their own prices.
OPA will also seek to remove the new permissive language for the mail order system which allows them to solicit business from participant information. OPA will also be looking for an increase in the professional fee from $3 to $5, and an increase in the fee annually on January 1, at the same rate of inflation as the manufacturers? prices for that year, thereby lifting the price controls placed on retail pharmacy at the inception of this program.
OPA will be vigorously opposing this legislation unless changes are made within the bill to make the legislation more pharmacy-friendly. We have shouldered the burden of this program for a year, and we will not sit by and allow more money to be taken from pharmacy while everyone else involved in this program makes a profit.
If you have any questions or comments about the issues mentioned in this article, please contact Kelly Vyzral, Director of Government Affairs, at 614.586.1497 or email@example.com.
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