November Legislative Update
Pseudoephedrine Sales, P.A. Prescribing, Drug Compounding, Diabetes CareKelly Vyzral, Director of Government Affairs
Pharmacy is fast becoming the hottest ticket at the Statehouse. As you can see from the update on legislation dealing with pharmacy, we are keeping very busy around the Statehouse representing and protecting the practice of pharmacy.
Sub. SB 53: Pseudoephedrine Sales
Sen. Carey's bill passed out of the Senate Judiciary- Criminal Justice Committee on October 5, 2005, and it was passed out of the full Senate unanimously October 18, 2005. We were 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 be placed behind a counter; exempts gel caps, liquids and pediatric products
Consumer must be 18-years-old to purchase the product
Sales are restricted to 9 grams per consumer per 30-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 source pseudoephedrine products under the supervision of an employee 18 years or older.
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
The bill now goes to the House. While it is in the House, we have a couple main objectives to accomplish. First, we would like to see a provision added that would allow the state law to pre-empt any existing or future local ordinances concerning the sale of pseudoephedrine. This would prevent individual cities or townships from passing their own ordinances that may be more restrictive. Secondly, we will be asking the legislature to grant retailers, who implement approved training programs for their employees in regard to methamphetamine production and abuse, "safe harbor" or affirmative defense against prosecution.
SB 154: P.A. Prescribing
This bill would give physician assistants (P.A.s) physician-delegated prescriptive authority. 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 allowed Advanced Practice Nurses (APNs) and P.A.s 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. Those terms are vague and could conceivably cover any circumstance. Pharmacists are the most accessible healthcare provider. They work nights, weekends, and holidays, and with the advent of the chain drug store, many pharmacies are open 24 hours a day. In current law, the nurse is already permitted to furnish a 72-hour sample of any drug or therapeutic device that is listed on the formulary. It is almost inconceivable to imagine a circumstance when an APN or P.A. would be prescribing that a pharmacy would not be available within 72 hours. The bill was amended to put P.A.s on the same level as APNs in giving them the ability to dispense antibiotics, antifungals, scabicides, contraceptives, prenatal vitamins, antihypertensives, as well as 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 in this bill to allow P.A.s to dispense medication is a threat to the health and safety of all Ohio's citizens. This bill would allow P.A.s to diagnose, prescribe and dispense. There is no check and balance in this equation. Pharmacists are the only health 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 pharmacists from this equation, you are losing a valuable safety net. SB 154 now awaits a vote before the full Senate.
HB 305: PA Prescibing
This is the companion bill to SB 154.
SB 188: Drug Compounding
SB 188 was introduced to settle an ongoing issue between the State Board of Pharmacy and some compounding pharmacies. It would affect only those compounders who are in the process of applying or who are 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 also provides that a terminal distributor compounding license is valid for one year, and requires the Board to review and renew licenses. The bill 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. OPA has requested, and the sponsor has agreed, to tighten up the language to make sure that the bill doesn't cast a wide net over all compounders, but only those in the process of applying to become manufacturers. OPA has also met with Bill Winsley, Executive Director of the State Board of Pharmacy, to discuss the problem of who will regulate these facilities. He has assured us that the bill gives the Board the ability to charge a fee for this license, and that fee will allow the Board of Pharmacy to hire agents on contract to inspect these facilities. OPA will be following this bill as an interested party. We would appreciate any comments or questions you have regarding this bill.
SB 113: Diabetes Care
SB 113 is important to watch, especially for those pharmacists involved in, or interested in, offering disease state management and diabetes care. It would require benefits for diabetes equipment, supplies, medication, and self-management education to be included in healthcare coverage. The bill establishes several conditions for coverage of self-management education and medical nutrition therapy including:
The treatment must be prescribed by a physician or other licensed individual authorized to prescribe the items.
During the first 12-month period after a patient begins to receive self-management education, the benefits must cover the expenses of 10 hours of education, which may include medical nutrition therapy, in a program based on the standards for diabetes self-management education as outlined in the American Diabetes Association's standards of care.
In each year following the first year of self-management education, the benefits must cover the expenses for two hours of self-management education, one hour of which may be used for medical nutrition therapy, as an annual education maintenance program for the patient, but only if the education is medically necessary and prescribed by a physician or other individual authorized by licensure to prescribe the education.
The education must be provided by a health professional with expertise in diabetes care authorized by licensure to provide the education.
Coverage must extend to medical nutrition therapy, as long as it is provided by a licensed dietitian, unless the patient's health plan does not include a dietitian in its network of providers.
Coverage must cover the expenses of any diabetes self-management education determined to be medically necessary, whether provided in a group setting, during home visits, or by individual counseling.
The benefits provided under the bill may be subject to co-payments that the Superintendent of Insurance considers appropriate and are consistent with any other benefit provided.
The bill's requirements apply to:
individual and group health insuring corporation (HMOs) policies, contracts, and agreements;
individual, group, and blanket sickness and accident insurance policies delivered, issued for delivery, or renewed in this state, other than those that provide coverage for specific diseases or accidents only, for hospital indemnity only, for supplemental Medicare benefits only, or for any other supplemental benefits only;
public employee benefit plans. The requirement that benefits be provided begins with policies, contracts, agreements, and plans entered into, renewed, or modified on or after the bill's effective date.
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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