WV Pharmacists Association

HB 2577 Summary: Part I

Click here for Part I of the sumary of HB 2577.

Governor Earl Ray Tomblin signs "Larry Border Pharmacy Practice Act" making major enhancements to pharmacy

Passed by the 2013 Legislature, House Bill 2577 was signed by Governor Earl Ray Tomblin at the Capitol May 7, modernizing the state's pharmacy law.

The ceremonial signing was attended by: Michelle Easton, Dean of the University of Charleston School of Pharmacy; Kevin Yingling, Dean of Marshall University School of Pharmacy; David Elliott, representing Pat Chase, Dean of WVU School of Pharmacy; and Board of Pharmacy officials, Sam Kapourales, Charles Wolcott and David Potters.

Delegate Don Perdue, chair of the House of Delegates Health and Human Resources Committee and one of the sponsors of HB 2577 also attended the event. He advised the Governor the bill was named after the late-Delegate Larry Border, a pharmacist who served in the House of Delegates and contributed to the bill before his death. The bill was approved for passage by Delegate Perdue's Committee prior to final passage by the Legislature on April 13.

Ann Border, Larry's widow who was elected to his seat in the House of Delegates, sat beside the Governor during his signing of the bill. He commended Larry for his service to Ann, having served with him in the Legislature for several years.

The new Act goes into effect July 1, 2013. It is a product of four years of work by stakeholders from community, clinical and academic settings. It failed to reach passage in two earlier attempts by lawmakers because of proposed changes to the generic substitution provision.

Others attending were: Janet Wolcott and Brian Gallagher, JD, RPh, of Marshall; Krista Capehart, Kristy Lucas and David Bowyer of University of Charleston; students from the three Pharmacy Schools; Greg Hoyer of Rite Aid; Bridget Lambert of WV Retailers Association; and Richard Stevens, WVPA Executive Director.

SCHOOLS OF PHARMACY REPORT

Legislation takes first step to modernizing pharmacy law

The WV House of Delegates Health and Human Resources Committee voted March 6 to approve House Bill 2577, proposed legislation supported by WVPA that will bring the practice of pharmacy into the 21st century in our State. The Committee is chaired by Delegate Don Perdue (D-Wayne) a retired pharmacist.

"The bill is the product of over two years work with committee chairs and legal staff," said Richard Stevens, Executive Director. All interested parties, including such state agencies as PEIA, Medicaid, the Boards of Medicine and Pharmacy, various health care organizations and our three schools of pharmacy met several times to produce legislation that codifies into law the many services pharmacists provide their patients and other health care practitioners.

"A lot of work by some very dedicated WVPA and WVHSP officers and members as well as representatives of chain pharmacies went into developing the proposal. And we certainly appreciate Delegate Perdue putting the bill before his Committee so it can begin going through the legislative process," added Stevens.

The bill should be in either the Senate Health or Judiciary Committee when WVPA hosts its "Pharmacy Day at the Legislature" on Monday, April 1. The time will be good to have pharmacists and students at the Capitol to encourage lawmakers to pass the legislation. Pharmacists are encouraged to attend the event and talk with their Senators and Delegates about the importance of the legislation.

National Association of Boards of Pharmacy reports increased use PMP InterConnect...

With one million requests processed as of January 2013, NABP PMP InterConnect^®, the system that facilitates the secure transfer of prescription monitoring program (PMP) data across state lines to authorized users, continues to help prevent the diversion and abuse of prescription drugs. The NABP InterConnect allows authorized users in participating states to request patients’ controlled substance prescription data and receive a consolidated patient report including data from other participating states’ PMPs. Sharing prescription drug data among states is an effective tool for reducing prescription drug abuse and doctor shopping and is a key element for early detection, intervention, and prevention of substance abuse by patients as well as diversion of controlled substances by health care providers.

The NABP InterConnect is a highly secure communications exchange platform that facilitates the transmission of PMP data across state lines to authorized requestors, while ensuring that each state’s data-access rules are enforced. Authorized users in 10 states – Arizona, Connecticut, Indiana, Kansas, Michigan, New Mexico, North Dakota, Ohio, South Carolina, and Virginia – are now sharing data through the NABP InterConnect. Ten additional states have signed memorandums of understanding (MOU) to participate in NABP InterConnect, and five states have MOUs under review. It is anticipated that approximately 25 states will be sharing data or will have executed an MOU to participate in NABP InterConnect in 2013. In addition, pilot programs in several states have been implemented with the aim of making PMP data more easily accessible to authorized providers at the point of care.

When the Doctor Is Not Needed

New York Times
Editorial
December 16, 2012

There is already a shortage of doctors in many parts of the United States. The expansion of health care coverage to millions of uninsured Americans under the Affordable Care Act will make that shortage even worse. Expanding medical schools and residency programs could help in the long run.

Read the article.

FDA Holds Meeting on Compounding

Representatives of about a dozen different pharmacy groups attended a meeting last week at the FDA to discuss pharmacy compounding issues in light of the recent meningitis tragedy. Each group was asked to give their perspective on the current compounding situation and react to the FDA's risk-based proposal to further regulate pharmacy compounding. WVPA was represented at the meeting.

Under the proposal, the FDA would define traditional pharmacy compounding as what most small pharmacies do, which would continue to be regulated by the states, and non-traditional pharmacy compounding, such as large scale compounding, which would be regulated by the FDA.

The general consensus among the pharmacy groups seemed to be that the proposal could create more rather than less confusion. However, there was agreement that the FDA should focus on those entities that are acting more like manufacturers rather than traditional compounders. The FDA did seem to place significant emphasis on how to assure the quality of sterile compounding, wherever such compounding was being done.

The FDA is meeting with state regulators to discuss how to move forward. Congress is expected to address the compounding issue next year.

DRUGS GOING GENERIC IN 2013 ...

Here is a list of brand-name prescription drugs expected to be released as generics in 2013, according to Medco Health Solutions, which manages pharmacy benefit programs.

Opana ER (pain); Zometa (bone complications from cancer); Valcyte (viral infections); Zomig (migraines); Fosamax Plus D (osteoporosis); Rilutek (amyotrophic lateral sclerosis); Temodar (glioblastoma multiforme); Cerezyme (Gaucher disease); Niaspan (high cholesterol); Advicor (high cholesterol); AcipHex (GERD); Vivelle-DOT (menopausal symptoms); Cymbalta (depression, anxiety, nerve/musculoskeletal pain, fibromyalgia).

50.12 - Pharmacy Access During a Federal Disaster or Other Public Health Emergency Declaration

(Rev. 8, Issued: 12-18-09, Effective/Implementation: 01-01-10)

If a Presidential major disaster or emergency declaration is issued or the Secretary declares a public health emergency, and the underlying circumstances are reasonably expected to result in a disruption in access to covered Part D drugs, CMS expects sponsors to lift their "refill-too-soon" edits. Part D sponsors may exercise some operational discretion as to how these edits are lifted during a disaster or emergency as long as access to Part D drugs is provided at the point-of-sale. For instance, Part D sponsors could implement an edit that is readily resolvable at the point-of-sale through the use of a pharmacist override code. CMS also expects Part D sponsors to allow an affected enrollee to obtain the maximum extended day supply, if requested and available at the time of refill.

CMS expects that Part D sponsors will continue to lift these edits until the termination of a public health emergency or the end of a declared disaster or emergency. In the case of a public health emergency, it terminates when it no longer exists or upon the expiration of the 90-day period beginning from the initial declaration, whichever occurs first. For major disasters declared by the President, Part D sponsors should pay particular attention to the closure of disaster incident periods listed in the Disaster Federal Register Notice section on Federal Emergency Management Agency’s (FEMA’s)Web site

http://www.fema.gov/news/disasters.fema, noting that in circumstances in which the incident period has not officially closed 30 days from the initial Presidential declaration. Part D sponsors may consider extending the implementation of the edits but are not required to do so. However, if sponsors choose to remove the edits, they need to work closely with enrollees who indicate that they are still displaced or otherwise impacted by the disaster or emergency.

More news here.