Presentation by CMS on "The 2012 Medicare Open Enrollment Period & The DMEPOS Competitive Bidding Program, Round 2" - Thursday, October 25th - Richmond

On Thursday, October 25, 2012 from 2:00 – 3:00 PM the Philadelphia Regional Office of the Centers for Medicare & Medicaid Services and The Virginia Bureau of Insurance will be hosting a meeting on: The 2012 Medicare Open Enrollment Period & The DMEPOS Competitive Bidding Program, Round 2

Featuring: Nancy B. O’Connor, Regional Administrator
Philadelphia Regional Office, The Centers for Medicare &

Medicaid Services

Thursday, October 25, 2012 from 2:00 – 3:00 PM

Hosted at the Virginia Bureau of Insurance
1300 East Main Street
Richmond, VA 23219
Court Room A

Please RSVP to: melissa.herd@cms.hhs.gov or 215-861-4165.

Southwest Virginia Prescription Drug Abuse Summit

Southwest Virginia Prescription Drug Abuse Summit
November 14, 2012
8:30 a.m. – 4:30 p.m.
Wytheville Meeting Center

For more information, please visit: http://www.justice.gov/usao/vaw/swvadrugsummit.html

Click here for Agenda

Click here for Registration

Welcome to the homepage for the Southwest Virginia Prescription Drug Abuse Summit. Hosted by the United States Attorney’s Office for the Western District of Virginia, and designed with partners in law enforcement, treatment and prevention and economic development, the summit will address the ever-expanding problem of prescription drug abuse and produce an action plan to combat it.

This one day, no cost, event will be held November 14, 2012 from 8:30 a.m. to 4:30 p.m. at the Wytheville Meeting Center in Wytheville, Virginia.

The goal of the first ever Southwest Virginia Prescription Drug Abuse Summit is to have members of the community, law enforcement, service providers and leaders of commerce join in and open and direct discussion about the impact the abuse of prescription drugs is having on our communities.

Panel discussions will address current trends in law enforcement; prevention, treatment and education, and the economic impact of prescription drug abuse in our area of the Commonwealth of Virginia.

USP-NF General Chapter 17 Prescription Container Labeling

In November 2012, USP will publish a new General Chapter <17> Prescription Container Labeling in USP 36-NF 31. The standard provides, for the first time, a universal approach to the format, appearance, content and language of instructions for medicines in containers dispensed by pharmacists. The new USP general chapter offers specific direction to label manufacturers, pharmacies and prescribers on how prescription labels should be organized in a "patient-centered" manner that reflects how most patients seek out and understand medication instructions. Read More

The USP effort to create these new standards developed from an Institute of Medicine (IOM)-led initiative to improve health literacy, which is defined as the degree to which people can obtain, process and understand the basic health information and services they need to make appropriate health decisions. According to IOM, 77 million Americans have limited health literacy, and a majority of Americans have difficulty understanding and using currently available health information and services. At a 2007 IOM workshop on Standardizing Medication Labels: Confusing Patients Less, USP Chief Executive Officer Roger L. Williams pledged that the organization would initiate work on a standardized prescription container label.  The resulting standard was finalized by the USP Nomenclature, Safety, and Labeling Expert Committee, which is chaired by Thomas Reinders, Pharm.D. The standard was developed by experts in patient safety, health literacy, pharmacy, medicine, human factors research and labeling technology. Key areas covered in General Chapter <17> include organizing the label in a patient-friendly way, using explicit language to describe dosages and intervals, improving readability with clear formatting, including "purpose for use" (e.g., "for high blood pressure") and addressing those with visual impairments and those with limited English comprehension.

Enforcement of the standard will be the decision of individual state boards of pharmacy, which may choose to adopt it into their regulations-similar to USP standards for sterile and nonsterile pharmaceutical compounding, both of which are widely recognized by states. At its 2012 annual meeting, the National Association of Boards of Pharmacy passed a resolution supporting state boards in requiring a standardized prescription container label.

Background

Resources

• Download USP-NF General Chapter <17> Prescription Container Labeling
• USP Press Release: First Universal Standards Guiding Content, Appearance of Prescription Container Labels to Promote Patient Understanding of Medication Instructions
• Sample labels illustrating key elements of General Chapter <17> (Note: The following examples do not reflect all possible configurations for a patient-centered label).
• Video: USP Nomenclature, Safetyand Labeling Committee Chair Thomas Reinders, Pharm.D.

DEA Regulations for Pre-populated Controlled Substance Prescription Requests

It has come to the attention of VPhA that significant concern exists in the industry regarding pre-printed forms that both retail and long-term care pharmacies use to "remind" prescribers that a patient is out of refills on certain controlled substance prescriptions. There has been a lot of messaging and general confusion in the marketplace since the letter from the Drug Enforcement Administration headquarters to Omnicare's general counsel regarding this topic surfaced. Click here for the letter.

NCPA spoke with the DEA regarding this issue in order to gain clarity. The DEA told NCPA that the pharmacist can't send a reminder letter that "provides a partially or fully pre-populated form" for the prescriber or prepare a prescription for signature because the pharmacist is NOT an agent of the prescriber. Any "reminder letters" can't look like a prescription.  DEA stated that it is aware of software that makes these forms look like prescriptions and this is not allowed. In other words, if a pharmacy faxes a refill request for a controlled substance to the prescriber that includes all of the previous prescription information pre-populated on the request form the prescriber cannot simply sign and return the reminder letter to the pharmacy and that serve as the original prescription. If a form has a reminder on the top portion and the bottom is blank whereby the prescriber has to write the prescription and sign, that is permitted.

VPhA encourages pharmacists to work with technology vendors to ensure that these forms are in full compliance with DEA rules. This may require a significant change in current practice that will be new to many prescribers.

VPhA would like to remind members that you should be aware of all requirements by the Virginia Board of Pharmacy for both written and faxed prescriptions.  These can be easily found on Guidance Document 110-35 by clicking here. 

Continuous Quality Improvement Programs Emergency Regulations Finalized - Effective October 1, 2012

Governor McDonnell has approved the emergency regulations requiring the implementation of continuous quality improvement (CQI) programs for all pharmacies.  These emergency regulations went into effect on October 1, 2012.  Of note, there will be a 6 month implementation allowance before enforcement will occur.  Thus, pharmacies will have until March 31, 2013 to come into compliance with the emergency regulations.

Since these are emergency regulations (effective for 1 year), a public comment period will open on October 8th to receive comments on the regulations and if changes are needed, the Board of Pharmacy will review and propose alternate permanent regulations in 2013.  More information on the future public comment period can be found by clicking here.

There are two ways that pharmacies can implement a CQI program.  

• Reporting dispensing errors to a "Patient safety organization" (PSO).  A complete listing of PSOs can be found at the AHRQ's webpage.  If you are "actively reporting" (reporting all dispensing errors and analyses of such errors to a PSO as soon as practical or at least within 30 days of identifying the error) to a PSO, your pharmacy is in compliance with the regulation
• Implementation of a CQI program that includes the following:
• Notification as well as Documentation and record requirements
• (a detailed list of the requirements can be found on pages 10 and 11 of the emergency regulations document)

Click here for the full text of the emergency regulations.  NOTE: the CQI requirements can be found in all text that is underlined in the document.