Pledge as a PHARMACIST in the Million Hearts Campaign!

Pledge as a PHARMACIST in the Million Hearts Campaign!  The pharmacy/pharmacist-specific pledge shows your commitment to educate patients, promote healthy habits, help with prescription instructions and adherence, and measure blood pressure.  It also send a message to the Department of Health and Human Services that pharmacists are serious about being healthcare team members in this initiative.  The steps are easy:

1. Go to: http://millionhearts.hhs.gov/pharmacies.html
2. Answer the five quick questions (pharmacist or pharmacy name, email, city, state & zip)- all are gathered only for verification of unique pledges
3. Click “count me in”

Virginia Health Innovation Network Launched

The Virginia Center for Health Innovation today launched the Virginia Health Innovation Network.

The Virginia Health Innovation Network is a product of the Virginia Center for Health Innovation (VCHI), a multi-stakeholder organization committed to accelerating the adoption of value-driven models of wellness and health care throughout Virginia. The Virginia Health Innovation Network is the premier vehicle for the work of the VCHI.

Members are invited to:
- Learn about existing health innovations and models currently in practice
- Connect with colleagues and join communities of interest
- Share and spread what works and generate new innovations

To participate in the Virginia Health Innovation Network, please visit: http://www.innovatevirginia.org/pages/home/

Virginia Board of Health Professions Announces Public Hearing to Receive Comments on Pharmacy Technician Scope of Practice

Following up on last year's Board of Health Professions study of pharmacists, the Board announced on Tuesday, May 14th that they will now move forward with studying the current duties, responsibilities, training and education of pharmacy technicians and will determine what changes, if any, should be made to laws and regulatory policies to best enable effective team approaches for the care of Virginia's patients.

The Board of Health Professions has announced the timetable for the pharmacy technician study:

• July 30, 2013: Public Hearing/Committee Meeting

• July-August 2013: Open Public Comment Period

VPhA encourages you to think about your current practice and if there are any unnecessary restrictions that you feel should be altered to ease the burden on pharmacists and pharmacy technician and better ensure access to healthcare through strengthened health professional teams.

• The full laws and regulations can be found here: http://www.dhp.virginia.gov/Pharmacy/pharmacy_laws_regs.htm 

• The Board of Pharmacy has a separate page for Pharmacy Technicians with additional information: http://www.dhp.virginia.gov/Pharmacy/news_technician.htm 

The VPhA Board of Directors would like to hear your thoughts and suggestions concerning the review of Pharmacy Technicians.  If you have comments, please feel free to response send us an email at vpha@virginiapharmacists.org.

USP Prescription Container Labeling Becomes Official Standard

The United States Pharmacopeia (USP)  General Chapter <17>Prescription Container Labeling, published in the USP 36-NF 31, became an official standard on May 1, 2013. The standards, which provide a universal approach to the format, appearance, content and language of instructions for medicines in containers dispensed by pharmacists, were published in General Chapter <17> in November 2012. Visit the National Association of Boardsof Pharmacy Web site for additional information. 

Free Archive of Immunization Webinars Posted (No CE Credit Available for Archive)

Unable to attend one of the three webinars hosted by VPhA and the Virginia Department of Health or in need of a refresher of the content?  Archives of all three programs are now available for you to view at your leisure.  Note: CE credit is NOT offered for the archived webinars.

- Immunization Update 2012
- Best Practices for Vaccine Administration and Documentation
- Preventing Hepatitis B Among Diabetics

Archive Viewing (Not Eligible for CE Credit)
To view the archived webcast of the programs:
1. Visit https://lobby.mc.iconf.net/gcc/conferencing/partaccess.asp?ba=6
2. Enter the Moderator's Meeting Number: 4970431
3. Click "View List of Archives" *
4. Select from the list of available archives and click "View"
     - Note: please ignore the "Expired" text after the Immunization Update 2012.  The "view" link is still active.

Planning is already underway for future webinars from VDH and VPhA. Please be on the lookout for future opportunities.

* Some internet browsers do not show the option to click "View List of Archives". If you do not see this option, please try an alternate internet browser such as Internet Explorer.

VPhA Tracking the 2013 Virginia General Assembly Session

With session less than a week away, VPhA has already identified 13 bills that impact pharmacy.  This number will grow over the next 2 weeks as a few thousand bills will be introduced by the 140 members of the Virginia General Assembly.

Work has already begun in amending or defeating negative bills and we are actively working to ensure safe passage of HB1501 which amends the Collaborative Practice language to allow for greater use and flexibility of Collaborative Practice agreements.

To follow along with VPhA's work at the General Assembly, please click here.

(Note: to ensure that you are viewing the most up-to-date bill list, please compare the date and time listed on the document vs the date and time listed on the web page.  If the dates do not match up, we ask that you hit refresh in your internet browser and this should give you the updated bill list document)

DEA Notice of Proposed Rulemaking: Regulations Governing the Secure Disposal of Controlled Substances by Both DEA Registrants and Ultimate Users.

On Friday, December 21st, the DEA posted a Notice of Proposed Rulemaking for requirements to govern the secure disposal of controlled substances by both DEA registrants and ultimate users.

The proposed regulations would allow retail pharmacies, manufacturers, distributors, reverse distributors to voluntarily administer mail-back programs and maintain collection receptacles (all after obtaining authorization from the DEA to be a "collector"). In addition, this proposed rule expands the authority of authorized retail pharmacies to voluntarily maintain collection receptacles at long term care facilities.

For complete information, including the proposed regulations, please visit: http://www.deadiversion.usdoj.gov/fed_regs/rules/2012/fr1221_8.htm

SUMMARY: This rule proposes requirements to govern the secure disposal of controlled substances by both DEA registrants and ultimate users. These regulations would implement the Secure and Responsible Drug Disposal Act of 2010 (Pub. L. 111-273) by expanding the options available to collect controlled substances from ultimate users for purposes of disposal to include: Take-back events, mail-back programs, and collection receptacle locations. These proposed regulations contain specific language to continue to allow law enforcement agencies to voluntarily conduct take-back events, administer mail-back programs, and maintain collection receptacles. These regulations propose to allow authorized manufacturers, distributors, reverse distributors, and retail pharmacies to voluntarily administer mail-back programs and maintain collection receptacles. In addition, this proposed rule expands the authority of authorized retail pharmacies to voluntarily maintain collection receptacles at long term care facilities. This proposed rule also reorganizes and consolidates existing regulations on disposal, including the role of reverse distributors.

DATES: Electronic comments must be submitted and written comments must be postmarked on or before February 19, 2013. Commenters should be aware that the electronic Federal Docket Management System will not accept comments after midnight Eastern Time on the last day of the comment period.

ADDRESSES: To ensure proper handling of comments, please reference "Docket No. DEA-316" on all electronic and written correspondence. DEA encourages all comments be submitted electronically through http://www.regulations.gov using the electronic comment form provided on that site. An electronic copy of this document is also available at the http://www.regulations.gov Web site for easy reference. Paper comments that duplicate the electronic submission are not necessary as all comments submitted to http://www.regulations.gov will be posted for public review and are part of the official docket record. Should you, however, wish to submit written comments via regular or express mail, they should be sent to the Drug Enforcement Administration, Attention: DEA Office of Diversion Control (OD/DX), 8701 Morrissette Drive, Springfield, Virginia 22152.

FOR FURTHER INFORMATION CONTACT: John W. Partridge, Executive Assistant, Office of Diversion Control, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 307-4654.

Board of Pharmacy 12/12/12 Meeting Summary

The Virginia Board of Pharmacy met on Wednesday, December 12th for their quarterly meeting.  VPhA members have access to VPhA's summary of the Board meeting.  To access this information, please click here.

The next Board of Pharmacy full meeting will be held on March 12, 2013 beginning at 9am.

OPEN PUBLIC COMMENT PERIOD: Periodic Review of Board of Pharmacy Regulations - Comment Period Ends December 5th

Public comment periods have now opened to receive comments on regulations governing agencies under the Virginia Board of Health Professions.  This includes the Board of Pharmacy and the Prescription Monitoring Program regulations.  To view ALL of the open comment periods, please click here and scroll down to the "Secretariat: Health and Human Resources" and look for the comment periods scheduled to Close on December 5th.

The Virginia Board of Pharmacy will be conducting a periodic review of its regulations.  The first step to the review process is to receive feedback from the public on the regulations.  Beginning in 2013, the Board will review the regulations and take into consideration public comments received during the 30 day comment period.  The regulations to be reviewed are:

• 18VAC110-20: Virginia Board of Pharmacy Regulations
• 18VAC110-30: Regulations for Practitioners of the Healing Arts to Sell Controlled Substances
• 18VAC110-40: Regulations Governing Collaborative Practice Agreements
• 18VAC110-50: Regulations Governing Wholesale Distributors, Manufacturers and Warehousers

The review is part of the Governor's Regulatory Reform Project with the goal of:

1. Repealing regulations that are unnecessary or no longer in use;
2. Reducing unnecessary regulatory burdens on individuals, businesses, and other regulated groups; and  
3. Identifying statutes that require unnecessary or overly burdensome regulations. 

Further, the Board is seeking comment on whether this regulation should be terminated, amended, or retained in its current form.
 
Public comment is sought on the review of any issue relating to this regulation, including whether the regulation (i) is necessary for the protection of public health, safety, and welfare or for the economical performance of important governmental functions; (ii) minimizes the economic impact on small businesses in a manner consistent with the stated objectives of applicable law; and (iii) is clearly written and easily understandable. 
 
The comment period began November 5, 2012 and ends on December 5, 2012. 
 
Comments may be submitted online to the Virginia Regulatory Town Hall at: http://www.townhall.virginia.gov/L/Forums.cfm.

• Click here to submit comments concerning Board of Pharmacy Regulations
• Click here to submit comments concerning Regulations for Practitioners of the Healing Arts to Sell Controlled Substances
• Click here to submit comments concerning Regulations governing Collaborative Practice Agreements 
• Click here to submit comments concerning Regulations governing Wholesale Distributors, Manufacturers and Warehousers  

Comments may also be sent to:
Elaine J. Yeatts, Agency Regulatory Coordinator
Department of Health Professions
9960 Mayland Drive, Suite 300
Henrico, VA 23233
 
FAX: (804) 527-4434
EMAIL: elaine.yeatts@dhp.virginia.gov

In addition to the Board of Pharmacy's periodic review, comments are also encouraged for the following regulations impacting pharmacy:

• Regulations Governing the Health Practitioners' Monitoring Program for the Department of Health Professions
• Click here for more information
• Regulations Governing the Prescription Monitoring Program
• Click here for more information

Following the close of the public comment period, a report of the periodic review will be posted on the Town Hall and published in the Virginia Register of Regulations.

FDA reports voluntary recall of all Ameridose drug products

The U.S. Food and Drug Administration announced today (October 31) that Ameridose, LLC, based in Westborough, Mass., is voluntarily recalling all of its unexpired products in circulation. Products from Ameridose can be identified by markings that indicate Ameridose by name or by its company logo disclaimer icon. A complete list of all products subject to this recall can be accessed at www.ameridose.com disclaimer icon.

For more information on this voluntary recall, please click here for the complete FDA news release.

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.

 

NPLEx Information (Electronic Pseudoephedrine log)

Pharmacies that sell pseudoephedrine-containing products must begin reporting all sales via an electronic reporting system (NPLEx) by January 1, 2013.  Pharmacies are encouraged to begin reporting to the system now to ensure compliance by the turn of the year.

NOTE: the NPLEx program and training should be made available to pharmacies AT NO CHARGE.  If you are experience any charges with accessing the program or training, please let us know at vpha@virginiapharmacists.org.

If you have not yet registered your pharmacy for NPLEx access, please visit: https://nplex.appriss.com/retail/pharmacy/loginRegister.do

Steps to Register:

1.  You will be prompted to enter store information.
1. A verification email will be sent to the email address you provide.
2. Make sure this email address is valid and accessible
2. Click the link provided in the email to continue registering.
3. You will be prompted to create an Account ID and password for the store. Click Continue.
4. You will be prompted to create an Administrative User and a PIN for the store. Click Save. This will complete registration.

EXEMPTION TO REPORTING:
Pursuant to § 18.2-265.8(B) of the Code of Virginia, a pharmacy or retail distributor which lacks broadband access or maintains a sales volume of less than 72 grams of ephedrine or related compounds in a 30-day period may be temporarily exempt from the requirement to report transactions to the electronic system, if an exemption is granted by the Department of State Police, pursuant to § 18.2-265.8(C) and § 19VAC30-220-20 of the Virginia Administrative Code.

To request an exemption from electronic reporting, a pharmacy or retail distributor must complete the entire form, provide any supporting documentation, and submit the form and supporting documents to:

Virginia Department of State Police
VAMPIS
PO Box 27472
North Chesterfield, Virginia 23261-7472

Questions may be directed to the Virginia State Police VAMPIS Coordinator at 804-674-2809.

BOARD OF PHARMACY OPEN PUBLIC COMMENT PERIOD: Working conditions for pharmacists

A public comment period is currently in progress to receive public comments for the Board of Pharmacy to consider addressing hours of continuous work by pharmacists.

"The purpose of the planned regulatory action is to address a petition for rulemaking requesting amendments that will specify a limitation of excessive hours of work without any breaks for pharmacists. Regulation is necessary to prevent, to the extent possible, prescription errors due to fatigue and lack of concentration by pharmacists in the important task of assuring the accuracy and integrity of controlled substances. The action is the result of a petition for rulemaking (notice originally published in the March 30th VPhA E-News) by a pharmacist and was strongly supported in comment on the petition."

Following receipt of all comments, the Regulation Committee of the Board will review regulations from other states and any comments received from the open public comment period. Draft regulations would then be proposed to the full Board.
 
The public comment period is open until October 10th to provide feedback on the potential regulations.

• Details can be found at: http://www.townhall.virginia.gov/L/viewaction.cfm?actionid=3755&display=general
• To submit comments to the Virginia Board of Pharmacy, please visit: http://www.townhall.virginia.gov/L/entercomment.cfm?stageid=6265

Vote & Vax 2012 Offers Flu Vaccinations and Preventive Services on Election Day

Only 34.7 percent of women and 29.3 percent of men in Virginia are up to date with a combination of select clinical preventive services, such as influenza vaccination, colorectal cancer screening and breast and cervical cancer screenings according to the National Association of Chronic Disease Directors. Thanks to a Health Aging grant from the National Association of Chronic Disease Directors, Virginia is taking action this fall to improve delivery of clinical preventive services and offer seasonal flu vaccine through a national initiative titled “Vote & Vax” (www.voteandvax.org). 

Vote & Vax Virginia 2012 builds on a decade of experience by Project Immunize Virginia by offering flu vaccines at polling locations in the following health districts: Central Shenandoah, Cumberland Plateau, Hampton, Peninsula, Prince William, and Richmond City.  This year, pharmacist-staffed clinics located at polling sites will offer insurance billing and collect co-pays or out-of-pocket payment for vaccines. 

In addition to vaccinations, activities such as education and referral for cancer and hypertension screening will be offered at each site by local coalitions.  Led by volunteers from the Medical Reserve Corps, these coalitions include area agencies on aging, nursing students, and other stakeholder groups, such as the Cancer Action Coalition of Virginia, AARP Virginia, and the Baptist General Convention of Virginia.

By lending your time and skills to a local coalition, you can help protect your community from the flu and play a role in the delivery of important preventative health services.  Please contact Joseph Hoyle, Clinical Preventive Services Coordinator, Virginia Department of Health at joseph.hoyle@vdh.virginia.gov for more information.

New Video, Website Help Health Plan Sponsors, Patients and Policymakers Maximize Prescription Drug Benefits, Reduce Wasteful Spending

A new video and website offer health plan sponsors (i.e., employers, unions, government programs, etc.), policymakers and patients resources to get the most out of their prescription drug benefit and to reduce unnecessary spending, the National Community Pharmacists Association (NCPA) announced. At the website www.whorunsmydrugplan.com, visitors can learn about common practices of giant pharmacy benefit managers (PBMs), who are hired to administer drug plans and negotiate prices for payers, but drive up health insurance costs and restrict patient choice. There they can also watch "The Third Wheel," a video that takes a humorous look at how prescription middlemen affect consumers' prescription benefit by inserting themselves into the relationship between patients, doctors and pharmacists.

For the complete press release from NCPA, please click here.

Team Up. Pressure Down. Coaching Patients to Take Control.

Citing strong evidence of effectiveness, the U.S. Preventive Services Task Force in May 2012 recommended team‐based care ‐‐ uniting the efforts of physicians, pharmacists, nurses and other health care professionals ‐‐ to improve blood pressure control. Join the launch and/or one of four live CPE webinars (starting on September 5th) to learn more about Team Up. Pressure Down., a new Million Hearts™ educational program that offers support and resources for health care professionals working to help Americans improve medication adherence and more effectively manage their blood pressure. To register for the launch webinar, visit http://TeamUpPressureDown.webex.com. To learn more about the free CPE webinar and to register, visit www.GoToCEI.org under “Of Interest”.