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CLICK HERE TO READ THE JANUARY 2012 NEWSLETTER

 

FRIDAY, JANUARY 20, 2012

NORTH CAROLINA PHYSICIAN MICHAEL NUNN APPEARS ON THE US DEPARTMENT OF HEALTH AND HUMAN SERVICES EXCLUSION LIST.  Several pharmacists have inquired of Board staff about the eligibility of Michael K. Nunn, DO, NC Medical License #36123 for participation in federal programs.  According to information obtained from the North Carolina Medical Board’s webpage, Dr. Nunn’s practice site is Community Wellness Center, 750 McCarthy Boulevard, New Bern, NC  28562.   The Office of Inspector General of the US Department of Health and Human Services lists Dr. Nunn on its Exclusion List.    Pharmacists wishing to do so may verify this information here:  exclusions.oig.hhs.gov.   HHS OIG states that the consequences of this exclusion are: 

No payment will be made by any Federal health care program for any items or services furnished, ordered or prescribed by an excluded individual or entity. Federal health care programs include Medicare, Medicaid, and all other plans and programs that provide health benefits funded directly or indirectly by the United States (other than the Federal Employees Health Benefits Plan). For exclusions implemented before August 4, 1997, the exclusion covers the following Federal health care programs: Medicare, Medicaid, Maternal and Child Health Services Block Grant, Block Grants to States for Social Service, and State Children's Health Insurance programs.

No program payment will be made for anything that an excluded person furnishes, orders, or prescribes. This payment prohibition applies to the excluded person, anyone who employs or contracts with the excluded person, any hospital or other provider for which the excluded person provides services, and anyone else. The exclusion applies regardless of who submits the claims and applies to all administrative and management services furnished by the excluded person.

www.oig.hhs.gov/faqs/exclusions-faq.asp  Accordingly, any pharmacy that were to bill any federal program for a prescription written by Dr. Nunn could find itself subject to a recoupment action. 

 

 

THURSDAY, JANUARY 19, 2012 - PHOTO ID FAQ

Questions Regarding S.L. 2011-349, Photo Identification Prior to Dispensing Certain Controlled Substances

As reported in Item 2227 of the October 2011 Newsletter, the North Carolina General Assembly passed, and Governor Perdue signed into law S.L. 2011-349, which requires presentation of a photo identification prior to the dispensing of certain controlled substances.  The statute is an amendment to the North Carolina Controlled Substances Act and codified at N.C.G.S. § 90-106.1 and is effective March 1, 2012.  Board staff has received numerous questions about this statute.  In response, Board staff has developed an FAQ document.  The FAQ was updated on January 5, 2012.  All pharmacists should review the updates to question #3 and new question #11.  Because this law is part of the NC CSA, the Drug Control Unit of the North Carolina Department of Health and Human Services also has administrative responsibilities for the statute.  Bill Bronson, the head of that unit, has reviewed this FAQ and agrees with its content.  CLICK HERE TO READ THE FAQs.

 


NEW CE OPPORTUNITIES FOR 2012: PHARMACISTS & TECHNICIANS, Remember to check our CE page often for upcoming CE programs in your area. (LAST UPDATED JANUARY 27, 2012.)

THURSDAY, JANUARY 19, 2012

DEA to Hold Fourth National Prescription Drug Take-Back Day April 28, 2012

The fourth Drug Enforcement Administration (DEA) National Prescription Drug Take-Back Day will take place on Saturday, April 28, 2012, from 10 AM to 2 PM, providing consumers in every state with a safe means for the disposal of unwanted, unused prescription medications. Authorized DEA take-back sites are coordinated with local law enforcement agencies so that prescription controlled substances may be accepted for disposal. DEA reminds consumers that the take-back service is free and anonymous, with no questions asked. Sites will accept tablets, capsules, and all other solid dosage forms of unwanted medication. Personal information may be blacked out on prescription bottles, or medications may be emptied from the bottles into the bins provided at the events. DEA will provide an online drug collection site locator in March 2012.

Consumers disposed of 995,185 pounds (498.5 tons) of unwanted medication during the first three DEA National Prescription Drug Take-Back Days and the third DEA take-back event on October 29, 2011, saw participation from 5,327 partners that provided take-back sites across all 50 states and the United States territories. More information and a link to photos are available on the DEA Web site.



THURSDAY, JANUARY 19, 2012

FDA Issues Notification Regarding Risks of Purchasing Unapproved Injectable Cancer Medications from Unlicensed Sources

Food and Drug Administration (FDA) is reminding health care providers to obtain and use only FDA-approved injectable cancer medications purchased directly from the manufacturer or from wholesale distributors licensed in the US. FDA explains that “current shortages of injectable cancer medications may present an opportunity for unscrupulous individuals to introduce non-FDA approved products into the drug supply, which could result in serious harm to patients.” FDA reports that the agency is aware of promotions and sales of unapproved injectable cancer medications directly to clinics in the US and that the medications were likely administered to patients. Examples of products include unapproved versions of FDA-approved medications such as Faslodex® (fulvestrant), Neupogen® (filgrastim), Rituxan® (rituximab), and Herceptin® (trastuzumab). FDA stresses the risks to patients when such unapproved medications are used. The agency outlines several steps health care providers should take to ensure patient safety:

  1. Obtain and use only FDA-approved injectable cancer medications purchased directly from the manufacturer or from wholesale distributors licensed in the US. FDA provides a Web page that lists for each state the online resource for verifying that a wholesale distributor is appropriately licensed.

  2. Determine if the medication you have received is FDA approved by checking the Orange Book or Drugs@FDA.

  3. Question whether a price sounds too good to be true. Deep discounts may be offered because the product is stolen, counterfeit, or unapproved.

  4. Carefully inspect the product and packaging and be alert for signs that the product is not FDA approved, such as if the packaging looks different or the dosing recommendations are unfamiliar.

FDA also notes that if a health care provider receives multiple complaints about the same product, such as a new side effect or lack of therapeutic effect, these may signal a product quality issue.

FDA reminds health care providers that in certain circumstances, the agency may authorize limited importation of medications that are in short supply. Such medications are imported from approved international sources and distributed in the US through a controlled network, and would not be sold in direct-to-clinic solicitations. If FDA has arranged for limited importation of the foreign version of a medication, information on obtaining that medication will be available in the Drug Shortages section of the FDA Web site.

Additional details are available in an FDA Drug Safety communication (PDF).

 

 

FRIDAY, JANUARY 13, 2012

Novartis Consumer Health Recalls Certain OTC Medications Due to Manufacturing Issues
As a precautionary measure, Novartis Consumer Health, Inc (NCH) has initiated a voluntary recall of certain over-the-counter (OTC) medications manufactured at a Lincoln, NE, facility. This recall includes all lots of select bottle packaging configurations of the following medications:

NCH initiated the recall because the products may contain stray tablets, capsules, or caplets from other Novartis products, or contain broken or chipped tablets, as indicated in a news release.

NCH is notifying distributors and customers to arrange for return of all recalled products. Consumers that have the recalled products should stop using them. Additional consumer information including details on the specific product lots recalled and instructions on returning affected medications for a refund are available on the Novartis Web site. NCH advised that consumers experiencing any problems with these medications should contact their health care provider. Related adverse events may be reported to the FDA MedWatch Adverse Event Reporting Program using the online form or by following the instructions for faxing or mailing a report on the FDA Web site.

 

 

WEDNESDAY, JANUARY 11, 2012

CARISOPRODOL PRODUCTS ARE NOW SCHEDULE IV CONTROLLED SUBSTANCES. CLICK HERE FOR MORE INFORMATION.

 

 

MONDAY, JANUARY 9, 2012

NORTH CAROLINA BOARD OF PHARMACY

JANUARY 9, 2012 STATEMENT CONCERNING THE USE OF WALGREENS’ TRANSFERSAFE PROGRAM

As many pharmacists are aware, Walgreens and Express Scripts have been engaged in a dispute concerning reimbursement rates offered by Express Scripts.  Effective January 1, 2012, the existing agreement between the two expired.  Accordingly, Walgreens is no longer an Express Scripts network provider. 

This development has led to the need for many Walgreens customers to transfer prescriptions to other pharmacies.  Walgreens has taken proactive steps to ease delays and patient access issues as patients seek to have their prescriptions transferred to other pharmacies.

Specifically, Walgreens has introduced a program called TransferSafe.  This is a secure, web-based tool whereby a non-Walgreens pharmacy may log in to the program, and enter information about the prescription a patient seeks to have transferred.  The system then retrieves the prescription from the Walgreens database and allows the requesting pharmacy to print the retrieved prescription information and document the transfer.

Like a number of other state boards of pharmacy, North Carolina rules require that a prescription transfer be communicated between pharmacists and/or certified technicians.  The pertinent North Carolina rule contains an exception that allows transfers facilitated by one pharmacist (or certified technician) accessing “an information file containing data for several locations.”  However, this form of transfer is permitted only if “all locations accessed are under common ownership or accessed pursuant to contractual agreement of the pharmacies.”  21 NCAC 46.1806(a)(1).  Neither circumstance exists in this instance.

Given the unusual circumstances created by the Walgreens/Express Scripts separation, however, the Board is concerned that strict adherence to Rule .1806(a)(1) could create significant delays or interruptions in patients’ medication therapies, with attendant risk to patient safety.  Accordingly, to prevent or mitigate such delays or interruptions, the Board has directed Board staff, as a matter of enforcement discretion, to allow North Carolina pharmacies to use the Walgreens TransferSafe program through April 15, 2012.

Walgreens representatives have stated that the TransferSafe program will be activated in North Carolina tomorrow, January 10, 2012.  Pharmacists seeking to access TransferSafe in order to transfer a prescription for their patient from Walgreens to their pharmacy should do the following:

1.   Access the web portal at http://TransferSafe.Walgreens.com.
2.   At the portal's webpage, enter the patient's prescription number and the patient's date of birth; in addition you will also need to enter security information available on that page.
3.   On the following page, enter your pharmacy's information: name of pharmacy, name of pharmacist, telephone number, and DEA registration.
4.   After submitting the above information, the prescription information will display on the screen. You should verify the prescription information, print it for your records, and then exit the system.

Questions concerning TransferSafe’s operation should be addressed to: TransferSafe@Walgreens.com.  More information may be found here: http://www.ncbop.org/PDF/HowToUseTransferSafe2012.pdf.

 

 

MONDAY, JANUARY 9, 2012

FDA Advises to Check Certain Endo Pharmaceuticals Opioids to Ensure Correct Medication is Received

Food and Drug Administration (FDA) and Endo Pharmaceuticals (Endo) are advising health care providers and patients to check certain prescription Endo opioid products to ensure that the correct medication is received, as a result of product manufacturing issues. Specifically, at a Novartis Consumer Health facility in Lincoln, NE, where certain opioid products are manufactured and packaged for Endo, manufacturing problems were discovered that could result in tablets from one product type being carried over into packaging of another product. FDA estimates that the likelihood of a patient receiving a stray pill of another medicine in their dispensed prescription medication is low, but to ensure patient safety, the agency advises that affected pills are examined. FDA advises that pharmacists visually inspect and verify the identity of all affected medications including “tablets counted out for dispensing in a separate container from the manufacturer’s bottle” and  the contents of “bottles that have never been opened when the entire bottle is being dispensed.” Patients prescribed the affected medications should also examine all pills in their bottles, making sure the size, shape, and color of each pill is the same. For example, if a patient discovers that one or more tablets in their dispensed medication looks different from the others, the medication should be returned to his or her pharmacist.

The following drugs are affected:


A list of these medications including descriptions and images of each pill are posted on the Endo Web site. FDA advises that patients discuss any related questions with their health care providers and that they may also contact Endo Pharmaceuticals at 800/462-3636.

FDA indicates in a Drug Safety Communication that Endo is not aware of any patient having experienced a confirmed product mix-up, nor any adverse events attributable to a product mix-up. Further, FDA indicates that only three product mix-ups with respect to these products have been reported by Endo since 2009 and that all three were detected by pharmacists.

Endo and FDA are also advising pharmacists that while manufacturing process improvements are implemented by Endo, there may be a short-term disruption in the supply of the affected products to patients. Information for pharmacists regarding potential supply disruption is posted on the Endo Web Site.

 

 

WEDNESDAY, JANUARY 4, 2012

REMINDER: ACCREDITATION COUNCIL FOR PHARMACY EDUCATION (ACPE) REQUIRES PHARMACISTS TO OBTAIN A UNIQUE ID AS PART OF CPE MONITOR INITIATIVE.  As the new year begins, Board staff reminds pharmacists that ACPE and the National Association of Boards of Pharmacy have launched “CPE Monitor” – an electronic system for pharmacists and pharmacy technicians to track completed continuing pharmacy education credits.  Participation in CPE Monitor requires pharmacists to obtain an NABP e-Profile ID. The e-Profile ID is required by ACPE to receive continuing education credits from ACPE-accredited providers. 

Click on the links below for more information:

Set up your NABP e-Profile to obtain your ID here.

Please note:  North Carolina pharmacists will still be required to self-report all continuing education into their Board of Pharmacy account through their personal log-on at the Board’s website.  ACPE (or ACPE providers) will not download continuing education information into your Board of Pharmacy account. 

 

 

TUESDAY, JANUARY 3, 2012

RENEW YOUR LICENSE/PERMIT/REGISTRATION FOR 2012

The 2012 renewal period ended on December 31. The Board allows a 60-day grace period to renew with no penalty so if you have not already renewed, CLICK HERE TO ACCESS THE LOG-IN LINKS. You must renew by March 1.

Click here for Frequently Asked Questions regarding the renewal process.

 

 

THURSDAY, DECEMBER 22, 2011

ELECTRONIC TRACKING OF PSEUDOEPHEDRINE SALES - SESSION LAW 2011-240 HOUSE BILL 12 TAKES EFFECT JANUARY 1, 2012.

 


MONDAY, NOVEMBER 21, 2011

PRESCRIPTIONS FROM GEORGIA-BASED “PAIN CLINICS”  

Board Staff has received numerous calls from pharmacists in North Carolina concerning prescriptions from “pain centers” in Georgia.  Board staff have seen prescriptions from such pain centers in the Atlanta area, as well as the Tucker, Georgia area.  As with prescriptions often seen from Florida, the typical presentation is from a patient from outside of North Carolina (although this is not exclusively so) who presents a prescription for various narcotics, especially oxycodone, and other controlled substances from a “pain clinic” in Georgia.  If the pharmacist contacts the Georgia facility, he/she is typically unable to speak with the prescriber, but is “assured” by someone in the office that the prescription is “legitimate.”  Most, if not all, such prescriptions appear not to be written for a legitimate medical purpose in the ordinary course of medical practice.  Pharmacists should be appropriately cautious.

 

 

Click here for important information about influenza/H1N1.

 

 

Health Advisories (last updated January 13, 2012) - Check here regularly for the latest alerts and recall notices.

 

 

Medicare/Medicaid (last updated December 13, 2011) - Check here regularly for the latest updates regarding Medicare/Medicaid.


 

Looking for a news item that is no longer here? Try our search page or send an email to Kristin Moore.

 

The North Carolina Board of Pharmacy's mission is to protect the public health, safety and welfare in pharmaceutical matters. The Board sets standards for academic and practical experience programs prior to licensure, issues permits to operate pharmacies and DME facilities, and annually renews licenses, permits and registrations.

For more information, please see About the NCBOP.


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