NC Vol. 36, No. 4 Page 1
6015 Farrington Rd, Suite 201 • Chapel Hill, NC 27517 • Tel: 919/246-1050
Fax: 919/246-1056 • www.ncbop.org
Apri l 2015
Published to promote compliance of pharmacy and drug law
News
North Carolina
Board of Pharmacy
continued on page 4
Item 2300 – Voting for Board Member
Election for Southeastern District
Opens April 15, 2015
As reported in the January 2015 Newsletter, the next
North Carolina Board of Pharmacy election will take
place in April and May 2015. One position on the Board
will be filled: the Southeastern District seat presently
held by Robert (Joey) McLaughlin. Mr McLaughlin will
complete his second consecutive five-year term on April
30, 2016, and as a result, is term-limited.
Nominations were open through March 15, 2015.
Please monitor the Board’s website for candidates’
names and biographies, which will be posted in early
April.
Voting will run from April 15 through May 15. All
pharmacists living in North Carolina and actively li-censed
as of March 15, 2015, will be eligible to vote. Just
as in years past, eligible voters will log into the Board’s
secure site using their license number and personal
identification number to cast their vote.
Voting closes on May 15, and votes will be tallied
immediately following. Provided that a run-off election
is not needed, results will be certified at the Board’s
June 16 meeting. Any necessary run-off election will
be held in late May/early June 2015.
Please contact Jack W. “Jay” Campbell IV or Kristin
Moore at the Board office if you have questions about
the election process.
Item 2301 – Proper Identification
of Compounding Risk Levels and
Notification to the Board
Pharmacies that hold a permit from the Board and
that engage in any type of compounding are required
to notify the Board. Such pharmacies must report (both
on an initial permit application and as part of each an-nual
renewal): (1) whether the pharmacy compounds;
(2) a good-faith estimate of the percentage of the phar-macy’s
dispensing that involves compounded products;
(3) whether the pharmacy engages in nonsterile com-pounding;
(4) whether the pharmacy engages in sterile
compounding; and if so, (5) what risk level of sterile
compounding, as defined by United States Pharmaco-peia
Chapter <797>, the pharmacy performs.
Accurate reporting of this information is crucial for
at least two reasons. First, failure to provide accurate
information in connection with seeking or renewing a
permit is grounds to revoke or void a pharmacy permit
(NCGS §90-85.38). Second, the Board’s risk-based in-spection
intervals are driven by the scope and type of
service provided at a pharmacy, particularly compound-ing
services.
In at least one recent case, a pharmacy reported that
it was only engaged in low-risk sterile compounding.
An inspection showed that the pharmacy was, in fact,
engaged in high-risk sterile compounding. Such misre-porting
is a serious issue, and will be treated as such.
In an effort to reduce any confusion concerning this
reporting requirement, Board staff has developed a
guidance document, which may be found at www.ncbop
.org/PDF/CompoundingRiskLevelsandCategoriesMar
2015.pdf.
Item 2302 – Voting for Election for
Rehabilitation Technology Supplier
Seat on the Device and Medical
Equipment Subcommittee Opens
in June
In June 2015, the Board’s Device and Medical Equip-ment
(DME) Subcommittee will hold an election for
the Rehabilitation Technician Supplier representative
seat. This seat is presently held by DME Subcommittee
Member Edward Dressen, who is eligible to run for a
second term.
a) Use a weekly dosage regimen default for oral
methotrexate. If overridden to daily, require a hard stop
verification of an appropriate oncologic indication.
b) Provide patient education by a pharmacist for all weekly
oral methotrexate discharge orders.
Question: Does the best practice of a weekly frequency default
for oral methotrexate apply to a specialty cancer hospital?
Answer: The intent of this best practice is to reduce errors when
methotrexate is prescribed as a weekly regimen for non-oncologic
or oncologic indications. Even when used for oncologic purposes,
oral methotrexate is sometimes prescribed as a weekly regimen,
not daily. Thus, this best practice applies to all patient care settings,
including specialty cancer hospitals.
Teaching Points (Both Verbal and Written)
􀆇􈝅 Explain the weekly dosing schedule.
􀆇􈝅 Explain that taking extra doses is dangerous.
􀆇􈝈 Have the patient repeat back the instructions.
􀆇􈝐 Provide the patient with the free ISMP high-alert medication
consumer leaflet on methotrexate (found at www.ismp.org/
AHRQ/default.asp).
To read all of the best practices, visit www.ismp.org/Tools/Best
Practices/default.asp.
ACPE Releases Updated Definition of CPE and
Guidance on CPD
The Accreditation Council for Pharmacy Education (ACPE)
has released two documents that provide guidance and support for
continuing pharmacy education (CPE) and continuing professional
development (CPD). The two documents, approved by the ACPE
board of directors, are described below.
􀆇􈝔 The revised Definition of Continuing Education for the Profes-sion
of Pharmacy defines the quality of CPE required by ACPE
and the competencies required for CPE activity content. The
Definition document will assist providers of CPE in planning
activities that will be applicable to the professional development
of pharmacists and certified pharmacy technicians.
􀆇􈝔 The Guidance on Continuing Professional Development (CPD)
for the Profession of Pharmacy incorporates feedback from a
broad survey of the pharmacy profession that was conducted
in July 2014. The Guidance document provides details on the
learning activities that may contribute to the professional devel-opment
of both pharmacists and pharmacy technicians beyond
CPE, and also “provides a process for pharmacists and pharmacy
technicians to meet and maintain defined competencies in areas
relevant to their respective professional responsibilities.”
Additional information, including links to the documents, is avail-able
in a press release on the ACPE website at www.acpe-accredit
.org/pdf/ACPEAdvancesCPE-CPDforPharmacists.pdf.
Hospira Issues Recall for Multiple Lots of
Ketorolac Tromethamine Injection Due to
Potential Contamination
Hospira, Inc, of Lake Forest, IL, has issued a voluntary recall
of ketorolac tromethamine injection, USP in the United States and
Singapore due to potential particulate matter. The presence of par-ticulate
was confirmed through a customer report of visible floating
particulate that was identified as calcium-ketorolac crystals. If in-
Page 2
National Pharmacy
(Applicability of the contents of articles in the National Pharmacy Comp
and can only be ascertained by examini
FDA’s New Database Simplifies Searching for
Guidance Documents
Food and Drug Administration (FDA) has released a new database
that houses most FDA guidance documents for regulatory profession-als.
The guidance documents for nearly all FDA-regulated professions
and industries are available in a searchable database that allows users
to enter keywords that update automatically as they are typed. Search
results may also be narrowed by product, date, document type, and
other terms. The database also indicates whether there is an open
comment period and the deadline for submitting comments.
The database can be accessed at www.fda.gov/Regulatory
Information/Guidances/default.htm.
2014-2015 Targeted Medication Safety Best
Practices for Hospitals
This column was prepared by the Institute
for Safe Medication Practices (ISMP). ISMP is
an independent nonprofit agency and federally
certified patient safety organization that analyzes medication errors,
near misses, and potentially hazardous conditions as reported by
pharmacists and other practitioners. ISMP then makes appropriate
contacts with companies and regulators, gathers expert opinion
about prevention measures, and publishes its recommendations. To
read about the risk reduction strategies that you can put into practice
today, subscribe to ISMP Medication Safety Alert!® Community/
Ambulatory Care Edition by visiting www.ismp.org. ISMP provides
legal protection and confidentiality for submitted patient safety data
and error reports. Help others by reporting actual and potential
medication errors to the ISMP National Medication Errors Reporting
Program Report online at www.ismp.org. Email: ismpinfo@ismp.org.
The purpose of the Targeted Medication Safety Best Practices
(TMSBP) for Hospitals is to identify, inspire, and mobilize wide-spread,
national adoption of consensus-based best practices on spe-cific
medication safety issues that continue to cause fatal and harmful
errors in patients despite repeated warnings in ISMP publications.
These best practices are realistic practices, already adopted by many
organizations, upon which hospitals can focus their medication safety
efforts. The best practices are applicable to all types of hospitals in-cluding,
but not limited to, critical access hospitals, cancer hospitals,
and children’s hospitals. They may also be applicable to other health
care settings, as well as non-inpatient areas of hospitals and hospital
systems. These best practices have been reviewed by an external
expert advisory panel and approved by the ISMP Board of Trustees.
Related issues of the ISMP Medication Safety Alert! are referenced
after each best practice.
Recurrent Issue of Serious Harm
Oral methotrexate for non-oncological indications administered
daily instead of weekly or twice weekly is a recurrent issue and one
of the six TMSBPs.
ISMP has published this error in seven ISMP Medication Safety
Alert! issues from 1996 to 2013. Although dosed daily for oncology
purposes, it is used weekly or twice weekly to treat a variety of
autoimmune diseases (eg, psoriasis, severe rheumatoid arthritis).
Error reports point to inadvertent ordering and/or entering as daily
instead of weekly or twice weekly, and lack of patient education/
understanding of medication dosing schedule. To minimize the risk
of error, Best Practice 2 calls for hospitals to:
Page 3
Compliance News
pliance News to a particular state or jurisdiction should not be assumed
ng the law of such state or jurisdiction.)
jected, medications contaminated with particulate matter may cause
localized inflammation, allergic reaction, granuloma formation, or
microembolic effects. Multiple lots are impacted by this recall and
are listed in a press release posted to the FDA website at www.fda
.gov/Safety/Recalls/ucm433857.htm. The lots were distributed from
February 2013 to December 2014 in the US. To date, there have been
no cases of adverse events associated with this medication. Adverse
reactions may be reported to FDA’s MedWatch Safety Information
and Adverse Event Reporting Program.
FDA Warns of Counterfeit Cialis Tablets Entering
the US
Potentially dangerous, counterfeit versions of Cialis® 20 mg tablets
were intercepted in the mail before reaching a US consumer, warns
FDA. Laboratory analysis of the counterfeit product showed that it
contained multiple active ingredients that could lead to adverse effects
or harm if used, indicates an FDA Drug Safety Announcement. The
agency reminds US consumers to only buy prescription medications
from state-licensed pharmacies located in the US. FDA notes that it
cannot confirm that the manufacturing, quality, storage, and handling
of products ordered from unlicensed websites follow US standards
because the products are from an unknown source.
To help consumers identify these counterfeit medications, FDA
provides guidelines in the safety announcement. For example, these
counterfeits list “AUSTR81137” on the front of the bottle and lack a
National Drug Code number. Other possible identifiers include mis-spellings
and unusual colors on the label, and a manufacturer listed as
“112 Wharf Road, WEST RYDE, NSW 2114” on the side of the bottle.
To date, FDA is not aware of any adverse events associated with
these counterfeit medications; however, consumers are encouraged
to talk to a health care provider about their condition and options for
treatment if a counterfeit product was received.
The National Association of Boards of Pharmacy® (NABP®) has
reviewed more than 10,900 websites selling prescription drugs to
patients in the US and found that nearly 97% are operating out of
compliance with pharmacy laws and practice standards established
to protect the public health. To help consumers in the US find the
safest sources for purchasing medications online, NABP developed
the Verified Internet Pharmacy Practice Sites® (VIPPS®) program.
NABP encourages consumers to look for the VIPPS Seal and to
check NABP’s list of accredited sites on the AWARXE® Prescription
Drug Safety Program website. In addition, consumers may soon
watch for pharmacy sites using the newly launched .pharmacy Top-
Level Domain; sites in the domain (with a website address ending
in .pharmacy) will be reviewed by NABP and approved only if they
are legitimate online pharmacies or pharmacy resources adhering to
applicable pharmacy laws and best practices.
Additional details on the counterfeit Cialis are available in a Drug
Safety Announcement posted to the FDA website at www.fda.gov/
Drugs/DrugSafety/ucm431071.htm. More information on VIPPS
and other NABP programs is available in the Programs section of
the NABP website, www.nabp.net.
New FDA Drug Info Rounds Training Videos
Review Drug Disposal and REMS
FDA Drug Info Rounds, a series of online videos, provides impor-tant
and timely drug information to practicing clinical and community
pharmacists so they can help patients make better decisions. The latest
Drug Info Rounds videos are as follows.
􀆇􈝉 In “Disposal of Unused Medicines,” pharmacists discuss how
consumers can safely dispose of expired or unused medications
to prevent abuse or misuse and accidental poisoning.
􀆇􈝉 In “REMS,” pharmacists discuss the many components of Risk
Evaluation and Mitigation Strategies (REMS) and how they can
help manage a drug product with known or potential serious risks.
Drug Info Rounds is developed with contributions from pharma-cists
in FDA’s Center for Drug Evaluation and Research, Office of
Communications, Division of Drug Information. These videos and
previous Drug Info Rounds resources are available on the FDA web-site
at www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/
ucm211957.htm.
FDA Issues New Drug Labeling Rules to Benefit
Pregnant, Breastfeeding Women
FDA announced new prescription drug labeling requirements that
will clarify how medications might affect women who are pregnant or
breastfeeding and men and women of reproductive potential. The final
“Content and Format of Labeling for Human Prescription Drug and
Biological Products; Requirements for Pregnancy and Lactation Label-ing
Rule” removes the previously used pregnancy letter categories – A,
B, C, D, and X – and places information into three main categories:
􀆇􈝐 Pregnancy: Labor and delivery guidelines now fall under this
category, which also now includes information for pregnancy ex-posure
registries. Such registries track data on the effects of certain
approved medications on pregnant and breastfeeding women.
􀆇􈝌 Lactation: Previously labeled “Nursing Mothers,” this category
provides information such as how much drug is secreted through
breast milk and the potential effects on a breastfed infant.
􀆇􈝆 Females and Males of Reproductive Potential: This is a new
category that includes information on how a certain medication
might affect pregnancy testing, contraception, and infertility.
The new labeling changes go into effect on June 30, 2015. Over-the-
counter medication labels will not be affected. The new rules
are available for download through the Federal Register at https://
s3.amazonaws.com/public-inspection.federalregister.gov/2014-28241
.pdf.
FDA Approves Zohydro ER With Abuse-
Deterrent Properties
In February 2015, FDA approved a new formulation of Zohydro®
ER with abuse-deterrent properties. The new formulation uses a tech-nology
that allows the drug to maintain its release properties when used
as intended, according to a press release from Zogenix. The abuse-deterrent
system, known as BeadTek, incorporates “pharmaceutical
excipients” that create a viscous gel when the medication is crushed and
dissolved in a liquid or solvent, thus making the product more difficult
to abuse through methods that involve crushing, breaking, or dissolving
the drug. In early 2014, Zohydro ER became the first extended-release,
single-ingredient hydrocodone product to receive approval for use in
the US. Approval of the drug came under criticism, with some orga-nizations
arguing that the potential for addiction, abuse, and misuse
could outweigh therapeutic benefits, in part because the drug lacked
abuse-deterrent properties. Zogenix indicates that transition to the new
abuse-deterrent formulation will take place in second quarter 2015.
Additional information on the new formulation is provided in a press
release available on the Zogenix website at http://ir.zogenix.com/phoenix
.zhtml?c=220862&p=irol-newsArticle&cat=news&id=2012326.
continued from page 1
The Rehabilitation Technician Supplier representative
must practice in the particular area for which he or she
is nominated, but need not practice exclusively in that
area. As of this writing, the nomination period (which
runs through April 1, 2015) is open.
All North Carolina DME permit holders residing in
the state as of March 15, 2015, are eligible to vote. As in
past years, voting will be electronic; a DME person-in-charge
will log into his or her individual Board account
to cast an electronic ballot. More details, including
instructions for requesting a paper ballot if preferred,
will follow in the coming weeks.
Item 2303 – Guidance on the Federal
Drug Quality and Security Act
North Carolina pharmacists are aware that in No-vember
2013, the federal Drug Quality and Security
Act (DQSA) became effective. Board staff periodically
receives questions about DQSA’s operation. To assist, a
guidance document is available at www.ncbop.org/faqs/
Pharmacist/faq_DQSA.htm. This guidance document
will be updated periodically.
Item 2304 – Public Hearing on
Proposed Amendments to Rule 21
NCAC 46.3301 Governing Technician
Registration Scheduled for Tuesday,
May 12, 2015
The Board has published proposed amendments to
the technician registration rule (21 NCAC 46.3301) to
improve conformity to the statutory requirements of
NCGS 90-85.15A, as well as address technician registra-tion
requirements at free and charitable pharmacies. A
public hearing will be held on May 12, 2015, at 9 AM at
the North Carolina Board of Pharmacy Office, located at
6015 Farrington Road, Suite 201, Chapel Hill, NC 27517.
The Board welcomes comment on the proposed
amendment. Any person may comment on the proposed
amendment by attending the public hearing on May 12,
2015, and/or by submitting a written comment by 9 AM
on May 12, 2015, to Jay Campbell, executive director,
North Carolina Board of Pharmacy, 6015 Farrington
Road, Suite 201, Chapel Hill, NC 27517; by fax to
919/246-1056; or by email to jcampbell@ncbop.org.
More information, including the text of the proposed
amendments, is found at www.ncbop.org/rulemakings
.htm.
Item 2305 – Substitution of Extended
Release Methylphenidate Products
Pharmacists are aware that Food and Drug Adminis-tration
(FDA) changed the “Orange Book” equivalency
rating of extended release methylphenidate products
manufactured by Mallinckrodt and Kudco from “AB”
to “BX” due to concerns about bioequivalence with
Janssen Pharmaceuticals’ Concerta® product. More
details concerning FDA’s action, the reasons for it,
and the consequences are found at www.fda.gov/drugs/
drugsafety/ucm422569.htm.
Note further that Janssen Pharmaceuticals manufac-tures
an “authorized generic” of Concerta, which is mar-keted
by Actavis under a licensing agreement. Actavis’
product is not marketed under the Concerta name, but it
is identical to Janssen’s Concerta. FDA’s “Orange Book”
rating change does not apply to the Actavis product.
Board staff has received questions as a result of the
FDA action. A guidance document is available at www
.ncbop.org/PDF/CONCERTA_METHYLPHENIDATE_
FAQ.pdf.
Page 4 – April 2015
The North Carolina Board of Pharmacy News is published by the North
Carolina Board of Pharmacy and the National Association of Boards of
Pharmacy Foundation™ (NABPF™) to promote compliance of pharmacy
and drug law. The opinions and views expressed in this publication do not
􀁑􅄀􀁈􄠀􀁆􄘀􀁈􄠀􀁖􅘀􀁖􅘀􀁄􄐀􀁕􅔀􀁌􄰀􀁏􄼀􀁜􅰀􀀃􀌀􀁕􅔀􀁈􄠀􀃀􌀀􀁈􄠀􀁆􄘀􀁗􅜀􀀃􀌀􀁗􅜀􀁋􄬀􀁈􄠀􀀃􀌀􀁒􅈀􀁉􄤀􀂿􋼀􀁆􄘀􀁌􄰀􀁄􄐀􀁏􄼀􀀃􀌀􀁙􅤀􀁌􄰀􀁈􄠀􀁚􅨀􀁖􅘀􀀏􀼀􀀃􀌀􀁒􅈀􀁓􅌀􀁌􄰀􀁑􅄀􀁌􄰀􀁒􅈀􀁑􅄀􀁖􅘀􀀏􀼀􀀃􀌀􀁒􅈀􀁕􅔀􀀃􀌀􀁓􅌀􀁒􅈀􀁏􄼀􀁌􄰀􀁆􄘀􀁌􄰀􀁈􄠀􀁖􅘀􀀃􀌀􀁒􅈀􀁉􄤀􀀃􀌀􀀱􃄀􀀤􂐀􀀥􂔀􀀳􃌀􀀩􂤀􀀃􀌀􀁒􅈀􀁕􅔀􀀃􀌀􀁗􅜀􀁋􄬀􀁈􄠀􀀃􀍂
Board unless expressly so stated.
Jack W. “Jay” Campbell IV, JD, RPh - State News Editor
Carmen A. Catizone, MS, RPh, DPh - National News Editor
& Executive Editor
Deborah Zak - Communications Manager