NC Vol. 28, No. 4 Page 1
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North Carolina
Board of Pharmacy
PO Box 4560, Chapel Hill, NC 27515-4560
6015 Farrington Rd, Suite 201
Chapel Hill, NC 27517
Tel: 919/246-1050 Fax: 919/246-1056
www.ncbop.org
April 2007
Item 2133 – Update on the North Carolina
Practical Examination
As many practitioners are aware, the North Carolina Board of
Pharmacy has proposed amendments to Rules .1505 and .1507
that would eliminate the North Carolina practical examination as a
condition of licensure. The amendments would replace the practical
examination with a review of licensure candidates’ qualifications
by Board staff. Moreover, the amendment would reduce the review
fee from $200 to $75.
Board staff has received a number of calls inquiring whether the
Board will administer a practical examination in June. Preceptors
may well – and understandably – be getting the same question from
pharmacy students. Board staff advises all licensure candidates to
assume that there will be a practical examination in June and
prepare accordingly.
The rule amendments have cleared the notice-and-comment
stage and have been adopted by the Board. Even so, these amend-ments
must still clear review by the Rules Review Commission
(RRC) prior to implementation. Board staff does not expect any
resistance to these amendments from the RRC. But, as observers
of the rule-making process are aware, predicting RRC response to
proposed amendments is an inexact science at best.
Licensure candidates are advised to read their application materi-als
carefully. Because of the pending amendments, the application
materials contain some specific directions about fees, fee deadlines,
and notices that differ from years past.
Item 2134 – Board Staff Receiving Complaints
from Physicians about Refill Authorization
Faxes
Several physicians in North Carolina have complained to the
Board about the volume and nature of refill authorization faxes
transmitted to their practices. These faxes, examples of which ap-pear
to be automatically generated, are causing at least two problems
in physicians’ offices. First, the sheer volume is overwhelming some
practices. Second, the refill requests are often for medications that
the physician has discontinued.
Board staff advises pharmacies that automatic refill requests of
this nature can interfere with the physician-pharmacist relationship,
with potentially negative consequences to patients. Moreover, gen-erating
refill requests for discontinued medications could result in
a refill being inadvertently authorized by the physician and risking
harm to the patient.
As a matter of basic professional courtesy and respect, Board
staff strongly advises pharmacists to coordinate their refill autho-rization
request methods with physicians’ offices and to select a
method that fits the particular practice and patients. One size does
not fit all in this area.
Item 2135 – Update on the Work Hours Rule
A number of pharmacists have inquired about the implementa-tion
status of the work-hour/break rule that the Board promulgated
in 1998 and that the North Carolina Supreme Court affirmed in
2006.
Despite the Supreme Court’s ruling late last year, several proce-dural
hurdles remain before implementation. The rule is proceeding
through the publication process and may have become effective by
the time this Newsletter is published. Board staff will keep pharma-cists
updated through the Web site – www.ncbop.org.
Item 2136 – Illegal Internet Operations
Continue to Solicit Independent Pharmacies in
North Carolina
Previous Newsletter items have alerted independent pharma-cists
that illegal Internet operations are soliciting them to act as
“fulfillment” centers. This continues to occur. The typical “pitch”
is that an Internet-based operation will forward some number of
prescriptions to the pharmacy on a daily or weekly basis, for which
the pharmacy may charge an extraordinarily large cash price. The
prescriptions, unsurprisingly, will consist primarily of controlled
substances (CS). These offers are indeed too good to be true and
pharmacists should not accept them.
Board staff encourages pharmacists who receive these offers,
however, to gather as much information as possible about the
operator and forward that information to the Board office. Alert,
diligent pharmacists in recent months have provided Board staff
with information that allowed immediate action, including issu-ing
cease and desist notices and alerting federal law enforcement
authorities.
Please monitor the Board Web site, where you will find infor-mation
about illegal Internet operations as Board staff members
receive more information.
Item 2137 – Roll Out of the Controlled
Substances Reporting Act
Most pharmacists are aware that the General Assembly enacted a
CS reporting system last year. The statute requires all dispensers to
report information about CS prescriptions to the state (more detail
about the statute may be found at the Board’s Web site).
than two years. In addition, clinicians and pharmacists should
always ask caregivers about their use of OTC combination medi-cations
to avoid overdose from multiple medications containing
the same ingredient.
The complete article is available at www.cdc.gov/mmwr/
preview/mmwrhtml/mm5601a1.htm.
Changes in Medication Appearance Should
Prompt Investigation
This column was prepared by the Institute for Safe
Medication Practices (ISMP). ISMP is an indepen-dent
nonprofit agency that works closely with United
States Pharmacopeia (USP) and FDA in analyzing
medication errors, near misses, and potentially haz-ardous
conditions as reported by pharmacists and
other practitioners. ISMP then makes appropriate contacts with com-panies
and regulators, gathers expert opinion about prevention mea-sures,
then publishes its recommendations. If you would like to report a
problem confidentially to these organizations, go to the ISMP Web site
(www.ismp.org) for links with USP, ISMP, and FDA. Or call 1-800/
23-ERROR to report directly to the USP-ISMP Medication Errors Re-porting
Program. ISMP address: 1800 Byberry Rd, Huntingdon Valley,
PA 19006. Phone: 215/947-7797. E-mail: ismpinfo@ismp.org.
As the number of generic products continues to increase, it seems
that both patients and practitioners have become desensitized to
changes in medication appearance. So much so that patients may
not question a change or, when they do, practitioners may simply
reassure them that it was due to a change in manufacturer without
actively investigating the reason. It is not uncommon for ISMP
to receive reports from both practitioners and consumers where a
change in medication appearance was not fully investigated and
subsequently contributed to an error.
In one case, a man shared an account of what his 86-year-old
father experienced over the course of nine days after his prescrip-tion
for minoxidil was mistakenly refilled with another medica-tion.
He had been taking minoxidil 2.5 mg for years at a dose
of 5 mg (2 tablets) twice daily. Due to failing vision, he did not
realize that his minoxidil tablets looked different. His daughter
noticed the change, but was unconcerned since the tablets had
previously changed appearance. Within a few days of taking the
medication, his appetite began to fade, he complained of a sore
throat, and felt like he was coming down with a cold. Soon after,
he developed a red rash on his face, had trouble maintaining his
balance, needed assistance with his daily activities, and wished
to remain in bed. When a family friend (a nurse) came to see him,
she noticed a very red, raised rash on his abdomen that looked
like a medication rash. She asked his daughter if he was taking
any new medications and was informed that there were no new
medications, but the minoxidil tablets looked different than be-fore.
The pharmacy was contacted about the change and a staff
member explained that it was a different generic for minoxidil,
and that the pills could be exchanged for those that he usually
received. There was no mention of a mistake being made when
the medication was exchanged. He was taken to the hospital the
following day, when he could barely walk.
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National Pharmacy Compliance (Applicability of the contents of articles in the National Pharmacy Compliance and can only be ascertained by examining the FD&C Act Holds Manufacturers Accountable
for Availability of Medication Guides
Under the Federal Food, Drug, and Cosmetic (FD&C) Act,
Food and Drug Administration (FDA) requires that Medication
Guides be dispensed with products the agency deems a serious
and significant public health concern. Medication Guides provide
consumers with information about the risks and benefits of these
drugs and are necessary for patients to use these products safely
and effectively.
FDA is interested in receiving reports about all instances in
which manufacturers, distributors, or packers are not complying
with the Medication Guide distribution requirements as set forth
in Title 21, Code of Federal Regulations (CFR), section 208.24,
Distributing and dispensing a Medication Guide.
The regulation requires manufacturers, distributors, or packers
to provide authorized dispensers with Medication Guides – or the
means to produce Medication Guides – in sufficient numbers to
provide one to each patient who receives the drug. The manufacturer
is responsible for ensuring that pharmacists have the Medication
Guides they need when dispensing these drugs to consumers.
Problems related to the availability of Medication Guides are
a labeling concern to FDA, and pharmacists are often the first to
become aware of these problems. Voluntary reporting by pharma-cists
of these instances would assist FDA in ensuring manufacturer,
distributor, and packer compliance with the Medication Guide
regulatory requirement.
In addition to reporting to FDA, the agency advises pharmacies
to contact the manufacturers directly to discuss problems associated
with the availability of Medication Guides.
More information is available at www.fda.gov/medwatch/
report/hcp.htm. Reports can also be made by phone at
1-800/FDA-1088.
Infant Deaths Attributed to Cough and
Cold Medications
The Centers for Disease Control and Prevention (CDC) issued
a Morbidity and Mortality Weekly Report article describing three
deaths of infants ranging in age from one to six months associ-ated
with cough and cold medications. These medications were
determined by medical examiners or coroners to be the underlying
cause of death.
According to the report, the three infants – two boys and one
girl – had what appeared to be high levels (4,743 ng/mL to 7,100
ng/mL) of pseudoephedrine in postmortem blood samples. One
infant had received both a prescription and an over-the-counter
(OTC) cough and cold combination medication at the same time;
both medications contained pseudoephedrine.
During 2004-2005, an estimated 1,519 children younger than
two years were treated in emergency departments in the United
States for adverse events, including overdoses, associated with
cough and cold medications.
Because of the risks, parents and caregivers should consult a
health care provider before administering cough and cold medica-tions
to children in this age group. Clinicians should use caution
when prescribing cough and cold medications to children younger
Page 3
Compliance News
Compliance News to a particular state or jurisdiction should not be assumed
the law of such state or jurisdiction.)
After this incident was explained to hospital staff, they contacted
the pharmacy. It was then revealed that he was given methotrex-ate
by mistake because the bottles were stored next to each other.
By this time, the man had taken 36 methotrexate 2.5 mg tablets,
his white blood cell and platelet counts were extremely low, and
he was in critical condition. We later learned that he passed away
during that hospital visit.
In another case, a breast cancer patient went to her pharmacy
to pick up a refill for Femara® (letrozole) but instead received the
estrogen replacement product femhrt® (norethindrone and ethinyl
estradiol). The patient recognized that the tablets were different, but
after she read the label on the prescription bottle, which indicated
Femara, she proceeded to use the tablets thinking the pharmacy
used another manufacturer’s product. After some time, she began
to experience bloating, low back pain, and menstrual spotting. The
error was discovered when she visited the clinic and the practitioner
asked to see her medication. It is believed that disease progression
had occurred secondary to the estrogen exposure, as evidenced by
increased tumor markers. As a result of the error, chemotherapy
was restarted.
The nature of these errors (wrong product dispensed on a refilled
prescription despite a correct interpretation of the prescription)
reinforces the need for the prescription verification process to be
standardized. Verification should include comparisons of the phar-macy
label with the selected manufacturer’s product and the original
prescription (whenever possible). In addition, the national drug code
(NDC) number on the manufacturer’s product should be compared
to the NDC number in the pharmacy computer system. Pharmacies
that utilize drug-imaging technology or bar code scanners as part of
their verification process experience fewer of these errors.
Patients should be made aware of what their medication will look
like and be educated to always question any change in its appear-ance.
Pharmacies could consider software that allows a description
of the medication’s appearance to be printed on either the pharmacy
label or receipt. Staff and patients should then be educated about
proper use of this method. Ideally, pharmacists should proactively
communicate with patients about the appearance of their medication
by showing the medication to them during counseling and alerting
them whenever a change occurs. Pharmacists should thoroughly
investigate questions raised by patients or caregivers. Consider
making it mandatory for pharmacists to investigate all inquiries
related to changes in medication appearance. Although an auxiliary
label can be placed on the medication container or the pharmacy
receipt to alert the patient or caregiver that a change in appearance
has occurred, the label may go unnoticed.
FDA Launches CDERLearn Educational
Tutorial on MedWatch
FDA’s Center for Drug Evaluation and Research (CDER)
has launched its new Web-based self-learning tutorial, FDA
MedWatch and Patient Safety, available at www.connectlive.
com/events/fdamedwatch. This tutorial is intended to teach
students in the health care professions and practicing health
care professionals about FDA’s Safety Information and Adverse
Event Reporting Program, known as MedWatch.
The module explains how MedWatch provides important and
timely clinical safety information on medical products, including
prescription and OTC drugs, biologics, medical and radiation-emit-ting
devices, and special nutritional products (eg, medical foods,
dietary supplements, and infant formulas). It also describes how the
reporting of serious adverse events, product quality problems, and
product use errors to MedWatch is essential to FDA’s safety monitor-ing
process and to improving patients’ safe use of medical products.
The module consists of a 30-minute video and PowerPoint program
with optional quiz and certificate of completion.
Three additional free programs for health professionals are avail-able
on the CDERLearn site, on the topics of the drug development
and review process, the generic drug review process, and osteopo-rosis.
Continuing education credit for these three programs may be
awarded after completion of a quiz and evaluation form.
More information is available at www.fda.gov/cder/learn/CDER-Learn/
default.htm.
ONDCPRA Increases Patient Limit for
Physicians Authorized under DATA 2000
The Office of National Drug Control Policy Reauthorization Act
of 2006 (ONDCPRA) has modified the restriction on the number of
patients a physician authorized under the Drug Addiction Treatment
Act of 2000 (DATA 2000) may treat.
Under DATA 2000, physicians were restricted to treating no more
than 30 patients at any one time. Under ONDCPRA, which became
effective on December 29, 2006, physicians meeting certain criteria
may notify the Secretary of Health and Human Services of their need
and intent to treat up to 100 patients at any one time.
To be eligible for the increased patient limit: (1) the physician must
currently be qualified under DATA 2000; (2) at least one year must
have elapsed since the physician submitted the initial notification for
authorization; (3) the physician must certify his or her capacity to refer
patients for appropriate counseling and other appropriate ancillary
services; and (4) the physician must certify that the total number of
patients at any one time will not exceed the applicable number.
DATA 2000 allows qualified physicians to dispense or prescribe
specifically approved Schedule III, IV, and V narcotic medications
for the treatment of opioid addiction in treatment settings other than
the traditional opioid treatment program (ie, methadone clinics). In
addition, DATA 2000 allows qualified physicians who practice opioid
addiction therapy to apply for and receive waivers of the registration
requirements defined in the Controlled Substances Act.
More information is available by phone at 866/287-2728,
via e-mail at info@buprenorphine.samhsa.gov, or online at
www.buprenorphine.samhsa.gov.
Deadline Approaches for Pharmacists to Use
NPI Numbers
The Administrative Simplification provisions of the Health Insur-ance
Portability and Accountability Act of 1996 (HIPAA) require
pharmacists to begin using the National Provider Identifier (NPI)
by May 23, 2007. These provisions are intended to improve the
efficiency and effectiveness of the electronic transmission of health
information. Pharmacists can apply online or print an application for
an NPI at https://nppes.cms.hhs.gov.
National Association of Boards of Pharmacy Foundation, Inc
1600 Feehanville Drive
Mount Prospect, IL 60056
NORTH CAROLINA BOARD OF PHARMACY
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Permit No. 5744
Continued from page 1
Page 4 – April 2007
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, Inc, to promote voluntary compliance of pharmacy and drug law.
The opinions and views expressed in this publication do not necessarily reflect
the official views, opinions, or policies of the Foundation or the 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
Larissa Doucette - Editorial Manager
Though effective in April 2006, the statute has not yet been
implemented. The North Carolina Department of Health and Human
Services reports that the system is scheduled to be rolled out on
July 1, 2007. Health Information Design, Inc has contracted with
the state to implement the program. By the time this Newsletter is
published, pharmacists should have received materials from Health
Information Design describing the program, the electronic format
for transmitting the required data, and a user manual. If you have
not received this information, please contact Johnny Womble via
e-mail at johnny.womble@ncmail.net.
Item 2138 – Board Policy Concerning
Bad Checks that Accompany Technician
Registrations/Renewals
By law, the pharmacist-manager is responsible for ensuring that
all pharmacy personnel employed at the pharmacy are properly
licensed or registered. This includes, obviously, ensuring that all
pharmacy technicians are currently registered with the Board.
Each year, the Board of Pharmacy receives a number of phar-macy
technician applications or renewals accompanied by bad
checks. Efforts to collect payment on such checks have proved
difficult at best.
When a technician registration/renewal check is returned to
the Board for insufficient funds, Board staff issues a first notice
demanding payment from the technician. If the first notice is not
successful, Board staff issues a second notice, this time to the
pharmacist-manager at the employing pharmacy.
Going forward, if the second notice does not result in appropri-ate
payment being rendered to the Board, Board staff will issue the
pharmacy permit, pharmacist-manager, and technician a notice for
disciplinary action. A technician who has not paid the registration
or renewal fee is not a properly registered technician. Employing
such technicians, therefore, violates North Carolina law.
Board staff will also begin posting the names and registration
numbers of any technicians who have submitted bad checks on the
Board’s Web site. Pharmacist-managers are strongly encouraged
to monitor this list periodically to ensure that any technicians they
employ do not appear.
Item 2139 – Registration of Pharmacy Students
Who are Employed as Pharmacy Technicians
In the April 2006 Newsletter (Item 2107), the Board stated its policy
about when and under what circumstances a student enrolled in a school
of pharmacy approved by the Board must register as a technician.
Under that policy, a pharmacy student “employed at a pharmacy as a
technician . . . must register with the Board . . . .” A pharmacy student
“working at a pharmacy as part of a school-sponsored experiential
program – ie, the student is not employed, but is receiving instruction
pursuant to a preceptor-student relationship . . . does not have to register
with the Board as a technician.”
Upon further reflection, the Board has decided to alter its policy
concerning pharmacy students and technician registration. Effective
immediately, a pharmacy student “enrolled in a school of pharmacy
approved by the Board under G.S. 90-85.13” is not required to register
as a technician. The Board believes that this policy is more consistent
with the language of the pharmacy technician statute and will mini-mize
confusion among pharmacy students, pharmacist-managers, and
preceptors.
Even with this change in policy, however, the Board emphasizes
the following:
♦ The student must be enrolled in a school of pharmacy to avoid the
registration requirement. “Pre-pharmacy” students who are not
actually enrolled in a school of pharmacy must register if employed
by the pharmacy to perform technician duties. Students who are
enrolled in a school of pharmacy and plan to work in a pharmacy
during holiday or semester breaks do not have to register as techni-cians
if they plan to return to school for the next session.
♦ The pharmacist-manager retains responsibility for ensuring that
all activity in the pharmacy is compliant with the laws and rules
governing the practice of pharmacy, including registration of all
personnel who perform technician duties (excluding students as
clarified in this statement).
♦ If a Board investigation determines that a pharmacy student work-ing
as a technician has violated the laws or rules governing the
practice of pharmacy, then the Board will share that information
with the student’s school of pharmacy. Moreover, such a deter-mination
could ultimately impact the student’s ability to obtain
a license to practice pharmacy, as well as result in other legal
consequences.