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Tel: 614/466-4143 Fax: 614/752-4836 Email: exec@bop.state.oh.us Web: www.pharmacy.ohio.gov |
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MAY 2005 ~~ |
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The Ohio State Board of Pharmacy News is
published by the Ohio State 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. William T. Winsley, MS,
RPh - State News Editor Carmen A. Larissa Doucette -
Editorial Manager |
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State
News Section |
Have
You Submitted Your CPE Report Form?
If your pharmacist number begins with 03-2, this is the year
that you are required to submit proof of your continuing pharmacy education
(CPE). By the time this Newsletter
arrives, you will probably be near the
reporting deadline of May 15. Please be sure that you submit your CPE Report
Form on time. If your report form is received in the Board office by May 15,
you may use CPE certificates dated on or after March 1, 2002. If the report
form is received after May 15, your CPE certificates must be dated within the
three-year period immediately preceding the date the CPE form arrives in the
office (eg, if the form arrives on May 28, 2005, then only certificates dated
on or after May 28, 2002, will be acceptable). Obviously, it is to your benefit
to submit the CPE Report Form on time. Please also note that your CPE Report
Form must be cleared before you will be sent a license renewal application.
Rules
Effective February 1, 2005
As discussed in the last Newsletter, the
4729-19-04
Minimum Standards for Compounding Parenteral or Sterile Product Prescriptions
On January 1, 2004, the United States Pharmaceopia (USP)
issued Chapter 797: Pharmaceutical Compounding – Sterile Preparations. This
chapter was written in an effort to ensure that compounded sterile products
were as safe and well-made as possible. Many pharmacists have heard about USP
Chapter 797 and have wondered if it applies to them and, if so, what they need
to do. The Board of Pharmacy has had rules about sterile product compounding in
place for several years. With the release of Chapter 797 by the USP, the Board
decided to review these rules to see if we needed to adjust them in any way. To
conduct this review, the Board appointed a committee made up of Board members,
Board staff, practicing hospital pharmacists, practicing compounding
pharmacists, and others. This committee met several times during the spring of 2004
and proposed several changes to the rules in order to bring them into closer
compliance with the requirements of USP Chapter 797. The consensus of the
committee was that most of the original rules correlated well, in general
terms, with the new USP Chapter 797. The main areas of change were in Rule
4729-19-04 and involve increased requirements
requirementsfor the policy and procedure manual and a major
addition to paragraph H, which deals with the issue of quality assurance for
the sterile compounding processes within the pharmacy. The revised paragraph on
Quality Assurance (QA) (4729-19-04 H) reads as follows:
(H) Quality assurance
There shall be a documented, ongoing quality assurance
control program that monitors personnel performance, equipment, finished
compounded drug products, and facilities.
(1) At a minimum, there shall be written quality assurance
programs developed that address:
a)
Adequate training and continuing
competency monitoring of all personnel in personal cleansing, proper attire,
aseptic technique, proper clean room conduct, and clean room disinfecting
procedures. Instructors shall have the appropriate knowledge and experience
necessary to conduct the training;
b)
Continued verification of compounding
accuracy including physical inspection of end products;
c)
Continued verification of automated
compounding devices;
d)
Continued verification that appropriate
beyond use dates are being assigned to compounded products;
e)
End product testing including, but not
limited to, the appropriate sampling of products if microbial contamination is
suspected. Additionally, if bulk compounding of parenteral or sterile products
is being performed using nonsterile chemicals, extensive end product testing
must be documented prior to the release of the product from quarantine. This
process must include appropriate tests for particulate matter and testing for
pyrogens.
(2) All clean rooms and laminar flow hoods shall have
environmental monitoring performed at least every six months to certify
operational efficiency. There shall be a plan in place for immediate corrective
action if operational efficiency is not certified. Records certifying
operational efficiency shall be maintained for at least three years.
All pharmacists who compound sterile products should review
all of the rules in Chapter 4729-19 carefully, paying particular attention to
the QA paragraph above, to ensure that their pharmacy is in compliance. Any
questions that arise should be directed to the Board office.
To view all of the changes to this rule or to review other
rule changes that took effect on February 1, 2005, a listing, showing changes, can be
found on the Board’s Web site, www.pharmacy.ohio.gov, by clicking on the
“What’s New” box. In addition, please remember that the most current source for
Board rules is still the Board’s Web site. On the home page, click on the “Laws
& Rules” box, and then click on “Administrative Code Rules” to see a
listing of all of the Board’s rules.
Disciplinary
Actions
Anyone having a question regarding the license status of a
particular practitioner, nurse, pharmacist, pharmacy intern, or dangerous drug
distributor in
State Dental Board –
614/466-2580, www.dental.ohio.gov
State Medical Board –
614/466-3934, www.med.ohio.gov
State Nursing Board –
614/466-3947, www.nursing.ohio.gov
State Optometry Board – 614/466- 5115, www.optometry.ohio.gov
State Pharmacy Board –
614/466-4143, www.pharmacy.ohio.gov
State Veterinary Medical Board – 614/644-5281, www.ovmlb.ohio.gov
Drug Enforcement Administration – 1-800/230-6844, www.deadiversion.usdoj.gov
State
Pharmacy Board
The disciplinary actions listed below include only those
where the individual’s license to practice has been suspended, revoked, or
restricted, and do not include any other actions taken by the Board. All
actions may be seen in the Board's minutes, which are posted on the Board’s Web
site under “Board Minutes.”
Orders
of the Board
Donald Christopher Hart, RPh;
Alan Patrick Horvath, RPh; Hilliard – License reinstated effective February 23, 2005; During the
first six months of practice, must work only with a pharmacist whose license is
in good standing, and may not work more than 40 hours per week; For five years
effective February 10, 2005, may not serve as a preceptor or train pharmacy
interns, may not serve as a responsible pharmacist, and may not destroy, assist
in, or witness the destruction of controlled substances.
Matthew Donavon Nourse, RPh; Lucasville – License reinstated effective January 14, 2005;
During the first six months of practice, must work only with a pharmacist whose
license is in good standing, and may not work more than 40 hours per week; For
five years effective January 6, 2005, may not dispense prescriptions for
himself or any family member, may not serve as a preceptor or train pharmacy
interns, may not serve as a responsible pharmacist, and may not destroy, assist
in, or witness the destruction of controlled substances.
David Michael Rebeck, RPh; Norton – License suspended indefinitely, minimum one year,
effective February 10, 2005, and may not be employed by or work in a facility
licensed by the Board while suspended.
Joseph Martin Rukse, Jr, RPh;
John J. Sholtis, RPh;
Settlement
Agreements
Morton H. Pierce, RPh;
Summary
Suspensions [Sec. 3719.121 of the
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National News Section |
Accutane, Palladone RMPs Designed to Protect Patient
Safety
Risk Management Programs (RMPs) are developed by drug
manufacturers to meet the requirements of FDA’s drug approval process, in
conjunction with FDA, to minimize risks associated with specific drug products.
To date, several specific drug products have formal risk management programs
beyond labeling alone, to further ensure patient safety. Two relevant examples
are Accutane® (Roche
Pharmaceuticals) and Palladone Capsules (Purdue Pharma LP).
Accutane
On November 23, 2004, FDA announced changes to the RMP for
isotretinoin (Accutane) that will be implemented in mid-2005 in order to reduce
the risk of birth defects associated with fetal exposure to the medication. All
of the manufacturers of isotretionin have entered into an agreement with
Covance, a drug development services company that currently coordinates the
registry for Celgene’s thalidomide. Covance’s task is to develop and operate a
universal enhanced RMP by mid 2005; this program will require patients,
dispensing pharmacists, and prescribers to register in a single, centralized
clearinghouse. The program will also mandate that a pregnancy test be performed
at certified laboratories instead of home or in-office testing. According to
the Accutane RMP, System to Manage Accutane Related Teratogenicity, when the
registry denies an authorization to fill the prescription, the prescribing physician
must explain the reason for denial to the patient; FDA specifically states that
the physician is responsible for informing a woman if a pregnancy test result
comes back positive.
Palladone
Due to Palladone’s (hydromorphone hydrochloride) high
potential for abuse and respiratory depression, the drug’s manufacturer, Purdue
Pharma LP, in conjunction with FDA, developed an RMP for this new
extended-release analgesic. Introduced to the market in January 2005, Palladone
is approved for the management of persistent, moderate to severe pain in
patients requiring continuous, around-the-clock analgesia with a high potency
opioid for an extended period of time (weeks to months) or longer. Palladone is
to be used in patients who are already receiving opioid therapy, who have
demonstrated opioid tolerance, and who require a minimum total daily dose of
opiate medication equivalent to 12 mg of oral hydromorphone. The analgesic’s
RMP was devised with four goals:
1. Facilitation of proper use (patient selection, dosing)
2. Avoidance of pediatric exposure
3. Minimization of abuse, and
4. Reduction of diversion
Palladone’s RMP includes provisions for understandable and
appropriate labeling, and proper education of health care professionals,
patients, and caregivers. In addition, the manufacturer has offered training
sessions to its sales representatives. The RMP provides for the observation and
surveillance of abuse and, if abuse, misuse, and/or diversion occur, this
program includes an array of interventions. A Medication Guide will be
distributed to patients prescribed Palladone. During the initial 18 months of
Palladone’s release to the market, the manufacturer will only promote Palladone
to a limited number of medical practitioners experienced in prescribing opioid
analgesics and will closely monitor and gather data on Palladone’s use and any
incidences of abuse or diversion, and report this information to FDA on a
regular basis.
Metronidazole and Metformin: Names Too Close for Comfort
This column was prepared by the Institute for Safe
Medication Practices (ISMP). ISMP is an independent nonprofit agency that works
closely with
A family practice physician in a community health center
prescribed metformin 500 mg b.i.d. to a newly diagnosed diabetic man from
The physician notified the pharmacy of the error and asked
the pharmacist to check the original prescription, which had been written
clearly and correctly for metformin. Upon further investigation, the pharmacist
found that the computer entry screen for selecting these medications included
“METF” (for metformin) and “METR” (for metronidazole). Apparently, one of the
pharmacy staff members had entered “MET” and selected the wrong medication that
appeared on the screen.
In another community pharmacy, the same mix-up happened
twice, one day apart. In one case, metformin was initially dispensed correctly,
even though the prescription had been entered incorrectly as metronidazole –
again, when the wrong mnemonic was chosen. The pharmacist who filled the
prescription clearly understood that the physician had prescribed metformin, so
he filled the prescription accordingly. However, he failed to notice the order
entry error, as he did not compare the prescription vial label to the drug
container label. Unfortunately, the initial order entry error led to subsequent
erroneous refills of metronidazole, as stated on the label. In the other case,
bulk containers of the medication were available from the same manufacturer,
both with similar highly stylized labels. Thus, confirmation bias contributed
to staff ’s selection of the wrong drug. After reading “MET” and “500” on the
label, the staff member believed he had the correct drug.
In a hospital pharmacy, metronidazole 500 mg and metformin
ER 500 mg were accidentally mixed together in the metronidazole storage bin.
This resulted in dispensing metformin instead of metronidazole. Fortunately, a
nurse recognized the error before giving the patient the wrong medication. Both
were generic products, although the brands Flagyl® (metronidazole) and Glucophage® (metformin) are also available.
Unit-dose packages of these drugs contain bar codes, and the printed
information is very small, which adds to their similar appearance.
Metronidazole-metformin mix-ups could be serious,
considering the different indications and the potential for drug interactions.
To avoid selecting the wrong drug from the screen, consider programming the
computer to display the specific brand names along with the generic names
whenever the “MET” stem is used as a mnemonic. To reduce similarity of the
containers, purchase these medications from different manufacturers. Another
option in hospital settings is to stock only the 250 mg tablets of
metronidazole, since metformin is not available in that strength. This option
allows a small risk for nurses who may administer just 250 mg when 500 mg is
prescribed, but the potential for harm from giving the wrong drug is greater.
It is also a good idea to separate the storage of these
products. During the dispensing process, drug names listed on written
prescriptions and hospital orders should be matched to computer labels and
manufacturers’ products. Since metformin is used to treat a chronic condition,
and metronidazole is more likely to be used for an acute condition, outpatient
refills for metronidazole are less common and, therefore, bear a second look.
Asking physicians to include the drug’s indication on the prescription can also
help prevent errors.
We have asked FDA to add these drugs to the list of
nonproprietary names that would benefit from using “Tall Man” letters.
Meanwhile, underline or highlight the unique letter characters in these drug
names to make their differences stand out.
‘Dietary Supplements’ Contain Undeclared
Prescription Drug Ingredient
In early November 2004, Food and Drug Administration (FDA)
cautioned the public about the products Actra-Rx and Yilishen, which have been
promoted via the Internet. These products, purported as “dietary supplements”
to treat erectile dysfunction and enhance sexual performance, were actually
found to contain the active prescription drug ingredient, sildenafil, the active
drug ingredient in Viagra®, which
is approved in the
The Journal
of the American Medical Association (JAMA)
published a research letter that explained the results of a chemical analysis
that found that Actra-Rx contained prescription strength quantities of
sildenafil. FDA conducted its own analysis, the results of which corroborated
the analysis published in JAMA. Sildenafil is known to interact with a number of
prescription medications. For example, sildenafil may potentiate the
hypotensive effects of medications containing nitrates, which are commonly used
to treat congestive heart failure and coronary artery disease.
FDA instructed those who are taking Actra-Rx and/or Yilishen
to stop and consult their health care provider and warned that the use of these
products could be dangerous to patients’ health. For more information, please
visit the following Web site:
www.fda.gov/bbs/topics/ANSWERS/2004/ANS01322.html.
NABP Releases Criteria for National Specified List of
Susceptible Products, Adds One Drug to List
In late 2004, the National Association of Boards of Pharmacy®
(NABP®)
Executive Committee finalized the criteria that detail standards and guidance
for NABP’s “National Specified List of Susceptible Products” (List) based upon
recommendations made by NABP’s National Drug Advisory Coalition (NDAC). Also,
in accordance with NDAC’s recommendation, the Executive Committee decided to
include Viagra® (sildenafil)
on NABP’s List.
NABP’s List, which the Association first released in early
2004, was created to help states reduce redundancy and represented a starting
point for states that had an imminent need for such direction. In addition, by
adopting NABP’s List, states collectively would be able to recognize one
national list instead of potentially 50 different lists.
The NDAC is a standing committee that was appointed by
NABP’s Executive Committee in accordance with the updated Model Rules for the
Licensure of Wholesale Distributors, which is a part of the
The updated “National Specified List of Susceptible
Products” is available on NABP’s Web site at www.nabp.net. NABP’s List criteria
that detail standards and guidance (eg, under what circumstances a product will
be considered for addition to NABP’s List) are also available on the
Association Web’s site and detailed in the February 2005 NABP Newsletter.
FDA Announces New CDERLearn Educational Tutorial
The US Food and Drug Administration’s (FDA) Center for Drug
Evaluation and Research (CDER) recently announced that its new online
educational tutorial “The FDA Process for Approving Generic Drugs” is now
available at http://www.connectlive.com/events/genericdrugs/.
This seminar provides viewers with an overview of FDA’s role
in the generic drug process. The tutorial also discusses various aspects of the
Abbreviated New Drug Application (ANDA) process, including how FDA’s approval
assures that generic drugs are safe, effective, and high quality drug products.
This program meets the criteria for up to one Accreditation
Council for Pharmacy Education contact hour (or 0.1 CEU).
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Applicability of the contents of articles in the National Pharmacy Compliance News to a particular state or jurisdiction should not be assumed and can only be ascertained by examining the law of such state or jurisdiction. |