Tel: 614/466-4143 Fax: 614/752-4836 Email: email@example.com Web: www.pharmacy.ohio.gov
~~ MAY 2005 ~~
William T. Winsley, MS, RPh - State News Editor
Larissa Doucette - Editorial Manager
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.
Anyone having a question regarding the license status of a
particular practitioner, nurse, pharmacist, pharmacy intern, or dangerous drug
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;
Morton H. Pierce, RPh;
Suspensions [Sec. 3719.121 of the
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).
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.
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
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).