State Board of Pharmacy; 77 South High Street, Room 1702; Columbus, Ohio 43215-6126

Tel: 614/466-4143                     Fax: 614/752-4836                  Eml: exec@bop.state.oh.us

 

 

OHIO STATE BOARD OF PHARMACY NEWS

~~ NOVEMBER 2003 ~~

 

 

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. Catizone, MS, RPh, DPh - National News Editor & Executive Editor

Reneeta C. "Rene" Renganathan - Editorial Manager

 

 

State News Section

 

 

New Changes in Pharmacist Administration of Adult Immunizations

 

House Bill 95 (HB 95), the state’s Budget Bill, was passed this summer and became effective immedi­ately. A budget bill generally has many amendments unrelated to state revenue and expenses that address a variety of issues. One such amendment in HB 95 affected the process of pharmacist admini­stration of adult immunizations. HB 95 changed Section 4729.41 of the Revised Code by re­moving the word “injec­tion” from the language. Therefore, the administration of adult immunizations by a pharmacist is no longer restricted only to injections. This will allow for the intranasal admini­stra­tion of FluMist™ by pharmacists.

 

However, a pharmacist may only administer an adult immunization after successfully com­plet­ing an Ohio State Board of Pharmacy-approved course in the administration of adult immunizations and having current certification in basic life support. A pharmacist must complete an entire course, pursuant to Rule 4729-5-36 of the Administrative Code, prior to administering an adult immuni­za­tion. A pharmacist cannot simply attend a continuing education program that only covers a single type of immunization and be able to administer that immunization to patients without completing the entire course. Additionally, if you have already completed a Board-approved immuniza­tion course, but it did not address FluMist and intranasal administration, you may not administer FluMist without further training. You may, of course, continue to administer the injec­tions that were covered in your training course. If there is a Board-approved supple­men­tal course available, you may take this supplemental course without having to repeat an entire im­mu­ni­za­tion course. At the time this article was written, no supplemental courses on FluMist had been approved by the Board. However, some pharmacies, associations, and colleges were working on supple­men­tal immunization programs to address FluMist and intranasal administration. You should check the Board’s Web site to determine what immunization courses and supplemental immunization courses have been approved.

 

Continuing Pharmacy Education Reminder

 

Remember that the continuing pharmacy education (CPE) reporting requirements are changing this coming year beginning with pharmacists whose license number begins with 03-1. Those phar­macists will be required to report their CPE no later than May 15, 2004. For that reporting period, you will be able to use CPE certificates dated on or after March 1, 2001, that were not used for the CPE reporting in 2001. Beginning in 2004, those who do not return the CPE report form by the required date will not receive a pharmacist renewal application until the CPE report form is received in the Board office. There have been numerous reminders of this change in previous editions of this Newsletter and during the last two renewal periods. Please take time this winter and review your CPE certificates to make sure that you will be able to meet the requirements by May 15.

 

Compounding Concerns

 

Preparing drug products for patients has been a part of pharmacy practice since the profession began. Obviously, the act of combining two or more ingredients to prepare a dosage form that is not commercially available is something pharmacists have always done. Traditionally, those products consisted primarily of pills (early preparations), capsules, powder papers, solutions, and suspensions. Except in hospitals, the prepa­ration of dosage forms that were required to be sterile was not usually done by pharmacists. This was because the retail pharmacy rarely had the equipment necessary to prepare a sterile product. Even in hos­pi­tals, the sterile products prepared were usually intended to be used within a short time after preparation. These products were rarely tested for sterility and content as a manufacturer’s product was and, therefore, were not intended to be stored and used over a pro­longed period of time.

 

Obviously, that is no longer the case. There are pharmacies and “pseudo-pharmacies” all over the country offering sterile products that they have prepared for sale with and without a prescription. As soon as a shortage of a drug product becomes known, these people are advertising their products to doctors’ offices, hospitals, and clinics throughout the country. Ironically, many of the drug shortages are caused by the manufacturers being unable to meet Food and Drug Administration’s (FDA) Good Manu­facturing Prac­tices (GMP) requirements. In spite of that, these pharmacies somehow think that they are able to produce a quality product, even though they do not follow the GMP requirements nearly as well as the manufacturers had been doing before they ran afoul of FDA.

 

Sterile product preparation is a matter of concern in Ohio as well as throughout the country. There have been deaths in other states due to “compounded” sterile products that were inadequately prepared, stored, or administered. Sterile product preparation is much more complex than prepa­ra­tion of capsules or solutions. Variables such as technique, timing, environment, ingredient purity, quality assurance, and storage all play a role in the value of the product to the patient. Prepa­ra­tion of  large batches of sterile products by individual pharmacies that do not have the ability to control all of these variables and are working from a recipe provided by someone else can lead to serious problems for patients.

 

In Ohio, a prescription is defined in the Revised Code as “an order for drugs or combinations or mix­tures of drugs to be used by a particular individual” [Revised Code Section 4729.01(H)]. This means that a prescriber may issue a prescription for a compounded product for a particular patient and the pharmacist may prepare the product and dispense it to that patient. Compounding, which can only be done pursuant to a prescription, is part of the practice of pharmacy and the Board sup­ports an individual pharmacist who wishes to practice this way. The key to this process is the fact that it is done for an individual patient, not as part of a large batch. Without a patient-specific pre­scrip­tion, the combination of two or more drugs to make another product is illegal under both federal and state law. All pharmacists intending to compound sterile products need to be aware of their limitations in controlling the variables mentioned above as well as the limitations placed upon them by the law.

 

Disciplinary Actions

 

Anyone having a question regarding the license status of a particular health care practitioner or dan­ger­ous drug distributor in Ohio should contact the appropriate licensing board:

State Medical Board--614/466-3934, www.med.ohio.gov

State Nursing Board--614/466-3947, www.state.oh.us/nur/

State Pharmacy Board--614/466-4143, www.state.oh.us/pharmacy/

 

State Pharmacy Board

 

The disciplinary actions listed below include only those in which the individual’s license to prac­tice has been suspended, revoked, or restricted, and does 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, located at www.state.oh.us/pharmacy.

 

Correction to the August 2003 State Board Newsletter

 

Donald Leroy Bennett, RPh; Westerville – Placed on probation for one year effective April 7, 2003; Will refrain from scheduling interns to perform duties that must only be performed by a pharma­cist unless properly supervised by a pharmacist as permitted by law and/or regulation.

 

Orders of the Board

 

CVS/Pharmacy #3131, TD; Westlake – License revoked effective September 2, 2003.

 

Robert C. Hershbine, RPh; Brunswick – License suspended indefinitely effective September 10, 2003, and may not be employed by or work in a facility licensed by the Board while suspended.

 

Mark Lawrence Iori, Pharmacy Intern; Batavia – License revoked effective July 21, 2003.

 

The Medicine Shoppe, TD; Columbus – License revoked effective June 6, 2003.

 

Matthew Donavon Nourse, RPh; Lucasville – License suspended indefinitely effective July 21, 2003, and may not be employed by or work in a facility licensed by the Board while suspended.

 

William C. Ringle, RPh; Westerville – License revoked effective June 6, 2003.

 

Joseph Martin Rukse, RPh; Barboursville, WV – License suspended indefinitely effective July 21, 2003, and may not be employed by or work in a facility licensed by the Board while suspended.

 

Thomas Allan Scott, RPh; Portsmouth – License suspended indefinitely effective September 10, 2003, and may not be employed by or work in a facility licensed by the Board while suspended.

 

John Randall Tomko, RPh; Hubbard – License reinstated October 3, 2003; may not serve as a preceptor or train pharmacy interns, may not serve as a responsible pharmacist, and may not destroy or witness the destruction of controlled substances for five years effective September 10, 2003.

 

Summary Suspensions  [Sec. 3719.121 of the Revised Code]

 

Matthew Bodnar, RPh; Toronto. Effective August 25, 2003.

 

John Joseph Sholtis, RPh; Steubenville. Effective September 9, 2003.

 

 

 

National News Section

 

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.

 

New Regulation Speeds Access to Generic Drugs

 

On August 18, 2003, Food and Drug Administration (FDA) implemented a final rule that speeds the approval of generic drugs. The final rule will limit the number of automatic 30-month stays that may delay generic drug availability. Now, a maximum of one 30-month stay will be permitted for each generic appli­cation.

 

The final rule clarifies the types of drug patents that can be submitted for listing in the FDA’s “Orange Book” and prevents innovator drug companies from submitting certain new patent claims that are unlikely to represent substantial new innovation in order to extend their marketing pro­tec­tion. FDA will only allow submission of patents that claim the drug substance (active ingredient); the drug product (formulation and composition); and the method of use (injectable, tablet, etc).

 

The FDA is working with Congress on generic approval issues during the process of completing dis­cus­sions on a Medicare drug benefit. Enactment of such a benefit may affect the implementation of some provisions for the 30-month stay included in the Final Rule, but FDA will work with Con­gress so product developers are not subject to multiple “regimes” of regulation of generic drug com­pe­ti­tion when the bills are passed.

 

Proposed Rule to Allow Electronic Orders for Controlled Substances

 

On June 27, 2003, the United States Drug Enforcement Administration (DEA) published a pro­posed rule that would allow for the electronic transmission and maintenance of orders for controlled substances as an alternative to the use of DEA Form 222 for DEA registrants who manufacture, dis­tri­bute, or purchase con­trolled substances. With this rule, DEA hopes to establish an electronic frame­work for controlled substance distribution in accordance with the Government Paperwork Eli­mi­na­tion Act of 1998 and the Electronic Sig­na­tures in Global and National Commerce Act of 2000 (E-Sign). The framework incorporates Public Key Infra­struc­ture/­digital signature technology intended to ensure the electronic system provides for mes­sage/­record integrity, authentication, and nonrepudiation.

 

Rx Pattern Analysis Tracking Robberies and Other Losses Initiative

 

The National Community Pharmacists Association (NCPA), National Association of Drug Diversion Inves­ti­ga­tors (NADDI), and the Pharmaceutical Security Institute are launching an information clear­ing­house for data related to pharmacy burglaries and thefts involving the loss of controlled sub­stances. Pattern Analysis Tracking Robberies and Other Losses, or RxPATROL™ is an initiative con­ceived, designed, developed, and funded by Purdue Pharma, LP. The program will be able to collect, collate, analyze, and disseminate phar­macy theft information to appropriate law enforcement agen­cies for further action.

 

An RxPATROL Theft Report Form has been developed to aid non-law enforcement personnel in com­plet­ing the theft report accurately and concisely. Loss Prevention personnel and independent pharmacy owners and managers will be able to access the Theft Report from the NADDI home page (www.naddi.org) as well through a link to the NCPA Web site (www.ncpanet.org). Another available service will be a timely incident analysis that will reveal trends that could potentially threaten phar­macists and pharmacy personnel. RxPATROL will provide this to NADDI, advising law enforce­ment and pharmacy personnel of emerging criminal trends.

 

NABP Wants Your Input for Testing Programs

 

Interested in examination item writing? If you are a pharmacy practitioner, educator, or regu­la­tor, NABP is seeking your expertise as an item writer for the North American Pharmacist Licensure Examination™, Multistate Pharmacy Jurisprudence Examination®, Foreign Pharmacy Graduate Equiva­lency Examination®, and the Disease State Management examinations. Those interested should send or fax a letter of interest and a current resume or curriculum vitae to NABP’s Executive Director/­Sec­re­tary, Carmen A. Catizone, at 700 Busse Highway, Park Ridge, IL 60068; fax 847/698-0124.

 

If chosen, you will receive training materials detailing the skills necessary for your designated exami­na­tion, and may be asked to attend a weekend workshop at NABP Headquarters or an area hotel with appli­cable expenses paid by NABP. Periodically, item writers will receive requests to develop new test items that will be considered for inclusion in NABP’s assessment programs.

 

If you are a state board of pharmacy member or staff member, you are particularly encouraged to take part in this item-writing process. Questions about item writing should be directed to Mr Catizone and/or the competency assessment director at NABP headquarters.

 

NABP Announces New FPGEE Administration Date, Successful June Examination

 

NABP is pleased to announce that December 6, 2003, will be the next administration date of the paper-and-pencil Foreign Pharmacy Graduate Equivalency Examination® (FPGEE®). The examination locations will be released at a later date.

 

As with the June 2003 FPGEE administration, qualified candidates will receive registration in­for­ma­tion via United States mail. Materials were mailed to qualified candidates on July  25, 2003.

 

In addition, the Saturday, June 21, 2003 FPGEE administration was a success as approximately 2,040 can­di­dates sat for the examination. NABP restarted the FPGEE on this day, offering it in four US locations: Dallas, TX; New York, NY; Northlake (Chicago area), IL; and Oakland, CA, after a security breach in October 2002 prompted a halt to the examination.

 

“NABP is proud to have been able to quickly isolate the compromise, secure the examination, and have a new examination ready for administration in 2003,” says Donna S. Wall, NABP president. “This involved the time and dedication of many people including volunteer item writers and NABP staff. With their efforts, NABP was able to create a new examination and process 3,000 applications in only seven months.”

 

All FPGEE candidates who qualified to sit for the examination were sent registration forms in Feb­ru­ary 2003. Candidates were able to choose from the four US locations in order of preference. Res­er­va­tions were made on a first-come, first-served basis and candidates were mailed admission tickets. Security fea­tures required candidates to present two forms of identification in addition to their admis­sion ticket, which featured the candidate’s photo; the checking of large items such as back­packs; and the posting of security guards.

 

Candidates who sat for the June 21 administration received their score results 10 weeks after the administration.

 

Candidates with questions may visit NABP’s Web site at www.nabp.net for updated in­for­ma­tion or e-mail the Customer Service Department at custserv@nabp.net. Individuals without Inter­net access may contact NABP’s Customer Service Department at 847/698-6227.

 

The Virtues of Independent Double Checks – They Really are Worth Your Time!

 

This column was prepared by the Institute for Safe Medication Practices (ISMP). ISMP is an in­de­pen­dent nonprofit agency that works closely with US Pharmacopeia (USP) and Food and Drug Admini­stra­tion (FDA) in analyzing 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, 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 Reporting Program. ISMP address: 1800 Byberry Rd, Huntingdon Valley, PA 19006. Phone: 215/947-7797. E-mail: ismpinfo@ismp.org.

 

Has your double check system ever failed, leading to a medication error that escaped your detection and ultimately reached a patient? If you answered “yes” to this question, you’re not alone. Here’s one recent example.

 

A pharmacist correctly calculated the dose and volume of interferon for an infant, but entered 0.68 mL into the computer instead of the correct volume of 0.068 mL (a common mistake docu­mented in the literature). A second pharmacist double-checked the calculation. He arrived at the correct volume of 0.068, but misread the computer entry of 0.68 by the first pharmacist as 0.068 due to “confirmation bias” – seeing only what one expects to see and overlooking any disconfirming evidence. As this example shows, there’s no question that double checks carried out by people fail at times. But have these failures led you to doubt the overall value of double check systems?  Given how busy pharmacists and other health care pro­fes­sion­als are, do you wonder if this error reduction strategy is even worth your time to carry out? We asked Dr Anthony Grasha, Professor of Psychology at the University of Cincinnati, to offer comment on this issue.

 

Research shows that people find about 95% of all mistakes when checking the work of others.1,2  Mathematically, the benefit of double checks can be demonstrated by multiplying this 5% error rate during the checking process and the rate in which errors occur with the task itself (the checking error rate x the task error rate). For example, if a pharmacy dispensing error rate is 5% (based on research findings), and a double-check occurs before medications are dispensed, then the actual chance of a dispensing error reach­ing the patient is 5% of 5%, or only 0.25%. Human factors suggest that double checks are more effec­tive if they are performed independently. For example, an error in prescription computer order entry will be detected more often if a second person independently checks the printed prescription label against the doctor’s original prescription to verify what was entered into the computer. Sharing prior calculations or performing a double check together with the person who originally completed the task is fraught with problems. In these instances, if a mistake is present, the person checking the work is more easily drawn into the same mistake, especially if it appears to be correct at first glance (eg, numbers correct but decimal point placement wrong or correct drug but wrong concentration selected).

 

Dr Grasha also points out that the effectiveness of double check systems depends on training staff to carry them out properly – as an independent cognitive task, not a superficial routine task.

 

Incidentally, the McKesson Foundation has provided Dr Grasha with a grant to develop a set of pharmacy-related error-prevention tools. These are free of charge and available at www.pharmsafety.net. Check it out!

 

References: 1) Grasha AF, et. al. Delayed verification errors in community pharmacy. Tech Report Number 112101. Cognitive Systems Performance Lab. Contact: Tony.Grasha@UC.Edu. 2) Campbell GM. and Facchinetti N. Using process control charts to monitor dispensing and checking errors. Am J Health-Syst Pharm 2000; 55: 946-952.

 

NABP Centennial Celebration Approaching

 

The National Association of Boards of Pharmacy® (NABP®) will be celebrating its centennial at the 100th Annual Meeting and Centennial Celebration, April 24-27, 2004, at the Fairmont Hotel, in Chi­cago, IL. For the past 100 years, NABP has been building a regulatory foundation for patient safety, and it will continue to support boards of pharmacy and pharmacists in the years to come. Look for more information about NABP’s Centennial Celebration on NABP’s Web site at www.nabp.net.

 

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