Tel: 614/466-4143         Fax: 614/752-4836           Email: exec@bop.state.oh.us           Web: www.pharmacy.ohio.gov




~~ FEBRUARY 2006 ~~



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

Larissa Doucette - Editorial Manager



State News Section


Do You Have Your New Terminal Distributor’s License?

      Please check the terminal distributor of dangerous drugs (TDDD) license at your facility to be sure you have received your 2006 TDDD license from the Ohio State Board of Pharmacy. The TDDD license is the license required for all pharmacies, hospitals, clinics, emergency medical services squads, etc. If you have not renewed or received your 2006 TDDD license, please call the Board office immediately. The 2005 TDDD licenses expired December 31, 2005.


Continuing Pharmacy Education Note


     The Board’s annual Jurisprudence Quiz is included as part of this Newsletter. The questions in the quiz relate to the topics covered in this Newsletter as well as the May, August, and November 2005 issues. If you need them, copies of the previous Newsletters can be found on the Board’s Web site at www.pharmacy.ohio.gov by clicking on “C.P.E. News and S.B.N.”

Please note that the deadline for submission of the completed quiz is March 31, 2006. Any answer sheets postmarked after March 31, 2006, will not be accepted for grading.


Final CPE Reminder


      This is a final reminder to those pharmacists whose license number begins with 03-3. This is the year for you to report your continuing education (CE). It will be due in the Pharmacy Board office no later than May 15, 2006. The continuing pharmacy education (CPE) report forms should be arriving in your mail sometime early in March 2006 while your renewal forms will not be arriving until mid-summer 2006. If you have not received your CPE reporting form by the end of March, please notify us at the Board office so we can get you a replacement. The CPE reporting forms will also be available on the Board’s Web site under “Forms.” The Web site forms can be filled out online and then you can print, sign, and mail them to the Board office.

      You will need to show 6.0 continuing education units (CEUs) (60 hours) of CE credit; 0.3 CEUs (3 hours) must be in Board-approved jurisprudence. (Please make sure that the courses are Board approved. There are a lot of courses coded as law that are not approved by the Board for use in meeting this requirement.) The other 57 hours may be in any category (01, 02, 03, or 04) that you wish.

      You may use certificates dated on or after March 1, 2003, that you did not use when reporting in 2003. In addition, please be sure that you have the certificates in hand before you enter the number on the form. Every year, we have a few pharmacists who put numbers down before they receive their certificate from the CE provider. Sometimes, that certificate then fails to arrive because they did not pass the examination. Falsifying the CPE reporting form is not something that the Board takes lightly. As long as you have the originals in your possession when you complete the reporting form, you should have no problem with this reporting period. If you fail to submit a CPE form in a timely manner, your renewal form will not be mailed to you until your CPE form is received.


BCMH Announces Two New MTMS Opportunities

      Pharmacists may be interested in the following two announcements received in the Board office from the Bureau for Children with Medical Handicaps (BCMH):

Pediatric Asthma:

      Pharmacists who are providers to the BCMH, Ohio Department of Health, may use the following current procedural terminology codes to bill for Medication Therapy Management Services (MTMS) provided to eligible children with severe pediatric asthma. The pharmacist must be working collaboratively with a Pediatric Pulmonologist, or receiving a referral, to perform the MTMS.

      The codes are American Medical Association (AMA)-approved codes. MTMS describes face-to-face patient assessment, and intervention as appropriate, by a pharmacist. MTMS is provided to optimize the response to medications or to manage treatment-related medication interactions or complications.

      MTMS includes the following documented elements: review of the pertinent patient history, medication profile (prescription and non-prescription), and recommendations for improving health outcomes and treatment compliance. These codes are not to be used to describe the provision of product-specific information at the point of dispensing or any other routine dispensing-related activities.

      The code descriptions, numbers, and compensation levels are as follows:

·     0115T – [MTMS] provided by a pharmacist, individual, face-to-face with patient, initial 15 minutes, with assessment, and intervention if provided; initial encounter. Compensation level:

·     $52.57.

·     0116T – Subsequent encounter. Compensation level: $34.35.

·     0117T – each additional 15 minutes. This code is to be listed separately in addition to code for the primary service. Use of the 0117T code is in conjunction with the 0115T or 0116T codes.

·     Compensation level: $24.74.

      These codes are effective immediately and can be used by BCMH pharmacist providers for BCMH-eligible recipients with asthma.

Pediatric Diabetes:

      The BCMH, Ohio Department of Health, will be extending MTMS to children with coverage to include those with diabetes.

      Pharmacists who are providers to BCMH will also be able to utilize MTMS codes when providing services to these patients. Previously the Bureau announced a similar action for children with severe pediatric asthma. The pharmacist must have a referral from the managing pediatric endocrinologist and be working collaboratively with that physician.

      The same CPT codes recently approved by the AMA are applicable for billing purposes for this set of patients. MTMS describes face-to-face patient assessment, and intervention as appropriate, by a pharmacist. MTMS is provided to optimize the response to medications or to manage treatment-related medication interactions or complications.

      MTMS includes the following documented elements: review of the pertinent patient history, medication profile (prescription and non-prescription), and recommendations for improving health outcomes and treatment compliance. These codes are not to be used to describe the provision of product-specific information at the point of dispensing or any other routine dispensing-related activities.

      The codes are effective immediately and can be used by BCMH pharmacist providers for BCMH-eligible recipients with diabetes as well as asthma.


New and Revised Rules Have Been Filed

      The Board filed several new and revised rules that became effective on January 1, 2006. The full text of these rules, showing changes, can be found on the Board’s Web site. Click on “What’s New” and you will find the document with the new rules. Included in these rules are a new chapter dealing with charitable pharmacies (4729-36) and a new chapter dealing with the Prescription Monitoring (drug database) program (4729-37). The next Newsletter will contain specific information about the new Prescription Monitoring program and the ways that pharmacists and prescribers can obtain information about their patients’ prescription histories.

      Another rule that was added in 2006 was Rule 4729-9-25 – “Drugs compounded for direct administration by a prescriber.” In 2005, the Legislature revised the definition of “Compounding” in §4729.01(C) of the Pharmacy Practice Act by adding paragraph 5 to allow for the limited supply of a compounded product to a prescriber at his or her office. The new paragraph in the definition of “Compounding” in the Revised Code is as follows:

(C) “Compounding” means the preparation, mixing, assembling, packaging, and labeling of one or more drugs in any of the following circumstances:

(5) Pursuant to a request made by a licensed health professional authorized to prescribe drugs for a drug that is to be used by the professional for the purpose of direct administration to patients in the course of the professional’s practice, if all of the following apply:

(a) At the time the request is made, the drug is not commercially available regardless of the reason that the drug is not available, including the absence of a manufacturer for the drug or the lack of a readily available supply of the drug from a manufacturer.

(b) A limited quantity of the drug is compounded and provided to the professional; and

(c) The drug is compounded and provided to the professional as an occasional exception to the normal practice of dispensing drugs pursuant to patient-specific prescriptions.

      The new rule promulgated by the Board defines what a “limited quantity” is and it also defines what constitutes an “occasional exception to the normal practice of dispensing drugs” so that the pharmacy does not end up being charged by Food and Drug Administration or the Board with manufacturing in violation of federal law. If you are a compounding pharmacy, please read this rule very carefully before you begin to provide any products directly to a prescriber’s office.


Disciplinary Actions

      Anyone having a question regarding the license status of a particular practitioner, nurse, pharmacist, pharmacy intern, or dangerous drug distributor in Ohio should contact the appropriate licensing board. The Professional Licensing Agency Web sites listed below may include disciplinary actions for their respective licensees.

      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



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.



DEA Releases Final Rule on Approved Narcotic Controlled Substances for Maintenance of Detoxification Treatment


      According to the June 23, 2005 Federal Register, Drug Enforcement Administration (DEA) has amended its regulations (§1301 and §1306) to allow qualified practitioners not registered as a narcotic treatment program to dispense and prescribe to narcotic dependent persons Schedule III, IV, and V narcotic controlled drugs approved by Food and Drug Administration (FDA) specifically for use in maintenance or detoxification treatment. This final rule is in response to amendments to the Controlled Substances Act by the Drug Addiction Treatment Act of 2000 (DATA) that are designed to increase and improve the treatment of narcotic addiction. In addition, the final rule is intended to accomplish the goals of DATA while preventing the diversion of Schedule III, IV, and V narcotic drugs approved for maintenance/detoxification treatment. This rule went into effect July 25, 2005.

      Additionally, the amended regulations require the practitioner to include on the prescription the identification number or written notice that the practitioner is acting under the good faith exception of §1301.28(e). In order to be valid, a prescription must be written for a legitimate medical purpose by a practitioner acting in the usual course of his or her professional practice. The prescription must also be dated as of, and signed on, the day issued and must contain the full name and address of the patient, the drug name, strength, dosage form, quantity prescribed, directions for use as well as the name, address, and registration number of the practitioner. Practitioners are not normally required to keep records of prescriptions issued, but DEA regulations require records to be kept by practitioners prescribing controlled substances listed in any schedule for maintenance or detoxification treatment of an individual.

      Any practitioner who dispenses or prescribes Schedule III, IV, or V narcotic drugs in violation of any of the conditions as specified in §1301.28(b), may have their practitioner’s DEA registration revoked in accordance with §1301.36.

      Due to the potential for diversion, and in an effort to verify compliance with these regulations, DEA intends to conduct at least two regulatory investigations per field office per year of practitioners dispensing and prescribing to narcotic-dependent persons Schedule III, IV, and V narcotic controlled drugs approved by FDA specifically for use in maintenance or detoxification treatment.


How FDA Reviews Drug Names

By Carol Holquist, RPh, FDA, Office of Drug Safety

      FDA has received approximately 18,000 reports of actual or potential medication errors since 1992 and continues to improve the process by which these errors are assessed. Over the past nine years, FDA has increased the safe use of drug products by minimizing user errors attributed to nomenclature, labeling, and/or packaging of drug products. The group in charge of these activities is the Office of Postmarketing Drug Risk Assessment (OPDRA) under FDA’s Center for Drug Evaluation and Research. Ten clinical pharmacists and physicians make up OPDRA’s medication error staff.


The Name Review Process

      Since October 1999, OPDRA has reviewed approximately 400 drug products. Proprietary names undergo a multifactorial review designed to improve consistency and minimize risk due to sound-alike and look-alike names. The process includes:

  • Expert panel review. An expert panel meets weekly to exchange opinions on the safety of a new proprietary name. The panel comprises OPDRA medication error prevention staff and representatives from the Division of Drug Marketing and Advertising Communications, who rely on their clinical, regulatory, and professional experiences to decide on the acceptability of a proprietary name.
  • Handwriting and verbal analysis. These are conducted within FDA to determine the degree of confusion in visual appearance or pronunciation between the proposed proprietary name and names of other United States drugs. FDA health professionals (nurses, pharmacists, and physicians) are requested to interpret both written inpatient and outpatient prescriptions and verbal orders in an attempt to simulate the Rx ordering process.
  • Computer-assisted analysis. Currently, OPDRA utilizes existing FDA databases to identify potential sound-alike and/or look-alike proprietary names. In the future, OPDRA plans to use validated computer software that will improve the ability to detect similarities in spelling and sound among proprietary names.
  • Labeling and packaging analysis. OPDRA provides a safety assessment of the container labels, carton and package insert labeling, and proposed packaging of each product to identify areas of potential improvement.
  • Overall risk evaluation. This final phase of the name review process weighs the results of each phase of the review as well as additional risk factors such as overlapping strengths, dosage forms, dosing recommendations, indications for use, storage, labeling, and packaging, and important lessons learned from the agency’s post-marketing experience.


How Can You Help?

      Pharmacists and other health professionals can assist FDA in minimizing medication errors by reporting any actual or potential medication errors to MedWatch, FDA’s medical product reporting and safety information program launched in June 1993. All identification of reporter, institution, and patient are kept confidential and are protected from disclosure by the Freedom of Information Act.

      Medication errors can easily be reported to MedWatch via telephone (1-800/FDA-1088), Web site (www.fda.gov/medwatch), and fax (1-800/FDA-0178). In addition, a standardized MedWatch adverse event reporting form (FDA Form 3500) is available to aid in submitting voluntary reports of medication errors. You should provide a complete description of the error; level of staff (e.g., pharmacist, nurse, physician) involved; medication involved; patient outcome; setting of the incident (e.g., inpatient, outpatient); relevant patient information (e.g., age and gender); date of event; manufacturer of the drug; dosage form and strength; and size of container. Finally, you will need to check both “Product Problem and/or Adverse Event” and “other” on the form.

      We also encourage you to include your suggestions for preventing errors. With your contributions to increased reporting and the new processes implemented by OPDRA, the agency can provide effective intervention strategies that will minimize the risks associated with medication errors.


What’s wrong with “U?”


      This column was prepared by the Institute for Safe Medication Practices (ISMP). ISMP is an independent nonprofit agency that works closely with United States Pharmacopeia (USP) and 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, and 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.

      The use of abbreviations is always problematic when communicating medical information. All too often, medical abbreviations hinder our understanding or are misread. Insulin errors are common and can cause significant patient harm. The cause of many insulin errors is related to the use of abbreviations when communicating prescription information. The abbreviation “U” to indicate “units” has contributed to many errors when it was misread as a zero (0) or a number 4.

      Over the years, numerous reports have been received through the USP-ISMP Medication Errors Reporting Program that describe the occurrence of 10-fold or greater overdoses of insulin because the abbreviation “U” has been misinterpreted. It is not uncommon for a “U” to be misread as a zero (0). For example, prescriptions for “6U regular insulin” have been misinterpreted and administered as 60 units of regular insulin. In another report, a prescriber wrote an order for “4U Reg” (see photo); however, someone misinterpreted the “U” as a “4.” The person who injected the insulin did not recognize that this was an excessive dose and proceeded to administer 44 units to the patient. The patient required glucose to reverse his acute hypoglycemia.

      In order to prevent errors such as these, health care practitioners should always write out the word “units.” Educate staff about the dangers involved with using this abbreviation. Practitioners must recognize the need for good communication skills and realize that the perceived time saved when using the abbreviation “U” for units may actually result in serious patient harm. Occasionally, while intending to do the “right thing,” errors still can occur. This was the case when a physician wrote a sliding scale insulin order for a hospitalized patient with a blood sugar of 396 mg/dL. When writing the insulin order, the physician included the word “units.” According to the order, this patient should have received 4 units of regular insulin subcutaneously. Unfortunately, because the letter “U” in units was separated from the rest of the word, “-nits,” the nurse read the order as 40 units and administered the dose to the patient. His blood sugar dropped to 54 mg/dL and he required dextrose to correct the hypoglycemia. The error was realized when the nursing notes were reviewed and it was documented that 40 units was administered.

      Pharmacy and nursing staff must carefully review insulin prescriptions, knowing that errors involving this abbreviation are common and can result in 10-fold or greater overdoses. Clarify any questionable insulin dosages and inform the prescriber of misinterpretations that could occur due to use of the abbreviation “U” for units. In addition, whenever possible, require an independent double check of insulin prescriptions before they are dispensed or administered.


Safeguards for Severe Acne Medication Announced


      Because isotretinoin (Accutane®) carries significant risks of birth defects for women who are pregnant or might become pregnant, FDA has unveiled safeguards for its distribution. (See related article, March 2005 NABP Newsletter, page 61.) The manufacturers of isotretinoin are launching a program called iPLEDGE™ in which doctors and patients register with the program and agree to accept certain responsibilities as a condition of prescribing or using the drug. Wholesalers and pharmacies must also comply with the program to be able to distribute and dispense the drug.

      In the wake of a February 2004 joint meeting between FDA’s Drug Safety and Risk Management Advisory Committee and Ophthalmic Drugs Advisory Committee, major improvements were recommended for the restricted distribution program for isotretinoin, which has proven effective in treating severe recalcitrant nodular acne. Under the recommendations, patients who could become pregnant are to have negative pregnancy testing and birth control counseling before receiving the drug. In addition, patients must complete an informed consent form and obtain counseling about the risks and requirements for safe use of the drug. Starting December 31, 2005, all patients and prescribers must register and comply with requirements for office visits, counseling, birth control, and other program components. After October 31, 2005, wholesalers and pharmacies were required to register with iPLEDGE in order to obtain isotretinoin from a manufacturer.

      Program information and registration is available at www.ipledgeprogram.com or 866/495-0654. For the purpose of increasing available information about isotretinoin and its associated risks, FDA also issued a Public Health Advisory and revised the Patient and Health Care Provider Information Sheets that detail the new patient and practitioner restrictions and responsibilities under the program. A reporting and collection system for serious adverse events associated with the use of the drug has also been established. Pregnancy exposures to isotretinoin must be reported immediately to FDA at the MedWatch phone number (1-800/332-1088), the iPLEDGE pregnancy registry (866/495-0654), or on the iPLEDGE Web site. Besides approving the iPLEDGE program, FDA approved changes to the existing warnings, patient information, and informed consent form to help patients and prescribers better identify and manage the risks of psychiatric symptoms and depression before and after taking the medication.