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October, 1992 North Carolina Board of Pharmacy

p.o. Box 459, Carrboro, NC 27510-0459 Published to promote voluntary compliance of pharmacy and drug law. 602H Jones Ferry Road, Carrboro, NC 27510-2165

Item 728 - Disciplinary Actions ofthe Board Campbell University are planning continuing education May: programs later tills year that will provide more specifics onpatient Sherwood Clifton Tate, Shelby. Prescription misfilling. Offi­ counseling and other matters. cial Board Caution. Item 730 - Hospital Renewals andJCAHO William H. Patton, Jerry P. Harper, and Marion Drug-Rite, Hospital pharmacists should pay particular attention to tills Marion. Dispensing prescription drugs without valid prescrip­ item. During a regular visit of the Joint Commission on Ac­ tions, refilling prescriptions without authorization, dispensing creditation of Healthcare Organizations (JCAHO), one item on generic products on prescriptions signed by the physician to their checklist was to determine that professional employees have dispense as written, misbranding of prescription drugs, failing current licenses to practice. In tms state, licenses and permits to record filling dates on prescription documents, and failing to expire on December 31. However, there is a 6O-day grace period keep and maintain adequate records of the dispensation of following that date during wmch pharmacists can practice with prescription drugs; failing to prevent the events from occurring tms year's license and not be in violation ofstate law. when the permit holder knew or should have known the viola­ Normally, JCAHO surveyors will not accept tms explanation tions were occurring. Permit suspended for 20 days, stayed for for visits in January and February. As a result, the Board office two years with specific conditions, including owners taking gets several panic calls from licensees attempting to get their jurisprudence examination within one year of date of Order; licenses and/or permits renewed in time for the JCAHO review. license of Patton suspended six months, stayed two years with Tms item reminds all hospital pharmacists, especially directors specific conditions; license of Harper suspended six months, of pharmacy, that it is in your best interest to have any license or stayed two years with specific conditions. permit promptly renewed prior to January 1. June: Russell V, Cobb, III and Dobson Drug Co., Inc., Dobson. Item 731 - Additional Guidelines for CE Selling prescription drugs without valid prescriptions; diversion At the June and July Board meetings, members discussed the ofprescription drugs; charged with Class I Felonies ofprescrip­ acceptability of certain kinds of continuing education for license tion drugs. License revoked. Phannacy pennit revoked. renewal. It was their consensus that Cardiopulmonary Resuscita­ James L. Patterson, Jr" Statesville. Obtaining and consuming tion (CPR), while meritorious, does not meet the intent of the Schedule IV controlled substance Adipex P and/or its generic Board rule on this subject. equivalent, Phentermine 37.5 mg, without authorization. Li­ The members also discussed a situation in wmch one individual cense suspended indefinitely, stayed five years with conditions. selected in the annual random continuing education audit had July: obtained all continuing education hours in management improve­ George D. Teal, New Bern. Obtaining and consuming PV ment, personnel, and other courses designed to improve job Tussin from the stock of pharmacies where employed without performance but not necessarily pharmacy practice skills. It was authorization. License suspended 90 days, stayed two years the members' consensus that the Board would not accept this type with conditions. of continuing education beginning in the 1993 renewal year. It 729 - was also the members' decision to limit preceptors to a total of Item Change ofPractice in January five hours in anyone year for supervising internsmp. Most pharmacists are aware that effective January 1, 1993, Please guide yourself accordingly in submitting CE credits for federal law will require a drug use review program for all your 1993 1icense renewal. Medicaid beneficiaries. Part of tms statute also provides for patient counseling for each Medicaid beneficiary who presents a Item 732 - The Hugo Rule prescription to a phannacist. The Board is also considering the Several years ago, Hurricane Hugo did substantial damage to adoption of rules on patient counseling, which are anticipated to North Carolina, including some pharmacies. As a result, the become effective by January 1, 1993. Board adopted rule .2502 (i), wmch requires that each pharmacist A number of educational programs are now available on tms manager have a plan to safeguard prescription records and phar­ subject, including one which was inserted into this and the July maceuticals in the event ofa hurricane or other predicted national issue oftms Newsletter. As ofthe copy deadline for tms Newslet­ disaster. ter, the University of North Carolina School of Pharmacy and Continued on page 4

NC Vol. 14, NO.2 Page 1 National Pharmacy

(Applicability of the contents of articles in the National Pharmacy Com! and can only be ascertained by examinin

Proper Completion ofDEA Form 222 .A separ~te but ~ela.ted issue has also been raised regard mg genenc substItut~onon order forms. DEA policy does Concerned about confusion surroundingthe proper completion not preclude genenc substitution of identical products ofDEA Form 222 in regards to the "number oflines completed" proVIded that the name and National Drug Code numbcl and the generic substitution on orderforms, the Deputy Assistant of the actual product shipped is reflected on the ("

Jliance News to a particular state or jurisdiction should not be assumed g the law of such state or jurisdiction.)

PMO Drug Labeling and Storage Requirements 2. Directions for use and prescribed withholding times for Pharmacists Who Dispense Animal Drugs for milk and meat. 3. Cautionary statements, if needed. The National Conference on Interstate Milk Shipments 4. Active ingredient(s) in the drug product. (Note: The (NCIMS), in accordance with the Memorandum ofUnder­ requirement for listing active drug ingredient(s) on standing with the Food and Drug Administration, has at the label is satisfied by the inclusion of the generic, its biennial conferences recommended changes and common, established, or chemical name of the drug. modifications to the Pasteurized Milk Ordinance (PMO). Listing drugs by trade or brand names is not satisfac­ Many of the recommended changes and modifications tory. from the NelMS in 1989 and 1991 related to the proper labeling, use, and on-farm storage of drugs intended for The Public Health Service/Food and Drug Administra­ treating dairy callie. The intent is to assure proper use of tion's recommended Pasteurized Milk Ordinance is the veterinary drugs, to prevent adulteration of the food basic standard used in the voluntary Cooperative State/ supply with illegal drug residues through misuse of drugs Federal Program for Certification of Interstate Milk Ship­ in food producing animals, and to promote the health of pers, a program participated in by all 50 states, the District treated animals. The following information is provide

Trade Name Company NDC Code Form Ingredients Quantity t------~------..---.---.- Estratest Solvay Pharmaceuticals, 110032-1026 tablet Esterified 1.25 mg Marietta, GA Methyltestosterone 2.5mg Estratest HS Solvay Phamlaceuticals, 110032-1023 tablet 0.625 mg Marietta, GA Methyltestosterone 1.25 mg Premarin Ayerst Labs, Inc., 110046-0879 tablet 1.25mg with Methyltestosterone New York, NY Methyltestosterone 10.0mg Premarin Ayerst Labs, Inc. 110046-0878 tablet Conjugated Estrogens 0.625 mg with Methyltestosterone New York, NY Methyltestosterone 5.0mg Cypionate Steris Labs, Inc., 110402-0257 Vial 50mg/ml - Cypionate Phoenix, AZ Steris Labs, Inc., 110402-0360 Vial Testosterone Enanthate 90 mg/ml - Injection Phoenix, AZ Estradiol Valerate 4mg/ml

Page 3 Continuedfrom page 1 received this issue if they recently changed residence or practice This is the hurricane season and, shortly prior to presstime, address. Please remind them of the need to promptly notify the Hurricane Andrew made its way through Florida and Louisiana. Board office of such changes. This is an appropriate time to remind pharmacist-managers of Item 737 - Sales Tax on Donated Drugs their responsibility in this area. The North Carolina Department ofRevenue has issued a notice Item 733 - Safety Line to drug manufacturers, distributors, and retailers relevant to the The Governor's Office of Citizen Affairs has published a practice of donating prescription or non-prescription drugs to telephone number to report suspected fire safety, health, or other non-profit organizations. Effective August 1, 1992, G.S. 105 hazards in your workplace. Reports can be made anonymously. 164.13 was amended by adding a new subdivision (13a), which The Office of Citizen Affairs will receive information and exempts from sales or use tax, legend and non-legend drugs forward itto the appropriate agency, whether it is the Department donated to a non-profit organization to be used for charitable ~f Labor, the Insurance Commissioner's Office, or the Occupa­ purposes. Any drug manufacturer or distributor or retail store that tIOnal Safety and Health Administration. This number is donates such medicines will be required to maintain adequate answered during normal business hours. At other times, you may records to support the claim for exemption. leave pertinent information on an answering machine. Other materials relevant to sales tax on prescriptions can be found in Item 655 in the November 1990 issue ofthis Newsletter Item 734 - Irate Customers 738 - Most community pharmacists will go to virtu2 "-. ~ ..." 1- - _.... to Item Paymentfor Referrals Prohibited avoid confrontations with customers, but thel short session ofthe General Assembly, a change in statute casions when nothing will help the situation. If :d, whichessentially prohibits the payment to a health care person in your pharmacy, who is disruptive t< oner for referrals. There is no criminal penalty for viola­ health and safety are at risk, you should consider t~ ~ • the statute; however, such activity can be grounds for the or sheriff, whichever is appropriate. Many communities have a health care provider's licensing board to suspend or revoke a 911 emergency response number and often just mentioning the license to practice. Although there are few, if any, referrals use of that service to an unreasonable customer can resolve the subject to this statute in phannacy, you should be aware that the issue. It's worthwhile to remember that the authorities exist to proscription of this activity exists. protect you as well as everyone else. Item 739 - Interns and Pharmacists Item 735 - Refills on PAjFNP Prescriptions The members of the Board discussed the possibility that some The Board of Medical Examiners has determined that it is interns may be using the phannacist designation prior to passing permissible for physician assistants and nurse practitioners to the licensure exam. The members considered this to be mislead­ indicate refills on prescriptions. If this is done, it should be ing conduct which would be subject to scrutiny in the future. accomplished "on the order of' the supervising physician and not Students or interns should avoid representing themselves as as part of the standard protocols for PAs/FNPs. phannacists, either on the telephone or by wearing a name tag or other insignia which might be inaccurate and inappropriate. Any Item 736 - Newsletter Mailing Change printed infonnation should clearly indicate that the student is Inthe past, the envelope which contained this Newsletter would either an intern or a degree candidate and, therefore, is not yet also include an AHEC Continuing Education Calendar. As a licensed to practice. cost- saving measure, the Board has decided to mail this publica­ tion from Chicago, so you may have noted the absence of infor­ The North Carolina Board of Pharmacy Nf:WS is published by the North mation about continuing education programs. CarolIna Board of Pharmacy and the National Association of Boards of Pharmacy Foundation, Inc., to promote voluntary compliance ofpharmacy The AHEC calendar will be included with the permit renewal and drug law. The opinions and views expressed in this publication do 110'1 mailing later this month, so please look for it with that material. necessarily renect the official views, opinions, or policies of the Foundation Future mailings ofAHEC program materials will be made within or the Board unless expressly so staled. each area. Additional information on ACPE-approved programs David R. Work,JD, RPh - State News Editor can be obtained by calling 1-800/533-3606. Carmen A. Catizone, MS, RPh - National News Editor & The new procedure, which is on a one-year trial basis, also Executive Editor involves the use ofan address list compiled about six weeks prior Janice Teplitz - Editorial Manager to mailing. As a result, some of your colleagues may not have This Newsletter printed at a cost of$.10 per copy.

Page 4 - October, 1992 ~-O'~I)rofit Organization I" U.S. Postage National Association of Boards of Pharmacy Foundation, Inc. i PAID 700 Busse Highway Pa,-k Ridge, Illinois Permit No. 75 Park Ridge, Illinois 60068 i L __ NORTH CAROLINA BOARD OF PHARMACY