ILJ I BE AWARE & TAKE CARE:. t'Talk to your pharmac,s .C A L I F O R N I AB O A R DO FP H A R M A C YJULY 2001Expiration Dates—Compliance GuidelinesExpiration Date—The expirationdate identifies the time duringwhich the prescription drug maybe expected to meet the requirements of the Pharmacopeialmonograph, provided it is keptunder the prescribed storageconditions.Prescription medication shall not bedispensed after the expiration date on themanufacturer’s container. The expirationdate placed on the prescription labelshould be that of the effectiveness of thedrug (Business and Professions Codesection 4076[a]). That date, in mostcircumstances, is the date printed onthe manufacturer’s container.Proper storage conditions of theprescription drug (Title 16 of theCalifornia Code of Regulations section1707.2[d]) should be reinforcedduring patient consultation.Guidelines from the UnitedStates PharmacopeiaBeyond-Use Date—The beyonduse date is the date after whichthe prescription drug may not beused.The beyond-use date defines anappropriate period of time during which aprescription drug may be retained by apatient after it is dispensed and takes intoaccount such factors as the conditionsunder which the medication may bestored in the patient’s home, the type of7 1packaging, the nature of the drug beingdispensed, and the frequency with whichthe package may be opened.For non-sterile solid and liquidpharmaceutical products repackaged intounit-dose or single-unit containers,pharmacists must affix a “beyond-usedate” that is “one year or less, unlessstability data or the manufacturer’slabeling indicates otherwise.” For allother non-sterile dosage forms, thebeyond-use date is “one year or the timeremaining of the expiration date.”Beyond-use dates for multiple-unitcontainers, such as a typical prescriptionvial, remain as follows:“not later than (a) the expiration date on the manufacturer’scontainer or (b) one year fromthe date the drug is dispensed,whichever is earlier.”(These packaging standards appear inthe first supplement to The United StatesPharmacopeia, 24th Rev., and TheNational Formulary, 19th Ed. (USP24/NF19).)Compliance DirectionThe pharmacy is not to dispenseexpired drugs. During an inspection, theinspector will randomly select somefilled prescriptions to compare theexpiration dates to the manufacturer’scontainer. If the expiration date on theprescription label exceeds the manufacturer’s date, this is a violation.00- - - -In This IssueExpiration Dates—Compliance Guidelines . Front PagePresident’s Message . 2Corresponding Responsibility . 3Changes in the Board . 4Pharmacy Board Meetings Are Open to the Public . 4Chlamydia Follow-Up . 5Expanded Enforcement Tools . 5Medical Device Retailers go to DHS . 6Be An Inspector for the Board of Pharmacy . 6New DEA Telephone Numbers . 7Pharmacy Self-Assessment Update . 7Rx for Good Practice . 8Regulation Update . 9Board Passes Quality AssuranceProgram Regulation . 9Disciplinary Actions by the Board . 11Storage of Exempt Dangerous Drugs . Back PageBoard Members . Back Page
ILJ I2BOARD OF PHARMACYJULY 2001President’s MessageBy Steve Litsey, Pharm.D., FCSHPPresident, Board of Pharmacycommenter’s name and mailingaddress.LEGISLATION AND REGULATIONGoals:To pursue legislation that ensuresbetter patient care. To provide effective regulation of theindividuals and firms who handle,dispense, furnish, ship and storeprescription drugs and devices inCalifornia.The Board: Supports SB 340 to allow dosageform changes by pharmacistswithout consulting the prescriber. Supports SB 1000 to extend theControlled Utilization Review andEvaluation System (CURES) sunsetdate and state intent of theLegislature to eliminate the triplicateprescription requirement as soon aspossible. Sponsored SB 1339 requiring aquality assurance program (QAP) inall pharmacies and adopted the QAPat the April 2001 Board meeting. Adopted a regulation expanding thecite and fine authority to cover allviolations of the pharmacy law. Adopted revision of the PharmacySelf-Assessment forms. Adopted revision of the DisciplinaryGuidelines. LICENSING COMMITTEEGoal:This message of The Script willfocus on the Board’s mission and goalsfor serving the consumers of Californiaby: Protecting their health, safety andwelfare with integrity and honesty. Helping them attain healtheducation, wellness and an improvedquality of life. Ensuring high quality pharmacists’care.The Board has five committees thatwork with the board staff and withconsumer, pharmacy, and legislativegroups to meet the mission. Thecommittees and resulting Board activitiesinclude:COMMUNICATION ANDPUBLIC EDUCATION COMMITTEEGoals:To encourage the public to discusstheir medication with theirpharmacist. To emphasize the importance ofcompliance with their medicationtherapy.The Board: 7 1Is revising the “Notice toConsumers.” It will includequestions that patients should askand understand before takingmedications, along with a Board ofPharmacy toll-free telephone numberfor consumers.Approved topics for future HealthNotes include “AlternativeMedicines,” “Pharmacists’ Care” and“Quality Assurance Programs.”To ensure that those entering andthose continuing the practice ofpharmacy meet minimum requirementsfor education, experience and knowledge.The Board: Received a report on the January23rd meeting of the PharmacyManpower Task Force—a workinggroup to ensure patient access topharmacists’ care and prescriptionservices. The 15-member task forcecollected approximately 32 proposedsolutions with written documentation. These proposed solutions werediscussed at the task force meetingon April 27th. A subsequent taskforce meeting was held on June 8that the USC School of Pharmacy, andthe next meeting is scheduled forJuly 24 at the San Diego WestgateHotel. Recommended support forregulatory change to all utilization ofautomated dispensing machines atremote pharmacies.ENFORCEMENT COMMITTEEGoals:To protect the public by preventingviolations. To effectively enforcing federal andstate pharmacy laws when violationsoccur.The Board: Adopted the proposed language ofTitle 16 of the California Code ofRegulations section 1711 to requirepharmacies to establish and maintaina quality assurance programdesigned to prevent medicationerrors. The Board has modified theproposed language and will noticethe changes for a 15-day commentperiod. Approved the policy to accept e-mailor fax comments on proposedregulations only if they contain the ORGANIZATIONALDEVELOPMENTGoals:To use strategic planning, budgetmanagement and staff developmentactivities to ensure the efficientachievement of the Board’s mission andgoals.The Board: Approved the recommended budgetchange proposals for 2002/03. Updated the environmental scan forits 2001/02 Strategic Plan.The Board’s Strategic Plan includes anumber of activities focused onimproving board operations and publicinformation. We will continue to seekadditional staff resources to better servethe consumers and our licensees. Our roleas board members requires no less.
ILJ IJULY 2001BOARD OF PHARMACY3Physicians and pharmacists have correspondingresponsibility when writing and dispensing controlledsubstance prescriptionsIf a physician writes a controlled substance prescription that is not for a legitimate medical purpose, thepharmacist shares a corresponding responsibility or liability with that physician if he or she fills thatprescription while knowing or having objective reason to know that the prescription was not issued for alegitimate medical purpose.A pharmacist’s “objective reason toknow” includes, but is not limited to,warnings or cautions or other suspiciousinformation from a Board inspector,Board publications, the media, otherpharmacy personnel, or personnel ofother drug entities. These are all ways ofputting a pharmacist on notice to becautious and to use that information andhis or her professional judgment todetermine whether a prescription shouldbe filled. The more the pharmacist isalready on notice to be cautious, the lessadditional information or factors wouldbe required to establish that he or shefailed to properly consider prescriptionsbefore filling them.That said, how does a pharmacistevaluate a controlled substanceprescription that appears—at least on itsface—to have all the elements of a validprescription? To make it easier toevaluate questionable prescriptions, theBoard has developed a set of guidelinequestions that pharmacists may askthemselves before dispensing. However,it is important to remember that theseguidelines do not cover everypossibility; nor will every question applyin every case.Are you able to verify the true nameand identity of the patient? Does the patient live within oroutside the normal trading areas ofthe pharmacy? Is the distance sogreat that it is unlikely the patientwould travel so far to fill alegitimate prescription? 7 1How far is the patient’s residencefrom the prescriber’s office?What is the patient’s physicalappearance and demeanor in relationto the drug being prescribed?If the patient’s diagnosis is known,is the prescribed drugtherapeutically appropriate? When a third party picks up theprescription, what is his or herrelationship to the patient? What ishis or her physical appearance anddemeanor?Is the frequency of refills or newprescriptions for the same drug thesame as in the directions for usegiven by the physician? How do the length and quantity ofthe prescribed drug therapycompare to recognized and acceptedprescribing practices? Is the physician prescribing unusualcombinations of drugs orantagonistic or contraindicateddrugs?What do you know about the drughistory of the patient? Questions Relating to the PrescribingPhysician Is information present in thepharmacy regarding the prescribingpatterns of the physician, includingthe type of drugs, their frequencyand volume? If not, is thatinformation readily available toyou? Of the physician’s total prescriptionsfilled at your pharmacy, does thereappear to be an excessive percentageof prescription written for controlledsubstances and other potentiallyabusable drugs? Is that informationreadily available to you? What is the nature of the physician’spractice, including any recognizedarea of specialty? Are the drugsprescribed appropriate for thatpractice or specialty? Are you aware of any prior criminalor disciplinary action taken againstthe prescriber?Questions Relating to the Patient Questions Relating to the TherapeuticAppropriateness of the Prescription What are the abuse history andcurrent patterns of abuse of theprescribed drug?Regulatory ReferencesUnder federal law and regulations(21 United States Code section 841,taken together with 21 Code of FederalRegulations section 1306.04[a]), apharmacist is criminally liable forknowingly filling prescriptions forcontrolled substances for other than alegitimate medical purpose. State law,Health & Safety Code section 11153(b)is similar.For disciplinary liability, the standardis clearly excessive furnishing for otherthan a legitimate medical purpose(Business & Professions Code section4301[e], taken together with H&SCsection 11153[a]) or dispensing acontrolled substance prescription whenthe pharmacist knows or has objectivereason to know that the prescription wasnot issued for a legitimate medicalpurpose (Title 16 of the California Codeof Regulations section 1761[b]).
ILJ I4BOARD OF PHARMACYChanges in the BoardThe Board wishes to extend its best wishes and appreciation to twodeparting members, Dr. Darlene Fujimoto and Richard Mazzoni.While saying goodbye to its departing members, the Board is alsopleased to welcome three new members: Stanley W. Goldenberg,R.Ph., Dr. Clarence Hiura, Pharm.D., and John E. Tilley, R.Ph.—all appointed by Governor Gray Davis.New MembersMr. Goldenberg, a graduate of theUniversity of Arizona College ofPharmacy, is a licensed pharmacist whohas specialized in long term carefacilities and skilled nursing facilitiessince 1972. He presently serves aspresident of Pharmatech LTC, acompany that provides research for anationwide network of skilled nursingand long term care facilities, of LongTerm Care Management Council and ofOsteographix Medical Associates, whichprovides osteoporosis testing andeducational services. Mr. Goldenberghas also served as president of AdvancedPharmaceutical Services, an institutionalpharmacy specializing in skilled nursingfacilities.Dr. Hiura, a resident of Los Angeles,earned a Pharm.D. degree from theUniversity of Southern California (USC)and has practiced pharmacy for morethan 42 years. He presently serves as vicepresident and part-time pharmacist atK.C. Pharmacies. He is president of theCalifornia Pharmacy Association Board,Inc. and vice president of UnitedPharmacy Network, Inc. Dr. Hiura is alsoa member of the board of directors forQSAD, a fund development organizationfor the USC School of Pharmacy. Dr.Hiura was a clinical associate professorat USC and is a member of the LosAngeles Pharmacy Task Force. He is aformer member of the California StateBoard of Pharmacy, having served from1979 to 1986.JULY 2001Mr. Tilley has practiced pharmacy for24 years, owned three ZweberApothecaries in Downey, California,since 1984 and owns pharmacies within26 Stater Brothers Markets in southernCalifornia. He is a past trustee andpresident of the California PharmacistAssociation (CPhA) and president of theCalifornia Pharmacists Political ActionCommittee. He is also a member of theAmerican Pharmaceutical Associationand serves on the board of directors forthe American College of Apo