Remote Prescription/Medication Order Processing

Transcription

Illinois Department of Financial and Professional RegulationDivision of Professional RegulationDrug Compliance Unit9511 Harrison Street, Suite LL 50, Des Plaines, IL 60016Phone: (847) 294-4900(Read this Page Carefully)REMOTE PRESCRIPTION/MEDICATION ORDER PROCESSINGPharmacy Self-Inspection FormIllinois Law holds the Pharmacist-in-Charge (PIC) and all pharmacists on duty responsible forensuring pharmacy compliance with all state and federal laws governing the practice ofpharmacy.The primary objective of this report, and your self-inspection, is to provide an opportunity toidentify and correct areas of non-compliance with state and federal law. The inspection reportalso serves as a necessary document used by the Drug Compliance investigators during aninspection to evaluate a pharmacy’s level of compliance. When a Drug Compliance investigatordiscovers an area of non-compliance, he or she may issue either a Deficiency Notice or a Noticeof Non-Compliance. Both require a written response from the PIC. Identifying or correcting anarea of non-compliance prior to a Drug Compliance investigator inspection may eliminate thereceipt of a Deficiency Notice/Notice of Non-Compliance for that item.Failure to complete this report by December 31st of each year may result in DisciplinaryAction. (Section 1330.800)NOTE: Neither the self-inspection nor a Drug Compliance investigator inspection evaluates yourcomplete compliance with all Laws and Rules of the practice of pharmacy. Further, nothingherein shall constitute a waiver of IDFPR enforcement discretion or constitute compliance withall applicable Laws and Rules governing the practice of pharmacy. This report is not finalagency action and is intended as guidance. This report is not intended, nor can it be relied uponto create any rights enforceable by any party in litigation or in any enforcement action broughtby IDFPR.

STATE OF ILLINOIS DEPARTMENT OF FINANCIAL AND PROFESSIONAL REGULATIONDRUG COMPLIANCE UNIT9511 HARRISON STREET, SUITE LL 50DES PLAINES, IL 60016-1563PHONE NUMBER: 847-294-4900(KEEP CURRENT THROUGHOUT THE YEAR, AS NEEDED)REMOTE PRESCRIPTION-MEDICATION ORDER PROCESSINGBUSINESS NAMEHOURSDEA REGISTRATIONNUMBEREXPIRESDATE OF INSPECTIONICSA LICENSE NUMBEREXPIRESPHARMACY LICENSE NUMBERMTWADDRESSTHFSATSUNCITYZIP CODEOWNERSHIPOWNERSOTHERHOURSEXCEPIndividual pharmacistIndividual Non-pharmacistPartnershipCorporationLLCNAME OF LICENSEER Ph IN CHARGETELEPHONE((PERSON IN CHARGE)TELEPHONE AFTER HOURSPHARMACY E-MAIL ADDRESS)OWNER’S E-MAIL ADDRESSCOUNTYLICENSE NUMBERIf the Pharmacist in charge listed above is the PIC in other pharmacies, list hereNAMEADDRESSPHONE NUMBER1.2.

QUESTIONYESNON/AAUTHORITYGENERALThe pharmacy’s license is current and posted.All required current licenses are posted in a conspicuouslocation in the pharmacy (pocket license or photocopymay be used when registrants are employed at multiplesites).Pharmacy is compliant with Section 1330.560 of theIllinois Pharmacy Practice Act Rules, RemotePrescription/Medication Order Processing.The PIC has personally reviewed the licenses of allregistrants and determined that they are current.All pharmacy technicians and certified pharmacytechnicians have completed the required training set forthin the Act and Rules.Meet all the requirements when there is a change inPharmacist-in-Charge including but not limited to propernotification to the Department.The facility must have a sign clearly identifying it as aRemote Prescription/Medication Order Processing site.SECURITY AND SANITATION225 ILCS 85/15225 ILCS 85/15(5)68 Administrative CodeSection 1330.56068 Administrative CodeSection 1330.66068 Administrative CodeSection 1330.21068 Administrative CodeSection 1330.66068 Administrative CodeSection 1330.510YESNON/AFacility is clean and sanitary.Facility area shall not be used for storage of merchandisethat interferes with the practice of pharmacy.The facility area and all store rooms shall be well-lightedand properly ventilated.REMOTE ORDER PROCESSINGREQUIREMTENTSAny pharmacy may provide remoteprescription/medication order processing services to anyother pharmacy as provided in Section 25.10 of the Actand the following further requirements:1) Any nonresident pharmacy remoteprescription/medication order processing servicesshall first be registered in its resident state andregistered in this State.2) There shall be a secure, HIPAA compliant,electronic communication system that shallinclude but not be limited to computer, telephoneand facsimile connections.3) The communication system shall give remoteaccess to all relevant patient information to allowthe pharmacist of the remote pharmacy toAUTHORITY68 Administrative CodeSection 1330.600 and225 ILCS 85/15(1)(b)68 Administrative CodeSection 1330.63068 Administrative CodeSection 1330.610(e)Security provisions are provided during the absence of apharmacist.68 Administrative CodeSection 1330.610(c)YESNON/AAUTHORITY68 Administrative CodeSection 1330.560(a)

perform remote medication order processing thatshall include all laboratory results and everypatient's or resident's medication profile, ifappropriate.4) The secure electronic communication systemshall be maintained on a daily basis. If thissystem malfunctions, the remote processingpharmacy shall cease operations related to theinstitution affected.5) Nothing in this Section shall relieve thepharmacist-in-charge of dispensing pharmaciesof compliance with Sections 1330.520 and1330.530.Policy and Procedure Manual:A policy and procedure manual shall be maintained bythe remote prescription/medication order processingpharmacy pertaining to the pharmacy's operations. Themanual shall:A. Be accessible to the remoteprescription/medication order processingpharmacy staff and the staff at the dispensingpharmacy;B. Be available for inspection by the Division;C. Outline the responsibilities of the remoteprescription/medication order processingpharmacy staff and the staff at the dispensingpharmacy;D. Include a current list of the name, address,telephone number and license number of eachpharmacist involved in remoteprescription/medication order processing;E. Include policies and procedures for:i.Protecting the confidentiality and integrityof patient information;ii.Ensuring that pharmacists performingremote prescription /medication orderprocessing have access to appropriatedrug information resources;iii.Ensuring that medical and nursing staffwhen appropriate, understand how tocontact a pharmacist;iv.Maintaining records to identify the name,initials or identification code of eachpharmacist who performs any processingfunction;v.Complying with federal and State lawsand regulations;vi.Operating or participating in a continuousquality improvement program forpharmacy services designed to68 Administrative CodeSection 1330.560(b)(1)

objectively and systematically monitorand evaluate the quality andappropriateness of patient care, pursueopportunities to improve patient care, andresolve identified problems;vii.Reviewing the written policies andprocedures and documenting the reviewannually.Every pharmacist providing remoteprescription/medication order processing services shallrecord on the order, in the computer system, or onanother appropriate, unalterable, uniformly maintainedand readily retrievable record the following information forevery medication order or prescription processed onbehalf of a dispensing pharmacy:A. The name, initials or other unique identifier of thepharmacist who verifies the medication order orprescription;B. The name of the patient or resident;C. The name, dose, dosage form, route ofadministration and dosing frequency of the drug;D. The date and time of verification;E. The name of the prescribing/ordering practitioner;F. Any other information that is required by thedispensing pharmacy being served for use in itsown records.The records for medications entered at the remoteprescription/medication order processing pharmacy mustbe distinguishable and readily retrievable from thoseentered at the institution being served.The pharmacist-in-charge of the remoteprescription/medication order processing pharmacy shallmaintain and have access to the following records for aminimum of 5 years:A. Records of medication orders processed;B. Records of the electronic communication systemmaintenance.The remote prescription/medication order processingpharmacy shall maintain a record containing the namesand license numbers of all pharmacies to which they areproviding services and the number of hours per day theservices are being provided.All pharmacists providing remote prescription/medicationorder processing at a remote pharmacy shall be licensedin Illinois. However, when pharmacists are providingremote prescription/medication order processing for acommunity pharmacy licensed in Illinois from acommunity pharmacy licensed in Illinois but located outof-state, only the pharmacist-in-charge of the remotepharmacy must be licensed in Illinois.68 Administrative CodeSection 1330.560(b)(2)68 Administrative CodeSection 1330.560(b)(3)68 Administrative CodeSection 1330.560(b)(4)68 Administrative CodeSection 1330.560(b)(5)68 Administrative CodeSection 1330.560(c)

68 Administrative CodeSection 1330.560(d)Only licensed pharmacists at the pharmacy providingremote pharmacy services shall conduct the drugutilization evaluation or review and validation of any orderprocessed within the remote pharmacy, except asprovided for in subsection (c).DO NOT SEND ANY PART OF THIS REPORT TO THE DEPARTMENT!KEEP IN THE PHARMACY FOR DRUG COMPLIANCE INVESTIGATOR’S REVIEW.COPIES SENT TO THE DEPARTMENT WILL BE DISCARDED.I hereby certify that I have verified that this pharmacy is in compliance with all laws and rulesrelated to the practice of pharmacy in the State of Illinois and the answers marked on this reportare true and correct to the best of my knowledge.PIC NAME:LICENSE NUMBER:PIC SIGNATURE:DATE:

every medication order or prescription processed on behalf of a dispensing pharmacy: A. The name, initials or other unique identifier of the . A. Records of medication orders processed; B. Records of the electronic communication system maintenance. 68 Administrative Code