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Chapter 8 Information Technology in Pharmacy Information Technology for the Health Professions, Third Edition Lillian Burke and Barbara Weill Copyright ©2009 by Pearson Education, Inc. Upper Saddle River, New Jersey 07458 All rights reserved. The Food and Drug Administration The federal agency responsible for protecting the public health by: Assuring the safety, efficacy, and security of: Human and veterinary drugs, biological products Medical devices Our nation’s food supply, cosmetics, and products that emit radiation. Source: FDA Mission Statement, www.fda.gov (nd; August 2, 2006). Information Technology for the Health Professions, Third Edition Lillian Burke and Barbara Weill Copyright ©2009 by Pearson Education, Inc. Upper Saddle River, New Jersey 07458 All rights reserved. The Food and Drug Administration (cont) The federal agency responsible for protecting the public health by: Advancing public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable Getting information to the public to use medicines and foods to improve health Source: FDA Mission Statement, www.fda.gov (nd, August 2, 2006. Information Technology for the Health Professions, Third Edition Lillian Burke and Barbara Weill Copyright ©2009 by Pearson Education, Inc. Upper Saddle River, New Jersey 07458 All rights reserved. The Food and Drug Administration (cont) The federal agency responsible for protecting the public health by: • Helping the public get the accurate, science-based information they need to use medicines and foods to improve their health. Source: FDA Mission Statement, www.fda.gov (nd; August 2, 2006). Information Technology for the Health Professions, Third Edition Lillian Burke and Barbara Weill Copyright ©2009 by Pearson Education, Inc. Upper Saddle River, New Jersey 07458 All rights reserved. PDUFA PDUFA (Prescription Drug User Fees Act renewed in 1997 and 2002 and 2007) Requires drug companies to pay fees to support the drug review process Requires “[C]ompanies [to] pay annual fees for each manufacturing establishment and for each prescription drug product marketed.” User fees have steadily risen, until in 1992, 51% of the FDA’s drug review budget came from the companies that the FDA regulates. Information Technology for the Health Professions, Third Edition Lillian Burke and Barbara Weill Copyright ©2009 by Pearson Education, Inc. Upper Saddle River, New Jersey 07458 All rights reserved. FDA and the Drug Industry FDA has many advisory panels; some of their members have financial ties to the drug industry Whether these facts have any effect on the FDA’s drug oversight is a matter for debate Information Technology for the Health Professions, Third Edition Lillian Burke and Barbara Weill Copyright ©2009 by Pearson Education, Inc. Upper Saddle River, New Jersey 07458 All rights reserved. Biotechnology and the Human Genome Project Rational drug design—using computers to model disease-causing molecules and create models of molecules that will fix them Biotechnology—the human body as a collection of molecules If one molecule is causing disease, another should be modeled by computer to fix it Information Technology for the Health Professions, Third Edition Lillian Burke and Barbara Weill Copyright ©2009 by Pearson Education, Inc. Upper Saddle River, New Jersey 07458 All rights reserved. Bioinformatics The application of IT to biology Seeks to organize biological data into databases Information Technology for the Health Professions, Third Edition Lillian Burke and Barbara Weill Copyright ©2009 by Pearson Education, Inc. Upper Saddle River, New Jersey 07458 All rights reserved. The Human Genome Project (1990–2003) Succeeded in mapping the human genome using computers to keep track of information Attempt to understand the molecular basis of genetic disease It should be noted that although genetic predisposition is important, other factors play a major role in the development of disease Information Technology for the Health Professions, Third Edition Lillian Burke and Barbara Weill Copyright ©2009 by Pearson Education, Inc. Upper Saddle River, New Jersey 07458 All rights reserved. DNA Getty Photodisc v18 disc 1 id#ST001002 Information Technology for the Health Professions, Third Edition Lillian Burke and Barbara Weill Copyright ©2009 by Pearson Education, Inc. Upper Saddle River, New Jersey 07458 All rights reserved. Developments in Biotechnology Herceptin used for breast cancer Lucentis (in clinical trials) for macular degeneration Avastin (fast track status) for cancer Tarceva (orphan drug status) for rare form of brain cancer Xolair for asthma Information Technology for the Health Professions, Third Edition Lillian Burke and Barbara Weill Copyright ©2009 by Pearson Education, Inc. Upper Saddle River, New Jersey 07458 All rights reserved. New Drugs Approved As of 2005 Arranon to treat patients with certain cancers Boostrixa for a booster against tetanus, diphtheria, and pertussis; Byetta to treat Type II diabetes Fluarix is a flu vaccine for adults Fortical Nasal Spray for osteoparosis Source: Approved Biotechnology Drugs Information Technology for the Health Professions, Third Edition Lillian Burke and Barbara Weill Copyright ©2009 by Pearson Education, Inc. Upper Saddle River, New Jersey 07458 All rights reserved. New Drugs Approved As of 2006 Amitiza for the treatment of chronic idiopathic constipation Dacogen for the treatment of Myelodysplastic Syndromes formerly known as pre-leukemia Eraxis for the treatment of candida fungal infections Gardasil for the prevention of cervical cancer caused by the human papillomavirus Information Technology for the Health Professions, Third Edition Lillian Burke and Barbara Weill Copyright ©2009 by Pearson Education, Inc. Upper Saddle River, New Jersey 07458 All rights reserved. Developments in Biotechnology (cont) In 2006, the gene (Runx1) identified with chronic pain was found In July of 2006, scientists made a major breakthrough in understanding the genetic makeup of the Wolbachia bacteria that infect mosquitoes and other insects that spread malaria Information Technology for the Health Professions, Third Edition Lillian Burke and Barbara Weill Copyright ©2009 by Pearson Education, Inc. Upper Saddle River, New Jersey 07458 All rights reserved. Developments in Biotechnology (cont) August 2006—“determined the structure of an important smallpox virus enzyme and how it binds to DNA.” This is crucial in the creation of drugs to fight smallpox August of 2006—the genes that increase the risk of heart attack were identified Hypertension susceptibility genes were identified in February 2006 Information Technology for the Health Professions, Third Edition Lillian Burke and Barbara Weill Copyright ©2009 by Pearson Education, Inc. Upper Saddle River, New Jersey 07458 All rights reserved. Developments in Biotechnology (cont) Antisense technology—experimental technology used to shut off diseasecausing genes; mixed results from trials RNA interference—used by cells to turn off genes; attempts at developing drugs using RNAi have not yet been successful Information Technology for the Health Professions, Third Edition Lillian Burke and Barbara Weill Copyright ©2009 by Pearson Education, Inc. Upper Saddle River, New Jersey 07458 All rights reserved. Stem Cells Cells that can develop into different types of body cells Theoretically they can repair the body As a stem cell divides, the new cells can remain a stem cell or become another kind of cell It is possible that stem cell research may lead to regenerative or rehabilitative medicine Information Technology for the Health Professions, Third Edition Lillian Burke and Barbara Weill Copyright ©2009 by Pearson Education, Inc. Upper Saddle River, New Jersey 07458 All rights reserved. Computer-Assisted Drug Trials Software allows simulated trials Computer-assisted trials do not replace human clinical trials Information Technology for the Health Professions, Third Edition Lillian Burke and Barbara Weill Copyright ©2009 by Pearson Education, Inc. Upper Saddle River, New Jersey 07458 All rights reserved. The Human Physiome Project Physiome project is creating virtual organs (mathematical models) on which to test medications It has created a virtual heart using mathematical equations to simulate the processes of the heart; it has been used in studies of irregular heartbeats A draft of the lungs and skeletal system has been finished Information Technology for the Health Professions, Third Edition Lillian Burke and Barbara Weill Copyright ©2009 by Pearson Education, Inc. Upper Saddle River, New Jersey 07458 All rights reserved. The Human Physiome Project (cont) The project is currently working on the digestive system and a database of cellular functions Mathematical models will not only allow the testing of drugs, but “also enable medical engineers to fashion customized implants…” and surgeons to perform “dry runs” of surgeries; the use of these models is still far from reality Information Technology for the Health Professions, Third Edition Lillian Burke and Barbara Weill Copyright ©2009 by Pearson Education, Inc. Upper Saddle River, New Jersey 07458 All rights reserved. Computer-Assisted Drug Review FDA reviews new drugs 1995—FDA started to computerize review using giant electronic spreadsheets to hold data Comparisons easier Process faster Information Technology for the Health Professions, Third Edition Lillian Burke and Barbara Weill Copyright ©2009 by Pearson Education, Inc. Upper Saddle River, New Jersey 07458 All rights reserved. The Computerized Pharmacy Computers and drug errors Errors stemming from software error Computerizing any part of the prescription and delivery of medication reduces medication errors Computer warning systems to prevent adverse drug events (ADEs) Information Technology for the Health Professions, Third Edition Lillian Burke and Barbara Weill Copyright ©2009 by Pearson Education, Inc. Upper Saddle River, New Jersey 07458 All rights reserved. Computers and Drug Errors In 2006, 7,000 medical errors caused by CPOE (computerized physician order entry) were analyzed Dosing errors were most common Most errors were traced to “faulty computer interface, miscommunication with other systems, and lack of adequate decision support” Information Technology for the Health Professions, Third Edition Lillian Burke and Barbara Weill Copyright ©2009 by Pearson Education, Inc. Upper Saddle River, New Jersey 07458 All rights reserved. Computers and Drug Errors (cont) In July 2006, “Preventing Medical Errors” stressed that medication errors are still a serious problem, harming 1.5 million people per year Several thousand people die each year Information Technology for the Health Professions, Third Edition Lillian Burke and Barbara Weill Copyright ©2009 by Pearson Education, Inc. Upper Saddle River, New Jersey 07458 All rights reserved. The Automated Community Pharmacy Using robots to fill prescriptions (V.A.) Entering prescriptions in a computer Robots counting tablets/capsules, printing label, selecting vial, and filling it Pharmacist caps vial, hands to customer Although 49% of chain pharmacies used at least two computerized devices—such as barcode scanners or tablet/capsule-counting devices—only 15% of independent pharmacies did Information Technology for the Health Professions, Third Edition Lillian Burke and Barbara Weill Copyright ©2009 by Pearson Education, Inc. Upper Saddle River, New Jersey 07458 All rights reserved. Automating the Hospital Pharmacy Prescription entered into a computer linked to the pharmacy Bar codes used to identify medications Information Technology for the Health Professions, Third Edition Lillian Burke and Barbara Weill Copyright ©2009 by Pearson Education, Inc. Upper Saddle River, New Jersey 07458 All rights reserved. The Hospital Pharmacy Robot and Bar Codes Bar codes identify medications Robots read bar codes, fill medication orders, keep track of inventory Bar codes on patient’s wristband and on the medication can be scanned As of 2006, only 15% of hospitals used a robotic system, up from 4.5% in 1999 Information Technology for the Health Professions, Third Edition Lillian Burke and Barbara Weill Copyright ©2009 by Pearson Education, Inc. Upper Saddle River, New Jersey 07458 All rights reserved. Point-of-Use Drug Dispensing Decentralized automated system Small computer attached to a cabinet holding medications Networked to hospital computer Nurse enters password and selects patient, enters drug order and computer delivers it by opening drawer containing medication Keeps track of inventory, connected to ADE warning system, decreases late and missed doses Introduced into doctors’ offices and clinics Information Technology for the Health Professions, Third Edition Lillian Burke and Barbara Weill Copyright ©2009 by Pearson Education, Inc. Upper Saddle River, New Jersey 07458 All rights reserved. Computerized IVs and Bar Codes The risk is far higher with intravenous drugs Two new safety technologies being introduced in 2006 Smart infusion systems with dose error reduction systems (DERS) BCMA (Bar Code Medication Administration) use bar codes to identify each patient and each medication, and according to clinical studies might prevent up to 58% of adverse drug events Information Technology for the Health Professions, Third Edition Lillian Burke and Barbara Weill Copyright ©2009 by Pearson Education, Inc. Upper Saddle River, New Jersey 07458 All rights reserved. Radio Frequency Identification (RFID) Tags RFID tags include an antenna, a decoder to interpret data, and the tag which includes information The antenna sends signals When the tag detects the signal it sends back information The tags can be used to keep track of anything—people, inventory, medications Information Technology for the Health Professions, Third Edition Lillian Burke and Barbara Weill Copyright ©2009 by Pearson Education, Inc. Upper Saddle River, New Jersey 07458 All rights reserved. Telepharmacy Uses a computer, a network connection, and a drug-dispensing unit to allow patients to obtain medications outside a traditional pharmacy Doctor enters prescription into computer linked to pharmacy Pharmacy sends a signal that opens drug cabinet in doctor’s office or clinic Expanding due to U.S. government interest Problems: states differ in regulations Information Technology for the Health Professions, Third Edition Lillian Burke and Barbara Weill Copyright ©2009 by Pearson Education, Inc. Upper Saddle River, New Jersey 07458 All rights reserved. Drug Delivery on a Chip Chips with embedded drugs implanted in patient—either releases drug by diffusion or biodegrades Newer chips (in development) deliver several medications over time Information Technology for the Health Professions, Third Edition Lillian Burke and Barbara Weill Copyright ©2009 by Pearson Education, Inc. Upper Saddle River, New Jersey 07458 All rights reserved. The Impact of IT on Pharmacy Fewer pharmacists needed to serve same populations Robots may be replacing pharmacists, allowing more involvement with patients The introduction of computerization in the drug delivery process reduces ADEs (lowers medication errors) Telepharmacy allows one pharmacist to serve a wide geographic area and is a convenience for patients Information Technology for the Health Professions, Third Edition Lillian Burke and Barbara Weill Copyright ©2009 by Pearson Education, Inc. Upper Saddle River, New Jersey 07458 All rights reserved.