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Topic 4: Information Systems and Technologies in Pharmacy Chapter 8: Information Technology for the Health Professions 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 Advancing public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable Helping the public get the accurate, science-based information they need to use medicines and foods to improve their health. Information Technology for the Health Professions, Fourth Edition Lillian Burke • Barbara Weill Some of the dangerous side effects of a drug appear only years after the drug has been approved and is on the market. The FDA can now require new trials to assess the safety of approved drugs. Information Technology for the Health Professions, Fourth Edition Lillian Burke • Barbara Weill PDUFA (Prescription Drug User Fees Act renewed in 1997, 2002, and 2007): Requires drug companies to pay fees to support the drug review process Requires companies 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, Fourth Edition Lillian Burke • Barbara Weill PDUFA IV is now set to expire in 2012; PDUFA V will be presented to Congress in 2012. The FDA appears to be ready to allow more consumer input in their decisions. FDA is in conflict with pharmaceutical companies over the FDA's proposal to lengthen review times because of the 2007 Congressional drug safety requirements. Information Technology for the Health Professions, Fourth Edition Lillian Burke • Barbara Weill A consumer representative (the National Consumers League [NCL]) stated that the FDA should be funded out of the general treasury; if not possible, then the NCL advocates that the user fees be added to FDA's budget, with no conditions. Information Technology for the Health Professions, Fourth Edition Lillian Burke • Barbara Weill 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. Financial interest must be disclosed in individual drug trials; meta-analyses (studies of studies) of drug trials do not disclose conflicts of interest. Information Technology for the Health Professions, Fourth Edition Lillian Burke • Barbara Weill In June 2006, the FDA released information on drugs that are being sold without FDA review. In October 2008, President Bush signed the Online Pharmacy Consumer Protection Act. Prohibits the dispensing of controlled substances over the Internet unless the prescriber and patient have met at least once face to face. Information Technology for the Health Professions, Fourth Edition Lillian Burke • Barbara Weill In 2010, a plan was released by the U.S. Intellectual Property Enforcement Coordinator to curb the sale of unsafe medications. In 2010, the Alliance for Safe Online Pharmacies estimated that 36 million Americans buy drugs online from any of 30,000-40,000 online pharmacies. Information Technology for the Health Professions, Fourth Edition Lillian Burke • Barbara Weill PharmacyChecker.com checks online pharmacies. One study found that prescription drugs ordered from online pharmacies verified by PharmacyChecker.com or the National Association of Boards of Pharmacy resulted in the delivery of safe, genuine medication. Other sites may sell fake medications. Information Technology for the Health Professions, Fourth Edition Lillian Burke • Barbara Weill Rational drug design Uses computers to model disease-causing molecules and create models of molecules that will fix them Biotechnology Sees the human body as a collection of molecules If one molecule is causing disease, another molecule should be modeled by computer to fix it Information Technology for the Health Professions, Fourth Edition Lillian Burke • Barbara Weill The application of IT to biology Seeks to organize biological data into databases Information Technology for the Health Professions, Fourth Edition Lillian Burke • Barbara Weill Succeeded in mapping the human genome using computers to keep track of information Attempts 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, Fourth Edition Lillian Burke • Barbara Weill Provides a comprehensive public resource that supports researchers aiming to study genetic variation that might cause human disease. Its samples come (with informed consent) from many different populations. In 2010, the 1000 Genomes Project published a map of genetic differences May help explaining susceptibility to disease. Information Technology for the Health Professions, Fourth Edition Lillian Burke • Barbara Weill Information Technology for the Health Professions, Fourth Edition Lillian Burke • Barbara Weill Information Technology for the Health Professions, Fourth Edition Lillian Burke • Barbara Weill Arranon treat patients with certain cancers Boostrix used for a booster against tetanus, diphtheria, and pertussis Byetta treat type II diabetes Fluarix a flu vaccine for adults. Fortical nasal spray for osteoporosis Information Technology for the Health Professions, Fourth Edition Lillian Burke • Barbara Weill 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 Amitiza Information Technology for the Health Professions, Fourth Edition Lillian Burke • Barbara Weill Adcirca For pulmonary arterial hypertension to improve exercise ability Afinitor For treatment of patients with advanced renal cell cancer Agriflu For immunization of adults against some flu Azerra For treatment of refractory chronic lymphocytic leukemia Caldolor For treatment of pain and fever Extavior For treatment of relapsing MS Fanapt For treatment of schizophrenia in adults Lamictal ODT For treatment of bipolar adults Ampyra For treatment of MS For a complete list, see Jennifer Van Brunt, “Biotech Drug Approvals: A Year of Firsts,” February 9, 2010 Information Technology for the Health Professions, Fourth Edition Lillian Burke • Barbara Weill Herceptin used for breast cancer Lucentis used in clinical trials for macular degeneration Avastin used in fast track status of cancer Tarceva used in orphan drug status for rare form of brain cancer Xolair used for asthma Information Technology for the Health Professions, Fourth Edition Lillian Burke • Barbara Weill 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, Fourth Edition Lillian Burke • Barbara Weill In August 2006, researchers 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. In August 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, Fourth Edition Lillian Burke • Barbara Weill Antisense technology Experimental technology used to shut off disease-causing 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. RNAi is currently being studied as a way of treating cancer and viruses in humans. Information Technology for the Health Professions, Fourth Edition Lillian Burke • Barbara Weill Stem cells 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, Fourth Edition Lillian Burke • Barbara Weill In the past, scientists have either had to use embryonic stem cells or generate embryonic-like stem cells, a difficult process. In 2011, scientists at the Scripps Research Institute succeeded in converting adult skin cells directly into beating heart cells. This technology might make possible new treatments for heart disease, Parkinson's, and Alzheimer's. Information Technology for the Health Professions, Fourth Edition Lillian Burke • Barbara Weill Software allows simulated trials. Computer-assisted trials do not replace human clinical trials. Information Technology for the Health Professions, Fourth Edition Lillian Burke • Barbara Weill 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, Fourth Edition Lillian Burke • Barbara Weill 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 Use of these models is still far from reality. Information Technology for the Health Professions, Fourth Edition Lillian Burke • Barbara Weill FDA reviews new drugs. In 1995—the FDA started to computerize review process using giant electronic spreadsheets to hold data: Comparisons easier Process faster Information Technology for the Health Professions, Fourth Edition Lillian Burke • Barbara Weill
