Transcript Chapter 8 - Victoria College

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



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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


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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.