Chapter 24 - Pharmacy Informatics - Enabling Safe and Efficacious Medication Use

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Drug Information: A Guide for Pharmacists, 5e
Chapter 24: Pharmacy Informatics: Enabling Safe and Efficacious Medication Use
Joshua C. Hollingsworth; Brent I. Fox
Learning Objectives
After completing this chapter, the reader will be able to
List the activities that occur at each step of the medication use process.
Define pharmacy informatics and other core informatics terms.
Discuss the role of pharmacy informatics at each step of the medication use process.
Describe challenges implementing computerized provider order entry.
Describe the components of an eprescribing system.
Describe the role of the three primary components of a clinical decision support system.
Describe limitations of health information technology that is used during the transcription step of the medication use process.
Compare and contrast the health information technology used during dispensing in acute care and community pharmacy settings.
Define the role of bar code medication administration.
Describe the role of the three primary components of a clinical surveillance system.
Describe the changing role of the patient in the United States (U.S.) health care system.
Explain the importance of interoperability to the future of the U.S. health care system, including the role of the U.S. government.
Describe the goal and structure of Meaningful Use.
Define privacy, security, and confidentiality as they relate to protected health information.
Key Concepts
1. The medication use process is a system of interconnected parts that work together to achieve the common goal of safe and effective medication
therapy.
2. All pharmacists are impacted by the electronic information systems that make up pharmacy informatics in virtually every aspect of practice.
3. The two broad categories of information used in pharmacy informatics, as well as other clinical informatics domains, are patientspecific
information and knowledgebased information.
4. The vision of health care is becoming more patient centered.
5. The current health care system is decentralized and fragmented. Because of this, significant communication gaps exist when multiple health care
institutions provide care for the same patient. Substantial evidence suggests that more effective communication would improve patient care and
reduce medical errors, such as adverse drug events.
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Chapter 24: Pharmacy Informatics: Enabling Safe and Efficacious Medication Use, Joshua C. Hollingsworth; Brent I. Fox Page 1 / 15
6. The desired result of interoperable systems and electronic health records (EHRs) is to readily provide all health practitioners in all locations,
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including the pharmacy, with access to information about a patient’s care, as needed.
7. The Center for Medicare and Medicaid Services (CMS) created the Meaningful Use program to incentivize the use of certified EHR technology. The
information and knowledgebased information.
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4. The vision of health care is becoming more patient centered.
5. The current health care system is decentralized and fragmented. Because of this, significant communication gaps exist when multiple health care
reduce medical errors, such as adverse drug events.
6. The desired result of interoperable systems and electronic health records (EHRs) is to readily provide all health practitioners in all locations,
including the pharmacy, with access to information about a patient’s care, as needed.
7. The Center for Medicare and Medicaid Services (CMS) created the Meaningful Use program to incentivize the use of certified EHR technology. The
Meaningful Use program focuses on (1) improving quality, safety, and efficiency, (2) engaging patients and their families, (3) improving care
coordination, as well as public and population health, and (4) maintaining privacy and security of protected health information (PHI). In general,
Meaningful Use criteria address the use of specific components of EHRs (like prescribing systems) to achieve specific outcomes, which can be
process oriented or patient oriented.
Introduction
Pharmacists of today have a multitude of responsibilities within their scope of practice. Whether verifying and filling prescriptions, compounding
medications, advising patients on proper medication use, or collaborating with other practitioners in the care of patients, at the forefront of a
pharmacist’s responsibilities is a focus on the safe and effective use of medication therapy. Specifically, pharmacists aim to maximize patient safety
while minimizing medication misadventures, such as medication errors and adverse drug events, which are covered in Chapters 15 and 16. And, given
the sheer amount of information involved and available today, this focus on safety and efficacy can only be reasonably obtained via pharmacists’
management of the information and related information systems involved in support of the medication use process. Pharmacists, regardless of
practice setting, must be able to input, access, share, evaluate, and utilize information in these systems to support their efforts in patient care.
Medication Use Process
❶ The medication use process is a system of interconnected parts that work together to achieve the common goal of safe and effective medication
therapy. The interconnected parts include the people, systems, procedures, and policies that manage medications and related information in patient
care. It should be noted here that Chapter 14 further covers a portion of the medication use process, specifically in the context of quality improvement.
The medication use process is cyclical in nature and begins with the prescribing stage. In this stage, the practitioner assesses whether medication
therapy is warranted and, if so, orders therapy accordingly. The health information technology (HIT) utilized at the prescribing stage includes
computerized provider order entry (CPOE), electronic prescribing (eprescribing), and clinical decision support systems (CDSS), including various
medication references.
In the next stage of the medication use process, the transcription stage, the ordered medication enters the pharmacy computer system, a pharmacist
assesses the appropriateness of the order, and any issues or discrepancies are addressed. HIT tools used at the transcription stage include CPOE and
eprescribing. Various drug information references, often electronic in nature, may be used and may be built into the systems (e.g., drug interaction
screening systems). Next is the dispensing stage. Here, the medication is prepared and distributed from the pharmacy, either directly to the patient or
to a health care provider. There are many HIT tools utilized in the dispensing stage, including bar code verification, automated dispensing cabinets,
syringe fillers, total parenteral nutrition compounders, and other robotics.
Following the dispensing stage is the administration stage in which the medication is reviewed for appropriateness and then given to, or taken by, the
patient. Health care providers, caregivers, the patient, and the patient’s family may be involved in the administration stage, depending on the setting.
HIT tools used here may include pointofcare bar coding, electronic medication administration records (eMARs), and intelligent infusion (smart)
pumps. The final stage in the medication use process is monitoring. At the monitoring stage, the patient’s response to the medication therapy is
assessed, outcomes are documented, and interventions are made as necessary. HIT tools used here include adverse drug event (ADE) surveillance,
antibiotic/drug surveillance, and rules engines. The following is a brief description of some of the HIT tools mentioned above1:
Adverse drug event (ADE) monitoring: Computer programs that use electronic data and predetermined rules to identify when an ADE may
have occurred or is about to occur to a patient within a hospital. This is separate from such programs as MedWatch (see Chapter 15), which is used
to report adverse effects to the U.S. Food and Drug Administration (FDA).
Automated dispensing cabinets (ADCs): Automated devices with a range of functions. Core capabilities include medication storage and
retrieval for administration to patients, especially in patient care areas, as well as audit trails of cabinet access. Other functions can include
medication charging and automated inventory management.
Chapter 24: Pharmacy Informatics: Enabling Safe and Efficacious Medication Use, Joshua C. Hollingsworth; Brent I. Fox
Bar code verification: The use of bar code scanning to ensure that the correct drug, strength, and dosage form were dispensed in the drug Page 2 / 15
selection process and the five rights of medication administration (i.e., right patient, right drug, right dose, right route, right time) are followed at
the point of care.
have occurred or is about to occur to a patient within a hospital. This is separate from such programs as MedWatch (see Chapter 15), which is used
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to report adverse effects to the U.S. Food and Drug Administration (FDA).
Automated dispensing cabinets (ADCs): Automated devices with a range of functions. Core capabilities include medication storage and
retrieval for administration to patients, especially in patient care areas, as well as audit trails of cabinet access. Other functions can include
medication charging and automated inventory management.
Bar code verification: The use of bar code scanning to ensure that the correct drug, strength, and dosage form were dispensed in the drug
selection process and the five rights of medication administration (i.e., right patient, right drug, right dose, right route, right time) are followed at
the point of care.
Clinical decision support systems (CDSS): Computer programs that augment clinical decision making by combining referential information
with patientspecific information to prevent negative actions and update providers of patient status.
Computerized provider order entry (CPOE): A process allowing medical provider instructions to be electronically entered for the treatment
of patients who are under a provider’s care.
Electronic medication administration record (eMAR): An electronic version of the traditional medication administration record. It supports
patient safety by incorporating clinical decision support and barcoded medication administration. It also enables realtime documentation and
billing of medication administration.
Electronic prescribing (eprescribing): The electronic process in which a prescription is initially entered in an electronic format and then
verified and processed in an electronic format, resulting in a labeled medication product, supportive documentation, and an updated, sharable
patient electronic medication profile.
Intelligent infusion (smart) pumps: Infusion pumps containing software designed to help eliminate pump programming errors through the
use of standardized drug databases and dosing parameters.
Rules engines: Computer programs, similar to ADE monitoring systems, with builtin, logic rules designed to aid in monitoring specific aspects
of patient care. For example, a rule developed in an attempt to prevent hypoglycemia in patients receiving insulin may require documentation of
the patient’s meal being delivered prior to the patient receiving mealtime insulin.
Pharmacy Informatics
The term informatics simply refers to the use of computers to manage data and information. Informatics exists at the intersection of people,
information, and technology.2 Pharmacy informatics refers to a form of clinical informatics that is applied to the discipline of pharmacy. More
specifically, pharmacy informatics focuses on the use of information, information systems, and automation technology to ensure safe and effective
medication usage. ❷ All pharmacists are impacted by the electronic information systems that make up pharmacy informatics in virtually every aspect
of practice. For example, patient records, medication administration and usage information, insurance information, as well as laboratory tests and
results are just a few of the categories of information that are managed in electronic environments.
❸ The two broad categories of information used in pharmacy informatics, as well as other clinical informatics domains, are patientspecific
information and knowledgebased information.3 Patientspecific information, which is created and applied in the process of caring for individual
patients, includes medication and medical histories, laboratory test results, radiology interpretations, immunization histories, physical assessments,
and other information that is unique to the specific patient. Today, this information is generated and housed in health care facilities, such as
pharmacies, hospitals, and clinics. Consumer health informatics, a rapidly growing field, has created an environment in which patients themselves are
also generating and managing healthrelated information in addition to and outside of these traditional settings. Aspects of consumer health
informatics can include Internetbased directtoconsumer advertising (see Chapter 23) and research activities.
Knowledgebased information, on the other hand, forms the scientific basis of health care and includes referential information (about medications,
procedures, disease states, etc.), clinical practice guidelines, as well as many other domains of health and medical knowledge.3 Pharmacists and other
healthcare providers make patient care decisions based on a combination of patientspecific and knowledgebased information, a process that can
often be a real challenge. Informatics addresses this challenge by using information technology (IT) to manage information, and the medication use
process is the context in which pharmacists work to promote safe and effective medication therapy. The following sections describe the role of
pharmacists, pharmacy informatics, and other HIT in the medication use process.
Order entry
In the 1999 report To Err Is Human: Building a Safer Health System, the Institute of Medicine (IOM) estimated that 44,000 to 98,000 deaths occur each
year in U.S. hospitals due to adverse drug events (ADEs). Chapters 15 and 16 provide a closer examination of adverse drug events and the larger topic
of medication misadventures; brief statistics are provided here. Nineteen percent of the ADEs were deemed to be due to medication errors, by far the
largest category of adverse events noted in the IOM report. The causes of errors and patient injury related to order entry identified in the report
often be a real challenge. Informatics addresses this challenge by using information technology (IT) to manage information, and the medication use
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process is the context in which pharmacists work to promote safe and effective medication therapy. The following sections describe the role of
pharmacists, pharmacy informatics, and other HIT in the medication use process.
Order entry
In the 1999 report To Err Is Human: Building a Safer Health System, the Institute of Medicine (IOM) estimated that 44,000 to 98,000 deaths occur each
year in U.S. hospitals due to adverse drug events (ADEs). Chapters 15 and 16 provide a closer examination of adverse drug events and the larger topic
of medication misadventures; brief statistics are provided here. Nineteen percent of the ADEs were deemed to be due to medication errors, by far the
largest category of adverse events noted in the IOM report. The causes of errors and patient injury related to order entry identified in the report
included illegible handwritten reports, manual order entry, and the use of nonstandard abbreviations.4 Further, a study by Bates and associates,5
which looked at more than 4000 hospital admissions over a 6month period, found that errors resulting in preventable ADEs occur most often (i.e.,
56% of cases) at the prescribing stage of the medication use process. As such, it is imperative that pharmacists identify and prevent ADEs at this early
stage in the medication use process. The three HIT tools that can aid in doing so include CPOE, electronic prescribing, and CDSS.
Computerized Provider Order Entry
CPOE, as described earlier, is the process allowing medical provider instructions to be entered electronically for the treatment of patients under a
provider’s care. Orders entered via a CPOE system are communicated to the medical staff and appropriate departments over a computer network.
CPOE eliminates illegible handwriting, decreases medical errors as well as the delay in order completion, improves patient care, and is, therefore, an
important component in health care information systems.6,7 Although features of a CPOE system may vary, ideal features are described here.
Provider orders should be standardized across the organization (see Chapter 12), but may also be individualized based on the provider or the
provider’s specialty through the use of order sets. Orders should be communicated to all departments and health care providers involved in the
patient’s care. Patientcentered decision support, including display of the patient’s medical history, current test results, and evidencebased guidelines
to support treatment options, should be readily available. CPOE systems must support clinical workflows through algorithms that provide clear,
concise, and actionable advice and warnings. The order entry process should be simple and allow efficient use by new or infrequent users. Access
must be secure, and a permanent record of access needs to be created with an electronic signature (i.e., any legally recognized means of indicating that
a person accepts the contents of an electronic message). The CPOE system should be portable, accepting and managing orders from all departments
through various devices, including desktop and laptop computers, smartphones, and tablets. Data should be collected for training, planning, and
analysis of patient safety events as part of ongoing quality initiatives. Diagnoses should be linked to orders at the time of order entry in order to
support drugcondition checking, improve documentation, and support appropriate charges. Like all HIT systems, appropriate backup and downtime
procedures should be established and routinized.
Despite having the ability to decrease ADEs, CPOE also potentially introduces new types of errors.8 Inexperienced providers and staff using CPOE may
actually cause slower order entry and persontoperson communication, especially at first. Alerts and warnings that appear too frequently may lead to
alert fatigue, a situation in which a provider ignores or overrides CDSS messages. Many other types of errors can occur, serving as a strong reminder
that all healthcare providers share responsibility to ensure safe use of CPOE and other HIT systems. As such, implementation of CPOE in a complex
medical environment can take years and requires ongoing design changes in order to adequately fit unique care settings. Given these issues, as well as
providers’ resistance to change and the costs involved, adoption of this technology by providers and hospitals in the United States has been slow.
However, use of CPOE is expected to increase as more hospitals become aware of the financial benefits of CPOE and as hospitals comply with
Meaningful Use criteria (see Key Concept #7 and below). A study by RAND Health found that the U.S. health care system could save $70 billion or more
annually, as well as reduce ADEs and improve the quality of care, if CPOE and other HIT were widely adopted.9
For wide adoption to be realized, there are certain barriers that must be overcome. In 2004, Poon and colleagues published a report identifying and
addressing these barriers.10 First is provider and organization resistance to change and CPOE adoption. Reasons cited for this resistance vary and
include perceptions such as paper methods are faster or more efficient, and that implementation attempts would be costly and unsuccessful. The
authors of the report identified four key areas on which to focus to overcome resistance. Strong hospital leadership is a necessary factor of
implementation of CPOE. Physician champions (i.e., wellrespected physicians) should be identified and involved. Workflow concerns should be
addressed and users should be reassured throughout the implementation process. And lastly, organizational expertise, being those providers who are
more comfortable with IT or who have had experience with CPOE, should be leveraged.
The second major barrier identified is the high cost of CPOE implementation and lack of capital. Strategies identified to overcome high costs include
realigning the hospital’s priorities to focus on patient safety, leveraging external influences such as published literature to increase awareness about
patient safety, and measuring CPOE’s impact on hospital efficiency. The last major barrier identified was selection of a specific CPOE product from the
many options available. As such, the report’s authors concluded that the product or company selected should be committed to the CPOE market,
willing and able to adapt products to specific hospital workflows, able to provide tools that help evaluate product functionality, as well as able to
Chapter 24: Pharmacy Informatics: Enabling Safe and Efficacious Medication Use, Joshua C. Hollingsworth; Brent I. Fox
provide information and references for other CPOE systems implemented by the company.
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Electronic Prescribing (eprescribing)
more comfortable with IT or who have had experience with CPOE, should be leveraged. Access Provided by:
The second major barrier identified is the high cost of CPOE implementation and lack of capital. Strategies identified to overcome high costs include
realigning the hospital’s priorities to focus on patient safety, leveraging external influences such as published literature to increase awareness about
patient safety, and measuring CPOE’s impact on hospital efficiency. The last major barrier identified was selection of a specific CPOE product from the
many options available. As such, the report’s authors concluded that the product or company selected should be committed to the CPOE market,
willing and able to adapt products to specific hospital workflows, able to provide tools that help evaluate product functionality, as well as able to
provide information and references for other CPOE systems implemented by the company.
Electronic Prescribing (eprescribing)
Although many definitions exist, eprescribing is commonly defined as ambulatory CPOE. A more precise definition would be a prescription entered by
a prescriber directly into an electronic format using agreedupon standards that is securely transmitted to the pharmacy that the patient chooses.
Faxes and printed prescriptions are not eprescriptions. One of the primary early challenges to nationwide eprescribing was a network on which to
transfer the prescriptions. Surescripts provides the connection network and verification between prescribers, insurance providers, and pharmacies.
The National Council for Prescription Drug Programs (NCPDP), which is accredited by the American National Standards Institute, provides the
standards for provider identification and telecommunication of pharmacy claims in this process.11
Aside from the prescriber, Surescripts, and the pharmacy, there are many other components that make up an eprescribing system. These
components include the computer software, the hardware needed to run the software, the organizations that support transmission and sharing of
data, data standardization, authorization of payment, communications to the pharmacy, and the processing of prescriptions within the pharmacy. The
eprescribing software should provide functionality to support accurate, efficient, and safe entry and transmission of prescriptions. The U.S.
government provides incentives to health care providers who implement eprescribing and electronic medical records (EMRs) that meet certain
minimal requirements. Such functionality includes generating a complete medication list; support for prescription ordering, printing, and electronic
transmission; inclusion of alerts for unsafe conditions (e.g., allergies); providing information on lower cost, therapeutic alternatives; and providing
information on formulary and patient eligibility based on the patient’s drug plan.12
The overall functionality of the eprescribing software depends on the management of multiple databases. A drug database is necessary and should
include decision support functions, such as therapeutic categories, drug–drug and drug–disease interactions, dose range checking, as well as allergy
warnings. A pharmacy database, which supports selection of and communication with the patient’s specific pharmacy, is needed. A user database,
consisting of a list of prescribers and other users along with their authority to prescribe, Drug Enforcement Agency (DEA) number, and other
identifiers, is also needed. A patient database, listing patients and all pertinent patient information to support eprescribing functions, must be
included and managed. Other databases that are necessary include medication insurance plans/formularies and medication profile information for
individual patients. Depending on the functionality of the eprescribing software, additional clinical information may also be available, such as
laboratory results, patient problems and diagnoses, and information from prior visits.
To fully comprehend the functionality of an eprescribing system, an understanding of prescribing workflow is necessary. The first step is patient
registration and eligibility verification, which generally occurs prior to or at the time the patient arrives for an appointment. Here, the patient’s
insurance coverage and address are verified, and the patient is put on a readily available selection list within the eprescribing system for prescribers.
The patient’s medication history and prescription eligibility, which are generally retrieved from Surescripts, are assessed next. Following this is the
medication entry step. Since prescription entry can vary greatly between and within practices, the eprescribing system should support quickly
transitioning between patients, data gathering, and ordering. Portable devices and the ability to quickly log into an immobile device (e.g., desktop
computer) are needed to support this type of workflow. Although not yet addressed by federal regulations, delegating the task of medication entry to
support staff introduces the potential for errors as reading and translating written prescriptions is often involved in this approach. The next step in the
prescribing workflow is prescriber selection of the pharmacy to which the prescriptions should be sent. A common error at this stage is selection of the
wrong pharmacy from the searchable database. Once the pharmacy is selected, the prescription is transmitted to the pharmacy using standard NCPDP
SCRIPT interface transactions. Although federal law, as of June 1 2010, does allow controlled substances to be prescribed electronically, not all states
have authorized such prescribing, particularly for Schedule II controlled substances.13
One area that has great potential for improvement with eprescribing is the renewal authorization process (i.e., authorization by the prescriber for
additional refills). Prior to eprescribing, renewal authorization required multiple telephone calls and was highly interruptive. Now, pharmacies can
initiate electronic renewal requests, which can be electronically processed and returned by the prescriber.
Clinical Decision Support Systems
According to the American Medical Association, clinical decision support (CDS) is described as “providing clinicians, patients or individuals with
knowledge and person specific or population information, intelligently filtered or presented at appropriate times, to foster better health processes,
better individual patient care, and better population health.”14 CDSS are the computing systems that provide CDS. The three basic components of a
CDSS include an inference engine, a knowledge base, and a communication mechanism. The inference engine, also known as the reasoning engine,
forms the brain of the CDSS, working to link patientspecific information with information in the knowledge base. It evaluates the available information
and determines what to present to the user. The knowledge base is composed of varied clinical knowledge, such as treatment guidelines, diagnoses,
initiate electronic renewal requests, which can be electronically processed and returned by the prescriber. Access Provided by:
Clinical Decision Support Systems
According to the American Medical Association, clinical decision support (CDS) is described as “providing clinicians, patients or individuals with
knowledge and person specific or population information, intelligently filtered or presented at appropriate times, to foster better health processes,
better individual patient care, and better population health.”14 CDSS are the computing systems that provide CDS. The three basic components of a
CDSS include an inference engine, a knowledge base, and a communication mechanism. The inference engine, also known as the reasoning engine,
forms the brain of the CDSS, working to link patientspecific information with information in the knowledge base. It evaluates the available information
and determines what to present to the user. The knowledge base is composed of varied clinical knowledge, such as treatment guidelines, diagnoses,
and drug–drug or drug–disease interactions. The communication mechanism allows entry of patient information and is responsible for
communicating relevant information back to the clinician. A CDSS that checks a patient’s age and immunization history against vaccination guidelines
and then presents recommendations to a provider serves as a useful example.
CDS can be generated in a variety of forms, including alerts, reminders, information displays, CPOE, electronic templates, and guidelines. CDSS have
been employed in many clinical care domains and have the ability to support a wide range of complex decisions at various stages in the patient care
process. In terms of preventive care, CDSS can provide reminders for vaccinations, cancer screenings, cardiovascular risk reduction, as well as other
preventive measures. A study by Shea and associates found a 77% increase in the use of preventive practices when computer reminders were used.15
There are several CDSS that have been designed to help clinicians diagnose based on the signs and symptoms exhibited by a patient. These systems
have the potential to reduce diagnostic errors, and should be linked with an EMR to achieve their full potential.16 CDSS are used to provide evidence
based treatment at the point of care, often drawing upon evidencebased guidelines, which are covered in Chapter 7.
Medication decision support is a large portion of the knowledge base for any CDSS. Basic support in this area includes drugallergy checking, basic
dosing guidance, formulary decision support, duplicate therapy checking, and drug–drug interaction checking. In the case of formulary decision
support, CDSS can prompt prescribers of the preferred medications (according to the hospital’s or insurer’s formulary) at the point in time in which
they are selecting from available medications. This allows prescribers to implement agreedupon formularies (see Chapter 12) within their practice
settings with minimal disruption. More advanced decision support may include dosing suggestions for geriatric patients or patients with renal
insufficiency, guidance for medicationrelated laboratory testing, drug–disease and drug–lab interaction checking, and drugpregnancy
contraindication checking. CDSS are also used for followup or corollary orders as well as adverse event monitoring. In fact, a study by Overhage et al.
showed a 25% improvement in corollary orders (orders that are routine under certain situations, such as a stool softener when a patient is receiving a
narcotic) with the use of CDSS.17 The main benefits of CDSS use include the ability to decrease adverse drug events, costs, and length of patient stay as
well as improve clinical workflow, provide useful information at the point of care, draw attention to possible drug interactions, and provide reminders
of warranted followup interventions.
CDSS also have their limitations. For instance, developing and maintaining a comprehensive knowledge base is time consuming and resource
intensive. CDSS need to communicate with other clinical information systems, such as EMRs, CPOE systems, and pharmacy systems. And excessive
alerting can lead to alert fatigue and clinicians ignoring the warnings.
Transcription
Transcription occurs when prescribed medications are transferred, either manually or electronically, to the pharmacy. Once received, pharmacists
must interpret the medication order and make an assessment in regard to any drugrelated problems. The goal of this process is to transform the
order into a dispensable form that can be safely and correctly interpreted at the administration step. Pharmacists may use CDSS, pharmacy computer
systems, and evidencebased medicine tools at this stage to perform their cognitive and administrative functions.
Pharmacists have traditionally relied on CDSS within the pharmacy information system to support safe and efficacious decision making regarding the
filling of prescriptions. Although the use of CDSS at the prescribing stage helps improve the quality of orders received by the pharmacy, problems still
exist with orders originating from CPOE systems and eprescriptions. For instance, CPOE systems, while reducing certain errors, have been to found to
increase other types of errors. A study by Koppel and associates found that a widely used CPOE system actually facilitated 22 types of medication error
risks, including pharmacy inventory displays being mistaken for dosage guidelines, fragmented CPOE displays that prevent full view of a patient’s
medications, and inflexible ordering formats that result in wrong orders.18 As such, pharmacists must remain diligent in their review of orders prior to
dispensing.
One of the main aspects of support provided by pharmacy CDSS software is information pertaining to drug–drug interactions (DDIs). This information
is meant to augment and increase pharmacists’ ability to detect clinically significant interactions. However, a study by Saverno and associates, which
analyzed the ability of pharmacy information systems and associated CDS to detect DDIs at 64 Arizona pharmacies, indicated that many pharmacy
CDSS perform suboptimally in terms of identifying wellknown, clinically relevant interactions. Specifically, only 28% of the participating pharmacies
accurately identified the interactions and noninteractions involved in the study’s fictitious patient medication orders.19 This further reiterates the
point that pharmacists must remain diligent when reviewing orders to be dispensed.
medications, and inflexible ordering formats that result in wrong orders.18 As such, pharmacists must remain diligent in their review of orders prior to
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dispensing.
One of the main aspects of support provided by pharmacy CDSS software is information pertaining to drug–drug interactions (DDIs). This information
is meant to augment and increase pharmacists’ ability to detect clinically significant interactions. However, a study by Saverno and associates, which
analyzed the ability of pharmacy information systems and associated CDS to detect DDIs at 64 Arizona pharmacies, indicated that many pharmacy
CDSS perform suboptimally in terms of identifying wellknown, clinically relevant interactions. Specifically, only 28% of the participating pharmacies
accurately identified the interactions and noninteractions involved in the study’s fictitious patient medication orders.19 This further reiterates the
point that pharmacists must remain diligent when reviewing orders to be dispensed.
Dispensing
Medications are prepared and distributed to patients in the dispensing stage of the medication use process. The actual activities involved at this step
vary depending on the setting (i.e., institutional or community pharmacy). However, there are many similarities shared between the two settings,
including acquiring medications from a supplier, stocking medications based on needs, as well as safely and accurately preparing and dispensing
medications based on the transcribed order. Further, there are many HIT tools utilized at the dispensing stage in both settings. That said, the two
settings also have their differences when it comes to dispensing and the HIT tools used in the process.
ACUTE CARE PHARMACY SETTING
Many aspects related to dispensing from an acute care pharmacy (i.e., institutional pharmacy) can be automated by HIT. All automated systems utilized
must be able to uniquely identify managed products, receive and interpret medication orders, perform appropriate dose calculations as needed, and
report transactions to other automated systems for billing or other purposes. In order for this to occur, all prescription medication packaging must be
marked with an assigned, 10digit National Drug Code (NDC), a requirement by the Food and Drug Administration (FDA). All NDCs consist of three parts:
a labeler code, a drug code, and a package code in one of the following configurations: 442, 541, or 532, representing labelerdrugpackage. The
labeler code is assigned by the FDA and identifies the vendor responsible for the final packaging of the drug. The drug code, which is assigned by the
vendor, identifies the drug form and strength of the product. Lastly, the package code, also assigned by the vendor, identifies the packaging level type
and size (e.g., unit, box, case, etc.). There is no central repository of NDCs and, although manufacturers are required to report NDCs to the FDA,
approval is not required. For automation to work properly, the pharmacy and related automated systems must maintain a current and accurate list of
known NDCs. Compounded preparations, on the other hand, require their own unique bar codes produced by the pharmacy.1
Carousel cabinets, automated dispensing cabinets, robotic cart filling systems, and sterile compounding devices are some of the other prominent HIT
tools used in automated drug distribution systems in acute care pharmacies. Carousel cabinets contain shelves that are attached to a carousel, which
rotates shelves for medication selection. Benefits of carousel cabinets include the freeing up of floor space, reduced walking associated with drug
distribution, and more accurate accounting of inventory. Automated dispensing cabinets (ADCs) are similar to carousels, except they do not use
rotating shelves. ADCs, which may be located either in the pharmacy or on patientcare units, maintain inventory and audit trails as well as perform
charging functions. Access to inventory contained in ADCs requires the user to log in, maintaining an audit trail of receiving and dispensing activity.
ADCs can be configured with a variety of different drawers so that specified users may only have access to certain drawers or even specific drawer
sections. Despite being able to limit access in this way, none of the drawers control the amount of product removed, which can be seen as a limitation.
In some situations (such as emergencies), override functions are permitted.1 Despite the obvious benefit of override access, this practice has also been
associated with medication errors, such as obtaining the wrong strength of medication and obtaining a medication after it has been
discountinued.20,21
While not as common as ADCs, robotic cart filling systems are commonly found in hospital settings as well. They utilize bar coding to locate, obtain,
package, and deliver medications. This is done by filling unitdose carts and most often requires significant repackaging efforts, as the medications
must be in containers that can be manipulated by the device. The preparation of sterile products for administration can also be automated. The FDA
classifies the devices that automate sterile dose preparations as pharmacy compounding devices.22 Total parenteral nutrition (TPN) compounders are
an example of this type of device. TPN compounders first compute a TPN formulation based on clinical requirements, and then drive a machine to
deliver the correct ingredients in the correct amounts and sequence.
COMMUNITY PHARMACY SETTING
In the community pharmacy, pharmacy information management systems (PIMS) serve as the core piece of HIT that supports pharmacy operations,
managing all data associated with prescriptions, patients, and prescribers. They contain key databases, such as drug files, DEA and national provider
identifier numbers, physician contact information, prescription pricing tables, thirdparty plan details, and patient profiles. The PIMS software and
related databases commonly reside on a server in the pharmacy, but they may be located on a central server, allowing access from multiple sites. In the
software as a service (SaaS) or application service provider (ASP) options, both the data and software are hosted offsite. PIMS may also have
integrated workflow systems with multiple workstations assigned specific tasks (e.g., intake, processing, and verifying of prescriptions). Bar code
scanning is an integral component of this workflow, which allows the tracking of every prescription through the filling queue. Such workflow systems
provide efficiency and are usually found in highvolume pharmacies.1
COMMUNITY PHARMACY SETTING Access Provided by:
In the community pharmacy, pharmacy information management systems (PIMS) serve as the core piece of HIT that supports pharmacy operations,
managing all data associated with prescriptions, patients, and prescribers. They contain key databases, such as drug files, DEA and national provider
identifier numbers, physician contact information, prescription pricing tables, thirdparty plan details, and patient profiles. The PIMS software and
related databases commonly reside on a server in the pharmacy, but they may be located on a central server, allowing access from multiple sites. In the
software as a service (SaaS) or application service provider (ASP) options, both the data and software are hosted offsite. PIMS may also have
integrated workflow systems with multiple workstations assigned specific tasks (e.g., intake, processing, and verifying of prescriptions). Bar code
scanning is an integral component of this workflow, which allows the tracking of every prescription through the filling queue. Such workflow systems
provide efficiency and are usually found in highvolume pharmacies.1
Other HIT utilized in the community pharmacy setting includes automated counting systems and robotics, interactive voice response (IVR) systems (i.e.,
the automated menu a caller is prompted through using the phone number pad), document scanning, and electronic signature capture. Refill requests
are commonly routed into the PIMS filling queue via IVR, which guides patients in entering in their refill information. This practice reduces the number
of phone calls that must be made and handled by pharmacy staff and also gives patients the ability to submit refills after hours. The Internet is also
being utilized for patient entered refill requests to the same effect. Further, IVR systems, along with text messaging, are being utilized to automate
outbound contact with patients, such as prescription pickup reminders and other, informative messages.
Another way new or refill prescriptions can enter the PIMS queue is via eprescribing. Eprescribing is a feature of almost every PIMS, most of which
route prescriptions through the Surescripts network. Faxed and paper prescriptions are scanned during intake, making the then digitized prescription
available at the filling and verification steps. The goal of digitization is to reduce the amount of paper handled and provide a faster way to file, index,
share, and search for information.1
Through the use of counting systems and/or robotic dispensing systems, the majority of a community pharmacy’s prescription volume can be
automated. Counting systems include countertop devices and standalone cabinets, while robotic dispensing fills and labels vials. Bar codes are used
in the dispensing process to match the medication with the patient and the prescription as entered in the computer system. This use of bar codes
allows multiple checks as an additional layer of safety. Bar code scanning can tie willcall management into the technologydriven workflow and
provides another searchable data point.1 Bar codes on willcall bags are scanned when bags are hung. This information is updated in the pharmacy
computer system for quick retrieval when the patient arrives, using light to identify the hanging bag in some instances.
Administration
Depending on the setting, medications may be administered by a health care provider, such as a physician, nurse, or pharmacist; a caregiver; or the
patient themselves. The two major HIT tools being used in hospital settings at this stage of the medication use process are bar code medication
administration (BCMA) systems and eMARs. BCMA systems are used at the point of care to ensure the five rights of medication administration are
followed. While use of these systems has been increasing steadily, there is a major issue that hinders implementation. While most products used in the
inpatient care setting have bar codes, there are some products that still require pharmacy to create and attach the bar code. Also, products that are
compounded for local use, such as intravenous antibiotics, need special bar codes that are not supported by the basic linear bar coding format. Two
dimensional bar codes can at least partly solve this issue. Alongside BCMA systems, the use of eMARs replaces paper records currently used to
document medication administration. eMARs decrease the potential for errors by eliminating the need to handwrite changes in medications and
allowing a medication change to be updated in real time in the patient’s medical record.1
Monitoring
Pharmacists’ monitoring activities vary greatly depending on their work setting and available resources. No matter the setting, however, monitoring
activities should result in clinical interventions, when necessary. A clinical intervention is the act of interceding with the intent of modifying the
medication use process. The broad categories of monitoring activities, and, therefore, clinical interventions, performed by pharmacists include
activities that promote safety, activities that promote quality, and activities that promote efficiency and costeffectiveness. For instance, a pharmacist
may intercept a medication ordered for which the patient has an allergy. Or a pharmacist may identify a less expensive, therapeutic alternative to the
prescribed medication in order to decrease costs for the patient.1
In the hospital setting, clinical surveillance systems are at the core of monitoring efforts. Clinical surveillance refers to active surveillance or watchful
waiting that includes a collection and analysis of patientspecific information that is then used to drive decisions. These systems are most often used
by pharmacy to monitor information from the pharmacy system (i.e., medication lists), laboratory results, and patient demographics from the
admission/discharge/transfer system. Rules are built to identify potential problems. For example, a rule may monitor all patients for orders of
naloxone, which is used to treat opioid overdose. Another rule may monitor for all patients receiving ranitidine whose platelet count has decreased to
less than 50% of the previous value, suggesting an occurrence of rare thrombocytopenia. Patients meeting these predefined rules are presented to
pharmacy staff for followup and evaluation.
Once a need is established and a clinical intervention has taken place, the process must be well documented. The purpose of clinical intervention
Access Provided by:
In the hospital setting, clinical surveillance systems are at the core of monitoring efforts. Clinical surveillance refers to active surveillance or watchful
waiting that includes a collection and analysis of patientspecific information that is then used to drive decisions. These systems are most often used
by pharmacy to monitor information from the pharmacy system (i.e., medication lists), laboratory results, and patient demographics from the
admission/discharge/transfer system. Rules are built to identify potential problems. For example, a rule may monitor all patients for orders of
naloxone, which is used to treat opioid overdose. Another rule may monitor for all patients receiving ranitidine whose platelet count has decreased to
less than 50% of the previous value, suggesting an occurrence of rare thrombocytopenia. Patients meeting these predefined rules are presented to
pharmacy staff for followup and evaluation.
Once a need is established and a clinical intervention has taken place, the process must be well documented. The purpose of clinical intervention
documentation is multifaceted. One primary purpose is to demonstrate the cost and quality impact of programs, such as clinical pharmacy services.
Documenting clinical interventions can also be used for staff performance improvement as well as quality improvement activities. Documentation
gives insight into what clinical staff members are doing, and, therefore, allows constructive feedback to be provided. Similarly, clinical intervention
documentation can be utilized to improve workflow.
There are certain basic elements that a good documentation system should have. The system should be easy to use and fit into the existing workflow
as much as possible. It should allow for quick documentation that includes sufficient details. Specifically, the system should have the capability to add
or modify interventions, manage drug and prescriber databases, and mirror the organization’s security policies. Further, all documentation should be
searchable, and the documentation system should provide a complete record of all clinical activities. Ideally, all practitioners providing care to the
same patient would document all monitoring and intervention activities in a shared record. The record would then be accessible by all other providers
who are also caring for that particular patient. In fact, a primary objective of the Pharmacy eHIT Collaborative, a multiorganizational group focused on
the role of pharmacists in the emerging electronic health record landscape, is to ensure that this is the case for the monitoring efforts of pharmacists.23
Reporting, which is the critical output of the documentation system, should be quick and easy. It should allow realtime selection and inclusion of any
combination of documented fields in the system.1
Case Study 24–1
You are a student pharmacist completing an inpatient pharmacy administration rotation. Through your rotation experiences, you have observed
and interacted with a variety of health information technologies and automation used to manage medications within the institution. Your preceptor
gives you the following assignment.
• Name the commonly encountered technologies used at each step of the medication use process to ensure safe and efficacious medication therapy.
The Future: Informatics in the U.S. Health Care System
❹ The vision of health care is becoming more patient centered. Health care is transitioning from industrial age medicine, which places focus on
professional care, is segmented, and is also highly expensive, to a new approach. This new approach, alternatively described as information age health
care, encourages lower cost individual care, getting friends and family involved, and using selfhelp networks as firstline approaches.24 This
transformation has been given the label participatory care, in that the new approach involves patients as highly active, decisionmaking members of
their own care team. Health 2.0, being the utilization of health care–related tools provided by Web 2.0, is the Weboriented extension of this new
participatory care approach. Web 2.0 simply refers to those applications of the Internet that are interactive and social, allowing for collaboration and
interactivity among patients, caregivers, and providers. Facebook (https://www.facebook.com/) is probably the most prominent example of Web 2.0.
Facebook, as is well known, is a social networking portal that allows users to interact and share pictures, videos, and links, among other things.
Patientslikeme® (http://www.patientslikeme.com/), being a Health 2.0 social networking portal, is similar to Facebook except that it focuses on allowing
people with the same medical condition to communicate with each other about healthrelated issues.
Other Web 2.0 and Health 2.0 resources include blogs, wiki sites, Twitter (https://twitter.com/), and personal health records (PHRs). With a blog,
anyone can post his or her thoughts on any topic at a particular site on the Internet as a blog entry. Readers can then leave related comments directly
below the published material. Wiki sites allow the publication of monographs via group participation, and the published material can be updated at
any time. The most wellknown example of a wiki site is Wikipedia, “the free encyclopedia that anyone can edit.”25 As for Health 2.0, RxWiki
(http://www.rxwiki.com/) is a wiki site that provides patients with drug monographs compiled by pharmacists. Twitter is a Web 2.0 service with the sole
focus being the ability to send short messages to groups. Twitter users can follow one or more members as well as be followed by members who want
to keep up with the insights of those they find interesting. Examples of some pharmacy applications for this kind of resource include promoting
medication adherence, prompting health behaviors, and producing warnings for patients. One of the best ways to learn about Health 2.0 resources
(including primary literature, for example) is to search for “Health 2.0 journal” in your preferred search engine.
PHRs are Health 2.0 applications that provide the patient increased opportunity to participate in the collection, maintenance, and sharing of their
personal healthrelated information through a Webbased environment. All the information is patient maintained, and PHRs should be designed as a
lifelong resource of patient health information. PHRs are ideally kept in a Webaccessible, electronic format that is secure and private but also
below the published material. Wiki sites allow the publication of monographs via group participation, and the published material can be updated at
Access Provided by:
any time. The most wellknown example of a wiki site is Wikipedia, “the free encyclopedia that anyone can edit.”25 As for Health 2.0, RxWiki
(http://www.rxwiki.com/) is a wiki site that provides patients with drug monographs compiled by pharmacists. Twitter is a Web 2.0 service with the sole
focus being the ability to send short messages to groups. Twitter users can follow one or more members as well as be followed by members who want
to keep up with the insights of those they find interesting. Examples of some pharmacy applications for this kind of resource include promoting
medication adherence, prompting health behaviors, and producing warnings for patients. One of the best ways to learn about Health 2.0 resources
(including primary literature, for example) is to search for “Health 2.0 journal” in your preferred search engine.
PHRs are Health 2.0 applications that provide the patient increased opportunity to participate in the collection, maintenance, and sharing of their
personal healthrelated information through a Webbased environment. All the information is patient maintained, and PHRs should be designed as a
lifelong resource of patient health information. PHRs are ideally kept in a Webaccessible, electronic format that is secure and private but also
universally available to providers treating the patient. Further, the ability to move information from a patient’s EMR, which is maintained by a health
care organization, to the patient’s PHR increases patient involvement in their own health care. Along with this ability, patients should also have the
ability to annotate the information coming in from their providers or EMR. It should be noted here that the PHR does not and is not meant to replace
the legal record of any provider.26 In order for PHRs to be interoperable and share data with other systems as described, standards of data
communication must be established and utilized. Current agreed upon standards include Continuity of Care Record (CCR) and Extensible Markup
Language (XML). Strong levels of data encryption and passwords are also required. Although still evolving, there are dozens of PHRs available today.
Two examples include Microsoft’s HealthVault (https://www.healthvault.com) and AHIMA’s MyPHR (http://www.myphr.com/).
Case Study 24–2
Your preceptor approaches you one morning and tells you about a new committee within the hospital that she has been asked to chair. The
committee’s role is to explore the emerging Health 2.0 domain and identify potential ways the hospital can become involved. Knowing that you are a
tech savvy person, your preceptor asks you to help conduct some of the initial research into the Health 2.0 domain. You are given the following
assignment.
• What are the primary journals that address the Health 2.0 domain?
• Suggest a few ways the hospital can use popular Web 2.0 tools for Health 2.0 efforts.
Interoperable Electronic Health Records
❺ The current health care system is decentralized and fragmented. Because of this, significant communication gaps exist when multiple health care
reduce medical errors, such as adverse drug events.4,27 Beyond the clinical improvements, there are also major financial benefits to be had, with
greater health information exchange and interoperability potentially saving the U.S. health care system $77.8 billion annually.28 Interoperability is
the ability of disparate computer systems to exchange information in a manner that allows the information to be used meaningfully.29 ❻ The desired
result of interoperable systems and EHRs is to readily provide all health practitioners in all locations, including the pharmacy, with access to
information about a patient’s care, as needed. As such, new health information systems (HIS) should focus on ensuring effective communication of
data between and within institutions, which includes a focus on data transfer across applications, devices, and geographical locations. Communication
standards are necessary to achieve this desired level of meaningful data exchange.
CURRENT STANDARDS
Several health care standards exist today. For instance, the NCPDP developed an eprescribing standard, NCPDP SCRIPT, for the transmission of
prescription information, along with relevant medical history information, electronically between prescribers, pharmacies, and payers. As mentioned
before, NDCs, created by manufacturers and registered with the FDA, are used as a standard way to signify the drug manufacturer, drug formulation,
and packaging type. RxNorm, produced by the National Library of Medicine (NLM), is a standard for supporting semantic interoperability between
pharmacy systems and drug terminologies by providing a standardized naming system for generic and branded drugs.30 Unified Medical Language
System (UMLS), also maintained by the NLM, enables interoperability between computer systems, such as EHRs, by providing a set of files and software
that bring together many medical vocabularies and standards.31 Contained within the UMLS is the Logical Observation Identifiers Names and Codes
(LOINC) terminology for laboratory test results and procedures. Another important medical terminology version also contained within UMLS is the
Systematized Nomenclature of MedicineClinical Terms (SNOMED CT). SNOMED CT maps to diagnosis and billing codes known as the International
Classification of Diseasetenth revision (ICD10). Further, Current Procedural Terminology (CPT®) codes, produced by the American Medical
Association (AMA), provide medical nomenclature used to report medical procedures and services performed under private and public health
insurance plans. 32
THE GOVERNMENT’s ROLE IN INTEROPERABILITY
pharmacy systems and drug terminologies by providing a standardized naming system for generic and branded drugs.30 Unified Medical Language
System (UMLS), also maintained by the NLM, enables interoperability between computer systems, such as EHRs, by providing a set of files and software
Access Provided by:
that bring together many medical vocabularies and standards.31 Contained within the UMLS is the Logical Observation Identifiers Names and Codes
(LOINC) terminology for laboratory test results and procedures. Another important medical terminology version also contained within UMLS is the
Systematized Nomenclature of MedicineClinical Terms (SNOMED CT). SNOMED CT maps to diagnosis and billing codes known as the International
Classification of Diseasetenth revision (ICD10). Further, Current Procedural Terminology (CPT®) codes, produced by the American Medical
Association (AMA), provide medical nomenclature used to report medical procedures and services performed under private and public health
insurance plans.32
THE GOVERNMENT’s ROLE IN INTEROPERABILITY
Technical standards are one piece of the interoperability puzzle. Other challenges include finding an organization or group to lead the charge through
associated business, administrative, and financial considerations. The U.S. government has been leading these efforts, beginning in 2004 when
President George W. Bush targeted computerizing health records in his State of the Union Address. That same year, President Bush established the
Office of the National Coordinator for Health Information Technology (ONC) within the Office of the Secretary of Health and Human Services (HHS).33
The two major goals of the ONC were widespread adoption of EHRs by 2014 and the creation and implementation of an interoperable health
information infrastructure.
In order to increase adoption and Meaningful Use of EHRs by providers and hospitals, CMS has developed a monetary incentive program. ❼ The
Meaningful Use program incentivizes hospitals and physicians to use EHRs to achieve specific outcomes, which may be process oriented or patient
oriented. For example, 60% of medication orders should be entered electronically or >50% of patients should have electronic access to their medical
information within 36 hours after discharge. The goals of the Meaningful Use program are to (1) improve quality, safety, and efficiency, (2) engage
patients and their families, (3) improve care coordination, as well as public and population health, and (4) maintain privacy and security of protected
health information (PHI). It is hoped that the adoption of and compliance with Meaningful Use will result in better clinical outcomes, improved
population health, increased health care transparency and efficiency, more robust data for research, and the empowerment of individuals and
patients.34
Further, there are specific objectives, broken down into three stages, set by CMS that eligible providers and hospitals must achieve to qualify for the
incentive program. Stage 1 focuses on providers capturing patient data and sharing that data with either the patient or other health care providers.
Stage 2, which begins in 2014 and focuses on advanced clinical processes, requires that a specified number of core and menu objectives be met.
Specifically, all of the 15 core objectives must be met, which includes items such as the use of CPOE and eprescribing, maintaining active drug and
allergy lists, checking for drug–drug and drug–allergy interactions, implementation of CDS, and protection of electronic health information. As for the
10 menu objectives, which include items such as submitting electronic data to immunization registries, drug formulary checking, electronic access to
health information for patients, and patientspecific education resources, five must be met.35 Stage 3, which begins in 2016 and is currently still being
formalized, will focus specifically on improved patient outcomes.
Case Study 24–3
You are wrapping up your rotation, and your preceptor comes to you with a final assignment. She has been tasked with representing the Pharmacy
Department on the committee that is overseeing the implementation of electronic health records in the institution. She knows very little about EHRs
and asks the following questions to get started.
• What group or organization is overseeing the EHR Meaningful Use program?
• Why would a hospital or provider want to start Meaningful Use earlier rather than later?
• What are the stages of Meaningful Use?
Greater Emphasis on Security, Privacy, and Confidentiality of Protected Health Information
As interoperability advances and more patient data are shared across providers and organizations, the issues of security, privacy, and confidentiality
of protected health information (PHI) inevitability arise. Protected health information includes any information that can be used to identify a
person, including information about medical conditions, payment for care, or actual care delivered.1 Privacy refers to being free from unauthorized
intrusions and the protection of PHI. In health care organizations, privacy is accomplished through policies that determine how and what information
is gathered, stored, and used, as well as how patients are involved in the process. Security here refers to restricting access to patient health data to
everyone except those with authorized access. This is accomplished through the use of electronic tools, such as login identifications and password
protection. Confidentiality here refers to the providerclient privilege that, under most circumstances, any healthrelated information communicated
between a provider and a patient is private. PHI can be in any form (e.g., written, oral, or electronic), and examples include patient name, address,
Social Security number, email address, or any other part of a medical record that could be used to identify a patient.1
Access Provided by:
As interoperability advances and more patient data are shared across providers and organizations, the issues of security, privacy, and confidentiality
of protected health information (PHI) inevitability arise. Protected health information includes any information that can be used to identify a
person, including information about medical conditions, payment for care, or actual care delivered.1 Privacy refers to being free from unauthorized
intrusions and the protection of PHI. In health care organizations, privacy is accomplished through policies that determine how and what information
is gathered, stored, and used, as well as how patients are involved in the process. Security here refers to restricting access to patient health data to
everyone except those with authorized access. This is accomplished through the use of electronic tools, such as login identifications and password
protection. Confidentiality here refers to the providerclient privilege that, under most circumstances, any healthrelated information communicated
between a provider and a patient is private. PHI can be in any form (e.g., written, oral, or electronic), and examples include patient name, address,
Social Security number, email address, or any other part of a medical record that could be used to identify a patient.1
As health care providers, pharmacists need to be aware of the existing and emerging regulations that apply to the security, privacy, and confidentiality
of PHI. For instance, the Health Breach Notification Rule, passed into law in 2009, requires that covered entities provide notice to patients following a
breach in security. Also, the Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act) establishes a framework that allows providers to
voluntarily and confidentially report patient safety events to patient safety organizations for aggregation and analysis purposes.36
HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT
Another major piece of legislation with which pharmacists and other providers need to be intimately familiar is the Health Insurance Portability and
Accountability Act (HIPAA), passed into law in 1996. The main component of concern here is the HIPAA Privacy Rule, which establishes how medical
information should be handled. The major goal of the Privacy Rule is to ensure proper protection of individuals’ health information while also allowing
the flow of health information needed to provide highquality health care. As such, the law defines PHI, describes how health care organizations can
use and disclose PHI, and outlines the requirements of health organizations to protect PHI from inappropriate disclosure and misuse. For instance, the
Privacy Rule specifies that PHI can be transmitted and used for treatment, payment, and operations (TPO) processes (i.e., general health care
operational use). And, as it is not intended to prevent providers from discussing the treatment of their patients, the rule specifies that some incidental
disclosures of PHI are permitted. That said, reasonable safeguards, such as speaking in a low voice, not discussing patient care in the presence of
others, and closing patient charts after use, should be used to limit such incidental disclosures. There are also certain disclosures, permitted by law,
which may be made to governmental agencies for such purposes as law enforcement, research, workers’ compensation, and organ donation. Further,
the HIPAA Privacy Rule requires that health care organizations notify patients of their rights when receiving care and also provides them with a process
to exercise those rights. Also, patients should be given the opportunity to agree or object to disclosures of their PHI while under the care of a health
care organization.1,37
There is also the HIPAA Security Rule, which covers electronic PHI (ePHI). ePHI is simply PHI stored in electronic form. Health care organizations are
required by the Security Rule to ensure the integrity, confidentiality, and availability of all ePHI created, received, maintained, or transmitted by the
organization. As such, most all organizations have fax, Internet, and email policies that outline appropriate use in order to protect ePHI.38
Conclusion
Pharmacy informatics is the scientific discipline found at the intersection of people, data, and technology systems. It is governed by business,
technical, and regulatory standards to ensure optimal use of patientspecific and knowledgebased information. Pharmacists rely on informatics to
support all of their activities associated with the medication use process. As EHR adoption increases in the United States, pharmacists and other health
care providers will continue to see a growing role of informatics in their practice, regardless of the setting.
References
1. Fox BI, Thrower MR, Felkey BG Building core competencies in pharmacy informatics. Washington, DC: American Pharmacists Association; 2010.
2. Hersh W. A stimulus to define informatics and health information technology. BMC Med Inform Decis Mak. 2009;9(1):24.
CrossRef [PubMed: 19445665]
3. Hersh W. Medical Informatics—improving health care through information. JAMA. 2002;288:1955–8.
4. Kohn LT, Corrigan JM, Donaldson MS To err is human: building a safer health system. Washington, DC: National Academies of Science 2000:1–5.
5. Bates DW, Cullen DJ, Laird N, et al. Incidence of adverse drug events and potential adverse drug events. Implications for prevention. ADE
Prevention Study Group. JAMA. 1995;274(1):29–34.
6. Kaushal R, Shojania KG, Bates DW. Effects of computerized physician order entry and clinical decision support systems on medication safety: a
3. Hersh W. Medical Informatics—improving health care through information. JAMA. 2002;288:1955–8.
Access Provided by:
4. Kohn LT, Corrigan JM, Donaldson MS To err is human: building a safer health system. Washington, DC: National Academies of Science 2000:1–5.
5. Bates DW, Cullen DJ, Laird N, et al. Incidence of adverse drug events and potential adverse drug events. Implications for prevention. ADE
Prevention Study Group. JAMA. 1995;274(1):29–34.
6. Kaushal R, Shojania KG, Bates DW. Effects of computerized physician order entry and clinical decision support systems on medication safety: a
systematic review. Arch Intern Med. 2003;163(12);1409–16.
7. Bates DW, Leape LL, Cullen DJ, et al. Effect of computerized physician order entry and a team intervention on prevention of serious medication
errors. JAMA. 1998;280(5):1311–6.
8. Koppel R, Metlay JP, Cohen A, et al. Role of computerized physician order entry systems in facilitating medication errors. JAMA.
2005;293(10):1197–203.
9. Hillestad R, Bigelow JH. Health information technology. Can HIT lower costs and improve quality? [Internet]. California: RAND Corporation; 2005
[cited 2012 Dec 28 ]. Available from: http://www.rand.org/pubs/research_briefs/RB9136.html. Accessed on December 28, 2012.
10. Poon EG, Blumenthal D, Jaggi T, et al. Overcoming barriers to adopting and implementing computerized physician order entry systems in U.S.
hospitals. Health Aff. 2004;23(4):184–90.
CrossRef
11. National Council for Prescription Drug Programs [Internet]. Scottsdale (AZ): National Council for Prescription Drug Programs; About—Contact Us;
[cited 2012 Dec 28 ]:[about 1 screen]. Available from: http://www.ncpdp.org/AboutUs
12. Centers for Medicare and Medicaid Services. Electronic Prescribing (eRx) Incentive Program [Internet]. Baltimore (MD): Centers for Medicare and
Medicaid Services; 2013 May 28 [cited 2012 Dec 28 ]:[about 3 screens]. Available from: http://www.cms.hhs.gov/ERxIncentive
13. U.S. Department of Justice Drug Enforcement Administration, Office of Diversion Control. Notices—2012 [Internet]. Springfield (VA): Drug
Enforcement Administration; 2012 Aug 1 [cited 2012 Dec 28 ]:[about 3 screens]. Available from:
http://www.deadiversion.usdoj.gov/fed_regs/notices/2012/fr0801_4.htm
14. Osheroff JA, Teich JM, Middleton B, et al. A roadmap for national action on clinical decision support. J Am Med Inform Assoc. 2007;14(2):141–5.
15. Shea S, DuMouchel W, Bahamonde L. A metaanalysis of 16 randomized controlled trials to evaluate computerbased clinical reminder systems
for preventive care in the ambulatory setting. J Am Med Inform Assoc. 1996;3(6):399–409.
16. Berner ES. Clinical decision support systems: theory and practice. 2nd ed. New York, NY: Springer; 2007.
17. Overhage JM, Tierney WM, Zhou XH, et al. A randomized trial of “corollary orders” to prevent errors of omission. J Am Med Inform Assoc.
1997;4(5):364–75.
2005;293(10):1197–1203.
19. Saverno KR, Hines LE, Warholak TL, et al. Ability of pharmacy clinical decisionsupport software to alert users about clinically important drug–
drug interactions. J Am Med Inform Assoc. 2011;18(1):32–37.
20. Oren E, Griffiths LP, Guglielmo BJ. Characteristics of antimicrobial overrides associated with automated dispensing machines. Am J Health Syst
Pharm. 2002;59(15);1445–8. [PubMed: 12166045]
Access Provided by:
2005;293(10):1197–1203.
19. Saverno KR, Hines LE, Warholak TL, et al. Ability of pharmacy clinical decisionsupport software to alert users about clinically important drug–
drug interactions. J Am Med Inform Assoc. 2011;18(1):32–37.
20. Oren E, Griffiths LP, Guglielmo BJ. Characteristics of antimicrobial overrides associated with automated dispensing machines. Am J Health Syst
Pharm. 2002;59(15);1445–8. [PubMed: 12166045]
21. Kester K, Baxter J, Freudenthal K. Errors associated with medications removed from automated dispensing machines using override function.
Hosp Pharm. 2006;41:53–537.
CrossRef
22. Class II special controls guidance document: pharmacy compounding systems; final guidance for industry and FDA [Internet]. Rockville (MD): U.S.
Department of Health and Human Services, Food and Drug Administration, Centers for Devices and Radiological Health; 2001 Mar 12 [cited 2012 Dec 29
]:[9 p.]. Available from: http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm073589.pdf
23. Pharmacy eHealth Information Technology Collaborative Home page [Internet]. Alexandria (VA): Pharmacy eHealth Information Technology
Collaborative; c2011 [cited 2012 Dec 29 ]. Available from: http://www.pharmacyhit.org/.
24. Smith R. Information technology and consumerism will transform health care worldwide. BMJ. 1997;314:1495.
25. Wikipedia: The Free Encyclopedia [Internet]. Wikipedia; [cited 20112 Dec 29 ]. Available from: http://en.wikipedia.org/wiki/Main_Page
26. AHIMA eHIM Personal Health Record Work Group. The role of the personal health record in the EHR. J AHIMA. 2005;76(7):64A–D.
27. eHealth Initiative. Migrating toward Meaningful Use: the state of health information Exchange. Washington, DC: eHealth Initiative; August 2009.
Available from: http://www.sftvision.com/2009SurveyReportFINAL.pdf
28. Walker J, Pan E, Johnson D, et al. The value of health care information exchange and interoperability [Internet]. Bethesda (MD): Health Affairs;
2005 Jan 19 [cited 2012 Dec 29 ]:[8p.]. Available from: http://content.healthaffairs.org/content/suppl/2005/02/07/hlthaff.w5.10.DC1
29. The National Alliance for Health Information Technology report to the Office of the National Coordinator for Health Information Technology on
defining key health information technology terms [Internet]. Department of Health and Human Services; 2008 Apr 28 [cited 2012 Dec 29 ]. 40 p.
Available from: http://cdm16064.contentdm.oclc.org/cdm/singleitem/collection/p266901coll4/id/2086/rec/10
30. U.S. National Library of Medicine [Internet]. Bethesda (MD): U.S. National Library of Medicine; 1993 Oct 10 [updated 2013 Jul 3 ]. RxNorm overview;
2005 May 5 [updated 2013 Mar 5 ; cited 2012 Dec 29 ]:[about 14 screens]. Available from:
https://www.nlm.nih.gov/research/umls/rxnorm/overview.html
31. U.S. National Library of Medicine [Internet]. Bethesda (MD): U.S. National Library of Medicine; 1993 Oct 10 [updated 2013 Jul 3 ]. UMLS quick start
guide; 2011 Mar 30 [updated 2012 Jul 27 ; cited 2012 Dec 29 ]:[about 2 screens]. Available from: http://www.nlm.nih.gov/research/umls/quickstart.html
32. American Medical Association. About CPT® [Internet]. Chicago (IL): American Medical Association; c19952013 [cited 2012 Dec 29 ]:[about 1 screen].
Available from: http://www.amaassn.org/ama/pub/physicianresources/solutionsmanagingyourpractice/codingbillinginsurance/cpt/about
cpt.page
33. Bush GW. Executive Order 13335—incentives for the use of health information technology and establishing the position of the National Health
Information Technology Coordinator [Internet]. Washington, DC: Federal Register; 2004 Apr 27 [cited 2012 Dec 29 ]:[3 p.]. Available from:
http://www.gpo.gov/fdsys/pkg/FR20040430/pdf/0410024.pdf
34. HealthIT.gov. Meaningful use definitions and objectives [Internet]. Washington, DC: The Office of the National Coordinator for Health Information
Technology; [cited 2012 Dec 29 ]:[about 1 screen]. Available from: http://www.healthit.gov/providersprofessionals/meaningfulusedefinition
objectives
35. An introduction to the Medicaid EHR Incentive Program for eligible professionals [Internet]. Baltimore (MD): Centers for Medicare and Medicaid
Services; [cited 2012 Dec 29 ]:[94 p.]. Available from: http://www.cms.gov/Regulationsand
Guidance/Legislation/EHRIncentivePrograms/Downloads/EHR_Medicaid_Guide_Remediated_2012.pdf
Information Technology Coordinator [Internet]. Washington, DC: Federal Register; 2004 Apr 27 [cited 2012 Dec 29 ]:[3 p.]. Available from:
Access Provided by:
http://www.gpo.gov/fdsys/pkg/FR20040430/pdf/0410024.pdf
34. HealthIT.gov. Meaningful use definitions and objectives [Internet]. Washington, DC: The Office of the National Coordinator for Health Information
Technology; [cited 2012 Dec 29 ]:[about 1 screen]. Available from: http://www.healthit.gov/providersprofessionals/meaningfulusedefinition
objectives
35. An introduction to the Medicaid EHR Incentive Program for eligible professionals [Internet]. Baltimore (MD): Centers for Medicare and Medicaid
Services; [cited 2012 Dec 29 ]:[94 p.]. Available from: http://www.cms.gov/Regulationsand
Guidance/Legislation/EHRIncentivePrograms/Downloads/EHR_Medicaid_Guide_Remediated_2012.pdf
36. Summary of selected federal laws and regulations addressing confidentiality, privacy and security [Internet]. Washington, DC: The Office of the
National Coordinator for Health Information Technology; 2010 Feb 18 [cited 2012 Dec 29 ]:[12 p.]. Available from:
http://www.healthit.gov/sites/default/files/federal_privacy_laws_table_2_26_10_final_0.pdf
37. Summary of the HIPAA Privacy Rule [Internet]. Washington, DC: U.S. Department of Health and Human Services; 2005 May [cited 2012 Dec 29 ]:[25
p.]. Available from: http://www.hhs.gov/ocr/privacy/hipaa/understanding/summary/privacysummary.pdf
38. HIPAA administrative simplification [Internet]. Washington, DC: U.S. Department of Health and Human Services; 2006 Feb 16 [cited 2012 Dec 29 ]:
[101 p.]. Available from: http://www.hhs.gov/ocr/privacy/hipaa/administrative/privacyrule/adminsimpregtext.pdf
Suggested Readings
1. Fox BI, Thrower MR, Felkey BG Building core competencies in pharmacy informatics. Washington, DC: American Pharmacists Association; 2010.
2. The Office of the National Coordinator for Health Information Technology [Internet]. Washington, DC: U.S. Department of Health and Human
Services; [updated 2011 Feb 18 ; cited 2012 Dec 12 ]. Available from: http://healthit.hhs.gov
3. Journal of the American Medical Informatics Association, http://jamia.bmj.com/.
4. Friedman CP. A ‘fundamental theorem’ of biomedical informatics. JAMIA. 2009;16:169–70. [PubMed: 19074294]
5. Pew Internet and American Life Project, http://www.pewinternet.org/.
6. American Society of HealthSystem Pharmacists. Technologyenabled practice: vision statement by the ASHP Section of Pharmacy Informatics and
Technology. Am J Health Syst Pharm. 2009;66:1573–77.
7. Journal of Medical Internet Research, http://www.jmir.org
8. Journal of Participatory Medicine, http://www.jopm.org
9. Journal of Biomedical Informatics, http://www.sciencedirect.com/science/journal/15320464
10. Pharmacy Informatics, http://www.pharmacyinformatics.com
11. Dumitru D The pharmacy informatics primer. Bethesda (MD): American Society of HealthSystem Pharmacists; 2009.

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