Chapter Twenty-Four

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 e-prescribing 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

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

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 (e-prescribing), 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 e-prescribing. 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 point-of-care 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.

     • 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 patient-specific 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 bar-coded medication administration. It also enables real-time documentation and billing of medication administration.

     • Electronic prescribing (e-prescribing): 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 built-in, 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. 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.

The two broad categories of information used in pharmacy informatics, as well as other clinical informatics domains, are patient-specific information and knowledge-based information.³ Patient-specific 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 health-related information in addition to and outside of these traditional settings. Aspects of consumer health informatics can include Internet-based direct-to-consumer advertising (see Chapter 23) and research activities.

Knowledge-based 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 patient-specific and knowledge-based 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 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 6-month 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. Patient-centered decision support, including display of the patient’s medical history, current test results, and evidence-based 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 drug-condition 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 person-to-person 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., well-respected 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 provide information and references for other CPOE systems implemented by the company.

Electronic Prescribing (e-prescribing)

Although many definitions exist, e-prescribing is commonly defined as ambulatory CPOE. A more precise definition would be a prescription entered by a prescriber directly into an electronic format using agreed-upon standards that is securely transmitted to the pharmacy that the patient chooses. Faxes and printed prescriptions are not e-prescriptions. One of the primary early challenges to nationwide e-prescribing 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 e-prescribing 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 e-prescribing 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 e-prescribing 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 e-prescribing 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 e-prescribing 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 e-prescribing 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 e-prescribing 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 e-prescribing 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 e-prescribing 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 e-prescribing is the renewal authorization process (i.e., authorization by the prescriber for additional refills). Prior to e-prescribing, 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 patient-specific 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 evidence-based 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 drug-allergy 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 agreed-upon formularies (see Chapter 12

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