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66 BASIC SKILLS IN INTERPRETING LABORATORY DATA
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MINICASE 2
Group A Streptococcal Pharyngitis and Point- of-Care Testing
Maya B., a 10- year- old girl, presents to the community pharmacy
in November with her mother. The mother states that Maya B.
reported a sore throat, mild cough, and headache after attending
a slumber party 2 days earlier. In addition, one of the other girls
attending the slumber party tested positive for GAS yesterday.
Maya B.’s physical findings include a red throat and tender cervical
lymph nodes.
QUESTION: What additional information should the pharmacist
obtain to determine if CLIAappropriate in this patient?
DISCUSSION: The pharmacist should obtain vital signs and calculate
a Modified Centor Criteria Score as part of the CPA to determine the
likelihood of GAS pharyngitis.
Maya’s vital signs are as follows: BP 120/70mm Hg, HR 80 beats/
min, RR 20 breaths/min, temperature 101°F, and weight 90 lb.
waived POCT for GAS would be
Performance Characteristics
CLIA- waived POC tests that detect GAS antigens have been
marketed for years and have evolved and improved through
several generations. e tests use a variety of antigen detection
methods (eg, latex agglutination, ELISAs, lateral ow immunochromatographic assays, and optical immunoassays). In
addition, several molecular methods to detect GAS exist that
use either rt-PCR or isothermal nucleic acid amplication are
now CLIA- waived. e use of antigen POC tests is addressed
in the IDSA guideline for the diagnosis and management of
GAS pharyngitis.96 However, the guideline was published before
the advent of the CLIA- waived molecular tests, so their use is
not addressed. e antigen CLIA- waived POC tests for GAS
infection have limited sensitivity; therefore, the IDSA guideline recommends conrming negative results in populations
at high risk of developing pharyngitis because of GAS or viral
etiologies with a throat culture to reduce the chance of missing
a positive case.96 e specicity associated with CLIA- waived
antigen POC tests for GAS infection is high; therefore, positive
results do not require a backup culture in a patient, regardless
of age.96 A comprehensive meta- analysis of 48 studies found that
sensitivity and specicity across all studies analyzed were 86%
and 96%, respectively.91 Investigators also found that although
there was marked variability in sensitivity, specicity varied little
across studies.91 In contrast to the IDSA guideline, overall, the
study demonstrated that the sensitivity of POC tests for GAS is
suciently high and a backup culture is not needed, particularly
given the low risk of complications such as acute rheumatic fever
92-95
Modified Centor Criteria Score
• Absence of cough (+1)
• Swollen and tender anterior
cervical lymph nodes (+1)
• Temperature >100.4°F (+1) • (+1)
• Tonsillar exudate or swelling (+1)
• Age (years):
3 to 14 (+1)
15 to 44 (0)
>45 (−1)
QUESTION: Based on the pharmacist’s findings, how should the
pharmacist proceed under CPA?
DISCUSSION: The pharmacist should perform a throat swab and
CLIA- waived POCT to verify the presence of GAS. The recommended
management of GAS according to the patient’s Modified Centor
Criteria score would be antibiotics based on the result of the CLIAwaived POC test. In addition, the pharmacist should recommend an
analgesic/antipyretic for symptom management.
Patient’s Calculated Score
• (0)
• (+1)
• (0)
• (+1)
• Score = 3; probability
of GAS ~28% to 35%
in the United States.91 Moreover, investigators concluded that the
high overall specicity of POC tests for GAS could minimize the
overdiagnosis of GAS pharyngitis and prevent unnecessary antibiotic use in such cases.91 Molecular CLIA- waived POC tests for
GAS have much higher sensitivity than the antigen- based tests,
which lowers the chance of missing a positive case.
96
COVID-19
Use in Pharmacy
Discovered in late 2019, the novel SARS-CoV-2 is associated
with a constellation of mild to life-threatening symptoms, known
as COVID-19, and has rapidly spread as a worldwide pandemic.
Early in the course of the pandemic, using the EUA provisions,
the FDA commissioner accelerated the marketing of POC tests
to detect SARS-CoV-2 (COVID-19 POC tests). Shortly thereaer, the Department of Health and Human Services issued a
policy permitting licensed pharmacists to order and administer
FDA- authorized COVID-19 POC tests.97 is policy illustrates
the important role pharmacists performing POCT can have in
providing services that contribute to the health and well- being
of their community. e policy extended the legal protections
under the Public Readiness and Emergency Preparedness Act
to pharmacists performing COVID-19 POC tests so they could
collect nasopharyngeal, throat, or nasal swabs from patients
with suspected infection and perform assays that have EUA.97
By leveraging the accessibility of pharmacists, the policy sought
to expand the nation’s testing capacity, so that if necessary, public
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TABLE 4-4. Modied Centor Score Criteria and Interpretation
TOTAL SCORE RISK OF GAS INFECTION (%)
• Absence of cough (+1)
• Swollen and tender anterior cervical lymph nodes (+1)
• Temperature >100.4°F (+1)
• Tonsillar exudate or swelling (+1)
• Age (yr):
3–14 (+1)
15–44 (0)
≥45 (−1)
health mitigation strategies, including contact tracing and isolation, could be employed. Under the policy, pharmacists can
also perform FDA- authorized serological COVID-19 tests.
However, for a pharmacist to perform a serological COVID-19
test marketed under an EUA, it would need to be CLIA- waived.
Such tests that are not CLIA- waived or lack a CLIA classication
are considered moderate- or high- complexity tests and are not
allowed to be performed outside an appropriately CLIA- certied
laboratory.98 us, pharmacists’ POCT eorts for COVID-19
entail testing patients for active infection using molecular or
antigen- based tests so that they may be linked to care or public
health professionals.
Determining Appropriate Testing Candidates
Decisions regarding who qualies for testing rest with state and
local health departments or healthcare providers. Individuals
are encouraged to visit their state or local health department’s
website for the latest local information on testing in their locale.
Application of COVID-19 Point- of-Care Testing in Practice
Many antigen or molecular COVID-19 POC tests have been
marketed under an EUA, but not all of them are considered
waived. Antigen or molecular tests have a variety of uses. ey
are recommended for diagnosis of acute infection in persons
with signs or symptoms of infection.99 To control transmission,
testing is performed with antigen or molecular tests in asymptomatic individuals with recent known or suspected exposure to
SARS-CoV-2.99 In addition, such tests are used for asymptomatic individuals without known or suspected exposure to SARSCoV-2 to assist in early detection in institutional settings.99
Antigen and molecular tests are also used to detect the resolution of infection to determine when individuals can end isolation.99 Lastly, antigen or molecular tests can be used in public
health surveillance eorts for SARS-CoV-2.
Serological COVID-19 tests have also been marketed under
an EUA, but to date, all but one of them are considered moderate- or high- complexity tests and are not allowed to be performed outside an appropriately CLIA- certied laboratory.
ese tests are not authorized for diagnosis of COVID-19; rather
they are recommended for situations in which it is necessary to
99
≥4
3 28–35
2 11–17
1 5–10
≤0
determine whether the individual being tested was previously
infected.
Performance Characteristics
Having EUA status means tests can be used in the declared
emergency, but the FDA has not thoroughly evaluated them
to grant approval. Gaining FDA EUA status requires minimal
performance data, and at the time of authorization, typically
tests only have data regarding limits of detection from contrived
samples. As experience is gained with tests during the evolving
pandemic, emerging clinical data, oen from small samples,
provide estimates of their negative percent agreement and
positive percent agreement (ie, specicity and sensitivity, respectively) as well as their NPV and PPV. Initial data contained in
the package inserts of the individual tests suggest the specicity
COVID-19 that could be performed outside an appropriately
CLIA- certied laboratory are similar (98.8% to 98.9%), regardless of the type (eg, antigen, molecular, or serological) test.
In addition, the overall sensitivity of such tests is high (93.9%
to 100%).
tests varies by test (84% to 98%) and appears to be slightly less
sensitive (mean 93.9%) than molecular (99.5%) or serological
(100%) tests.
POC tests for respiratory viruses in that molecular tests are typically highly specic and more sensitive than antigen tests. Like
other respiratory viruses, the performance characteristics such
as NPV and PPV of these tests will likely be inuenced by viral
load, when and how viral shedding occurs, patient characteristics, and sample type. e eects of annual genomic dris or a
shi should it occur on these tests is unknown.
GOOD LABORATORY PRACTICES
To provide consistency in the patient care process, it is vital
to develop appropriate policies and procedures specic to each
CLIA- waived POC test to optimize the ability of the test to
produce results that aid in chronic disease state management
or detect the analyte of interest without overtesting. For CLIAwaived POC tests in chronic disease state management, pharmacists should specify the frequency of testing as part of the
88-91
51–53
1–2.5
100-110
However, though high, the sensitivity of antigen
100-110
ese initial ndings are consistent with other
100-110
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patient- specic care plan in accordance with relevant national
clinical guidelines. In addition, frequency of monitoring should
be driven by the patient’s disease progression and achievement
of treatment goals. Although CLIA- waived tests are determined
to be simple for the user, it is necessary for a pharmacist to be
properly trained on each CLIA- waived device and for the laboratory to follow “good laboratory practices” for waived testing
sites per CDC guidelines.5 ese practices include steps that
should be taken before initiating or expanding CLIA- waived
POCT services and include actions taken during and aer the
actual performance of test (Figure4-1).
5
Before Initiating Services (Preparation Phase)
Recommended practices prior to initiating POCT services
involve regulatory, logistic, procedural, and personnel considerations. An initial step toward initiating CLIA- waived POCT
services is to identify a qualied individual who will be responsible and accountable for testing operations.
ously, some states have additional requirements that must be met
to fulll this role. Individuals leading and working in a waived
laboratory must be familiar with local, state, and federal regulatory requirements. In addition to the CLIA requirements and
state pharmacy practice acts, practitioners need to be familiar
with state and local regulations governing laboratory operations, federal laws governing privacy (eg, Health Insurance
Portability and Accountability Act), Occupational Safety and
Health Administration (OSHA) work place safety standards (eg,
OSHA standards related to workplace hazards and bloodborne
pathogens standards), and information from the CDC and CLSI
regarding biosafety and precautions for preventing the transmission of bloodborne pathogens in the workplace.
iarity with these regulations and resources will help ensure that
any CLIA- waived POCT services protect patient condentiality
and are safe for both the patient and testing personnel.
Many factors must be considered prior to initiating services
to create a testing space that meets the needs of the practice setting, employees, patients, and the environmental requirements
specied in the test manufacturers’ package insert. Additional
considerations that are addressed include a scal assessment of
5,9
As described previ
5,9
Having famil-
5
the proposed POCT services and an analysis of oered tests so
that all factors required to properly conduct the test(s) of interest can be determined (eg, advantages and disadvantages of the
available devices, any additional equipment, and access to ancillary care services).
5
Developing written policies and procedures that clearly outline the responsibilities and testing instructions for testing personnel and facility directors is a critical process that must occur
before testing begins. Procedures should be based on the manufacturer’s instructions and be used to train testing personnel.5 In
addition to test performance, the policies and procedures should
outline and standardize specimen collection techniques, QC
procedures, proper handling and storage of tests and reagents,
and documenting and reporting results.
5
Testing personnel are a critical component to any CLIA- waived
POCT service. Because personnel at waived testing sites are not
subject to prociency testing, it is essential that they be trained
by a qualied person and be competent in any test they will per-
form before performing the test.5 Training should include an
observed performance of the trainee performing the test. Many
training resources are available through test manufacturers and
distributors, professional organizations, and governmental agencies. Training should be documented and reviewed on a regular
basis to ensure that all updates or changes are noted. Although
prociency testing is not mandated, including such assessments is
recommended as part of any quality assurance program.
Test Ordering and Sample Collection
(Preanalytical Phase)
Considering all aspects in the planning phase helps ensure
personnel have the resources, understanding, and skills needed
to perform a CLIA- waived POC test properly during the preanalytical phase. Good laboratory practices in this phase include
conrming the test has been properly ordered, identifying
the patient, labeling the sample collection device to avoid any
confusion with other patients, providing the patient with pretest
education or information, reviewing the complete test procedure, and preparing the test area and materials.
5
5
Preanalytical Phase
Preparation Phase
Policy and Procedures
Testing environment
Training
Workflow
Testing confirmation
Pretest communication
Preparation
FIGURE 4-1. Steps of Good Laboratory Practices
Analytical Phase
Internal Quality Control
External Quality
Assurance
Result interpretation
Postanalytical Phase
Test interpretation
Communication
Biohazard disposal
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During Testing (Analytical Phase)
Good laboratory practices in the analytical phase involve QC,
test performance, and result interpretation and documentation.5
e QC measures are important to ensure proper training of
the user’s technique, the integrity of the testing device, and the
overall performance of the POCT analytical device. It is a process
that consists of two components: internal QC and external QA.
Internal QC requires the analysis of manufacturer- provided QC
materials. ese materials are imbedded in the test in known
concentrations and produce a result that indicates whether
the analytical method and the reading device are functioning
properly. e purpose of internal QC is to monitor the precision
and function of the analytical method over time. In contrast,
external QA monitors the testing process from specimen application to result interpretation. External QA requires analyzing patient- like samples comprised of liquid or other materials
similar to patient specimens provided by the manufacturer or
purchased separately. ese patient- like samples can be run
before or concurrent with patient samples, and their results are
compared across testing personnel to monitor the accuracy of
reporting. QC test results should be documented, and any action
taken in response to QC tests should be recorded. e CLIAwaived laboratory director should incorporate a QC plan in the
site’s policy and procedures.5 e POC test and device manufacturer provides QC materials, which oen include internal
and external controls. A test site should determine QC testing
frequency that ts its operations for each test system, but at
a minimum, QC testing should be performed as oen as the
product insert recommends.
Each CLIA- waived POC test and device can require dierent
techniques for acquiring or testing a sample. erefore, CLIA
requirements stipulate that when personnel perform the tests,
they must strictly adhere to the manufacturer’s guidelines and
follow specic storage conditions for the test and test materials
(eg, testing strips, cartridges, cassettes, and reagent). Temperature and humidity may also be critical factors in providing a successful test result. e CLIA- waived POC test results should be
interpreted within the manufacturer’s specied time period, and
the test should be repeated if the results conict with the available clinical information or are invalid.5 Once valid test results
are obtained, they should be documented according to established policy and procedures in a timely fashion.
5
After Testing (Postanalytical Phase)
Good laboratory practices in the postanalytical phase involve
issuing test reports, performing supplemental or conrmatory
testing, testing area cleanup, disposing biohazard waste, and
documenting testing activities. e pharmacist’s appropriate
interpretation of the test results is a critical part of the postanalytical phase, along with communicating the results to the
patient and provider. e pharmacist’s discussion of a laboratory
result with the patient should be well planned and considerate
of the patient’s response. When a pharmacist encounters a test
result that requires follow- up with a physician for further evaluation, it is important to communicate with the patient’s physician
and have referral resources ready and available as needed. In
some cases, good laboratory practices and state or local statutes
mandate that test results for certain infectious diseases also be
reported to local or state public health agencies.5 For all postanalytical phase activities, the testing site should have specic
policies and procedures clearly dened and in place.
LIMITATIONS OF POINT- OF-CARE
TESTING
Legal and Regulatory Barriers to Pharmacists
Performing Clinical Laboratory Improvement
Amendments–Waived Point- of-Care Tests
Under CLIA requirements, there are no minimum educational
or training requirements needed for the director or testing
personnel.
serve in either of these roles and perform a CLIA- waived POC
test. However, the ability of pharmacists to use the result of a
CLIA- waived POC test to make a therapeutic decision for the
management of chronic diseases or acute infections falls under
the scope of practice, which is regulated by state agencies and
boards of pharmacy.2 However, studies have identied that
legislative and regulatory variability across states may produce
confusion among practitioners and represent a barrier to pharmacists’ eorts to perform POCT.
CLIA- waived POCT may not be explicitly addressed in many
pharmacy practice acts, such activities may be permissible
under CPA/CDTM agreement provisions in state regulations
or statutes.2 A few states, however, still do not have these provisions in their pharmacy practice acts. ere is variability across
states with CPA/CDTM agreement provisions in terms of specicity, scope, and structure.2 For example, some states restrict
CPAs/CDTM agreements to written agreements for individual patients, whereby pharmacists can treat a patient for the
condition specied in the protocol only if they have advanced
authorization from the patient’s primary care provider. Such
an approach poses a challenge for patients who do not have a
primary care provider.
3,5
erefore, in nearly all states, pharmacists can
2,111
Although performing
81
Lack of Training/Education
According to their classication, CLIA- waived POC tests are
simple to perform with low risk for erroneous results or harm to
patients if they are performed incorrectly.3 However, they are not
error proof; CLIA regulations explicitly stipulate that individuals
who perform the tests must strictly adhere to the manufacturer’s instructions.3 Although CDC and CMS studies indicate that
waived laboratories (including pharmacies) generally perform
testing correctly, the results of the agencies’ surveys also highlight
the need for additional education and training for site directors
and testing personnel.5 Because CLIA requirements do not specify
any level of education for directors or testing personnel in waived
laboratories, lack of education regarding CLIA- waived testing is a
gap that exists across all healthcare professional education.5 Two
national surveys of academic pharmacy suggest that education
on CLIA- waived POC tests for infectious diseases is generally
70 BASIC SKILLS IN INTERPRETING LABORATORY DATA
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lacking from professional pharmacy degree programs.
112,113
is
is an opportunity for the expansion of core curricula that would
enhance pharmacists’ participation in POCT services. Training
for pharmacists is available through an accredited national certificate training program oered by a national pharmacy professional organization that is designed for community pharmacists
to implement testing programs for inuenza, GAS, HIV, and
114
HC V.
and expand POCT services.
Data suggest that the program can help improve training
115
Overtesting
Overtesting is a concern with CLIA- waived POC tests for infectious diseases because they are qualitative and detect seasonal
pathogens that produce infections with nonspecic symptoms
(eg, GAS and inuenza) or produce infections that are most
prevalent in specic high- risk populations (eg, HIV and HCV);
therefore, overtesting is a concern. To optimize the ability of the
test to detect the analyte of interest and avoid overtesting, pharmacists should develop practices that enable them to distinguish
patients who could benet from testing. Because low disease
prevalence can negatively impact the PPV of qualitative tests,
pharmacists can optimize test performance and minimize overtesting by performing relevant physical assessments and gathering additional information to identify those in need of testing.
Taking such steps will also enable them to make referrals to
physicians for follow- up or make immediate referrals to emergency medical care.
FUTURE APPLICATIONS FOR CLINICAL
LABORATORY IMPROVEMENT
AMENDMENTS–WAIVED POINT- OFCARE TESTS IN OUTPATIENT
PHARMACY PRACTICE SETTINGS
With continued transformations in the delivery of healthcare in
the United States and advances in technology, there will likely be
many more innovative applications of CLIA- waived POC tests
for chronic disease state and infectious diseases in outpatient
pharmacy practice settings. e growing shortage of primary
care providers will lead to an increasing role of pharmacists
performing CLIA- waived POC test to screen for and manage
chronic diseases. Scientic advances in genetic testing and
molecular diagnostics will increase the POC tests on the market.
e potential to perform POC pharmacogenomic testing will
enable pharmacists to help guide and select therapies based on
a patient’s genetic make- up, limiting side eects and increasing
ecacy. e development of new molecular- based CLIA- waived
POC tests or improved current antibody/antigen- based tests
may make it more practical to test infectious disease analytes of
public health interest (eg, tuberculosis and pathogens responsible for sexually transmitted infections). In addition, in cases
such as sexually transmitted infections, molecular- based CLIAwaived POC tests could allow a pharmacist working under a
CPA/CDTM agreement to institute prompt therapy under
protocol. Adapting to these changes will be vital for pharmacists
to develop workow processes and nancial models to sustain
CLIA- waived POCT.
Ongoing reforms to the U.S. healthcare delivery system
will continue to raise awareness of pharmacists as ready access
points to the healthcare system. To fully realize this potential for
POCT services in outpatient pharmacy practice settings, local,
state, and federal regulations governing pharmacy practice must
continue to evolve so pharmacists can practice to their fullest
professional potential. Technological advances in health informatics will ultimately enable the pharmacist to have access to
electronic medical records (EMRs) regardless of practice setting.
Similarly, pharmacists will transmit CLIA- waived POCT results
to a patient’s EMRs, their primary provider, and other relevant
public health agencies.
LEARNING POINTS
1.
How have the CLIA-88 created opportunities for
pharmacists in outpatient settings?
ANSWER: Technology has allowed many laboratory tests use ful
in the detection and management of chronic diseases and infec-
tions to be simplied and classied as CLIA- waived. CLIA- waived
POCT represents an opportunity for pharmacists in outpatient
settings to expand their patient care services.
2. What must pharmacis ts know to properly perform CLIA-
waived tests in their practice settings?
ANSWER: To properly perform a CLIA- waived test in outpatient
settings, pharmacists must understand the basis of the test, how
to handle specimens, and how to perform the test. They must
also understand all relevant state and federal regulations related
to performing such tests and reporting the results.
3.
What must pharmacists know to provide useful POCT
services in their practice settings?
ANSWER: To provide useful POCT services, pharmacists must
understand how to identify patients who would benet from
testing. In addition, they must understand how to evaluate the
various performance characteristics and the limitations of
the test.
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Interpretation of Serum
https://t.me/med1917
DrugConcentrations
5
OBJECTIVES
After completing this chapter, the
reader should be able to
•
Justify the need for concentration
monitoring of a drug based on its
characteristics and the clinical
situation
•
Identify and justify information
needed when requesting and
reporting drug concentrations
•
Describe and categorize factors
that may contribute to interpatient
variation(s) in a therapeutic range
of
drug concentrations
•
Explain the importance of
documenting the time a sample
is obtained relative to the last
dose as well as factors that can
affect interpretation of a drug
concentration, depending on
when
it was obtained
•
Compare linear to nonlinear
pharmacokinetic behavior with
respect to how drug concentration
measurements are used to make
dosage regimen adjustments
•
Describe how altered serum binding,
active metabolites, or stereoselective
pharmacokinetics can impact the
interpretation of drug concentration
measurements
Riane Ghamrawi and Lindsay Benedik
e pharmacist is a key member in the therapeutic drug monitoring process. is
chapter is designed to review the indications for drug concentration monitoring and
discuss how drug concentrations obtained from the clinical laboratory, specialized
reference laboratory, or physician’s oce should be interpreted. General considerations for interpretation are described as well as unique considerations for drugs that
commonly undergo therapeutic drug monitoring. Future directions of therapeutic
drug monitoring are also discussed.
is chapter is not intended to provide an in-depth review of pharmacokinetic
dosing methods; nevertheless, knowledge of certain basic pharmacokinetic terms and
concepts is expected. e general phrase drug concentration will be used throughout
the chapter unless specic references to serum, plasma, whole blood, and saliva are
more appropriate. e bibliography lists numerous texts about therapeutic drug monitoring and clinical pharmacokinetic principles with applications to clinical practice.
THERAPEUTIC DRUG MONITORING
erapeutic drug monitoring is broadly dened as the use of drug concentrations
to optimize drug therapy for individual patients.1 Prior to using drug concentrations to guide therapy, physicians adjusted drug doses based on their interpretation
of clinical response. In many cases, drug doses were increased until obvious signs
of toxicity were observed (eg, nystagmus for phenytoin or tinnitus for salicylates).
e idea that intensity and duration of pharmacologic response depended on serum
drug concentration was rst reported by Marshall and then tested for the screening
of antimalarials during World War II.
how steady-state serum concentrations of commonly used drugs can vary 10-fold
among patients receiving the same dosage regimen.4 He further described how serum
concentrations predict the intensity of therapeutic or toxic eects more accurately
than dosage.
Starting in the 1960s, there was rapid improvement in analytical methods used for
drug concentration measurements; extensive research correlating serum or plasma
drug concentrations with clinical ecacy and toxicity quickly followed. Today, with
the emergence of immunoassays that require no specialized equipment, drug concentration measurements can be easily performed in outpatient clinic oces.
e increased availability and convenience of drug assay methods has led to a
number of concerns. Is therapeutic drug monitoring being done simply because it is
available, rather than because it is clinically necessary? ere are numerous reports
of suboptimal therapeutic drug monitoring practices that contribute to inappropriate decision-making as well as wasted resources.
whether therapeutic drug monitoring actually improves patient outcomes.
tively, many clinicians claim that therapeutic drug monitoring is greatly underused
and could, if appropriately used, further improve patient care and reduce healthcare
10-12
costs.
involved in the therapeutic drug monitoring process to make its use more appropriate and cost-eective. Such education eorts have been shown to eectively reduce
the number of inappropriate drug concentration requests.
Clearly, there is a need for more education of all healthcare professionals
2,3
Koch-Weser, in a hallmark paper, described
5-7
Questions have been raised about
13
8,9
Alterna
-
DOI 10.37573/9781585286423.005
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