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Guideline Summary
Guideline Title
Ancillary applications: drug prescription/dispensing and forensics. In: Laboratory medicine practice guidelines: guidelines and recommendations for laboratory analysis and application of pharmacogenetics to clinical practice.
Bibliographic Source(s)
Jortani S, Wong S. Ancillary applications: drug prescription/dispensing and forensics. In: Valdes R Jr, Payne DA, Linder MW, editor(s). Laboratory medicine practice guidelines: guidelines and recommendations for laboratory analysis and application of pharmacogenetics to clinical practice. Washington (DC): National Academy of Clinical Biochemistry (NACB); 2010. p. 35-8. [25 references]
Guideline Status

This is the current release of the guideline.

Scope

Disease/Condition(s)

Diseases or conditions for which analysis of gene variations may be used for purposes of guiding the use of medications and related therapeutics

Guideline Category
Assessment of Therapeutic Effectiveness
Evaluation
Risk Assessment
Technology Assessment
Clinical Specialty
Medical Genetics
Pathology
Pharmacology
Intended Users
Clinical Laboratory Personnel
Pharmacists
Physicians
Utilization Management
Guideline Objective(s)

To provide evidence based recommendations that can improve and enhance applications in the prescription of drugs and in forensics

Target Population

Individuals with genetic variants associated with drug-metabolizing enzyme

Interventions and Practices Considered
  1. Appropriate consent from the patient and establishing measures to protect his/her health information
  2. Availability of pharmacogenetic genotype information to drug dispensing organizations for purposes of alerting either physicians or patients of possible drug interactions
  3. Close collaboration between hospital-based drug dispensing departments and clinical laboratories
  4. Blood as the preferred specimen for forensics purposes
  5. Maintenance of chain of custody for forensic samples according to established laboratory protocol
  6. Consideration of genes that affect pharmacodynamics in drug toxicity as warranted
  7. Interpretation of pharmacogenetic testing results in forensic toxicology to be done by individuals with adequate training in forensics, toxicology, and pharmacogenetic testing
  8. Reporting to be accompanied by information about the degree of a particular polymorphism's role in the pharmacokinetics or dynamics of the drug(s)
  9. To protect the health information of the living relatives, obtain their consent prior to pharmacogenetic testing of the deceased.
Major Outcomes Considered
  • Drug-related adverse events
  • Drug toxicity

Methodology

Methods Used to Collect/Select the Evidence
Searches of Electronic Databases
Description of Methods Used to Collect/Select the Evidence

For a specific clinical use, pertinent clinical questions were formulated and key search terms were ascertained for the literature search. A time frame of literature searches was conducted from 1995 until December 2009 on MEDLINE or PubMed databases. The specific search terms were pharmacogenetics, pharmacogenomics, clinical applications of pharmacogenetics, personalized medicine and clinical laboratories.

Number of Source Documents

Not stated

Methods Used to Assess the Quality and Strength of the Evidence
Weighting According to a Rating Scheme (Scheme Given)
Rating Scheme for the Strength of the Evidence

Levels of Evidence

  1. Evidence includes consistent results from well-designed, well-conducted studies in representative populations.
  2. Evidence is sufficient to determine effects, but the strength of the evidence is limited by the number, quality, or consistency of the individual studies; generalizability to routine practice; or indirect nature of the evidence.
  3. Evidence is insufficient to assess the effects on health outcomes because of limited number or power of studies, important flaws in their design or conduct, gaps in the chain of evidence, or lack of information. Expert consensus is the basis for the recommendation.
Methods Used to Analyze the Evidence
Systematic Review
Description of the Methods Used to Analyze the Evidence

Not stated

Methods Used to Formulate the Recommendations
Expert Consensus
Description of Methods Used to Formulate the Recommendations

Not stated

Rating Scheme for the Strength of the Recommendations

Strength of Recommendations

A. The National Academy of Clinical Biochemistry (NACB) strongly recommends adoption; there is good evidence that it improves important health outcomes and concludes that benefits substantially outweigh harms.

B. The NACB recommends adoption; there is at least fair evidence that it improves important health outcomes and concludes that benefits outweigh harms.

C. The NACB recommends against adoption; there is evidence that it is ineffective or that harm outweighs benefit.

I. The NACB concludes that the evidence is insufficient to make recommendations; evidence that it is effective is lacking, of poor quality, or conflicting; and the balance of benefits and harms cannot be determined.

Cost Analysis

A formal cost analysis was not performed and published cost analyses were not reviewed.

Method of Guideline Validation
Peer Review
Description of Method of Guideline Validation

This document was approved by the National Academy of Clinical Biochemistry (NACB) Board of Directors in July 2009. The NACB is the Academy of the American Association for Clinical Chemistry.

Recommendations

Major Recommendations

Definitions of the levels of evidence (I-III) and the strength of the recommendations (A, B, C, I) are presented at the end of the "Major Recommendations" field.

Note from the National Academy of Clinical Biochemistry (NACB) and the National Guideline Clearinghouse (NGC): Laboratory Analysis and Application of Pharmacogenetics to Clinical Practice has been divided into individual summaries. In addition to the current summary, the following are available:

Applications in Dispensing of Medications

  1. Should information related to pharmacogenetic (PGx) test availability be made part of the information provided to patients when dispensing drugs? If so, by whom or how?
  2. Should PGx test information be considered an integral part of the drug-dispensing safety awareness practice?

    Recommendation 1

    After appropriate consent from the patient and establishing measures to protect his/her health information, PGx genotype information can be made available to drug-dispensing organizations to be used as part of their drug-dispensing safety verification procedures (B-II).

  1. Should information-related relationships be fostered between drug dispensing providers at hospitals and clinical laboratories providing PGx testing services?

    Recommendation 2

    Hospital-based drug dispensing departments and clinical laboratories are encouraged to work in close collaboration and establish policies to make available timely genotyping information useful for guiding the dispensing of medication for hospitalized patients and for recommendations after discharge (B-II).

Applications in Forensics

  1. In forensic applications of PGx-testing, what is (are) the preferred specimen(s), and what diligence should be established for purposes of evidence acquisition?

    Recommendation 1

    For forensic purposes, blood is considered to be the preferred specimen of choice and can be used whenever available (A-II).

    Recommendation 2

    Chain of custody should be maintained for forensic samples, according to the established protocols by each laboratory (A-II).

  1. What type of information and correlations should be used to optimize the application of PGx data in forensic cases?

    Recommendation 3

    Whenever possible, in cases in which polymorphic enzymes are suspected as factors in drug toxicity, other relevant issues, such as polymorphisms in receptors, transport proteins, and genes that affect pharmacodynamics should also be considered (B-III).

  1. What qualifications by way of training and experience should be required for individuals reporting and interpreting PGx information when applied to forensics?

    Recommendation 4

    Interpreting pharmacogenetic testing results in forensic toxicology should be done by individuals with adequate training in forensics, toxicology, and pharmacogenetic testing and familiarity with metabolic pathways (B-III).

  1. What type of information should accompany a PGx test report as it applies to applications in forensics?

    Recommendation 5

    Whenever possible, reporting should be accompanied by information about the degree of a particular polymorphism’s role in the pharmacokinetics or dynamics of the drug(s) in question (B-II).

  1. Are there any particular or specific ethical considerations that may apply to the use of PGx data with regard to applications in forensics?

    Recommendation 6

    Ethical consideration: currently, institutional review board and informed consent of the decedent's family do not enter in postmortem analysis. However, consultations with the supervising legal authorities/medical management are essential in maintaining high ethical standards and preserving the rights of the decedent and the family members (B-II).

Definitions:

Levels of Evidence

  1. Evidence includes consistent results from well-designed, well-conducted studies in representative populations.
  2. Evidence is sufficient to determine effects, but the strength of the evidence is limited by the number, quality, or consistency of the individual studies; generalizability to routine practice; or indirect nature of the evidence.
  3. Evidence is insufficient to assess the effects on health outcomes because of limited number or power of studies, important flaws in their design or conduct, gaps in the chain of evidence, or lack of information. Expert consensus is the basis for the recommendation.

Strength of Recommendations

A. The National Academy of Clinical Biochemistry (NACB) strongly recommends adoption; there is good evidence that it improves important health outcomes and concludes that benefits substantially outweigh harms.

B. The NACB recommends adoption; there is at least fair evidence that it improves important health outcomes and concludes that benefits outweigh harms.

C. The NACB recommends against adoption; there is evidence that it is ineffective or that harm outweighs benefit.

I. The NACB concludes that the evidence is insufficient to make recommendations; evidence that it is effective is lacking, of poor quality, or conflicting; and the balance of benefits and harms cannot be determined.

Clinical Algorithm(s)

Not provided

Evidence Supporting the Recommendations

Type of Evidence Supporting the Recommendations

The type of supporting evidence is identified and graded for each recommendation (see "Major Recommendations").

Benefits/Harms of Implementing the Guideline Recommendations

Potential Benefits

Improvements and enhancements in the prescription of drugs and in forensics

Potential Harms

Not stated

Implementation of the Guideline

Description of Implementation Strategy

An implementation strategy was not provided.

Institute of Medicine (IOM) National Healthcare Quality Report Categories

IOM Care Need
Getting Better
IOM Domain
Effectiveness

Identifying Information and Availability

Bibliographic Source(s)
Jortani S, Wong S. Ancillary applications: drug prescription/dispensing and forensics. In: Valdes R Jr, Payne DA, Linder MW, editor(s). Laboratory medicine practice guidelines: guidelines and recommendations for laboratory analysis and application of pharmacogenetics to clinical practice. Washington (DC): National Academy of Clinical Biochemistry (NACB); 2010. p. 35-8. [25 references]
Adaptation

Not applicable: The guideline was not adapted from another source.

Date Released
2010
Guideline Developer(s)
National Academy of Clinical Biochemistry - Professional Association
Source(s) of Funding

National Academy of Clinical Biochemistry

Guideline Committee

National Academy of Clinical Biochemistry (NACB) Committee

Composition of Group That Authored the Guideline

Committee Members: Roland Valdes Jr, PhD, DABCC, FACB, University of Louisville, Louisville, KY; Deborah A. Payne, PhD, DABMM, DABCC, FACB, Molecular Services, UniPath LLC, Denver, CO; Mark W. Linder, PhD, DABCC, FACB, Department of Pathology and Laboratory Medicine, University of Louisville, Louisville, KY; Gilbert Burckhart, PhD, Pharmacy, University of Southern California, Los Angeles, CA; Daniel H. Farkas, PhD, HCLD, Sequenom Center for Molecular Medicine, Grand Rapids, MI; Felix Frueh, PhD, Medco Health Solutions Inc, Bethesda, MD; Jean-Pierre Morello, PhD, Teva Neuroscience Canada, Montreal, Quebec, Canada; Atiqur Rahman, PhD, Division of Clinical Pharmacology, US Food and Drug Administration, Silver Spring, MD; Gualberto Ruaño, MD, PhD, Genomas Inc and Hartford Hospital, Hartford CT; Les Shaw, PhD, Department of Pathology and Laboratory Medicine, Hospital of the University of Pennsylvania, Philadelphia, PA; Saeed Jortani, PhD, DABCC, FACB, Department of Pathology and Laboratory Medicine, University of Louisville, Louisville, KY; Werner Steimer, MD, Department of Clinical Chemistry and Pathobiochemistry, Institut fur Klinische Chemie und Pathobiochemie, Munich, Germany; Steven Wong, PhD, Department of Pathology, Medical College of Wisconsin, Milwaukee, WI; Jeanne Carr, PhD, Department of Pathology, St. Jude Children's Research Hospital, Memphis, TN

Financial Disclosures/Conflicts of Interest

Not stated

Guideline Status

This is the current release of the guideline.

Guideline Availability

Electronic copies: Available from the National Academy of Clinical Biochemistry (NACB) Web site External Web Site Policy.

Print copies: National Academy of Clinical Biochemistry publications are available through American Association for Clinical Chemistry (AACC) Press. To make a purchase or request a catalog, contact AACC Customer Service at 202-857-0717 or custserv@aacc.org.

Availability of Companion Documents

None available

Patient Resources

None available

NGC Status

This NGC summary was completed by ECRI Institute on November 4, 2010. The information was verified by the guideline developer on December 15, 2010.

Copyright Statement

National Academy of Clinical Biochemistry's (NACB) terms for reproduction of guidelines are posted with each set of guidelines.

Disclaimer

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The National Guideline Clearinghouse™ (NGC) does not develop, produce, approve, or endorse the guidelines represented on this site.

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