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Medical Product Safety Data Details

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  • MPS-1 Increase the proportion of medical-surgical hospitals that report adverse drug events

    About the Data

    Description of the data source, numerator, denominator, survey questions, and other relevant details about the national estimate.

    Data Source: 
    National Survey of Pharmacy Practice in Hospital Care Settings
    Changed Since the Healthy People 2020 Launch: 
    Yes
    Measure: 
    percent
    Baseline (Year): 
    60.7 (2009)
    Target: 
    66.8
    Target-Setting Method: 
    10 percent improvement
    Numerator: 

    Number of general and children’s medical-surgical hospitals that report adverse drug events externally (e.g. to FDA, Medwatch, Institute for Safe Medication Practices, manufacturer)

    Denominator: 

    Number of general and children’s medical-surgical hospitals

    Comparable Healthy People 2010 Objective: 
    Adapted from HP2010 objective
    Questions Used to Obtain the National Baseline Data: 

      From the 2009 National Survey of Pharmacy Practice in Hospital Care Settings:

      [NUMERATOR:]

      Does your hospital report adverse drug events externally (e.g., FDA, Medwatch, ISMP, manufacturer)?

      1. Yes
      2. No
    Data Collection Frequency: 
    Periodic
    Methodology Notes: 

      For this objective, an adverse drug event is an injury resulting from the use of, or not using, a needed medication. Adverse drug events include both adverse drug reactions and medication errors, including both errors of commission and omission, that result in adverse clinical outcomes.

      General and children’s medical-surgical hospitals were stratified by the size of the hospital (number of staffed beds), then sampled randomly. The sample focused on inpatient settings, rather than ambulatory settings. Specialty, federal, and VA hospitals were excluded from the sampling frame. The pharmacy directors of sampled hospitals were surveyed by mail.

      Hospitals were counted as reporting adverse drug events externally if they reported to FDA, Medwatch, Institute for Safe Medication Practices, or the manufacturer.

    Caveats and Limitations: 
    40% response to paper survey.
    Changes Between HP2010 and HP2020: 
    This objective differs from Healthy People 2010 objective 17-01a in that the survey methodology did not use stratified random sampling nor were responses weighted.

    Revision History

    Any change to the objective text, baseline, target, target-setting method or data source since the Healthy People 2020 launch.

    Description of Changes Since the Healthy People 2020 Launch: 
    In 2013, the objective and baseline statements were revised to more accurately reflect the measure. The original objective statement was "Increase the proportion of health care organizations that are monitoring and analyzing adverse events associated with medical therapies within their systems." The revised objective statement is "Increase the proportion of general and children's medical-surgical hospitals that report adverse drug events." The original baseline statement was "60.7 percent of of general and children’s hospital systems reported adverse drug events externally in 2009." The revised objective statement is "60.7 percent of medical-surgical hospitals reported adverse drug events in 2009." The data source, data, target, and target setting method were not revised. In 2014, the baseline statement was corrected to remove the extra word "percent."

    References

    Additional resources about the objective

    1. Farley DO, Haviland A, Champagne S, et. Al Berdahl TA. Adverse-Event-Reporting Practices by U.S. Hospitals: Results of a National Survey. Qual Saf Health Care 2008, Dec; 17(6): 416-423.
    2. Pedersen, CA, Schneider, PJ, Scheckelhoff, DJ. ASHP National Survey of Pharmacy Practice in Hospital Settings: Monitoring and Patient Education-2006. Am J Health-Syst Pharm 2007 Mar; 64.
    3. Pedersen, CA, Schneider, PJ, Scheckelhoff, DJ. ASHP National Survey of Pharmacy Practice in Hospital Settings: Monitoring and Patient Education-2012. Am J Health-Syst Pharm 2013 May; 70.
  • MPS-2 Increase the safe and effective treatment of pain

    • MPS-2.1 (Developmental) Reduce the proportion of patients suffering from untreated pain due to a lack of access to pain treatment

      About the Data

      Description of the data source, numerator, denominator, survey questions, and other relevant details about the national estimate.

      Changed Since the Healthy People 2020 Launch: 
      Yes
      Measure: 
      *** Missing ***
      Numerator: 

      *** Missing ***

      Comparable Healthy People 2010 Objective: 
      Not applicable

      Revision History

      Any change to the objective text, baseline, target, target-setting method or data source since the Healthy People 2020 launch.

      Description of Changes Since the Healthy People 2020 Launch: 
      In 2015, this objective was archived due to lack of a viable data source.
    • MPS-2.2 Reduce the number of non-FDA-approved pain medications

      About the Data

      Description of the data source, numerator, denominator, survey questions, and other relevant details about the national estimate.

      Changed Since the Healthy People 2020 Launch: 
      Yes
      Measure: 
      number
      Baseline (Year): 
      575 (2007)
      Target: 
      518
      Target-Setting Method: 
      10 percent improvement
      Numerator: 

      Number of non-FDA-approved pain medications (opioids, NSAIDs, and acetaminophen used to treat pain) that are on the market in one year

      Comparable Healthy People 2010 Objective: 
      Not applicable
      Methodology Notes: 

        Pain medications are defined as opioids, non-steroidal anti-inflammatory drugs (NSAIDS), and acetaminophen.

        Each new drug application that goes through the FDA Approval Process is given a unique identifier and, once approved by the FDA, is required to list the product with the FDA in the database. The data for this objective will select Drug Listings for a given year that are determined to be “Unapproved” in the Drug Registration and Listing Database. The goal of this objective is to decrease the overall number of “Unapproved” drugs that are marketed and, subsequently listed with the FDA. This is not to imply that “Unapproved” drugs should not be listed with the FDA, but that the number of “Unapproved” marketed drugs should be minimized.

        The estimates are reflective of the drugs that have multiple ingredients, potency levels in a drug, and different routes of administration.

      Caveats and Limitations: 
      For the purposes of this measure, pain medications are defined as opioids, NSAIDS, and acetaminophen.

      Revision History

      Any change to the objective text, baseline, target, target-setting method or data source since the Healthy People 2020 launch.

      Description of Changes Since the Healthy People 2020 Launch: 
      In 2014, this objective was archived due to lack of a viable data source.

      References

      Additional resources about the objective

      1. Approvals of FDA-Regulated Products. US Food and Drug Administration.
      2. FDA Enforcement Report Index

      3. Is It Really FDA Approved? US Food and Drug Administration, September 30, 2008.
      4. Marketed Unapproved Drugs: Compliance Policy Guide Center for Drug Evaluation and Research. US Food and Drug Administration, June 2006.
      5. National Drug Code Directory

      6. US Sales and Prescription Information

    • MPS-2.3 (Developmental) Reduce serious injuries from the use of pain medicines

      About the Data

      Description of the data source, numerator, denominator, survey questions, and other relevant details about the national estimate.

      Changed Since the Healthy People 2020 Launch: 
      Yes
      Measure: 
      *** Missing ***
      Numerator: 

      *** Missing ***

      Comparable Healthy People 2010 Objective: 
      Not applicable

      Revision History

      Any change to the objective text, baseline, target, target-setting method or data source since the Healthy People 2020 launch.

      Description of Changes Since the Healthy People 2020 Launch: 
      In 2015, this objective was archived due to lack of a viable data source.
    • MPS-2.4 Reduce drug overdose deaths involving opioids, excluding heroin

      • MPS-2.4.1 Reduce drug overdose deaths involving natural, semi-synthetic, and synthetic opioids, excluding heroin

        About the Data: National

        Description of the data source, numerator, denominator, survey questions, and other relevant details about the national estimate.

        Data Source: 
        Bridged-race Population Estimates
        National Vital Statistics System-Mortality
        Changed Since the Healthy People 2020 Launch: 
        Yes
        Measure: 
        per 100,000
        Baseline (Year): 
        5.4 (2010)
        Target: 
        Not applicable
        Target-Setting Method: 
        This measure is being tracked for informational purposes. If warranted, a target will be set during the decade.
        Target-Setting Method Justification: 
        This measure is being tracked for informational purposes to better understand the subtleties of the data source in identifying overdose deaths involving opioids. If warranted, a target will be set during the decade.
        Numerator: 

        Number of overdose deaths involving natural, semi-synthetic, and synthetic opioids excluding heroin

        Denominator: 

        Number of persons

        Comparable Healthy People 2010 Objective: 
        Not applicable
        Data Collection Frequency: 
        Annual
        Methodology Notes: 

          Opioids are drugs that are usually prescribed to relieve pain by acting on the central nervous system. They include: natural and semisynthetic opioids such as morphine, codeine, hydrocodone, and oxycodone; methadone, which is a synthetic opioid used to treat opioid dependence and pain; and other synthetic opioids (excluding methadone) such as fentanyl, tramadol and meperidine.

          For this objective, drug overdose deaths involving natural, semi-synthetic, and synthetic opioids excluding heroin are identified from mortality data by selecting deaths with an ICD-10 underlying cause code of:.

          X40-44 (unintentional poisoning),
          X60-64 (intentional self-poisoning),
          X85 (homicide by poisoning), or
          Y10-Y14 (poisoning of undetermined intent)
          AND a multiple cause code of:
          T40.2 (natural and semi-synthetic opioids such as morphine, codeine, hydrocodone, oxycodone),
          T40.3 (methadone), or
          T40.4 (synthetic opioids excluding methadone, such as fentanyl, tramadol and meperidine)

        Caveats and Limitations: 
        NVSS-M data cannot distinguish between deaths from opioids that were acquired legally by prescription and deaths from opioids that were acquired illegally or were used by someone other than the person for whom they were prescribed. NVSS-M data cannot distinguish between a drug manufactured pharmaceutically and one manufactured illicitly. For example, illicitly manufactured fentanyl cannot be distinguished from prescription fentanyl using death certificate data.
        Trend Issues: 
        The NVSS-M is derived from information on death certificates. Some death certificates do not include detailed information on the specific drug(s) involved in a drug poisoning death. For example, in 2010, the specific drugs involved were not reported for approximately 25% of drug poisoning deaths. However, the quality and completeness of drug information on death certificates has improved. In 2014, the percent of drug poisoning deaths that lacked information on the specific drugs involved decreased to 19%. The impact of improvements in reporting should be considered when monitoring the mortality rates for specific drugs.

        About the Data: State

        Description of the data source, numerator, denominator, survey questions, and other relevant details about the state-level data.

        Data Source: 
        Bridged-race Population Estimates
        National Vital Statistics System-Mortality
        Measure: 
        per 100,000
        Numerator: 

        Number of overdose deaths involving natural, semi-synthetic, and synthetic opioids excluding heroin

        Denominator: 

        Number of persons

        Data Collection Frequency: 
        Annual
        Methodology Notes: 

            Opioids are drugs that are usually prescribed to relieve pain by acting on the central nervous system. They include: natural and semisynthetic opioids such as morphine, codeine, hydrocodone, and oxycodone; methadone, which is a synthetic opioid used to treat opioid dependence and pain; and other synthetic opioids (excluding methadone) such as fentanyl, tramadol and meperidine.

            For this objective, drug overdose deaths involving natural, semi-synthetic, and synthetic opioids excluding heroin are identified from mortality data by selecting deaths with an ICD-10 underlying cause code of:.

            X40-44 (unintentional poisoning),
            X60-64 (intentional self-poisoning),
            X85 (homicide by poisoning), or
            Y10-Y14 (poisoning of undetermined intent)
            AND a multiple cause code of:
            T40.2 (natural and semi-synthetic opioids such as morphine, codeine, hydrocodone, oxycodone),
            T40.3 (methadone), or
            T40.4 (synthetic opioids excluding methadone, such as fentanyl, tramadol and meperidine)

        Caveats and Limitations: 
        NVSS-M data cannot distinguish between deaths from opioids that were acquired legally by prescription and deaths from opioids that were acquired illegally or were used by someone other than the person for whom they were prescribed. NVSS-M data cannot distinguish between a drug manufactured pharmaceutically and one manufactured illicitly. For example, illicitly manufactured fentanyl cannot be distinguished from prescription fentanyl using death certificate data.
        Trend Issues: 
        The NVSS-M is derived from information on death certificates. Some death certificates do not include detailed information on the specific drug(s) involved in a drug poisoning death. For example, in 2010, the specific drugs involved were not reported for approximately 25% of drug poisoning deaths. However, the quality and completeness of drug information on death certificates has improved. In 2014, the percent of drug poisoning deaths that lacked information on the specific drugs involved decreased to 19%. The impact of improvements in reporting should be considered when monitoring the mortality rates for specific drugs.

        Revision History

        Any change to the objective text, baseline, target, target-setting method or data source since the Healthy People 2020 launch.

        Description of Changes Since the Healthy People 2020 Launch: 
        In 2016, the developmental objective MPS-2.4, "Reduce deaths from the use of pain medications," was split into 4 measurable objectives: MPS-2.4.1, "Reduce drug overdose deaths involving natural, semi-synthetic, and synthetic opioids excluding heroin;" MPS-2.4.2, "Reduce drug overdose deaths involving natural and semi-synthetic opioids excluding heroin;" MPS-2.4.3, "Reduce drug overdose deaths involving methadone;" and MPS-2.4.4, "Reduce drug overdose deaths involving synthetic opioids excluding methadone." These measures are being tracked for informational purposes; if warranted, targets will be set within the decade. In 2017, the estimates for geographic location were updated to reflect the 2013 urban/rural classification scheme.
      • MPS-2.4.2 Reduce drug overdose deaths involving natural and semi-synthetic opioids, excluding heroin

        About the Data: National

        Description of the data source, numerator, denominator, survey questions, and other relevant details about the national estimate.

        Data Source: 
        Bridged-race Population Estimates
        National Vital Statistics System-Mortality
        Changed Since the Healthy People 2020 Launch: 
        Yes
        Measure: 
        per 100,000
        Baseline (Year): 
        3.5 (2010)
        Target: 
        Not applicable
        Target-Setting Method: 
        This measure is being tracked for informational purposes. If warranted, a target will be set during the decade.
        Target-Setting Method Justification: 
        This measure is being tracked for informational purposes to better understand the subtleties of the data source in identifying overdose deaths involving opioids. If warranted, a target will be set during the decade.
        Numerator: 

        Number of overdose deaths involving natural and semi-synthetic opioids excluding heroin

        Comparable Healthy People 2010 Objective: 
        Not applicable
        Data Collection Frequency: 
        Annual
        Methodology Notes: 

          Opioids are drugs that are usually prescribed to relieve pain by acting on the central nervous system. They include: natural and semisynthetic opioids such as morphine, codeine, hydrocodone, and oxycodone; methadone, which is a synthetic opioid used to treat opioid dependence and pain; and other synthetic opioids (excluding methadone) such as fentanyl, tramadol and meperidine.

          For this objective, drug overdose deaths involving natural and semi-synthetic opioids excluding heroin are identified from mortality data by selecting deaths with an ICD-10 underlying cause code of:.

          X40-44 (unintentional poisoning),
          X60-64 (intentional self-poisoning),
          X85 (homicide by poisoning), or
          Y10-Y14 (poisoning of undetermined intent)
          AND a multiple cause code of:
          T40.2 (natural and semi-synthetic opioids such as morphine, codeine, hydrocodone, oxycodone),

        Caveats and Limitations: 
        NVSS-M data cannot distinguish between deaths from opioids that were acquired legally by prescription and deaths from opioids that were acquired illegally or were used by someone other than the person for whom they were prescribed. NVSS-M data cannot distinguish between a drug manufactured pharmaceutically and one manufactured illicitly. For example, illicitly manufactured fentanyl cannot be distinguished from prescription fentanyl using death certificate data.
        Trend Issues: 
        The NVSS-M is derived from information on death certificates. Some death certificates do not include detailed information on the specific drug(s) involved in a drug poisoning death. For example, in 2010, the specific drugs involved were not reported for approximately 25% of drug poisoning deaths. However, the quality and completeness of drug information on death certificates has improved. In 2014, the percent of drug poisoning deaths that lacked information on the specific drugs involved decreased to 19%. The impact of improvements in reporting should be considered when monitoring the mortality rates for specific drugs.

        About the Data: State

        Description of the data source, numerator, denominator, survey questions, and other relevant details about the state-level data.

        Data Source: 
        Bridged-race Population Estimates
        National Vital Statistics System-Mortality
        Measure: 
        per 100,000
        Numerator: 

        Number of overdose deaths involving natural and semi-synthetic opioids excluding heroin

        Data Collection Frequency: 
        Annual
        Methodology Notes: 

            Opioids are drugs that are usually prescribed to relieve pain by acting on the central nervous system. They include: natural and semisynthetic opioids such as morphine, codeine, hydrocodone, and oxycodone; methadone, which is a synthetic opioid used to treat opioid dependence and pain; and other synthetic opioids (excluding methadone) such as fentanyl, tramadol and meperidine.

            For this objective, drug overdose deaths involving natural and semi-synthetic opioids excluding heroin are identified from mortality data by selecting deaths with an ICD-10 underlying cause code of:.

            X40-44 (unintentional poisoning),
            X60-64 (intentional self-poisoning),
            X85 (homicide by poisoning), or
            Y10-Y14 (poisoning of undetermined intent)
            AND a multiple cause code of:
            T40.2 (natural and semi-synthetic opioids such as morphine, codeine, hydrocodone, oxycodone),

        Caveats and Limitations: 
        NVSS-M data cannot distinguish between deaths from opioids that were acquired legally by prescription and deaths from opioids that were acquired illegally or were used by someone other than the person for whom they were prescribed. NVSS-M data cannot distinguish between a drug manufactured pharmaceutically and one manufactured illicitly. For example, illicitly manufactured fentanyl cannot be distinguished from prescription fentanyl using death certificate data.
        Trend Issues: 
        The NVSS-M is derived from information on death certificates. Some death certificates do not include detailed information on the specific drug(s) involved in a drug poisoning death. For example, in 2010, the specific drugs involved were not reported for approximately 25% of drug poisoning deaths. However, the quality and completeness of drug information on death certificates has improved. In 2014, the percent of drug poisoning deaths that lacked information on the specific drugs involved decreased to 19%. The impact of improvements in reporting should be considered when monitoring the mortality rates for specific drugs.

        Revision History

        Any change to the objective text, baseline, target, target-setting method or data source since the Healthy People 2020 launch.

        Description of Changes Since the Healthy People 2020 Launch: 
        In 2016, the developmental objective MPS-2.4, "Reduce deaths from the use of pain medications," was split into 4 measurable objectives: MPS-2.4.1, "Reduce drug overdose deaths involving natural, semi-synthetic, and synthetic opioids excluding heroin;" MPS-2.4.2, "Reduce drug overdose deaths involving natural and semi-synthetic opioids excluding heroin;" MPS-2.4.3, "Reduce drug overdose deaths involving methadone;" and MPS-2.4.4, "Reduce drug overdose deaths involving synthetic opioids excluding methadone." These measures are being tracked for informational purposes; if warranted, targets will be set within the decade. In 2017, the estimates for geographic location were updated to reflect the 2013 urban/rural classification scheme.
      • MPS-2.4.3 Reduce drug overdose deaths involving methadone

        About the Data: National

        Description of the data source, numerator, denominator, survey questions, and other relevant details about the national estimate.

        Data Source: 
        Bridged-race Population Estimates
        National Vital Statistics System-Mortality
        Changed Since the Healthy People 2020 Launch: 
        Yes
        Measure: 
        per 100,000
        Baseline (Year): 
        1.5 (2010)
        Target: 
        Not applicable
        Target-Setting Method: 
        This measure is being tracked for informational purposes. If warranted, a target will be set during the decade.
        Target-Setting Method Justification: 
        This measure is being tracked for informational purposes to better understand the subtleties of the data source in identifying overdose deaths involving opioids. If warranted, a target will be set during the decade.
        Numerator: 

        Number of overdose deaths involving methadone

        Comparable Healthy People 2010 Objective: 
        Not applicable
        Data Collection Frequency: 
        Annual
        Methodology Notes: 

          Opioids are drugs that are usually prescribed to relieve pain by acting on the central nervous system. They include: natural and semisynthetic opioids such as morphine, codeine, hydrocodone, and oxycodone; methadone, which is a synthetic opioid used to treat opioid dependence and pain; and other synthetic opioids (excluding methadone) such as fentanyl, tramadol and meperidine.

          For this objective, drug overdose deaths involving natural and semi-synthetic opioids excluding heroin are identified from mortality data by selecting deaths with an ICD-10 underlying cause code of:.

          X40-44 (unintentional poisoning),
          X60-64 (intentional self-poisoning),
          X85 (homicide by poisoning), or
          Y10-Y14 (poisoning of undetermined intent)
          AND a multiple cause code of:
          T40.3 (methadone)

        Caveats and Limitations: 
        NVSS-M data cannot distinguish between deaths from opioids that were acquired legally by prescription and deaths from opioids that were acquired illegally or were used by someone other than the person for whom they were prescribed. NVSS-M data cannot distinguish between a drug manufactured pharmaceutically and one manufactured illicitly. For example, illicitly manufactured fentanyl cannot be distinguished from prescription fentanyl using death certificate data.
        Trend Issues: 
        The NVSS-M is derived from information on death certificates. Some death certificates do not include detailed information on the specific drug(s) involved in a drug poisoning death. For example, in 2010, the specific drugs involved were not reported for approximately 25% of drug poisoning deaths. However, the quality and completeness of drug information on death certificates has improved. In 2014, the percent of drug poisoning deaths that lacked information on the specific drugs involved decreased to 19%. The impact of improvements in reporting should be considered when monitoring the mortality rates for specific drugs.

        About the Data: State

        Description of the data source, numerator, denominator, survey questions, and other relevant details about the state-level data.

        Data Source: 
        Bridged-race Population Estimates
        National Vital Statistics System-Mortality
        Measure: 
        per 100,000
        Numerator: 

        Number of overdose deaths involving methadone

        Data Collection Frequency: 
        Annual
        Methodology Notes: 

            Opioids are drugs that are usually prescribed to relieve pain by acting on the central nervous system. They include: natural and semisynthetic opioids such as morphine, codeine, hydrocodone, and oxycodone; methadone, which is a synthetic opioid used to treat opioid dependence and pain; and other synthetic opioids (excluding methadone) such as fentanyl, tramadol and meperidine.

            For this objective, drug overdose deaths involving natural and semi-synthetic opioids excluding heroin are identified from mortality data by selecting deaths with an ICD-10 underlying cause code of:.

            X40-44 (unintentional poisoning),
            X60-64 (intentional self-poisoning),
            X85 (homicide by poisoning), or
            Y10-Y14 (poisoning of undetermined intent)
            AND a multiple cause code of:
            T40.3 (methadone)

        Caveats and Limitations: 
        NVSS-M data cannot distinguish between deaths from opioids that were acquired legally by prescription and deaths from opioids that were acquired illegally or were used by someone other than the person for whom they were prescribed. NVSS-M data cannot distinguish between a drug manufactured pharmaceutically and one manufactured illicitly. For example, illicitly manufactured fentanyl cannot be distinguished from prescription fentanyl using death certificate data.
        Trend Issues: 
        The NVSS-M is derived from information on death certificates. Some death certificates do not include detailed information on the specific drug(s) involved in a drug poisoning death. For example, in 2010, the specific drugs involved were not reported for approximately 25% of drug poisoning deaths. However, the quality and completeness of drug information on death certificates has improved. In 2014, the percent of drug poisoning deaths that lacked information on the specific drugs involved decreased to 19%. The impact of improvements in reporting should be considered when monitoring the mortality rates for specific drugs.

        Revision History

        Any change to the objective text, baseline, target, target-setting method or data source since the Healthy People 2020 launch.

        Description of Changes Since the Healthy People 2020 Launch: 
        In 2016, the developmental objective MPS-2.4, "Reduce deaths from the use of pain medications," was split into 4 measurable objectives: MPS-2.4.1, "Reduce drug overdose deaths involving natural, semi-synthetic, and synthetic opioids excluding heroin;" MPS-2.4.2, "Reduce drug overdose deaths involving natural and semi-synthetic opioids excluding heroin;" MPS-2.4.3, "Reduce drug overdose deaths involving methadone;" and MPS-2.4.4, "Reduce drug overdose deaths involving synthetic opioids excluding methadone." These measures are being tracked for informational purposes; if warranted, targets will be set within the decade. In 2017, the estimates for geographic location were updated to reflect the 2013 urban/rural classification scheme.
      • MPS-2.4.4 Reduce drug overdose deaths involving synthetic opioids, excluding methadone

        About the Data: National

        Description of the data source, numerator, denominator, survey questions, and other relevant details about the national estimate.

        Data Source: 
        Bridged-race Population Estimates
        National Vital Statistics System-Mortality
        Changed Since the Healthy People 2020 Launch: 
        Yes
        Measure: 
        per 100,000
        Baseline (Year): 
        1.0 (2010)
        Target: 
        Not applicable
        Target-Setting Method: 
        This measure is being tracked for informational purposes. If warranted, a target will be set during the decade.
        Target-Setting Method Justification: 
        This measure is being tracked for informational purposes to better understand the subtleties of the data source in identifying overdose deaths involving opioids. If warranted, a target will be set during the decade.
        Numerator: 

        Number of overdose deaths involving synthetic opioids excluding methadone

        Comparable Healthy People 2010 Objective: 
        Not applicable
        Data Collection Frequency: 
        Annual
        Methodology Notes: 

          Opioids are drugs that are usually prescribed to relieve pain by acting on the central nervous system. They include: natural and semisynthetic opioids such as morphine, codeine, hydrocodone, and oxycodone; methadone, which is a synthetic opioid used to treat opioid dependence and pain; and other synthetic opioids (excluding methadone) such as fentanyl, tramadol and meperidine.

          For this objective, drug overdose deaths involving natural and semi-synthetic opioids excluding heroin are identified from mortality data by selecting deaths with an ICD-10 underlying cause code of:.

          X40-44 (unintentional poisoning),
          X60-64 (intentional self-poisoning),
          X85 (homicide by poisoning), or
          Y10-Y14 (poisoning of undetermined intent)
          AND a multiple cause code of:
          T40.4 (synthetic opioids excluding methadone, such as fentanyl, tramadol and meperidine)

        Caveats and Limitations: 
        NVSS-M data cannot distinguish between deaths from opioids that were acquired legally by prescription and deaths from opioids that were acquired illegally or were used by someone other than the person for whom they were prescribed. NVSS-M data cannot distinguish between a drug manufactured pharmaceutically and one manufactured illicitly. For example, illicitly manufactured fentanyl cannot be distinguished from prescription fentanyl using death certificate data.
        Trend Issues: 
        The NVSS-M is derived from information on death certificates. Some death certificates do not include detailed information on the specific drug(s) involved in a drug poisoning death. For example, in 2010, the specific drugs involved were not reported for approximately 25% of drug poisoning deaths. However, the quality and completeness of drug information on death certificates has improved. In 2014, the percent of drug poisoning deaths that lacked information on the specific drugs involved decreased to 19%. The impact of improvements in reporting should be considered when monitoring the mortality rates for specific drugs.

        About the Data: State

        Description of the data source, numerator, denominator, survey questions, and other relevant details about the state-level data.

        Data Source: 
        Bridged-race Population Estimates
        National Vital Statistics System-Mortality
        Measure: 
        per 100,000
        Numerator: 

        Number of overdose deaths involving synthetic opioids excluding methadone

        Data Collection Frequency: 
        Annual
        Methodology Notes: 

            Opioids are drugs that are usually prescribed to relieve pain by acting on the central nervous system. They include: natural and semisynthetic opioids such as morphine, codeine, hydrocodone, and oxycodone; methadone, which is a synthetic opioid used to treat opioid dependence and pain; and other synthetic opioids (excluding methadone) such as fentanyl, tramadol and meperidine.

            For this objective, drug overdose deaths involving natural and semi-synthetic opioids excluding heroin are identified from mortality data by selecting deaths with an ICD-10 underlying cause code of:.

            X40-44 (unintentional poisoning),
            X60-64 (intentional self-poisoning),
            X85 (homicide by poisoning), or
            Y10-Y14 (poisoning of undetermined intent)
            AND a multiple cause code of:
            T40.4 (synthetic opioids excluding methadone, such as fentanyl, tramadol and meperidine)

        Caveats and Limitations: 
        NVSS-M data cannot distinguish between deaths from opioids that were acquired legally by prescription and deaths from opioids that were acquired illegally or were used by someone other than the person for whom they were prescribed. NVSS-M data cannot distinguish between a drug manufactured pharmaceutically and one manufactured illicitly. For example, illicitly manufactured fentanyl cannot be distinguished from prescription fentanyl using death certificate data.
        Trend Issues: 
        The NVSS-M is derived from information on death certificates. Some death certificates do not include detailed information on the specific drug(s) involved in a drug poisoning death. For example, in 2010, the specific drugs involved were not reported for approximately 25% of drug poisoning deaths. However, the quality and completeness of drug information on death certificates has improved. In 2014, the percent of drug poisoning deaths that lacked information on the specific drugs involved decreased to 19%. The impact of improvements in reporting should be considered when monitoring the mortality rates for specific drugs.

        Revision History

        Any change to the objective text, baseline, target, target-setting method or data source since the Healthy People 2020 launch.

        Description of Changes Since the Healthy People 2020 Launch: 
        In 2016, the developmental objective MPS-2.4, "Reduce deaths from the use of pain medications," was split into 4 measurable objectives: MPS-2.4.1, "Reduce drug overdose deaths involving natural, semi-synthetic, and synthetic opioids excluding heroin;" MPS-2.4.2, "Reduce drug overdose deaths involving natural and semi-synthetic opioids excluding heroin;" MPS-2.4.3, "Reduce drug overdose deaths involving methadone;" and MPS-2.4.4, "Reduce drug overdose deaths involving synthetic opioids excluding methadone." These measures are being tracked for informational purposes; if warranted, targets will be set within the decade. In 2017, the estimates for geographic location were updated to reflect the 2013 urban/rural classification scheme.
  • MPS-3 (Developmental) Reduce the number of adverse events from medical products

    About the Data

    Description of the data source, numerator, denominator, survey questions, and other relevant details about the national estimate.

    Changed Since the Healthy People 2020 Launch: 
    Yes
    Measure: 
    *** Missing ***
    Numerator: 

    *** Missing ***

    Comparable Healthy People 2010 Objective: 
    Not applicable

    Revision History

    Any change to the objective text, baseline, target, target-setting method or data source since the Healthy People 2020 launch.

    Description of Changes Since the Healthy People 2020 Launch: 
    In 2015, this objective was archived due to lack of a viable data source.
  • MPS-4 Increase the number of safe and effective medical products – diagnostics, drugs and biologics - associated with predictive biomarkers

    About the Data

    Description of the data source, numerator, denominator, survey questions, and other relevant details about the national estimate.

    Data Source: 
    Releasable Pre-Market Approval (PMA) database
    List of Cleared and Approved Companion Diagnostic Devices (In Vivo and Imaging tools)
    Drugs@FDA
    Changed Since the Healthy People 2020 Launch: 
    Yes
    Measure: 
    count
    Baseline (Year): 
    35 (2014)
    Target: 
    39
    Target-Setting Method: 
    10 percent improvement
    Numerator: 

    Number of safe and effective medical products that are associated with predictive biomarkers

    Comparable Healthy People 2010 Objective: 
    Not applicable
    Data Collection Frequency: 
    Biennial
    Methodology Notes: 

      Personalized medicine is the tailoring of medical treatment to individuals during all stages of care, including prevention, diagnosis, treatment, and follow-up, the goal being to predict who will respond to a medical therapy or who will suffer ill effects. Personalized medicine generally involves the use of two medical products: a diagnostic device, which includes predictive biomarkers, and a therapeutic device. A diagnostic device is used to predict an individual’s response to a specific therapeutic device. The success of personalized medicine depends on the development of accurate and reliable diagnostics and, in some cases, on the identification of predictive biomarkers. A predictive biomarker is used to identify if a given patient is likely to respond to a treatment intervention in a particular way. This indicator focuses on diagnostic and therapeutic devices – safe and effective medical products – that are associated with predictive biomarkers.

      One example of a medical product associated with a predictive biomarker is for targeted cancer therapy. In August 2011, FDA simultaneously approved a medical product, a drug called vemurafenib (Zelboraf), along with its diagnostic test, the Cobas 4800 BRAF V600E mutation test, for use in treating metastatic or inoperable melanoma. Metastatic melanoma is a highly aggressive form of skin cancer with a 5-year survival rate of only 15 percent. Vemurafenib works by inhibiting the BRAF V600E mutation that is found in approximately half of melanoma patients. Melanomas that lack the mutation are not inhibited by the vemurafenib treatment. The BRAF V600E mutation test helps doctors predict the patients who are more likely to benefit from the vemurafenib treatment, and select a different treatment for those whom the vemurafenib treatment may have no effect.

      Data from the Releasable Pre-Market Approval (PMA) and Drugs@FDA database are extracted to create the “List of Companion Diagnostic Devices: In vitro and Imaging Tools.” This list provides information on the drug trade name, generic name, New Drug Application (NDA) and Biologic License Application (BLA) approvals, device trade name, PMA, 510(k) device manufacturer, and Intended Use (IU)/Indications for Use (IFU). Each entry in this list is reviewed to determine the number of medical products and companion diagnostics that provide information essential for the safe and effective use of a corresponding therapeutic product associated with a predictive biomarker.

    Revision History

    Any change to the objective text, baseline, target, target-setting method or data source since the Healthy People 2020 launch.

    Description of Changes Since the Healthy People 2020 Launch: 
    In 2014, MPS-4 became a measurable objective. The objective title was changed from "Increase the USE of …" to "Increase the NUMBER of safe and effective medical products that are associated with predictive biomarkers." The baseline is "15 safe and effective medical products were associated with predictive biomarkers through 2010." A target was not set for this objective because historical data are not available. In 2017, the objective moved from informational to measurable with a target. The baseline and baseline year was revised. The baseline changed from 15 in 2010 to 35 in 2014.

    References

    Additional resources about the objective

    1. FDA. Companion Diagnostic Devices (In Vitro and Imaging Tools) Database. Silver Spring, MD. Last accessed, October 24, 2014.
    2. FDA. Drugs@FDA Database. Silver Spring, MD. Last accessed, October 24, 2014.
    3. FDA. Premarket Approval (PMA) Database. Silver Spring, MD. Last accessed, October 24, 2014.
  • MPS-5 Reduce emergency department (ED) visits for common, preventable adverse events from medications

    • MPS-5.1 Reduce emergency department (ED) visits for overdoses from oral anticoagulants

      About the Data

      Description of the data source, numerator, denominator, survey questions, and other relevant details about the national estimate.

      Data Source: 
      National Ambulatory Medical Care Survey
      National Electronic Injury Surveillance System-Cooperative Adverse Drug Event Surveillance Project
      National Hospital Ambulatory Medical Care Survey
      Changed Since the Healthy People 2020 Launch: 
      Yes
      Measure: 
      per 10,000 outpatient prescription visits
      Baseline (Year): 
      35.9 (2006–07)
      Target: 
      32.3
      Target-Setting Method: 
      10 percent improvement
      Numerator: 

      Estimated number of ED visits for overdoses from oral anticoagulants

      Denominator: 

      Estimated number of outpatient prescription visits at which oral anticoagulants were prescribed

      Comparable Healthy People 2010 Objective: 
      Not applicable
      Data Collection Frequency: 
      Biennial
      Methodology Notes: 

        Measuring national rates of emergency department (ED) visits for adverse events from medications requires using two data sources. Stable annual national estimates of ED visits for adverse events due to specific medications may be calculated using NEISS-CADES, but NEISS-CADES does not collect prescribing data. N(H)AMCS data can be used to calculate national estimates of medication prescribing, but N(H)AMCS data are not robust enough to calculate stable annual estimates of ED visits for adverse events to specific medications.

        To calculate the numerator: The cause/mechanism of each adverse drug event visit is coded as allergic reaction, side-effect or overdose. Only ED visits due to overdoses are included in the numerator. In addition, up to two drugs may be implicated in the adverse event. If an oral anticoagulant appears as an implicated drug, the associated ED visit is included in the numerator. To calculate the denominator: Up to eight drugs may be identified as prescribed or continued during the outpatient visit. If an oral anticoagulant appears as a prescribed or continued drug, the associated outpatient visit is included in the denominator.

      Revision History

      Any change to the objective text, baseline, target, target-setting method or data source since the Healthy People 2020 launch.

      Description of Changes Since the Healthy People 2020 Launch: 
      In 2012, the original baseline was revised from 39.9 to 35.9 per 10,000 outpatient prescription visits due to a change in the baseline year from 2007 to 2006-2007. The target was adjusted from 35.9 to 32.3 per 10,000 outpatient prescription visits to reflect the revised baseline using the original target-setting method.

      References

      Additional resources about the objective

      1. Budnitz DS, Pollock DA, Weidenbach KN, Mendelsohn AB, Schroeder TJ, Annest JL. National surveillance of emergency department visits for outpatient adverse drug events. JAMA 2006;296:1858-66.
      2. Budnitz DS, Shehab N, Kegler SR, Richards CL. Emergency department visits for adverse drug events in older adults: the contribution of potentially inappropriate medication use. Ann Intern Med 2007;147:755-765.
      3. Jhung MA, Budnitz DS, Mendelsohn AB, Weidenbach KN, Nelson TD, Pollock DA. Evaluation and overview of the National Electronic Injury Surveillance System-Cooperative Adverse Drug Event Surveillance project (NEISS-CADES). Medical Care 2007;45 (suppl 2):S96-S102.
    • MPS-5.2 Reduce emergency department (ED) visits for overdoses from injectable antidiabetic agents

      About the Data

      Description of the data source, numerator, denominator, survey questions, and other relevant details about the national estimate.

      Data Source: 
      National Ambulatory Medical Care Survey
      National Electronic Injury Surveillance System-Cooperative Adverse Drug Event Surveillance Project
      National Hospital Ambulatory Medical Care Survey
      Changed Since the Healthy People 2020 Launch: 
      Yes
      Measure: 
      per 10,000 outpatient prescription visits
      Baseline (Year): 
      43.4 (2006–07)
      Target: 
      39.1
      Target-Setting Method: 
      10 percent improvement
      Numerator: 

      Estimated number of ED visits for overdoses from injectable antidiabetic agents

      Denominator: 

      Estimated number of outpatient prescription visits at which injectable antidiabetic agents were prescribed

      Comparable Healthy People 2010 Objective: 
      Not applicable
      Data Collection Frequency: 
      Biennial
      Methodology Notes: 

        Measuring national rates of emergency department (ED) visits for adverse events from medications requires using two data sources. Stable annual national estimates of ED visits for adverse events due to specific medications may be calculated using NEISS-CADES, but NEISS-CADES does not collect prescribing data. N(H)AMCS data can be used to calculate national estimates of medication prescribing, but N(H)AMCS data are not robust enough to calculate stable annual estimates of ED visits for adverse events to specific medications.

        To calculate the numerator: The cause/mechanism of each adverse drug event visit is coded as allergic reaction, side-effect or overdose. Only ED visits due to overdoses are included in the numerator. In addition, up to two drugs may be implicated in the adverse event. If an injectable antidiabetic agent appears as an implicated drug, the associated ED visit is included in the numerator. To calculate the denominator: Up to eight drugs may be identified as prescribed or continued during the outpatient visit. If an injectable antidiabetic agent appears as a prescribed or continued drug, the associated outpatient visit is included in the denominator.

      Revision History

      Any change to the objective text, baseline, target, target-setting method or data source since the Healthy People 2020 launch.

      Description of Changes Since the Healthy People 2020 Launch: 
      In 2012, the original baseline was revised from 51.3 to 43.4 per 10,000 outpatient prescription visits due to a change in the baseline year from 2007 to 2006-2007. The target was adjusted from 46.2 to 39.1 per 10,000 outpatient prescription visits to reflect the revised baseline using the original target-setting method.

      References

      Additional resources about the objective

      1. Budnitz DS, Pollock DA, Weidenbach KN, Mendelsohn AB, Schroeder TJ, Annest JL. National surveillance of emergency department visits for outpatient adverse drug events. JAMA 2006;296:1858-66.
      2. Budnitz DS, Shehab N, Kegler SR, Richards CL. Emergency department visits for adverse drug events in older adults: the contribution of potentially inappropriate medication use. Ann Intern Med 2007;147:755-765.
      3. Jhung MA, Budnitz DS, Mendelsohn AB, Weidenbach KN, Nelson TD, Pollock DA. Evaluation and overview of the National Electronic Injury Surveillance System-Cooperative Adverse Drug Event Surveillance project (NEISS-CADES). Medical Care 2007;45 (suppl 2):S96-S102.
    • MPS-5.3 Reduce emergency department (ED) visits for overdoses from narrow-therapeutic-index medications

      About the Data

      Description of the data source, numerator, denominator, survey questions, and other relevant details about the national estimate.

      Data Source: 
      National Ambulatory Medical Care Survey
      National Electronic Injury Surveillance System-Cooperative Adverse Drug Event Surveillance Project
      National Hospital Ambulatory Medical Care Survey
      Changed Since the Healthy People 2020 Launch: 
      Yes
      Measure: 
      per 10,000 outpatient prescription visits
      Baseline (Year): 
      8.9 (2006–07)
      Target: 
      8.0
      Target-Setting Method: 
      10 percent improvement
      Numerator: 

      Estimated number of ED visits for overdoses from narrow-therapeutic-index medications (digoxin, phenytoin, carbemazepine, divalproex, lithium)

      Denominator: 

      Estimated number of outpatient prescription visits at which narrow-therapeutic-index medications (digoxin, phenytoin, carbemazepine, divalproex, lithium) were prescribed

      Comparable Healthy People 2010 Objective: 
      Not applicable
      Data Collection Frequency: 
      Biennial
      Methodology Notes: 

        Measuring national rates of emergency department (ED) visits for adverse events from medications requires using two data sources. Stable annual national estimates of ED visits for adverse events due to specific medications may be calculated using NEISS-CADES, but NEISS-CADES does not collect prescribing data. N(H)AMCS data can be used to calculate national estimates of medication prescribing, but N(H)AMCS data are not robust enough to calculate stable annual estimates of ED visits for adverse events to specific medications.

        To calculate the numerator: The cause/mechanism of each adverse drug event visit is coded as allergic reaction, side-effect or overdose. Only ED visits due to overdoses are included in the numerator. In addition, up to two drugs may be implicated in the adverse event. If a narrow-therapeutic-index medication (digoxin, phenytoin, carbemazepine, divalproex, lithium) appears as an implicated drug, the associated ED visit is included in the numerator. To calculate the denominator: Up to eight drugs may be identified as prescribed or continued during the outpatient visit. If a narrow-therapeutic-index medication (digoxin, phenytoin, carbemazepine, divalproex, lithium) appears as a prescribed or continued drug, the associated outpatient visit is included in the denominator.

      Revision History

      Any change to the objective text, baseline, target, target-setting method or data source since the Healthy People 2020 launch.

      Description of Changes Since the Healthy People 2020 Launch: 
      In 2012, the original baseline was revised from 9.2 to 8.9 per 10,000 outpatient prescription visits due to a change in the baseline year from 2007 to 2006-2007. The target was adjusted from 8.3 to 8.0 per 10,000 outpatient prescription visits to reflect the revised baseline using the original target-setting method.

      References

      Additional resources about the objective

      1. Budnitz DS, Pollock DA, Weidenbach KN, Mendelsohn AB, Schroeder TJ, Annest JL. National surveillance of emergency department visits for outpatient adverse drug events. JAMA 2006;296:1858-66.
      2. Budnitz DS, Shehab N, Kegler SR, Richards CL. Emergency department visits for adverse drug events in older adults: the contribution of potentially inappropriate medication use. Ann Intern Med 2007;147:755-765.
      3. Jhung MA, Budnitz DS, Mendelsohn AB, Weidenbach KN, Nelson TD, Pollock DA. Evaluation and overview of the National Electronic Injury Surveillance System-Cooperative Adverse Drug Event Surveillance project (NEISS-CADES). Medical Care 2007;45 (suppl 2):S96-S102.
    • MPS-5.4 Reduce emergency department (ED) visits for medication overdoses among children less than 5 years of age

      About the Data

      Description of the data source, numerator, denominator, survey questions, and other relevant details about the national estimate.

      Data Source: 
      Bridged-race Population Estimates
      National Electronic Injury Surveillance System-Cooperative Adverse Drug Event Surveillance Project
      Changed Since the Healthy People 2020 Launch: 
      Yes
      Measure: 
      per 10,000
      Baseline (Year): 
      32.7 (2007–08)
      Target: 
      29.4
      Target-Setting Method: 
      10 percent improvement
      Numerator: 

      Estimated number of ED visits for medication overdoses among children <5 years of age

      Denominator: 

      Estimated number of children in the U.S.<5 years of age

      Comparable Healthy People 2010 Objective: 
      Not applicable
      Data Collection Frequency: 
      Biennial
      Methodology Notes: 

        The denominator measure for the indicator: “Reduce emergency department (ED) visits for medication overdoses among children <5 years of age” is different than the denominator for the other indicators regarding rate of ED visits for medication overdose.

        The denominator for this measure is the U.S. resident population of children <5 years of age (rather than a measure of medications prescribed for these children) because over 80% of ED visits for overdoses among children <5 years old are due to unsupervised ingestions, very often ingestion of medications prescribed or intended to be used by another older child or an adult. Thus, the population of children <5 years of age (rather than children <5 years of age who are prescribed medications) is the best measure of the population at risk.

        To calculate the numerator: The cause/mechanism of each adverse drug event visit is coded as allergic reaction, side-effect or overdose. Only ED visits due to overdoses are included in the numerator.

        CENSUS NOTE FOR MULTIPLE DATA YEARS: Population denominators for emergency department visit rates are calculated based on sums of the bridged-race estimates of the U.S. resident populations for each of the data years involved (e.g., the denominator of a rate for 2009-2010 combined is the sum of the population estimates for 2009 and 2010). For census years (e.g. 2010), population counts enumerated as of July 1 are used. Intercensal population estimates are used in rate calculations for the years between censuses (e.g. 1991-1999, 2001-2009).

      Revision History

      Any change to the objective text, baseline, target, target-setting method or data source since the Healthy People 2020 launch.

      Description of Changes Since the Healthy People 2020 Launch: 
      In 2012, the original baseline was revised from 32.8 to 32.7 per 10,000 children <5 years due to a change in the baseline year from 2008 to 2007-2008. The target was adjusted from 29.5 to 29.4 per 10,000 children <5 years to reflect the revised baseline using the original target-setting method. In 2015, the denominator data source name was revised from Population Estimates to Bridged-Race Population Estimates for Census 2000 and 2010. The numerator data source, baseline estimate, target, and target setting method remain unchanged.

      References

      Additional resources about the objective

      1. Budnitz DS, Pollock DA, Weidenbach KN, Mendelsohn AB, Schroeder TJ, Annest JL. National surveillance of emergency department visits for outpatient adverse drug events. JAMA 2006;296:1858-66.
      2. Cohen AL, Budnitz DS, Weidenbach KN, Jernigan DB, Schroeder TJ, Shehab N, Pollock DA. National surveillance of emergency department visits for outpatient adverse drug events in children and adolescents. J Pediatr 2008;152: 416-421.
      3. Jhung MA, Budnitz DS, Mendelsohn AB, Weidenbach KN, Nelson TD, Pollock DA. Evaluation and overview of the National Electronic Injury Surveillance System-Cooperative Adverse Drug Event Surveillance project (NEISS-CADES). Medical Care 2007;45 (suppl 2):S96-S102.