# 17  {#section .Chapter-# .unnumbered}

# Medical Product Safety

17-1 Monitoring of adverse medical events

17-1a Medical therapies

17-1b Medical devices

17-2 Linked, automated information systems

17-2a Hospitals and comprehensive, integrated health care systems

17-2b Pharmacists and other dispensers

17-3 Provider review of medications taken by patients

17-4 Receipt of useful information about prescriptions from pharmacies

17-5 Receipt of oral counseling about medications from prescribers and
dispensers

17-5a Prescribers

17-5b Pharmacists

17-6 Blood donations

17-1. (Developmental) Increase the proportion of health care
organizations that are linked in an integrated system that monitors and
reports adverse events.

  ----------------------- -----------------------------------------------
  17-1a. (Developmental)  
  Health care             
  organizations that are  
  linked in an integrated 
  system that monitors    
  and reports adverse     
  events associated with  
  medical therapies.      

  **Comments**            An operational definition could not be
                          specified at the time of publication.

                          Proposed national data sources are the Office
                          of Postmarketing Drug Risk Assessment (OPDRA),
                          MedWatch, and Manufacturer and User Device
                          Experience (MAUDE) Database, FDA.

                          An adverse event is an undesirable result from
                          use of a medical product. This includes terms
                          such as adverse drug reaction (ADR), adverse
                          experiment, and adverse effect.

                          See Appendix A for focus area contact
                          information.
  ----------------------- -----------------------------------------------

  ----------------------- -----------------------------------------------
  17-1b. (Developmental)  
  Health care             
  organizations that are  
  linked in an integrated 
  system that monitors    
  and reports adverse     
  events associated with  
  medical devices.        

  **Comments**            An operational definition could not be
                          specified at the time of publication.

                          Proposed national data sources are the Office
                          of Postmarketing Drug Risk Assessment (OPDRA),
                          MedWatch, and Manufacturer and User Device
                          Experience (MAUDE) Database, FDA.

                          An adverse event is an undesirable result from
                          use of a medical product. This includes terms
                          such as adverse drug reaction (ADR), adverse
                          experiment, and adverse effect.

                          A medical device is an instrument, apparatus,
                          implement, implant, machine, or other similar
                          or related article intended in use for the
                          diagnosis of disease or other conditions, or in
                          the cure, mitigation, treatment, or prevention
                          of disease.

                          See Appendix A for focus area contact
                          information.
  ----------------------- -----------------------------------------------

17-2. (Developmental) Increase the use of linked, automated systems to
share information.

  ----------------------- -----------------------------------------------
  17-2a. (Developmental)  
  By health care          
  professionals in        
  hospitals and           
  comprehensive,          
  integrated health care  
  systems.                

  **Comments**            An operational definition could not be
                          specified at the time of publication.

                          Proposed national data sources are the National
                          Survey of Pharmacy Practice in Acute Care and
                          Survey of Managed Care and Ambulatory Care
                          Pharmacy Practice in Integrated Health Systems,
                          American Society of Hospital Pharmacists
                          (ASHP).

                          See Appendix A for focus area contact
                          information.
  ----------------------- -----------------------------------------------

  ----------------------- -----------------------------------------------
  17-2b. (Developmental)  
  By pharmacists and      
  other dispensers.       

  **Comments**            An operational definition could not be
                          specified at the time of publication.

                          Proposed national data sources are the National
                          Survey of Pharmacy Practice in Acute Care and
                          Survey of Managed Care and Ambulatory Care
                          Pharmacy Practice in Integrated Health Systems,
                          American Society of Hospital Pharmacists
                          (ASHP).

                          See Appendix A for focus area contact
                          information.
  ----------------------- -----------------------------------------------

  ----------------------- -----------------------------------------------
  17-3. (Developmental)   
  Increase the proportion 
  of primary care         
  providers, pharmacists, 
  and other health care   
  professionals who       
  routinely review with   
  their patients aged 65  
  years and older and     
  patients with chronic   
  illnesses or            
  disabilities all new    
  prescribed and          
  over-the-counter        
  medicines.              

  **Comments**            An operational definition could not be
                          specified at the time of publication.

                          Proposed data sources are the Survey on
                          Prescription Drug Issues and Usage, AARP; and
                          the Physician Survey under the Medication Error
                          Reduction Initiative.

                          This objective is adapted from a measure in
                          Healthy People 2000 objective 12.6 (Food and
                          Drug Safety), which tracked the proportion of
                          primary care physicians who routinely review
                          with their patients aged 65 years and older all
                          prescriptions and over-the-counter medicines
                          taken by their patients each time a new
                          medication is prescribed.

                          This measure tracks the proportion of primary
                          care physicians, pharmacists, and other health
                          care professionals who routinely review with
                          their patients aged 65 years and older, as well
                          as patients with chronic illnesses or
                          disabilities all new prescribed and
                          over-the-counter medicines.

                          See Appendix A for focus area contact
                          information.
  ----------------------- -----------------------------------------------

  ----------------------- -----------------------------------------------
  17-4. (Developmental)   
  Increase the proportion 
  of patients receiving   
  information that meets  
  guidelines for          
  usefulness when their   
  new prescriptions are   
  dispensed.              

  **Comments**            An operational definition could not be
                          specified at the time of publication.

                          A proposed national data source is the
                          Patient/Consumer Medication Information Survey,
                          FDA.

                          This objective is adapted from a measure in
                          Healthy People 2000 objective 12.8 (Food and
                          Drug Safety), which tracked the proportion of
                          people who receive useful information verbally
                          and in writing for new prescriptions from
                          prescribers or dispensers. This measure tracks
                          the proportion of patients receiving
                          information that meets guidelines for
                          usefulness when new prescriptions are
                          dispensed.

                          See Appendix A for focus area contact
                          information.
  ----------------------- -----------------------------------------------

17-5. Increase the proportion of patients who receive verbal counseling
from prescribers and pharmacists on the appropriate use and potential
risks of medications.

  ----------------------- -----------------------------------------------
  17-5a. Prescribers      

  **Comments**            A complete operational definition was not
                          provided at the time of publication.

                          The national data source is the National Survey
                          of Prescription Drug Information Provided to
                          Patients, FDA.

                          This objective is adapted from a measure in
                          Healthy People 2000 objective 12.8 (Food and
                          Drug Safety), which tracked the proportion of
                          people who receive useful information verbally
                          and in writing for new prescriptions from
                          prescribers or dispensers. This measure tracks
                          the proportion of patients receiving verbal
                          counseling from prescribers only on appropriate
                          use and potential risk of medications.

                          See Appendix A for focus area contact
                          information.
  ----------------------- -----------------------------------------------

  ----------------------- -----------------------------------------------
  17-5b. Pharmacists      

  **Comments**            A complete operational definition was not
                          provided at the time of publication.

                          The national data source is the National
                          Pharmacy Consumer Survey, American
                          Pharmaceutical Association.

                          This objective is adapted from a measure in
                          Healthy People 2000 objective 12.8 (Food and
                          Drug Safety), which tracked the proportion of
                          people who receive useful information verbally
                          and in writing for new prescriptions from
                          prescribers or dispensers. This measure tracks
                          the proportion of patients receiving verbal
                          counseling from pharmacists only on appropriate
                          use and potential risk of medications.

                          See Appendix A for focus area contact
                          information.
  ----------------------- -----------------------------------------------

  ----------------------- -----------------------------------------------
  17-6. Increase the      
  proportion of persons   
  who donate blood, and   
  in so doing ensure an   
  adequate supply of safe 
  blood.                  

  **Comments**            A complete operational definition was not
                          provided at the time of publication.

                          The national data source is the American
                          Association of Blood Banks.

                          See Appendix A for focus area contact
                          information.
  ----------------------- -----------------------------------------------