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Evidence-Based Geriatric Pharmacotherapy: 2010  H. Edward Davidson, PharmD, MPH Eastern Virginia Medical School Insight Therapeutics, LLC
Vaccines
Varicella Zoster Infection Primary Infection (Chickenpox) Latency Reactivation (Shingles) Varicella Zoster Dorsal   Ganglion
Varicella Zoster In US (Pre-Vaccine Era) Primary Infection in the U.S. 4 million cases annually 95% of persons infected by age 15 145 deaths annually; adult rate higher 12,000 hospitalizations annually
Varicella Zoster In US (Post-Vaccine Era) Primary Infection in the U.S. ~ 800,000 cases annually 81% of persons vaccinated ~ 1500 hospitalizations annually 66 deaths  annually
Risk Factors for “Shingles” ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Reducing Incidence of “Shingles” ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Number of Herpes Zoster  Cases Observed in MSGP4 Age Zoster cases Data – Children < 16 years Data – No Children Model – Children < 16 years Model – No Children Brisson, M et al. Vaccine. 2002 MSGP4 = National Survey of Morbidity in General Practice 4
Prediction of Post-Vaccination Incidence of Herpes-Zoster No Vaccination Best Fit, 20yrs immunity 95% CI, 7-41yrs immunity Zoster incidence rate (per 100,000  per year) Year after start of vaccination Brisson, M et al. Vaccine. 2002
Herpes Zoster Related Hospitalizations and Expenditures Before and After Introduction of the Varicella Vaccine in the  United States Patel MS et al. Infect Control Hosp Epidemiol 2008;29:1157-63
Herpes-Zoster Related Hospitalizations ,[object Object],[object Object],[object Object],[object Object],[object Object]
HZHDs and VRHDs by Year Universal Vaccination in U.S.
HZHDs by Year and Age Universal Vaccination in U.S.
Cost of HZHD and VRHD by Year Universal Vaccination in U.S.
Barriers to Use of  Herpes Zoster Vaccine ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Perceived Barriers to Administering HZ Vaccine in the Office 56 19 13 12 Difficulty in obtaining vaccine 35 30 23 12 More pressing medical issues 42 22 20 16 Need to store in freezer 34 18 25 23 Patient pick-up at pharmacy 19 17 21 43 Up-front costs for practice 13 10 25 52 Reimbursement issues 7 10 30 53 Cost for patient Not at all Minor Somewhat Major Responses, % Barrier
Provider strength of recommendation for herpes zoster vaccine compared with other vaccines Hurley L P et al. Ann Intern Med 2010;152:555-560 ©2010 by American College of Physicians
Take away … ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],1. Schiller JS, Euler GL. CDC, 2010.
Psychopharmacology
Snitz BE, O'Meara ES, Carlson MC, et al. Ginkgo biloba for preventing cognitive decline in older adults: a randomized trial. JAMA 2009;302:2663–2670.  DeKosky ST, Williamson JD, Fitzpatrick AL, et al. Ginkgo biloba for prevention of dementia. JAMA 2008; 300: 2253–2262.
Overview of GEMS ,[object Object],[object Object],[object Object],[object Object]
Secondary Outcomes ,[object Object],[object Object],[object Object],[object Object],[object Object]
Sites in GEMS ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Randomized Design of GEMS Persons with Normal Memory Function  or  Mild Cognitive Impairment (MCI) Consent / Randomize (3,069) Ginkgo biloba or Placebo ,[object Object],[object Object],[object Object]
GEMS Results: Baseline Characteristics
GEMS Results:  Baseline Characteristics
GEMS Results: Cumulative  Dementia Rates by Treatment
GEMS Results Hazard Ratios for Cox Regression Analyses All Dementia  and Subtypes of Dementia comparing Ginkgo to placebo
GEMS Results Adverse Events
Overall Conclusion Ginkgo biloba  at 120 mg twice a day is not effective in reducing the overall incidence of dementia or Alzheimer’s disease in older adults.  Neither is  Ginkgo biloba  effective in preventing dementia in persons with mild cognitive impairment.
GEMS Memory Study
 
 
 
A Case Study of Herbal Remedy Polypharmacy ,[object Object],[object Object],[object Object],[object Object],[object Object]
Prescription Medications ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Dietary and Herbal Supplements ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Strategies to Address this Issue ,[object Object],[object Object],[object Object],[object Object],[object Object]
Preferred Medications in the Elderly ,[object Object],[object Object],[object Object]
“Positive” Beers Criteria ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Definition: IOM ,[object Object],[object Object],[object Object],[object Object]
AHRQ’s Role in  Comparative Effectiveness Using Information to Drive Improvement: Scientific Infrastructure to Support Reform Lead federal funding Engage private sector Aggregate best evidence to inform complex learning  and implementation challenges Increase knowledge base  to spur high-value care 21 st  Century Health Care
Comparative Effectiveness  and the Recovery Act ,[object Object],[object Object],[object Object],[object Object],Federal Coordinating Council appointed to coordinate comparative effectiveness research across the federal government
Preferred CNS Medications for the Elderly Entacapone (add-on only) Ropinirole Carbidopa/Levodopa Parkinson’s Disease Citalopram Duloxetine Escitalopram Bupropion Mirtazapine Depression Donepezil Galantamine (ER only) Memantine (add-on only) Dementia Medication Therapeutic Area
Take Away … ,[object Object],[object Object],[object Object],[object Object],[object Object]
Chronic Kidney Disease
Creatinine Excretion and Serum Creatinine by Age Creatinine Excretion, mg/day Serum Creatinine Conc., mg % Average Age, years 20 40 60 80 10 73 122 152 94 68 29
Equations for Estimating GFR Abbreviated MDRD Study Equation GFR (mL/min/1.73 m 2 ) = 186.3    SCr   -1.154    Age -0.203       0.742 (if female)    1.210 (if African American)  MDRD = Modification of Diet in Renal Disease; CrCl = creatinine clearance;  SCr=serum creatinine in mg/dL Levey AS, et al. Ann Intern Med. 2003;139:137-47. Cockcroft-Gault Equation CrCl  = (mL/min) (140  – Age)    Weight in kg 72    SCr    0.85 if female
Prevalence of Low GFR in Nursing  Home Elderly – Cockcroft-Gault  Age (years) Percent of Patients Garg AX, et al. Kid Int 2004;65:649-53.
Prevalence of Low GFR in Nursing Home Elderly – MDRD Age (years) Percent of Patients Garg AX, et al. Kid Inter 2004;65:649-53.
Cockcroft-Gault (CG) or MDRD? ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],KDOQI = Kidney Disease Outcomes Quality Initiative
Drugs That Need Special Attention in CKD ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Gabardi S, Abramson S. Med Clin N Am 2005;89:649-87.
Drugs That Need Special Attention in CKD (2) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Gabardi S, Abramson S. Med Clin N Am 2005;89:649-87.
Drugs That Need Special Attention in CKD (3) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Gabardi S, Abramson S. Med Clin N Am 2005;89:649-87.
Drugs That Need Special Attention in CKD (4) ,[object Object],[object Object],[object Object],[object Object],[object Object],Gabardi S, Abramson S. Med Clin N Am 2005;89:649-87.
Drugs That Need Special Attention in CKD (5) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Gabardi S, Abramson S. Med Clin N Am 2005;89:649-87.
Transitions of Care
Transition of Care vs Transitional Care ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Coleman E, et al. J Am Geriatr Soc 2003;51:556-7.
Ineffective Transitions  Lead to Poor Outcomes ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Australian Council for Safety and Quality in Health Care. Clinical hand-over and Patient Safety literature Review Report. March 2005. Available www.safetyandquality.org/internet/safety/publishing.nsf/Content/ AA1369AD4AC5FC2ACA2571BF0081CD95/$File/clinhovrlitrev.pdf
Care Transitions 30 Days Following Acute Care Hospital Home 64% 77% 13% 11% Nursing Facility Hospital or TCU 16% 10% 74% TCU = Transitional Care Unit Coleman EA et al. Health Svcs Research 2004;37:1423-40
Predictors of Complicated  Care Transitions ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Coleman EA et al. Health Svcs Research 2004;37:1423-40. Increasing Risk
Medication Discrepancies:  Hospital to SNFs Transitions ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],SNF=Skilled nursing facility
Models of Care ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Project RED http:// www.bu.edu/fammed/projectred/index.html http://relationalagents.com/red_demo_4545.wmv
CTM-3 ,[object Object],[object Object],[object Object],http://www.caretransitions.org/documents/CTM3Specs0807.pdf
“ Ideal Transition Record” (ACP, SGIM, SHM, AGS, ACEP,  and SAEM) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Snow V et al. J Gen Intern Med 2009;24:971-6.
Medication List Toolkit www.patientsafety.org/page/109587/
H.R. 3590 and H.R. 4872 ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Working to Address the Issues www.ntocc.org
Recent Practice Guidelines  ,[object Object],[object Object],[object Object]
Questions?

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Davidson Grandrounds2010 Final

  • 1. Evidence-Based Geriatric Pharmacotherapy: 2010 H. Edward Davidson, PharmD, MPH Eastern Virginia Medical School Insight Therapeutics, LLC
  • 3. Varicella Zoster Infection Primary Infection (Chickenpox) Latency Reactivation (Shingles) Varicella Zoster Dorsal Ganglion
  • 4. Varicella Zoster In US (Pre-Vaccine Era) Primary Infection in the U.S. 4 million cases annually 95% of persons infected by age 15 145 deaths annually; adult rate higher 12,000 hospitalizations annually
  • 5. Varicella Zoster In US (Post-Vaccine Era) Primary Infection in the U.S. ~ 800,000 cases annually 81% of persons vaccinated ~ 1500 hospitalizations annually 66 deaths annually
  • 6.
  • 7.
  • 8. Number of Herpes Zoster Cases Observed in MSGP4 Age Zoster cases Data – Children < 16 years Data – No Children Model – Children < 16 years Model – No Children Brisson, M et al. Vaccine. 2002 MSGP4 = National Survey of Morbidity in General Practice 4
  • 9. Prediction of Post-Vaccination Incidence of Herpes-Zoster No Vaccination Best Fit, 20yrs immunity 95% CI, 7-41yrs immunity Zoster incidence rate (per 100,000 per year) Year after start of vaccination Brisson, M et al. Vaccine. 2002
  • 10. Herpes Zoster Related Hospitalizations and Expenditures Before and After Introduction of the Varicella Vaccine in the United States Patel MS et al. Infect Control Hosp Epidemiol 2008;29:1157-63
  • 11.
  • 12. HZHDs and VRHDs by Year Universal Vaccination in U.S.
  • 13. HZHDs by Year and Age Universal Vaccination in U.S.
  • 14. Cost of HZHD and VRHD by Year Universal Vaccination in U.S.
  • 15.
  • 16. Perceived Barriers to Administering HZ Vaccine in the Office 56 19 13 12 Difficulty in obtaining vaccine 35 30 23 12 More pressing medical issues 42 22 20 16 Need to store in freezer 34 18 25 23 Patient pick-up at pharmacy 19 17 21 43 Up-front costs for practice 13 10 25 52 Reimbursement issues 7 10 30 53 Cost for patient Not at all Minor Somewhat Major Responses, % Barrier
  • 17. Provider strength of recommendation for herpes zoster vaccine compared with other vaccines Hurley L P et al. Ann Intern Med 2010;152:555-560 ©2010 by American College of Physicians
  • 18.
  • 20. Snitz BE, O'Meara ES, Carlson MC, et al. Ginkgo biloba for preventing cognitive decline in older adults: a randomized trial. JAMA 2009;302:2663–2670. DeKosky ST, Williamson JD, Fitzpatrick AL, et al. Ginkgo biloba for prevention of dementia. JAMA 2008; 300: 2253–2262.
  • 21.
  • 22.
  • 23.
  • 24.
  • 25. GEMS Results: Baseline Characteristics
  • 26. GEMS Results: Baseline Characteristics
  • 27. GEMS Results: Cumulative Dementia Rates by Treatment
  • 28. GEMS Results Hazard Ratios for Cox Regression Analyses All Dementia and Subtypes of Dementia comparing Ginkgo to placebo
  • 30. Overall Conclusion Ginkgo biloba at 120 mg twice a day is not effective in reducing the overall incidence of dementia or Alzheimer’s disease in older adults. Neither is Ginkgo biloba effective in preventing dementia in persons with mild cognitive impairment.
  • 32.  
  • 33.  
  • 34.  
  • 35.
  • 36.
  • 37.
  • 38.
  • 39.
  • 40.
  • 41.
  • 42. AHRQ’s Role in Comparative Effectiveness Using Information to Drive Improvement: Scientific Infrastructure to Support Reform Lead federal funding Engage private sector Aggregate best evidence to inform complex learning and implementation challenges Increase knowledge base to spur high-value care 21 st Century Health Care
  • 43.
  • 44. Preferred CNS Medications for the Elderly Entacapone (add-on only) Ropinirole Carbidopa/Levodopa Parkinson’s Disease Citalopram Duloxetine Escitalopram Bupropion Mirtazapine Depression Donepezil Galantamine (ER only) Memantine (add-on only) Dementia Medication Therapeutic Area
  • 45.
  • 47. Creatinine Excretion and Serum Creatinine by Age Creatinine Excretion, mg/day Serum Creatinine Conc., mg % Average Age, years 20 40 60 80 10 73 122 152 94 68 29
  • 48. Equations for Estimating GFR Abbreviated MDRD Study Equation GFR (mL/min/1.73 m 2 ) = 186.3  SCr -1.154  Age -0.203  0.742 (if female)  1.210 (if African American) MDRD = Modification of Diet in Renal Disease; CrCl = creatinine clearance; SCr=serum creatinine in mg/dL Levey AS, et al. Ann Intern Med. 2003;139:137-47. Cockcroft-Gault Equation CrCl = (mL/min) (140 – Age)  Weight in kg 72  SCr  0.85 if female
  • 49. Prevalence of Low GFR in Nursing Home Elderly – Cockcroft-Gault Age (years) Percent of Patients Garg AX, et al. Kid Int 2004;65:649-53.
  • 50. Prevalence of Low GFR in Nursing Home Elderly – MDRD Age (years) Percent of Patients Garg AX, et al. Kid Inter 2004;65:649-53.
  • 51.
  • 52.
  • 53.
  • 54.
  • 55.
  • 56.
  • 58.
  • 59.
  • 60. Care Transitions 30 Days Following Acute Care Hospital Home 64% 77% 13% 11% Nursing Facility Hospital or TCU 16% 10% 74% TCU = Transitional Care Unit Coleman EA et al. Health Svcs Research 2004;37:1423-40
  • 61.
  • 62.
  • 63.
  • 64. Project RED http:// www.bu.edu/fammed/projectred/index.html http://relationalagents.com/red_demo_4545.wmv
  • 65.
  • 66.
  • 67. Medication List Toolkit www.patientsafety.org/page/109587/
  • 68.
  • 69. Working to Address the Issues www.ntocc.org
  • 70.

Notas del editor

  1. The number of cases of zoster observed in MSGP4 and predicted by the ‘best-fit’ model stratified by 5-year age group and household exposure to children (1-year age groups were actually used in the analysis). Figure 3(a) – Brisson M, Gay NJ, Edmunds WJ, Andrews NJ. Exposure to varicella boosts immunity to herpes-zoster: implications for mass vaccination against chickenpox. Vaccine. 2002;20:2500-7.
  2. Incidence of zoster over time after the introduction of vaccination for the ‘best-fit’ model (1/ σ = 20 years) and the 95% confidence bounds of 1/ σ (7 and 41 years). Figure 4(b) – Brisson M, Gay NJ, Edmunds WJ, Andrews NJ. Exposre to varicella boots immunity to herpes-zoster: implications for mass vaccination against chickenpox. Vaccine. 2002;20:2500-7.
  3. Provider strength of recommendation for herpes zoster vaccine compared with other vaccines.
  4. It is important to note that these estimates are assuming stable (or very slowly progression deterioration – as in most CKD conditions) renal function and cannot be expected to represent a true picture of renal function when the creatinine is rapidly changing. This variability in serum creatinine is less likely in patients with CKD unless they have acute or chronic renal failure from a superimposed insult. Ideal body weight (IBW) is recommended for using Cockcroft-Gault except when the patients actual body weight is less than ideal, in which case you use the actual weight. For obese pts, use of the IBW or a “fudge factor” such as an adjusted dosing weight may yield a better estimate. If the patient is greater than 20% over IBW, use the following: [(Actual weight – IBW) x 0.4 ] + IBW = Adjusted dosing weight Levey AS, Coresh J, Balk E, et al. National Kidney Foundation practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Ann Intern Med. 2003;139:137-47
  5. The objective of this study was to estimate the prevalence of low glomerular filtration rate (GFR) in a large sample of elderly adults living in long-term care facilities, and to compare two commonly used methods for estimating GFR. A total of 9931 residents aged 65 years and older participated in a retrospective cross-sectional study of 87 long-term care facilities in Ontario. GFR was estimated by the Cockcroft-Gault and Modification of Diet in Renal Disease Study (MDRD) equations. The prevalence of low GFR, using the Cockcroft-Gault equation (&lt;30 mL/min), was compared with the MDRD equation (&lt;30 mL/min/1.73 m 2 ). A total of 17.0% (95% CI 15.6 to 18.5) of men and 14.4% (95% CI 13.6 to 15.3) of women had a serum creatinine concentration above the laboratory reported upper reference limit of normal. The prevalence of both elevated serum creatinine and low GFR were observed to increase with age (P &lt; 0.0001). The Cockcroft-Gault equation produced a consistently lower estimate of GFR than did the MDRD equation, a discrepancy most pronounced in the oldest residents. Among all men, a low GFR was more prevalent using the Cockcroft-Gault (10.3%, 95% CI 9.2 to 11.5) than MDRD (3.5%, 95% CI 2.8 to 4.2) equation, with a similar difference also seen in women (23.3%, 95% CI 22.4 to 24.3 versus 4.0%, 95% CI 3.6 to 4.5), respectively Garg AX, et al. Estimating the prevalence of renal insufficiency in seniors requiring long-term care. Kid Int 2004;65:649-53.
  6. Of all residents whose Cockcroft-Gault estimated GFR was under 30 mL/min, 14.7% (95% CI 13.2 to 16.3) were found to have GFR greater than 60 mL/min/1.73 m2 according to the MDRD equation. The authors concluded age-associated renal impairment is common among elderly long-term care residents, but there exists a clear discrepancy between the Cockcroft-Gault and MDRD equations in predicting GFR. Garg AX, et al. Estimating the prevalence of renal insufficiency in seniors requiring long-term care. Kid Inter 2004;65:649-53.
  7. The Cockcroft-Gault equation is best used for dosing medications. The K/DOQI recommends using the MDRD equation for diagnosing CKD. Levey AS, Coresh J, Balk E, et al. National Kidney Foundation practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Ann Intern Med. 2003;139:137-47
  8. Patients with chronic kidney disease (CKD) are at high risk for adverse drug reactions and drug-drug interactions. Drug dosing in these patients often proves to be a difficult task. Renal dysfunction-induced changes in human pathophysiology regularly results may alter medication pharmacodynamics and handling. Several pharmacokinetic parameters are adversely affected by CKD, secondary to a reduced oral absorption and glomerular filtration; altered tubular secretion; and reabsorption and changes in intestinal, hepatic, and renal metabolism. In general, drug dosing can be accomplished by multiple methods; however, the most common recommendations are often to reduce the dose or expand the dosing interval, or use both methods simultaneously. Some medications need to be avoided all together in CKD either because of lack of efficacy or increased risk of toxicity. Nevertheless, specific recommendations are available for dosing of certain medications and are an important resource, because most are based on clinical or pharmacokinetic trials. Gabardi S, Abramson S. Drug dosing in chronic kidney disease. Med Clin N Am 2005;89:649-87.
  9. Gabardi S, Abramson S. Drug dosing in chronic kidney disease. Med Clin N Am 2005;89:649-87.
  10. Gabardi S, Abramson S. Drug dosing in chronic kidney disease. Med Clin N Am 2005;89:649-87.
  11. Gabardi S, Abramson S. Drug dosing in chronic kidney disease. Med Clin N Am 2005;89:649-87.
  12. A useful reminder is that insulin in cleared by the kidney (and sulfonylureas as well) and that hypoglycemia (or for that matter improvement of glycemic control) may be a sign of worsening renal function.
  13. Transition of care is the movement of patients from one health care practitioner or setting to another as their condition and care needs change and it necessarily occurs at multiple levels. It occurs 1) within settings, such as primary care and specialty care in the context of care in the community, 2) between settings, such as someone who moves from the hospital to the rehabilitation facility, and it occurs 3) across health states, such as from receiving care in the home to needing care in assisted living. Persons whose conditions require complex, continuous care frequently require services from different practitioners in multiple settings, but practitioners in each setting often operate independently, without knowledge of the problems addressed, services provided, information obtained, medications prescribed, or preferences expressed in previous settings. The growing national trend for physicians and other clinicians to restrict their practices to single settings (e.g., hospitals, skilled nursing facilities, or ambulatory clinics) and not to follow complex patients as they move between settings heightens this potential for fragmentation of care. During transitions, these patients are at risk for medical errors, service duplication, inappropriate care, and critical elements of the care plan “falling through the cracks.” Ultimately, poorly executed care transitions may lead to poor clinical outcomes; dissatisfaction among patients; and inappropriate use of hospital, emergency, postacute, and ambulatory services. Coleman EA, Boult C. Improving the quality of care for persons with complex care needs. J Am Geriatr Soc 2003;51:556-7.
  14. The Australian Resource Centre for Healthcare Innovations (ARCHI) was contracted by the Australian Council for Quality and Safety in Health Care (the Council) to undertake a comprehensive review of published and unpublished literature on clinical handover and patient safety. The literature review was designed to identify: • factors relating to clinical handover associated with patient safety; • the effectiveness of safety cultures within non-health industries; and • the quality of evidence and gaps in research. For the purpose of the report, clinical handover includes communication between the change of shift, communication between care providers about patient care, handoff, records, and information tools to assist in communication between care providers about patient care. Patient safety includes the variables that limit or affect preventable adverse patient outcomes and errors. Information that transfers between practitioners about patient care is becoming recognized as an important consideration in improving patient safety, work flow and quality care. Ineffective handover can lead to wrong treatment, delays in medical diagnosis, life threatening adverse events, patient complaints, increased health care expenditure, increased hospital length of stay, and a range of other effects that impact on the health system. A number of industries, unrelated to the health system, can provide new insights into improving handover and workers’ safety. For this reason there are sections relating to nonhealth related industries in this report. These industry areas are most commonly mining, heavy industries, and aviation. It is anticipated that the practices adopted and evaluated in non-health industries could be applied to the health sector. This review was undertaken over a 3-month period and used published and unpublished literature that describes the handover process and the impact on safety. Literature was drawn from the ARCHI extensive network of practitioners and researchers internationally contributing particularly to the collection of “grey literature” or unpublished material. Extensive searching was undertaken using electronic databases including websites.