FromEvidence-Based MedicinetoEvidence-Based PolicyProf. dr. Mohammad Hakimi, SpOG(K), PhD.

Case Presentation:Prophylactic Antibiotics for C-Section

IntroductionAntibiotic prophylaxis is useful in reducing incidences of surgical (operation) site infection.The use of antibiotic prophylaxis is however characterized by inappropriate practices such as use of broad-spectrum antibiotics; administering at wrong time; and continuing for too longUse of single dose has been found to be as effective as multiple doses and also cost effective to patients [1].The recommended duration of prescribed antibiotics prophylaxis for c-section has reduced from 5 days to 3 days then to 24 hrs and finally to a single dose [2] .DUE serves as a structured criteria based method of identifying, monitoring and correcting challenges encountered in practice [1] Hopkins L, Smaill F. Antibiotic prophylaxis regimens and drugs for cesarean section. Cochrane Database of Systematic Reviews 1999, Issue 2[2] Liabsuetrakul T, Lumgiganon P and Chongsuvivatwong V, Prophylactic Antibiotic Prescription for Cesarean Section, International Journal for Quality in Health Care 2002: Vol.14(6) pp. 503-508

Cost Implications of Overuse of AntibioticsMater Hospital, Kenya

Illustration using Co-amoxiclav Inj. 1.2g -Extrapolated to 600 C-Sections Annually

Chart5

412200

1236600

824400

Co-Amoxiclav

template 1 injectables

Cost of Surgical Propylaxis for C-Sections

Data source - Jan to June 2006

COST OF A SINGLE DOSECo-AmoxiclavCefuroximeComments

1.2 gm Inj.1.5 gm Inj.

ADrug Cost582492Acquisition cost (i.e. cost of drug to the pharmacy)

BPharmacy time cost2525If applicable, calculate time in minutes to prepare a single dose multiplied by average cost of employee

CNursing time cost1515time in minutes to prepare/administer a single dose multiplied by average cost of employee

DSyringe/Needle5050

EIV Set

FIV Fluids

Gloves1515

GTotal Cost to administer a single dose of antimicrobial687597Add data from items A to F (automatically calculated)

Number of C-sections9999This is the actual number of C-sections cases analyzed for the study

HTotal Cost for C-sections68,01359,103This is the actual cost of 99 C-sections analyzed for the study (automatically calculated)

INumber of yearly C-Sections600600300 C-sections were performed in Jan-June 2006 - Assumption is that 600 C-sections are performed in one year

JYearly Cost for 1 dose412,200358,200Number of yearly C-sections multiplied by total cost of a single dose of antimicrobial (automatically calculated)

KYearly Cost for 3 doses1,236,600n/aNumber of C-sections multiplied by total cost of a single dose of antimicrobial times 3 (automatically Calculated)

LCost Savings per year for using a single dose824,400878,400Difference in yearly cost for 3 doses versus 1 dose (automaticially calculated)

Note: All costs in Kenya Shillings

template 2 oral ABX

Cost of Surgical Propylaxis for C-Sections-Additional Oral Doses

Data source - Jan to June 2006

COST OF ORAL ANTIBIOTICSOral Co-amoxiclav 625mg TabletOral Cefuroxime 500mg TabletComments

ADrug Cost99169.9Acquisition cost (i.e. cost of drug to the pharmacy)

BPharmacy time cost2525If applicable, calculate time in minutes to prepare a single dose multiplied by average cost of employee

CNursing time cost77time in minutes to prepare/administer a single dose multiplied by average cost of employee, for doses given as inpatient

DSyringe/Needle

EIV Set

FIV Fluids

Gloves

GTotal Cost to administer a single dose of oral antimicrobial131201.9Add data from items A to F (automatically calculated)

Number of C-sections9999

Number of C-sections receiving oral antibiotic7878This is the actual number of C-sections cases receiving oral antibiotics for the study

HTotal Cost for C-sections receiving oral antibiotics1021815748.2This is the actual cost per single dose of oral antibiotic of C-sections analyzed for the study (automatically calculated)

Number of yearly C-Sections600600

INumber of yearly C-Sections receiving oral antibiotic473473300 C-sections were performed in Jan-June 2006 - Assumption is that a similar proportion of patients will get oral antibiotics in 600 C-sections are performed in one year

JYearly Cost for 1 dose of oral antibiotics61,92795,444Number of yearly C-sections multiplied by total cost of a single dose of antimicrobial (automatically calculated)

KYearly Cost for oral antibiotic 10 doses619,273954,436yearly cost for one dose of oral antimicrobial (automatically calculated) times 12 (automatically Calculated)

Average cost saving per patient receiving oral antibiotics1,3102,019

Overall cost saving per year on use of oral antibiotics1,573,709

LOverall Cost Savings per year for using a single dose2,452,109Comprises Difference in yearly cost for 3 doses versus 1 dose (automaticially calculated) plus cost saving on oral antibiotic

Note: All costs in Kenya Shillings

Sheet1

Sheet1

412200

1236600

824400

Co-Amoxiclav

Summary

ComponentCo-AmoxiclavCefuroxime

Yearly Cost for 1 dose$412,200358,200.00

Yearly Cost for 3 doses$1,236,600-

Extrapolated Cost Savings per year for using a single dose$824,400878,400.00

Yearly Cost for additional oral antibiotic 10 doses$619,273954,436.36

Average cost saving per patient on eliminating oral antibiotics$1,3102,019.00

Overall cost saving per year on eliminating use of oral antibiotics$1,573,709

Overall Cost Savings per year for using a single dose$2,452,109

ComponentCefuroxime

Yearly Cost for 1 dose358,200.00

Yearly Cost for 3 doses-

Extrapolated Cost Savings per year for using a single dose878,400.00

Yearly Cost for additional oral antibiotic 10 doses954,436.36

Average cost saving per patient on eliminating oral antibiotics2,019.00

Overall cost saving per year on eliminating use of oral antibiotics

Overall Cost Savings per year for using a single dose

ComponentCo-Amoxiclav Inj. 1.2gCefuroxime 1.5g Inj.

Single dose$412,200358,200.00

3-doses$1,236,600-

Savings for Single Dose$824,400878,400.00

Cost of Oral Doses$619,273954,436.36

Overall Cost Savings for Using Single Dose Injection Only$1,573,709

Overall Cost Savings per year for using a single dose$2,452,109

Summary

0

0

0

Co-Amoxiclav

Sheet3

Average Cost of an EmployeeNursePharmacy

Average Monthly Salary25,000.0050,000.00

Total Hours worked per month162.00162.00

Cost per hour154.32308.64

Cost per minute2.575.14

Time to prepare/dispense dose5.005.00

Time cost12.8625.72

Summary of Cost Implications* of Antibiotic Overuse*Note: Costs extrapolated to 600 C-sections annually

template 1 injectables

Cost of Surgical Propylaxis for C-Sections

Data source - Jan to June 2006

COST OF A SINGLE DOSECo-AmoxiclavCefuroximeComments

1.2 gm Inj.1.5 gm Inj.

ADrug Cost582492Acquisition cost (i.e. cost of drug to the pharmacy)

BPharmacy time cost2525If applicable, calculate time in minutes to prepare a single dose multiplied by average cost of employee

CNursing time cost1515time in minutes to prepare/administer a single dose multiplied by average cost of employee

DSyringe/Needle5050

EIV Set

FIV Fluids

Gloves1515

GTotal Cost to administer a single dose of antimicrobial687597Add data from items A to F (automatically calculated)

Number of C-sections9999This is the actual number of C-sections cases analyzed for the study

HTotal Cost for C-sections68,01359,103This is the actual cost of 99 C-sections analyzed for the study (automatically calculated)

INumber of yearly C-Sections600600300 C-sections were performed in Jan-June 2006 - Assumption is that 600 C-sections are performed in one year

JYearly Cost for 1 dose412,200358,200Number of yearly C-sections multiplied by total cost of a single dose of antimicrobial (automatically calculated)

KYearly Cost for 3 doses1,236,600n/aNumber of C-sections multiplied by total cost of a single dose of antimicrobial times 3 (automatically Calculated)

LCost Savings per year for using a single dose824,400878,400Difference in yearly cost for 3 doses versus 1 dose (automaticially calculated)

Note: All costs in Kenya Shillings

template 2 oral ABX

Cost of Surgical Propylaxis for C-Sections-Additional Oral Doses

Data source - Jan to June 2006

COST OF ORAL ANTIBIOTICSOral Co-amoxiclav 625mg TabletOral Cefuroxime 500mg TabletComments

ADrug Cost99169.9Acquisition cost (i.e. cost of drug to the pharmacy)

BPharmacy time cost2525If applicable, calculate time in minutes to prepare a single dose multiplied by average cost of employee

CNursing time cost77time in minutes to prepare/administer a single dose multiplied by average cost of employee, for doses given as inpatient

DSyringe/Needle

EIV Set

FIV Fluids

Gloves

GTotal Cost to administer a single dose of oral antimicrobial131201.9Add data from items A to F (automatically calculated)

Number of C-sections9999

Number of C-sections receiving oral antibiotic7878This is the actual number of C-sections cases receiving oral antibiotics for the study

HTotal Cost for C-sections receiving oral antibiotics1021815748.2This is the actual cost per single dose of oral antibiotic of C-sections analyzed for the study (automatically calculated)

Number of yearly C-Sections600600

INumber of yearly C-Sections receiving oral antibiotic473473300 C-sections were performed in Jan-June 2006 - Assumption is that a similar proportion of patients will get oral antibiotics in 600 C-sections are performed in one year

JYearly Cost for 1 dose of oral antibiotics61,92795,444Number of yearly C-sections multiplied by total cost of a single dose of antimicrobial (automatically calculated)

KYearly Cost for oral antibiotic 10 doses619,273954,436yearly cost for one dose of oral antimicrobial (automatically calculated) times 12 (automatically Calculated)

Average cost saving per patient receiving oral antibiotics1,3102,019

Overall cost saving per year on use of oral antibiotics1,573,709

LOverall Cost Savings per year for using a single dose2,452,109Comprises Difference in yearly cost for 3 doses versus 1 dose (automaticially calculated) plus cost saving on oral antibiotic

Note: All costs in Kenya Shillings

Sheet1

Sheet1

412200

1236600

824400

Co-Amoxiclav

Summary

ComponentCo-AmoxiclavCefuroxime

Yearly Cost for 1 dose$412,200358,200.00

Yearly Cost for 3 doses$1,236,600-

Extrapolated Cost Savings per year for using a single dose$824,400878,400.00

Yearly Cost for additional oral antibiotic [10 doses]$619,273954,436.36

Average cost saving per patient on eliminating oral antibiotics$1,3102,019.00

Estimated cost saving per year on eliminating use of oral antibiotics$786,855

Estimated Cost Savings per year for using a single dose of Cefuroxime Inj$1,665,255

ComponentCefuroxime

Yearly Cost for 1 dose358,200.00

Yearly Cost for 3 doses-

Extrapolated Cost Savings per year for using a single dose878,400.00

Yearly Cost for additional oral antibiotic 10 doses954,436.36

Average cost saving per patient on eliminating oral antibiotics2,019.00

Overall cost saving per year on eliminating use of oral antibiotics

Overall Cost Savings per year for using a single dose

Summary

412200

1236600

824400

Co-Amoxiclav

Sheet3

Average Cost of an EmployeeNursePharmacy

Average Monthly Salary25,000.0050,000.00

Total Hours worked per month162.00162.00

Cost per hour154.32308.64

Cost per minute2.575.14

Time to prepare/dispense dose5.005.00

Time cost12.8625.72

Antibiotics Prophylaxis for C-sectionAdministration of single dose is relatively rare Use of 3 doses, instead of a single dose of Co-amoxiclav carries huge cost implications as illustrated above. To increase the quality of antimicrobial prophylaxis in Caesarean section surgery, efforts should be put into developing guidelines acceptable to all disciplines.Other consequences of overuse of antibiotics include:Increase in antibiotic resistance and adverse drug reactionsIncrease in costs of healthcare including costs of drugs, pharmacy time, nursing care and time, and cost of consumables e.g. syringes, needles

Key Lessons learnedFear of the unknown - Irrational prescribing Combination of strategies is critical for sustainable improvementSlight policy changes can result in significant cost savingsTeamwork and mentorship is key in ensuring continuity of intervention despite staff turnoverDedication and motivated staff are key in sustainingOperational research should be integrated into regular schedule for maximum effectiveness

Strategies to Improve Antibiotic UseEvidence-Based MedicineEvidence-Based Policy

Paradigm Shift:Evidence-Based MedicineDe-emphasizes intuition, unsystematic clinical experience, and pathophysiologic rationale as sufficient grounds for clinical decision makingStresses the examination of evidence from clinical researchRequires new skills of the physician, including efficient literature searching and the application of formal rules of evidence evaluating the clinical literature

What is EBM?Evidence-based medicine (EBM) requires the integration of:The best research evidence with Our clinical expertise and Our patients unique values and circumstances.

How Do We Actually Practice EBM?Step 1: converting the need for information (about prevention, diagnosis, prognosis, therapy, causation, etc.) into an answerable question.

How Do We Actually Practice EBM?Step 2: tracking down the best evidence with which to answer that question.

How Do We Actually Practice EBM?Step 3: critically appraising that evidence for its validity (closeness to the truth), impact (size of the effect), and applicability (usefulness in our clinical practice).

How Do We Actually Practice EBM?Step 4: integrating the critical appraisal with our clinical expertise and with our patients unique biology, values, and circumstances.

How Do We Actually Practice EBM?Step 5: evaluating our effectiveness and efficiency in executing steps 14 and seeking ways to improve them both for next time.

ScenarioYou are charged with formulating a local clinical policy in your hospital about antibiotics prophylaxis at caesarean sections

The Clinical QuestionWhich antibiotic regimen is most effective in reducing the incidence of infectious morbidity in women undergoing cesarean section?

Structured Question

ParticipantsWomen undergoing any type of caesarean sectionsInterventionA single dose of prophylactic antibioticComparisonA multiple dose of prophylactic antibioticOutcomesMaternal: febrile morbidity, endometritis, wound infection and pyelonephritis.Neonatal: neonatal sepsis, neonatal septic work-up and neonatal intensive-care unit (NICU) admission.

**Hierarchy of EvidenceBestEvidenceWorstEvidence

The EvidenceHopkins L, Smaill F. Antibiotic prophylaxis regimens and drugs for cesarean section. Cochrane Database of Systematic Reviews 1999, Issue 2. Art. No.: CD001136. DOI: 10.1002/14651858.CD001136.

Main Results 1/3Fifty-one trials published between 1979 and 1994 were included in the review and four were excluded from the review. The following results refer to reductions in the incidence of endometritis.

Main Results 2/3Both ampicillin and first generation cephalosporins have similar efficacy with an odds ratio (OR) of 1.27 (95% confidence interval (CI): 0.84-1.93). In comparing ampicillin with second or third generation cephalosporins the odds ratio was 0.83 (95% CI 0.54-1.26) and in comparing a first generation cephalosporin with a second or third generation agent the odds ratio was 1.21 (95% CI 0.97-1.51).

Main Results 3/3A multiple dose regimen for prophylaxis appears to offer no added benefit over a single dose regimen; OR 0.92 (95% CI 0.70-1.23). Systemic and lavage routes of administration appear to have no difference in effect; OR 1.19 (95% CI 0.81-1.73).

Authors Conclusions Both ampicillin and first generation cephalosporins have similar efficacy in reducing postoperative endometritis. There does not appear to be added benefit in utilizing a more broad spectrum agent or a multiple dose regimen. There is a need for an appropriately designed randomized trial to test the optimal timing of administration (immediately after the cord is clamped versus pre-operative).

Strategies to Improve Antibiotic UseManagerial StrategiesDrug use evaluationGuideline on antibiotic prophylaxis in C-section.Clinical pharmacy programs.Use of automatic stop ordersEducational StrategiesFace-to-face communicationEducation outreachGroup sessions Influencing opinion leadersPrinted educational materials

PolicyThe definition of policy is often broad, including laws, regulations, and judicial decrees as well as agency guidelines and budget priorities.

PolicyPolicy is a set of principles guiding decision making. Walt (1994) distinguishes between systemic (macro) policy, which determines the basic characteristics of a society, and sectoral (micro) policy, which concerns lower-level decisions within it.

Spasoff RA. Epidemiologic Methods for Health Policy. New York, NY: Oxford University Press; 1999.

Evidence inEvidence-Based PolicyFor policy-relevant evidence, both quantitative data (e.g., epidemiological) and qualitative information (e.g., narrative accounts) are important.Policymakers operate on a different hierarchy of evidence than scientists, leaving the 2 groups to live in so-called parallel universes.Policy makers were not trained to distinguish between good and bad data, and were, therefore, prone to the influence of misused facts often presented by interest groups.

Barriers to Implementing Effective Public Health Policy 1/6

BarrierExampleLack of value placed on preventionOnly a small percentage of the annual US health care budget is allocated to population-wide approaches.Insufficient evidence baseThe scientific evidence on effectiveness of some interventions is lacking or the evidence is changing over time.

Barriers to Implementing Effective Public Health Policy 2/6

BarrierExampleMismatched time horizonsElection cycles, policy processes, and research time often do not match well.Power of vested interestsCertain unhealthy interests (e.g., tobacco, asbestos) hold disproportionate influence.

Barriers to Implementing Effective Public Health Policy 3/6

BarrierExampleResearchers isolated fromthe policy processThe lack of personal contact between researchers and policymakers can lead to lack of progress, and researchers do not see it as their responsibility to think through the policy implications of their work.

Barriers to Implementing Effective Public Health Policy 4/6

BarrierExamplePolicymaking process can be complex and messyEvidence-based policy occurs in complex systems and social psychology suggests that decision-makers often rely on habit, stereotypes, and cultural norms for the vast majority of decisions.

Barriers to Implementing Effective Public Health Policy 5/6

BarrierExampleIndividuals in any one discipline may not understand the policymaking process as a wholeTransdisciplinary approaches are more likely to bring all of the necessary skills to the table.

Barriers to Implementing Effective Public Health Policy 6/6

BarrierExamplePractitioners lack the skills to influence evidence-based policyMuch of the formal training in public health (e.g., masters of public health training) contains insufficient emphasis on policy-related competencies.

Domains of Evidence-Based Public Health Policy 1/3

DomainObjectiveData SourceExampleProcessTo understand approaches to enhance the likelihood of policy adoptionKey informant interviews Case studiesSurveys of setting-specificpolitical contextsUnderstanding the lessons learned from different approaches and key players involved in state health reforms.

Domains of Evidence-Based Public Health Policy 2/3

DomainObjectiveData SourceExampleContentTo identify specific policy elements that are likely to be effectiveSystematic reviews Content analysesDeveloping model laws on tobacco that make use of decades of research on the impacts of policy on tobacco use.

Domains of Evidence-Based Public Health Policy 3/3

DomainObjectiveData SourceExampleOutcomeTo document the potentialimpact of policySurveillance systems Natural experiments Trackingpolicy-related endpointsTracking changes in rates of self-reported seat belt use in relation to the passage of seat belt laws.Describing the cost-effectiveness of child immunization requirements.

Brownson RC, Chriqui JF, and Stamatakis KA. Understanding Evidence-Based Public Health Policy. Am J Public Health 2009;99:15761583.It has long been known that public health policy, in the form of laws, regulations, and guidelines, has a profound effect on health status. For example, in a review of the 10 great public health achievements of the 20th century, each of them was influenced by policy change such as seat belt laws or regulations governing permissible workplace exposures.

Brownson RC, Chriqui JF, and Stamatakis KA. Understanding Evidence-Based Public Health Policy. Am J Public Health 2009;99:15761583.As with any decision-making process in public health practice, formulation of health policies is complex and depends on a variety of scientific, economic, social, and political forces.

Criteria used to evaluate policy recommendationsSupported by systematic, empirical evidenceSupported by cogent argumentScale of likely health benefitLikelihood that the policy would bring benefits other than health benefitsFit with existing or proposed government policyPossibility that the policy might do harmEase of implementationCost of implementation

Macintyre, et al. Using evidence to inform health policy: case study.BMJ 2001;322:2225.

Axes of evidence-based decision-makingDobrow et al. Evidence-based health policy: context and utilisation. Social Science & Medicine 2004;58:207217.

Politicians dont like evidence-based decision making; they prefer decision-based evidence making.

Retired Federal Government Scientist

***cogent = meyakinkan, kuat