Assessment of Injection Practices in India (2002-2003) An IndiaCLEN Program Evaluation Network Study

1
Assessment of Injection Practices in India
(2002-2003) An IndiaCLEN Program Evaluation
Network Study

• In Partnership with
• Ministry of Health and Family Welfare, GOI
• World Bank
• Clinical Epidemiology Unit
• All India Institute of Medical Sciences
• New Delhi

Assessment of Injection Practices In India An
IPEN Study
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Scheme of presentation

1. Objectives of the study methodology
2. Magnitude of injections
3. Safety profile of injections
4. Sterilization disposal
5. Summary discussion points

Assessment of Injection Practices In India An
IPEN Study
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Assessment of Injection Practices in India

• Research Questions
• What is the current frequency of injection use in
  India?
• 2. What proportion of injections in India are
  unsafe?
• 3. What proportion of injections are not
  required?
• What determines use of injections?
• Outcome of the Study
• What options are available for India to improve
  rationale and safe use of injections?

Assessment of Injection Practices In India An
IPEN Study
Assessment of Injection Practices In India An
IPEN Study
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Assessment of Injection Practices in India
(2002-2003) An IndiaCLEN Program Evaluation
Network Study
Assessment of Injection Practices In India An
IPEN Study
Assessment of Injection Practices In India An
IPEN Study
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Qualitative Study
Health policy makers
Health program managers
Community
Determinants of Injection Practices
Public H F Immunization
Curative Private H F
Professional bodies
Industry
Prescribers
Providers
Assessment of Injection Practices In India An
IPEN Study
Assessment of Injection Practices In India An
IPEN Study
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Assessment of Injection Practices in India
(2002-2003) An IndiaCLEN Program Evaluation
Network Study
Study Centers(Qualitative Study)
Assessment of Injection Practices In India An
IPEN Study
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Data Collection
Stakeholders Stakeholders Interviews Interviews FGDs
Stakeholders Stakeholders Expected Conducted FGDs
District level Providers District level Providers 120 120
Professional Bodies Representatives Professional Bodies Representatives 48 48
Commercial Sector Representatives Commercial Sector Representatives 72 72
Prescribers Prescribers 288 288 24_at_
Injection givers Injection givers 288 288 24_at_
Clients (Curative Injections) Utilizers 576 578 42
Clients (Curative Injections) Non-utilizers 576 578 42
Clients (Immunization Injections) Clients (Immunization Injections) 288 291
Facilitators Facilitators 144 144
Bio-medical Waste Handlers Bio-medical Waste Handlers 240 240
TOTAL TOTAL 2640 2647 (22) 96
22 Interviews were conducted to replace the
interviews rejected at Regional Centers _at_ FGD
with Informal Prescribers could not be conducted
at one center due to their non-availability an
additional FGD with Injection Givers was
conducted instead
Assessment of Injection Practices In India An
IPEN Study
Assessment of Injection Practices In India An
IPEN Study
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Quantitative Study
Observation of Health facility
Community Interview of Clients
Community Health Facility survey for prevalence
of injections Injection practices
Direct Observation of Injection practices
Exit Interviews
Prescribers Interview
Assessment of Injection Practices In India An
IPEN Study
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IPEN Study
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Objectives of the study

1. To determine the magnitude of unsafe injections
   (both curative and preventive)

• To achieve this we observed injection procedures
  at each of the three health facilities
• Govt. Health Facility
• Private Health Facility
• Immunization Clinic

Assessment of Injection Practices In India An
IPEN Study
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IPEN Study
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Objectives of the study cont

1. To determine the proportion of health care
   facilities (public / private / immunization
   clinics) where process of injections is unsafe
2. To determine the proportion of health care
   facilities where sharps waste management is
   inadequate

To achieve these we observed three health
facilities at each cluster Govt. Health
Facility Private Health Facility
Immunization Clinic
Assessment of Injection Practices In India An
IPEN Study
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IPEN Study
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Objectives of the study Contd

1. To determine the proportion of prescriptions
   given at health facilities (public / private)
   that include injection(s)
2. To determine the proportion of patients with
   common conditions (fever, diarrhea and ARI) which
   are prescribed injections

To achieve this we did Govt. Health Facility
- 5 Exit interviews Private Health Facility - 5
Exit interviews
Assessment of Injection Practices In India An
IPEN Study
Assessment of Injection Practices In India An
IPEN Study
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Objectives of the study Contd

1. To determine the frequency of injections in the
   community (injections / person / unit time)
2. To determine the indications of injections
   (curative / preventive)

To achieve this we did Community Survey - 10
Male Clients (per cluster) 10 Female Clients
Assessment of Injection Practices In India An
IPEN Study
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IPEN Study
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Study Methodology

1. Population based Survey
2. Health facility based Survey

Rapid population based cluster survey at
household and health facilities Communities
selected using probability proportionate to
size (PPS) technique Census data base (1991)
utilized for selecting the clusters (Growth rate
of 2.28 is added to simulate current
population) Separate group of clusters for
Urban and Rural areas
Assessment of Injection Practices In India An
IPEN Study
Assessment of Injection Practices In India An
IPEN Study
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Assessment of Injection Practices in India
(2002-2003) An IndiaCLEN Program Evaluation
Network Study
Study Zones
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IPEN Study
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Assessment of Injection Practices in India
(2002-2003) An IndiaCLEN Program Evaluation
Network Study
Study Centers(n84)(Quantitative Study)
Medical Colleges 69 NGOs 9 Pub Health Inst
6
Assessment of Injection Practices In India An
IPEN Study
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Data Collection Contd..
Urban Urban Rural Rural Total Total
Proposed Done () Proposed Done () Proposed Done ()
Govt. Health facility
Observation 600 601 (100.1) 600 596 (99.3) 1200 1197 (99.8)
Injection Procedure Observation 3000 2962 (98.7) 3000 2980 (99.3) 6000 5942 (99.0)
Prescriber Interview 600 601 (100.1) 600 602 (100.3) 1200 1202 (100.2)
Exit Interview 3000 3006 (100.2) 3000 3009 (100.3) 6000 6015 (100.3)
Pvt. Health Facility
Observation 600 602 (100.3) 600 598 (99.7) 1200 1200 (100)
Injection Procedure Observation 3000 2968 (98.9) 3000 2991 (99.7) 6000 5959 (99.3)
Prescriber Interview 600 601 (100.1) 600 598 (99.7) 1200 1200 (100)
Exit Interview 3000 3004 (100.1) 3000 2993 (99.8) 6000 5997 (99.9)
Immunization Clinic
Observation 600 601 (100.1) 600 594 (99) 1200 1195 (99.6)
Injection Procedure Observation 3000 2965 (98.8) 3000 3002 (100.1) 6000 5967 (99.5)
Clients
Men 6000 6010 (100.2) 6000 6013 (100.2) 12000 12023 (100.2)
Women 6000 5976 (99.6) 6000 5976 (99.6) 12000 11974 (99.8)
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Characteristics of Interviews (Community Survey
Exit Survey at Health Facility)
Approached Not Available Refused Participated Participation Rate
Community Survey Community Survey Community Survey Community Survey Community Survey Community Survey
Rural 16950 4034 930 11986 92.8
Urban 16681 4071 621 11989 95.1
Total 33631 8105 1551 23975 93.9
Exit Interview Exit Interview Exit Interview Exit Interview Exit Interview Exit Interview
GHF
Rural 3442 433 3009 87.4
Urban 3512 506 3006 85.5
Total 6954 939 6015 86.5
PHF
Rural 3393 400 2993 88.2
Urban 3433 429 3004 87.5
Total 6826 829 5997 87.9
These columns together are denominators for
participation rate
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Characteristics of Interviews (Health facility
Survey)
Approached Not Available Refused Participated Participation Rate
GHF GHF GHF GHF GHF GHF
Rural 681 30 0 651 100
Urban 640 32 6 602 99.0
Total 1321 62 6 1253 99.5
PHF PHF PHF PHF PHF PHF
Rural 803 61 78 664 89.4
Urban 833 91 113 629 84.8
Total 1636 152 191 1293 87.1
IMC IMC IMC IMC IMC IMC
Rural 701 50 1 650 99.9
Urban 677 19 9 649 98.8
Total 1378 69 10 1296 99.2
All India All India All India All India All India All India
Rural 2185 141 79 1965 96.1
Urban 2147 142 128 1877 93.6
Total 4332 283 207 3842 93.7
These columns together are denominators for
participation rate
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Quality Assurance Mechanisms
Facilitate common understanding of the
objectives and data collection methods
Obtain group consensus in finalizing the
interview schedules
National Protocol Finalization
Workshop (CCTZCPI)
Level 1
Ensure common understanding of the
objectives and data collection methods
Provide hands on experience
Zonal Workshops (CCTZCResearch Teams)
Level 2
Check quality of work being done by each
team in the field Take corrective steps, if
needed
CCT Members Field Visits (Assigned Zones)
Level 3
Scrutinize responses and appropriate coding
on the schedules ICR sheets
Data Collection(Research Teams)
Level 4
Checks for completeness Checks for
appropriate tick marks on the ICR sheets Do
consistency range checks
Data Management (CCO)
Level 5
Assessment of Injection Practices In India An
IPEN Study
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IPEN Study
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Magnitude of various types of injections in the
country
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IPEN Study
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Magnitude of Injections in India - I
Total Rural Urban Significance Test (p)
No. of inj/person/year based on three month recall Total 3.0 3.0 2.9 0.86
No. of inj/person/year based on three month recall ? 1 year 5.8 5.7 6.3 0.115
No. of inj/person/year based on three month recall gt 1 year 2.8 2.9 2.7 0.635
No. of injections /person/year (2 week recall) Total 5.8 6.1 4.9 0.008
No. of injections /person/year (2 week recall) ? 1 year 9.5 9.2 10.1 0.35
No. of injections /person/year (2 week recall) gt 1 year 5.6 6.0 4.6 0.004
The No. of injections received in last three
months The no. of injections received in last
two weeks
Assessment of Injection Practices In India An
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Magnitude of Injections in India - II (based on
two week recall) Zone wise estimation
ALL INDIA 5.8
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IPEN Study
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Magnitude of Vaccine Injections in India-I
Total Rural Urban
Proportion of injections as vaccines in past three months Total 17.6 16.1 21.7
Proportion of injections as vaccines in past three months ? 1 year 65.3 62.8 71.2
Proportion of injections as vaccines in past three months gt 1 year 12.2 11.1 15.2
Of the no. of injections recd in last 3 months
how many were vaccine injections.
Assessment of Injection Practices In India An
IPEN Study
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Magnitude of Vaccine Injections in
India-II (proportion of all injections 3 month
recall) Zone wise estimation
ALL INDIA 17.6
Assessment of Injection Practices In India An
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Magnitude of Vaccine Curative Injections at
different Health Facilities(as per reason given
for last injection)
Settings Vaccines Vaccines Vaccines Curative
Settings ? 1 year gt 1 year Total Curative
Private 22.9 43.6 31.9 77.1
Government 77.1 56.4 68.0 22.9
Assessment of Injection Practices In India An
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Proportion of prescriptions containing advise for
Injection
Type of Health Facility Type of Health Facility Observations Exit Interviews
Government Government 38.5 40.3
Private Private 45.9 47.6
ALL INDIA Total 40.8 45.7
ALL INDIA Rural 45.3 48.9
ALL INDIA Urban 36.3 42.6
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Magnitude of Plastic Syringe Use(as a Proportion
of Last Injection Given)
All India Estimate 72.8
All India 95 CI 71.4 74.2
Rural Estimate 68.2
Rural 95 CI 66.1 70.3
Urban Estimate 77.4
Urban 95 CI 75.5 79.3
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Magnitude of Plastic Syringe Use (as a
Proportion of Last Injection Given)
ALL INDIA 72.8
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Safety profile of injections

• Criteria for unsafety
• Areas of unsafety

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Criteria for unsafe injection

• Major criteria (any 1 of the following)
• Use of opened/used plastic/glass syringe/needle.
• Syringe/needle flushed before use
• Injection given over clothes.
• Needle wiped with a swab
• Needle touching any surface before use.
• One syringe-needle used for more than one
  patient.
• Minor criteria ( more than 3 of the following)
• Not wearing gloves / Not washing hands before
  giving injection
• Glass syringe/needle picked up from boiler
• Drug drawn from broken vial or multidose vial
  with needle or mixing 2-3 medicines
• Multidose vial not wiped clean before drawing
• Injection site not cleaned
• Recapping needle
• Not flushing glass syringe after use

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Areas of unsafety

• Using equipment of doubtful sterility
• Reusing unsterile injection equipment
• Unsafe injection giving habits

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Characteristics of unsafe Injection All India
Total Plastic Glass
Unsafe 60.5 54.3 81.1
Questionable Sterility 23.8 17.7 45.2
Reuse 16.2 11.8 31.6
Wrong Habits of Injection Givers 50.7 46.1 65.0
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Characteristics of unsafe Injection Govt.
Health Facility
Total Plastic Glass
Unsafe 68.6 61.3 84.1
Questionable Sterility 29.6 20.8 46.9
Reuse 17.2 11.3 27.9
Wrong Habits of Injection Givers 56.9 52.7 66.4
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Characteristics of unsafe Injection Private
Health Facility
Total Plastic Glass
Unsafe 59.7 55.8 80.8
Questionable Sterility 23.3 18.6 49.3
Reuse 19.2 13.7 45.5
Wrong Habits of Injection Givers 50.5 47.2 64.4
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Characteristics of unsafe Injection
Immunization Clinic
Total Plastic Glass
Unsafe 73.9 64 86.3
Questionable Sterility 27.1 18.3 38.6
Reuse 15.2 11.6 21.5
Wrong Habits of Injection Givers 65.5 56.2 75.1
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Magnitude of Plastic Syringe Use(as a proportion
of past injection given - health facility wise)
Type of health facility Estimate 95 CI
Govt 62.6 59.7 65.4
Private 80.5 78 83
Imm Clinic 52.2 49 55.4
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Characteristics of unsafe injections health
facility wise
Total Plastic Glass
All India 60.5 54.3 81.1
Govt HF 68.6 61.3 84.1
Pvt HF 59.7 55.8 80.8
Imm Clinic 73.9 64 86.3
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Sterilization Disposal profile
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Sterilization Equipments Fuels at Health
Facilities
Type of Health Facility Type of Health Facility Sterilization Equipments Sterilization Equipments Fuel Availability
Type of Health Facility Type of Health Facility Available Functional (as of Available) Fuel Availability
Government Government 95.0 96.7 90.3
Private Private 72.5 99.6 69.8
Immunization Clinic Immunization Clinic 88.6 97.3 84.4
ALL INDIA Total 80.2 98.2 77.3
ALL INDIA Rural 81.7 98.2 78.5
ALL INDIA Urban 78.8 98.2 76.1
Sterilizer / Pressure Cooker/ Autoclave
Kerosene /Gas / Wood / Oil / Electricity
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Definition Acceptable injection related waste
disposal at health facility level

• If used plastic syringes were disposed using ONE
  of the following methods
• Put in a jar /containing hypochlorite solution.
• Collected in a dustbin
• Broke the syringe or needle and then discarded.

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Acceptable method of injection related waste
disposalat HF level (as observed by the
investigators)
Type of Health Facility Type of Health Facility Generic Observation Specific Observation Generic Observation Specific Observation
Type of Health Facility Type of Health Facility Plastic Syringes Plastic Syringes Plastic Needles Plastic Needles
Government Government 60.5 72.4 54.8 82.1
Private Private 62.3 74.2 50.8 85.9
Immunization Clinic Immunization Clinic 50.9 78.6 43.2 86.4
ALL INDIA Rural 58.4 66.1 47.6 69.6
ALL INDIA Urban 69.8 74.1 56.9 77.1
ALL INDIA Total 64.3 70.4 52.4 73.6
Assessment of Injection Practices In India An
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Definition Acceptable terminal disposal of
injection related waste

• If used plastic syringes were disposed using ONE
  of the following methods
• Buried in a pit.
• Carried away by municipal/panchayat workers for
  proper disposal.
• Sent to incinerator.

Assessment of Injection Practices In India An
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Acceptable Terminal Disposal of injection related
wastes at health facilities (as observed by
investigators)
Type of Health Facility Type of Health Facility Estimate 95 CI
Government Government 53.5 49.8 - 57.2
Private Private 41.5 37.9 - 45.2
Immunization Clinic Immunization Clinic 49.1 45.3 - 52.9
ALL INDIA Rural 43.7 40.8 - 46.7
ALL INDIA Urban 50.3 47.3 - 53.3
ALL INDIA Total 47.1 44.9 - 49.2
Assessment of Injection Practices In India An
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Health facilities selling plastic injection waste
to rag-pickers
Type of health facility Estimate 95 CI
Govt 3.2 1.8 4.5
Private 15.1 12.3 17.9
Imm Clinic 2.9 1.6 4.2
All India 8 6.9 9.1
Assessment of Injection Practices In India An
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Summary Points to Ponder
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IPEN Study
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Magnitude of Injections in India Its
Implications
Yearly burden
3 Month Recall 2 Week Recall
Annual 300 cr 600 cr
Unsafe (0.6) 180 cr 360 cr
Likely Burden of New Cases of Blood Borne Infections Likely Burden of New Cases of Blood Borne Infections Likely Burden of New Cases of Blood Borne Infections Likely Burden of New Cases of Blood Borne Infections
HBV HCV HIV
Total
Immunization Sector
(Y Hutin)
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Summary Points to Ponder - II

• 60 of of injections administered at the country
  level are unsafe.
• Safety of injections is poorest at immunization
  clinics.
• Use of glass syringes increases unsafety by over
  20 as compared to plastic syringes.
• Use of glass syringe is maximum at immunization
  clinics

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IPEN Study
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Determinants of unnecessary injections(from
qualitative data)

• Prescribers / Injection givers -Prescribing
  unnecessary injections is quite common -
  to satisfy patients - for quick relief - to
  make money - to maintain credibility keep
  practice floating - influenced by the medical
  representatives - to clear stock of injectables
  lying in stores - patients demand for injections
  
• Prescribers even give distilled water injections
  at times, to satisfy patients demand
• More by the quacks PPs and in home setting

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Summary Points to Ponder - IV

• 73 of all injections administered in the
  country use plastic syringes and/or needles
• Rural areas 68
• Urban area 77

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IPEN Study
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Summary Points to Ponder - V

• Disposal of injection related waste
• Acceptable waste disposal
• at health facilities level 65
• Acceptable terminal
• waste disposal 47

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Magnitude of Injections In India_at_ Location of
Injection
Public Sector Private sector
Curative (Unsafe 0.6) 60 cr (36 cr) 185 cr (111 cr)
Vaccines (Unsafe 0.6) 36 cr (22 cr) 19 cr (11 cr)
Total (Unsafe) 96 cr (58 cr) 204 cr (122 cr)
_at_ Estimate based on 3 month recall
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Points to Ponder - VII
Issues related to unsafety can be categorized
under
Problem area Possible area of remedy
Use of unsafe injection equipment (39) Different type of injection equipment / improve sterilization habits
Reuse of unsterile injection equipment (27) Different type of injection equipment / ?? Behavioral change
Wrong habits of injection givers (84) Proper Training / behavioral change
Assessment of Injection Practices In India An
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Thank you
Assessment of Injection Practices In India An
IPEN Study
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TimelineCommunication of Results
Activity Date Months
Communication of Preliminary Results 10 December, 2003
Report Writing December - February, 2003
Circulation of Draft Report among partners February, 2003
Submission of Final Report March, 2003
Assessment of Injection Practices In India An
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Acceptable method of waste disposal (as observed
by Investigators)
Type of Health Facility Type of Health Facility Generic Observation Generic Observation Specific Observation Specific Observation
Type of Health Facility Type of Health Facility Plastic Syringes Plastic Needles Plastic Syringes Plastic Needles
Government Government 60.5 54.8 72.4 82.1
Private Private 62.3 50.8 74.2 85.9
Immunization Clinic Immunization Clinic 50.9 43.2 78.6 86.4
ALL INDIA Rural 58.4 47.6 66.1 69.6
ALL INDIA Urban 69.8 56.9 74.1 77.1
ALL INDIA Total 64.3 52.4 70.4 73.6
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Terminal Disposal of wastes at health facilities
Type of Health Facility Type of Health Facility Estimate 95 CI
Government Government 53.5 49.8-57.2
Private Private 41.5 37.9-45.2
Immunization Clinic Immunization Clinic 49.1 45.3-52.9
ALL INDIA Rural 43.7 40.8-46.7
ALL INDIA Urban 50.3 47.3-53.3
ALL INDIA Total 47.1 44.9-49.2
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TimelineCommunication of Results
Activity Date Months
Communication of Preliminary Results 10 December, 2003
Report Writing December - February, 2003
Circulation of Draft Report among partners February, 2003
Submission of Final Report March, 2003
Assessment of Injection Practices In India An
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Summary Discussion Points -I
59
Summary Discussion Points -II
60
Summary Discussion Points -III
61
Summary Discussion Points -IV
62
Injection Givers at various Health Facilities
Type of Health Facility Type of Health Facility Helper/ Trainee/ Assistant Health Worker/ Compounder/ Pharmacist/Nurse Doctor/ Prescriber
Government Rural 7.4 95.1 8.6
Government Urban 5.4 94.9 7.1
Government Total 6.9 95.1 8.2
Private Rural 22.2 29.4 65.6
Private Urban 18.3 47.5 49.3
Private Total 21.1 34.5 61.0
Immunization Clinic Rural 2.4 98.1 2.5
Immunization Clinic Urban 3.8 96.2 3.8
Immunization Clinic Total 2.8 97.6 2.8
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Interaction between Prescribers Clients (as
observed by Investigators)
Type of Health Facility Type of Health Facility No discussion/ Doctor decides Prescriber promotes injection Client demands injection
Government Government 61.6 10.9 11.0
Private Private 54.6 17.7 11.3
ALL INDIA Rural 54.6 17.1 11.8
ALL INDIA Urban 59.0 13.3 8.5
ALL INDIA Total 56.8 15.2 10.2
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Unsafe Injection Use at Health Facilities
(Government, Private vs Immunization)
ALL INDIA Govt. - 68.6 Pvt. -
59.8 Immn. - 73.9
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Number of Injections per Person per Year
(According to two week recall - Rural vs Urban)
ALL INDIA Rural - 6.3 Urban - 5.2
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Number of Injections per Person per Year
(According to three month recall)
ALL INDIA 3.1
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Number of Injections per Person per Year
(According to two week recall - Rural vs Urban)
ALL INDIA Rural - 3.1 Urban - 3.1
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Proportion of Injections as Vaccines in last 3
months (Rural vs Urban)
ALL INDIA Rural - 20.6 Urban - 26.7
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Plastic Syringe Used as a Proportion of Last
Injection Given(Rural vs Urban)
ALL INDIA Rural - 59.0 Urban - 74.0
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Rationale of prescribing Injections
Type of Health Facility Other Diseases Diarrhea / Fever / Cough
Government 46.4 34.2
Private 51.9 49.5
Total 48.5 42.9
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Availability of Fuels at Health facilities
ALL INDIA 77.3
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Availability of Fuels at Various Health
facilities (Government, Private vs Immunization)
ALL INDIA Govt. - 90.3 Pvt. -
69.8 Immn. - 84.4
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Proportion of Unsafe Injections due to Injection
Equipment, Reuse Recycle
Type of Health Facility Type of Health Facility Injection Equipment Reuse/Recycle (Plastic)
Government Government 33.9 27.6
Private Private 31.4 23.9
Immunization Clinic Immunization Clinic 29.6 29.2
ALL INDIA Rural 34.2 28.5
ALL INDIA Urban 24.8 16.9
ALL INDIA Total 29.5 22.3
Assessment of Injection Practices In India An
IPEN Study