ASSESSMENT OF COLD CHAIN STATUS FOR

IMMUNIZATION IN CENTRAL ETHIOPIA

By

Bezunesh Rogie

Advisors: Professor Yemane Berehane (MD, MPH, PhD)

Dr. Filimona Bisrat (MD, MPH)

May, 2012

Outline of the presentation

1. Introduction

2. Rationale of the study

3. Study context/Area

4. Objectives

5. Methods

6. Results and Discussions

7. Strength and Limitation

8. Conclusions

9. Recommendations

10. Acknowledgement 2

Introduction

• Globally Expended Program on Immunization (EPI) was launched by WHO in 1974 against six childhood diseases: polio, measles, tetanus, diphtheria, pertussis, and tuberculosis.

• Ethiopia had introduced EPI in 1980 with the intention of increasing the annual coverage by 10% and reach 100% coverage in 1990.

• In the past decade, more efforts had been focused towards the increment of vaccine coverage, considered as one of the indicators to measure the success of immunization programs.

And in 3

Introduction con..

• Inadequate attention was given to address the issue of quality of vaccination that greatly depended on two main factors;

cold chain management that plays a great role for vaccine potency and

competence of health workers to manage the cold chain and administer safe vaccines for targeted groups.

• Current global efforts towards eradication of vaccine preventable diseases can not be successful without due attention to the effectiveness of the vaccines.

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Rationale of the Study

• Immunization is the most cost effective public health intervention that reduced the burden of infectious diseases globally.

• However, for the effectiveness of immunization, in addition to the high coverage, availability, functionality and proper management of cold chain system and provision of safe vaccines are mandatory.

• The routine immunization coverage in Ethiopia, particularly in big & agrarian regions; Oromiya, Amhara & Southern Nations and Nationalities has been on increasing trend for the last few years.

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Rationale cont…

• On the other hand; some reports indicated the occurrence of outbreak of vaccine preventable diseases.

• This study was, therefore, conducted to assess the status of cold chain and practice for immunization in public health facilities to recommend for development of appropriate strategies that will help for the improvement of immunization quality.

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General Objective

• To assess the cold chain status and practice in 116

health facilities located in three CCRDA/CORE

Group Ethiopia districts of Oromiya, SNNP and

Amhara Regions of Ethiopia .

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Specific objectives

1. To assess status of cold chain in public health facilities

2. To asses knowledge of health workers on cold chain management

3. To identify factors associated with knowledge of health workers on cold chain management

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Methods and Materials

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Study Context/AreaThe study was conducted in three districts; Bora (Oromiya), Soddo (Southern Nations & Nationalities People)and Basona worana (Amhara) Regional States respectively.

The common features of these districts were; all are agrarian supported by CCRDA/CGPP relatively documented a good coverage of Penta 3 located in the Central part of Ethiopia At around 130kms distance to the south, south west and

northern direction respectively from Addis Ababa(the Capital of Ethiopia)

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Study Design and Population

Study design

• An Institution based cross sectional study was conducted in 116 out of 117 public health facilities in selected districts in December 2011 and January 2012 using quantitative data collection tools.

Study Population

• All public health facilities which had been rendering immunization service and

• All health workers that had been administering vaccination in the same facilities during data collection period

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Sample Size and Sampling

Sample size for health facilities• 116 facilities rendering routine immunization services

were included for observation of cold chain.

• 103 health posts and 13 health centers were included for direct observation of cold chain status

Sample size for Health workers• The same number of health workers who had been

administering vaccination during data collection period were observed for their practices and interviewed for their knowledge on the cold chain management and injection safety. (1 Health worker/facility)

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Pictorial presentation of Study Context and Sampling Procedure

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Data Collection tools and procedures

Instruments• Structured close ended Questionnaires, and Observation Check

Lists that were adapted from WHO were prepared in English and

• Amharic version used for data collection

Data Collectors• Experienced Health Officers and Nurses were recruited from

facilities outside study areas to collect and coordinate data collection.

• One data collector was assigned per health facility per day

Data collection procedure• Routine immunization service providers approached at their

facilities

• Requested for their consent, observed for their practice and interviewed for their knowledge on cold chain and injection safety14

Data quality

• Two days training including field exercise was conducted outside the study districts,

• Data collection tools were pre-tested and reviewed to include the findings.

• Daily check up on the content and quality of collected data was done

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Data Entry and Analysis

Data Processing

• Data entry and cleaning was handled by the data entry clerk and investigator using EPI-info version 3.5.1.

• Then after, the data was exported to SPSS Version 16 for further univariate, bivariate and multivariate analysis.

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Data Entry and Analysis Cont…Data Analysis Procedure

• Odds Ratio was calculated to test the degree of association between knowledge(dependent) and professional qualification, myears of experence on routine immunization and exposure to training on cold chain (independent ) variables at 95% Confidence Interval (CI).

• As the outcome variable is categorical, logistic regression was used for controlling of potential confounders.

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Study variables

The Independent Variables were

• Qualification (Professional background)

• Year of service on immunization program,

• In-service trainings

The Dependent Variable was

• Knowledge of health workers on cold chain management

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Operational DefinitionsUnsatisfactory knowledge: Immunization providers

those scored less than or equal to 21 points (below the mean score).

Satisfactory knowledge : Providers those scored greater than 21 points (above the mean score).

Knowledge about cold chain: Having an understanding on the existence of a network of refrigerators, cold boxes and vaccine carriers to keep vaccines at the right temperature range (+20c – +80c) to safeguard their potency during transportation, storage and distribution to the point of delivery

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Operational Def…

• Practice on cold chain: Maintaining a network of refrigerators, cold boxes & vaccine carriers for keeping vaccines within the recommended range of temperature (+20c – +80c) to safeguard their potency during transportation, storage and delivery.

• Good condition cold chain equipment: The cold chain equipment the are intact and clean to keep vaccines with in the required temperature range (+20c – +80c).

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Results and Discussion

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Result 1. Profile of the Study Population

1.1. General Characteristics of Health FacilitiesAmong 116 facilities, 13 (11.2%) were H/Centre and

103(88.8%) were Health Posts.

Ten(8.6%)health facilities were located in urban and 106(91.4%)in rural setting.

Thirty one (26.7%) were located with in 10kms and the remaining 85(73%) located 11kms to 55kms away from the district health offices

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1.1. General Characteristics of H/F Cont.. Out of 116 facilities, 38(32.8%) facilities had

refrigerators, and out of these only 22(57.9%) were functional.

(Therefore, more than 94 (67.2%)facilities transported vaccines from where there is functional fridges)

Seven (18.4%) had a functional generators for backup service and

Twelve (31.6%) had a car/motorbike for transportation of vaccines in case of refrigerator/power failure.

Fuel was available for only 4(57.1%) generators, 8(66.7%) car/motorbikes and 9(23.7%) refrigerators.

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1.1. General Characteristics of H/F Cont..

From 38 health facilities with refrigerators,

12(31.6%) had trained personnel and 8(21.1%) had spare parts for minor maintenance.

Twenty four(63.2%) facilities permanently assigned personnel to follow up the cold chain during working hours

Only 14(36.8%) assigned personnel during holydays/weekends

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Table 1: Infrastructure and Cold Chain Equipment/Resource Availability in the Study Facilities (CORE Group Polio Project Implementation Districts in Amhara, Oromiya and SNNPR, Ethiopia), December 2011 – January 2012

Characteristics

Frequency

Yes (%) No (%)

Availability of refrigerator in the health facility (n=116)

38(32.8) 78(67.2)

Functionality of the refrigerator in the facility (n=38)

22(57.9) 16(42.1)

Availability of functional generator in the facility (n=38)

7(18.4) 31(81.6)

Availability of functional car/motorbike in the facilities to use in case of refrigerator failur (n=38)

12(31.6) 26(68.4)

Availability of trained personnel for minor maintenance(n=38)

12(31.6) 26(68.4)

Availability of spare parts for minor maintenance(n=38)

8(21.1) 30(78.9)

Availability of permanently assigned personnel for cold chain follow up(n=38)

24(63.2) 14(36.8)

Availability of personnel assigned during holidays/weekend for cold chain follow-up(n=38)

14(36.8) 24(63.2)

Availability of kerosene for generator for at least 72 hours(n=7)

4(57.1) 3(42.9)

Availability of kerosene for refrigerator(n=38) 9(23.7) 29(76.3)25

1.2. Profile of the Health workers

Of 116 providers included in the study, 18 (15. 5%) were Nurses and 98(84.5%) were Health Extension Workers(HEWs).

Among the Nurses, 13were providing immunization services in Health Centers and 5 in urban health posts

All Health Extension Workers were serving in rural health posts.

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1.2.Profile of the Health workers Cont..

Thirty(25.9%)providers had served for a period of 2 years or less while 68(58.6%) had worked for more than 2 years in the routine immunization unit .

Out of 73 (62.9%) trained respondents, 31 (42.5%) trained on Immunization in Practice

(IIP) for six days 17 (23.3%) on Injection Safety for three days 25 (34.2%) had received other trainings related to

minor maintenance of refrigerator.

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Result 2. Availability and Adequacy of Vaccines and Logistics

With respect to cold chain equipments, No vaccines shortage was identified during data

collection period

Fifty eight(50%) facilities had adequate ice packs and

One hundred four(89.7%) had vaccine carriers in good condition

Only 65(56%) had foam pad

Of 38 facilities that had refrigerators, 33(86.8%) had functional cold boxes

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Result 3: Status of cold chain

Important Traits of cold chain Availability of thermometer All 22 facilities having functional refrigerators had

functional thermometer.

Reading of thermometer On the day of data collection, out of 22 functional fridges,

16/22 (72.7%) showed temperature reading with in the standard range (+20c – +80c).

(In the remaining 6(27.3%) facilities vaccines exposed for the temperature beyond (+20c – +80c), which can be potential cause for loss of vaccine potency) .

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Result 3: Status of cold chain cont…

Availability and updating of Temperature Monitoring Chart

• Fourteen out of 22(63.35)functional fridges had a temperature monitoring charts

• Thirteen (92.9%) updated their recordings twice daily

Vaccine arrangement

• Was proper in only 10/22(45.5%) facilities. (Therefore, vaccines in the remaining 12(54.5%) will be at risk of losing their potency )

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Result 3: Status of cold chain cont…

Utilization of Foam Pads• For keeping vaccines cool during vaccination sessions

were being properly used in only 10/65(15.4%)facilities

Availability of other materials with vaccines • In 9/22(40.9% ) facilities, laboratory reagents, anti-

rabies vaccines and maternity medicines were placed with EPI Vaccines;

(Two related dangers; failure to maintain vaccine temperature and administering of wrong medicines that have similar container)

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Result 3 : Status of cold chain &Important traits of cold chain in study areas, Dec. 2011 –

Jan. 2012

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Result 4: Assessment of Knowledge of Vaccine Providers’ on Cold Chain Management

Recommended range of temperature and frequency of recording and shake test

Out of 116 health workers questioned about the recommended range of temperature for vaccine storage, 91 (78.4%) responded correctly

(failure to know the recommended range of temperature will open the way for outbreak of vaccine preventable diseases and cause wastage of money spent for purchase of vaccines )

Frequency of temperature recording was correctly described by 67(57.8%)

Result 4: Assessment of Knowledge of Vaccine Providers’ …

Vaccine arrangement in the chest type of fridge

Proper compartment for placement of oral polio vaccine(OPV) tetanus toxoid(TT) and diphtheria, pertusis, tetanus, hepatitis B and

hemophilus influenza type B (pentavalent) vaccines was correctly described by 83(71.6%), 58(50%) and 30 (25.9%)respondents respectively

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Result 4. Assessment of Knowledge cont..

Vaccines that required shake test and its purpose Only 15(12.9%) health workers knew the three

vaccines that requires a shake test

The purpose for application of the shake test was correctly mentioned by 42(36.2%) health workers

Types of Vaccines most sensitive to heat, extreme cold and light

Were correctly identified by 52(44.8%), 25(21.6%) and 58(50%) respondent respectively.

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Result 4: Assessment of knowledge cont..

Vaccines need conditioned ice packs during transportation

• Known by only 15(21.6%) respondents. (Since more than 94 facilities transporting vaccines from other facilities, all of them should at least to know how to pack different vaccines in the same container while transporting)

How to reconstitute vaccines

• None of the providers were able to fully answer how to handle the reconstituted vaccines

• Only 18(15.5%) answered three out five questions correctly, while the remaining correctly responded to less than three questions

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Result 4: Assessment of knowledge cont.. Vaccines under MDOVP • Seventy three (62.9%) providers new about two vaccines

under Multi Dose Open Vials Policy(MDOVP) and

• All preconditions necessary to administer MDOVP were mentioned by only 37(31.9%)respondents

• At least three preconditions were mentioned by 36(31%)

• While 34(29.3%) respondents did not know of either

• 54(46.6%) respondents correctly mentioned the length of time required to keep vaccines in the vaccine carrier after outreach session

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Result 4: Assessment of knowledge on cold chain management in the study areas in Dec. 2011 – Jan. 2012

The level of knowledge of providers on the cold chain management was classified as Not satisfactory and Satisfactory based on mean score which is 21.

• Accordingly, 63 out of 116(54%) providers have Satisfactory knowledge . (above the mean score)

• And 53(45%) provider have Not satisfactory knowledge. (less or equal to the mean score)

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Level of knowledge of cold chain management

Factors associated with the knowledge of cold

chain managementProfessional Qualification and Year of Service on EPI

have significant association with knowledge on cold chain management.

The result of logistic regression analysis indicated that;1. The Odds of having satisfactory knowledge on cold chain

management among Nurses was about 9 times more likely than Health Extension Workers (Adjusted OR 8.83, 95% CI 1.4 – 19.4).

2. The Odds of having satisfactory knowledge among providers who have more than two years of experience on EPI were about four times more likely than those with less than two years services (Adjusted OR 3.57, 95% CI, 1.02 – 12.4).

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Table 2: Factors associated with knowledge of cold chain management in study areas

Character Level of knowledge

Not Satisfactory Satisfactory Crude OR(95% CI)

Adjusted OR(95% CI)

Qualification

HEW* 50(49%) 48(51%)

Nurse 3(16.7%) 15(83.3) 5.2 (1.4 -19.14) 8.83(1.86-41.9)

Year of Service on EPI

Less than 1 yr* 1(14.3%) 6(85.7%)

1 – 2 yrs 14(60.9%) 9(39.1%) 0.21(0.024-1.82) 0.51(0.04-5.98)

Greater than 2 yrs 38(44.2%) 48(55.8%) 1.97(0.77-5.03) 3.57(1.02-12.41)

Ever received training on IIP/Cold chain

Yes 31(42.5%) 42(57.5%) 1.42(0.67-3.03) 1.45(0.60 – 3.50)

No* 22(51.2%) 21(48.8%)

*Reference

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DiscussionIn this assessment, out of 116 health facilities, only

38(32.8%)had refrigerators, of which only 22/38(57) were functional.

Health workers from the remaining 94(81%) facilities transported vaccines from health facilities where there were functional refrigerators, which can be a potential cause for cold chain breakage that can adversely affect vaccine potency through exposing for high temperate.

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Discussion

Of 16/22() functional refrigerators working with both electricity and kerosene;

7/16(43.8%) reported frequent kerosene shortage. Since electric supply is not regular, availability of reserve kerosene should be prerequisite for maintenance of vaccine potency and sustainability of immunization services delivery.

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Discussion

In case of any emergency situation, interruption of power or kerosene supply, generators and vehicles were available in only 7(18.4%) and 12(31.6%)facilities respectively.

Frequent cut in power supply can have a direct impact on storage temperature and non availability of standby generator will adversely affect vaccine potency at the vaccination centers.

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Discussion

During our survey, trained personnel and spare parts for minor maintenance were available in 12(31.6%) and 6(15.8%) health facilities respectively

• As vaccines are biological products that need continuous maintenance within a recommended narrow range of temperature.

• In this respect availability of trained personnel and spare parts at all health facility level are mandatory for regular follow-up and timely maintenance

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Discussion

One encouraging finding of this study was that all 22(100%) functional refrigerators had thermometer.

However, only 16(72.7%) had reading within the recommended temperature range (+20c – +80c).

Vaccines in the remaining 6(27.3%) refrigerators were exposed to temperature outside the recommended range. This situation could potentially lead to loss of costly vaccines and accidental administration of compromised vaccines.

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Discussion

Of 22 functional refrigerators, only 14(63.6%) had a temperature recording chart and among these, 13/14(92.9%) maintained the twice daily recording practice.

• WHO has recommended that the temperature range for vaccines should be (+20c – +80c), to be read and recorded twice daily.

• This procedure helps for self monitoring to prevent breaking of cold chain that can contribute for primary failure of immunization services.

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Discussion

One of the disturbing practice identified in this study was that the arrangement of vaccines in refrigerators was not correct in 12/22(54.5%) health facilities.

The success of efforts by countries against vaccine preventable diseases is attributed in part to proper storage and handling of vaccines. By arranging vaccines in the right compartment of different types of refrigerators could prevent vaccines from exposing to the wrong temperature and losing their potency.

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Discussion

This study also showed that vaccines were sharing space with laboratory reagents and other medicines in 9(40.9%) fridges

Ideally the fridges containing vaccines should not be used to store other drugs in order to prevent two potential dangers; problem of not maintaining the recommended temperature range and wrongly administering drugs that have been packaged in similar color vials as the vaccines vials.

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Discussion

Of 116 health workers included in the study, 91 and 15 knew the recommended range of temperature for vaccine storage and vaccines that need shake test respectively.

The poor knowledge about correct storage temperature and shake test may be expected to adversely affect the quality of administered vaccines and consequently can give way for outbreaks of vaccine preventable diseases as it is evidenced in many parts of the country.

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DiscussionAccording to our findings, of 116 interviewed

vaccine providers, 63 had satisfactory knowledge on the cold chain management.

• The result of logistic regression analysis pointed out that Nurses were nine times more likely to have satisfactory knowledge on cold chain management compared to Health Extension Workers , which indicated that HEWs need more standardized in service training that is supported with practical demonstrations and well-designed supportive supervision in order to improve the quality of immunization services in Ethiopia, since both groups are equally assigned to deliver vaccination services.

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Discussion

This study also revealed 52(44.8%), 25(21.6%) and 58(50%)respectively health workers had knowledge about which vaccines are most sensitive to heat, extreme cold and light.

By following a few simple steps and implementing best storage and handling practices, providers can ensure that children and their mothers will get the full benefit of vaccines they received.

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Strength of the study

• All governmental health facilities that rendered routine immunization services in three districts were included in the study.

• This process helped us to have general insight about the status of cold chain of immunization in Ethiopia.

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Limitation• Budget and time constraint to include additional

districts that might help to establish a significant statistical association with some other factors.

• This study is based on cross sectional design which may not allow establishment of temporal relationship between exposure and outcome of interest.

• May be there was information sharing among health workers working in different health facilities as the assessment was done in different days

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Conclusion

• This study pointed out that there are gaps in knowledge and also in practice with respect to cold chain management .

• Therefore, vaccines in some facilities had been at a high risk of losing their potency due to substandard storage, lack of regular monitoring and observance of recommended range of temperature which need special attention.

• Professional qualification and working experience on EPI were factors that contributed on the knowledge of cold chain management.

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RecommendationsThe Districts Health Office in collaboration with partner

organizations should ;

Organize appropriate in-service trainings on Immunization in Practice(IIP) and cold chain management that is supported with practical demonstration and structured periodic supportive supervision as the previously conducted doesn’t make a difference.

More focus should be given to improve the knowledge of HEWs on cold chain management.(by FMoH)

Possible mechanism for transition of Kerosene/Electric refrigerators with Solar derived refrigerators

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Recommendations cont.. Conduct regular maintenance of fridges and ensure

regular supply of kerosene

Ensure distribution and usage of Foam Pad at all facility level for maintenance of vaccine temperature during vaccination sessions

Allocate at least one refrigerator per health facility with adequate amount of spare parts for minor maintenance

Carryout capacity assessment on the health workers and organize periodic refresher training to fill gap related to immunization.

Further study should be done at district and facilities level and on Client Satisfaction using both qualitative and quantitative methods

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Thank You !!!

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