Adequacy assessment of immunobiological agent conservation in the Western Health macro-region of Minas Gerais State, Brazil: a descriptive study, 2017**Article derived from the Master's degree dissertation entitled 'Evaluation of the psychometric properties of the Immunobiological Agent Conservation Assessment Scale', submitted by Gabriela Gonçalves Amaral to the Nursing Postgraduate Program of the Universidade Federal de São João del-Rei in 2020.

Gabriela Gonçalves Amaral Eliete Albano de Azevedo Guimarães Laís Oliveira de Moraes Tavares Brener Santos Silva Daniel Nogueira Cortez Valéria Conceição de Oliveira About the authors

Abstract

Objective:

To describe the adequacy of immunobiological agent conservation in vaccination rooms in the municipalities of the Western health macro-region of the state of Minas Gerais, Brazil.

Methods:

This was a descriptive study, based on a validated scale, with a maximum score of 15 points. A descriptive analysis and an association test between the scores obtained by the municipalities and variables of the external context were performed.

Results:

275 out of a total of 295 existing vaccination rooms were evaluated. Immunobiological agent conservation in the West macro-region obtained an average score of 4 points (standard score, 0 to 15). There was a poor availability of immunization supplies aimed at immunobiological agent conservation, and work processes, that require improvement. Small municipalities presented better immunobiological agent conservation (p=0.011).

Conclusion:

Immunobiological agent conservation in vaccination rooms in the Western health macro-region of Minas Gerais State was considered inadequate.

Keywords:
Vaccines; Immunization; Refrigeration; Descriptive Epidemiology

Introduction

Immunobiological agent conservation influences on vaccine effectiveness and, consequently, the success of the National Immunization Program (PNI).11. Ashok A, Brison M, Letallec Y. Improving cold chain systems: challenges and solutions. Vaccine. 2017 Apr 19;35(17):2217-23. doi: https://doi.org/10.1016/j.vaccine.2016.08.045.
https://doi.org/https://doi.org/10.1016/...

2. Ogboghodo EO, Omuemu VO, Odijie O, Odaman OJ. Cold chain management practices of health care workers in primary health care facilities in Southern Nigeria. Pan Afr Med J. 2017 May 11;27:34. doi: https://doi.org/10.11604/pamj.2017.27.34.11946.
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-33. Bogale HA, Amhare AF, Bogale AA. Assessment of factors affecting vaccine cold chain management practice in public health institutions in east Gojam zone of Amhara region. BMC Public Health. 2019 Nov 1;19(1):1433. doi: https://doi.org/10.1186/s12889-019-7786-x.
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During the process, the cold chain is the system for storing and transporting immunobiological agents from the manufacturer’s point of origin to users in vaccination rooms, public or private, requiring adequate storage and transportation to guarantee the recommended temperature.44. Ministério da Saúde (BR). Manual de rede de frio do programa nacional de imunização [Internet]. 5a ed. Brasília, DF: MS; 2017 [acesso 13 maio 2021]. Disponível em: Disponível em: https://portalarquivos2.saude.gov.br/images/pdf/2017/dezembro/15/rede_frio_2017_web_VF.pdf
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.55. Cavallaro KF, Francois J, Jacques R, Mentor D, Yalcouye I, Wilkins K, et al. Demonstration of the use of remote temperature monitoring devices in vaccine refrigerators in Haiti. Public Health Rep. 2018;133(1):39-44. doi: https://doi.org/10.1177/0033354917742119
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According to the recommendations of the World Health Organization (WHO), at the municipal level, immunobiological agents should be transported and stored at temperature between +2 ºC and +8 ºC; 6 at the national and state levels, it is worth mentioning that some immunobiological agents can be stored at temperature between -25 °C and -15 °C.55. Cavallaro KF, Francois J, Jacques R, Mentor D, Yalcouye I, Wilkins K, et al. Demonstration of the use of remote temperature monitoring devices in vaccine refrigerators in Haiti. Public Health Rep. 2018;133(1):39-44. doi: https://doi.org/10.1177/0033354917742119
https://doi.org/https://doi.org/10.1177/...

The adequacy of the cold chain aims to ensure the immunogenicity of immunobiological agents, sensitive to temperature changes.77. Lennon P, Atuhaire B, Yavari S, Sampath V, Mvundura M, Ramanathan N, et al. Root cause analysis underscores the importance of understanding, addressing, and communicating cold chain equipment failures to improve equipment performance. Vaccine. 2017 Apr 19;35(17):2198-202. doi: http://dx.doi.org/10.1016/j.vaccine.2016.09.068.
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.88. Hibbs BF, Miller E, Shi J, Smith K, Lewis P, Shimabukuro TT. Safety of vaccines that have been kept outside of recommended temperatures: Reports to the Vaccine Adverse Event Reporting System (VAERS), 2008-2012. Vaccine. 2018 Jan 25;36(4):553-8. doi: https://doi.org/10.1016/j.vaccine.2017.11.083.
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High temperature impacts on the reduction of immunobiological agent quality, while freezing can irreversibly damage these produts.99. World Health Organization. How to monitor temperatures in the vaccine supply chain [Internet]. Geneva: WHO ; 2015 Jul [acesso 14 maio 2021]. Disponível em: Disponível em: https://apps.who.int/iris/bitstream/handle/10665/183583/WHO_IVB_15.04_eng.pdf;jsessionid=988E6BD55C623F9F7508B6FDB9359B79?sequence=1
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.1010. Centers for Disease Control and Prevention. Vaccine storage and handling toolkit. Atlanta (GA): CDC; 2019 [acesso 14 maio 2021]. Disponível em: Disponível em: https://www.cdc.gov/vaccines/hcp/admin/storage/toolkit/storage-handling-toolkit.pdf
https://www.cdc.gov/vaccines/hcp/admin/s...
The inadequate temperatures to which immunobiological agents are exposed, provides evidence of the failure in the maintenance of the cold chain and may result in reduction of protection of individuals against vaccine preventable diseases, in addition to the possibility of causing undesirable adverse events, interfering negatively in the adherence of the population to vaccination.66. World Health Organization. Aide-memoire for prevention of freeze damage to vaccines [Internet]. Geneva: WHO; 2019 Mar 11 [acesso 13 maio 2021]. Disponível em: Disponível em: https://apps.who.int/iris/bitstream/handle/10665/69673/WHO_IVB_07.09_eng.pdf?sequence=1
https://apps.who.int/iris/bitstream/hand...
A large amount of financial resources has been invested to maintain the cold chain, in order to provide effective immunobiological agents and thus ensure safety for users.77. Lennon P, Atuhaire B, Yavari S, Sampath V, Mvundura M, Ramanathan N, et al. Root cause analysis underscores the importance of understanding, addressing, and communicating cold chain equipment failures to improve equipment performance. Vaccine. 2017 Apr 19;35(17):2198-202. doi: http://dx.doi.org/10.1016/j.vaccine.2016.09.068.
https://doi.org/http://dx.doi.org/10.101...
.1111. Oli AN, Agu RU, Ihekwereme CP, Esimone CO. An evaluation of the cold chain technology in South-East, Nigeria using immunogenicity study on the measles vaccines. Pan Afr Med J. 2017;27(Supp 3):28. doi: https://doi.org/10.11604/pamj.supp.2017.27.3.11491.
https://doi.org/https://doi.org/10.11604...
In some countries in Africa, Asia and Europe, however, these chains do not work as they should, and a common event is observed: failure to maintain the cold chain,11. Ashok A, Brison M, Letallec Y. Improving cold chain systems: challenges and solutions. Vaccine. 2017 Apr 19;35(17):2217-23. doi: https://doi.org/10.1016/j.vaccine.2016.08.045.
https://doi.org/https://doi.org/10.1016/...
.33. Bogale HA, Amhare AF, Bogale AA. Assessment of factors affecting vaccine cold chain management practice in public health institutions in east Gojam zone of Amhara region. BMC Public Health. 2019 Nov 1;19(1):1433. doi: https://doi.org/10.1186/s12889-019-7786-x.
https://doi.org/https://doi.org/10.1186/...
.1212. Sow C, Sanou C, Medah C, Schlumberger M, Mireux F, Ouédraogo I, et al. Challenges of cold chain quality for routine EPI in south-west Burkina-Faso: An assessment using automated temperature recording devices. Vaccine. 2018 Jun 18;36(26):3747-55. doi: https://doi.org/10.1016/j.vaccine.2018.05.062.
https://doi.org/https://doi.org/10.1016/...
as it also occurs in Brazil.1313. Santos YR, Oliveira VC, Guimarães EAA, Silva BS, Moraes JT, Cortez DN. Normative evaluation of vaccine rooms in the western region of the state of Minas Gerais, October 2015 to August 2016. Vigil Sanit Debate. 2017;5(3):44-52. doi: https:doi.org/10.22239/2317-269x.00923.
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14. Siqueira LG, Martins AMEBL, Versiani CMC, Almeida LAV, Oliveira CS, Nascimento JE, et al. Assessment of the organization and operation of vaccine rooms in primary health care in Montes Claros, Minas Gerais, Brazil, 2015. Epidemiol Serv Saude. 2017;26(3):557-68. doi: https://doi.org/10.5123/s1679-49742017000300013.
https://doi.org/https://doi.org/10.5123/...

15. Elisário RN, Siman AG, Moreira TR, Carvalho CA, Amaro MOF. Avaliação das salas de vacinas nas unidades de estratégia de saúde da família. Enferm Rev [Internet]. 2018 [acesso 14 maio 2021];20(3):1-17. Disponível em: Disponível em: http://periodicos.pucminas.br/index.php/enfermagemrevista/article/view/17228
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-1616. Galvão MFPS, Almeida PC, Lopes MSV, Coutinho JFV, Martins MC, Barbosa LP. Evaluation of vaccination rooms in primary health care units. Rev Rene. 2019;20:e39648. doi: https://dx.doi.org/10.15253/2175-6783.20192039648.
https://doi.org/https://dx.doi.org/10.15...

As such, we highlight the need to conduct studies that systematically evaluate the adequacy of the cold chain in order to provide safe and effective immunobiological agents to the population. This study aimed to describe the adequacy of immunobiological agent conservation in vaccination rooms in the municipalities in the Western health macro-region of Minas Gerais.

Methods

This was a descriptive study to evaluate the adequacy of immunobiological agent conservation in vaccination rooms in urban Primary Healthcare Centers (PHC) in the Western health macro-region of Minas Gerais State Minas Gerais, in 2017 (Figure 1).

Located among the Central, South and Upper Paranaíba regions, with a territorial extension of 28,136.5 km², the Western health macro-region of Minas Gerais has an average human development index (HDI) of 0.70 and a population of 1,280,907 inhabitants. It is divided into eight micro-regions, considered from their respective polo municipalities: (i) Bom Despacho, with seven municipalities; (ii) Campo Belo, seven municipalities; (iii) Divinópolis, eight municipalities; (iv) Formiga, eight municipalities; (v) Itaúna, four municipalities; (vi) Lagoa da Prata/Santo Antônio do Monte, five municipalities; (vii) Oliveira/Santo Antônio do Amparo, six municipalities; and (viii) Pará de Minas, with eight municipalities.1717. Secretaria de Estado de Saúde de Minas Gerais. Deliberação CIB-SUS/MG n. 3.013, de 23 de outubro de 2019. Aprova o Ajuste/2019 do Plano Diretor de Regionalização PDR/SUS-MG e dá outras providências [Internet]. 2019 [acesso 14 maio 2021]. Disponível em: Disponível em: http://www.saude.mg.gov.br/images/documentos/Del%203013%20-%20SUBGR_SDCAR_DREA%20-%20Ajuste%20PDR%20vers%C3%A3o%20CIB%20-%20alterada%2015.10.pdf
http://www.saude.mg.gov.br/images/docume...

In the 53 municipalities of the Western health macro-region, there are 295 vaccination rooms belonging to the public health network, inserted in the Family Health Strategy (FHS) or distributed among PHCs, polyclinics and hospitals. Immunization activities are performed by the nursing team, under the supervision of a nursing professional.

All immunization rooms inserted in the urban PHCs were eligible for the study, excluding those located in the rural area and/or which only served as support points to health teams during their work in rural areas, whose limited access and/or lack of physical structure is recognized.

The independent variables of the study that were selected defined two categories for the studied municipalities: population size (less than or equal to 10,000 inhabitants; greater than 10,000 inhabitants);1818. Arcari JM, Barros APD, Rosa RS, Marchi R, Martins AB. Perfil do gestor e práticas de gestão municipal no sistema único de saúde (SUS) de acordo com porte populacional nos municípios do estado do Rio Grande do Sul. Cienc Saude Colet. 2020;25(2):407-20. doi: https://doi.org/10.1590/1413-81232020252.13092018.
https://doi.org/https://doi.org/10.1590/...
and FHS coverage (less than or equal to 80%; greater than 80%).1919. Pinto LF, Giovanella L. The family health strategy: expanding access and reducing hospitalizations due to ambulatory care sensitive conditions (ACSC). Cienc Saude Colet. 2018;23(6):1903-13. doi: https://doi.org/10.1590/1413-81232018236.05592018.
https://doi.org/https://doi.org/10.1590/...
The Primary Health Care Information System (SIAB) database, under the national coordination of the Ministry of Health, was used to collect data on population size and FHS coverage. Regarding the variables selected for the vaccination rooms, their insertion or not in the FHS was analyzed. As for nursing professionals working in these rooms, the professional category (nurse; nursing technician; nursing assistant) and professional formation (level of study: Technical; Graduation; Specialization; Master's degree; PhD) were investigated.

The Immunobiological Agent Conservation Assessment Scale (EACI) was adopted,2020. Amaral GG, Oliveira VC, Guimarães EAA, Reis IA, Viegas SMF, Pinto IC, et al. Evaluation of the psychometric properties of the Immunobiological Agent Conservation Assessment Scale. J Nurs Meas. 2020 Oct 16;28(3): JNM-D-20-00032. doi: http://dx.doi.org/10.1891/JNM-D-20-00032.
https://doi.org/http://dx.doi.org/10.189...
validated for the Brazilian context, aimed at measuring the conservation of immunobiological agents at the local level, specifically in vaccination rooms. The EACI enables the identification of weaknesses in the context in which the vaccination rooms are inserted, and also the implementation of interventions to improve the cold chain. The EACI is comprised of five items, which use a Likert scale (it shows the level of agreement with an affirmation) as an option of answers, organized in an ordinal scale, with opposite and symmetric extreme points, and the following possibilities are in between: never (0); almost never (1); almost always (2); always (3). The score obtained by the EACI represents 15 points, stratified into: 0 - 9 points the immunobiological agent conservation is 'inadequate', and 10-15, 'adequate'. The five evaluation items include: (i) the availability of batteries or generators, in case of power grid failure; (ii) the existence of other temperature measurement instrument in addition to maximum and minimum thermometer (instantaneous temperature reading); (iii) the existence of a refrigerated chamber for immunobiological agent storage; (iv) air conditioned vaccination room (between +18 ºC and +20 ºC); and (v) the transportation from the municipal facilities (immunobiological agent center) to the vaccination rooms, in refrigerated vehicles. In addition to these items, there are seven more, of descriptive nature, for an optimization of the evaluation of vaccination rooms:(i) use of polyurethane cooler boxes; (ii) the exclusivity of the vaccination room for vaccination-related activities; (iii) updating of the professional working in the room, in immunization training; (iv) the occurrence of direct sunlight or other heat source close to immunobiological agent storage equipment; (v) the replacement of reusable ice coils after the expiration date; (vi) preventive maintenance for immunobiological agent conservation equipment; and (vii) keeping the professional working in the room informed on immunization updates available.

The application of the EACI was performed by one of the researchers, in person, in a reserved room in a PHC, with a nursing professional who was the technical responsible for the vaccination room; or with a nursing technician or assistant working in the same room. The interview was conducted after the research participant received guidance on the objectives of the study and signed a Free and Informed Consent Form. It is worth mentioning that an identification code was assigned to each of the participants, respecting their anonymity.

Data were collected during the second half of 2017, during visits to all vaccination rooms in the 53 municipalities in the Western health macro-region of Minas Gerais, when the EACI was applied, in addition to direct observations made by the researchers that enabled the elaboration of a field diary.

Descriptive analysis of the variables related to the characterization of the municipalities, vaccination rooms and the professionals working in these rooms was performed, in addition to the items related to the EACI and respective scores obtained by the immunization rooms. Pearson's chi-square test was used to verify the association between the scores obtained by the municipalities and external context variables (population size; FHS coverage). All analyses were performed by adopting a significance level of 5%. Data were processed using EpiData software (version 3.1) and analyzed in Epi InfoTM (version 7.2).

The study project was approved by the Human Research Ethics Committee of the Federal University of São João del-Rei. Opinion No. 2134434, issued on September 16, 2015, and Certificate of Submission for Ethical Appraisal (CAAE) No. 47997115.2.0000.5545.

Results

Of the 295 public vaccination rooms in the Western health macro-region of Minas Gerais State, 275 were evaluated; 20 were excluded because they did not meet the eligibility criteria. Of the 275 professionals interviewed, who worked in the vaccination rooms, 156 (56.7%) were nursing technicians; 85 (30.9%), nurses; and 34 (12.4%), nursing assistants. Regarding education level, of the 275 professionals, 190 (69.0%) had medium or technical level, 42 (15.3%) had a degree in nursing; 42 (15.3%) had a specialization degree; and one (0.4%) had a Master's degree.

The West health macro-region presented an average of 95.0% coverage of FHS, 46 (86.8%) of its municipalities presented a coverage higher than 80%. Most vaccination rooms were inserted in the FHS (n=261; 95.0%), and located in municipalities with more than 10,000 inhabitants. (n=235; 85.4%) (Table 1).

The majority of the vaccination rooms did not have electric power generators, UPS (Uninterruptible Power Supply) or refrigerated chambers with available batteries in good conditions, in case of a power outage (n=206; 74.9%); and there were not other temperature measurement instruments apart from the maximum and minimum thermometer (n=185; 67.3%). Most rooms had neither refrigerated chambers for immunobiological agent storage (n=182; 66.2%), nor air conditioners in order to maintain indoor room temperature between +18 ºC and +20 ºC (n=199; 72.3%) (Table 2).

Most rooms were exclusively used for vaccination-related activities (n=167; 60.7%) and kept their refrigeration equipment away from the occurrence of sunlight or other heat sources (n=211; 76.7%). However, a regular preventive maintenance of most refrigeration equipment was not carried out, as recommended by the Brazilian PNI (n=214; 77.8%); and in several vaccination rooms, reusable ice coils were not replaced after the expiration date (n=134; 48.7%) (Table 2).

Immunobiological agent conservation in the vaccination rooms in the Western health macro-region was classified as inadequate, based on the EACI, reaching an average score of 4 points, ranging between 1 and 7 points according to their micro-regions (Table 3). There was a lack of supplies for immunobiological agent conservation; and the work processes required improvement. It is worth highlighting that only 13 (24.5%) municipalities carried out adequate immunobiological agent conservation. Moreover, in the analysis among micro-regions, four municipalities stood out as ‘extreme points’, i.e., two for reaching the maximum Score of the EACI (located in 2 and 4 microregions), and two for not scoring on any items of the EACI (located in 3 and 8 micro-regions).

A better adequacy of immunobiological agent conservation was observed in small municipalities, with up to 10,000 inhabitants. In the association analysis, it could be seen that the population size was statistically associated with the scores obtained by the municipalities related to immunobiological agent conservation: p=0.011. The FHS coverage was not associated with the scores achieved: p=0.667 (Table 4).

Figure 1
- Health Macro-regions of Minas Gerais State, Brazil, 2021

Table 1
- Characterization of municipalities and vaccination rooms (n=275), Western health macro-region, Minas Gerais State, Brazil, 2017

Table 2
- Adequacy of immunobiological agent conservation in vaccination rooms (n=275), Western healt macro-region, Minas Gerais, Brazil, 2017

Table 3
- Adequacy of immunobiological agent conservation (n=275) by micro-regions of the Western health macro-region, Minas Gerais State, Brazil, 2017
Table 4
- Adequacy of immunobiological agent conservation (n=275) according to population size and the Family Health Strategy coverage, Western health macro-region, Minas Gerais State, Brazil, 2017

Discussion

The vaccination rooms in the Western health macro region of Minas Gerais State presented failures that may compromise the immunobiological agent conservation. In most municipalities, it could be seen that some activities and parameters, standardized by the PNI, were not adequate for these standards. The EACI is based on the current WHO and the Brazilian PNI guidelines for the characterization of an ideal vaccination room, which justifies the failures pointed out in this study.

Caution is required with the generalization of the analyses and conclusions presented. The conditions for immunobiological agent conservation identified in vaccination rooms in the Western health macro-region of Minas Gerais, may not reflect the situation of other macro-regions of the state, other locations in Brazil or in the world. However, the results presented can support the implementation of actions aimed at improving the cold chain evaluated, by showing the real conditions of vaccination rooms in the Western health macro-region of Minas Gerais. The research provides support for managers and health professionals in order for them to improve work processes and structural conditions necessary for immunobiological agent conservation in their municipalities.

Electrical grid stability, added to energy reserve for critical situations, is of fundamental importance for immunobiological agent conservation.77. Lennon P, Atuhaire B, Yavari S, Sampath V, Mvundura M, Ramanathan N, et al. Root cause analysis underscores the importance of understanding, addressing, and communicating cold chain equipment failures to improve equipment performance. Vaccine. 2017 Apr 19;35(17):2198-202. doi: http://dx.doi.org/10.1016/j.vaccine.2016.09.068.
https://doi.org/http://dx.doi.org/10.101...
.99. World Health Organization. How to monitor temperatures in the vaccine supply chain [Internet]. Geneva: WHO ; 2015 Jul [acesso 14 maio 2021]. Disponível em: Disponível em: https://apps.who.int/iris/bitstream/handle/10665/183583/WHO_IVB_15.04_eng.pdf;jsessionid=988E6BD55C623F9F7508B6FDB9359B79?sequence=1
https://apps.who.int/iris/bitstream/hand...
.2121. Guimarães EAA, Oliveira VC, Oliveira MM, Viegas SMF, Ferreira AP, Dias FCS. Critical events in the maintenance of vaccine conservation. Rev Enferm UFPE on line. 2018;12(6):1781-9. doi: https://doi.org/10.5205/1981-8963-v12i6a230909p1781-1789-2018.
https://doi.org/https://doi.org/10.5205/...
The refrigerated chamber is a battery-powered device. These batteries provide an autonomy for a period between 6 and 72 hours. Therefore, the Centers for Disease Control and Prevention of the United States (CDC/USA) and the Brazilian PNI have recommended that the household refrigerators should be replaced with refrigerated chambers.44. Ministério da Saúde (BR). Manual de rede de frio do programa nacional de imunização [Internet]. 5a ed. Brasília, DF: MS; 2017 [acesso 13 maio 2021]. Disponível em: Disponível em: https://portalarquivos2.saude.gov.br/images/pdf/2017/dezembro/15/rede_frio_2017_web_VF.pdf
https://portalarquivos2.saude.gov.br/ima...
.1111. Oli AN, Agu RU, Ihekwereme CP, Esimone CO. An evaluation of the cold chain technology in South-East, Nigeria using immunogenicity study on the measles vaccines. Pan Afr Med J. 2017;27(Supp 3):28. doi: https://doi.org/10.11604/pamj.supp.2017.27.3.11491.
https://doi.org/https://doi.org/10.11604...
The cold chain is badly affected by household refrigerators, despite their lower cost. They are not able to control the temperature efficiently, thus, the immunobiological agents may be exposed to temperature changes, resulting in a significant loss of their immunogenic potency.11. Ashok A, Brison M, Letallec Y. Improving cold chain systems: challenges and solutions. Vaccine. 2017 Apr 19;35(17):2217-23. doi: https://doi.org/10.1016/j.vaccine.2016.08.045.
https://doi.org/https://doi.org/10.1016/...
In the scenario of research, the majority of the vaccination rooms evaluated, were equipped with household refrigerators, which, unlike the refrigerated chambers, are not battery-powered devices.

National and international studies also report the predominance of the use of household refrigerators for immunobiological agent conservation.1212. Sow C, Sanou C, Medah C, Schlumberger M, Mireux F, Ouédraogo I, et al. Challenges of cold chain quality for routine EPI in south-west Burkina-Faso: An assessment using automated temperature recording devices. Vaccine. 2018 Jun 18;36(26):3747-55. doi: https://doi.org/10.1016/j.vaccine.2018.05.062.
https://doi.org/https://doi.org/10.1016/...
.1616. Galvão MFPS, Almeida PC, Lopes MSV, Coutinho JFV, Martins MC, Barbosa LP. Evaluation of vaccination rooms in primary health care units. Rev Rene. 2019;20:e39648. doi: https://dx.doi.org/10.15253/2175-6783.20192039648.
https://doi.org/https://dx.doi.org/10.15...
.2121. Guimarães EAA, Oliveira VC, Oliveira MM, Viegas SMF, Ferreira AP, Dias FCS. Critical events in the maintenance of vaccine conservation. Rev Enferm UFPE on line. 2018;12(6):1781-9. doi: https://doi.org/10.5205/1981-8963-v12i6a230909p1781-1789-2018.
https://doi.org/https://doi.org/10.5205/...

To meet the recommendations of the CDC/USA and Brazilian PNI, the Ministry of Health published the Ordinance GM/MS No. 2,855, of November 5, 2019, freeing up resources to municipalities with up to 100,000 inhabitants for the acquisition of refrigerated chambers, in order to expand and ensure better storage structure for immunobiological agents.2222. Ministério da Saúde (BR). Portaria n. 2.855, de 5 de novembro de 2019. Estabelece incentivo financeiro para a aquisição de câmaras refrigeradas para as salas de imunização da Rede de Frio. Brasília, DF: Diário Oficial da União; 5 nov. 2019 [acesso 14 maio 2021]. Disponível em: https://www.in.gov.br/web/dou/-/portaria-n-2.855-de-5-de-novembro-de-2019-226514823?inheritRedirect=true&redirect=%2Fconsulta%3Fq%3Dtribunal%26start%3D10029%26delta%3D75%26publish%3Dpast-month
Disponível em: https://www.in.gov.br/web...
During a meeting with health managers from the Western health macro-region, to discuss the results of this study, some comments were made on the acquisition of refrigerated chambers with the support of these resources.

Although no other temperature measurement instruments are used in the immunization rooms in the Western health macro-region of Minas Gerais, as recommended by the WHO,2323. World Health Organization. Immunization coverage [Internet]. Geneve: WHO; 2018 update 2020 Jul 15; acesso 15 maio 2021]. Disponível em: Disponível em: http://www.who.int/mediacentre/factsheets/fs378/en/
http://www.who.int/mediacentre/factsheet...
it is worth mentioning: good practices for monitoring refrigeration equipment were observed in most rooms. Such practices are essential for the control of immunobiological agent temperatures.44. Ministério da Saúde (BR). Manual de rede de frio do programa nacional de imunização [Internet]. 5a ed. Brasília, DF: MS; 2017 [acesso 13 maio 2021]. Disponível em: Disponível em: https://portalarquivos2.saude.gov.br/images/pdf/2017/dezembro/15/rede_frio_2017_web_VF.pdf
https://portalarquivos2.saude.gov.br/ima...
.1111. Oli AN, Agu RU, Ihekwereme CP, Esimone CO. An evaluation of the cold chain technology in South-East, Nigeria using immunogenicity study on the measles vaccines. Pan Afr Med J. 2017;27(Supp 3):28. doi: https://doi.org/10.11604/pamj.supp.2017.27.3.11491.
https://doi.org/https://doi.org/10.11604...
.2424. Hanson CM, George AM, Sawadogo A, Schreiber B. Is freezing in the vaccine cold chain an ongoing issue? A literature review. Vaccine. 2017 Apr 19;35(17):2127-33. doi: https://doi.org/10.1016/j.vaccine.2016.09.070.
https://doi.org/https://doi.org/10.1016/...

Factors such as air conditioning and keeping the reusable ice coils at room temperature are also essential for the maintenance of temperatures.1212. Sow C, Sanou C, Medah C, Schlumberger M, Mireux F, Ouédraogo I, et al. Challenges of cold chain quality for routine EPI in south-west Burkina-Faso: An assessment using automated temperature recording devices. Vaccine. 2018 Jun 18;36(26):3747-55. doi: https://doi.org/10.1016/j.vaccine.2018.05.062.
https://doi.org/https://doi.org/10.1016/...
In the rooms evaluated, temperatures outside the recommended range; and reports of air conditioners that had been turned off on cold days or during the vaccination in newborns and the elderly were observed. Studies conducted in the states of Bahia and Minas Gerais in 2015, identified irregular temperatures, even in vaccination rooms equipped with air conditioning.1515. Elisário RN, Siman AG, Moreira TR, Carvalho CA, Amaro MOF. Avaliação das salas de vacinas nas unidades de estratégia de saúde da família. Enferm Rev [Internet]. 2018 [acesso 14 maio 2021];20(3):1-17. Disponível em: Disponível em: http://periodicos.pucminas.br/index.php/enfermagemrevista/article/view/17228
http://periodicos.pucminas.br/index.php/...
.2525. Rios NM, Carneiro BR, Andrade RM. Aspectos observacionais das salas de vacina de três municípios do interior da Bahia. Rev Inov Tecnol Cienc. 2015;1(1):63-70. Disponível em: http://periodicos.ftc.br/index.php/ritec/article/view/128/106
http://periodicos.ftc.br/index.php/ritec...

In the majority of the municipalities, the vehicles used in the transportation of immunobiological agents were not refrigerated, putting at risk the maintenance of temperatures during transportation, which is an indispensable measure according to the Brazilian PNI.44. Ministério da Saúde (BR). Manual de rede de frio do programa nacional de imunização [Internet]. 5a ed. Brasília, DF: MS; 2017 [acesso 13 maio 2021]. Disponível em: Disponível em: https://portalarquivos2.saude.gov.br/images/pdf/2017/dezembro/15/rede_frio_2017_web_VF.pdf
https://portalarquivos2.saude.gov.br/ima...
A study conducted in the Philippines in 2017 reported that 95.5% of the respondents 'did not believe' that inadequate storage of immunobiological agents during transportation would increase the risk of exposure to conditions that would compromise the immunogenicity of these products.2626. Maglasang PL, Butalid ML, Pastoril MF, Pratama AN, Tan EY. A cross-sectional survey on cold chain management of vaccines in Cebu, Philippines. Pharm Pract (Granada). 2018;16(2):1167. doi: https://doi.org/10.18549/PharmPract.2018.02.1167.
https://doi.org/https://doi.org/10.18549...
Thus, the importance of constant monitoring during transportation is emphasized in order to ensure the maintenance of temperatures and other immunobiological requirements,1111. Oli AN, Agu RU, Ihekwereme CP, Esimone CO. An evaluation of the cold chain technology in South-East, Nigeria using immunogenicity study on the measles vaccines. Pan Afr Med J. 2017;27(Supp 3):28. doi: https://doi.org/10.11604/pamj.supp.2017.27.3.11491.
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.2121. Guimarães EAA, Oliveira VC, Oliveira MM, Viegas SMF, Ferreira AP, Dias FCS. Critical events in the maintenance of vaccine conservation. Rev Enferm UFPE on line. 2018;12(6):1781-9. doi: https://doi.org/10.5205/1981-8963-v12i6a230909p1781-1789-2018.
https://doi.org/https://doi.org/10.5205/...
especially when the available vehicles do not meet the requirements for adequate transportation.2727. Kitamura T, Bouakhasith V, Phounphenghack K, Pathammavong C, Xeuatvongsa A, Norizuki M, et al. Assessment of temperatures in the vaccine cold chain in two provinces in Lao People’s Democratic Republic: a cross‑sectional pilot study. BMC Res Notes. 2018 Apr 27;11(1):261. doi: https://doi.org/10.1186/s13104-018-3362-1.
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.2828. Das MK, Arora NK, Mathew T, Vyas B, Sindhu M, Yadav A. Temperature integrity and exposure to freezing temperature during vaccine transfer under the universal immunization program in Three States of India. Indian J Public Health. 2019;63(2):139-42. doi: https://doi.org/10.4103/ijph.IJPH_123_18.
https://doi.org/https://doi.org/10.4103/...

The association between small-sized municipalities and a better conservation of immunobiological agents may be due to the fact that these municipalities have a better fiscal management, both internally and in society, given a greater link and proximity among the population, professionals and managers.2929. Klering LR, Kruel AJ, Stranz E. Os pequenos municípios do Brasil - uma análise a partir de índices de gestão. Análise. 2012;23(1):31-44. Disponível em: http://revistaseletronicas.pucrs.br/ojs/index.php/face/article/view/11433
https://doi.org/http://revistaseletronic...
A study conducted in the state of Rio Grande do Sul, in 2017, showed that smaller municipalities have optimized financial control, effectiveness of personnel management, better definition and implementation of investments, based on health and education improvement, and better quality of life index.1818. Arcari JM, Barros APD, Rosa RS, Marchi R, Martins AB. Perfil do gestor e práticas de gestão municipal no sistema único de saúde (SUS) de acordo com porte populacional nos municípios do estado do Rio Grande do Sul. Cienc Saude Colet. 2020;25(2):407-20. doi: https://doi.org/10.1590/1413-81232020252.13092018.
https://doi.org/https://doi.org/10.1590/...

If adequate immunobiological agent conservation prevents immunobiological agent losses,22. Ogboghodo EO, Omuemu VO, Odijie O, Odaman OJ. Cold chain management practices of health care workers in primary health care facilities in Southern Nigeria. Pan Afr Med J. 2017 May 11;27:34. doi: https://doi.org/10.11604/pamj.2017.27.34.11946.
https://doi.org/https://doi.org/10.11604...
.2121. Guimarães EAA, Oliveira VC, Oliveira MM, Viegas SMF, Ferreira AP, Dias FCS. Critical events in the maintenance of vaccine conservation. Rev Enferm UFPE on line. 2018;12(6):1781-9. doi: https://doi.org/10.5205/1981-8963-v12i6a230909p1781-1789-2018.
https://doi.org/https://doi.org/10.5205/...
.2424. Hanson CM, George AM, Sawadogo A, Schreiber B. Is freezing in the vaccine cold chain an ongoing issue? A literature review. Vaccine. 2017 Apr 19;35(17):2127-33. doi: https://doi.org/10.1016/j.vaccine.2016.09.070.
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management practices and frequent cold chain evaluations are equally essential for achieving the effectiveness, sustainability and good performance of immunization programs, thus qualified professionals and managers are required in this service.33. Bogale HA, Amhare AF, Bogale AA. Assessment of factors affecting vaccine cold chain management practice in public health institutions in east Gojam zone of Amhara region. BMC Public Health. 2019 Nov 1;19(1):1433. doi: https://doi.org/10.1186/s12889-019-7786-x.
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.3030. Brison M, LeTallec Y. Transforming cold chain performance and management in lower-income countries. Vaccine. 2017 Apr 19;35(17):2107-9. doi: http://dx.doi.org/10.1016/j.vaccine.2016.11.067.
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Both measures, immunobiological agent conservation and work process improvement, can certainly impact on the reduction of the costs of immunization programs.11. Ashok A, Brison M, Letallec Y. Improving cold chain systems: challenges and solutions. Vaccine. 2017 Apr 19;35(17):2217-23. doi: https://doi.org/10.1016/j.vaccine.2016.08.045.
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.44. Ministério da Saúde (BR). Manual de rede de frio do programa nacional de imunização [Internet]. 5a ed. Brasília, DF: MS; 2017 [acesso 13 maio 2021]. Disponível em: Disponível em: https://portalarquivos2.saude.gov.br/images/pdf/2017/dezembro/15/rede_frio_2017_web_VF.pdf
https://portalarquivos2.saude.gov.br/ima...
.77. Lennon P, Atuhaire B, Yavari S, Sampath V, Mvundura M, Ramanathan N, et al. Root cause analysis underscores the importance of understanding, addressing, and communicating cold chain equipment failures to improve equipment performance. Vaccine. 2017 Apr 19;35(17):2198-202. doi: http://dx.doi.org/10.1016/j.vaccine.2016.09.068.
https://doi.org/http://dx.doi.org/10.101...

8. Hibbs BF, Miller E, Shi J, Smith K, Lewis P, Shimabukuro TT. Safety of vaccines that have been kept outside of recommended temperatures: Reports to the Vaccine Adverse Event Reporting System (VAERS), 2008-2012. Vaccine. 2018 Jan 25;36(4):553-8. doi: https://doi.org/10.1016/j.vaccine.2017.11.083.
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-99. World Health Organization. How to monitor temperatures in the vaccine supply chain [Internet]. Geneva: WHO ; 2015 Jul [acesso 14 maio 2021]. Disponível em: Disponível em: https://apps.who.int/iris/bitstream/handle/10665/183583/WHO_IVB_15.04_eng.pdf;jsessionid=988E6BD55C623F9F7508B6FDB9359B79?sequence=1
https://apps.who.int/iris/bitstream/hand...

All vaccination rooms evaluated showed similarities in management, i.e., vaccination activities performed by the nursing team and supervised by a nurse. The role of a professional nurse who is the technical responsible for vaccination activities, is fundamental to the management and monitoring of the maintenance of the cold chain, in addition to promoting improvement of the nursing team through systematic training, which, consequently, impacts on the quality of care provided in vaccination rooms.33. Bogale HA, Amhare AF, Bogale AA. Assessment of factors affecting vaccine cold chain management practice in public health institutions in east Gojam zone of Amhara region. BMC Public Health. 2019 Nov 1;19(1):1433. doi: https://doi.org/10.1186/s12889-019-7786-x.
https://doi.org/https://doi.org/10.1186/...
.2020. Amaral GG, Oliveira VC, Guimarães EAA, Reis IA, Viegas SMF, Pinto IC, et al. Evaluation of the psychometric properties of the Immunobiological Agent Conservation Assessment Scale. J Nurs Meas. 2020 Oct 16;28(3): JNM-D-20-00032. doi: http://dx.doi.org/10.1891/JNM-D-20-00032.
https://doi.org/http://dx.doi.org/10.189...
Therefore, the use and dissemination of tools for the evaluation of activities in vaccination rooms, such as EACI, can support this management process.

Taking these results, it can be concluded that immunobiological agent conservation in vaccination rooms in the Western health macro-region of the state of Minas Gerais was inadequate. Significant improvement should be made in these rooms, until they reach adequate parameters for a vaccination room and, consequently, contribute significantly to the success of the activities of the Brazilian PNI.

References

  • *
    Article derived from the Master's degree dissertation entitled 'Evaluation of the psychometric properties of the Immunobiological Agent Conservation Assessment Scale', submitted by Gabriela Gonçalves Amaral to the Nursing Postgraduate Program of the Universidade Federal de São João del-Rei in 2020.

Publication Dates

  • Publication in this collection
    23 Aug 2021
  • Date of issue
    2021

History

  • Received
    25 Nov 2020
  • Accepted
    06 Apr 2021
Secretaria de Vigilância em Saúde - Ministério da Saúde do Brasil Brasília - Distrito Federal - Brazil
E-mail: leilapgarcia@gmail.com