By Thatiana Nomi.
According to World Health Organization (WHO), the application of vaccines prevents 2 to 3 million deaths per year from diphtheria, tetanus, pertussis and measles, but another 1,5 could be avoided through greater vaccination coverage, possible if supply chains were more efficient. By the way, this is a subject that does not receive much attention from the media, which usually gives more prominence to the development of new vaccines. However, if vaccines do not reach people, there is no immunization.
Basically, there are 2 areas of vaccination: emergency, based on humanitarian logistics, and continuous, carried out periodically through a structured chain. O supply chain leaders of immunization corresponds to the network of locations, people, equipment and information necessary for vaccines to reach the population in ideal conditions. Chains usually have 4 levels: central warehouse, regional warehouses, municipal warehouses and vaccination rooms. The development of vaccine supply models dates back to the late 70s as a result of efforts to eradicate smallpox. A major global milestone was the creation of the WHO Expanded Program on Immunization in 1974 to expand childhood vaccination coverage. The program was designed to manage the distribution of a small number of vaccines in a limited number of locations.
Since then, the complexities have only increased: population growth, epidemiological transformations, variety of vaccines, expansion of the target population, rising costs and new requirements in the cold chain. At the end of 2014 WHO published a document call-to-action to highlight the need to improve logistics processes: Immunization Supply Chain and Logistics – A Neglected but Essential System for National Immunization Programs. The document compares the scenario of the 80s with the current one. Today, immunization programs need to cover 2,5 times more diseases, there is demand for storage and transport of 4 times more vaccine volume, and the costs to immunize a person are 6 times higher.
Complexity factors
Vaccines are complex to manage, as they are biological medicines, with “live” components in their formulation. When exposed to inappropriate temperatures, the inactivation of immunogenic components occurs, and the vaccine loses its function. Specifications depend on the immunobiological, but temperatures generally must be maintained in the range of 2° to 8° C, or in negative temperatures of -25° to -15° C. Many are also preserved by lyophilization (dehydration), requiring dilution before of the application. For this purpose, a corresponding diluent is required, which, unlike vaccines, must be stored in an air-conditioned environment at a temperature of 25°C.
In the beginning, the biggest logistical challenges stemmed from the lack of temperature monitoring systems and the lack of adequate equipment for storage and transport. Over the years, these difficulties have resulted in a series of technological innovations. Specific refrigeration equipment was developed, adaptations were made to deal with power outages, high-performance thermal boxes were developed, and devices such as bottle monitors (thermochromic labels that visually indicate if the product was kept at ideal temperatures) were created. .
Even with advances, the problem of missing vaccines is still very relevant. The UN estimates that about half of the vaccines produced in the world are wasted, either because the vial expires after or before it is opened, or because of equipment failure, problems in transportation, storage, or improper handling. Warehouses are often unable to support the growing volume, which is aggravated by packaging that takes up significant space. Another issue is the annual flu vaccination campaigns, carried out at specific times. These operations are complex, requiring more resources (space and equipment), which may later end up being idle. Coupled with the fact that costs have been rising, this means that managers in these chains must work harder to maintain adequate stock levels of each of the various types of vaccine, accurately forecast demand and reduce waste.
The Brazilian picture
The conditions in Brazil, both its characteristics (population size and territorial extension) and its infrastructure, do not facilitate immunization actions. Here, the National Immunization Program (PNI), established in 1973, governs. The purchase of vaccines is centralized by the Ministry of Health, but planning is decentralized, so that the Municipal Secretariats have autonomy to define which vaccines are needed in each location. The Brazilian chain has 5 levels, as shown in figure 1. National deposits are located in RJ, state deposits are 1 per UF, regional deposits are generally located in municipalities with administrative headquarters of the health system, municipal deposits are almost 1 per municipality , and vaccination rooms are units that provide health services.
Structured supply chain leaders of Brazilian immunization
The government reports an average immunization coverage of 95%, from 1994 to 2014. Just a note about the indicator is in order here. Coverage is usually measured in children younger than 1 year, considering a specific group of vaccines. However, the indicator uses the total doses applied in the numerator, ignoring factors of epidemiological adequacy (application at the correct age) and immunological adequacy (application at the correct intervals). In other words, there is some overestimation in the numbers. Other methodological points can be questioned, but even if the number is inflated, it is recognized that the Brazilian program is a reference in mass vaccination campaigns.
But this does not mean that the results are obtained efficiently. It is not uncommon to come across news about the waste or, ironically, the lack of vaccines. In 2011, Brazil wasted more than 6 million doses of the H1N1 vaccine per expiration date (a waste of R$78 million). In March 2015, 6 states reported a serious lack of vaccines, including BCG, which protects against tuberculosis and whose application to newborns is recommended soon after birth. And despite this coverage rate, the country suffers from yellow fever again. At first, the vaccine was only recommended for regions considered at risk. In the event of an outbreak in unlikely locations, the initial logistical operation should be emergency, and then the need for continuous supply or not is reassessed. But Brazil's emergency response capacity is not the best: from January to the end of April of that year, 715 cases were confirmed, resulting in 240 deaths.
The fact that each PNI management level develops its logistics operations in isolation, and the fact that the planning support systems are not integrated make us question the efficiency of the chain. Netto (2008) reports that the Immunobiological Stock and Distribution Information System (SI-EDI) does not perform resupply calculations, for example, with manual calculations or with the aid of spreadsheets. There is no visibility of the stock in the chain, and it does not seem that the municipalities are capable of carrying out optimal planning. As for transport, the author also reports that, due to lack of financial resources, inappropriate vehicles are often used, especially at regional and municipal levels. The homogeneity of coverage in the country is also questioned. Domingues and Teixeira (2013) report that, in 2011, only 53,7% of Brazilian municipalities had adequate BCG vaccination coverage in children under 1 year of age, for example.
Despite the clear need to invest in the development of their professionals, companies still face many challenges when it comes to training and business qualification.
The role of supply chain management
If in 1976 the distribution of vaccines was referred to as vaccine cold chain, in the last 5 years the term began to be replaced by the concept of supply chain leaders. As the complexity factors grow, and the costs with procurement and transport of materials go up, there is an ever-increasing effort to integrate the various distribution plans. Routine immunization services at fixed facilities, immunization programs in remote locations, and one-off vaccination campaigns must increasingly be thought of in an integrated way, as parts of a central plan, for example. Initiatives to reassess supply chains range from restructuring the network, modes of transport, forecasting methods, assessing the impact of packaging size on transport and storage, studying the trade-offs between transport and storage, and measuring the impacts of introducing new vaccines in the existing chain.
In a survey of the Brazilian health market, ILOS found that the average out-of-stock of companies was 10,4%, with 91% of executives believing that it is possible to reduce this number to some degree. And while they believe it is possible to reduce unavailability, 52% of respondents said it is also possible to reduce inventory levels. The survey included 50 companies in the pharmaceutical industry, and 86% of them reported having a well-defined inventory policy, reviewed at least once a year. If in the private sector it is believed plausible to reduce inefficiencies, imagine the existing opportunities for improvement in the supply chain leaders of Brazilian vaccination.
In April of that year, the Vaccine Journal published a special edition: Building Next-Generation Immunization Supply Chains. One of the studies used a model to simulate the flow of vaccines in the Republic of Benin (a country in western Africa), considering different network configurations. When the introduction of the rotavirus vaccine was considered, analyzes showed that vaccine availability would drop from 93% to 71%, and the logistical cost per dose would rise from $0,23 to $0,26. However, by changing the structure of the chain by grouping municipal deposits into zones, carrying out capacity expansions and changes in the transport strategy, the simulations showed that it was possible to provide 99% availability, at a lower cost of $0,18 per dose.
Benin's initial and alternative immunization supply chain structures
Thinking about the future, one should also take into account the fact that there is a trend towards drug development in the biologics segment. Just like vaccines, which have “live” components, these drugs will also need the cold chain, not only in the logistical processes, but also at the points of sale.
Conclusions
Storage and distribution processes may not be as glamorous as scientific advances in the development of new vaccines, but they are no less important. O Global Vaccine Action Plan of the WHO, an immunization effort ratified by 194 member countries of the entity, has objectives such as the eradication of polio and the achievement of target coverage in all regions and communities of the world in the period from 2011 to 2020 (the “vaccine decade”) . Both in Brazil and around the world, this will only be possible once authorities understand the importance of managing immunization supply chains. And once they understand, they will need to take action to overcome current bottlenecks and inefficiencies. Before that, many people will still not have access to the protection they are entitled to, and a lot of money will be spent down the road.
References
- Brown, S. et al. The benefits of redesigning Benin's vaccine supply chain (2014)
- Domingues, C. and Teixeira, A. Vaccination coverage and vaccine-preventable diseases in Brazil in the period 1982-2012: PNI advances and challenges (2013)
- Moeti, M. et al. No product, no program: The critical role of supply chains in closing the immunization gap (2017)
- Netto, G. Contribution to improve the logistical management of the cold chain of immunobiologicals in the Brazilian Immunization Program (2008)
- World Health Organization
Thatiana Nomi
5 years of experience in consulting projects in Logistics and Supply Chain. Worked on logistics network optimization projects, service cost, logistics master plan, inventory policy definition, sales forecast, S&OP (Sales and Operations Planning) and transportation planning and management.
