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AVAILABILITY AND STORAGE OF VACCINES IN COMMUNITY PHARMACIES

CHAPTER ONE

INTRODUCTION

1.0   Background of the Study

Immunization is the process by which an individual’s immune system becomes fortified against an agent (known as the immunogen). When this system is exposed to molecules that are foreign to the body, called non-self, it will orchestrate an immune response, and it will also develop the ability to quickly respond to a subsequent encounter because of immunological memory. This is a function of the adaptive immune system. Therefore, by exposing an animal to an immunogen in a controlled way, its body can learn to protect itself; this is called active immunization (Okwor, et al., 2012)

The most important elements of the immune system that are improved by immunization are the T cells, B cells, and the antibodies B cells produce. Memory B cells and memory T cells are responsible for a swift response to a second encounter with a foreign molecule. Passive immunization is direct introduction of these elements into the body, instead of production of these elements by the body itself. Immunization is done through various techniques, most commonly vaccination. Vaccines against microorganisms that cause diseases can prepare the body’s immune system, thus helping to fight or prevent an infection. The fact that mutations can cause cancercells to produce proteins or other molecules that are known to the body forms the theoretical basis for therapeutic cancer vaccines. Other molecules can be used for immunization as well, for example in experimental vaccines against nicotine (NicVAX) or the hormone ghrelin in experiments to create an obesity vaccine. Immunizations are definitely less risky and an easier way to become immune to a particular disease by risking a milder form of the disease itself. They are important for both adults and children in that they can protect us from the many diseases out there.

Through the use of immunizations, some infections and diseases have almost completely been eradicated throughout the United States and the World. One example is polio. Thanks to dedicated health care professionals and the parents of children who vaccinated on schedule, polio has been eliminated in the U.S. since 1979 (American Pharmaceutical Association [Apha] , 2013). Polio is still found in other parts of the world so certain people could still be at risk of getting it. This includes those people who have never had the vaccine, those who didn’t receive all doses of the vaccine, or those traveling to areas of the world where polio is still prevalent.

Immunization is the most precious gift that a health care worker can give a child and it remains the most cost effective preventative health intervention presently known (South Africa, 2003; Cameroun, 2009). Vaccines are sensitive biological substances that gradually lose their potency with time (World Health Organization [WHO] , 1998) and this loss of potency can be accelerated when stored out of the recommended range of temperature (WHO, 2004). Any loss of potency in a vaccine is permanent and irreversible. Consequently, a proper storage of vaccines at the recommended temperature conditions is vital so that vaccines’ potency is retained up to the moment of administration (WHO, 1998).

Before the development and wide use of human vaccines, few people survived childhood without experiencing a litany of diseases including measles, mumps, rubella, chickenpox, whooping cough, and rotavirus diarrhea. In addition to these universal diseases of childhood, thousands of children each year suffered or succumbed to life threatening episodes of paralytic poliomyelitis, diphtheria, or bacterial meningitis caused by Haemophilus influenza type b (Hib) or Streptococcus pneumonia (Sutter, et al., 1999).

Vaccines are considered to be one of the most cost-effective preventive measures against certain diseases, and the Centers for Disease Control and Prevention (CDC) declared vaccinations to be one of the top 10 public health achievements of the 20th century (WHO, 1998), vaccinations have saved millions of lives since their introduction more than 200 years ago (WHO, 2004).

Community pharmacists are uniquely placed to provide support and advice to the general public compared with other health care professionals. The combination of location and accessibility means that most consumers have ready access to a pharmacy where health professional advice is available on demand (Bradshaw et al., 1998). A high level of public trust and confidence in pharmacists’ ability to advice on non-prescription medicines is afforded to community pharmacists (Pharmacy Research UK., 2009). Although there is a general global move to liberalize non-prescription markets, pharmacies in many countries still are the main suppliers of non-prescription medicines (Tisman, 2010). Pharmacists are therefore in a position to facilitate consumer self-care and self-medication, which needs to be built on and exploited.

A recent survey of public health leaders (Rambhia, et al., 2009) identified pharmacists as playing a key role in vaccine administration and pandemic planning. Evidence in published medical literature suggests that pharmacies are uniquely positioned to influence previously difficult-to-reach populations (Crawford, et al., 2011; Westrick, 2010). A review of pharmacy-led immunization programs (Francis and Hinchliffe, 2011) concluded that pharmacies might be especially effective in immunizing high-risk, older adults who are more likely to need prescription medications and, therefore, use pharmacy services. Pharmacist interventions have been shown to improve medication adherence (Jiang, et al., 2010), provide increased access to health care expertise and advice, and perform a variety of primary care services (Taitel, et al., 2011).

Rutter, (2015) in his submission noted that the pharmacy has a long history of facilitating self-care, however, more than ever before, pharmacists and their staffs are being provided opportunities to expand their contributions which include involvement in routine immunization. Although considerable barriers still existif the community pharmacy is to maximize its potential there is urgent need to ask about pharmacists’ ability and readiness to embrace change especially as it relates to vaccine storage (Rutter, 2015).

1.1 Type of Vaccines

Vaccines are dead or inactivated organisms or purified products derived from them. There are several types of vaccines in use (National Institute of Allergy and Infectious Disease, 2012). These represent different strategies used to try to reduce risk of illness, while retaining the ability to induce a beneficial immune response.

Inactivated Vaccines

Some vaccines contain inactivated, but previously virulent, micro-organisms that have been destroyed with chemicals, heat, radiation, or antibiotics. Examples are influenza, cholera, bubonic plague, polio, hepatitis A, and rabies vaccines.

Attenuated Vaccines

Some vaccines contain live, attenuated microorganisms. Many of these are active viruses that have been cultivated under conditions that disable their virulent properties, or that use closely related but less dangerous organisms to produce a broad immune response. Although most attenuated vaccines are viral, some are bacterial in nature. Examples include the viral diseases yellow fever, measles, rubella, and mumps, and the bacterial disease typhoid. The live Mycobacterium tuberculosis vaccine developed by Calmette and Guérin is not made of a contagious strain, but contains a virulently modified strain called “BCG” used to elicit an immune response to the vaccine. The live attenuated vaccine-containing the strain Yersinia pestis EV is used for plague immunization. Attenuated vaccines have some advantages and disadvantages. They typically provoke more durable immunological responses and are the preferred type for healthy adults. But they may not be safe for use in immunocompromised individuals, and may rarely mutate to a virulent form and cause disease

Toxoid

Toxoid vaccines are made from inactivated toxic compounds that cause illness rather than the micro-organism. Examples of toxoid-based vaccines include tetanus and diphtheria. Toxoid vaccines are known for their efficacy. Not all toxoids are for micro-organisms; for example, Crotalus atrox toxoid is used to vaccinate dogs against rattlesnake bites.

Subunit Vaccines

Protein subunitrather than introducing an inactivated or attenuated micro-organism to an immune system (which would constitute a “whole-agent” vaccine), a fragment of it can create an immune response. Examples include the subunit vaccine against Hepatitis B virus that is composed of only the surface proteins of the virus (previously extracted from the blood serum of chronically infected patients, but now produced by recombination of the viral genes into yeast), the virus-like particle (VLP) vaccine against human papillomavirus (HPV) that is composed of the viral major capsid protein, and the hemagglutinin and neuraminidase subunits of the influenza virus. Subunit vaccine is being used for plague immunization.

Conjugate Vaccines

Certain bacteria have polysaccharide outer coats that are poorly immunogenic. By linking these outer coats to proteins (e.g., toxins), the immune system can be led to recognize the polysaccharide as if it were a protein antigen. This approach is used in the Haemophilus influenzae type B vaccine

Experimental Vaccines

A number of innovative vaccines are also in development and in use, they include;

Dendritic cell vaccines

The combine dendritic cells with antigens in order to present the antigens to the body’s white blood cells, thus stimulating an immune reaction. These vaccines have shown some positive preliminary results for treating brain tumors (Kim and Liau, 2010) and are also tested in malignant melanoma (Anguille, et al., 2014).

Recombinant Vector

By combining the physiology of one micro-organism and the DNA of the other, immunity can be created against diseases that have complex infection processes

DNA vaccination

An alternative, experimental approach to vaccination called DNA vaccination, created from an infectious agent’s DNA, is under development. The proposed mechanism is the insertion (and expression, enhanced by the use of electroporation, triggering immune system recognition) of viral or bacterial DNA into human or animal cells. Some cells of the immune system that recognize the proteins expressed will mount an attack against these proteins and cells expressing them. Because these cells live for a very long time, if the pathogen that normally expresses these proteinsis encountered at a later time, they will be attacked instantly by the immune system. One potential advantage of DNA vaccines is that they are very easy to produce and store. As of 2015, DNA vaccination is still experimental and is not approved for human use (Arce-Fonseca,et al., 2015)

T-cell receptor peptide vaccines

These are under development for several diseases using models of valley fever, stomatitis, and atopic dermatitis. These peptides have been shown to modulate cytokine production and improve cell mediated immunity.

Targeting of identified bacterial proteins

Targeting of identified bacterial proteins that are involved in complement inhibition would neutralize the key bacterial virulence mechanism (Meri, et al., 2008).

While most vaccines are created using inactivated or attenuated compounds from micro-organisms, synthetic vaccines are composed mainly or wholly of synthetic peptides, carbohydrates, or antigens.

Valence

Vaccines may be monovalent (also called univalent) or multivalent (also called polyvalent). A monovalent vaccine is designed to immunize against a single antigen or single microorganism (Scot, 2004)). A multivalent or polyvalent vaccine is designed to immunize against two or more strains of the same microorganism, or against two or more microorganisms (Sutter et al., 1999). The valency of a multivalent vaccine may be denoted with a Greek or Latin prefix (e.g., tetravalent or quadrivalent). In certain cases a monovalent vaccine may be preferable for rapidly developing a strong immune response (Neighmond, 2010).

Heterotypic

Also known as Heterologous or “Jennerian” vaccines these are vaccines that are pathogens of other animals that either do not cause disease or cause mild disease in the organism being treated. The classic example is Jenner’s use of cowpox to protect against smallpox. A current example is the use of BCG vaccine made from Mycobacterium bovis to protect against human tuberculosis (Scot, 2004).

1.2 Challenges to Vaccine Utilization in Nigeria

Recent WHO estimates indicate that close to amillion children (868,000 children) under the age office years die in Nigeria each year and this placesNigeria in the second position in terms of globalannual childhood deaths after India (Ayene, 2014). The continued low uptake of immunization threatens Nigeria’s efforts at meeting the Millennium Development Goal (MDG) 4, which aims to significantly reduce child mortality. Vaccine preventable deaths comprise about twenty percent of childhood deaths (FBA Systems Analyst, 2005). There is no doubt that the major challenges to effective vaccine utilization or routine immunization in Nigeria ranges from religion, political, lack of storage facilities amongst others as discussed below.

Politics

Politics is most often related to the art and the activities employed to governing a country or society but it can also within good reason be extended to the practice and theory of influencing other people on a civic or individual level (Abdulraheem, et al., 2011). Governance includes the processes of determining policies to address different problems, including health challenges that arise within a state. In the context of routine immunization, politics is relevant to the development of the health system. Questions regarding what policies to adopt with regard to health issues such as routine immunization have political undertone (Anyene, 2014). Policies regarding the primary health care system within which routine immunization is undertaken in Nigeria is linked to politics. Political issues such as leadership of Local Government Areas (LGA), allocation to the LGAs et cetera, eventually affects primary health care, as that level of government is mostly responsible for it. It is also important to note in Nigeria that the politics of routine immunization is broadly spread from the top, starting with the Federal Executive Council, the Legislature (NASS), Minister of Health and the Federal Ministry of Health, the Governors, the Commissioners and the State Ministries of Health, to the Local Government Chairmen and all 774 local governments in Nigeria.

Rejection of Routine Immunization

Another problem and challenges facing immunization programmes in Nigeria is the rejection of selected vaccines/vaccination by parents or religious bodies more especially in the northern part of this country (Jegede, 2007; Ankarah, 2005). The reasons for such rejection are outlined below;

Fear and Confusion

Many decision-makers and caregivers reject routine immunization due to rumours, incorrect information, and fear. Attempts to increase coverage must include awareness of people’s attitudes and the influence of these on behaviour. Fears regarding routine immunization are expressed in many parts of Nigeria. Fathers of partially immunised children in Muslim rural communities in Lagos State see hidden motives linked with attempts by nongovernmental organisations (NGOs) sponsored by unknown enemies in developed countries to reduce the local population and increase mortality rates among Nigerians. Belief in a secret immunization agenda is prevalent in Jigawa, Kano and Yobe States, where many believe activities are fuelled by Western countries determined to impose population control on local Muslim communities (Feildein, 2005; Yola, 2003)

Low Confidence and Lack of Trust

Lack of confidence and trust in routine immunization as effective health interventions appears to be relatively common in many parts of Nigeria (Babalola, 2005). A 2003 study in Kano State found that 9.2% of respondents (mothers aged 15–49) evinced ‘no faith in immunization’, while 6.7% expressed ‘fear of side effects’. For many, immunization is seen to provide at best only partial immunity, e.g. in Kano and Enugu (Brieger, 2004; Fieldein,2005). The widespread misconception that immunization can prevent all childhood illnesses reduces trust because when, as it must, immunization fails to give such protection, faith is lost in immunization as an intervention, for any and all diseases.

Religious Factors

Nigeria is a very religious country with religion and spirituality permeating all aspects of life. Matters around health, including immunization, are not excluded from this infiltration (Anyene, 2009). Some of the ways in which religion has impacted uptake of routine immunization are described below. Conspiracy theories linking vaccination and fertility control and/or sterilization have been propounded and promoted by religious leaders, particularly in the North including in States with the least immunization coverage rates. One such theory is that polio vaccination and other vaccines are a part of a western plot to sterilize young girls and eliminate the Muslim population (Jegede, 2007). Generally, the Muslim north has the low immunization coverage, the least being 6% (northwest) and the highest being 44.6% (southeast). In Ekiti state (southwest), for example, the northeast and west of Ekiti, with a stronger Islamic influence, has low immunization coverage and also poor educational attainment (Ophori, et al., 2014). Christians have 24.2% immunization coverage as compared to only 8.8% for Muslims (Ankrah, et al., 2005).

Cultural Practices

Cultural practices, like religion and politics, play a key role in uptake of routine immunization. Immunization directly affects the issue of childrearing and child care and these are issues that have a cultural foundation. Certain cultural practices though acceptable for many years, have however, been found to be detrimental to immunization uptake, child survival and development. While this has been recognized and efforts to counter detrimental cultural practices are undertaken in different parts of the country, they have not always been successful, partly because these cultural practices are sometimes deeply entrenched and other times because there is insufficient engagement with the community and therefore inadequate sensitivity to the issues and education on their harms.

One such cultural practice which occurs in Yobe State is that a woman should remain indoors for 40 days after giving birth. This prevents her from accessing both postnatal-care for herself and immunization services for her newborn (Rafau, 2004). In some communities, having babies at home is still the norm. In such situations, the opportunities for immunization, especially the early ones such as BCG and OPV1, given right after birth and six weeks after respectively, may be missed (Ubajaka, et al., 2012).

In some communities, a husband’s permission is required in order for a woman, typically the primary caregiver, to leave the house as well as to give any form of medical treatment or obtain any health services for the child (Mongono, 2013). Cultural practices and beliefs may be responsible for some of the disparities in immunization uptake. For instance, males are more likely to receive full immunization compared to girls, emphasizing cultural attitudes to gender, where male children are often more highly regarded and desired than females. However, it has been stated that the disparity is generally not significant. These gender disparities also affect education. Males in some areas are more likely to have had the opportunity of education than females. Studies have shown that the more educated a mother is the higher the chances that her children would be immunized (Babaloloa, 2006). Confusion remains significant in Katsina and in other Northern States regarding the need for immunization. There is uncertainty as to the reasons why a perfectly healthy looking infant should receive an injection. This raises suspicion and closes minds to what immunization truly has to offer. The same sensitivity and consistency applied to addressing the effect of religion on vaccine-related matters should be applied to cultural issues. It is very important to understand the cultural beliefs and practices and develop and implement the right kind of engagement, education and other strategies.

Poverty

The poorer parents are, the more likely they are to fail to immunise their children (FBA, Systems Analyst, 2005), increasing morbidity and mortality and further impoverishing the families and creating a vicious circle. Even though immunization is free, in some areas people still pay for items such as transportation for health workers attending to patients in hard to reach areas. Such receipt is required to be shown before vaccination takes place. Many are unable to pay these monies and therefore do not present their children for immunization (Oluwadare, 2012). The failure of governments to address issues relating to poverty and to undertake effective poverty alleviation exercises therefore affects adversely the rates of routine immunization in Nigeria.

1.3 The Pharmacist and Vaccination

One important cause of vaccine failure may be the use of poor or impotent vaccine mostly due to improper storage (Rathore, 1987). According to the Canadian National Vaccine Storage and Handling Guidelines for Immunization Providers, (2007), all vaccines must be maintained in a cold chain network. The Cold Chain refers to maintaining potency and integrity of a vaccine by ensuring optimal conditions during storage, handling and transport. This process includes stakeholders, equipment, and facilities from manufacture to administration and is designed to ensure that proper storage temperatures and protection from light is maintained at every step.

According to the American Pharmaceutical Association 2013 report, it was revealed that all 50 states in the United State have approved the involvement of pharmacists in routine immunizations. Likewise, the involvement of pharmacists in Mannitoba Canada as reported by Wei et al., (2016) revealed that pharmacists contributed to the efficacy of routine immunization against influenza virus.

In a country like Nigeria were electricity or power supply is poor and vaccines are also handled by untrained personnel who do not know the need for cold chain system in vaccine storage problems must definitely abound (Okwor, et al., 2009). An exposure to excessive cold, heat, or light will result in cumulative and irreversible loss of potency. The Cold Chain mandates that the optimum temperature for refrigerated vaccines remain between +2°C and +8°C, and that frozen vaccines remain at a temperature of -15°C or lower. Protection from light is necessary for light sensitive vaccines. The pharmacists’ role in the Cold Chain is to maintain its integrity by properly receiving, handling and transporting vaccines including the proper use and management of equipment, refrigerators, thermometers, temperature monitoring devices, transport coolers, insulation supplies and ice pack (Public Health Agency of Canada [PHAC] , 2007).

1.4 General Recommendations for Safe Storage and Handling of Vaccines in a Pharmacy (PHAC, 2007)

Temperature

Thermostats should never be relied upon to monitor temperature as they may not measure the temperature where the vaccines are stored. It is recommended that additional thermometers be placed inside the unit next to the vaccines on the storage shelf and that these thermometers be used for monitoring purposes. Room temperature should also be monitored at every refrigerator reading. To provide the best safety margin for temperature fluctuations within the +2°C to +8°C range, the refrigerator compartment should be set at +5°C which is mid-range and allows for suitable temperature fluctuations. The freezer should be set at -15°C or colder. The temperature of each compartment must be checked at least once in the morning when the door is opened for the first time and at the end of the day just before the door is closed for the last time. The thermometer should be positioned so that the fridge does not have to be opened to read the temperature (CDC, 2015).

Refrigerated and Frozen Vaccines

Heat sensitive vaccines experience an irreversible and cumulative loss of potency following cold chain breaches whereas cold sensitive vaccines experience an immediate loss of potency following freezing. Vaccines should always be placed on the middle rack in the center of the refrigerator or freezer and never on the side of the door or in the vegetable crisper bins.

How to Adjust Temperature

The temperature should be adjusted when it is outside the recommended range already or if over time the temperature trends demonstrate it to be moving toward the upper or lower temperature limit. Only the designated vaccine coordinator should adjust the temperature and if any additional staff notices the unit requires adjustment, they are to alert the vaccine coordinator. When adjusting the freezer temperature, take into consideration that this may potentially affect the temperature of the air venting into the fridge compartment. A warning sign should be placed on the unit saying “DO NOT adjust refrigerator or freezer temperature controls.”

When adjusting the temperature, determine if it is necessary to remove all vaccines and store them appropriately. Check the temperatures inside the refrigerator and freezer and adjust the thermostat slightly. Adjustments should be done slowly; careful not to exceed the recommended temperature range. The temperature inside the unit may take about a half hour to stabilize at which time it should then be rechecked. As needed, continue to adjust the thermostat every half hour but be sure the temperature inside the unit has stabilized before returning the removed vaccines

Factors Affecting Temperature Variation

There are many factors that can alter the temperature of vaccines inside a refrigerator or a freezer. The only way to be sure of temperature stability is to do twice daily testing and to record the data. Temperatures can vary in the storage unit based on the contents or load, the seasonal temperature, how often the door is opened or left ajar, and power interruptions. It is recommended not to open the door more than four times a day, as this exposes the vaccines to temperature

Equipment and Maintenance

a. Thermometers

Thermometers have different calibrations and accuracies thus ask the manufacturer for the accuracy of your specific thermometer, ensuring it has a calibration accurate within +/- 1°C. The only thermometer recommended for domestic vaccine storage units are min/max thermometers that are properly monitored. These thermometers monitor the temperature constantly and can provide the duration of time the unit has operated outside of the recommended temperature range. Min/max thermometers still must be checked twice a day. Record the current temperature as well as the min and max temperature since the last time it was reset. The thermometer must be reset each time a reading is taken in order to clear the min/ max temperatures. You may want to consider an alarmed min/max thermometer regardless of if you store a large or small supply of vaccinesin your unit in order to ensure there are no after-hours breaches in the cold chain that would go unnoticed until the next day. Always properly record and store the daily thermometer readings and have them available for audit if a cold chain incident occurs. In the event of a look-back, retain the temperature logs for 2 years.

Thermometer placement is also essential! They should be placed in the center of the unit away from the walls, door or fan and adjacent to the vaccines in the vaccine box on the middle shelf.

Back Up Equipment

Always anticipate that vaccine storage equipment may fail. Arrange to have a backup generator available or another facility with proper equipment where the vaccines may be temporarily stored.

Daily, Weekly, Quarterly, and Annual Equipment Maintenance Tasks

Regular maintenance of all equipment is recommended to maintain optimal functioning thus preventing equipment malfunctions. Recording that maintenance tasks were completed is as important as performing the tasks. Always record the date equipment was installed, when repairs and routine cleaning tasks were done, the manufacturer’s instructions for routine maintenance, and the contact information for the service provider.

1.5 Role of Pharmacists in Vaccine Utilization

The effective utilization and successful routine immunization is influenced by varying factors which could aid or hamper the process. One of such factors is the role that could be played by community pharmacists. These roles are multifaceted and are discussed below.

Pharmacists as vaccine educators

Community pharmacists are valuable sources of information for patients. As vaccine educators, pharmacists act to educate and recommend to the patients the importance of and need for receiving vaccinations. Physician views toward the community pharmacist’s role in patient advocacy include assisting physicians in monitoring pharmacotherapy, and providing patient counseling and medical information (Bradshaw and Doucette, 1998; Owens et al., 2009) The coordination and education regarding the importance of receiving routine and recommended vaccinations, and the vaccine product itself, would fall into this view of community pharmacists as sources of information. As discussed earlier, pharmacists have been trained in providing clinical services and patient communication; it is only appropriate that they employ this training in advocating vaccinations. Pharmacist-provided patient vaccine education, screening, and recommendations have been shown to increase vaccination rates (Fuchs, 2006).

Pharmacists have been successful in their role as vaccine educators by screening patients and providing recommendations to patients and providers. As providers of medication therapy management and a source of patient medication records, community pharmacists are able to identify patients at risk for vaccine-preventable diseases through use of pharmacy data and patient interviews (Kassam, et al., 2001). Community pharmacists also educate the community through awareness campaigns and distributing literature on the need for vaccination and where to obtain the needed vaccinations. Using a combination of screening pharmacy records, distributing vaccine literature, and urging vaccination, community pharmacists in the Isle of Wight, England, vaccinated 9.7% of all patients who received influenza vaccine on the island during the 2010–2011 influenza seasons. They also noted that it was a pharmacy staff reminder that led to the initiation of two-thirds of these vaccinations (Warner, et al., 2013). Similar results exist for pharmacist-driven interventions for the zoster vaccine. Pharmacists and pharmacy staff who promoted the zoster vaccine and provided personal selling and patient education were able to increase the number of zoster vaccinations compared with when there was no pharmacist intervention (Teetre, et al., 2014; Wang, et al.,2013).

Pharmacists as Vaccine Facilitators

The early involvement of pharmacists with immunizations was limited to the distribution of vaccine products and hosting of immunization providers in their pharmacy. Community pharmacists facilitated immunizations given by other health care providers, such as physicians and nurses, by providing their pharmacies as venues to provide vaccines. Hosting other providers was usually limited to 2–3 days during the fall and for a short number of hours during each event. Revenue generated from such events was also retained by the providers of immunization, and the pharmacy benefited through goodwill and collateral sales (Grabenstein, 1998). However, with all states currently allowing pharmacists to immunize, modern community pharmacists now use their pharmacies to host their own immunization services year-round. This movement away from being distributors or facilitators to being full providers of immunizations may explain the scarce literature on the role of pharmacists as vaccine facilitators and distributors.

As vaccine distributors, pharmacies facilitate other providers in administering vaccinations by ordering and distributing vaccine products to physicians and medical clinics. In a random sample of community pharmacies from 17 states, about one in five pharmacies engaged in vaccine distribution by reselling or distributing vaccines to local physicians and/or clinics (Hung, et al., 2007).

The pharmacist’s role as a facilitator improves immunization rates by increasing other health care providers’ accessibility to vaccine products and the locations where these providers can offer immunization services. In this role, pharmacists also aid other providers in improving their immunization offerings and rates of immunizations. It is important to note that while community pharmacists no longer serve in the originally defined role of facilitators (hosting other providers of immunizations), serving as facilitators was important in the progression of community pharmacists to immunizers by presenting the public with the concept of vaccination delivery in the pharmacy setting. For countries looking to implement pharmacy-based immunization delivery services, it is suggestedthat pharmacists serve as vaccine facilitators to trial immunization services in the pharmacy and expose the public and health system to vaccine delivery occurring in the community pharmacy.

Pharmacists as Immunizers

According to the APhA Annual Pharmacy-Based Influenza and Adult Immunization Survey 2013, pharmacists provide vaccinations in 86% of community pharmacy settings. Patients are also increasingly being referred to the pharmacy for immunizations by the pharmacists (AphA, 2013) with pharmacists authorized to administer vaccines in all 50 states, the most effective and efficient pharmacist role for providing vaccination services is to serve as an immunizer. As active immunizers, pharmacists assess patients for indications and contraindications and administer vaccines directly to the patients that they serve. Immunizing pharmacists follow the recommendations and immunization schedules provided by the Advisory Committee on Immunization Practices and the Centers for disease Control and prevention (CDC, 2015), in a review of interventions to increase influenza and pneumococcal vaccination rates among community-dwelling adults, results showed that pharmacist interventions were ineffective when pharmacists only gave reminders to physicians and did not themselves administer the vaccinations (Lau, et al., 2012). This role as an immunizer offers pharmacists the ability to deliver complete and successful immunization services by combining the roles of vaccine educator and immunizer.

There is abundant evidence from literature with data supporting the role and impact of community pharmacists as immunizers. Community pharmacy-based immunization services are a cost-effective, convenient, and accessible alternative for the public to receive vaccinations (Levi, et al., 2010). As stated earlier, one of the greatest barriers to vaccinations is accessibility. With pharmacists as immunizers, pharmacists are able to immediately act on their recommendations (administer the patient the vaccine) without referring the patient elsewhere, where the patient may not follow through or forget. With increased accessibility, pharmacists have helped to improve immunization rates, bring patients up-to-date on vaccinations, and reach those who may not otherwise have an opportunity to be vaccinated (Goad, 2013; Warner, et al., 2013; Hung, et al., 2007).

1.6 Problem Statement

More than 40,000 to 50,000 adult and child death could have been prevented annually in Nigeria if there was a successful routine immunization for certain preventable diseases of which include measles, herpes zoster, tetanus and a host of others (Abdhuraheem, et al., 2011). The federal government and donor agencies make so much effort and spend close to 50 billion dollars annually in the supply chain of vaccines but when these monies are spent and the purpose for which they are spent are not achieved due to a reduced potency of such vaccines or due to inadequate manpower for vaccine delivery to the target population.It can be said to be an investment in futility. The underutilization of these widely available vaccines has created an opportunity for pharmacists to play a role in improving immunization rates and thus advancing public health. Community pharmacy-based vaccination services will go a long way to increasing the number of immunization providers and the number of sites where patients can receive immunizations. It is thus important to understand the current role of community pharmacy-based immunization in Delta state as well as to assess the level of availability of such vaccines in community pharmacies and the storage mechanisms and facilities available to them to ensure that the cold chain vaccine delivery process is maintained.

1.7 Justification of Study

The justification of these study sterns from the fact that with the erratic power supply in Nigeria, there is a high level of possibility for vaccines to lose their potency before they are delivered to the target population. For immunization to remain relevant, immunization providers must device means of maintaining the recommended storage conditions for vaccines from the transport to storage and eventual delivery to patients. This study remains important as vaccine storage is one important factor that could influence the potency level of vaccines as well as the success of any immunization programme. Also, availability of vaccines in community pharmacies is a crucial factor in cases of envenomation by rodents, snakes and other venomous creatures. It is also important in uptake of vaccines by adults who may be susceptible vaccine preventable diseases. It is therefore important to find out what the actual situation is in relation to availability and storage facilities for vaccines. Bearing this in mind, a thorough search across literature reveals a high level of the involvement of community pharmacists in routine immunizations in developed countries like USA, Canada, UK and Australia. However, there is limited literature on the vaccine storage practices as well as the involvement of community pharmacists in Nigeria in immunization programmes of which this study hopes to bridge the existing gap.

1.8 Research Objectives

The objective of this research is to access availability and storage of vaccines in community Pharmacies in Delta state.

Specific Objectives

The specific objectives of this study are outlined as follows;

To determine the availability of childhood vaccines in Community pharmacies.

To determine the availability of adult vaccines in Community pharmacies.

To determine availability and adequacy of vaccine storage facilities in Community pharmacies

To explore variables that affect vaccine availability and storage in Delta state.

To explore variables that affects the involvement of community pharmacists in routine vaccination in Delta State.

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