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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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