PHARM312 Public Health Pharmacy with Pharmacoepidemiology

FINALS Term E.J.L.T.

7 PHARMACISTS, VACCINES,
AND PUBLIC HEALTH

PART I: VACCINE-PREVENTABLE DISEASES

INTRODUCTION
 Pharmacists, as immunization advocates and providers, should be able to counsel and educate
their patients regarding the benefits of vaccination
 Special emphasis would be placed on influenza and pneumococcal disease since these are the two
vaccines to be initially provided in the community pharmacy setting

A. INFLUENZA
 A highly infectious illness caused by influenza virus, which was first isolated in 1933 (type A) and
1936 (type B)
 The 1st influenza pandemic was recorded in 1580; 4 pandemics have been recorded in the 20 th
century, wherein an estimate of 21 million deaths were recorded in 1918-1919
 In 1936, it was discovered that the influenza virus could be grown in embryonated hen’s egg
 In 2003, the 1st live attenuated influenza vaccine was licensed by the US FDA
 THREE types of influenza viruses are:

INFLUENZA VIRUS TYPE DESCRIPTION

IV-A  Can affect animals (Will birds) and humans
 Constantly changing and is the cause for large
flu epidemics
 Can be spread through air droplets
(sneezing), causing its other variant (A2) to
spread around
 Can be broken down into different strains
 Hemagglutinin (virus attachment) &
Neuraminidase (penetration into cells) are the
proteins found on the surface of IV-As
IV-B  Found only on humans
 Although may only cause less severe
reaction, it can be extremely harmful
IV-C  Found only on humans
 milder than either A or B
 People do not become ill
 Does not cause epidemics
NAMING
 Accepted in 1979 by WHO
 Published in 1980
 Antigenic DRIFT vs. SHIFT
DRIFT SHIFT
 Small changes/mutations to virus’ surface  Major, abrupt change in one or both surface
antigens (HA or NA), which produce new antigens (HA or NA)
viral strains that are fairly closely related to  AS occurs at varying intervals and likely is the
one another and may be recognized by the result of reassortment (exchange of gene
immune system (cross-protection) segment) between IV-As, usually those that
 May result in epidemic affect humans and birds
 Changes due to AD can accumulate over  Results in a new IV-A subtype that is so
time, straining the ability of a person’s different from previous subtypes in humans that
immune system to recognize the new virus most people do not have immunity to new virus
 Changes in viruses due to AD can cause  Can lead to worldwide pandemic if the virus is
widespread infection because the efficiently transmitted from person to person
protection that remains from past  Example of this is when a novel H1N1 virus
exposures to similar viruses is incomplete emerged in 2009, with a combination of genes
 Occurs in all 3 types of influenza from American pigs, Eurasian pigs, birds, and
humans
 Since late 19th century, 4 AS occurrences have
led to major influenza pandemics
 Changes due to AS can occur occasionally.
When an IV-A undergoes both kinds of
changes, it is capable of evading host
immunity, with profound implications for
epidemiology and control, which is why
seasonal influenza (IV-A) are updated
frequently, to maintain protection in risk groups
against currently circulating strains
MODE OF TRANSMISSIONS
DIRECT INDIRECT
Direct contact Airborne
 Skin-to-skin  Dust
 Kissing  Droplet nuclei (measles)
 Sex (mononucleosis & gonorrhea)
 Soil/vegetation contact (hookworm)
Droplet spread Vehicle-borne
 Sneezing  Food (botulism)
 Coughing (pertussis)  Water (HV-A)
 Talking (meningococcal)  Biologic products (blood)
 Fomites (inanimate objects)
Vector-borne (mechanical or biologic)
 Fleas (mechanical) [Yersinia pestis]
 Ticks (mechanical) [Borrelia burgdorferi]
 Flies (mechanical) [Shigella]
 Mosquitoes (biological) [Aedes aegypti]
 Mosquitoes (biological) [Plasmodium]
RISK FACTORS
 Something that increases the chance of developing a disease

INFLUENZA VACCINES

INFLUENZA DESCRIPTION BRANDS ADVERSE

VACCINES REACTIONS
INACTIVATED  IM or ID  Flucelvax®  Local: 15-20%
INFLUENZA  Trivalent or Quadrivalent  FluBok®  Non-specific:
VACCINE (IIV)  Single or Multiple-dose  Fluzone High- 1%
 Vials Dose®  Hypersensitivity,
 Pre-filled syringes  Fluzone ID® allergic (rare)
  Preservative-free  Afluria®
 60% effective among
healthy patients <65 y.o.
 50-60% effective among
elderly
 80% effective in preventing
death
LIVE  Approved in 2003,  FluMist Among 10-40%
ATTENUATED containing the same Quadrivalent  Cough
INFLUENZA viruses as IIV  Fluenz Tetra  Runny nose
VACCINE (LAIV)  Single-dose sprayer unit  Nasal
designed to deliver half a congestion
dose in each nostril  Sore throat
 The virus stays and  Chills
replicates in
nasopharyngeal mucosa No serious ADRs
after administration among adults
 Injection prep. contains no
preservatives
 Approved only for healthy,
non-pregnant individuals
from 2-49 y.o.
 87% effective against
culture-confirmed influenza
in children
 No evidence in adults

B. PNEUMOCOCCAL DISEASE
o Bacterial infection of the lungs caused by Streptococcus pneumoniae, first isolated by
Pasteur in 1881
o More than 80 serotypes have been described by 1940
o First vaccine was introduced in 1977 in the Us
o 1st pneumococcal conjugate was licensed in 2000

CAUSES:
 Virus
 Bacteria
 Fungi
 Ventilator-associated

PNEUMOCOCCAL VACCINES (including CONJUGATE)

PNEUMOCOCCAL DESCRIPTION BRANDS ADVERSE

VACCINES REACTIONS
POLYSACCHARIDE  First in the US, introduced  Pneumovax®23  Local reactions
VACCINE in 1977 (PPSV23) (current  Moderate
 Contained purified in the US) systemic
polysaccharide antigen  Uses phenol as reactions (not
from 14 different preservative common)
pneumococcus types  Not effective in  Systemic
children <2 y.o. reactions (rare)
and older
patients with
chronic
diseases
14-VALENT  Contained purified capsular  Approved for
VACCINE polysaccharide antigen use in persons
from 23 pneumococcus >50 y.o. and ≥2
types that cause 60-76% of y.o. who are at
 invasive diseases high risk
PNEUMOCOCCAL  Purified capsular  PCV13 (Prevnar  Local reactions
CONJUGATE polysaccharide from 13 13®
VACCINE (PCV) types of pneumococcus  PCV15
conjugated to a nontoxic (Vaxneuvance®)
variant of diphtheria toxin  PCV20
(PCV13) (Prevnar20®)
1st form  Based in US (2000)
 Purified capsular
polysaccharide of 7
serotypes of S.
pneumoniae (PCV7)
conjugated to a nontoxic
diphtheria toxin (CRM197)

2nd form  Based in US (2010)

 13-valent pneumococcal
conjugate vaccine
 Contains 6 more serotypes
+ 7 serotypes in PCV7 also
conjugated with CRM197
 In 2008, this accounted for
61% of invasive
pneumococcal disease
cases in children <5 y.o.
 Approved by US FDA as a
single-dose for ≥50 y.o.

ELIGIBLE PARTICIPANTS FOR PNEUMOCOCCAL VACCINE IN THE PHILIPPINES

 >50 y.o.
 If <50 y.o., the following conditions must be met:
o Chronic lung disease
o Chronic cardiovascular/renal/liver disease
o Diabetes mellitus
o Alcoholism
o Cochlear implants
o Cerebrospinal fluid (CSF) fluid leaks
o Immunocompromised conditions
 Residents of nursing homes and long-term care facilities
 Smokers

DOSING

ELDERLY, IMMUNOCOMPETENT PCV13, then PPSV23 6-12 months

IMMUNOCOMPROMISED PCV13, then PPSV23 at least 8 weeks
BOOSTER PPSV23 (single dose) after 5 years

C. TETANUS, DIPHTHERIA, and PERTUSSIS

TETANUS
o aka “Lockjaw”
o Acute disease caused by neurotoxin produced by bacterium Clostridium tetani characterized
by generalized rigidity and convulsive spasms of the skeletal muscles

TETANUS TOXOID
Tetanus toxin inactivated from formaldehyde
3-4 doses + booster q.10.y. + diphtheria toxoid (Pediatric (DT)/Adult (Td)
toxoid)
 DIPHTHERIA
o Toxin-mediated caused by Corynebacterium diphtheriae affecting mucous membranes of the
nose and throat

DIPHTHERIA TOXOID
Toxin à Toxoid
In combination with tetanus toxoid + acellular pertussis vaccine
Pediatric (DT)/Adult (Td) toxoid + Diphtheria toxoid + Tetanus toxoid + acellular
Pertussis vaccine
DTaP (pedia) or TdaP (adults)

PERTUSSIS
o Whooping cough
o First described in the 16th century, caused by Bordetella pertussis

PERTUSSIS TOXOID
 Whole cell
 Acellular (DTaP [Infanrix]/TdaP [Daptacel, Boostrix, Adacel])

DTAP COMBINATION VACCINES

PEDIARIX® GSK
2002
5-valent (DTaP, Hepa B, inac. Polio)
>6 weeks old
3 doses at 2, 4, 6 months
PENTACEL®
Lyophilized Hib (ActHIB) reconstituted with a liquid DTaP-IPV solution
KINRIX®
DTaP + IPV
On the 5th dose of DTaP or 4th dose of IPV (4-6 y.o.)

D. MEASLES, MUMPS, RUBELLA

MEASLES-MUMPS-RUBELLA VACCINE (MMR)

Live, providing life-long immunity
Min req: 12mos. (2nd dose will be at 4-6 y.o.)
Max req: 12 y.o.
Contra: Hypersensitivity reaction history; with mod-to-sev illness

MEASLES
o Highly contagious viral illness
o 7th century
o Remains a common and often fatal childhood disease
o Paramyxoviridae family (enveloped proteins)
 Fusion (F) à fusion of virus and host cell membranes (penetration & hemolysis)
 Hemagglutin (H) à adsorption of virus to cells (important surface antigen)

MUMPS
o Swollen parotid glands
o Paramyxoviridae family
o Causes parotitis, orchitis, and oophoritis

RUBELLA
o “Little red” or “German measles”
o Togaviridae family (RNA virus)
o Causes Congenital Rubella Syndrome (CRS)
E. VARICELLA AND HERPES ZOSTER

VARICELLA
o “Chickenpox”
o Varicella zoster virus (VZV)
o Primary infection would be reactivation of latent infection “Herpes Zoster” (shingles)
o Herpesvirus family
o Could be transmitted via air or direct contact with the shed from skin lesions

VARICELLA VACCINES
VARIVAX®
Live attenuated (for children >12mos.)

PROQUAD® (an MMRV)

Attenuated viruses (for 12mos-12 y.o.)

ZOSTAVAX® (HZ vaccine)

Higher titer than MMRV (for >50 y.o.)

HERPES ZOSTER
o aka “shingles”
o Manifestation of VZV; any individuals who have had Varicella have chances of getting HZ
o Age is a risk factor
o Affected people are older and immunocompromised
o Herpesvirus family

HERPES ZOSTER VACCINE

VARIVAX®
Live attenuated (for children >12mos.)

PROQUAD® (an MMRV)

Attenuated viruses (for 12mos-12 y.o.)

ZOSTAVAX® (HZ vaccine)

Higher titer than MMRV (for >50 y.o.)
SC

F. HEPATITIS

HEPATITIS A
o Transmitted via fecal, person-to-person, contamination of objects, food, and water
o Viral shedding can be prolonged among immunocompromised
o HAV (Single serotype, RNA virus of Picornaviridae family)

HEPATITIS-A VACCINES
HAVRIX®
Prepared with 2-phenoxyethanol (preservative)
2nd dose administered 6-12 months after 1st dose
Pedia formulation (12mos.-18 y.o.)
Adult formulation (>19 y.o.)

VAQTA®
No preservative
2nd dose administered 6-18 months after 1st dose
Pedia formulation (12mos.-18 y.o.)
Adult formulation (>19 y.o.)

HEPATITIS B
o If becoming chronic, could lead to liver cirrhosis and liver cancer
 o HBsAg discovered in 1965
o Dane particle (complete virion of HB) discovered in 1970
o Serologic tests for HB discovered in 1970s
o (HBV) DNA virus of Hepadnaviridae family
o HBsAg and HBeAg are the “markers”

HEPATITIS-B VACCINES
RECOMBIVAX HB®
Contains Aluminum hydroxyphosphate as adjuvant
No preservative
Both for pedia and adults
Single syringe doses for 0, 1, 6 months
Not recommended for pedia and adults with normal immune status

ENGERIX-B®
Contains Aluminum hydroxide as adjuvant
No preservatives
Both for pedia and adults
Single syringe doses for 0, 1, 6 months
Not recommended for pedia and adults with normal immune status

G. HUMAN PAPILLOMAVIRUS
o Small, double-stranded DNA infecting the epithelium
o Low-risk for oncogenesis (T6 and T11) and high-risk for oncogenesis (T16 and T18), based
on association with cervical cancer
o Transmitted via sex and maternal genital (in infants)

HPV VACCINES
GARDASIL®
2006
Licensed for both males and females in 2009

CERVARUX®
For 4 HPV types included in Gardasil + 5 additional types (T31, 33, 45, 52, 58)

H. INVASIVE MENINGOCOCCAL DISEASE

o Invasive, acute, bacterial, discovered in 1805
o N. meningitidis (aerobic encapsulated diplococcus)
o Serogroups are classified based on immunologic reactivity (A, B, C, Y, W135)
o Transmitted via person-to-person by mucosal with respiratory droplets from nose and throat
o May be asymptomatic carriers

MENINGOCOCCAL POLYSACCHARIDE VACCINES (MPSV)

First licensed in 1974

MENOMUNE®
Current 4-valent polysaccharide in 1981
MENINGOCOCCAL CONJUGATE VACCINE (MCV)
Single component
MENACTRA®
MENVEO®

Combination (with Hib vaccine)

MENHIBRIX®

I. TYPHOID FEVER
o Caused by Salmonella typhii
o Acquired while traveling internationally
 o Transmitted through food, water with feces of people with the disease, those with chronic
typhoid conditions
o Very low chances of getting in developed countries

TYPHOID FEVER VACCINES

INACTIVATED
SC administration
1-dose for protection given at least 2 weeks before travel
Not for children <2 y.o.
Booster necessary q.2.weeks

LIVE-ATTENUATED
ORAL administration
4-doses; 2 days apart; last dose given at least 1 week before travel
Not for children <6 y.o.
Booster necessary q.5.years

J. RABIES
o RNA of Rhabdoviridae family
o Differing antigenic variants distinguished by lab setting, more often in mammals
(domestic/wild)
o Easily killed by sunlight, soap, and drying
o Dogs are main carriers in Asia and Africa

RABIES VACCINE
INACTIVATED
IM administration in the deltoid
3-5 shots
Recommended for groups at higher risk of exposure

RABIES IMMUNOGLOBULIN
Post-exposure treatment for immediate short-term protection (near the wound)

SERIES VACCINATIONS
1st dose given stat, with additional doses given on days 3, 7, and 14 after 1st
Those exposed to rabies but immunized, must have 2 extra doses: 1st after last
stat, then 2nd 3 days after
PHARM312 Public Health Pharmacy with Pharmacoepidemiology
FINALS Term E.J.L.T.

PHARMACISTS, VACCINES,
7 AND PUBLIC HEALTH
(Supplementals)

TRIPLE BURDEN OF DISEASE

1. Infectious diseases are still common
2. Non-communicable diseases are on the rise
3. Disaster-related health problems increasingly affect the country

FACTORS THAT CONTRIBUTE TO THE RISE OF INFECTIOUS DISEASES

1. Malnutrition in resistance to infection
2. Immunocompromise due to NCDs
3. Hospitalizations that predispose patients to nosocomial infections
4. Emergency situations (e.g., disasters) cause lack of potable water, sanitation, malnutrition, and
increased population in evacuation centers
5. Poverty and heavy burden on individuals and the health system to respond to the health needs of
the population highlight the importance of preventive measures

BENEFITS AND IMPACT ON PUBLIC HEALTH OF IMMUNIZATION

1. Prevent infection and infectious diseases
2. Control mortality, morbidity, and complications
3. Protection of unvaccinated citizens
4. Societal and economic benefits
5. Prevent AMR
6. Safe travel and mobility
7. Protection against bioterrorism
8. Enhancing equity

MAIN TARGETS OF IMMUNIZATION PROGRAMS

 “The ideal goal of immunization is disease eradication. However, this is not easy to achieve. The
next feasible goal for most countries is to eliminate a vaccine-preventable disease locally”
1. Disease eradication (immunity and surveillance)
2. Disease elimination (threats, reservoir diseases, vaccinations)

PHARMACISTS IN IMMUNIZATION PROGRAMS

 Ability to utilize their practice settings to advocate for immunization and increase their
responsibilities in the area of public health
 Prominent role in public health through health promotion and disease prevention
 A pharmacist-run clinic aims to provide alternative resources for immunization through the health
system (advocacy)

CONSIDERATIONS IN ESTABLISHING PHARMACY-BASED IMMUNIZATION SERVICES

1. Education and training
2. Legislative framework
3. Existing immunization programs in the country
4. Economic factors and sustainability

RESOURCES
1. PPhA
- Events, CPDs, devt of RPh profession in the PH
2. DOH
- Local outbreaks, govt programs, official announcements

3. FDA
- Product registration status, recall, regulation of establishments and other important
announcements

4. WHO
- Updated overall situation, intl guidelines and recommendations for managing outbreaks

5. CDC
- Updated information on prevention and control of infectious diseases, and important vaccine
information

6. ACIP
- Current recommendations on use of vaccines in the US; immunization schedules

7. Immunization Action Coalition

- Free educational materials for health professionals for safe and effective immunization services

PHARM312 Public Health Pharmacy with Pharmacoepidemiology
FINALS Term E.J.L.T.

7 EXPANDED PROGRAM ON
IMMUNIZATION

PART II: EXPANDED PROGRAM ON IMMUNIZATION

INTRODUCTION
 EPI was established in 1976 to ensure infants/children and mothers have access to routinely
recommended infant/childhood vaccines
o Tuberculosis
o Poliomyelitis
o Diphtheria
o Tetanus
o Pertussis
o Measles
 In 1986, 21.3% of children have been fully immunized in <14 months

GLOBAL SITUATION
 In 2002, WHO estimated that 1.4M deaths among children <5 y.o. due to diseases that could have
been prevented by routine vaccination, which represents 14% of global total mortality in children <5
y.o.

BURDEN
 Fully Immunized Child (FIC) coverage improved by 10% and the Child Protected at Birth (CPAB)
against Tetanus improved by 13% compared to any prior period
 The PH had once historically had the highest coverage for FIC and CPAB

EPI
 The program has the critical objective of providing Filipino children with access to safe and effective
vaccines that will protect them from common but deadly diseases such as measles, diphtheria,
tetanus, and whooping cough

OTHER RECOMMENDED VACCINES

 Influenza
 Pneumococcal
 Diphtheria, Tetanus, Pertussis (DTaP and TdaP)
 Measles, Mumps, Rubella (MMRV)
 Varicella
 Hepatitis A
 HPV
 IPV
 Rotavirus

VACCINES FOR SPECIAL GROUPS

 Not part of EPI or other recommended vaccines but available data support its use in certain
conditions:
o Meningococcal
o Rabies
o Typhoid
PHARM312 Public Health Pharmacy with Pharmacoepidemiology
FINALS Term E.J.L.T.

7 COLD CHAIN MANAGEMENT

PART III: COLD-CHAIN MANAGEMENT

INTRODUCTION
 It is a system ensuring the potency of a vaccine from the moment it leaves the vaccine
manufacturer through the shipping and storage, until administration
 “All licensed establishments engaged in the manufacture, distribution, exportation, importation,
selling, transportation/shipment of vaccines, biologics, and other temperature-sensitive drug
products are hereby directed to comply with the Cold Chain Management requirement” (A.O. 2016-
0003, sec. V, chp. 3)
 Older version is from a Bureau Circular 2007-003 (02/01/2007)
 “All establishments and outlets applying for a license to manufacture, import, distribute, or sell
vaccines and other biological products are hereby directed to comply with the said requirements.
This compliance will partly determine whether a certain establishment is capable to handle vaccines
and biological products and shall be reflected in its License to Operate (LTO)” (R.A. 9711)

SALIENT POINTS
 Designed personnel and backup personnel have written duties and are trained in vaccine storage
and handling
 Accurate and calibrated thermometers are placed properly in all vaccine storage units
 Temperature logs are reviewed for completeness and any deviations from recommended storage
temperatures
 Immediate action on any out-of-range temperatures is recommended
 Vaccines exposed out of range temperatures are marked as “DO NOT USE” and isolated physically
 There must a written, signed, and dated SOPs in place