\Capstone

Project [PHR417]

Pharmacovigilance data reporting from the patients of

Rheumatoid Arthritis"
A SURVEY SUBMITTED IN PARTIAL FULFILMENT OF THE
REQUIREMENTS FOR THE AWARD OF THE DEGREE OF
BACHELOR OF PHARMACY

Submitted By
Ashutosh Gupta
(Reg. no.- 11204695)
Under the guidance of
Dr. Surajpal Verma
Assistant

Professor

School of Pharmaceutical Sciences

Lovely Faculty of Applied Medical Sciences
Lovely Professional University
PUNJAB-144411
October, 2015

Pharyngitis
Tonsillopharyngitis (pharyngitis) is an inflammatory syndrome of the oropharynx. It is mainly
tranmitted through contact with respiratory secretions but can also be occured through food and
fomite contact. Most cases of pharyngitis are uncomplicated and self-limited, but the associated
swelling may threaten airway patency or disturb the ingestion of adequate liquids, which ,may leads
to clinically significant dehydration. The infectious causes of pharyngitis can also affect other
organs, such as the spleen, brain, heart, kidneys and lungs.
Viruses are mostly responsible for pharyngitis in both children and adults. Group A beta-hemolytic
Streptococcus (GABHS) is the most common bacterial cause of pharyngitis in children, with a peak
incidence of 30%. Pharyngeal pain is the most common symptom, that is aggravated by swallowing
and may radiate to the ears. Examination of pharyngitis reveals fever, pharyngeal erythema,
pharyngeal or tonsillar exudate, and tonsillar enlargement. The infection tends to localize to
lymphatic tissue and produces suppuration and swelling of the tonsils, along with tender cervical
adenopathy. Occlusion of the eustachian tubes may result in secondary otitis media. Clinical
differentiation of the causative organisms is virtually impossible.1,2,5-7
Pharyngitis is a common manifestation of infectious mononucleosis (caused by EBV) in young
adults.1,2,5 Symptoms develop after an incubation period of 4 to 7 weeks. Fever and a tonsillar
exudate or a membrane (that is cheesy or creamy white) is often present. Cervical as well as
generalized lymphadenopathy (90-100%) and splenomegaly (50%) are usually noted, and palatal
petechiae may be present. Hepatomegaly is present in 10 to 15% of cases. Periorbital edema and
rash are rare findings. In up to 90% of patients with mononucleosis who are given ampicillin or
amoxicillin, a diffuse macular rash develops that may be misdiagnosed as an allergic reaction.
Management
Patients with pharyngitis should be treated symptomatically with topical anesthetic rinses or
lozenges and with acetaminophen or ibuprofen. Oral hydration and saltwater gargles are helpful.
Most cases of pharyngitis are self-limited and follow a benign course.1,5-7 Antibiotics are overused
in the treatment of pharyngitis and are not indicated in the vast majority of cases of pharyngitis
diagnosed in the United States.
Treatment of infectious mononucleosis is supportive (see Chapter 130). Patients should avoid
contact sports for 6 to 8 weeks to minimize the small risk of splenic rupture. Corticosteroids are
indicated for patients with tonsillar hypertrophy that threatens airway patency, severe
thrombocytopenia, or hemolytic anemia.1,2 Acyclovir, valacyclovir, or famciclovir is indicated in
immunocompromised patients with herpetic pharyngitis and may be beneficial in the treatment of
acute herpetic pharyngitis.1,7
PREVENTIONS: Clean cushions, soft toys curtains and furniture regularly.
Choose wood or hard vinyl floor coverings instead of carpet.
Keep your pets outside as much as possible.
Wash and groom the pets regularly.
If allergic to pollens avoid grassy areas
Keep doors and windows shut during mid morning and early evening, when there is most
pollen in air.
Keep your home dry and well ventilated

If allergic to pollen shower, wash your hair and change your clothes after being outside.

Epiglottitis
Adult epiglottitis can lead to rapid, unpredictable airway obstruction. The incidence of pediatric
epiglottitis has diminished since the introduction of Haemophilus influenzae vaccine. At the same
time, there has been an apparent increase in adult epiglottitis, possibly because of increased
recognition.1,6,18,19
PREVENTION
Keep away from infected persons.
Keep vaccination up to date.
Keep house hold clean.
Do not come in contact with any dirty animal.

Principles of Disease
Adult epiglottitis is a localized cellulitis involving the supraglottic structures, including the base of
the tongue, vallecula, aryepiglottic folds, arytenoid soft tissues, lingual tonsils, and epiglottis.
Inflammation does not extend to the infraglottic regions. Some adults have a normal epiglottis in the
setting of severe supraglottic involvement. The term supraglottitis is a more accurate description of
this disease process. Adults with epiglottic involvement are prone to epiglottic abscesses.18,19
Adult epiglottitis can be caused by many viral, bacterial, or, rarely, fungal pathogens, but the most
commonly isolated bacterial pathogen is H. influenzae type b.20 Although it is isolated from only a
minority of affected patients, H. influenzae infection is associated with a more aggressive disease
course. The predominant organisms isolated from epiglottic abscesses are Streptococcus and Staphylococcus species. Adult epiglottitis may also result from thermal injury.1,18,19
Adult epiglottitis has no age or seasonal prevalence. Males and smokers are more
commonly affected. Adults with epiglottitis typically experience a prodrome resembling
that of a benign upper respiratory tract infection. The duration of the prodrome is usually 1
to 2 days but may be as long as 7 days or as short as several hours. Patients who have a
rapid onset of the disease as well as those with comorbid conditions (especially diabetes)
are more likely to require airway intervention.1,18,19
PREVENTION

Keep away from infected persons.

Keep vaccination up to date.

 Keep house hold clean.

Do not come in contact with any dirty animal.
LARYNGITIS
Laryngitis is manifested as hoarseness and aphonia. It is usually caused by viral upper respiratory
tract infections. In up to 10% of cases, bacterial infections (including streptococcal infection and
diphtheria) may be responsible. Rare causative entities are tuberculosis, syphilis, leprosy,
actinomycosis, and fungi. Noninfectious causes include tumors, caustic or thermal injuries, trauma,
and esophageal reflux disease.14,15 Laryngitis generally is a benign viral illness with peak
symptoms lasting 3 to 4 days. Voice rest often is recommended, but there is no evidence that this
is of any benefit in terms of duration or severity of symptoms. Antibiotics are not indicated unless
signs of bacterial infection are present.16 Steroids may hasten resolution of symptoms.17
PREVENTION
Practicing good personal hygiene.
Avoiding close contact with people who are infected.
Do not smoke.
Regularly clean throat.
Raise head with pillows when sleeping.
Do not shout or sing loudly or for long time.
RHINOSINUSITIS
Perspective and Principles of Disease
As sinusitis usually involves the nasal cavity, the term rhinosinusitis is preferred. These terms will
be used interchangeably in this section.36,37
The paranasal sinuses (frontal, maxillary, ethmoid, and sphenoid) are named for the facial bones
with which they are associated. Pneumatization may involve other bones but represents extension
from the main sinus. The maxillary, anterior ethmoid, and frontal sinuses drain into the medial
meatus, located between the inferior and middle nasal turbinates. This area is named the
ostiomeatal complex and is the focal point of sinus disease. The posterior ethmoid sinus drains into
the superior meatus and the sphenoid sinus just above the superior turbinate.36,37
Sinusitis can be classified into acute viral, acute bacterial, chronic, and recurrent acute variations.
Approximately 90% of patients with colds have an element of the acute viral form. Acute viral
sinusitis may lead to the development of the acute bacterial variety. Streptococcus pneumoniae,
nontypable H. influenzae, and M. catarrhalis are the primary pathogens responsible for acute
bacterial and recurrent acute sinusitis. P. aeruginosa is associated with sinusitis in the setting of
HIV infection and cystic fibrosis. Anaerobic bacteria, streptococcal species, and S. aureus are more
prominent causes of chronic sinusitis. Fungi also have a role in chronic sinusitis. Rhizopus,
Aspergillus, Candida, Histoplasma, Blastomyces, Coccidioides, and Cryptococcus species, as well
as other fungi, may cause sinusitis, primarily in immunocompromised hosts. It is important to
distinguish infectious from allergic sinusitis. Allergic sinusitis is associated with sneezing, itchy
eyes, allergen exposure, and previous episodes.36-39
Clinical Features
Frontal sinusitis can cause severe headache localized to the forehead and orbit. Sphenoid sinusitis
may cause vague headaches and focal pain almost anywhere in the head. Maxillary sinusitis may be
seen with pain over the zygoma, in the canine or bicuspid teeth, or periorbitally. Ethmoid sinusitis

can cause medial canthal pain and periorbital or temporal headaches.36,37,

Management
Most cases of acute sinusitis are self-limited and resolve spontaneously; therefore management
should focus on symptomatic treatment and patient education. The goal of symptomatic treatment
should be to reduce patient discomfort and includes appropriate pain management and local
decongestant therapy. When allergic symptoms are prominent or the patient has a history of allergic
rhinosinusitis, antihistamines, such as loratadine 10 mg daily, are helpful, but antihistamines
otherwise are of no value. Sinus self-irrigation with a Neti pot or powered commercial irrigator can
be helpful for patients with chronic low-grade symptoms or frequently recurring acute episodes.
PREVENTIONS: Clean cushions, soft toys curtains and furniture regularly.
Choose wood or hard vinyl floor coverings instead of
carpet.
Keep your pets outside as much as possible.
Wash and groom the pets regularly.
If allergic to pollens avoid grassy areas
Keep doors and windows shut during mid morning and
early evening, when there is most pollen in air.
Keep your home dry and well ventilated
If allergic to pollen shower, wash your hair and change
your clothes after being outside.

PREFACE [SUMMARY STATEMENTS 8, 9, 13]

Rhinitis, as defined for the purposes of this document, ischaracterized by 1 or more of the following
nasal symptoms:congestion,rhinorrhea (anterior and posterior), sneezing, anditching. Rhinitis is
usually associated with inflammation, but someforms of rhinitis such as vasomotor rhinitis or
atrophic rhinitis arenot predominantly inflammatory.
Rhinitis is a significant cause of widespread morbidity, medicaltreatment costs, reduced work
productivity, and lost school days.
Although sometimes mistakenly viewed as a trivial disease,symptoms of allergic and nonallergic
rhinitis may significantly
affect a patients quality of life and can be associated withconditions such as fatigue, headache,
cognitive impairment, and
sleep disturbance. Appropriate management of rhinitis may be animportant component in effective
management of coexisting or
complicating respiratory conditions, such as asthma, sinusitis, andsleep apnea. The financial burden
to society for allergic rhinitis issubstantial. The total direct ($7.3 billion) and indirect costs

($4.28billion, including loss of productivity) estimated in the United

States for 2002 were $11.58 billion.1Allergic rhinitis affects between 10% and 30% of all adults
and
as many as 40% of children.2,3-6 In most studies, the ratio of allergicto pure nonallergic rhinitis is
3:1.2 Preliminary data suggest
that 44% to 87% of patients with rhinitis may have mixed rhinitisa combination of allergic and
nonallergic rhinitis.2,7 Worldwide,
the prevalence
REFERENCES
1. Schoenwetter WF, Dupclay L Jr, Appajosyula S, Botteman MF, Pashos CL. Economic
impact and quality-of-life burden of allergic rhinitis. Curr Med Res Opin
2004;20:305-17. IV
2. Settipane RA. Rhinitis: a dose of epidemiological reality. Allergy Asthma Proc
2003;24:147-54. IV
PREVENTIONS: Clean cushions, soft toys curtains and furniture regularly.
Choose wood or hard vinyl floor coverings instead of
carpet.
Keep your pets outside as much as possible.
Wash and groom the pets regularly.
If allergic to pollens avoid grassy areas
Keep doors and windows shut during mid morning and
early evening, when there is most pollen in air.
Keep your home dry and well ventilated
If allergic to pollen shower, wash your hair and change
your clothes after being outside.
References
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2. Bisno AL: Acute pharyngitis. N Engl J Med 2001; 344:205.
3. Esposito S, et al: Acute tonsillopharyngitis associated with atypical bacterial infection in
children: Natural history and impact of macrolide therapy. Clin Infect Dis 2006; 43:206.
4. Tiemstra J, Miranda RL: Role of nongroup A streptococci in acute pharyngitis. J Am Board
Fam Med 2009; 22:663.
5. Bisno AL, et al: Practice guidelines for the diagnosis and management of group A streptococcal
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