INTRODUCTION

1. RESPIRATORY TRACT INFECTIONS

It is the infection which involve parts of the respiratory system like throat, lung, air sacs, etc. It is
mainly divided into upper and lower respiratory tract infections. These infections generally
spread from one person to another by direct contact or through the airborne particles or droplets
from the person who are infected. It can be asymptomatic and can be so severe that it can be fatal
too.

UPPER RESPIRATORY TRACT LOWER RESPIRATORY TRACT

INFECTIONS INFECTIONS
Laryngitis Pneumonia

Tonsillitis Acute bronchitis

Acute rhinitis COPD

Sinusitis Asthma

Pharyngitis COVID

Common cold Influenza

1
1.1 UPPER RESPIRATORY TRACT INFECTIONS

The infection involving upper tracts of the respiratory system like nose, pharynx, larynx, tonsils,
nostrils, sinus regions. This includes laryngitis, tonsillitis, sinusitis, common cold. They are
mainly caused by the bacteria and virus and involve wide range of diseases and rarely they can
be fungal.

1.11 LARYNGITIS

It is the inflammation of the larynx which can be acute, chronic, and infective and inflammatory
conditions.

Acute infections can be mild over a period of less than 7 days with the symptoms of fever and
airway distress. It can be caused by virus like Rhinovirus, Adeno virus, Influenza virus, RSV.
Bacterial causes be S. pneumonia, Moraxella catarrhalis, H. influenza. It can be The most
common causes of the laryngitis may include smoking, allergens, reflux and unhygienic vocal
cords. Chronic infections can last for more than 3 weeks which can be caused by the inhalation
of the irritants like fumes, allergens, acid reflux, and smoking.

The risk factors for developing this infection may be exposure to the irritating substance for a
long period of time, or having a RTI or using the voice aggressively for long period, alcohol
consumption.

The clinical presentation in the patients with pharyngitis may show low hoarse voice, heavy
mucous in their throat and dry throat, coughing up blood, difficulty in swallowing, fever.

2
  PATHOPHYSIOLOGY
 Smoking: cigarettes may have the chemical composition of the nitric oxide,
formaldehyde, acetone etc. By the inhalation of these substances may trigger
inflammation and also they damage the lining of the membrane by drying the laryngeal
mucosal lining that decreases the mucosal viscoelasticity. This loss may elevate the
subglottal pressure which is required for the vocal fold vibration initiation. The smoking
also increases T lymphocyte and macrophages and increased neutrophil count within the
secretions.
 Reflux: the acid reflux when comes in the contact with the mucosal lining of the larynx
may damage the wall and produce the inflammatory cytokine.

It can be diagnosed by physical examination and obtaining patient history. Laryngoscopy is a

procedure done to examine the vocal cords.

For viral etiology it can be treated using antiviral medications like osetamivir, zanamivir. Cough
suppressants like dextromethorphan may provide relief to the patient. The laryngitis can be
treated with the medications, voice therapy to improve speech and preventing with the contact
with the irritants like tobacco, smoking, allergens etc. To prevent dryness of the throat, avoid
smoking and keep yourself away from smoke. Hydrate yourself frequently which helps in
thinning the mucous. Avoid spicy food which can cause stomach burn. Consume the healthy diet
which must include vitamin like Vitamins A, E and C.

3
1.12 SINUSITIS

It is the inflammation of the paranasal sinus which can be bacterial or viral etiology. The most
common pathogens which causes sinusitis include: Streptococcus pneumonia, H. influenza,
Moraxella catarrhalis, Staphylococcus aureus, and also allergens, irritants like pollen, animal
dander, smoke, dust, conditions like dental infections, allergic rhinitis. The resolution of the
symptoms takes nearly from 7 to 15 days. Most patients will be better within 7 to 10 days. When
symptoms persist beyond 7 days, bacterial sinusitis is more likely. Complications are very rare .
The bacterial sinusitis often worsens after 5 days and more severe than viral. It is diagnosed from
the physical examination and also from the findings using plain radiographs, CT scan.

The common signs and symptoms which include fever, headache, nasal congestion, thick green
or yellow discharge, general malaise, facial pain and increased nasal discharge.

PATHOPHYSIOLOGY

There is a failure in the transportation of the mucous and decrease in the sinus ventilation which
contribute to the development of the sinusitis. Mucosal edema or any abnormality causes the
obstruction of the sinus ostia. The inflammation may lead to the conversion of the ciliated
columnar cells to mucous secreting cells. This obstruction leads to the accumulation of the
secretions which act the medium for the growth of the bacteria. Allergic rhinitis is also the major
reason for developing the sinusitis.

4
The appropriate treatment for the sinusitis is Amoxicillin clavulanate. Fluoroquinolones and
Clarithromycin, Doxycycline are used in case of penicillin allergy Apart from antibiotics nasal
decongestants, mucolytic agents, intranasal corticosteroids can be used for the relief from the
symptoms. Antihistamines should be considered if there is allergic history. Humidification and
nasal wash can be used to get relief from the symptoms. Topical steroids are used to reduce the
mucosal edema. Sipping hot fluids and steam inhalation may improve the function of the cilia
and reduce the pain. Have increased fluid intake and have good oral hygiene, avoid smoking are
best ways to prevent sinusitis. Functional Endoscopic Sinus surgery(FESS) is the surgical
approach for sinusitis.

1.13 TONSILITIS

It is the inflammation of the pharyngeal tonsils which is caused by the bacteria group A beta
hemolytic Streptococcus pyogenes (GABHS) and sometimes there may be a viral cause. It
mainly occurs in the young adults. Viral tonsillitis can be caused by the Epstein barr virus, rhino
virus, enterovirus, influenza etc.

The most common signs and symptoms fever, sore throat, dysphagia, odynophagia etc. Sore
throat, fever, chills, odynophagia, cervical adenopathy, trismus, halitosis, erythematous and
exudative tonsils and tonsillar pillars. The presence of conjunctivitis, coryza, cough, stomatitis,

diarrhea and hoarseness strongly suggest a viral etiology. complications of tonsillitis can be
suppurative or non-suppurative in nature. Suppurative complications include peritonsillar
abscess, parapharyngeal or retropharyngeal space abscess, and suppurative cervical

5
lymphadenitis. Acute airway compromise, rheumatic fever, glomerulonephritis, and scarlet fever
are non-suppurative complications of tonsillitis caused by GABHS. Streptococcal toxic shock
syndrome, an uncommon but rapidly progressive disease, can complicate cases of pharyngitis
caused by a toxic-producing strain of GABHS

The diagnosis of the tonsillitis can be done by the nasopharyngeal swab culture. One of the most
commonly used in-office diagnostic tests for GABHS is the Rapid Antigen Detection Test
(RADT).

Penicillin’s like Amoxicillin clavulanate is the treatment of choice for bacterial tonsillitis.
Patients with the penicillin allergy can be treated with the 3 rd generation cephalosporin like
cephalexin, cefadroxil Bed rest, hydration, analgesics, and oral hygiene. Most cases of viral
tonsillitis self-resolve in 3–4 days. Recommended analgesics include acetaminophen and non-
steroidal anti-inflammatory drugs (NSAIDs). Another management apart from the medication is
tonsillectomy. Surgical removal of the tonsils is the common procedure done in the prevention of
tonsillitis. It is indicated when individual have experience more than 6 episodes. It can be
utilization of vaccine to avoid the occurrence. Hydration and adequate rest must be maintained.

1.4 PHARYNGITIS

Pharyngitis contains sore throat, fever, pharyngeal inflammation characterized by erythema and
edema. It is benign and mostly due to viral infections.

The viral causes include rhinovirus, enterovirus, influenza A and B, parainfluenza virus, corona
virus etc. are responsible for causing this condition. Bacteria like Streptococcus Group A,
Streptococcus C and G, Neisseria Gonorrhea, Influenza.

PATHOPHYSIOLOGY The GAS adhere to the epithelial cells in the respiratory tract which is
contributing factor in developing the pharyngitis. The GAS grow on the mucosal surfaces of the
pharynx and invade the cells involves that the production of bradykinin which is triggered by the
rhinovirus infection and the production of bradykinin causes sore throat. Along with bradykinin,
inflammatory mediators like prostaglandins and causes sore throat.

6
It causes the clinical manifestations like Fever, headache, GI symptoms like nausea, vomiting
and abdominal pain and tender lymphadenopathy. Physical examination reveals edema,
erythema, tonsillar enlargement, edematous uvula and petechial rash in the palate of the mouth.

The pharyngitis has been diagnosed by the throat or swab culture. Respiratory virus can be
identified by the viral culture or nasopharyngeal swab or by PCR or RT-PCR techniques. Rapid
antigen testing can be done.

Generally, pharyngitis can be treated using antibiotic regimen. A course of 10-day therapy of
penicillin or amoxicillin which is the choice of treatment. The patient who are allergic to
penicillin must be prescribed with macrolide, like Erythromycin and broad spectrum
cephalosporin like Cefixime. Acetaminophen or Ibuprofen are indicated for all ages which acts
as analgesic and antipyretic agents. Proper oral hydration and rest provide better relief to the
patient. Warm water gargles, soft foods, frozen foods provide soothing effect on the tissues. OTC
lozenges, sore throat drops provide relief from pain. Laryngoscopy can be recommended to the
patients with the chronic pharyngitis and when the culture tests are negative.

1.2 LOWER RESPIRATORY TRACT INFECTIONS

It involves the infections that affect the lower part of the respiratory tract like bronchioles, the
trachea, the alveoli.

The common infections that affect the lower tract involves, pneumonia, COPD, asthma,
bronchitis, COVID.

1.21 BRONCHITIS & BRONCHIOLITIS

It is the inflammation of the bronchial tree. Chronic bronchitis is caused by varieties of the
environmental factors like smoking and caused by pathogen like H. influenza and S. pneumonia.
Bronchiolitis is caused by Respiratory syncytial virus. Other than RSV it is caused by
Parainfluenza virus and adeno virus.

7
PATHOPHYIOLOGY

The infection causes the mucosa to become edematous which produce more amount of the
secretions. The mucosal damage can be simple or may be lead to serious damage to epithelium
based on the organism which is involved. There is increased no. of mucous producing cells in the
patient with chronic bronchitis and there will be inflammation due to the production of the
inflammatory cytokines like IL-4. In chronic bronchitis results due to the hypersecretion of the
mucous from the glands due to increased goblet cells and mucociliary clearance is also delayed.

The underlying pathophysiology is inflammation of the small airways (bronchioles). Infection of

the bronchiolar and ciliated epithelial cells produces increased mucous secretion, cell death and
sloughing, followed by a submucosal edema. This combination of debris and edema causes distal
airway obstruction. During expiration, the additional dynamic narrowing produces
disproportionate airflow decrease and air trapping. The effort of breathing is increased due to
increased end expiratory lung volume and decreased lung compliance. The typical clinical
presentation of this condition is cough. The cough generally lasts up to 3 weeks and sometimes
over a month. Along with cough there will be mucopurulent sputum, which may be present
especially in the morning. Fever, wheezing and increased respiratory rate are typical findings.

This condition can be diagnosed by obtaining a sputum culture. For viral diagnosis,
nasopharyngeal swab or culture are obtained. Serological testing like ELISA or DNA probe
testing are done for the identification of the organisms.

8
Amantadine, rifanidine are the prophylactic treatment for Influenza A virus. Apart from these
medications, Corticosteroids, Bronchodilators, and anti tussives may provide more relief to the
patient. Intake of pain killers like acetaminophen or ibuprofen may reduce pain and fever spikes.
Hydration is important which helps in tins the mucous and easily clears. The cough suppressants,
cool mist vaporizer or humidifier and bronchodilators which decreases the irritation.

1.22 PNEUMONIA

Pneumonia is defined as the infection of the lung that involve alveoli or intestititium by the
pathogens. The term pneumonia and pneumonitis are used synonymously for the inflammation
of the lungs.

Pneumonia has been classified into 3types:

1. Community Acquired Pneumonia (CAP)

2. Health care associated Pneumonia (HCAP)

9
 3. Hospital Acquired Pneumonia (HAP)
4. Ventilator Associated Pneumonia (VAP)

1.22a COMMUNITY ACQUIRED PNEUMONIA

CAP is defined as the infection in the lung parenchyma in patients who has not been hospitalized
in health care facility for more than 14 days. Commonly CAP is caused by

S. pneumoniae which accounts for two thirds of all pneumonia. Other pathogens which are
responsible for CAP are H. influenzae, Chlamydophila pneumonia, Legionella species,
Pseudomonas aeruginosa, S. aureus. After bacteria, it is causes by the viral agents like influenza
virus, RSV, para influenza virus, corona virus.

It can be diagnosed by radiological examination like CT chest which helps in identifying the
severity of the disease. Effusion, consolidation provides the evidence for bacterial condition
whereas, diffuse parenchymal involvement suggest for viral pneumonia. Routine laboratory
testing is done in order to identify the etiological agent involved in CAP. Some patients with
CAP have increased procalcitonin levels and hence acts as the biomarker.

Sputum culture must be done before initiating the antibiotic therapy.

The most clinical presentations in the patient with CAP include cough with or without
expectoration, SOB, pleuritic chest pain and one of the systemic feature is chills and rigors or
severe malaise.

The treatment of CAP for inpatient or outpatient is based on the scores CURB – 65.

Antibiotic is choice of therapy for severe CAP. Macrolide and beta lactam are the choice of
therapy in outpatient CAP. The duration of therapy for outpatients is 5 days. For inpatients once
the patient is found to be afebrile, they can be discharged.

Choice of empiric antimicrobial therapy in adult CAP Type of CAP Preferred drug Alternative
Comments Outpatients without co-morbidities Co amoxiclav, Macrolides Cefuroxime
Cefpodoxime Beta lactam preferred over macrolides due to high prevalence of macrolide
resistance in S. pneumonia in India. Doxycycline monotherapy not recommended Outpatients
with co-morbidities* or use of antimicrobial in 3 months Co-amoxiclav and macrolide/doxycy
cline Cefuroxime/ cefpodoxime and macrolide/doxycycline Inpatient, non ICU Ceftriaxone with

10
macrolide/doxycycline Cefotaxime/ amoxiclav with macrolide/doxycycline If there is
hypersensitivity to beta lactams: respiratory fluoroquinolones (exclude TB 41 first) Inpatient
ICU Ceftriaxone with macrolide/doxycycline, Cefotaxime, Piperacillin-tazobactam with
macrolide Inpatient ICU with risk factors for Pseudomonas aeruginosa/ other enteric gram
negative bacteria# Piperacillin tazobactam/ macrolide/doxycycline Cefepime/imipenem with
macrolide/doxycycline The use of carbapenems is preferred over beta lactam beta lactamase
inhibitor combinations in patients with septic shock.

1.22b HOSPITAL ACQUIRED PNEUMONIA

It is the pneumonia that may occur 48hr or more than 48 hours after the hospital admission. It is
termed as nosocomial infection. Early occurrence of the HAP occurs within 4 days of
hospitalization with the etiological factors of S. pneumonia, H. influenzae and S. aureus whereas
ventilator associated pneumonia is defined as the pneumonia that arises 48 hours after
endotracheal intubation.

The occurrence of HAP may vary with age, type of hospital, and type of ward.

11
The diagnosis of HAP is based upon the presence of the infiltrate and evidence tht the infiltrate is
of the infectious etiology.

For VAP, blind tracheobronchial aspiration (TBAS) is done which is non-invasive technique
used for the diagnosis. Bronchoscopy with bronchoalveolar lavage (BAL) which helps in
sampling the segments of the lung of the patients who are suspected with pneumonia. One of the
advanced method is Protected specimen brush (PSB) which can be advanced through a
bronchoscope. Microscopic analysis can also be done which may include the polymorphonuclear
leukocytes analysis. It helps in identifying the pathogen.

For the treatment the choice of antibiotic should be based on the pathogens. In case of MRSA,
vancomycin or linezolid is recommended. In patients with no risk factor for MRSA, antibiotic
against MSSA like Piperacillin tazobactum, Cefepime, levofloxacin, Imipenam were prescribed.

12
For patients with HAP who have factors for Pseudomonas or other gram-negative infection or
high risk for mortality, prescribe antibiotics from 2 different classes with activity against P.
aeruginosa (weak recommendation, very low-quality evidence). Other patients with HAP may
be prescribed a single antibiotic active against P. aeruginosa, like piperacillin-tazobactam,
cefepime, ceftazidime, levofloxacin, ciprofloxacin, imipenem, meropenem, amikacin,
gentamicin, and aztreonam.

1.23 CHRONIC OBSTRUCTIVE PULMONARY DISEASE

COPD is a leading cause of morbidity and mortality across the world It is the lung condition
characterized by the symptoms of cough, dyspnea, sputum or exacerbation due to the
abnormality of the airways or air sacs which is often progressive. The main environmental
exposures leading to COPD are tobacco smoking and inhalation of toxic particles and gases from
air pollution, both environmental and host factors like abnormalities in the lung development and
accelerated lung aging.

Disease Severity has typically been determined using the degree of lung function impairment,
although the wisdom of this approach has been questioned recently, with the suggestion that
factors such as arterial blood gas values, timed walk distance, sensation of dyspnea, and body
mass index be included in this determination.

The ATS criteria classify COPD into 3 stages:

Stage 1: FEV1 ≥50% of predicted

Stage 2: FEV1 35–49% of predicted

Stage 3: FEV1 < 35% of predicted

The ERS criteria also classify COPD into 3 stages:

Mild: FEV1 ≥ 80% of predicted

Moderate: FEV1 50% to < 80% of predicted

Severe: FEV1 < 50% of predicted)

13
The GOLD criteria also classify COPD into 4 stages:

Stage 1: FEV1 ≥ 80% of predicted

Stage 2: FEV1 50% to < 80% of predicted

Stage 3: FEV1 30 to < 50% of predicted

Stage 4: FEV1 < 30% of predicted

The pathological changes occur in the large and small airways and the lung parenchyma Irritant
exposure mobilizes macrophages, neutrophils, and lymphocytes in the lungs leading to
inflammation and cellular death

Chronic bronchitis: continual bronchial inflammation increases the size and number of mucus
glands leading to copious, thick mucus that cannot be cleared due to impaired ciliary function
Eventual involvement of all airways leads to obstruction and V/Q mismatch

Emphysema: alveolar destruction through the breakdown of elastin and cellular apoptosis
leading to the decreased area for gas exchange. Alveolar destruction creates large blebs and
produces a V/Q mismatch and loss of elastic recoil.

14
For the diagnosis a detailed history of the patient is obtained. The detailed information regarding
the exposure to the risk factors, such as smoking and environmental factors, their past medical
history including early life events, asthma or any allergies, their family history.

Physical examination is rarely used as the diagnostic feature of COPD as it has low specificity
and sensitivity. Spirometry is most commonly used method for the measurement of the airflow
obstruction. Other physiological test carried out for the diagnosis of COPD include the
measuring lung volumes, Carbon monoxide diffusing capacity of the lungs(DLco), oximetry
exercise testing. Pulse oximetry can be used to measure the patient’s arterial oxygen saturation
PaO2. Apart from physiological tests, chest X ray, CT plays a major role in diagnosis of COPD.
All the patients with the diagnosis of COPD must be screened for AATD (Alpha -1 antitrypsin
deficiency). Most patients with COPD have the blood eosinophil more or equal to 300 cells
provide the evidence of COPD patients who re at higher risk of developing an exacerbation.

The main goal of therapy for COPD is to reduce the hospitalizations, prevent the occurrence of
the occurrence of the exacerbation, and decrease the severity of the disease.

The initial line of therapy is bronchodilator treatment which is based on the breathlessness effect.
It can be either short acting of long acting. The combination of LAMA and LABA is
recommended to reduce the exacerbations. Use of LABA+ICS in COPD is not recommended.
LAMA+LABA+ICS is superior choice of therapy if eos is more or equal to 300 cells.

Formoterol and salmeterol are the LABA used BID to improve the FEV1 and lung volumes.
Antimuscrinic agents like tiotropium, ipratropium bromide are used BID or sometimes OD.
Methylxanthines like theophylline, doxophylline provides the bronchodilating effect. PDE-4
inhibitor like Roflumilast prescribed OD used to reduces the severity of exacerbations of COPD.
Sometimes antibiotics are prescribed for the prophylactic therapy. Azithromycin is commonly
prescribed at dose of 250/500mg per day.

Apart from these therapies AATD augmentation therapy can be done which minimizes the
progression of the disease.

Routine follow up is necessary for the COPD patients. At each visit questionnaires like CAT can
be analyzed. It can be managed by life style modification like smoking cessation, pulmonary

15
rehabilitation (PR), long term oxygen therapy(LTOT), non –invasive positive pressure
ventilation (NPPV), lung transplantation and lung volume reduction surgery 1.3ASTHMA

Asthma is most common, chronic respiratory illness affecting nearly 29% of the population
across the world. It is characterized by the clinical presentation of wheeze, SOB, chest tightness
with or without cough. There are many phenotypes of asthma. Some of them are:

a) Allergic asthma: due to the allergic disease like eczema or allergic rhinitis or sometimes
food or drug.
b) Non- allergic asthma: not associated with any sort of allergies. Neutrophils, eosinophils
and inflammatory cells are present in the sputum of these patients.
c) Cough variant asthma: cough is the only predominant symptom of these patients and
some may develop wheezing.
d) Asthma with obesity: some obese patients have prominent respiratory symptoms and
show a different pattern of inflammation of airway.

PATHOPHYSIOLOGY

Asthma exacerbation occurs in two phases: the early phase and the late phase. The early phase is
initiated by IgE antibodies, which bind to high-affinity mast cells and basophils, releasing
cytokines and histamine, prostaglandins, and leukotrienes. These cells contract the smooth
muscle, causing airway tightening. Th2 lymphocytes play a crucial role in this process,
producing interleukins (IL-4, IL-5, IL-13) and GM-CSF to sustain inflammation. IL-3 and IL-5
help eosinophils and basophils survive, while IL-13 is involved in remodeling, fibrosis, and
hyperplasia.

The late phase occurs within hours, with eosinophils, basophils, neutrophils, and helper and
memory T-cells localizing to the lungs, performing bronchoconstriction and causing
inflammation. This leads to increased work of breathing and an intermittent airflow obstruction.
Airway hyper responsiveness is a crucial feature of asthma, with various mechanisms
contributing to its severity. Bronchial provocation tests are used to assess this, as it is associated
with a greater decline in lung function and increased risk for asthma development from
childhood to adulthood.

16
These mechanisms change the compliance of the lungs slightly, increasing the work of breathing.
Inflammation, granular white blood cells, exudate, and mucous occupying the bronchiolar trees
make it increasingly difficult to breathe normally. The number of myofibroblasts, which give rise
to collagen, causes an increase in the epithelium, narrowing the smooth muscle layer and lamina
reticularis. This thickening of the basement membrane can lead to irreversible obstruction of
airflow due to airway remodeling. Epithelial cells transition to mesenchymal cells, increasing
smooth muscle content. Eosinophils can further exacerbate airway remodeling by releasing TGF-
B and cytokines.

Asthma is characterized by the variable expiratory airflow limitation lung function tests can be
carried out It is most reliable and assessed by spirometry. FEV1 and ratio of FEV1 and FVC re
assessed. The FEV1 or PEF values are reduced in many of the abnormalities of the lung.
Reduced ratio indicates limitation in the expiratory flow. Other diagnostic tests which are used
for assessing asthma is bronchial provocation tests, allergy tests, exhaled nitric oxide tests.
Imaging tests like CT is employed for the conditions like emphysema, bronchiectasis etc.

The clinical management is started by offering a short acting beta 2 agonist for the asthma that is
newly diagnosed. SABA is used as reliever therapy for adults who have infrequent, short lived
wheeze with normal lung function. Low dose ICS is often prescribed as the first line
maintenance therapy for the patients whose asthma is uncontrolled with SABA. If the asthma
remains uncontrolled, along with ICS have a add on therapy with LRTA and review to treatment
response in 4 to 8 weeks. If asthma is uncontrolled in adults (aged 17 and over) on a low dose of
ICS and a LABA, with or without an LTRA, as maintenance therapy, offer to change the
person's ICS and LABA maintenance therapy a MART regimen with a low maintenance ICS
dose. MART is a form of combines ICS and LABA treatment. Non pharmacological
interventions include smoking cessation, pulmonary rehabilitation programs, and avoidance of
the exposure of the allergens or irritants, avoiding drugs that may worsen the condition, reducing
the weight, dealing with stress and preventing the exposure from chemicals.

DRUG UTILIZATION AND EVALUATION

17
Drug Utilization Review (DUR) is an ongoing, systematic quality-improvement activity
constructed to ensure the effective and appropriate use of medicines. It can also be considered a
formulary system management technique. It comprises a comprehensive review of a patient's
health and medication history before, during, and after dispensing medicines to optimize patient
outcomes. As a result, it provides quality assurance, prescriber feedback, corrective action, and
additional evaluations. Hence, DURs performed by pharmacists improve the quality of patient
care, enhance therapeutic outcomes, prevent adverse drug reactions, and reduce inappropriate
pharmaceutical expenditures, reducing overall healthcare costs.

Although distinctions have been made among the terms drug-use evaluation, drug-use review
(DUR), and medication use evaluation (MUE), they all refer to the systematic evaluation of
medication use employing standard, observational quality-improvement methods. The Centers
for Medicare & Medicaid Services (CMS) promotes the term DUR for the Medicare Part D
prescription drug benefits. The Academy of Managed Care Pharmacy refers to DUR as the most
common designation for the retrospective, concurrent, or prospective medication review process
in the healthcare marketplace. The American Society of Health-System Pharmacists (ASHP)
currently utilizes the nomenclature of medication use evaluation (MUE).

MUE encompasses the goals and objectives of drug use evaluation (DUE) in its broadest
application, emphasizing improving patient outcomes. MUE, rather than DUE, emphasizes the
need for a more multifaceted approach to improving medication use. However, MUE has a
common goal with the pharmaceutical care it supports: to improve the quality of life of an
individual patient by achieving predefined, medication-related therapeutic outcomes. Through its
focus on the medication use system, the MUE process helps to identify actual and potential
medication-related problems, resolve actual medication-related problems, and prevent potential
medication-related problems that could interfere with achieving optimum outcomes from
medication therapy.

MUEs and DURs fall into three categories: prospective, concurrent, and retrospective. In a
prospective review, evaluating a therapeutic intervention is planned and takes place before the
medication is dispensed. In a concurrent review, the review is ongoing, and drug therapy is
monitored during treatment. Finally, in a retrospective MUE, the evaluation and review of the
therapy occur after the patient has received the medication.

18
 DUR is a performance improvement method that evaluates and improves medication-use
processes to optimize patient outcomes. Specific elements addressed in each medication use
evaluation are:

 Define the purpose, focus, and priorities

 Develop the usage criteria to be evaluated

 Collect the usage data; review and evaluate the data collected

 Develop and implement actions to improve medication usage

 Assess the actions that were implemented

 Document the results

 Report the results to other

Steps in the DUR Process

 Identification of Optimal Use: The established criteria define the optimal use of drugs,
which focus on relevant patient health outcomes and are in scope for DUR. Medicine use
is monitored for optimal use in advance.

 Measurement of Actual Use: The precise use of medications can be acquired from
medical, prescription, or electronic health records.

 Assessment: This step involves using a computerized algorithm, identifying members

who meet the DUR criteria, and comparing optimal and actual use. It helps identify and
evaluate discrepancies and, if appropriate, intervene.

 Intervention: This corrective action is implemented if any targeted areas of concern are
identified in the previous steps, i.e., economic considerations, prescribing patterns, and
adverse drug reactions.

 Evaluate the DUR Program: Evaluation of the effectiveness of the DUR program is
performed to evaluate the outcomes and document reasons. Appropriate alteration to the
DUR program and persistent surveillance should be conducted.

19
  Report the DUR Findings: This is the final step; reporting the results to the pharmacy and
therapeutics committee and clinician when appropriate.

DUR programs play an important role in serving healthcare systems to understand the
prescribing, administration, and drug utilization process. Employers and health care plans have
found DUR programs valuable and used the results to foster efficient use of health care
resources.

Pharmacists performing DUR play an important role in this process, as their main expertise is
medication therapy management. The pharmacist uses the DUR to evaluate prescribing trends of
clinicians within a specific patient population by medicine-specific criteria or disease state (i.e.,
hypertension, asthma, diabetes, depression). In collaboration with prescribers, pharmacists can
initiate actions to optimize drug therapy for patients.

Concurrent evaluation, collecting data during care delivery and sometimes as a component of the
care process, is usually preferred over retrospective methods. Concurrent evaluation allows
organizations to select relevant outcomes for collection rather than rely on outcomes routinely
documented within patient medical records. For example, quality-of-life measures remain an
infrequently documented measure in medical records. Only through concurrent evaluation can
that outcome measure be reliably captured.

Medications recently added to the formulary should be evaluated, especially if there is the
potential for inappropriate use or concerning adverse effects. This process should occur 6 to 12
months after their addition to the formulary. High-cost, high-use, and problem-prone medications
also are good candidates for evaluation.

Prospective DUR

This approach places accountability on the health care practitioner to review the prescription
when presented for filling and proactively resolve potential problems related to drug therapy. It
allows the pharmacist and other health care practitioners to communicate with patients and the
health care team to optimize the treatment plan for each patient. In institutional and retail setups,
a pharmacist can evaluate the prescription order when dispensing and, utilizing clinical data from
the patient's medical and pharmacy records, determine the appropriateness of the prescribed drug

20
therapy. If the pharmacist identifies possibilities for improved patient care, they can
communicate with the prescriber to discuss the treatment alternatives

21