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Dissertation
Submitted to
THE TAMILNADU Dr. M.G.R MEDICAL
UNIVERSITY
In partial fulfilment of the requirements for
the award of the degree of
M.D PHARMACOLOGY
Branch VI
May 2018
DRUG PRESCRIBING PATTERN WITH COST ANALYSIS
AND MONITORING OF ADVERSE DRUG REACTIONS IN
DEPARTMENT OF DERMATOLOGY:A PROSPECTIVE
OBSERVATIONAL STUDY
Dissertation
Submitted to
THE TAMILNADU Dr. M.G.R MEDICAL
UNIVERSITY
In partial fulfilment of the requirements for
the award of the degree of
M.D PHARMACOLOGY
Branch VI
May 2018
DRUG PRESCRIBING PATTERN WITH
COST ANALYSIS AND MONITORING OF ADVERSE DRUG
REACTIONS IN DEPARTMENT OF DERMATOLOGY: A
PROSPECTIVE OBSERVATIONAL STUDY
4
Acknowledgement
In the first place, I would like to express my gratitude to my professor, mentor and
guide Dr. Reneega Gangadhar, for her valuable and constant guidance, supervision
and support throughout the study. Her patience and understanding during times of
difficulties in the study period helped me a lot under such circumstances. Her constant
motivation has helped me to overcome all the challenges and difficulties that I came
across this research work. Her encouragement from the inception of this research to
its culmination has always been profound. It has been an extraordinary experience
working under her.
I am very much grateful and thankful to my Co-Guide Dr. Padma Prasad .M.K,
Associate Professor, Department of Dermatology for his immense help with his ideas,
valuable contributions, patience and generous encouragement during the research
work and preparation of the manuscript. Dr. Ganesh .V, Associate Professor,
Department of Pharmacology for his support and guidance all throughout the study.
I extend my thanks to my Assistant professors Dr. Sarath Babu .K for his valuable
suggestion, support and encouragement during the preparation of the manuscript and
Dr. V. M. Sandeep for his valuable inputs during all the stages of my study.
I extend my sincere heartfelt thanks to Dr. Velayuthan Nair, Chairman and
Dr. Rema V. Nair, Director, for permitting me to carry out the study in the hospital
and providing facilities to accomplish my dissertation work. Then I would also like to
thank the Principal of the Institution Dr. Padmakumar for his valuable support
extended to me.
I express my special thanks to my colleague Dr. Sushmita Ann. S. J, for giving
me uncountable constructive ideas and encouragement to do the study. I also thank
my senior Post Graduates Dr. Prathab Asir. A, Dr. Anandhalakshmi. A and Dr.
Arjun. G. Nair and my junior Post Graduates Dr.Priyanka. R , Dr. Ramakrishnan
Nair and Dr. Charmilla. V for their help and support.
Last but not the least, I thank Sister.Jacqueline , Department of Dermatology
and Mrs. Florence Vimala. P and Mrs. Sangeetha. M, Department of Pharmacology
for their assistance and help extended to me during the study .
Abbreviations
AB
Antibody
ADP Adenosine Diphosphate
ADR Adverse drug reaction
AG Antigen
AGA Androgenetic Alopecia
CDSCO Central Drug Standard Control Organization
CYP3A4 CytochromeP450 3A4
DNA Deoxyribonucleic acid
DUS Drug utilization study
EDL Essential Drug List
FDE Fixed Drug Eruptions
hdIVIg High-dose intravenous immunoglobulin
IFN-α Interferon α
IgG Immunoglobulin G
IHEC Institutional Human Ethics Committee
IL-10 Interleukin -10
IL-12 Interleukin -12
INR Indian rupee
NSAIDs NonsteroidalAntiinflammatory Drugs
OPD Outpatient Department
PUVA Psoralen and ultraviolet A
TNF-α Tumour Necrosis Factor α
UMC Uppsala Monitoring Centre
UV Ultraviolet radiation
WHO World Health Organization
Contents
Table of Contents
Sl. No Page No
1. Introduction 1
2. Review of literature 6
3. Aims and objectives 53
4. Materials and Methods 54
5. Observation & Results 59
6. Discussion 73
7. Conclusion 77
8. References I- XI
9. Annexure
I IHEC certificate XII
II Consent form XIII
III Case Record form XIV
IV WHO-UMC Causality assessment scale XV
V Adverse drug reaction reporting form XVI
List of tables
Table
No
Title Page
No
1. Age wise prevalence of dermatological drug use 59
2. Gender wise prevalence of dermatological drug use 59
3. Distribution of patients based on illness 60
4. Distribution of encounters based on number of drugs
prescribed 61
5. Frequency of utilization of different classes of
dermatological drugs in a two drugs prescription 63
6. Frequency of utilization of different classes of
dermatological drugs in a three drugs prescription 63
7. Frequency of utilization of different classes of
dermatological drugs in a four drugs prescription 64
8. Frequency of utilization of different classes of
dermatological drugs in a five drugs prescription 64
9. Frequency of utilization of different antihistaminics
prescribed 65
10. Frequency of utilization of different antifungals
prescribed 65
11. Frequency of utilization of different antibiotics prescribed 66
12. Frequency of utilization of different steroids prescribed 66
13. Frequency of utilization of different keratolytics and
emollients prescribed 67
14. Frequency of utilization of vitamins and minerals
prescribed 67
15. Frequency of utilization of different fixed drug
combinations 69
16. Summary of prescribing indicators 70
17. Number and percentage of prescriptions based on the cost 71
18. Number and percentage of ADRs 72
List of figures
Figure
No
Title Page No
1. Distribution of encounters based on number of drugs
prescribed 61
2. Distribution of various classes of dermatological drugs
prescribed 62
3. Percentage of drugs prescribed from WHO essential drug
list 68
4. Causality assessment of ADRs of dermatological drugs
by WHO-UMC causality assessment scale 72
Introduction
1 | P a g e
INTRODUCTION
Skin constitutes as the largest organ of human body and thus it is exposed
to injury by various extrinsic factors such as environmental, chemical, infectious
agents as well as intrinsic factors such as metabolic, genetic and immunological.
Metaphorically skin acts as a mirror to various internal diseases , constituting that
many systemic diseases are identified by their dermatological manifestations.1
In Developing countries skin diseases have a greater impact on the quality
of life of people,it is more so in a country like India which has a wide variation of
climate, religion, customs & socioeconomic status in different parts of the
country.2In India patients in the second and third decades of age group (3.7% to
51.17% ) form the largest part of population suffering from various skin
diseases.3The most prevalent dermatological conditions include scabies,
pyoderma, dermatitis, urticaria, fungal skin infection, acne, alopecia and less
common are eczematous disorder like psoriasis, skin cancer and cutaneous adverse
drug reaction.4
Most of the skin diseases are chronic in nature and they require lifelong
treatment . Therefore appropriate diagnosis by physician and rational prescription
of drugs based on his understanding of both risk and benefit of drugs is important
component of drug therapy.4Various combination of drugs generally used in the
treatment of skin diseases like proactive antibiotic, antifungal, benzoyl peroxide,
Introduction
2 | P a g e
steroids, salicylic acid, anti-histaminic,vitamins and minerals, analgesics usually
depends upon prescriber’s choice . 5
A prescription is a written communication from a registered medical
practitioner or other licensed practitioners to a pharmacist providing with salient
instructions regarding the dispensing of prescribed medication. It designates a
medication to be administered to a particular patient by combined skill and
services of both the physician and the pharmacist Drug prescribing practice is a
science and an art itself. It conveys the message from the prescribing physician to
the patient. 6
Medication problem is tragic and costly for patients and professionals
alike.7 Rational use of drug is defined by WHO as" patients receive medicines
appropriate to their clinical needs in doses that meet their own individual
requirements for an adequate period of time, at the lowest cost to them and their
community".8A recent observation is that many doctors are frequently adopting
polypharmacy which has lead to a steep rise in the cost of the treatment as well as
adverse drug effects. 8
In many developing countries, an important portion of government and
household expenditure is the drug cost and improper use of drugs results in major
health hazard and increases treatment costs.9
Prescription audit plays an important role in constituting guidelines for
improving drug utilization patterns and restricting irrational prescribing. Medical
treatments at all levels of health care systems has been improved by drug
Introduction
3 | P a g e
utilization studies 10
.In 1985 WHO convened a major conference in Nairobi on the
rational use of drug and from that time onwards efforts have been made to
improve the drug use pattern and prescription behaviour.11
According to a WHO report ,based on a "community based surveillance of
anti-microbial use and resistance in the resource constrained settings" antibiotic
use & antimicrobial resistance is increasing in India from 5 pilot projects , three
from India (Delhi, Mumbai and Vellore) and two from South Africa .12
Henceforth
the pattern of drug use in hospital setting needs to be monitored systematically in
order to analyse their rationality and to provide feedback to drug prescribers .This
is essential to increase the therapeutic benefits and reduce the adverse effects. 13
The World Health Organization (WHO)-India programme on the rational use of
drugs aims at promoting rational prescribing through strategies like intervention
to correct drug use problems, adoption of essential drug list, development of
standard treatment guidelines, determining and restricting irrational prescribing. 14
An estimate of around 30-40% of total health budget of the third world countries
are spent on drugs,some of which are useless and expensive and doubles their
expenditure on drugs every 4 years while GNP(Gross National Product) doubles
every 16 years.According to Planning commission paper of 2009,health care
expenses were responsible for the rise in poverty. It is estimated in 2004-2005 that
an additional 39 million people were pushed into poverty due to out of pocket
payment for drugs. National Sample Survey Office (NSSO) data for the same year
Introduction
4 | P a g e
had shown that of the total medical expenditure percapita,medicines alone
accounted for 74% expenses in the rural and 67% in urban areas. 15
Adverse drug reaction(ADR) are unintended effects of drugs occurring
during use of drugs. Majority of ADRs are minor reactions and are self limiting
but sometimes they are severe and potentially life threatening .14
Therefore ADR
monitoring is mandatory.16
Therefore periodic auditing of prescriptions and pharmacovigilance is
essential inorderto increase the therapeutic efficacy, decrease adverse effects and
provide feedback to prescribers. Setting up Hospital formulary depending on
geographic profile of disease and availability of drugs is also the need of the hour.4
At present there is an increasing trend for irrational prescribing of dermatology
drugs .Inappropriate drug has a direct impact as well as indirect impact on the cost
to health system and individuals.Therefore periodic evaluation of drug utilization
patterns are essential inorder to enable suitable modification in prescription of
drugs to increase therapeutic benefits and decrease adverse effects as well as to
minimize the expenditure cost of drugs being used.8
Till now very few systematically analyzed data are available on the drug
utilization pattern, and adverse drug reaction profile in dermatology Outpatient
department (OPD) in India.4
Drug utilization studies, cost analysis and Adverse drug reaction studies in
the dermatology department have not been reported so far in our institution.
Introduction
5 | P a g e
Hence, this study is an attempt to assess the drug prescribing patterns with cost
analysis and to monitor adverse reactions in the patients selected for analysis.
Review of Literature
6 | P a g e
Review of literature:
Dermatology is the study of skin and its associated structures including
hair, nail and of their diseases. Skin is considered as the boundary between
ourselves and the world around us.16
It is one of the many specialties that has
evolved from general internal medicine.17
Skin as an organ has certain roles:
1. It acts as a barrier, preventing the entry of noxious chemicals and
infectious organisms, and also preventing the exit of water and other
chemicals.
2. It reflects internal changes and reacts to external changes also.
3. It can sweat, grow hair, erect its hairs, change colour, smell, grow nails,
and secrete sebum.
4. When confronted with insults from outside, it usually adapts easily and
returns to a normal state.
The skin has three layers. The outer one is the epidermis,underlying to it
is the dermis and beneath the dermis is a loose connective tissue , the
subcutis/hypodermis.18 Based on the skin layers the quantitation of the flux of
drugs and drug vehicles form the basis for a pharmacokinetic analysis of
dermatologic therapy and techniques.19
Review of Literature
7 | P a g e
History
Contributions of Heberden, Cullen, and Hebra, laid the foundations on
which the pioneer specialist dermatologists of the following century were able
to build .20
In India, therapeutics of dermatoses were known and practised by
our ancient physicians for centuries, Charaka Samhita contains one chapter on
the subject.21
Another Indian literature Atreya Punarvasu has described
eighteen dermatoses.22
Later on Ayurvedic dermatology was influenced by the
Unani system. During the British era , Dr. Vandyke Carter, Surgeon Major,
HMS Indian Medical Services, was requisitioned to take stock of the various
dermatological situation in India.This, perhaps, was the first scientific endeavor
to study dermatoses in the Indian subcontinent, where hardly any statistics were
available.23
Epidemiology:
According to WHO survey of a total of 18 prevalence studies of the general
population in developing countries which were considered as the
representative of the large geographical areas, reported high prevalence figures
for skin diseases (21-87%).24 The pattern of skin diseases in India is influenced
by the developing economy, level of literacy, social backwardness, varied
climate, industrialization, access to primary health care, and different religious
ritual and cultural factors.25
In a study by Grover et al, prevalence of skin
disorders presented with female preponderance and the largest group of
population (50.7%) was in their second and third decades.26
Review of Literature
8 | P a g e
Classification of Dermatological condition18
:
Dermatological conditions are categorised into :
1. Disorders of keratinization
2. Papulosquamous disorders
3. Eczema and dermatitis
4. Reactive erythemas and vasculitis
5. Bullous diseases
6. Connective tissue disorders
7. Disorders of blood vessels and lymphatics
8. Sebaceous and sweat gland disorders
9. Regional dermatology
10. Infections
11. Infestations
12. Skin reactions to light
13. Disorders of pigmentation
14. Skin tumours
Review of Literature
9 | P a g e
Treatment
From diagnosis to assessing the effectiveness of therapy,dermatology is
a visually oriented specialty.27
Non Pharmacological interventions 27:
Depression, anxiety and anger are commonly observed emotional
reactions in individuals with skin disease. Negative emotional states such as
stress, anxiety, depression, and anger can elicit or exacerbate skin
disease.Worsening of skin disease, stress and negative emotional states
increase the release of proinflammatory cytokines and produce negative effects
on barrier function. These type of patients require :
1. Lifestyle modification- Healthy diet , using precautionary measures at
work place ,using sunshades or umbrella
2. Cosmetic intervention
3. Cognitive behaviour Pshycotherapy
Pharmacological interventions28,29
:
1. Glucocorticoids
2. Retinoids
3. Vitamin Analogs
4. Photochemotherapy
5. Antihistamines
6. Antimicrobial Agents
Review of Literature
10 | P a g e
7. Antimalarial agents
8. Cytotoxic and Immunosuppressive drugs
9. Anti-Inflammatory drugs
10. Biological agents
11. Sunscreens
12. Intravenous Immunoglobulin
13. Emollients
14. Coolants
15. Capsaicin &Podophyllin
16. Topical Anesthetics
17. Opioid receptor antagonist
18. Anxiolytics &Tricyclic antidepressants
19. Selective serotonin reuptake inhibitors
20. Antipsychotic agents
21. Keratolytic agents
22. Drugs for Androgenetic Alopecia
23. Drugs for Hyperpigmentation
Glucocorticoids 28,29
Glucocorticoids have immunosuppressive and anti-inflammatory
properties. They are administerd locally ,through topical and intralesional
routes and systemically, through intramuscular, intravenous and oral routes.28,29
In a study by Divya shanthi et al stated that dermatitis was the most common
Review of Literature
11 | P a g e
conditions for which topical corticosteroids were being prescribed 30
and the
most common adverse effect reported in a Study by Shakya Shrestha S et al
was shedding of skin 7(35%).31
Mechanism of action28,29
Glucocorticoids impair immunological competence.They suppress all
types of hypersensitization and allergic phenomena. Corticosteroids penetrate
cells and binds to high affinity cytoplasmic receptor proteins which results in
structural change in the steroid receptor complex that allows its migration into
nucleus and binding to glucocorticoid response elements on the chromatin.
This further results in transcription of specific m-RNA and regulates protein
synthesis. Furthermore glucocorticoids cause greater suppression of cell
mediated immunity in which T-cells are primarily involved.This is the basis of
use in autoimmune disease. Glucocorticoids also cause attenuation of increased
capillary permeability,local exudation,cellular infiltration,phagocytic activity
and late responses like capillary permeability, local exudation, collagen
deposition, fibroblastic activity and scar formation.The cardinal signs of
inflammation such as redness,heat,swelling and pain are suppressed.
Pharmacokinetic:
Corticosteroids are metabolized by hepatic microsomal enzymes by
reduction of keto groups and oxidative cleavage of 20C side chain.The
metabolites formed are further conjugated with glucuronic acid or sulfate and
are excreted in urine. Plasma t 1/2 is longer because of its action through
Review of Literature
12 | P a g e
intracellular receptors and regulation of protein synthesis. The synthetic
derivatives are more resistant to metabolism and are longer acting
comparatively.
Adverse reaction:
a. Local adverse effects :
1. Thinning of epidermis - atrophy
2. Telangiectasia, Striae
3. Easy bruising
4. Hypopigmentation
5. Delayed wound healing
6. Fungal and bacterial infections
7. Chronic use may cause - skin atrophy , striae , telangiectasia , purpura and
acniform eruptions
b. Systemic adverse effects :
1. Adrenal pituatory suppression can occur if large amounts are applied
topically
2. Cushing's syndrome
3. Glucose intolerance or overt diabetes mellitus and hypertension
4. Osteoporosis, avascular bone necrosis
Review of Literature
13 | P a g e
Therapeutic uses :
1. Eczematous skin disease
2. Pemphigus vulgaris , exfoliative dermatitis
3. Napkin rash
4. Steven Johnson syndrome
5. Lichen planus
6. Discoid Lupus erythematosus
7. Alopecia areata
Retinoids
In a study Maria de Fátima de Medeiros Brito et al had reported that
cheilitis occurred in 94% of the cases treated with retinoids and presence of
cheilitis acts as a marker for action of the drug.32
Retinoids are natural and
synthetic compounds that can exhibit vitamin-A like biological activity or bind
to nuclear receptors of retinoids. First generation retinoids include: retinol
(Vitamin A) , tretinoin (all-trans-retinoic acid) , isotretinoin (13-cis-retinoic
acid) and alitretinoin( 9-cis-retinoic acid). Second generation retinoids are
known as aromatic retinoids. Third generation retinoids include :tazarotene,
bexarotene and adapalene.28
In another study by Wei Li, Ying Liu et al had
reported that retinoids are definitely effective in severe acne, certain forms of
psoriasis and other disorders of keratinization - all diseases for which there has
been no satisfactory treatment.33
Review of Literature
14 | P a g e
Mechanism of action:
Retinoids selectively activates retinoic acid receptors and retinoid-x
receptors which controls genes of diffrentiation within the dermis . It causes
inhibition of activator protein-1, a transcription factor composed of c-Jun and
c-Fos that normally activates the synthesis of matrix metalloproteinases in
response to UV radiation. It also increases the level of CD25,low affinity IL-2
receptors on malignant lymphocytes of T-cell origin.
Pharmacokinetic:
Trans retinoic acid is used topically, while 13-cis retinoic acid is given
orally for acne. Retinoic acid is rapidly metabolized and excreted in bile and
urine. It is used as 0.025%-0.05% gel or cream. Bexarotene is metabolized by
CYP3A4.
Adverse reaction:
1. Erythema,desquamation,burning and stinging sensation
2. Photosensitivity reaction
3. Retinoid toxicities such asmucocutaneous side effects such as -chelitis,
xerosis, blepharoconjunctivitis , cutaneous photosensitivity , photophobia ,
myalgia , arthralgia , headache , alopecia,nail fragility and increased
susceptibility to staphylococcal infections
4. Retinoid dermatitis
5. Serum lipid elevation
6. Retinoid induced embryopathy
Review of Literature
15 | P a g e
Therapeutic uses:
1. Non-inflammatory (comedonal) acne , acne vulgaris
2. Fine wrinkles and dyspigmentation
3. Photoaging
4. Psoriasis
5. Cutaneous lesions of Kaposi sarcoma
6. Early stage of cutaneous T-cell lymphoma
Contraindication:
Systemic retinoids and Topical retinoids are contraindicated in women
who are pregnant, contemplating pregnancy or breast-feeding. Furthermore
Systemic retinoids are relatively contraindicated in : Leukopenia , alcoholism,
hyperlipidemia , hypercholestrolemia , hypothyroidism and significant hepatic
or renal disease.
Vitamin Analog
Vitamin Analog, carotene is a precursor of vitamin A. It is abundantly
present as dietary supplement in green and yellow vegetables . Calcipotriene is
a topical vitamin D analog which also used in dermatological conditions28,29
.
Studies by Wadhwa B et al point towards a role of vitamin D as an
immunomodulator and have opened channels to discover its therapeutic
efficacy in atopic dermatitis, psoriasis, and skin cancer.33
Review of Literature
16 | P a g e
Mechanism of action:
- carotene has an anti-oxidant effect that decreases the production of
free radicals or singlet oxygen. While calcipotriene exerts its effect through the
vitamin D receptor, by binding with the vitamin D receptor ,the drug-receptor
complex associates with the retinoid receptor- and binds to vitamin D
response elements on DNA.
Pharmacokinetics:
Calcipotriene - on absorption through skin, gets inactivated rapidly
andhence therapeutic response occurs only after 4-8 weeks. Topical
calcipotriene has the ability to cross the placenta. It gets rapidly metabolized
by the liver to inactive metabolites and excreted via bile. Only 20–30% of
supplemental beta carotene is absorbed unchanged . Photosensitivity protecting
action occurs after at least 2–4 weeks . It is principally metabolized in the small
intestine and in the liver , to vitamin A . Excretion is by fecal route and urine in
the form of metabolites.
Therapeutic use:
1. Psoriasis
2. Reduces photosensitivity in patients with erythropoietic protoporphyria
Adverse reaction:
Hypercalcemia and hypercalciuria- develops when dose of calcipotriene
exceeds the recommended dose 100g/wk limit. It can also causes perilesional
irritation and photosensitivity.
Review of Literature
17 | P a g e
Photochemotherapy
In 2005, Man et al reported a twofold increased risk of basal cell
carcinoma after 4 years of follow-up in a cohort of 1,908 patients treated with
phototherapy, but no increased risk of squamous cell carcinoma or
melanoma.34
Phototherapy and Photochemotherapy are treatment methods in
which UV or visible radiations is used to induce a therapeutic response either
alone or in the presence of a photosensitizing drug.28
A study by Patrizi et al
had stated that photochemotherapy is one of the frequently used treatment for
dermatological diseases such as psoriasis, acne, and Atopic dermatitis, as well
as for sleep disorders and some psychiatric illnesses.35
Psoralens and UVA28,29
Psoralens are lipophilic molecules which are derived from fusion of a
furan with a coumarin.
Mechanism of action:
The action spectrum of oral PUVA is between 320 and 340 nm.Two
distinct photoreactions takes place. Type 1 reaction involves the oxygen-
independent photoaddition of psoralens to pyrimidine bases in DNA. While
Type II reaction involves the transfer of energy to molecular oxygen. These
phototoxic reactions stimulate melanocytes and induce antiproliferative,
immunosuppressive and anti-inflammatory effects.
Review of Literature
18 | P a g e
Therapeutic uses:
1. Vitiligo
2. Cutaneous T-Cell lymphoma
3. Psoriasis
4. Atopic dermatitis
5. Alopecia aqreata
6. Lichen planus
7. Urticaria pigmentosa
Adverse reaction:
1. Phototoxic reactions
2. Pruritis
3. Hypertrichosis
4. GI disturbance
5. CNS disturbance
6. Bronchoconstriction
7. Hepatic toxicity
8. Herpes simplex recurrence
9. Retinal damage
10. Photoaging
11. Nonmelanoma skin cancer
12. Melanoma
13. Cataract
Review of Literature
19 | P a g e
Method of drug administration:
Photosensitizing agents such as methoxsalen or trioxsalen or bergapten
can be administered as oral, topical lotion or bath water
Photopheresis28
It is a process by which extracorporeal peripheral blood mononuclear
cells are exposed to UVA radiation in the presence of methoxsalen.
Mechanism of action:
Mechanism of extracorporeal photopheresis include apoptosis of T cells,
generation of clone-specific suppressor T cells, Shifting of T cells phenotype,
production of an immune response against the pathogenic T cells and release
cytokines.
Adverse reaction:
1. Phototoxic reactions
2. Temporary dyspigmentation
3. Potential scarring
Therapeutic use:
Actinic keratosis
Method of drug adminstration:
Protoporphyrin IX is adminstered as topical cream or solution of a
prodrug.
Review of Literature
20 | P a g e
Photodynamic therapy28
This therapy uses photosensitizing drugs and visible light for
dermatological disorders. Two drugs are approved for topical photodynamic
therapy ,it includes - aminolevulinic acid and methyl aminolevulinate.
Mechanism of action:
Aminolevulinic acid and methyl aminolevulinate are prodrugs which get
converted to protoporphyrin IX within living cells.In the presence of UVA2 of
wavelength of 320-340 nm and oxygen, protoporphyrin produces singlet
oxygen which will oxidize cell membranes,proteins and mitochondrial
structure leading to apoptosis.
Therapeutic use:
1. Precancerous actinic keratoses
2. Thin , non-melanoma skin cancer
3. Acne
4. Photorejuvenation
Adverse reaction:
1. Phototoxic reaction
2. GI disturbance
3. Hypotension
4. Congestive heart failure
5. Loss of venous access after repeated venipuncture
Review of Literature
21 | P a g e
Antihistamines
Histamines are potent vasodilators and a stimulant of nociceptive itch
receptors.Oral antihistamines, H1 receptor antagonists have anticholinergic
activity and sedative property which aid in treatment of pruritus. First-
generation antihistamine includes hydroxyzine, diphenhydramine,
promethazine, cyproheptadine and doxepin. Second generation antihistamine
includes cetrizine, levocetirizine, loratadine, desloratadine and
fexofenadine.28,29
In a study on antihistamines , Kolasani BP et al had reported
that the top three disorders, for which antihistamines were prescribed, were
psoriasis followed by eczema and allergic contact dermatitis. They also noted
that hydroxyzine had higher sedation, whereas levocetirizine had the least
sedation, pheniramine had the highest anticholinergic side effects, and
cetirizine/levocetirizine had a minimal or no anticholinergic side effects
comparatively.36
Mechanism of action:
Histamine gets released from mast cells following AG:AB reaction on
their surface in immediate type of hypersensitivity reactions.H1 antagonists
effectively controls this manifestation by inhibiting the histamine release.
Pharmacokinetics:
Antihistamines are metabolised in liver by microsomal
enzymes.Therapeutic effectiveness is observed when antihistamines are given
Review of Literature
22 | P a g e
for a longer period ,which can result due to induction of microsomal P-450
enzymes.Patients with hepatic impairment can result in elimination of
antihistamine slowly.
Therapeutic uses:
1. Hypersensitive type I reactions
2. Urticaria
3. Itching and Angioedema
Adverse reactions:
1. Sedation, diminished alertness and concentration
2. Light headedness
3. Motor incoordination
4. Fatigue
5. Dryness of mouth
6. Altered bowel movements
7. Urinary hesitancy
8. Blurring of vision
9. Epigastric distress and headache
10. Contact dermatitis
Review of Literature
23 | P a g e
Antimicrobial Agents
Antibiotics :
Commonest dermatological disorder treated with either topical or
systemic antibiotics is acne vulgaris. Commonly used topical antimicrobials in
acne include clindamycin, erythromycin, mupirocin, benzoyl peroxide,
sulfacetamide/sulfur combinations, metronidazole and azelaic acid. Other
agents include tetracycline, doxycycline, minocycline and trimethoprim-
sulfamethoxazole. Tetracyclines are the most commonly employed antibiotics
for dermatological manifestations.28,29
According to a study by Shamna AM et
al beta-lactam drugs (penicillin, cephalosporin) and macrolides were the most
frequently prescribed antimicrobial agents for skin and soft tissue infections
Moreover the antibiotic class of drugs which were mostly accounted included
cephalosporins (34.69%) followed by fluoroquinolones and others in which
type A reactions were more compared to type B and 59.18% of them were
predictable.37
Mechanism of action:
Antibiotics have four different mechanism:
1. It can inhibit cell wall synthesis
2. Alter the cell membrane integrity
3. Inhibits ribosomal protein synthesis
4. Suppression of DNA synthesis
Review of Literature
24 | P a g e
Therapeutic uses:
1. Pyoderma due to gram positive organisms like staphylococcus aureus and
streptococcus pyogenes
2. Impetigo due to Staphylococcus aureus and Streptococcus pyogenes
3. Superficial infections caused by wounds and injuries
4. Deeper bacterial infections like folliculitis, erysipelas, cellulitis and
necrotizing fasciitis
Adverse reactions :
1. Dizziness
2. Hyperpigmentation of skin and mucosa
3. serum-sickness like reaction
4. drug-induced lupus erythematosus
5. Allergic contact dermatitis especially on disrupted skin
Antifungals
A Meta-analysis by Chia-Hsuin Chang et al had reported that with the
the risk of liver injury requiring termination of treatment with antifungals
ranged from 0.11% (continuous itraconazole 100 mg/day) to 1.22%
(continuous fluconazole 50 mg/day) and the risk of having asymptomatic
elevation of serum transaminase but not requiring treatment discontinuation
was less than 2.0% .38
Antifungals belonging to azole group and
amphotericin-B can be used systemically as well as topically. Other antifungals
used therapeutically for dermatological manifestation includes
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azoles-miconazole and econazole , allylamines- naftifine and terbinafine ,
griseofulvin, triazoles.28,39
Another study by Mandeep Kaur et al had reported
that by comprising all factors , ketoconazole and fluconazole were the most
effective drugs that were used and terbinafine was the less commonly used
drug for treatment of dermatological conditions.40
Mechanism of action 28,39
Azole group of antifungals binds to cytochrome P-450 dependent 14-
demethylase enzyme which results in hinderance of ergosterol synthesis .
Furthermore inhibition of fungal respiration under aerobic condition occurs.
Griseofulvin causes disruption of mitotic spindle and arrests the fungal mitosis
at metaphase . It also has the property to bind to newly synthesised keratin
making it resistant to fungal invasion. Terbinafine on the other hand inhibits
fungal enzyme squalene epoxidase which converts squalene to lanosterol which
can affect the fungal cell membrane integrity and function. Terbinafine also
inhibits squalene epoxidase and decreases ergosterol biosynthesis.
Therapeutic uses :
1. Localized tinea corporis and uncomplicated tinea pedis
2. Localized cutaneous candidiasis and tinea versicolor
3. Tinea capitis
4. Onychomycosis
5. Dermatophytosis caused by microsporum , trichophyton and
epidermophyton
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Adverse reaction:
1. Headache,nausea,vomiting,photosensitivity and peripheral neuritis
2. Hepatotoxicity
3. Griseofulvin can cause disulfiram-like reaction with ethanol
4. Epigastric distress
5. Itraconazole on high dose can cause hypokalemia,hypertension and
oedema
Antiviral Agents
Common dermatological viral infections include Human papillomavirus,
Herpes simplex virus, Condyloma accuminatum,Molluscum contagiosum and
varicella zoster virus.28,39
A study done by Forbes J H et al, had reported that the
most commonly prescribed antiviral was aciclovir (69.0%), followed by
famciclovir (27.8%) and valaciclovir (3.5%) .41
An Observational study by
Jayanthi CR et al had reported that among the distribution of various ADRs
across therapeutic classes Antivirals accounts for 6.7%.42
Antiviral drugs given
for dermatological manifestation include acyclovir, penciclovir, valacyclovir,
famciclovir, docosnal trifluoridine and cedofovir.28,39
Mechanism of action:
Antiviral drugs act by inhibiting viral DNA polymerase and prevents its
replication by terminating the elongation of the viral DNA.
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Therapeutic use:
1. Herpes simplex virus
2. Varicella zoster
3. Mucocutaneous HSV
4. Condylomata
5. Herpes labialis
Adverse reactions:
1. Phlebitis
2. Rash and mild hypotension
3. Renal toxicity
Antimalarial agents
In a retrospective study done by Gina C A et al had reported that a significant
subgroup of patients whose skin lesions had been unresponsive to a single
antimalarial benefitted from combination therapy with hydroxychloroquine and
quinacrine or chloroquine and quinacrine.43
Antimalarials commonly used in
dermatology include Chloroquine, Hydroxychloroquine and Quinacrine.28,39
Mechanism of action:
Stabilization of lysosomes
Inhibition of antigen presentation
Inhibition of prostaglandin synthesis
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Inhibition of pro-inflammatory cytokine synthesis
Photoprotection
Inhibition of immune complex formation
Anti-thrombotic
Therapeutic uses:
1. Cutaneous lupus erythematosus
2. Cutaneous dermatomyositis
3. Polymorphous light eruption
4. Porphyria cutaneous tarda
5. Sarcoidosis
Adverse reactions:
1. Nausea
2. Vomiting
3. Dizziness
4. Headache
5. Urticaria
6. Blurred vision
7. Hypotension and T-wave abnormalities in ECG
8. GIT distress
9. Hemolytic anaemia
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Cytotoxic and Immunosuppressive drugs
In a study by Callen JP , Cytotoxic and Immunosuppresive drugs such as
methotrexate, azathioprine, cyclophosphamide, chlorambucil, cyclosporine,
and other related drugs were reported to have potential benefits in the
treatment of severe recalcitrant cutaneous disease.44
Cytotoxic and Immunosuppressive drugs include antimetabolites such as
methotrexate, azathioprine and fluorouracil , alkylating agents such as
cyclophosphamide and calcineurin inhibitors such as cyclosporine, tacrolimus
and pimecrolimus.29
Mechanism of action:
Methotrexate acts by supressing immunocompetent cells in the skin and also
decreases the expression of cutaneous lymphocyte associated antigen positive
T cell and endothelial cell. Other antimetabolites act by interfering with DNA
synthesis by blocking the methylation of deoxyuridylic acid to thymidylicacid.
Calcineurin inhibitors acts by inhibiting calcineurin, a phosphatase that
normally dephosphorylates the cytoplasmic subunit of nuclear factor of
activated T cell.29
Therapeutic uses:
1. Pityriasis lichendosis et varioliformis
2. Lymphomatoid papulosis
3. Sarcoidosis
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4. Pemphigus Vulgaris
5. Pityriasis rubra pilaris
6. Lupus erythematosus
7. Dermatomyositis
8. Cutaneous T cell lymphoma
9. Psoriasis
10. Pyoderma gangrenosum
11. Behcets disease
12. Actinic keratoses
13. Actinic cheilitis
14. Bowen's disease
15. Keratocanthoma
16. Wart
17. Prokeratoses
18. Atopic dermatitis
Adverse reactions:
1. Bone marrow supression
2. Hepatic fibrosis
3. Abnormal Liver function test
4. Inflammation of the treated area
5. Hepatitis
6. Lymphoproliferative malignancy
7. Hypertension and renal dysfunction
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Anti-Inflammatory drugs
Some common anti inflammatory drugs administered for dermatological
manifestation include: Mycophenolate mofetil, Imiquimod, Vinblastine,
Dapsone & Thalidomide.28
In a study by Totri CR et al on prescribing practices
for systemic agents had reported that the most commonly used second-
line agent was anti-inflammatory drug mycophenolate mofetil (30.4%) The
main factors that discouraged their use were the side-effect profiles (82.6%)
and perceived risks of long-term toxicity (81.7%).45
Mechanism of action:
They can modulate inflammatory cytokines such as TNF-, IFN-, IL-10, IL-
12, cyclooxygenase-2. It can also modulate T cells by altering their patterns of
cytokine release and can increase keratinocyte migration and proliferation. It
also has the property to inhibit adherence of antibodies to neutrophils and
decrease the release of eicosanoids and block their inflammatory effects.
Anti-inflammatory drug such as mycophenolate has the ability to inhibit the
enzyme inosine monophosphate dehydrogenase.
Therapeutic uses:
1. Autoimmune blistering disorder
2. Inflammatory disease- psoriasis, atopic dermatitis and
pyodermagangrenosum
3. Actinic keratoses
4. Dermatitis herpatiformis& leprosy
5. Linear immunoglobulin dermatosis
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6. Bullous systemic lupus erythematosus
7. Erythema elevatumdiutinum
8. Acne fulminans
9. Pustular psoriasis
10. Lichen planus
11. Pemphigus vulgaris
12. Bullous pemphigoid
13. Leukocytoclasticvasculitis
14. Urticarial vasculitis
Adverse reactions:
1. Progressive multifocal leukoencephalopathy and pure red cell aplasia
2. Irritant reactions such as edema,vesicles,erosions or ulcers
3. Agranulocytosis,peripheral neuropathy and psychosis
4. In utero exposure can cause limb abnormalities and congenital anomalies
5. Irreversible neuropathy
Biological agents
Biological agents mainly targets specific mediators of immunological
reactions. They include T-cell activation inhibitors such as alefacept &
efalizumab, tumour necrosis factor inhibitors such as etanercept, infliximab
and adalimumab , cutaneous T cell lymphoma such as denileukin diftitox.28
David Chandler et al had stated that biological therapies provide a targeted
approach to treatment through interaction with specific components of the
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underlying immune and inflammatory disease processes but further research in
this field is needed to establish the efficacy, safety and cost-effectiveness of the
biological therapies currently available, and to support the development of new
treatments options.46
Mechanism of action:
T cell activation inhibited by binding to CD-2 on the surface of T-cell
Apoptosis of memory-effector T cell leading to reduction in CD4
lymphocyte counts
Tumour necrosis factor inhibitors blocks the TNF-
It also inhibits protein synthesis through ADP ribosylation leading to cell
death
Therapeutic uses:
1. Psoriasis
2. Psoriatic arthritis
3. Cutaneous T -cell lymphoma
Adverse reactions:
1. Peripheral leukocytosis
2. Thrombocytopenia & rebound psoriasis
3. exacerbation of congestive heart failure
4. Pain, fever, chills , nausea ,vomiting and diarrhoea
5. Hypersensitivity reaction
6. Capillary leak syndrome
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Sunscreens
Sunscreens can be classified into UVA agents and UVB agents.
UVA agents are : avobenzone, oxybenzone, titanium oxide ,zinc oxide and
ecamsule
UVB agents such as : p-aminobenzoic acid esters, cinnamates, octocrylene and
salicylates.29
In a study by D Rweyemamu out of 830 drugs prescribed , sunscreens (68)
were one of the topical miscellaneous drugs prescribed.47
Mechanism of action:
Sunscreens consists of chemical agents that can absorb incident solar radiation
of UVB and/or UVA ranges and physical agents that can block or reflect
incident energy and reduce the transmission to skin
Therapeutic uses:
1. Prevents incident sunlight that can cause erythema or redness on skin
2. Reduce actinic keratoses
3. Squamous cell carcinoma of skin
Intravenous Immunoglobulin
Intravenous immunoglobulin are given as off-label use in dermatology.It is
mostly contraindicated in patients with selective IgA deficiency.28
In a study by
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David Chandler , there has been reports of clinical improvement in patients
with atopic dermatitis treated with adjunctive high-dose intravenous
immunoglobulin (hdIVIg) . However, small clinical trials have failed to
demonstrate any significant clinical improvement, and have shown
significantly lower efficacy of IVIg.46
Mechanism of action:
Suppression of Ig G production
Accelerated catabolism of Ig G
Neutralization of complement mediated reaction
Neutralization of pathogenic antibodies
Downregulation of inflammatory cytokines
Inhibiton of autoreactive T lymphocytes
Inhibiton of immune cell trafficking
Blockade of Fas-ligand/Fas receptor interactions
Therapeutic use:
1. Autoimmune bullous disease
2. Toxic epidermal necrolysis
3. Connective tissue disease
4. Vasculitis
5. Urticaria
6. Atopic dermatitis
7. Graft-versus host disease
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Adverse reaction:
1. Fluid overload in congestive heart failure and renal failure patients
2. Renal failure in patients with rheumatoid arthritis or cryoglobulinemia
Emollients
Emollients are bland oily substances which helps in soothening and softening
the skin surface. Some commonly used emollients include olive oil, arachis oil,
sesame oil, cocoabutter, hard and soft paraffin, liquid paraffin,wool fat,bees
wax and spermaceti. 28
A study by Purushotham K et al had reported that
emollients and skin protective agents were one of the commonly prescribed
class of drugs (51%).48
Mechanism of action 49
Emollients acts as an inert oily layer over the surface of the skin. This residual
film of oil on the skin surface aids in prevention or at least impedes evaporation
of water from the skin surface and reduces the rate at which water is
traversing the skin, thus trapping it within the upper layers of stratum
corneum, this allows softening and smoothening of the skin surface.
Therpeutic uses:
1. Dry skin conditions in patients with atopic dermatitis, hypothyroidism,
uraemia and lymphoma.
2. Eczema
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Keratolytic agents
Keratolytic agents used in dermatology include salicylic
acid,resorcinol,urea and sulfur.28,29
In a study by Anuj Kumar Pathak ,
keratolytics were grouped under other drugs and these constituted 5.91% of
the prescriptions.1 In another study by Doddarangaiah R S , steroids with
keratolytic was prescribed in 33.21% of patients .50
Mechanism of action:
Breaking of intercellular junctions
Increasing stratum corneum water content
Increasing desquamation
Therapeutic uses:
1. Psoriasis
2. Seborrheic dermatitis
3. Xerosis
4. Icthyoses
5. Verrucae
6. Hyperkeratotic lesions like corn warts , psoriasis , chronic dermatitis,
ringworm, athletes foot.
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Drugs for Androgenetic Alopecia
Androgenetic alopecia (AGA) is a common dermatological condition
associated with frequent hair thinning or hair loss affecting both men and
women. Commonly used drug for androgenetic alopecia include minoxidil and
finasteride.29,39
A study by B.S Chandrasekhar on Topical minoxidil fortified
with finasteride showed that 84.44% patients maintained the density well,
showing the effectiveness of the combination in maintaining hair growth.51
Mechanism of action:
It enhances follicular size resulting in thicker hair shafts
It stimulates and prolongs anagen phase of the hair cycle resulting in longer
and increased number of hairs
Adverse effects:
1. Allergic and contact dermatitis
2. Genital abnormalities in male fetuses if exposed to pregnant women
3. Decreased libido
4. Erectile dysfunction
5. Ejaculation disorder
6. Decreased ejaculate volume
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Drugs for Hyperpigmentation
Melanizing agents include hydroquinone, monobenzone and Azelaic
acid. It is effective mostly for hormonally or light induced pigmentation within
the epidermis.28,29
Debabrata Bandyopadhyay had stated that hydroquinone
remained the gold standard of topical treatment but concerns regarding its side
effects still remains.52
Mechanism of action:
It inhibits tyrosinase and other melanin forming enzymes
Decreases the formation of and increases degradation of melanosomes
Therapeutic uses:
1. Melasma
2. Chloasma of pregnancy
3. Widespread vitiligo patients
4. Acne and papulopustular rosacea
Adverse effects:
1. Skin irritation , rashes and allergy
2. Dermatitis
3. Ochronosis
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Anti-Seborrheic agent
Rosso J Q Det al reported that the treatment options for seborrheic
dermatitis, involving scalp or other sites, included several studies inclusive of
multiple agents (number of studies, N=number of actively treated subjects):
selenium sulfide 2.5% shampoo (1, N=95), propylene glycol solution 35 to
50% (1, N=37), hydrocortisone 1% cream (3, N>58), ketoconazole 2%
shampoo (3, N=181), ketoconazole 2% cream (4, N=89), miconazole 2%
cream (1, N=22), bifonazole 1% shampoo (2, N=59), ciclopirox 1% cream (1,
N=57), ciclopirox 1.5% shampoo (1, N=102), and lithium succinate 8%/zinc
sulfate 0.05% ointment (1, N=82)53
. Seborrheic dermatitis occurs in areas
which are rich in sebaceous gland and is asscoiated with erythematous and
scaling lesions. Anti-seborrheic agents include selenium sulfide , zinc
pyrithione , corticosteroids , imidazole antifungals , sulfur , resorcinol , coaltar ,
ammoniated mercury and salicylic acid.29
Mechanism of action:
It acts as an fungicidal agent to Pityrosporum ovale which is a causative
agent for seborrhoea
It reduces epidermal turnover
Adverse reactions:
1. Sensitivity reactions
2. Atrophy
3. Purpura
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Drugs for Acne vulgaris
Acne vulgaris is a common dermatological manifestation among
adolescent boys and girls. It occurs by androgenic stimulation of sebaceous
follicles of face and neck leading to colonization by bacteria and yeast such as
propionibacterium acne, staphylococcus epidermis and pityrosporum ovale.
Some commonly used drugs for acne vulgaris include topical drugs such as
benzoyl peroxide , retinoic acid, adapalene ,topical antibiotic and azelaic acid
and systemic drugs such as antibiotics which includes tetracycline,minocycline
or erythromycin and isoretinoin.29
In a study Nibedita Patro et al reported that
out of 3634 drugs prescribed, 1724 (47.44%) were oral and 1910 (52.56%)
were topical formulations. In oral formulations, isotretinoin {1174 (68.10%)}
was the most frequently prescribed drug, as compared to 550 (31.90%)
prescriptions of antibiotics. Doxycycline {298 (54.18%)} was the most
frequently prescribed oral antibiotic followed by azithromycin {213 (38.73%)},
minocycline{30 (5.45%)} and clarithromycin {9 (1.64%)}.54
Mechanism of action:
It is efficacious against Propionibacterium acne
It promotes lysis of keratinocytes and comedolytic property
Adverse effects:
1. Dryness of skin
2. Marked scaling
3. Erythema
4. Edema
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5. Contact sensitization
6. Warmth and stinging sensation
7. Cheilitis
8. Epistaxis
9. Pruritis
10. Conjunctivitis
11. Paronychia
12. Rise in serum lipids and intracranial tensions
13. Musculoskeletal symptom
Drug utilization studies
Drug utilization studies play a major role in helping to understand,
interpret, and also improve the prescribing, administration, and use of
medications in a well managed health care systems.55
The pioneering work of
Arthur Engel in Sweden and Pieter Siderius in Holland alerted many
investigators to the importance of comparing drug use.
Definition56
According to WHO drug utilization is defined as“ the marketing,
distribution, prescription and use of drugs in a society, with special emphasis
on the resulting medical, social and economic consequences”.
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Why drug utilization studies ?57
The major objective of DUS is to facilitate a rational use of drugs in the
population. The objectives are :
To increase our understanding of how drugs are being used.
To give an early signal of irrational use of a drug
To analyse whether the steps taken to improve drug utility have acquired the
required impact.
To help the healthcare system to know, interpret, analyse andimprove the drug
prescription, use and administration of medication.
To provide insight into the effectiveness of drug use.
To set priority for sensible distribution of healthcare budgets
Sources of drug utilization data56
Data sources for drug utilization can be obtained from general
practitioners , from pharmacy records , from drug regulatory agencies , from
drug suppliers and from population through health surveys like surveys
conducted among females, elderly out patients or at nationallevel.
Study designs for drug utilization studies56
The study designs in DUS are mainly:
Prospective
Concurrent
Retrospective
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Prospective drug utilization study consists of evaluating the patient’s
disease and its intended drug therapy before a drug is given.
It generally addresses the generic substitution, drug-disease contraindications,
therapeutic interchange and wrongdosage, improper duration of treatment,
clinical abuse and drug allergy.
Concurrent drug utilization study consists of monitoring of drug therapy
which is on progress, to guarantee positiveresults. It also addresses drug - age
precautions, extreme dose, low or high dosage, over or underutilization, drug-
drug interactions.
Retrospective drug utilization studies consists of review of drug therapy
after the patient has taken the drug. It also notices the prescribing pattern of the
drugs, administeration or dispensing of drugs to avoid improper use of drugs.
This study includes case report, case series and case control studies.
Assessment of WHO drug use indicators56
A. Core indicators:
a) Prescribing indicators:
Average number of medications per consultation- to measure the degree of
polypharmacy.Combination drugs are counted as one.
Percentage of medications prescribed by generic name - to measure the
tendency to prescribe by generic name.
Percentage of medications prescribed from essential drug list.
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Percentage of consultations with an antibiotics prescribed.
b) Patient care indicators:
Average consultation time
Average dispensing time
Patient’s awareness about correct dosage
Percentage of drugs actually dispensed
c) Facility indicators:
Availability of copy of Essential Drug List (EDL)
Availability of important drugs
B. Complementary indicators:
Percentage of patients treated without medications
Average drug cost per consultation - to measure cost of drug treatment
Percentage of drug cost spent on injections- to measure the overall impact of
infection where commonly overused.
Normal values:
Average number of drug per consultation - 2-3
Percentage of consultation with an injection prescribed - 16-20%
Percentage of drugs prescribed by generic name - 100%
Percentage of drugs prescribed from essential drug list (EDL) - 80-100%
Percentage of consultation with antibiotics prescribed - should not be above
40%
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Steps in drug utilization studies58
:
1) Recognize the therapeutic areas of practice or drugs to include in the program
2) Design of study
3) Define criteria and standards
4) Design the data collection form
5) Data collection
6) Evaluate results
7) Provide feedback of results
8) Develop and implement interventions
9) Reassess and revise the drug utilization evaluation program
Pharmacovigilance
Nowadays people are using more of efficacious andnewer drugs for
diverse medical conditions in large scale. The two important concerns
regarding any drug are their safety and efficacy. Hence pharmacovigilance
plays a vital role in the rational use of drugs by giving details about the adverse
drug reactions occuring due to drugs in the general population.59
Definition59
:
WHO defined the Pharmacovigilance as the pharmacological science
relating to the detection, evaluation, understanding and prevention of adverse
effects, particularly long term and short term side effects of medicines.
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Current status of Pharmacovigilance in India
Now a days in India, pharmacovigilance situation has been progressing
gradually step by step than what it was present earlier in the past.60
In the
world survey , India has been enlisted as the fourth amongproducers of
pharmaceuticals. It is rising as one of the nation for the clinical trial hub in the
world .59
Many new drugs has been introduced by our country and hence an
energetic pharmacovigilance system in the country is essential to guard the
people from the possible harm that may arise by some of these new drugs.61
Evidently, the Central Drugs Standard Control Organization (CDSCO) has
started a well planned and highly participative National Pharmacovigilance
Program. It is based mainly on the recommendations made in the WHO
document titled “Safety Monitoring of Medicinal Products Guidelines for
Setting up and Running a Pharmacovigilance Centre”.62
In India the rate of
pharmacovigilance accounts for less than 1% when compared to the world rate
of 5%. This has occured due to lack of knowledgeabout the subject and also
deficiency in training.
Pharmacoeconomics65
Pharmacoeconomics is the science of assigning costs and outcomes of drug
therapy. Pharmacoeconomics includes the identification, measurement and
comparison of the costs, risks, results and benefits of programmes, services or
individual therapies.
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Its aim is to compare the alternative solutions which are available on
the basis of the relationship between necessary resources and results to be
obtained. This definition highlights two concepts of fundamental importance
for application of the economic principle the possibility of choosing between
alternatives and comparing on the basis of costs and effects.
Studies on Drug utilization pattern for skin disease in
Dermatology
In a study by Rathod SS et al on prescribing practices of topical
corticosteroids in the outpatient dermatology department of a rural tertiary care
teaching hospital ,had stated that out of 500 prescriptions - (2,050 drugs) the
average number of drugs per prescription being 4.1. About 66% of the
prescriptions contained four to five drugs. This reflects a trend toward
polypharmacy.64
In a study by M.H.Sumana et al on prescription analysis of drugs used in
outpatient department of dermatology at tertiary care hospital had shown that
among the drugs prescribed, antihistaminics were the most commonly used
(29.6%),followed by corticosteroids (22.2%), antibacterials(16.9%), and out of
total 280 prescribed , antihistaminics - 95.5% were prescribed by oral route and
4.5% by injectable route. Among the total 210 of corticosteroids prescribed
74.8% were topical 16.4% by injectable route and only 8.7% by oral route. A
total of 160 antibacterials were prescribed, out of which 89.5% by oral route,
7.2% topical route and 3.1% as injectables. Among the antifungals prescribed
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(106), 71.1% were topical and 28.9% oral preparations. A total of 46 emollient,
creams were prescribed. Vitamins, minerals and antioxidants comprised about
70 drugs, out of which 90% were advised by oral route and 10% topically. 22
antiseptics & ectoparasiticides were prescribed and all by topical route.
Antiviral agents were 10 in number and were prescribed mainly by oral route.
Rest of the drugs were miscellaneous out of which 25.2% of them were oral
drugs, 73.3% topical agents and 1.5% were injectables.10
In another study by
Anand S et al on the prescription pattern for dermatological conditions among
specialists and general practitioner had stated that the commonly prescribed
class of drugs were antifungals-15.02%, anti-allergics-12.95%, antibiotics-
3.92%, steroids 29.16%, scabicides 8.49%,analgesics 3.92% , anti-dandruff
preparations 7.62% and vitamins & minerals 0.54%.65
In a study by Anuj Kumar Pathak et al had reported that antihistaminics
were the most common drugs prescribed (24.13%) and among antihistaminics,
second generation antihistaminics - levocetrizine (41.22%), cetrizine (19.17%)
and fexofenadine (17.85%) were common , while highly sedative hydroxyzine
(11.77%) was used less commonly. Antifungals (21.02%) were the second
most commonly prescribed drug class. Among oral antifungals, fluconazole
(53.12%), itraconazole (21.73%) were used and among topical agents
clotrimazole, ketoconazole were used in form of powder, shampoo and soaps.
Antibiotics (15.91%) were used in both oral (39.27%) as well as topical
(60.73%) route. Among oral antibiotics, azithromycin, amoxicillin-
clavulinicacid and cefadroxil were used and among topical antibiotics,
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clindamycin for acne treatment was very common. Other than this mupirocin
and fusidic acid and other fixed dose combinations of two or more antibiotics
or along with steroids were used very frequently. Among antiparasites
permethrin, ivermectin for scabies and albendazole and mebendazole as
anthelmintics were prescribed in very few cases.1
In a study by Gupta S et al stated that Antifungals (19.4%), Antibiotics
(17.6%), Antihistamines (15.9%) and Corticosteroids (9.4%) were the most
common class of drugs prescribed in theirhospital. This study had revealed that
the commonly prescribed antifungals were terbinafine, ketoconazole,
sertaconazole, fluconazole, itraconazole and miconazole, while the commonly
prescribed antibacterials were clindamycin, azithromycin, nadifloxacin,
cefpodoxime, fusidic acid, neomycin, doxycycline and linezolid. Commonly
prescribed H1antihistamines were levocetrizine, hydroxyzine, fexofenadine and
loratadine. Topical corticosteroids (glucocorticoids) commonly employed were
betamethasone, clobetasol, mometasone, halobetasol, beclomethasone,
halometasone. The common insecticide chosen for scabies was permethrin
topically.66
Studies related to Pharmacovigilance of drugs used in
dermatology
A prospective study conducted by Shah SP. et al on the analysis of
cutaneous adverse drug reactions at a tertiary care hospital– reported Fixed
Drug Eruptions (FDEs ) - (27.3 %) were the commonest presentation followed
by maculopapular rashes (24.5 %). They also reported that antibiotics (39%)
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were the most commonly suspected drugs followed by unknown medicines of
29% for cutaneous ADR.67
Nandha et al in a study had stated that most of the common offending
drug class belonged to antimicrobials followed by NSAIDS.66
A study by Saha A et al reported that the commonest cutaneous ADRs were
morbilliform eruption (30.18%), followed by fixed drug eruption(24.52%).
This study also stated that 17% of cutaneous ADRs were due to Sulfa drugs
followed by fluroquinolones(11.30%).68
Lihite RJ et al had stated in his study that the incidence of dermatological
adverse drug reactions in outdoor patients accounted for 1.6%.69
A Study
conducted by Achayra T et al had reported that the severity of adverse
cutaneous drug reactions assessment to be 83% moderate and 15% mild in
nature using a Hartwig and Siegel’s scale.70
Gohel D on his study on evaluation of dermatological adverse drug
reaction in the outpatient department of dermatology at a tertiary care hospital
revealed that the incidence of dermatological ADRs in outdoor patients was
3.78% out of which the most common offending drug classes were anti-
microbial agents 42 (43.30%) followed by NSAIDs - 26 (26.80%) ,
corticosteroids 9 (26.80%) and anti-epileptic 5 (5.15%) .71
In another study by V.M. Motghare on prescription pattern and adverse drug
reaction profile of drugs prescribed in dermatology out-patient department
found that the most common ADR reported were of Maculopapular rash
(44.44%) followed by fixed drug eruption(22.22%) and acneform eruption
Review of Literature
52 | P a g e
(16.66%). ADR findings in that study suggested that the cause for most adverse
drug reactions were antimicrobials (50%) followed by NSAIDs (22%).
Severity assessment by modified Hartwig and Siegel’s scale in the study
showed that out of 18 ADRs, 8(44.44%) were mild, 8 (44.44%) were
moderateand 2 (11.11%) were severe in nature in nature.72
Studies on cost of drugs used for skin diseases
In a study by Narwane S.P et al had stated that an average total cost per
prescription was found to be INR135.60, while average hospital and outside
pharmacy costs were INR19.40 and INR116.20 respectively .73
In a study by
Bijoy KP et al on drug prescribing pattern and economic analysis for skin
diseases in dermatology OPD reported that the average cost of drugs per
prescription was found to be 196.74 INR.13
In a study by Gawde SR et al had stated that in India, the proportion of
insurance in health-care financing is very low. Only about 10% of the
population is covered through health financing schemes. Moreover the role of
pharmacoeconomics in India is at starting point at present.74
Data analyzed in a
study by Vineeta D et al on Assessment of Drug Prescribing Pattern and Cost
Analysis for Skin Disease in Dermatological Department of Tertiary Care
Hospital showed that, before intervention average cost of drugs per prescription
was found to be 376.97 INR and post- intervention average cost of drugs per
prescription was found to be 299.20 INR. Maximum percentage drug cost were
spent on combination preparations (38.63%) followed by others (24.62%) and
antibiotics (17.80%).5
Aims and objectives
53 | P a g e
Aims and objectives
To determine the prescribing pattern of drugs, their cost and adverse
reactions in the outpatient department of dermatology of a tertiary care
hospital.
Objectives :
1. To analyse the pattern of drugs prescribed in dermatology using WHO
prescribing indicators.
2. To evaluate the cost of therapy per prescription
3. To assess causality of the adverse drug reactions
WHO prescribing indicators analyzed are :
1. Average number of medications per encounter - to measure the degree of
polypharmacy . Combination drugs are counted as one.
2. Percentage of medications prescribed by generic name - to measure the
tendency to prescribe by generic name.
3. Percentage of medications prescribed from essential drug list
4. Percentage of encounter with an antibiotic prescribed.
Methodology
54 | P a g e
Methodology
Materials and methods:
Study design:
This study was a cross sectional study.
Study setting:
This study was conducted at outpatient clinic of Department of
Dermatology at Sree Mookambika Institute of Medical Sciences,
Kulasekaram, Kanyakumari district, Tamilnadu.
Period of study:
This study was done for 1 year from February 2016 to January 2017.
Inclusion criteria:
i.Patients attending Dermatology Out Patient Department from
February 2016 to January 2017
ii. Patients of both sexes above the age of 18 years
iii. Same patients attending outpatient department with a new
dermatological condition during the study period.
Exclusion criteria:
i. Patients already recruited in the study coming for review to the
outpatient department , SMIMS
ii. Patient with adverse drug reaction after taking medications
elsewhere other than Dermatology department , SMIMS
Methodology
55 | P a g e
Institutional Human Ethics Committee(IHEC) Approval:
The study proposal was approved by the Institutional Human Ethics
Committee (IHEC) of SMIMS with Ref. No. SMIMS/IHEC/2015/A/06.
The certificate of approval for the same has been enclosed (Annexure-I).
Confidentiality and anonymity of patients information were maintained
during and after the study.
Procedure:
The study was carried out in Dermatology department of
SMIMS, after getting approval from Institutional Human Ethics
Committee (IHEC). Patients visiting the Dermatology outpatient
department of the institution and those satisfying the inclusion and
exclusion criteria were included in the study .Written informed consent
was obtained from each patient. Once the consultation by the physician
is over, details in the prescriptions issued to patients were recorded in
case record form (Appendix-III).The demographic data of the patient ,
presenting complaints and drug reactions were recorded .The newly
diagnosed patients and patients already on treatment elsewhere who
attended the dermatology OPD in SMIMS for the first time were
included . The drug details included were dose , route and frequency of
medication. Other co-morbid conditions and associated medications
taken concurrently were also recorded.
Methodology
56 | P a g e
Outcome parameters :
A. Data obtained from case record form were evaluated for:
i.Pattern of dermatological drugs used as per demographic profile
ii.Frequency in utilization of different classes of dermatological drugs
prescribed
iii.Number of patients receiving fixed dose combinations for
dermatological treatment
B.Prescribing indicators
The data collected were analysed and compared with values of WHO
prescribing indicators given below :
i.Average number of drugs prescribed per encounter (Avg. no. of drugs
prescribed per encounter) was calculated to measure the degree of
polypharmacy
Average number of drugs prescribed per encounter =
Total number of drugs prescribed
Number of encounters surveyed
Combinations of drugs for one health problem were counted as one.
ii. Percentage of drugs prescribed by generic name (% of drugs prescribed
by generic name ) was calculated to measure the tendency of prescribing
by generic name :
Methodology
57 | P a g e
% of drugs prescribed by generic name =
Number of drugs prescribed by generic name
Total number of drugs prescribed
iii. Percentage of encounter with an antibiotic prescribed was calculated to
measure the overuse of antibiotics
% of encounter with antibiotic prescribed =
Number of encounters with antibiotic prescribed
Number of encounters surveyed
iv. Percentage of drugs prescribed from EDL was calculated to measure
the degree to which practices conform to a national drug policy as
indicated in the national list of India
% of drug prescribed from EDL =
Number of drugs prescribed from EDL
Total number of drugs prescribed
The above data were compared with WHO values given below :
1. Average number of drugs per encounter : 2-3
2. Percentage of drugs prescribed by generic name : 100%
3. Percentage of drugs prescribed from EDL : 80-100%
4. Percentage of encounter with antibiotics prescribed : less than
40%
x 100
x100
x 100
Methodology
58 | P a g e
C. Average drug cost per encounter per day
Avg . drug cost per encounter /day =
Total cost of all drugs prescribed
No. of encounter surveyed
D. Number of patients who experienced different ADRs for different
classes of dermatological drugs
E. Casuality assessment of ADRs reported in patients prescribed with
dermatological drugs by using WHO-UMC causality assessment scale
(Appendix - IV).
Analysis of data :
The data collected were entered into MS Excel 2016 spreadsheet and
subsequently analyzed . Descriptive statistical analysis was done with
the data collected.
Observation & results
59 | P a g e
Observation & results
A descriptive, quantitative and cross-sectional survey was conducted to
determine the drug prescribing pattern, cost analysis and ADRs at the outpatient
department of dermatology. A sample of 171 patient encounters was assessed
prospectively from February 2016 to January 2017. Data were collected from
prescriptions.
The baseline demographic characteristics and pattern of dermatological drug
use :
(Table - 1,2,3)
Table-1: Age wise prevalence of dermatological drug use
Age (years) Number of cases (n) Percentage
Less than 20 20 11.70
21-40 80 46.78
41-60 49 28.65
Above 60 22 12.87
Total 171 100.00
The usage of dermatological drugs was maximum in the age group of 21-40
yrs (n=80, 46.78%).The mean age was 38.67
Table-2: Gender wise prevalence of dermatological drug use
Gender Number of cases (n) Percentage
Male 66 38.60
Female 105 61.40
Total 171 100.00
The usage of dermatological drugs was maximum among females (n=105,
61.40%)
Observation & results
60 | P a g e
Table-3: Distribution of patients based on illness
Type of illness Number of cases(n) Percentage
Eczema 37 21.64
Tinea 27 15.79
PMLE 10 5.85
Dermatitis 17 9.94
Urticaria 27 15.79
Others 53 30.99
Total 171 100.00
PMLE -Polymorphous Light Eruption
Based on the type of illness treated, the common dermatological condition was
eczema (n=37, 21.64% ) and those classified as other type of illness were
paronychia onychomycosis, herpes zoster , acne vulgaris, scabies, hypermelanosis,
hyperhydrosis, crack feet, melasma , pyogenic granuloma , vitiligo , candidiasis,
furunculosis, folliculitis, psoriasis, pityriasis rosea ( n= 53, 30.99%)
Observation & results
61 | P a g e
Figure-1: Distribution of encounters based on number of drugs prescribed
Out of 171 prescriptions, three drugs per prescription were most commonly
prescribed (n=72, 42.10%) and least common was five drugs per prescription
(n=10, 5.84%)
Table - 4 : Distribution of encounters based on number of drug prescribed
Number of cases (n) Percentage
Single drug 14 8.18%
Two drugs 51 29.82%
Three drugs 72 42.10%
Four drugs 24 14.03%
Five drugs 10 5.84%
Total 171 100.00
Maximum number of patients (n=72, 42.10%) received three drugs for
dermatological disorders. Most commonly prescribed monotherapy drug was
tablet levocetrizine in 14 patients (8.18%)
0
10
20
30
40
50
60
70
80
One drug Two Drugs Three
Drugs
Four
Drugs
Five Drugs
Nu
mb
er o
f en
cou
nte
rs
Number of drugs
Observation & results
62 | P a g e
Utilization of various classes of dermatological drugs
prescribed
Figure-2: Distribution of various classes of dermatological drugs prescribed
Out of 171 prescriptions, the class of drugs most commonly prescribed was
antifungals (27 % ) and least prescribed was antidandruff (1.05%)
0 5 10 15 20 25
Antihistamine
Anti fungal
Anti biotic
Steroids
Keratolytic & emollients
vitamin & minerals
Antiparasite & antiseptic
Antidandruff
others
Percentage (%)
Cla
ss o
f d
rug
s
12.05
1.05
1.26
5.07
9.09
17.12
9.51
23.25
21.56
Observation & results
63 | P a g e
Table-5: Frequency of utilization of different classes of dermatological drugs
in a two drugs prescription
Drug Number (n) Percentage
Corticosteroid 22 22.44
Antihistamine 26 26.53
Antibacterial 5 5.10
Antibiotic 11 11.22
Emollient &Keratolytic 13 13.26
Vitamins & minerals 4 4.08
Antifungal 12 12.24
Antihelmintic 2 2.04
Antimetabolite 1 1.02
Antiviral 2 2.04
Total 98 100.00
Maximum number of patients (n=26, 26.53%) received antihistamine in a
two drug prescription pattern.
Table-6: Frequency of utilization of different classes of dermatological drugs
in a three drugs prescription
Drug Number (n) Percentage
Corticosteroid 45 20.83
Antihistamine 56 25.92
Antibacterial 9 4.16
Antibiotic 9 4.16
Emollient &Keratolytic 28 12.96
Vitamins & minerals 9 4.16
Antifungal 52 24.07
Antihelmintic 3 1.38
Skin antiseptic & disinfectant 1 0.46
Miscellaneous 4 1.85
Total 216 100.00
Maximum number of patients (n=56, 25.92%) received antihistamine in a
three drug prescription pattern
Observation & results
64 | P a g e
Table-7: Frequency of utilization of different classes of dermatological drugs
in a four drugs prescription
Drug Number (n) Percentage
Corticosteroid 12 14.28
Antihistamine 18 21.42
Antibacterial 3 3.57
Antibiotic 4 4.76
Emollient &Keratolytic 9 10.71
Vitamins & minerals 8 9.52
Antifungal 24 28.57
Antiviral 3 3.57
Miscellaneous 3 3.57
Total 84 100.00
Maximum number of patients (n=24, 28.57%) received antifungal in a four
drug prescription pattern
Table-8: Frequency of utilization of different class of dermatological drugsin
a five drugs prescription
Drug Number (n) Percentage
Antihistamine 6 13.04
Antibacterial 2 4.34
Antibiotic 5 10.86
Emollient &Keratolytic 4 8.69
Corticosteroid 6 13.04
Antifungal 4 8.69
Vitamins & Minerals 8 17.39
Antihelmintic 2 4.34
Antiviral 2 4.34
Antiscabies 2 4.34
Miscellaneous 4 8.69
Total 46 100.00
Maximum number of patients (n=8, 17.39%) received vitamins & minerals
in a five drug prescription pattern
Observation & results
65 | P a g e
Table-9: Frequency of utilization of different antihistaminics prescribed
Name of antihistamine Frequency Percentage
Tablet CPM 41 36.28
Tablet Lorfast 16 14.16
Tablet Levocetirizine 51 45.13
Tablet Fexofenadine (Allegra) 3 2.65
Tablet Cetirizine 2 1.77
Total 113 100.00
The most frequently prescribed antihistamine was levocetirizine (n= 51,
45.13%)
Table-10: Frequency of utilization of different antifungals prescribed
Name of antifungal Number(n) Percentage
KZ cream 4 4.76
KZ Shampoo 10 11.90
Tablet Fluconazole 35 41.67
Clotrimazole (Candid) cream 11 13.10
Miconazole nitrate (DK)gel 18 21.43
Clotrimazole(Canesten)cream 3 3.57
Tablet Itraconazole 2 2.38
Terbinafine(Terbest)cream 1 1.19
Total 84 100.00
The most frequently prescribed antifungal was tablet fluconazole (n= 35,
41.67%)
Observation & results
66 | P a g e
Table-11: Frequency of utilization of different antibiotics prescribed
Name of antibiotic Number(n) Percentage
Tablet Doxycycline 5 20
Tablet Cefuroxime 1 4
Mupirocin oinment 7 28
Capsule Amoxicillin 7 28
Tablet Ceftriaxone 2 8
Clindamycin (Clear) gel 2 8
Tablet Sulfamethoxazole + Trimethoprim
DS (Bactrim)
1
Total 25 100.00
The most frequently prescribed antibiotic was amoxicillin ( n= 7, 28%) &
mupirocin (n= 7, 28%)
Table-12: Frequency of utilization of different steroids prescribed
Name of corticosteroids Number(n) Percentage
Betamethasone (Betnovate) cream 8 10.53
Injection Dexamethasone 3 3.95
Clobetasol Propionate (Tennovate) cream 1 1.32
Triamcinolone acetonide (Oraways) gel 2 2.63
Clobetasol Propionate + Salicylic acid
(Propysalicnf) 6 cream
23 30.26
Hydrocortisone (Lycor) 1% cream 6 7.89
Clobetasol (Clovate) cream 6 7.89
Mometasone (HH sone) cream 12 15.79
Tablet Prednisolone 3 3.95
Fusidic acid (HH Fudic) cream 4 5.26
Tablet Deflazacort (Defza) 1 1.32
Tablet Methylprednisolone (Zempred) 5 6.58
Mometasone & Salicylic acid (HH Salic )
6% cream
2
Total 76 100.00
Out of 171 prescription , the most frequently prescribed steroid was
propysalic nf 6 cream ( n=23, 30.26%) which is composed of clobetasol
propionate and salicylic acid
4
2.63
Observation & results
67 | P a g e
Table-13: Frequency of utilization of different keratolytics and emollients
prescribed
Name of Keratolytic& Emollient Number(n) Percentage
Dermadew aloe cream 6 8.96
Dermadew soap 4 5.97
Moisturex cream 18 26.87
Sun ban cream 12 17.91
Ban A Tan cream 2 2.99
Calamine lotion 7 10.45
Liquid paraffin 18 26.87
Total 67 100.00
The most commonly prescribed keratolytics & emollients was liquid paraffin ( n=
18, 26.87%)
Table-14: Frequency of utilization of vitamins and minerals prescribed
Name of Vitamins & Mineral Number(n) Percentage
Tablet Vitamin C 1 4.76
Syrup Zincovit 1 4.76
Tablet Brisc 8 38.10
Mutivitamin tablet 4 19.05
Tablet B complex 2 9.52
Capsule Derantox 2 9.52
Capsule Renerve plus 1 4.76
Capsule HH Omega 2 9.52
Total 21 100.00
Dermadew aloe cream - aloevera gel + liquid paraffin + white soft paraffin
Dermadew soap - aloevera+ cocoabutter + coconut oil + palm oil + glycerin + olive fruit
extract
Moisturex cream - urea + lactic acid + propyleneglycol + liquid paraffin
Sun ban cream - octylmethoxycinnamate + titanium dioxide
Ban a Tan cream -alpha arbutin + liquorice extract + mulberry extract
Observation & results
68 | P a g e
Out of 171 prescriptions maximum number of patients (n=8, 38.10%) received
tablet brisc under vitamin and mineral class of drugs
Figure- 3: Percentage of drugs prescribed from WHO essential drug list
Out of 171 prescriptions maximum (34.98 %) received antihistamines and least
number of patients (0.38%) recieved antiscabies class of drugs.
0.00 5.00 10.00 15.00 20.00 25.00 30.00 35.00
Corticosteroid
Antihistamine
Antibacterial
Vitamins & Minerals
Antiscabies
Emollient & Keratolytic
Antibiotic
Antifungal
Antihelmintic
Miscellaneous
Percentage (%)
Syrup Zincovit - multivitamin + copper + L-lysinemonohydrochloride + potassium iodine +
carbohydrate + iodine + selenium
Tablet Brisc -antioxidant + multimineral + multivitamin
Capsule Derantox -beta-carotene + biotin + elemental copper + elemental manganese + selenium
dioxide + zinc sulphate
Capsule HH Omega -omega3fattyacid + vitamin C&E + zinc + biotin + lutein + zeaxanthin +
copper + selenium
Capsule Renerveplus - alpha lipoic acid +chromium+folic acid + inositol + methylcobalmin +
selenium + zinc
Capsule HH Omega -omega-3 fatty acids + vitamin C + vitamin E +zinc + biotin +lutein + copper +
selenium
Observation & results
69 | P a g e
Table-15: Frequency of utilization of different fixed drug combinations
Fixed dose combination Number(n) Percentage
Clobetasol propionate + salicylic acid
(Propysalicnf) 6 cream
23 35.93
Alpha arbutin+liquorice extract + mulberry extract
(Ban a tan ) cream 4 6.25
Capsule Amoxicillin+clavulanate
potassium(hhamoxiclav )
1 1.56
Aloe vera gel + liquid & white paraffin
(Dermadew aloe) cream
6 9.37
Betnovate n cream 7 10.93
Tablet Sulfamethoxazole+ Trimethoprim
(bactrim) ds
1 1.56
Calamine +diphenhydramine hydrochloride +
camphor (Caladryl) lotion
2 3.12
Clotrimazole+beclometasonedipropionate
(Canesten S) cream
2 3.12
Octinoxate+Avobenzone+oxybenzone+octocryl
ene+Zinc oxide (Photoban) cream
2 3.12
Hydroquinone+tretinoin+mometasonefuroate
(Lookbrite and melacare forte) cream
3 4.68
Octylmethoxycinnamate+titanium dioxide
(Sun ban) cream 12 18.75
Clobetasol propionate+ gentamicin sulphate
(Clop g ) cream
1 1.56
Total 64 100
Out of 171 prescriptions the most common fixed drug combination
prescribed as per WHO essential drug list was propysalicnf 6 cream ( n= 23 ,
35.93%) which is composed of clobetasol and salicylic acid.
Observation & results
70 | P a g e
WHO prescribing indicators data
1. Average number of drugs prescribed per encounter =
Total number of drugs prescribed = 477 =
Number of encounters surveyed
2. Percentage of drugs prescribed by generic name =
Number of drugs prescribed by generic name
Total number of drugs prescribed
3. Percentage of encounter with antibiotic prescribed =
Number of encounters with antibiotic prescribed
Number of encounters surveyed
4. Percentage of drugs prescribed from EDL=
Number of drugs prescribed from EDL
Total number of drugs prescribed
Table-16 : Summary of Prescribing indicators data
Prescribing indicators Average or
percentage
WHO
standard
Average number of drugs per
encounter
2.78 2-3
Percentage of drugs prescribed by
generic name
40.67 100%
Percentage of drugs prescribed from
EDL
48.84 80-100%
Percentage of encounter with
antibiotic prescribed
14.61 Less than 40%
x 100=
=
x 100 = 25 x 100 =
171
x 100 = 233 x 100 =
171
2.78
= 40.67
14.61
48.84
171
194 x 100
171
Observation & results
71 | P a g e
Based on WHO prescribing indicators , the average number of drugs per
encounter was 2.78 , which was within the range limit of WHO standard and it
indicated that there was no polypharmacy. The percentage of drugs prescribed by
generic name was 40.67% which was lesser than the recommended WHO standard
and the percentage of drugs prescribed from EDL was 48.84 which was also
lesser. The lesser percentage of prescribing drugs by generic name and lesser
percentage of drugs prescribed from EDL indicates the irrational use of
dermatological drugs . The percentage of encounter with antibiotic prescribed was
14.61 which was within the range of WHO standard.Hence there was no overuse
of antibiotics.
Table-17: Number and percentage of prescriptions based on the cost
Cost of prescription in Rs. Number(n) Percentage (%)
Less than 100 40 23.39
101-500 106 61.99
501-1000 19 11.11
Above 1000 6 3.51
Total 171 100.00
Average drug cost per encounter per day =
Total cost of all drugs prescribed = 47882.69 =
Number of encounter surveyed 171
Out of 171 prescription, the maximum number of prescription cost was in
between the range of Rs 101- 500 /- (n = 106 , 61.99%) and least number of
prescription was in the range of above Rs 1000 /- ( n=6, 3.51%) . The average
cost per encounter per day was Rs 280.01 /-
280.01
Observation & results
72 | P a g e
Table-18: Number and percentage of ADRs
Type of ADR Number(n) Percentage (%)
No ADR 167 97.66
Epigastric pain 1 0.58
Gastritis 1 0.58
Loose stools 1 0.58
Hypersensitivity 1 0.58
Total 171 100.00
Figure- 4:Causality assessment of ADRs of dermatological drugs by WHO-
UMC causality assessment scale
Out of 171 prescriptions , as per WHO-UMC causality assessment scale
(Annexure-IV) the maximum number of ADRs were classified under possible
(50%).
0
5
10
15
20
25
30
35
40
45
50
Probable Possible Unlikely
Per
cen
tage
of
AD
Rs
WHO-UMC causality assessment scale
25.00
50.00
25.00
Discussion
73 | P a g e
Discussion
This study analysed 171 prescriptions for drug utilization pattern , cost
analysis and adverse drug reaction profile of drugs in the outpatient department
of Dermatology, Sree Mookambika Institute of Medical Sciences,
Kulasekharam, Tamilnadu. Drug utilisation studies can aid in the improvement
of quality of treatment and prescribing pattern of dermatological drugs Thus
ultimate aim of the study is to help the dermatologist in achieving rational and
affordable treatment to their patients in terms of cost, and adverse effects.
In this study 171 prescriptions were analysed. Prevalence of
dermatological drug usage was more among females (61.40%) followed by
males (38.60%) which was in line with the study of Sumana MH and Shetti
SA.10
The commonest age group suffering from skin diseases was 21-40 years
(n=50) which was comparable to the study done by Kaur S.75
It was found that
there was a progressive decrease in the number of patients after 40 years (41-60
yrs =49 ; Above 60 yrs =22) .
Based on disease distribution , the present study depicted that eczema
(n= 37, 21.64%) was one of the most common dermatological manifestation
which was similar to a study done by Joel JJ et al 76
who stated that ezcema
(n= 66,16.5%) was the commonest dermatological condition in their study .
The second most common fungal infection was Tinea and urticaria
Discussion
74 | P a g e
(n=27,15.79%). This may be due to sweating , high humidity and poor personal
hygiene.
The average number of drugs per encounter was 2.78 which is
acceptable compared with WHO standard (2-3) In a similar study done by
Saleem M T K et al , the average number of drugs per encounter was 2.46
which was also in the acceptable range .8
The low values might mean there is
constraint in the availability of drugs or prescribers have appropriate training in
therapeutics. It also indicates that there was no polypharmacy.
The most frequently prescribed among oral antifungals was fluconazole
(41.67% ) which was also similar to a study conducted by Saleem MTK et al.8
Amongst topical agents Miconazole gel was most frequently used.
In this study the percentage of encounter with antibiotics was 14.61 % which is
low compared to the WHO standard (<40%) and this was comparable with a
similar study conducted by Patil A et al .77
This finding suggest that antibiotics
were prescribed appropriately and there was no overuse.
In our study the number of patients recieving fixed dose combination
was 64 (37.42%) which was similar to a study done by Tikoo D et al.14
The percentage of drug prescription by generic name was 40.67% in this
study which is not similar to WHO standard (100%) .In a similar study carried
out by Patil A et al percentage of drugs prescribed by generic name was
31.1%77
, which was also lower than our finding.
The percentage of drugs prescribed from WHO essential drug list in this
study period was 48.84% which is not identical to the WHO standard (100%).
Discussion
75 | P a g e
A similar low percentage (44.2%) was obtained by Patil A et al 77
in his study .
The lesser percentage of drugs prescribed by generic name and less percentage
of drugs prescribed from EDL indicates the irrational use of dermatological
drugs.
The maximum number of prescription cost was between the range of
INR 101-500 /- ( n = 106, 61.99%) in the present study which was found to be
similar in a study conducted by Pathak AK et al.1
In our study average drug
cost per prescription was INR 280/- which was high compared to the study by
Narwane SP et al.73
This high cost may be attributed to absence of generic
drugs in prescription as well as high cost of dermatological products. This cost
excluded the amount spent by patient on other expenditures. Use of generic
drugs will reduce the economic burden of the disease.
In a study Saha A et al showed that majority of adverse drug reactions were
classified as probable or possible which was similar to this study in which
majority of the ADRs were possible ( 50%) based on WHO-UMC causality
assessment scale.78
Rational prescription includes prescribing medication appropriately
considering the safety profile and cost effectiveness of the prescribed drug.
Appropriate and effective monitoring of ADR is the best way to safeguard the
public. In a country like India with varied socioeconomic status, it is important
to have a vigilant pharmacovigilance programme..
Limitations of our study were socioeconomic state of the patients was
not analyzed and it was conducted at a single centre. It was a cross-sectional
Discussion
76 | P a g e
study with limited sample size. The study duration was for one year and
seasonal variation could also influence the prescribing trend.
Conclusion
77 | P a g e
Conclusion
The pattern of drugs used in a dermatological outpatient department
was studied among 171 subjects of Sree Mookambika Institute of Medical
Science, from the period of February 2016 to January 2017. From our study
findings we were able to conclude that:
1. Mean age of study population using dermatological drugs was
38.67years.
2. Female preponderance was higher in all age groups.
3. Highest number of dermatological conditions attended to was
eczema.
4. Three drug prescription was the most commonly prescribed pattern.
5. Antifungals were the most commonly prescribed class of drugs
among 171 prescriptions.
6. Maximum prescribed antifungal drug was Tablet Fluconazole.
7. Based on WHO essential drug list antihistamines were the most
commonly prescribed and least prescribed was antiscabies class of
drugs.
8. Average number of prescriptions per encounter was 2.78, which was
within the WHO standard (2-3).
9. Only 40.67% of drugs were prescribed with generic name, which was
lower than the WHO standard (100%).
Conclusion
78 | P a g e
10. Only 14.61 % of antibiotics were prescribed , which was within the range
of WHO standard , indicating there was no overuse of antibiotics.
11. 48.84 % of drugs were from EDL, which was lesser than the WHO
standard (80-100%).
12. Average drug cost per encounter per day was Rs. 280.01/- and the
percentage of prescription falling in the range of cost Rs. 101 to Rs. 500 /-
was 61.99% (n=106).
13. Maximum ADR was possible (50 %) as per WHO causality assessment
scale.
References
I
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annexure-I
XII XII
Annexure - II
XIII
CONSENT FORM
PART 2 OF 2
PARTICIPANTS CONSENT FORM
The details of the study have been explained to me in writing and the details have been
fully explained to me. I am aware that the results of the study may not be directly beneficial to
me but will help in the advancement of medical sciences. I confirm that I have understood the
study and had the opportunity to ask questions. I understand that my participation in the study is
voluntary and that I am free to withdraw at any time, without giving any reason, without the
medical care that will normally be provided by the hospital being affected. I agree not to restrict
the use of any data or results that arise from this study provided such a use is only for scientific
purpose(s). I have been given an information sheet giving details of the study. I fully consent to
participate in the study titled ‘Drug Prescribing Pattern with Cost Analysis and Monitoring of
Adverse Drug reaction in Department of Dermatology: A Prospective Observational Study’
Serial No/Reference No: O.P No:
Name of the Participant:
Address of the Participant:
Contact number of the Participant:
Signature/Thumb impression of the participant
Witnesses:
1.
2.
Date:
Place:
Annexure-III
XIV
SREE MOOKAMBIKA INSTITUTE OF MEDICAL SCIENCES
Kulasekharam, Kanyakumari District,Tamil Nadu, India -629161
Department of Pharmacology
Title of the Study : "Drug Prescribing Pattern with Cost Analysis and
Monitoring of Adverse Drug Reaction in Department of Dermatology : A
Prospective Observational Study "
Subject number : I.P.No.: Date :
Name :
Age: Sex: M/F
Address with contact number :
Diagnosis:
Complications (if any):
Prescription details
S.NO Drug
(Brand
Name)
Generic
name
Dose Frequency Duration Route Before/
after
food
Cost(Rs.) /
Regime
Signature of the Principal Investigator
CASE RECORD
FORM
annexure- IV
XV
ADR ASSESSMENT SCALES
Scale 1: WHO CAUSALITY ASSESSMENT OF SUSPECTED ADVERSE DRUG
REACTIONS
(The Uppsala monitoring centre 2002)
Term Description
Certain
A clinical event, including laboratory test abnormality, was occurring
in a plausible time relationship to drug administration, and which
cannot be explained by concurrent disease or other drugs or chemicals.
The response to withdrawal of the drug (dechallenge) should be
clinically plausible. The event must be definitive pharmacologically or
phenomenologically, using a satisfactory rechallenge procedure if
necessary.
Probable/
Likely
A clinical event, including laboratory test abnormality, with a
reasonable time sequence to administration of the drug, unlikely to be
attributed to concurrent disease or other drugs or chemicals, and which
follows a clinically reasonable response on withdrawal (dechallenge).
Rechallenge information is not required to fulfill this definition.
Possible
A clinical event, including laboratory test abnormality, with a
reasonable time sequence to administration of the drug, but which
could also be explained by concurrent disease or other drugs or
chemicals. Information on drug withdrawal may be lacking or unclear.
Unlikely
A clinical event, including laboratory test abnormality, with a
temporal relationship to drug administration which makes a causal
relationship improbable, and in which other drugs, chemicals or
underlying disease provide plausible explanations.
Conditional/
Unclassified
A clinical event, including laboratory test abnormality, reported as an
adverse reaction, about which more data is essential for a proper
assessment or the additional data are under examination.
Unassessible/
Unclassifiable
A report suggesting an adverse reaction, which cannot be judged
because information is insufficient or contradictory, and which cannot
be supplemented or verified.
SUSPECTED ADVERSE DRUG REACTION REPORTING FORM For VOLUNTARY reporting of Adverse Drug Reactions by healthcare professionals
INDIAN PHARMACOPOEIA COMMISSION (National Coordination Centre-Pharmacovigilance Programme of India)
Ministry of Health & Family Welfare
Government of India
Sector-23, Raj Nagar, Ghaziabad-201002
www.ipc.nic.in
(AMC/ NCC Use only)
AMC Report No.
Worldwide Unique
A. PATIENT INFORMATION 12. Relevant tests / laboratory data with dates
1.Patient Initials
____________
2. Age at time
of Event or
date of birth ____________
3. Sex M F
4. Weight _Kgs
B. SUSPECTED ADVERSE REACTION 13. Other relevant history including pre-existing medical
conditions (e.g. allergies, race, pregnancy, smoking, alcohol
use, hepatic/ renal dysfunction etc)
7. Describe reaction or problem
5. Date of reaction started (dd/mm/yyyy)
6. Date of recovery (dd/mm/yyyy)
14. Seriousness of the reaction
15. Outcomes
C. SUSPECTED MEDICATION(S) S.No 8. Name
(brand and
/or generic
name)
Manufacturer (if known)
Batch
No./ Lot
No.
(if known)
Exp. Date
(if known))
Dose
used
Route
used Frequency Therapy dates (if known,
give duration) Reason for use of
prescribed for
Date
started
Date
stopped
i.
ii.
iii.
iv.
S.No
As per C
9. Reaction abated after drug stopped or dose
reduced
10. Reaction reappeared after reintroduction
Yes No Unknown NA Reduced dose Yes No Unknown NA If reintroduced dose
i.
ii.
iii.
iv.
11. Concomitant medical product including self
medication and herbal remedies with therapy dates
(exclude those used to treat reaction)
D. REPORTER (see confidentiality section on first page)
16. Name and Professional Address :_
Pin code: E-mail _________
Tel. No. (with STD code): _________
Occupation Signature _________________
17. Causality Assessment 18. Date of this report (dd/mm/yyyy)
� Death (dd/mm/yyyy)
� Life threatening
� Hospitalization/prolonged
� Disability
� Congenital-anomaly
� Required intervention
to prevent permanent
impairment / damage
� Other (specify)
� Fatal
� Continuing
� Recovering
� Recovered
� Unknown
� Other (specify)
XVI