dissertation - semantic scholar...at present there is an increasing trend for irrational prescribing...

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

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


dermatological drugs in a three drugs prescription 63


dermatological drugs in a four drugs prescription 64


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


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


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


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


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


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


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


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


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


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


16 | P a g e


- 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.


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.


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.


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


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 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.


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.


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


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


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


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


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


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


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

http://www.sciencedirect.com/science/article/pii/S0002934307004500


25 | P a g e

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


26 | P a g e

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


Antiviral drugs act by inhibiting viral DNA polymerase and prevents its

replication by terminating the elongation of the viral DNA.


27 | P a g e

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


Stabilization of lysosomes

Inhibition of antigen presentation

Inhibition of prostaglandin synthesis


28 | P a g e

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


29 | P a g e

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


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


30 | P a g e

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


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


31 | P a g e

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


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


32 | P a g e

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


33 | P a g e

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


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


34 | P a g e

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


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


35 | P a g e

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


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


7. Graft-versus host disease


36 | P a g e

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


37 | P a g e

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


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.


38 | P a g e

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


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


39 | P a g e

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


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


40 | P a g e

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


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


41 | P a g e

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


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


42 | P a g e

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”.


43 | P a g e

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


44 | P a g e

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.


45 | P a g e

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%


46 | P a g e

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.


47 | P a g e

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.


48 | P a g e

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


49 | P a g e

(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,


50 | P a g e

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%)


51 | P a g e

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


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


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


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


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


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%)


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%)


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


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


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.


in a three drugs prescription





Antibiotic 9 4.16



Antifungal 52 24.07


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


64 | P a g e


in a four drugs prescription





Antibiotic 4 4.76



Antifungal 24 28.57

Antiviral 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




Antibiotic 5 10.86



Antifungal 4 8.69

Vitamins & Minerals 8 17.39


Antiviral 2 4.34

Antiscabies 2 4.34


Total 46 100.00

Maximum number of patients (n=8, 17.39%) received vitamins & minerals

in a five drug prescription pattern


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%)


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


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


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


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.


70 | P a g e

WHO prescribing indicators data

1. Average number of drugs prescribed per encounter =

Total number of drugs prescribed = 477 =


2. Percentage of drugs prescribed by generic name =

Number of drugs prescribed by generic name


3. Percentage of encounter with antibiotic prescribed =

Number of encounters with antibiotic prescribed


4. Percentage of drugs prescribed from EDL=

Number of drugs prescribed from EDL


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


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


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

References

1. Pathak AK , Kumar S, Kumar M, Mohan L, Dikshit H. Drug utilisation pattern

for skin diseases in Indian tertiary care hospital -A prescription survey. J of

Clin and Diagn Res 2016;10(2):1-5

2. Sajith M, Lokhande KD, Padma S, Pawar AP. Prevalence of various skin

disorders and prescribing pattern of antihistamines in tertiary centre hospital.

Int J Pharm Sci Res 2014;5(3):73-77.

3. Gupta S, Khan W, Krishna A. A Pattern of skin diseases and common drugs

prescribed in dermatology OPD of an Indian tertiary care hospital. Int J Basic

ClinPharmacol 2017;6:203-7.

4. Motaghare VM ,Bajait CS, Turnakar A, Sontakke SD, Chavan S. Prescription

pattern and adverse drug reaction profile of drugs prescribed in dermatology

out-patient department at a tertiary care teaching hospital. Ind J Pharm and

Pharmacol 2016;3(4):173-177.

5. Vineeta D, Sharad P, Ganachari MS , Geetanjali S, Santosh S. Assessment of

drug prescribing pattern and cost analysis for skin disease in dermatological

department of tertiary care hospital :An interventional study . J Pharmacovigil

2016;4(3):211.

6. Bennett PN, Brown M J. Prescribing, consumption, economics and patient

compliance. Clinical Epidemiology.9th ed. Gurgaon. Elsevier India Private

Limited, 2005.p.15-22.

References

II

7. Siddhart V, Arya S, Gupta Sk . A Study of prescribing practices in outpatient

department of an apex tertiary care institute of India. Int J Res Foundation

Hosp Healthc Adm 2014;2(1):31-35.

8. Saleem MTK ,Dilip C, Nishad VK . Assessment of drug prescribing patterns in

dermatology outpatient department in a tertiary care hospital , Malabar,

Kerala. Ind J of Pharm Pract 2012;5(3):62-68.

9. Adebayo ET, Hussain NA . A baseline study of drug prescribing practices in a

Nigeria military hospital. Niger J clin Pract 2009;12(3):268-72.

10. Sumana MH, Shetti SA. Prescription analysis of drugs used in outpatient

department of dermatology at tertiary care hospital . Asian J of Biomed and

Pharmaceut Sci 2015;5(46):13-15.

11. Kumar MA, Noushad PP, Shailaja K, Jayasutha J, Ramasamy C. A study on

drug prescribing pattern and use of corticosteroids in dermatological

conditions at tertiary care teaching hoapital. Int J Pharm Sci Rev Res

2011;9:132–5.

12. Revathysaravanan, Muthukumar GLA. A Surveillance study of antibiotic use

in Pondicherry . Int J Basic Clin Pharmacol. 2012;1:202–10

13. Bijoy KP, Vidyadhar RS, Palak P, Chintan SP, Atmaram PP. Drug

prescribing and economic analysis for skin diseases in dermatology OPD of

an Indian tertiary care teaching hospital: a periodic audit. Indian J Pharm

Pract 2012;5(1):28–33.

References

III

14. Tikoo D, Chopra SH, Kaushal S, Dogra S. Evaluation of drug use pattern in

dermatology as a tool to promote rational prescribing. JK Sci. 2011;

13(3):128–31.

15. Kushwah A, Kothari S, Saraswat PK ,Tomar A. A clinical study to find out

cutaneous Adverse drug reaction profile in a tertiary care hospital. Int J

Pharm Scr Met .2014 ; 4 (3 ): 137-144

16. Hunter J, Savin J , Dahl M .Clinical Dermatology. 3rd ed ; Blackwell

science:2003. p. 7-28.

17. Thappa DM, Kumari R. Emergence of dermatology in India. Ind J Dermatol

Vernereol Leprol 2009;75:86-92

18. Weller R, Hunter J, Savin J, Dahl M .Clinical Dermatology. 4th ed ; Blackwell

science : 2008 : 10-33

19. Robertson DB ,Maibach HI .Dermatologic Pharmacology. In Katzung BG ,

Trevor AJ , editors .Basic and clinical pharmacology . 13th ed New Delhi :

McGraw Hill Education, 2015:1033-51

20. Behl PN. Heritage page-Growth of dermatology in India. Ind J Dermatol

2001;46:188-92

21. Samhita C. Vol. 3. Chapter 7. Jamnagar, India: Shree Gulabkunverba

Ayurvedic Society

22. Behl PN. Ayurvedic Dermatology in the concept of modern medicine. Ind J

Dermatol Venereol 1957 ; 23 : 2

References

IV

23. Fox T, Farquar T. Scheme for obtaining a better knowledge of endemic skin

disease in India. London : George Edward eyre & william spottoswoode ;

1872

24. Discussion papers on child health, Epidemiology and management of

common skin diseases in children in developing countries [Online]. 2005

Nov 20 [ cited 2017 Feb 6 ] ; Available from :URL: whqlibdoc.who.

int/hq/2005/WHO_FCH_CAH_05.12_eng.pdf

25. Jain S, Barambhe MS, Jain J, Jajoo UN, Pandey N. Prevalence of skin

disease in rural central India: A community-based, cross-sectional,

observational study. J Mahatma Gandhi Inst Med Sci 2016 ; 21 : 111-5

26. Grover S, Ranyal RK, Bedi MK. A cross section of skin disease in rural

Allahabad. Ind J Dermatol 2008 ; 53:179-81

27. Fried RG , Hussain SH. Non pharmacologic management of common skin

and psychocutaneous disorders. Dermatologic Therapy 2008;21:60-68

28. Burkhart C, Morell D, Goldsmith L, Brunton L, Chabner BA, Knollman B

editors. Goodman & Gilman's The Pharmacological Basis of Therapeutics.

12th ed., New York: McGraw-Hill , 2011 : 1803-30

29. KD Tripathi .Essentials of Medical Pharmacology. 7 th ed ., New Delhi :

Jaypee Brothers Medical Publishers , 2014 : 886-904

30. Divyashanthi CM, Manivanan E. Prescribing analysis of corticosteroids

among the dermatology in patients : A prospective observational study . Int J

Pharm Bio Sci 2014;5(2) : 324-30

whqlibdoc

References

V

31. Shakya Shrestha S, Bhandari M et al. Study on corticosteroids use pattern in

dermatological practice and investigating adverse effects of corticosteroids

including its associated factors. Kathmandu Univ Med J 2015;51(3):261-7

32. Brito MF, Sant'Anna IP, Galindo JC, Rosendo LH, Santos JB . Evaluation of

clinical adverse effects and Laboratory alteration in patients with acne

vulgaris treated with oral isoretinoin . An Bras Dermatol 2010; 85(3):331-6

33. Wei li, Ying li, QuanLuo, Xue-mei Li, Zhang XB. Off-label use of retinoids

in dermatology. Our Dermatol Online 2012; 1:259-278

34. Man I, Crombie lk, Dawe RS, Ibbotson SH, Ferguson J. The

photocarcinogenic risk of narrow band UVB (TL-01) phototherapy : early

follow-up data. Br J Dermatol 2005; 152: 755-57

35. Patrizi A, Raone B, Ravaioli GM . Management of atopic dermatitis: safety

and efficacy of phototherapy. Clinical, cosmetic and investigational

dermatology 2015; 8: 511-20

36. Kolasani BP, Divyashanthi CM, Sasidharan P, Kothandapany SV.

Prescription analysis of both H1 and H2 antihistamines among inpatients of

dermatology department of a tertiary care teaching hospital in coastal town of

south india. Natl J Physiol Pharm Pharmacol 2016 ; 6(6):537-43

37. Shamna M, Dilip C, Ajmal M, Mohan P, Shinu C, Jafer CP , Mohammed Y.

A prospective study on adverse drug reactions of antibiotics in tertiary care

hospital. Saudi Pharmaceut J 2014;22:303-08

References

VI

38. Chang CH, Young-xu Y, Kurth T, Orav JE, Chan AK .The safety of oral

antifungal treatments for superficial dermatophytosis and onychomycosis. A

meta-analysis. Am J med 2007;120(9):791-8

39. Sharma HL, Sharma KK. Textbook of Pharmacology. 2 nd ed., New Delhi :

Paras Medical Publishers, 2013 : 764-84.

40. Kaur M, Kumar S, Singh P . A cost analysis study on drug prescribing pattern

of antifungals in dermatological conditions at tertiary care teaching hospital.

Euro J Pharmac and Med Res 2017; 4 (4):461-64

41. Forbes HJ, Thomas SL, Smeeth L, Langan SM. Prescription of antiviral

therapy after herpes zoster in general practice: who receives therapy? .Brit J

Gen Prac 2012;62(605):e808-e814.

42. Jayanthi C R, Renuka M, Panchaksharimath P. An observational study to

analyze the adverse drug reactions among the elderly at a tertiary care

hospital. Biomed Pharmacol J 2017 ; 10(1):345-52

43. Charlene G, Werth VP. Combination antimalarials in the treatment of

cutaneous dermatomyositis. Arch Dermatol 2005;141:855-859

44. Callen JP. Immunosuppressive and cytotoxic drugs in dermatology: A

practical overview and personal perspective . J cut med and surg 1996 ; 1(1) :

58-64

References

VII

45. Totri CR, Eichenfield L F, Logan K, Porudfoot L, Schmitt J, Lara-corrales I,

Sugarman J, Tom W, Siegfried E, Cordoro K, Paller AS, Flohr C. Prescribing

practices for systemic agents in the treatment of severe pediatric atopic

dermatitis in the US and Canada.The PeDRA TREAT survey. J of Amer Aca

of Dermatol 2017; 76(2): 281-85

46. David Chandler and Anthony Bewley; Biologics in dermatology

pharmaceuticals (basel) 2013; 6(4): 557-578

47. Rweyemamu D, Runyoro DKB, Temu MJ. Pattern of skin diseases and

prescribing practice in dermatology in public and faith based hospitals in

three regions of Tanzania. J Pharm Sci and Res 2017 ; 9(1):55-62

48. Purushotam K, Eesha BR. Prescription trend of topical corticosteroids in

outpatient of dermatology in a tertiary care hospital in Tumakaru, Karnataka.

Int J Pharmacol and Clin Sci 2016 ; 5(3): 71-82

49. Siddappa K. Dry skin conditions, eczema and emollients in their

management. Ind J Dermatol, Venereol and Lepros 2003 ; 69 (2): 9-75

50. Mahindrakar MB, Shivanand D R. Topical corticosteroids prescription trends

in dermatology outpatients unit of a tertiary care research institute hospital ,

South India. Ind J ClinExpDermatol 2016; 2(1):8-11

51. Chandrasekhar BS, Nandhini T, Vasanth V, Sriram R, Navale S. Topical

minoxidil fortified with finasteride: An account of maintenance of hair

density after replacing oral finasteride. Ind Dermatol Onl J 2015; 6(1):17-20

52. Bandyopadhyay D. Topical treatment of melasma. Ind J Dermatol 2009;

54(4):303-9

References

VIII

53. Rosso JQD. Adult seborrheic dermatitis: A status report on practical topical

management . J Clin Aesthet Dermatol 2011;4(5):32-8

54. Patro N, Jena M, Panda M ,Dash M . A study on the prescribing pattern of

drugs for acne in a tertiary care hospital in odisha. J Clin Diagn Res

2015;9(3): 04 -06

55. PRxN DUR. [Online]. 2009 October [cited 2016 May 21]; Available from:

URL:https://www.prxn.com/docs/PRXN%20DUR.pdf

56. Shalini KC, Mistry RA, Singh AP, Jadav SP, Patel NM, Trivedi HR. Drug

utilization studies: An overview.Int J Pharm Nanotechnol 2010; 3(1):803-10

57. Sjöqvist F, Birkett D. Drug Utilization. In: Souich PD, Orme M, Erill S ,

editors. The IUPHAR compendium of basic principles for pharmacological

research in humans.1 st ed., IUPHAR 2004 : 76-86

58. Sachdeva PD, Patel BG. Drug utilization studies - scope and future

perspectives.Int J Pharm Biol Res 2010; 1(1):11-17

59. Patel A, Giles D, Thomas V, Gurubasavarajaswamy PM, Patel R

.Pharmacovigilance : a review . Int J Pharm Biol Arch 2011; 2(6):1569-74.

60. Zaki SA. Adverse drug reaction and casuality assessment scales .Lung India

2011; 28(2):152-3

61. Rohilla A, Singh N, Kumar V, Sharma MK, Dahiya A, Kushnoor A.

Pharmacovigilance : needs and objectives . J Adv Pharm Edu Res 2012 ;

2(4):201-5

References

IX

62. Raut AL, Patel P, Patel C, Pawar A. Preventibility, predictability and

seriousness of adverse drug reactions amongst medicine inpatients in a

teaching hospital : A prospective observational study. Int J Pharm Chem Sci

2012 ;1(3):1293-9

63. Kumar S, Baldi A. Pharmacoeconomics : principles, methods and economic

evaluation of drug therapies. PhTechMed 2013 ; 2(5):362-369

64. Rathod SS, Motaghare VM, Deshmukh VS, Deshpande RP, Bhamare CG,

Patil JR . Prescribing practices of topical corticosteroids in the outpatient

dermatology department of a rural tertiary care teaching hospital. Ind J

Dermatol 2013;58 (5):342-5

65. Anand S, Thanikaivel S .Prescription pattern for dermatological conditions

among specialists and general practitioner. Int J Pharm Sci Rev Res 2015;34

(1): 136-40

66. Nandha R ,Gupta A, Hashmi A. Cutaneous adverse drug reactions in a

tertiary care teaching hospital : A North Indian Perspective . Int J of Appl and

Bas Med Res 2011 ;1(1):50-3

67. Shah SP, Desai MK, Dikshit RK. Analysis of cutaneous adverse drug

reactions at a tertiary care hospital - a prospective study. Trop J Pharm Res

2011; 10(4):517-22

68. Saha A, Das NK, Hazra A, Gharami RC, Chowdury SN, Datta PK .

Cutaneous adverse drug reaction profile in a tertiary care outpatient setting in

eastern India. Ind J Pharmacol 2012; 44 (1):792-7

References

X

69. Ratan JL, Mangala L. A study on cutaneous adverse drug reactions in ADR

monitoring centre of tertiary care hospital, Guwahati. J of Applied

Pharmaceut Sci 2013;3(3):78-81

70. Acharya T, Mehta D, Shah H, Dave J. Pharmacovigilance study of adverse

cutaneous drug reactions in a tertiary care hospital. Natl J Physio Pharm

Pharmacol 2013;3 :75-81

71. Gohel D, Bhatt SK, Malhotra S. Evaluation of dermatological adverse drug

reaction in the outpatient department of dermatology at a tertiary care

hospital. Ind J of Pharm Pract 2014;7(3):42-49

72. Motaghare VM, Bajait CS, Turnakar A, Sontakke SD ,Chavan S. Prescription

pattern and adverse drug reaction profile of drugs prescribed in dermatology

outpatient department at a tertiary care hospital . Ind J of Pharm and

Pharmacol 2016;3(4):173-77

73. Narwane P, Patel TC, Shetty YC, Chikhalkar SB. Drug utilization and cost

analysis for common skin diseases in dermatology OPD of an Indian tertiary

care hospital -A prescription survey . Brit J Pharmaceut 2011;1(1):9-18

74. Gawde SR, Shetty YC, Merchant S, Kulkarni UJ, Nadkar MY. Drug

utilization pattern and cost analysis in rheumatoid arthritis patients - a cross-

sectional study in tertiary care hospital , mumbai . Brit J of Pharmaceut Res

2013;3(1):37-45.

75. Uppal R, Sharma SC, Bhowmik SR, Sharma PL, Kaur S.Topical

corticosteroids usage in dermatology. Int J Pharm Therap Toxicol 1991;29 :

48-50

References

XI

76. Joel JJ, Jose N, Shastry CS. Patterns of skin disease and prescribing trends in

rural India. Acad J Pharm 2013;2(4) : 304- 309

77. Patil A, Dighe D, Kolte S, Jadhav PR, Deshmuk YA . Drug utilization pattern

in dermatology outpatient department at tertiary care hospital in Navi

mumbai . Int J Bas &Clin Pharmacol 2017 ; 6(3) : 559 -562

78. Saha A, Das NK, Hazra A, Gharami RC, Chowdury SN, Datta PK.

Cutaneous adverse drug reaction profile in a tertiary care outpatient setting in

eastern India . Ind J Pharmacol 2012 ; 44 :792-7

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


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


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

dissertation - semantic scholar...at present there is an increasing trend for irrational prescribing...

Documents