Dipika Mishra - Graduation Project 2019

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GRADUATION PROJECT VISUAL COMMUNICATION (BACHELOR OF DESIGN)

Vol. 1 of 1

Project Title:

A Social Campaign on Commonly used prescriptive/non-prescriptive medicines and its unknown side effects by the users. Name:

Dipika Mishra (20170301088) Project Mentor:

Sambit Kumar Pradhan

2019



The Graduation Project Evaluation Jury recommends DIPIKA MISHRA from Visual Communication for the Master’s/ Bachelor’s Graduation Degree of Unitedworld Institute of Design, Karnavati University, Gandhinagar, India herewith, for the project titled Commonly

used prescriptive/non-prescriptive medicines and its unknown side

effects by the users. The project is complete in every aspect in accordance to the guidelines set by the institution.

Chairperson

Members

Signature

Name

Organization

Signature

Name

Organization

Signature

Name

Organization

Signature

Name

Organization

*Subsequent remarks regarding fulfilling the requirements


COPYRIGHT Š 2019

Student document publication, meant for private circulation only. All rights reserved. No part of this document will be reproduced or transmitted in any form or by any means including photocopying, xerography, photography and videography recording without written permission from the publisher, Dipika Mishra and Unitedworld Institute of Design. All Illustrations and photographs in this document are Copyright Š 2019 by respective people and organizations. All copyrights Written and designed by Dipika Mishra, under the guidance of Sambit Kumar Pradhan. Printed digitally in Ahmedabad, Gujarat, India, March, 2019.

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ORIGINALITY STATEMENT

COPYRIGHT STATEMENT

I hereby declare that this submission is my own work and it contains no full or substantial copy of previously published material, or it does not even contain substantial proportions of material which have been accepted for the award of any other degree or diploma of any other educational institution, except where due acknowledgment is made in this degree project. Moreover I also declare that none of the concepts are borrowed or copied without due acknowledgment. I further declare that the intellectual content of this degree project is the product of my own work, except to the extent that assistance from others in the project’s design and conception or in style, presentation and linguistic expression is acknowledged. This degree project (or part of it) was not and will not be submitted as assessed work in any other academic course.

I hereby grant the Unitedworld Institute of Design the right to archive and to make available my degree project/thesis/dissertation in whole or in part in the Institutes’s Knowledge Management Centre in all forms of media, now or hereafter known, subject to the provisions of the Copyright Act. I have neither used any substantial portions of copyright material in any document nor have I obtained permission to use copyright material.

Student Name in Full:

Student Name in Full:

Dipika Mishra

Date:

Dipika Mishra

Signature: Date:

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About UID Unitedworld Institute of Design (UID) is one of the premier Design Institutes of India located in Gandhinagar, Gujarat. The institute aims to create globally sought –after professionals who can exhibit their creativity and trigger novel trends. UID’S pursuit for excellence has made its name shine with an extraordinary record of success in a short span. UID offers a diverse range of UG and PG courses in the area of art & design. These programs are designed with strong professional emphasis and in close partnership with the industry. Every course has been structured to deliver insights into the importance of individual and collective creativity, be it a theoretical assessment, design practice, evaluations or artistic considerations.

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Visual Communication at UID Unitedworld Institute of Design (UID) is one of the premier Design institutes of India. The institute aims to create globally sought –after professionals who can exhibit their creativity and trigger novel trends. UID’S pursuit for excellence has made its name shine with an extraordinary record of success in a short span. UID offers a diverse range of UG and PG courses in the area of art & design. These programs are designed with strong professional emphasis and in close partnership with the industry. Every course has been structured to deliver insights into the importance of individual and collective creativity, be it a theoretical assessment, design practice, curatorial evaluations or artistic considerations.

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About me I am a 21 year old graphic design student, People around me often define me as prudent, I am an extrovert through and through, Always on the lookout to learn something new, All my circles feel that I am a real hardworker, Though my sense of humour might be considered a tad shade darker.

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About the mentor Sambit is an architect who studied Lifestyle Accessory Design for his masters from the National Institute of Design, Ahmedabad. Even though his formal education is largely in the industrial and spatial design domain, he has always had a keen interest in communication design and over the past 7 years he has worked as a communications content writer and editor, screen and stage actor, has written and co-written lyrics, dialogues and scripts for short films and has worked as a voice artist. As a design educator he covers a diverse range of subjects- space, forms, structures, design process, lateral thinking, storytelling, experiential design, prints, culture studies, theatre, films etc. He believes that key to good design is empathy and the ability to simultaneously cater to the specifics as well as their larger enveloping context(s). He hopes to one day publish at least one book pertaining to design education in India and another of poetry.

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Contents 01

02

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INTRODUCTION

PRE-RESEARCH

RESEARCH

Acknowledgements Preface Introduction Motivation Aim of the project Possible deliverables Research areas Tentative timeline

Drug OTC medicines Clinical pharmacy Prescription writing Essential medicines What are schedules Adverse Drug Reactions(ADRs) Contraceptives

Mindmapping Web as a source of medication Self medication Visits Interviews Survey Commonly used drugs Commonly used medicines

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04

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CONCEPTS

EXECUTION

CONCLUSION

Main areas of problem Target audience Campaigns Fianl design brief

Illustrations Iconography Formatting Final posters Testing

Personal Experiences Challenges Learning References Credits Bibliography

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Acknowledgements This document is a consolidation of my learnings of the four years of education I have received at Unitedworld Institute of Design, Gandhinagar, India. The final outcome of this project required a lot of guidance and assistance from many people and I am extremely privileged to have got this all along the completion of my project. All that I have done is only due to such supervision and assistance and I would never forget to thank them. I would like to express my deepest gratitude to my mother and father for their support and encouragement. They make me whatever I am today and what I will be. I thank my project guide Prof. Sambit Kumar Pradhan for investing faith in my project and offering me a sense of clarity and direction wherever I was lost.

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I would like to thank all my faculties Prof. Lolita Dutta, Prof. Titu Mili, Prof. Honey, Prof. Mukesh Singh, for their continuous contribution to design education and sharing their wealth of knowledge to help me grow. I extend my thanks to our academic department and teaching staff at UID for an enriching educational experience during the years. Last but not least, I want to thank my college mates for the overwhelming experience and interesting conversations during the years.


Preface People often buy OTC medicines usually upon self-diagnosis, upon other’s word and doubtful facts. Many people due to which never come to know that their body is getting affected by continuous use of those medicines and only at a later stage do they realize the ill-effects. Addiction sets in before one realizes. The victims often tend to be school and college kids. Besides, these medicines are also abused as cheap legal substitutes for banned substances like cocaine, heroin etc. Awareness amongst the most effected ages along with sensitive counselling for both the addict and their family is necessary to avert such situations.

https://www.healthline.com/health/allergies/antihistamine-brands

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Motivation

Objective and Overview

Research areas

My motivation of this project is due to very less awareness on this topic and continuous happening of this problem.

The process of this project will include researching out the main fields of cause and generation of the problems in different age groups. This project will focus only on Indian case studies and the present situation of the audience in this country through extensive surveys and medicals store visits and later analysis of the data.

Research areas include surveys with the patients who buy medicines without prescription,visiting doctors as they are the prescription writers, visiting pharmacies and going to different NGOs along with meeting govt. officials who are conducting health related programmes.

Aim of the project To create awareness towards judicious use of OTC medicines and prevent their intentional or accidental abuse in India. The intention of this project will be to make people aware about how every person’s body is different and how the use of medicines should not depend on each other’s cure and effects. On the contrary also looking into the situation of drug abuse and how OTCs can be used as drugs.

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Possible deliverables - Social campaign - Short awareness film - Guideline book - Series of posters on dos and don’ts - A play for awareness


Tentative timeline

Research Concept Finalising Design production Final Designs Documentation

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PRE-RESEARCH

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“Drugs do not work untill you take them.�

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Drug “A drug is a substance or product, which is used or intended to be used to modify or explore the physiological or pathological state for the benefit of the recipient�.

https://upperarlingtonoh.gov/event/prescription-drug-take-back-day/2019-04-27/

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What are OTC medicines?

Clinical pharmacy

People often buy OTC medicines usually upon self-diagnosis, upon other’s word and doubtful facts. Many people due to which never come to know that their body is getting affected by continuous use of those medicines and only at a later stage do they realize the ill-effects. Addiction sets in before one realizes. The victims often tend to be school and college kids. Besides, these medicines are also abused as cheap legal substitutes for banned substances like cocaine, heroin etc.

It involves the cooperation of the pharmacist and the physician in educating the patient about the complaints and counseling him on how to take the medicines and monitoring medication errors in the drug therapy.

Awareness amongst the most effected ages along with sensitive counselling for both the addict and their family is necessary to avert such situations.

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Dosage form

Manufacturing and expiring dates of the drug

Concerns with respect to expiry dates

A drug is a product designed for administration to the human beings in the cure, prevention or diagnosis of a disease or for relief of symptons.

Manufacturing date: of the medicines is stamped on the outer carton as well as on the product strip/neck. A unique batch number or lot number categorizes the the manufacturing date.

Loss of efficacy : The critial amount of drug required for its therapeutic effect may not be peresent in the formulation that is past its expiry date.

Suitable dosage forms serve one or more of the following purposes: 1. Protect the drug from destruction by atmospheric air or mositure (eg. coated tablets). 2. Protect the drug from destruction by gastric acid or enzymes. 3. Mask the bitter or unpleasant taste or flavor of the drug. 4. Provide extended drug action. 5. Provide optimal drug action. 6. Provide direct access of the drug to body tissues. 7. Facilitate easy administration of drugs.

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Expiry date: depends on the rate of decomposition of the medicinal product. The rate of decomposition depends on the temperature, relative humidity, light exposure and addition of preservatives. Preservatives of different types inhibit microbial growth and hence degradation and spoilage. Expiry date of a preparation is carried out by primary, secondary and real time data stability tests. The Shelf Life: of the product is then calculated by extrapolation for degradation that are obtained from stability tests. The shelf life is the period between the manufacturing and the expiry date. It is specified by instructions on storage given on outer container and inner packing.

Contamination : Bacterial and fungal contamination of the drug may occur. It may occur before the expiry date if the drug is not preserved as per specifications. Toxicity : Degradation of products that are formed may be toxic.


Label

It is usually attached or printed on the container or strip and also on the outer carton which provides useful information about the following : - The trade and the generic name of the drug. - The type of formulation. - Ingredients of the preparation and their quantity. - The dosage instructions. - The manufacture and expiry date of the preparations. - Instructions for use of the preparations. - Precautions and warnings if any, with respect to the use of the drug. - Address of the manufacturer and the marketing agency of the drug. - Batch number, manufacturing license number and the M.R.P. of the preparation. - Schedule of the drug.

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Package Insert

It provides vital information about the preparation. It is placed inside the container. It is revised periodically and provides the following information: - Trade and generic name of the drug. - Composition of the preparation. - The pharmacological actions. - Indications, contraindications and dosage instructions. - Precautions and warnings with respect to the drug. - Adverse drug reactions. - Presentation of the preparation. - Name and address of the manufaturer and the distributor of the preparation. - Schedule of the drug.

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Prescription writing

A prescription is a written order of a physicial to a pharmacist, with names and doses of the drugs, instructions for preparation and dispensing for the pharmacist and mode of administration for the patient. All prescriptions should be legible, unambiguous, dated and signed clearly for optional communication between the prescriber, pharmacist and the nurse. Nowadays, pre-compounded drugs (readymade presparations marketed by pharmaceutical companies) routinely prescribed.

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Parts of prescription

A prescription consists of the foloowing parts: i. Superscription ii. Insription iii. Subscription iv. Transcription

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“Prescribe the right drug to the right patient in the right dose by the right route at the right time intervals�.

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Principles of prescription

1. The name of prescription for your letterhead. 2. Legibly and indeligibly. 3. The patients name, age ad address. Should not include abbreviations of names of drugs/ preparations or instructions about taking the medicines. Should have clear information of dose, dosing intervals, time of the day, relation to meals and duration of therapy. 4. Should include the minimum dosing interval and the maximum number of doses per day. 5. In case of scheduled drugs, the quantity of drug to be supplied at the time and how many times the prescribed drugs may be supplied without revalidation should be included.

Patient non-compliance

6. Should advise to the parents/ patients that no medicine should be added to the infant’s feeding bottle; tablets/ capsules should be take in sitting position and should be washed down with plenty of water; ointments should be used as supplied and should not be diluted for use; residual ointment by a patient should be discarded and not stored for future use; medicines should be stored beyond the reach of children.

Except when hospitalised, patients are responsible for taking their own drugs. Often there is a discrepancy between what is prescribed and what the patient actually takes. The reasons for non-compliance are:

7. Doctor’s Sign is mandatory in the prescription.

- Adverse Reactions

8. The date and the registration number shoud be mentioned.

- Poor Motivation

- Complexity of the regimen. - Cost

- Length of therapy 9. The doctor must avoid painful IM injections in children whenever possible. Liquid preparations are more suitable for childern and older people.

- Natural disinclination to take injections - Self medication - Internet as a source of information

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Emergency medicines

These are life saving medicine and require an immediate administration in an emergency. They can sustain life and/or prevent further complication and therefore should be available at all healthcare facilities i.e out-patient departments, clinics, dispensaries and as well as primary, secondary and tertiary health care centres For example Paracetamol, injections, diclofenac injections, atropine injections, adrenaline injections, isosorbide dinitrate, ceftazidime injection etc.

Paracetamol [Photo Credit: The Telegraph]

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Essential medicines

The WHO has defined Essential Medicines (drugs) as “those that satisfy the priority healthcare needs of the population. They are selected with due regard to public health relevance, evidence on efficacy and safety, and comparative cost effectiveness.

Sr. No Name of the Drug 1 Paracetamol 2 3

Ibuprofen Diazpam

Essential medicines are intended to be available within the context of functioning health systems at all times and in adequate amounts, in appropriate dosage forms, withassured quality and adequate information, and at a price the individual and the community can afford.

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IV Fluids

5 6

Atropinesulphate Metoclopromide

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Adrenaline Saltbutamol Injection

9 10 11 12 13

Glyceryl Trinitrite Surgical Dressing Lignocaine Ferrous Sulphate Oral Rehydration Salt

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Aspirin

Formulation and Strength Tablet 250mg, 500mg Syrup 150mg/5mL Tablet 200mg, 400mg Injection 5mg/mL in 2mL ampoule Tablet 5mg 5% Dextrose 500mL, 1L Normal Saline 1L, Ringer lactate 1L Injection 0.6 mg/mL ampoule Tablet 10mg, Injection 5mg/mL in 2mL ampoule Injection 1mg/ml (1:1000) ampule Tablet 2mg, 4 mg, Aerosol 100 mcg/ puff Injection 50mcg/mL in 1mL ampoule Tablet 0.5mg sublingual Providone iodine ointment Injection 1% 2% vial Tablet 200mg Powder in sachet to be dissolved in 1L of water Tablet 150mg, 300mg

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What are Schedules?

Prescriptive drugs

Non-Prescriptive drugs (OTC)

The Drugs and Cosmetics Rules, 1945 contains provisions for classification of drugs under given schedules and there are guidelines for the storage, sale, display and prescription of each schedule.

Schedule C

They are considered to be relatively safe drugs, used for common ailments and can be sold over the counter without prescription.

The Rule 67 details the conditions of licenses. The Rule 97 contains the labeling regulations.

Schedule F

Schedule K

Vaccines and sera

Paracetamol, Aspirin, Antacids, Laxatives etc.

Biological and special products For example, Insulin and antibiotics.

Schedule G Drugs to be labeled with the words ‘caution-it is dangerous to take this prescription except under medical supervision’.

Schedule H Drugs sold by retail only and are made available to the patient only on prescription of a qualified registered medical practitioner. eg. Ciprofloxacin

Schedule X Liable to cause abuse, addiction and and so there Wis restriction on sale od such drugs eg. opioids, barbiturates, amphetamines, etc. The supply of these drugs has to be maintained and recorded in a register.

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Systematic routes of drug administration The drug administered through systemic routes is intended to be absorbed into the blood stream and distributed all over, including the site of action, through circulation.

Source book: Essentials of medical pharmacology pg. no. 7

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Adverse drug reactions (ADRs) Adverse drug reaction is “an appreciably harmful or unpleasant reaction, resulting from an intervention related to the use of a medicinal product, which predicts hazard from future administration and warrants prevention or specific treatment, or alteration of the dosage regimen, or withdrawal of the product.” Such reactions are currently reported by use of WHO’s Adverse Reaction Terminology, which will eventually become a subset of the International Classification of Diseases. Adverse drug reactions are classified into six types (with mnemonics): dose-related (Augmented), non-dose-related (Bizarre), dose-related and time-related (Chronic), time-related (Delayed), withdrawal (End of use), and failure of therapy (Failure). Timing, the pattern of illness, the results of investigations, and rechallenge can help attribute causality to a suspected adverse drug reaction. Management includes withdrawal of the drug if possible and specific treatment of its effects. https://www.verywellhealth.com/what-is-an-adverse-reaction-3959900

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Categorisation of ADRs Side Effects

Secondary Effects

Toxic Effects

These are unwanted but often unavoidable pharmacodynamic effects that occur at therapeutic doses. Generally, they are not serious, can be predicted from the pharmacological profile of a drug and are known to occur in a given percentage of drug recipients. Reduction in dose, usually ameliorates the symptoms.

These are indirect consequences of a primary action of the drug, e.g. suppression of bacterial flora by tetracyclines paves the way for superinfections; corticosteroids weaken host defence mechanisms so that latent tuberculosis gets activated.

These are the result of excessive pharmacological action of the drug due to overdosage or prolonged use. Overdosage may be absolute (accidental, homicidal, suicidal) or relative (i.e. usual dose of gentamicin in presence of renal failure). The manifestations are predictable and dose related. They result from functional alteration (high dose of atropine causing delirium) or drug induced tissue damage (hepatic necrosis from paracetamol overdosage).

A side effect may be based on the same action as the therapeutic effect, e.g. atropine is used in preanaesthetic medication for its antisecretory action. The same action produces dryness of mouth as a side effect. Glyceryl trinitrate relieves angina pectoris by dilating peripheral vasculature which is also responsible for postural hypotension and throbbing headache.

The CNS, CVS, kidney, liver, lung, skin and blood forming organs are most commonly involved in drug toxicity.

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Poisoning

Intolerance

Idiosyncrasy

In a broad sense, poisoning implies harmful effects of a chemical on a biological system It may result from large doses of drugs because ‘it is the dose which distinguishes a drug from a poison’. Poison is a ‘substance which endangers life by severely affecting one or more vital functions’. Not only drugs but other household and industrial chemicals, insecticides, etc. are frequently involved in poisonings. Specific antidotes such as receptor antagonists, chelating agents or specific antibodies are available for few poisons. General supportive and symptomatic treatment is all that can be done for others, and this is also important for poisons which have a selective antagonist.

It is the appearance of characteristic toxic effects of a drug in an individual at therapeutic doses. It is the converse of tolerance and indicates a low threshold of the individual to the action of a drug. These are individuals who fall on the extreme left side of the Gaussian frequency distribution curve for sensitivity to the drug.

It is genetically determined abnormal reactivity to a chemical. The drug interacts with some unique feature of the individual, not found in majority of subjects, and produces the uncharacteristic reaction. As such, the type of reaction is restricted to individuals with a particular genotype. In addition, certain bizarre drug effects due to peculiarities of an individual (for which no definite genotype has been described) are included among idiosyncratic reactions.

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For example, one tablet of chloroquine may cause vomiting and abdominal pain in an occasional patient.

For example Barbiturates cause excitement and mental confusion in some individuals.


Drug allergy

Photosensitivity

Drug dependence

It is an immunologically mediated reaction producing stereotype symptoms which are unrelated to the pharmacodynamic profile of the drug, generally occur even with much smaller doses and have a different time course of onset and duration. This is also called drug hypersensitivity; but does not refer to increased response which is called supersensitivity.

It is a cutaneous reaction resulting from drug induced sensitization of the skin to UV radiation. The reactions are of two types:

Drugs capable of altering mood and feelings are liable to repetitive use to derive euphoria, recreation, withdrawal from reality, social adjustment, etc. Drug dependence is a state in which use of drugs for personal satisfaction is accorded a higher priority than other basic needs, often in the face of known risks to health.

The target organs primarily affected in drug allergy are skin, airways, blood vessels, blood and gastrointestinal tract. Allergic reactions occur only in a small proportion of the population exposed to the drug and cannot be produced in other individuals at any dose.

Phototoxic: Drug or its metabolite accumulates in the skin, absorbs light and undergoes a photochemical reaction followed by a photobiological reaction resulting in local tissue damage (sunburn-like), i.e. erythema, edema, blistering which have fast onset and shorter duration after exposure ends. This is followed by hyperpigmentation and desquamation. The lesions may be more severe with larger doses of the drug. The shorter wave lengths (290–320 nm, UV-B) are responsible. Photoallergic: Drug or its metabolite induces a cell mediated immune response which on exposure to light of longer wave lengths (320–400 nm, UV-A) produces a papular or eczematous contact dermatitis like picture that may persist long after exposure.

Psychological dependence: It is said to have developed when the individual believes that optimal state of wellbeing is achieved only through the actions of the drug. The subject feels emotionally distressed if the drug is not taken. Reinforcement is the ability of the drug to produce effects that the user enjoys and which make him/her wish to take it again or to induce drug seeking behaviour. Physical dependence: It is an altered physiological state produced by repeated administration of a drug which necessitates the continued presence of the drug to maintain physiological equilibrium. Discontinuation of the drug results in a characteristic withdrawal (abstinence) syndrome.

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Drug abuse

Drug habituation

Drug addiction

Drug abuse: Refers to use of a drug by selfmedication in a manner and amount that deviates from the approved medical and social patterns in a given culture at a given time. The two major patterns of drug abuse are:

It denotes less intensive involvement with the drug, so that its withdrawal produces only mild discomfort.

It is a pattern of compulsive drug use characterized by overwhelming involvement with the use of a drug. Procuring the drug and using it takes precedence over other activities. Even after withdrawal most addicts tend to relapse.

Continuous use: The drug is taken regularly, the subject wishes to continuously remain under the influence of the drug, e.g. opioids, alcohol, sedatives. Occasional use: The drug is taken off and on to obtain pleasure or high, recreation (as in rave parties) or enhancement of sexual experience, e.g. cocaine, amphetamines, psychedelics, binge drinking (alcohol), cannabis, solvents (inhalation), etc.

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Consumption of tea, coffee, tobacco, social drinking are regarded habituating, physical dependence is absent.

Amphetamines, cocaine, cannabis, LSD are drugs which produce addiction but little/no physical dependence.


Drug withdrawal reactions

Teratogenicity

Mutagenicity & Carcinogenicity

Apart from drugs that are usually recognised as producing dependence, sudden interruption of therapy with certain other drugs also results in adverse consequences, mostly in the form of worsening of the clinical condition for which the drug was being used, e.g.:

It refers to the capacity of a drug to cause foetal abnormalities when administered to the pregnant mother. The placenta does not constitute a strict barrier, and any drug can cross it to a greater or lesser extent. The embryo is one of the most dynamic biological systems and in contrast to adults, drug effects are often irreversible.

It refers to capacity of a drug to cause genetic defects and cancer respectively. Usually oxidation of the drug results in the production of reactive intermediates which affect genes and may cause structural changes in the chromosomes. Covalent interaction with DNA can modify it to induce mutations, which may manifest as heritable defects in the next generation. If the modified DNA sequences code for factors that regulate cell proliferation/growth, i.e. are protooncogenes, or for proteins that inhibit transcription of protooncogenes, a tumour (cancer) may be produced.

(i) Acute adrenal insufficiency may be precipitated by abrupt cessation of corticosteroid therapy.

Drugs can affect the foetus at 3 stages :

(ii) Severe hypertension, restlessness and sympathetic overactivity may occur shortly after discontinuing clonidine.

(i) Fertilization and implantation—conception to 17 days—failure of pregnancy which often goes unnoticed.

(iii) Worsening of angina pectoris, precipitation of myocardial infarction may result from stoppage of blockers.

(ii) Organogenesis—18 to 55 days of gestation—most vulnerable period, deformities are produced.

(iv) Frequency of seizures may increase on sudden withdrawal of an antiepileptic.

(iii) Growth and development—56 days onwards — developmental and functional abnormalities can occur.

These manifestations are also due to adaptive changes and can be minimized by gradual withdrawal.

Even without interacting directly with DNA, certain chemicals can promote malignant change in genetically damaged cells, resulting in carcinogenesis. Page continued...

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Continued from Pg. 37

Drug induced diseases These are also called iatrogenic (physician induced) diseases, and are functional disturbances (disease) caused by drugs which persist even after the offending drug has been withdrawn and largely eliminated, For example, Hepatitis by isoniazid.

Drug regulations

Pharmacovigilance

To regulate the import, manufacture, distribution and sale of drugs, the Government of India has formulated the Drugs and Cosmetic Act. Drugs Controller General of India (DCGI) and Food and Drug Administration (FDA) govern this act.

Pharmacovigilance has been defined by the WHO (2002) as the ‘science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug related problems.’ The information generated by pharmacovigilance is useful in educating doctors about ADRs and in the official regulation of drug use. Its main purpose is to reduce the risk of drug-related harm to the patient. It has an important role in the rational use of medicines, as it provides the basis for assessing safety of medicines.

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ADR reporting

What to report?

Who can report?

Where to report?

-Report serious adverse drug reactions. A reaction is serious when the patient outcome is:

All healthcare professionals (Clinicians, Dentists, Pharmacists and Nurses) can report adverse drug reactions.

Duly filled Suspected Adverse Drug Reaction Reporting Form can be send to the nearest Adverse Drug Reaction Monitoring Centre (AMC) or directly to the National Coordination Centre (NCC).

-Death -Life-threatening -Hospitalization (initial or prolonged) -Disability (significant, persistent or permanent)

-Call on Helpline (Toll Free) 1800 180 3024 to report ADRs. -Or can directly mail this filled form to pvpi@ipcindia.net or pvpi.ipcindia@gmail.com

-Congenital anomaly -Required intervention to prevent permanent impairment or damage

-A list of nationwide AMCs is available at: http://www.ipc.gov.in, http://www.ipc.gov.in/PvPI/ pv_home.html

-Report non-serious, known or unknown, frequent or rare adverse drug reactions due to Medicines, Vaccines and Herbal products.

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What happens to the submitted information?

Mandatory field for suspected ADR reporting form

-Information provided in this form is handled in strict confidence. The causality assessment is carried out at AMCs by using WHO-UMC scale. The analyzed forms are forwarded to the NCC through ADR database.

-Patient initials,

Finally the data is analyzed and forwarded to the Global Pharmacovigilance Database managed by WHO Uppsala Monitoring Centre in Sweden.

-Date of onset of reaction,

-The reports are periodically reviewed by the NCC-PvPI. The information generated on the basis of these reports helps in continuous assessment of the benefit-risk ratio of medicines.

-Reporter information.

-The information is submitted to the Steering committee of PvPI constituted by the Ministry of Health & Family Welfare. The Committee is entrusted with the responsibility to review the data and suggest any interventions that may be required.

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-Age at onset of reaction, -Reaction term(s),

-Suspected medication(s) and

https://universalmedicaldata.com/sulfa-medical-alert-bracelets/


Some Drugs to be used with special care in the elderly

Risky drugs

Vulnerable patients

NSAID (Nonsteroidal anti-inflammatory drug)

Those that affect a vital process in the body, for example, warfarin, chlorpromazine and morphine.

Elderly patients recieving many drugs.

CNS depressants

Those that have a steep dose-response curve, for example, verapamil, levodopa and chlorpropamide.

Neuroleptics

Patients with liver/kidney damage.

Antihypertensives and other drugs causing postural hypertension

Those that have saturable kinetics, for example, phenytoin, theophylline and salicylates.

Diuretics

Those that demonstrate dose dependant toxicity, for example, digoxin, lithium, aminoglycosides and methotrexate.

Anticholinergics and drugs with cholinergic adverse effects Digoxin Drugs causing bone marrow depression Nephrotoxic drugs Gastric metabolism of alcohol is lower in women than in men, which is responsible for gender related differences in blood alcohol levels.

Those where a loss of effect leads to a breakthrough of disease, for example, quinidine, glucocorticoids and antiepileptics; and

Patients with unstable disease, for example, epileptics, brittle diabetics, demented patients and those with cardiac disease. Patients dependant upon drug treatment for survival, for example, transplant recipients and patients with Addison’s disease; and Patients who have more than one prescribing doctor.

Those where the patient depends on the prophylactic action, for example, oral contraceptives and cyclosporine.

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Hormonal contraceptives

Female contraceptives

These are hormonal preparations used for reversible suppression of fertility. Because of our alarming population trends, antifertility drugs are the need of the day. In developing countries particularly, the mortality rate has declined and birth rate has increased due to urbanization.

Over 100 million women worldwide are currently using hormonal contraceptives. With these drugs, fertility can be suppressed at will, for as long as desired, with almost 100% confidence and complete return of fertility on discontinuation. The efficacy, convenience, low cost and overall safety of oral contraceptives (OCs) has allowed women to decide whether and when they want tobecome pregnant and to plan their activities. A variety of oral and parenteral preparations are now available offering individual choices.

In the earlier part of 20th century, methods of contraception used (condoms, diaphragms, spermicidal creams, foam tablets, etc.) were intimately related to sexual intercourse, therefore, despised by most couples. These also have higher failure rate. Rock and Pincus (1955) announced the successful use of an oral progestin for contraception, separating fertility control from coitus.

https://www.mariestopes.org.za/the-different-types-of-female-contraceptives/

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Types of methods of female contraceptives Oral Combined Pill: It contains an estrogen and a progestin in fixed dose for all the days of a treatment cycle (monophasic). While both estrogens and progestins synergise to inhibit ovulation, the progestin ensures prompt bleeding at the end of a cycle and blocks the risk of developing endometrial carcinoma due to the estrogen. One tablet is taken daily for 21 days, starting on the 5th day of menstruation. The next course is started after a gap of 7 days in which bleeding occurs. Thus, a cycle of 28 days is maintained. Calendar packs of pills are available. This is the most popular and most efficacious method.

Phased Pill: Triphasic regimens have been introduced to permit reduction in total steroid dose without compromising efficacy by mimicking the normal hormonal pattern in a menstrual cycle. The estrogen dose is kept constant (or varied slightly between 30–40 µg), while the amount of progestin is low in the first phase and progressively higher in the second and third phases. Phasic pills are particularly recommended for women over 35 years of age and for those with no withdrawal bleeding or breakthrough bleeding while on monophasic pill, or when other risk factors are present.

Progestin-Only Pill (Minipill): It has been devised to eliminate the estrogen, because many of the long-term risks have been ascribed to this component. A low-dose progestin-only pill is an alternative for women in whom an estrogen is contraindicated. It is taken daily continuously without any gap. The menstrual cycle tends to become irregular and ovulation occurs in 20–30% women, but other mechanisms contribute to the contraceptive action. The efficacy is lower (96– 98%) compared to 98–99.9% with combined pill. Pregnancy should be suspected if amenorrhoea of more than 2 months occurs. This method is less popular. Page continued...

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Continued from Pg. 43

Injectable

Emergency (Postcoital) Pill: These are for use in a woman not taking any contraceptive who had a sexual intercourse risking unwanted pregnancy. The most commonly used and standard regimen is :

These have been developed to obviate the need for daily ingestion of pills. They are given i.m. as oily solution; are highly effective;over 50 million women have used them so far.

- Levonorgestrel 0.75 mg two doses 12 hours apart, or 1.5 mg single dose taken as soon as possible, but before 72 hours of unprotected intercourse.

Implants: These are drug delivery systems implanted under the skin, from which the steroid is released slowly over a period of 1–5 years. They consist of either:

- Ulipristal 30 mg single dose as soon as possible, but within 120 hours of intercourse. - Mifepristone 600 mg single dose taken within 72 hours of intercourse. Emergency postcoital contraception should be reserved for unexpected or accidental exposure (rape, condom rupture) only, because all emergency regimens have higher failure rate and side effects than regular low-dose combined pill.

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(a) Biodegradable polymeric matrices—do not need to be removed on expiry. (b) Non-biodegradable rubber membranes—have to be removed on expiry

Norplant: A set of 6 capsules each containing 36 mg levonorgestrel (total 216 mg) for subcutaneous implantation is available in some countries, but has been discontinued in the USA. Works for up to 5 years. A progesterone impregnated intrauterine insert PROGESTASERT has been introduced in some countries. It contains 52 mg of levonorgestrel which primarily acts locally on endometrium. The device remians effective for 5 years, but efficacy is rated lower.


Adverse Effects Since contraceptives are used in otherwise healthy and young women, adverse effects, especially long-term consequences assume great significance. The adverse effects are dose dependent; most of the past data with high-dose preparations cannot be directly extrapolated to the present-day lowdose preparations which carry relatively minor risk. Nonserious side effects: These are frequent, especially in the first 1–3 cycles, and then disappear gradually. 1. Nausea and vomiting: similar to morning sickness of pregnancy. 2. Headache is generally mild; migraine may be precipitated or worsened. 3. Breakthrough bleeding or spotting: especially with progestin only preparations. Rarely bleeding fails to occur during the gap period. Prolonged amenorrhoea or cycle disruption occurs in few women taking injectables or minipill.

Side effects that appear later :

Serious complications:

1. Weight gain, acne and increased body hair may be noted due to androgenic action of older 19-nortestosterone progestins. The newer ones like desogestrel are relatively free of this effect.

1. Leg vein thrombosis and pulmonary embolism

2. Chloasma: pigmentation of cheeks, nose and forehead, similar to that occurring in pregnancy.

3. Rise in BP

3. Pruritus vulvae is infrequent. 4. Carbohydrate intolerance and precipitation of diabetes in few subjects taking high dose preparations; but this is unlikely with the present pills. Many large studies have found no link between OC use and development of diabetes. 5. Mood swings, abdominal distention are occasional; especially reported with progesterone only contraceptives.

2. Coronary and cerebral thrombosis resulting in myocardial infarction or stroke.

4. Estrogen tends to raise plasma HDL/LDL ratio (beneficial), but the progestin nullifies this benefit. 5. Genital carcinoma: an increased incidence of vaginal, cervical, and breast cancers was feared on the basis of animal data. 6. Benign hepatomas: which may rupture or turn malignant. 7. Gallstones: Estrogens increase biliary cholesterol excretion.

4. Breast discomfort.

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Relative contraindications

Interactions with contraceptives

(requiring avoidance/ cautious use under supervision)

Failure may occur if the following drugs are used concurrently:

1. Diabetes: control may be vitiated.

(a) Enzyme inducers: phenytoin, phenobarbitone, primidone, carbamazepine, rifampin, ritonavir. Metabolism of estrogenic as well as progestational component is increased.

2. Obesity 3. Smoking 4. Undiagnosed vaginal bleeding 5. Uterine leiomyoma: may enlarge with estrogenic preparations; progestin only pills can be used. 6. Mentally ill 7. Age above 35 years 8. Mild hypertension 9. Migraine 10. Gallbladder disease

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(b) Suppression of intestinal microflora: tetracyclines, ampicillin, etc. Deconjugation of estrogens excreted in bile fails to occur → their enterohepatic circulation is interrupted → blood levels fall.

Hailshadow/Getty Images (https://www.verywellhealth.com/medications-that-cancause-interactions-with-the-pill-906876)


Male contraceptives

The only way to suppress male fertility by drugs is to inhibit spermatogenesis. Though considerable effort has been made in this direction and effective drugs have been found, no satisfactory/ acceptable solution is yet tangible.

3. Gonadotropin suppression inhibits testosterone secretion as well, resulting in loss of libido and impotence: unacceptable to all me and to most spouses. 4. Risk of adverse effects.

Reasons are : 1. Complete suppression of spermatogenesis is relatively difficult without affecting other tissues: millions of spermatozoa are released at each ejaculation vs a single ovum per month in women.

5. Most importantly—men don’t get pregnant: few would be ready to bear the contingency of regular medication so that their sexual partners do not become pregnant.

2. Spermatogenesis takes 64 days. A drug which even completely inhibited spermatogenesis will take a long latent period to produce infertility. Accordingly, return of fertility will be slow. https://www.statnews.com/2018/05/11/contraceptives-for-men-pharma/

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RESEARCH

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Mindmap

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Web as a source of drug information

Self medication

The internet is also a source of drug information, available to most health professionals as well as consumers. However, it is important to screen authentic information on the various websites. Many health and medical websites post information collected from other websites or sources. If the person or organsisation in charge of the site did not write the material, the original source should be clearly identified. Be careful of the sites that don’t say where the information comes from.

Self-medication has traditionally been defined as “the taking of drugs, herbs or home remedies on one’s own initiative, or on the advice of another person, without consulting a doctor.” Families, friends, neighbors, the pharmacist, previous prescribed drug, or suggestions from an advertisement in newspapers or popular magazines are common sources of self-medications. Now-a-days, self-medication should be seen as the “desire and ability of people/patients to play an intelligent, independent and informed role, not merely in terms of decision-making but also in the management of those preventive, diagnostic and therapeutic activities which concern them.” Some governments are increasingly encouraging self-care of minor illnesses, including self-medication. Although responsible self-medication help to reduce the cost of treatment, travelling time as well as doctor’s time i.e., consultation time.

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Major problems related to self-medication are wastage of resources, increased resistance of pathogens and causes serious health hazards such as adverse reaction and prolonged suffering. Antimicrobial resistance is a current problem world-wide particularly in developing countries where antibiotics are available without any prescription. Hence, the government should take necessary steps to regulate responsible self-medication. This can be done by making availability of safe drugs along with proper instructions about its use and if in need consulting a physician. In India, it is very common to see self-medication practice and which is emerging challenge to health care providers.


Potential benefits

Potential risks

Individual level - An active role in his or her own health care Self-reliance in preventing or relieving minor symptoms or conditions - Education opportunities on specific health issues (i.e. stop smoking aids and products to treat heartburn) - Convenience - Economy, particularly since medical consultations will be reduced or avoided.[26]

- Incorrect self-diagnosis - Failure to seek appropriate medical advice promptly - Incorrect choice of therapy - Failure to recognize special pharmacological risks - Rare but severe adverse effects - Failure to recognize or self-diagnosis contraindications, interactions, warnings and precautions - Failure to recognize that the same active substance is already being taken under a different name - Failure to report current self-medication to the prescribing physician (double medication/ harmful interaction) Failure to recognize or report adverse drug reactions - Incorrect route of administration - Inadequate or excessive dosage - Excessively prolonged use - Risk of dependence and abuse - Food and drug interaction - Storage in incorrect conditions or beyond the recommended shelf life.

At community level Good self-medication can also provide benefits such as: - Saving scarce medical resources from being wasted on minor conditions - Lowering the costs of community funded health care programs - Reducing absenteeism from work due to minor symptoms - Reduce the pressure on medical services where health care personnel are insufficient - Increase the availability of health care to populations living in rural or remote areas.

http://www.newindianexpress.com/cities/bengaluru/2018/jul/25/self-medicationcan-do-more-harm-than-good-1848578.html

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Existing NGOs,Organisations, initiated programes in this area CDSCO

IPC

PvPi

The Central Drugs Standard Control Organization (CDSCO) is the national regulatory body for Indian pharmaceuticals and medical devices, and serves parallel function to the European Medicines Agency of the European Union, the PMDA of Japan, the Food and Drug Administration of the United States and the Medicines and Healthcare products Regulatory Agency of the United Kingdom.

Indian Pharmacopoeia Commission (IPC) is an autonomous institution of the Ministry of Health and Family Welfare which sets standards for all drugs that are manufactured, sold and consumed in India.

Indian Pharmacopoeia Commission (IPC) is an autonomous institution of the Ministry of Health and Family Welfare which sets standards for all drugs that are manufactured, sold and consumed in India. The set of standards are published under the title Indian Pharmacopoeia (IP) which has been modelled over and historically follows from the British Pharmacopoeia. The standards that are in effect since December 1, 2010, is the Indian Pharmacopoeia 2010 (IP 2010). The Pharmacopoeia 2014 was released by Health Minister Ghulam Nabi Azad on November 4, 2013 .

Within the CDSCO, the Drug Controller General of India (DCGI) regulates pharmaceutical and medical devices, under the gamut of Ministry of Health and Family Welfare. The DCGI is advised by the Drug Technical Advisory Board (DTAB) and the Drug Consultative Committee (DCC). It is divided into zonal offices which do pre-licensing and postlicensing inspections, post-market surveillance, and recalls when needed. Though the CDSCO has a good track record with the World Health Organization,it has also been accused of past collusion with independent medical experts and pharmaceutical companies.

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The set of standards are published under the title Indian Pharmacopoeia (IP) which has been modelled over and historically follows from the British Pharmacopoeia. Its headquater is in Ghaziabad U.P., India.


WHO

NHM

The World Health Organization (WHO) is a specialized agency of the United Nations that is concerned with international public health. It was established on 7 April 1948, and is headquartered in Geneva, Switzerland. The WHO is a member of the United Nations Development Group. Its predecessor, the Health Organisation, was an agency of the League of Nations.

The National Health Mission (NHM) was launched by the government of India in 2013 subsuming the National Rural Health Mission and National Urban Health Mission. It was further extended in March 2018, to continue until March 2020.

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Visits

WHO and NHM As suggested by family doctors and my medical friends and the internet, World Health Organisation was located in Civil hospital, Gandhinagar, Gujarat. After my visit their, the officials told me that WHO is been closed and I could go to NHM (National Health Mission) for further research. Though NHM also did not turn out to be very helpful as I visited NHM four times and everytime the director was busy or was not their in the office.

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CDSCO The Gujarat headquater of Central Drug Standards Control Orgnisation is located in Old terminal building, Air cargo complex, Airport. When I tried to visit to the place, the way to the building required authoritive allowance as it was near the runway of sardar vallabhbhai Patel International Airport. I also tried to go through the Army Cantonament road but again I was refused to go in.

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Sardar Vallabhbhai Patel De-addiction cum Rehabilitation Centre Interview with Mr. Praful Chandulal- Project director Q. What message do you convey? A. We make people aware of our primary subject that addiction is a disease. Secondly, damage due to addiction, which may be physical, financial or social. Family support in rehab is very important, so family members have to be made equally aware. Q. Does the patient himself/herself doesn’t realize that he/she is drug addicted? A. The family members may not realize but the patients know for sure as they themselves know the extent of the drugs they take daily. That is why, when we make such awareness camps, we leave our means of communication, such as literature, leaflets, periodicals, with them. Q. What are the other forms of awareness you promote your program through? A. We organize skits with the help of Gujarat Vidyapeeth students. There’s a course called Master of Social Welfare, where the students are taught about various social issues that exist in the society. Students from 1st Semester visit these villages to make people aware of these topics through different activities. In the second year,

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these students conduct a survey in accordance with the problems that exists within the village. The 3rd year is finished off with a performance on regarding topics.

these are addicted to cheap wine. Recently, new drugs such as brown sugar are emerging in Ahmedabad and Surat.

Q. What are some most commonmedicines used by the addicts which are easily available through pharmacists? A. There are many such medicines which are easily available in the market some of them are Alprazolam, Benadryl, MD, Anloc, Diazapam which is now banned, Scitalopram, Imipramine, Spasmo, Phansidin, Corex, Forex, Valium 10 ( now banned), Fortvin (injection), Declofenac.

Q. Do you know cases where the patient has abused a medicine which was available previously but has been banned now? A. There are cases where people have abused sleeping tablets. These pills have been banned now and can be accessible only to doctors and that too on prior order. There are medicines which minimize the effect of opium withdrawals. These medicines also have a history of abuse. That is why, nowadays, doctors and deaddiction centers like ours need to have a license to order such medicines.

Q. How educated are these patients? Is your target audience limited to villages only? A. We target cities, villages and institutes in those places as well. Patients come here from Maharashtra, UP and Bihar as well. But, most of our patients come from Rajasthan.

Q. Who are the other authoritative members you work with? A. We have a circle of a medical officer and a psychiatrist also, under which we help these patients.

Q. What is the financial background of these patients? A. Most of the addicts are labourers. Maximum of

Q. How do you attract these addicts to your program? A. We don’t go out and compel these addicts to come for our program. Instead, we just make them


aware that such a program, like ours, exists and if anyone wants to get cured willingly, can join. Q. Do you support patients which are extreme cases only? A. Whoever comes here, come only when they hit rock bottom. They suffice even if they are not socially acceptable and even if all hope is lost. Addicts arrive to such programs only if the drugs have started affecting his/her body physically. Q. How many patients can you accommodate? A. We have 15 beds which remain full almost thoughout the year. But, the ratio of patients vary to more than 15 a month for our 25 day program. Q. Do the patients get cured completely in this program? A. Physical detox happens within 15-20 days. After the end of the program, patients become physically competent and also gain weight. They realize that it is possible to live without the drug. They start exercising and start taking steps towards a healthier lifestyle. *Mr. Praful refused to get a picture of him clicked.

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Venus Pharmacy This visit turned to be a very helpful research on the use of the most common medicines in the market. Manish Manghtani, the owner of this shop did not only tried to make me aware about the medicines but he also allowed me to click pictures of all medicines which are sold on daily basis.

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Survey

Writing down the questions Before starting with project it was necessary to take a survey to know whether the problem really exists or not. To make the the questionnaire simple and easy I tried to minimise the questions so that it becomes easy for the person who is answering in a reasonable period of time and at the same time providing me with the necessary information needed.

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Commonly used/ prescribed drugs

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Commonly used non-prescriptive medicines

Final medicines Benadryl I-pill Alprax Calpol Combiflam Okacet Meftal Lopamide O2 Nise Vigora Wikoryl Disprin Intagesic-MR Isotroin Crocin Vicks

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Disprin

Uses Disprin Tablet is used for pain relief and fever. It relieves pain and inflammation in conditions like headache, joint pain, muscle pain and toothache.

Side Effects Gastrointestinal irritation Nausea Vomiting Dyspepsia Gastritis Bleeding disorder Low blood platelets Gastric erosion Gastric ulcer

Warnings Alcohol: It is unsafe to consume alcohol with Disprin Tablet. Taking Disprin Tablet with alcohol increases the associated risk of stomach bleeding.

Drug Interactions Pregnancy: Disprin Tablet is unsafe to use during pregnancy. There is positive evidence of human fetal risk, but the benefits from use in pregnant women may be acceptable despite the risk, for example in life-threatening situations. Please consult your doctor. Lactation: Disprin Tablet is probably unsafe to use during lactation. Limited human data suggest that the drug could represent a significant risk to the baby. Driving: Disprin Tablet may make you feel dizzy, drowsy or affect your vision. Do not drive until your vision is clear. Kidney: Disprin Tablet should be used with caution in patients with kidney disease. Dose adjustment of Disprin Tablet may be needed. Please consult your doctor. Use of Disprin Tablet is not recommended in patients with severe kidney disease. Liver: Disprin Tablet should be used with caution in patients with liver disease. Disprin Tablet is not recommended in patients with severe liver disease.

Taking Disprin with any of the following medicines can modify the effect of either of them and cause some undesirable side effects Nimesulide Brand(s): Nimsun, Abinim, Nimulis (LIFE-THREATENING) Deflazacort Brand(s): Defmark, Zacdef, Ecodef (SERIOUS) Methotrexate Brand(s): Methosis (SERIOUS) Budesonide Brand(s): Budojet (SERIOUS) Prednisolone Brand(s): Ranisol, Vepred, Catapred (SERIOUS) Methylprednisolone Brand(s): Zencort-M, Welone (SERIOUS) Losartan Brand(s): Losin, Tosar (MODERATE)

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Benadryl

Uses Benadryl Syrup is used in the treatment of cough.

Side Effects Stomach pain / epigastric pain Dizziness Sleepiness Coordination impaired Thickened respiratory tract secretions Allergic reaction

Warnings Alcohol: Benadryl Syrup may cause excessive drowsiness with alcohol. Pregnancy: Benadryl Syrup is highly unsafe to use during pregnancy. Human and animal studies have shown significant adverse effects on the foetus.

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Alternate Brands Lactation: No information is available on the use of Benadryl Syrup during lactation. Please consult your doctor. Driving: Benadryl Syrup may make you feel dizzy, sleepy, tired, or decrease alertness. If this happens, do not drive. Kidney: Benadryl Syrup is probably unsafe to use in patients with kidney disease and should be avoided. Please consult your doctor. Liver: There is limited information available on the use of Benadryl Syrup in patients with liver disease. Please consult your doctor.

COF-RYL Cough Syrup Cipla Ltd Tussberry-N Syrup Acinta Pharmaceuticals Pvt Ltd Cofsils Cough Syrup Cipla Ltd


Meftal- SPAS

Uses

Warnings

Meftal-Spas Tablet is used in the treatment of menstrual pain and colicky pain. It relieves colicky pain associated with intestinal, biliary, and ureteric colic.

Alcohol: It is unsafe to consume alcohol with Meftal-Spas Tablet. Taking Mefenamic acid with alcohol increases the risk of stomach bleeding.

Side Effects Nausea Vomiting Diarrhea Indigestion Dryness in mouth Loss of appetite Sleepiness/Weakness Nervousness Blurred vision Heartburn

Pregnancy: Meftal-Spas Tablet may be unsafe to use during pregnancy. Animal studies have shown adverse effects on the foetus, however, there are limited human studies. The benefits from use in pregnant women may be acceptable despite the risk. Please consult your doctor. Lactation: Meftal-Spas Tablet is probably unsafe to use during lactation. Limited human data suggest that the drug could represent a significant risk to he baby.

Liver: Meftal-Spas Tablet should be used with caution in patients with liver disease. Dose adjustment of Meftal-Spas Tablet may be needed. Please consult your doctor.

Alternate Brands Dysmen Tablet Maneesh Pharmaceuticals Ltd Colimex MF Tablet Wallace Pharmaceuticals Pvt Ltd Mefkind-Spas Tablet Mankind Pharma Ltd

Driving:Meftal-Spas Tablet may make you feel dizzy, drowsy or affect your vision. Do not drive until your vision is clear. Kidney: Meftal-Spas Tablet should be used with caution in patients with kidney disease. Dose adjustment of Meftal-Spas Tablet may be needed. Please consult your doctor. Use of Meftal-Spas Tablet is not recommended in patients with severe kidney disease.

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Isotroin

Uses

Warnings

Isotroin 20 Capsule is used in the treatment of acne.

Exposure to sun: Use of this medicine can cause adverse reactions of the skin on sun exposure. You should either avoid stepping out at daytime or take appropriate precautionary measures.

Side Effects Bone and joint pain Bleeding from nose Scaling, burning, redness, and swelling of skin Nausea and Vomiting Stomach pain Diarrhea Pain and tenderness of eyes Itchy and dry skin Heart burn Rectal bleeding Difficult or painful urination Increased thirst Increased heartbeat Ringing or buzzing in the ears

Other skin creams: This medicine may interact with other skin care or medicinal products. Consult your doctor before starting the use of other products along with this medicine. Contraception: Appropriate means of birth control should be adopted while using this medicine. It can cause oral/hormonal contraception failure and hence use of multiple contraception is advised. Contact your doctor immediately if you suspect a pregnancy while using this medicine. Depression: Use of this medicine has been known to cause varying levels of depression in different people. Report any current/past incidences of depression, agitation, anxiety, or other psychotic disorders to the doctor.

Disturbance in vision: Use of this medicine may cause disturbances in vision. Report any incidence of disturbance in the vision to the doctor. Hyperlipidemia:Use of this medicine has been associated with an increased level of lipids and triglycerides in the body and hence should be used with caution in patients suffering from hypercholesterolemia and other associated diseases.

Alternate Brands Acnex 20 MG Capsule Unichem Laboratories Ltd. Acutret 20 MG Capsule Ipca Laboratories Pvt. Ltd. D Acne I 20 MG Capsule Glenmark Pharmaceuticals Ltd. Tufacne 20 MG Capsule Abbott Healthcare Pvt. Ltd.

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Okacet

Drug Interactions

Uses Allergies such as runny nose, watery eyes, sneezing, skin itching and hives can be effectively treated with this medicine.

Side Effects Headache Sleepiness Unusual tiredness and weakness Dry mouth Nausea or Vomiting

Warnings Pregnancy: This medicine is not recommended for use in pregnant women unless necessary. Pregnancy: This medicine is not recommended for use in pregnant women unless necessary. All the risks and benefits should be discussed with the doctor before taking this medicine.

Breast-feeding: This medicine is not recommended for use in breastfeeding women unless necessary. All the risks and benefits should be discussed with the doctor before taking this medicine. If the medicine is used, the infant should be monitored closely for any undesired side effects. CNS Depression: This medicine may cause mild to moderate CNS depression, resulting in sleepiness, difficulty in concentrating, etc. It is advised that you do not perform any activities that require high mental alertness such as driving a vehicle or operating machinery if you experience any of these side effects during treatment with this medicine. Alcohol use: This medicine is not recommended for use in patients who consume alcohol on a regular basis due to the increased risk of serious adverse effects. Elderly: This medicine should be administered with caution in the elderly population due to the increased risk of severe adverse effects.

Alprazolam (SERIOUS) Codeine (SERIOUS) Isocarboxazid (SERIOUS)

Alternate Brands Avil Nu 10 MG Tablet Sanofi India Ltd. Cetirizine 10 MG Tablet Wockhardt Ltd. Cetlergy 10 MG Tablet Zuventus Healthcare Ltd. Day One 10 MG Tablet Abbott Healthcare Pvt. Ltd. Setride 10 MG Tablet Wockhardt Ltd.

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O2

Uses

Warnings

Drug Interactions

O2 TABLET is a combination medicine used for the treatment of diarrhea of mixed infection in adults patients only.

Tendinitis and Tendon ruputure: Use of this medicine will increase the risk of developing tendinitis or tendon rupture during the treatment or several months after the treatment. This may affect your shoulders, hands, ankles, or other parts of your body. Drug-resistance:Usage of this medicine without sufficient proof or suspicion of a bacterial infection should be avoided. Irrational dosing might fail in providing benefits and may even cause toxicity. It may also increase the risk of development of bacteria that are drug resistant. Photosensitivity: This medicine may make you more sensitive to sunlight or tanning lights. You are advised to use sunscreen and wear protective clothing to avoid adverse reactions to sunlight during treatment with this medicine. Liver impairment: This medicine should be used with caution in patients with liver diseases. Multiple sclerosis:This medicine should be used with extreme caution in patients suffering from this neurodegenerative disorder of the brain. Drowsiness: This medicine may cause dizziness, drowsiness, or sleepiness and interfere with eyesight.

Escitalopram (SEVERE) Vecuronium (MODERATE) Warfarin (SEVERE) Ethinyl Estradiol (MODERATE) Corticosteroids (SEVERE) Quinidine (SEVERE) Aspirin (MODERATE) Antidiabetic drugs (MODERATE)

Side Effects Abdominal pain Anxiety Black or tarry stools Confusion Fever Painful urination Decreased appetite Joint pain Change in taste Excessive air or gas in stomach Runny Nose Nausea and Vomiting Sleeplessness Dizziness Change in pulse rate Difficulty in breathing Shaking of the hands or feet Skin rash and itching Red spots on skin

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Alternate Brands FRIMIXON TABLET Novartis India Ltd. NORMET TABLET Zuventus Healthcare Ltd. ONOFF OZ (RANBAXY) TABLET Sun Pharma Laboratories Ltd. ORNI O TABLET Zydus Cadila


Lopamide

Drug Interactions

Uses It is used to relieve the symptoms of diarrhea that starts suddenly and lasts for a few days. It is also used to treat long-term diarrhea associated with other diseases.

Side Effects Bloating Constipation Loss of appetite Severe stomach ache Paralytic ileus Allergic skin reaction Dizziness Dry mouth

Warnings Tendinitis and Tendon ruputure: Use of this medicine will increase the risk of developing tendinitis or tendon rupture during the treatment or several months after the treatment. This may affect your shoulders, hands, ankles, or other parts of your body.

Tendinitis and Tendon ruputure: Use of this medicine will increase the risk of developing tendinitis or tendon rupture during the treatment or several months after the treatment. This may affect your shoulders, hands, ankles, or other parts of your body. Drug-resistance:Usage of this medicine without sufficient proof or suspicion of a bacterial infection should be avoided. Irrational dosing might fail in providing benefits and may even cause toxicity. It may also increase the risk of development of bacteria that are drug resistant. Photosensitivity: This medicine may make you more sensitive to sunlight or tanning lights. You are advised to use sunscreen and wear protective clothing to avoid adverse reactions to sunlight during treatment with this medicine. Liver impairment: This medicine should be used with caution in patients with liver diseases. Multiple sclerosis:This medicine should be used with extreme caution in patients suffering from this neurodegenerative disorder of the brain. Drowsiness: This medicine may cause dizziness, drowsiness, or sleepiness and interfere with eyesight.

Escitalopram (SEVERE) Vecuronium (MODERATE) Warfarin (SEVERE) Ethinyl Estradiol (MODERATE) Corticosteroids (SEVERE) Quinidine (SEVERE) Aspirin (MODERATE) Antidiabetic drugs (MODERATE)

Alternate Brands FRIMIXON TABLET Novartis India Ltd. NORMET TABLET Zuventus Healthcare Ltd. ONOFF OZ (RANBAXY) TABLET Sun Pharma Laboratories Ltd. ORNI O TABLET Zydus Cadila

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Nise

Uses Nise Tablet is used for pain relief and fever.

Side Effects

Kidney: Nise Tablet should be used with caution in patients with kidney disease. Use of Nise Tablet is not recommended in patients with severe kidney disease.

Vomiting Nausea Diarrhea

Liver: Nise Tablet is probably unsafe to use in patients with liver disease and should be avoided. Please consult your doctor.

Warnings

Drug Interactions

Alcohol: Interaction with alcohol is unknown. Please consult your doctor.

Taking Nise with any of the following medicines can modify the effect: Ketorolac Brand(s): Ketin (LIFE-THREATENING)

Pregnancy:Nise Tablet is unsafe to use during pregnancy. There is positive evidence of human fetal risk, but the benefits from use in pregnant women may be acceptable despite the risk, for example in life-threatening situations. Please consult your doctor. Alcohol: Interaction with alcohol is unknown. Please consult your doctor.

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Paracetamol/Acetaminophen Brand(s): Vandol, Amidol, Tempsol (LIFE-THREATENING) Ibuprofen Brand(s): Brufen (LIFE-THREATENING)

Aceclofenac Brand(s): Acifon, Reclofen, Aceclocare (LIFE-THREATENING) Diclofenac Brand(s): Vindec, Orogesic AQ, Diclam (LIFE-THREATENING)

Alternate Brands Nimulid Tablet, Panacea Biotec Ltd Nicip Tablet, Cipla Ltd Nobel Tablet, Mankind Pharma Ltd


Vigora

Drug Interactions

Uses Vigora 100 Red Tablet is used in the treatment of erectile dysfunction.

Side Effects Runny nose Flushing (sense of warmth in the face, ears, neck and trunk) Headache Dizziness Back pain Blurred vision Nausea Muscle pain Stomach upset Vision changes Rash

Warnings Hypotension (low blood pressure levels) Consumption of this medicine can cause a mild and short-lasting decrease in blood pressure levels.

Deformation of penis: This medicine should be used with caution in patients having a physical deformity of the penis which may be due to angulation, cavernosal fibrosis. Priapism:This medicine may cause Priapism, a painful erection lasting for more than 4 hours. Patients suffering from sickle cell anemia, multiple myeloma, leukemia, physical deformation of the penis, etc. are at higher risk of priapism. Priapism may result in penile tissue damage as well as permanent loss of sexual potency. Loss of hearing: This medicine may cause a sudden decrease in hearing capabilities along with a buzzing or a ringing sound in the ears. Loss of vision: This medicine may cause a sudden loss of vision in one or both the eyes. It may also cause impairment in color differentiation capacity. Heart diseases: This medicine should be used with extreme caution if you have a disease of the heart and blood vessels.

Amlodipine (MODERATE) Carbamazepine (MODERATE) Clarithromycin (SEVERE) Dexamethasone (MODERATE) Imatinib Mesylate (SEVERE) Ketoconazole (SEVERE) Atazanavir (SEVERE) Nitroglycerin (SEVERE) Isoniazid (MODERATE) Terazosin (MODERATE) ACE inhibitors (MODERATE) Atenolol (MODERATE) Tamsulosin (MODERATE) Warfarin (MODERATE)

Alternate Brands Kamagra 50 MG Tablet, Ajanta Pharma Ltd. Penegra 50 MG Tablet, Zydus Cadila Vega 50 MG Tablet, Mankind Pharmaceuticals Ltd. Viraha 50 MG Tablet, Micro Labs Ltd. Zenegra 50 MG Tablet,Alkem Laboratories Ltd.

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Alprax

Uses

Warnings

Drug Interactions

Alprax 0.5 MG Tablet SR is used to treat panic disorders , anxiety, extreme fear and tension due to stress.

Alcohol: Alprax is unsafe to be used with alcohol.

Do not consume with: Cetirizine Metoclopramide Opioids Azole antifungal agents Antihypertensives Disease interactions

Side Effects Changes in pattern of speech Unsteadiness Loss of coordination Drowsiness Blurred vision Abdominal pain Difficult or painful urination Headache Chest pain Sleeplessness Irregular menstrual periods Decreased appetite Weight loss Double vision Sudden sweating

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Pregnancy:There is positive evidence of human fetal risk. . Breast-feeding: This medicine is known to be excreted into human breast milk and may cause undesired effects in the breastfed infants. Drug dependence: Alprax 0.5 MG Tablet SR has the tendency to cause dependency and abuse, particularly after a prolonged use or excessive dosages. Interdose symptoms: The symptoms of early morning anxiety have been reported in patients. Suicidal tendency: Use of benzodiazepines in depression conditions may increase the risk of suicide. Therefore, this medicine should be used with caution in patients with depression. Impaired kidney and liver function: This medicine should be used with caution in individuals with impaired kidney function and liver function.

Alternate Brands Alzolam 0.5 MG Tablet SR Sun Pharma Laboratories Ltd. Anzilum 0.5 MG Tablet SR Cadila Pharmaceuticals Ltd. Restyl 0.5 MG Tablet SR Cipla Ltd. Trika 0.5 MG Tablet SR Unichem Laboratories Ltd. Restyl SR-0.5 Tablet Cipla Ltd.


I-pill

Uses

Warnings

Drug Interactions

Ipill 1.5 MG Tablet belongs to the category of progestins. It is used as an emergency contraceptive. This medicine helps in preventing pregnancy if taken within 72 hours of an unprotected intercourse.

Effect on menstrual cycle: Use of this medicine can impact the onset and duration of the menstrual period after use. It may also make the bleeding light or heavy. Any unusual effect of this medicine that lasts for more than 5 days should be reported to the doctor. Sexually transmitted disease: This medicine will not provide any protection against diseases that transmits via sexual contact. Weight gain: Use of this medicine can cause moderate to significant weight gain and hence should be used with caution if you are obese or are suffering from obesity related disorders. Infections Use of this medicine, especially for a prolonged duration, may increase the chances of infection. Liver/Kidney impairment: This medicine should be used with caution in patients having an impaired liver/kidney function. The use of this medicine should be discontinued if symptoms like jaundice, edema occur. Cancer: Use of this medicine may increase the chances of cancer of the breast and the ovaries.

Carbamazepine Griseofulvin Phenytoin Tranexamic Acid Bosentan Amprenavir

Side Effects Difficulty in breathing Swelling of face, lips, eyelids, tongue and hands Severe abdominal pain Heavy menstrual bleeding Spotting or bleeding between periods Nausea and Vomiting Unusual tiredness and weakness Dizziness Breast pain and tenderness Change in libido Diarrhea Blood clot formation Stroke

Alternate Brands My Pal 1.5 MG Tablet Pfizer Ltd. Niel-72 1.5 MG Tablet Lupin Ltd. Sirf Ek 1.5 MG Tablet Cipla Ltd. GESTAREST 72 TABLET Macleods Pharmaceuticals Pvt. Ltd. OC 21 TABLET Ranbaxy Laboratories Ltd.

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CONCEPTS

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Step 1: Finding the main areas of problem under this topic.

Step 2: Deciding the target audience.

-Prescription writing (knowing your prescrption) -Know your doctor. -Self medication -Use of old medicines -Use of old prescriptions -Peer reference -Antibiotics misuse -Poor knowledge of medicines -Lack of awareness of danger -More than one prescribing doctors. -Dependent upon drug treatment. -Pharmacist is the medicine prescriber.

Age group 1: 1 year -15 years old children Age group 2: 18 years - 30 years old young adults Age group 3: Above 60 years old senior adults

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Step 3 : Deciding how to solve the problems in different age groups. Campaign 1

Campaign 2

Campaign 3

This campaign will mostly target on the parents of the children, mostly those parents who have more than one child.

This campaign will mostly target on elder teenagers, hostelites, young adults who are away from from their homes and are earning.

(Age group 1: Parents of 1 year -15 years old children)

(Age group 2: 18 years - 30 years old young adults)

This campaign will mostly target on elderly people who suffering from instable diseases and are facing symtoms on daily basis and are consuming old precribed medicines or are used to the medicines they are intaking since forever, mostly vulnerable patients.

Possible deliverables might include: - Series of posters - Guideline book The deliverables can be distributed at following places: -Pediatrician clinics.

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Possible deliverables might include: - Series of posters on different commonly used medicines which are bought more often.

(Age group 3: Above 60 years old senior adults)

The deliverables can be distributed at following places: -Physician clinics -Through pharmacists -In college campuses -In hospitals -Pharmaceutical shops

Possible deliverables might include: - Series of posters - Guideline book - Newspaper Ads -Roads mostly covered by elder people to do morning walks. -Parks -Physician cilinics. -Pharmaceutical shops


Final design brief Campaign 2 Why Campaign 2?

How to solve the problem?

Deliverables

The final campaign choosen was of the age group of 18 year old to 30 year old adults as this age group is the most abused age group and if they are made aware of the intake of drugs they can stop themselves for carrying it further.

As the research suggests comonly used medicines and its uses, side effects, warnings, drug interactions with other medicines, this project can help the patient to know the basic information he/she should know before consuming a particular medicines with its alternate names.

Listing down common medicines and making a series of infographics by provinding important information about the syrups, tablets and capsules which then can be put up in hospitals, pharmacies and campuses. This later can be converted into a social media campaign after uploading them online with a campaign #knowyourmeds.

Also most often this age group is not earning and are in their graduate or post graduate year where they tend to save money and skip the step of going to the doctor. They tend to follow old prescriptions or prescription of their friends.

This project might have one or two multilingual experiments which might be in Gujarati and Hindi also as the research is done on the basis of Ahmedabad area the commonly used languages in this region are English, Hindi and majorly Gujarati.

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EXECUTION

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ILLUSTRATIONS Trying mediums

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Vicks

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Alprax

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Benadryl

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Combiflam

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Disprin

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i-pill

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Isotroin

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Lopamide

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Meftal-SPAS

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Calpol

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Intagesic-MR

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Nise

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O2

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Wikoryl

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Crocin

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Okacet

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Vigora

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Iconography

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Gastrointestinal irritation

Gastric Erosion

Stomach ache

Nausea or Vomiting

Gastric Ulcer

Nose bleeding

Constipation

Deafness

Skin allergy/ Allergic reactions

Stomach burn

Indigestion

Increased heart rate

Bleeding

Painful urination

Dizziness/Drowsiness

Low blood platelets

Runny nose

Loss of vision


Decreased urine output

During pregnancy

Epilepsy

Abdominal discomfort

Unsafe to drive

Dry mouth

Heart burn

Unsafe with liver diseases

Unsafe with Aspirin

Headache

Unsafe with alcohol

Unsafe for Asthamatic patients

Loss of Appetite

Unsafe during Lactation

Joint pain

Diarrhoea

Unsafe with Kidney diseases

Numbness

Ureteric colic

Unsafe with heart disease

Gastrointestinal bleeding

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Vision disturbances

Increase in weight

Blood donating

Hypercholesterelomia

Bacterial Infections

Spotting

Osteoporosis

Breast cancer

Decrease in blood pressure

Brain pressure

Depression

Painful erection

Sun exposure

Unsafe with diabetic patients

Glaucoma

Contraceptive pills

Grape fruit

Fatigue

Tinnitus

AIDS

Bloating


Infographic Posters

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Process

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Trying in different languages As I wanted to target more audience for the project I tried creating a gujarati translated poster for the same.

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Testing Being a non- medical student it was necessary to get the information included in the posters to be approved by few doctors who are physicians and are in that field since a long period of time.

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Dr. Raman Patel (M.D Consulting Physician and Cardiologist)


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Dr. Vivek Bhave ( M.D. General Medicine)

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Dr. Gunjan Jain ( M.D. Paediatrician)

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Yogita Gupta (M.Sc. Microbiology)


Conclusion

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Personal Experience

Challenges

Learning

Conducting such research was indeed a tough yet an engaging task. Through this project my sole intention has been for better sharing of medical information to the end consumers i.e. the patients. By designing of informative posters it not only helps a normal consumer to be aware of the medicine but also diseases and takes into account the externality of basic know how that consumers are not aware of. This project besides this also helped me to acknowledge this problem and enriched my knowledge about various generic medicines being used inefficiently across the market and this project aims to address the same.

In course of five months there were various hurdles which came in the process of such execution. Firstly, the tedious yet learning task of taking appointments from various doctors and medical students and extracting the basic information from the complex whole that they provided. Secondly, transforming the complex information about the medicines I received to basic know how in form of signs and posters. Lastly, trying to transform the signs and posters in the linguistic language to further remove the barrier of complexity for the consumers.

By executing such a project has been largely a greater learning process coupled with various tasks of managing, collecting and organising complex set of information. Not only did it help me achieve my objective of contributing something to the society through the means of design but also get a personal satisfaction of accomplishing such a task. Therefore, by the words of Ellis Boyd to Andy Dufyresnce that “Hope is a good thing, may be the best of the things, and no good thing never dies�, my effort towards the hope of bridging the gap between consumers and medical professionals can hence come to fruitution.

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References

Credits

Bibliography

Books:

Shirali Tiwari, a school friend and a 4th year MBBS student has helped me through out the project. She is right now studying in GMERS Medical College Himmatnagar.

www.1mg.com -medicines information -saridon images

GMERS Medical College, Himmatnagar Practical Journal Garg Pharmacology Books / MCQ Books Indian Drug Review (IDR) CIMS Annual Report 2018

Manish Manghwani, currently a pharmacist at Venus Pharmacy, Sargasan, Gandhinagar, for letting me know how the market works. Raman Patel, MBBS and MD for giving an insight about the patients.

www.practo.com -medicine information www.medindia.com www.wedmd.com Google forms for survey.

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