Objective of the study

The purpose of this research was:-

To understand demand of narcotic analgesic drugs (morphine, pethidine, fentanyl) in Ahmedabad.

To understand supply of narcotic analgesic drugs (morphine, pethidine, fentanyl) in Ahmedabad.

By this research I will also try to find preference level of narcotic analgesics (opioids) over Non-narcotic analgesics (NSAIDs) by the doctors of Ahmedabad.

By this research I also tried to find hurdles faced by the doctors in using this prohibited drugs and also the hurdles faced by the retailers in selling this drugs.

Even I tried to find out what will be preference of the doctors if new molecule Sufentanyl (this drug is much more potent than other narcotic analgesic drugs) is introduced.

ASSUMPTIONS AND LIMITATIONS

Assumptions

In this study it is assumed that the entire population of anesthesiologist and retailers selling narcotic analgesic drugs is represented by the selected sample.

Limitations

The selected sample may not be representing the entire population. The results from the entire populations may be different.

The responses given by the respondents may be biased. This may distort the results.

The sample is selected only from the city Ahmedabad .So the results may not reflect the view of entire state or nation.

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Pharmaceutical industry

The Indian Pharmaceutical Industry stands at an interesting stage today. Having started out in a small way in 1901 India was highly dependent on U.K., France and Germany for its requirements of drugs and medicines. In 1948 the sale of pharmaceuticals products in the country amounted to just Rs.10 crores. By 1954 the figure had risen to Rs.54 crores and by 1960 to Rs.70 crores today the Indian Pharmaceuticals market, with a size of USD 2.7 billion is ranked 20 th in value terms. The market is estimated to grow at over 11.6% annually. (Source: ORG-MARG, August 2002.)

In 1961 Senator estes Kefauer who headed an official committee to investigate the monopolistic practices of U.S. drug firms reported: Prices of certain drugs and antibiotics in India were among the highest in the world and that, in drugs, India was one of the highest priced nations. Today, the situation has been reversed with the prices of formulation in India among the lowest in the world. The rapid development of the Indian drugs and pharmaceutical industry has made it easier for people to access almost all-new therapies that are launched worldwide. As a result the life expectancy has also increased substantially from 45 to 65 years.

The Indian pharmaceutical industry is highly fragmented with over 20,000 pharmaceutical companies. The leading 250 pharmaceutical companies control 70% of the market. While, the domestic companies account for the MNCs. contributes 67% of the total market (source: ORG-MARG, Moving Annual Total, and August 2002)

Over the years, the Indian pharmaceutical companies have used reverse engineering capabilities to pioneer new process for products. This combined with a strong distribution network and brand management skills have helped the Indian pharmaceutical companies dominate the market.

Over the next five to ten years, however, the competitive dynamics of the Indian pharmaceutical industry is all set to change .The introduction of product patents beyond 2005 and exclusive Marketing Rights (EMRs) will change the rules of the game. Companies will also have to focus on basic research or collaborate with patent holders to launch new products in the market.

Globalization will become increasingly important for Indian companies in the post GATT era. To succeed in a new competitive environment, Indian pharmaceutical companies will have to focus on new product introductions and innovations through Research and Development.

3

Industry analysts have been optimistic that the Indian Pharmaceutical companies will be able to successfully meet the challenges of the competition. Indian companies have gone ahead and R & D is emerging as a profit center. New drug delivery systems and even drug testing or clinical trials can be a profit center in India. This sector will never run out of fashion.

4

About Claris

Claris Lifesciences limited is an international pharmaceutical company dedicated to the development, manufacturing and marketing of research-based products and therapies of world-class quality for acute illness and surgical situations.

Claris is an R&D based, international pharmaceutical company offering products and delivery systems of world – class quality, to achieve the objective of saving lives worldwide.

The architects of Claris are a team comprising of scientists, pharmaceutical experts and management professionals, who bring to the company a combination of Vision, R&D capabilities, technological know how, International exposure and manufacturing expertise. The company’s range of products and delivery systems extends across Critical care, External and parental Nutrition, Renal care including Transplant Therapy and medical Equipment.

The company enjoys Market Leadership position in several product categories in India and significant presence globally. Claris has marketing operations in more than 30 countries, through its subsidiaries, offices and distributors, with a customer profile including institutions, major corporate hospitals and international aid agencies.

IT ENABLING

The company invested in IT infrastructure by getting the latest PCs, having lease lines at its corporate headquarters, and going in for state-of-the-art hosting facility with one of the top 5 hosting service providers in the U.S.A. It is strengthening its IT infrastructure backbone by investing in high technology servers and high-speed networks.

Claris has plans to link our new manufacturing campus with the corporate office so as to enable exchange of data, voice and video in a more sophisticated and economic manner.

Claris is further investing in a customized ERP package, which will integrate all its business process tightly .It is going in for CRM (Customer Relationship Management), SCM (Supply Chain Management) and KM (Knowledge Management) packages which will extend to customers, doctors, suppliers , and partners like distributors and C&F agents.

TECHNOLOGYThe company has laid emphasis on Quality and Technology from its early stages of growth. Its modern manufacturing facility uses sophisticated state of the art

5

technology, sourced from world leaders. The facility is designed to produce aqueous and oil based products in glass containers and bags. Apart from manufacturing for Claris, this facility also caters to the needs of companies in India and abroad for international markets of toll manufacturing.

PROPRIETARY TECHNOLOGY CAPABILITIES

The Company has capabilities in bringing laboratory batches to full production scale successfully, through it process-engineering competence. This technological excellence also goes beyond process and it has executed several projects with its technology platforms including:

o Non PVC bag manufacturing technology o Dialysis bags and accessorieso Fat emulsion based productso Micro emulsion technologyo Integrating of clinical needs and medical devices via custom made

software for its delivery systems.o Biomedical equipment development and manufacturing for operation

rooms and ICUs.

EMOTIONAL PHARMACOPOEIA

The quality philosophy of Claris is the commitment to achieve a level of perfection that surpasses every pharmacopoeial standard. It’s final test for quality is a very simple question that they ask themselves without fail, “Would we use it to treat our dearest ones?”

If the answer is an unhesitant ‘Yes’ the product has passed final quality test. At Claris this is called ‘Emotional Pharmacopoeia”.

Manufacturing processes and systems are oriented for consistent batch quality. This focus on quality begins with the housing of the central laboratory facilities within clean rooms from Clestra, France – a world leader in the industry.

Claris has an advanced laboratory set up equipped with facilities for chemical and instrumental analysis. The laboratory is capable of undertaking the most comprehensive tests for various pharmacopoeia parameters.

Claris believes in building quality through every step of production. This is done by having a separate team for in process quality checks (QA) and finished products’ testing (QC) at the end. Separate managers head both these functions. This total commitment to quality, coupled with international exposure to technology, aids them in their efforts to help save human lives worldwide.

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Business Profile

Critical care

The Claris product basket in Critical Care includes Anesthesia, Blood and Plasma products, I.V. fluids and advanced Antiinfectives/Antibacterials.The company’s expertise in lipid based technology has made it one of the few companies in the world to manufacture propofol. The entry of this advanced anesthetic revolutionized the way anesthesia was given in the country.Today,proviveTM iis an internationally accepted brand while profolTM is the no.1 brand of propofol in India and one of the best selling success stories.

Claris is the first Indian and one amongst the first few companies of the globe to have manufactured profol Intravenous Injection.

Claris is the first Indian and one amongst the first few companies of the globe to have manufactured Profol Intravenous Injection.

Nutrition

The link between malnutrition and increased risk of complications in patients is a proven one. Good nutrition practice makes a vital difference in quality and time of recovery of such patients.

Nutrition solutions from Claris include Enternal and Parental Nutritional products and delivery systems. Claris is the market leader in Parental Nutrition, with a product range encompassing amino acid solutions, fat emulsions, trace elements and advanced delivery systems like PNATM and CelemixTM , which come with the convenience of multiple nutrients and the flexibility to add other nutrients for a tailor made preparation .Products individually or as a combination, are designed to meet specific and unique nutritional needs of different patients suffering from malnutrition.

Claris is the first Indian company to manufacture parental fat emulsion.

The product range of Claris comprises of Total Parental Nutrition , Blood and Plasma , Anesthetic Range and organ preservation solution

RENAL CARE

Kidney failure is one of the most debilitating diseases to occur to a human being .Its incurable nature makes it critical diseases like cancer or AIDS.

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In the Renal Care, segment, Claris offers a range across systems, solutions, medicines, disposables and equipment.

The company is the first in India and one of the few in the world to manufacture perfusolTM – cold organ preservation system for transplant, and RenografTM – multi organ perfusion system.

Today , RenografTM is used in one out of every three transplants in India.

PHARMACEUTICAL GENERICS

Claris offers injectables and oral dosage forms across various therapeutic groups with focus on antibiotics , antibacterials , antinfectives ,etc.Medical devices and disposables .The company’s range of products in medical devices and disposables includes blood bags, two piece syringes , needles , I.V. infusion sets and disposables for haemodynamics.

MEDICAL EQUIPMENT

As in all spheres of life, technology is adding convenience to medicine also. Claris has a broad spectrum of medical equipment including the Protiva 2000TM – anesthesia pump, Infulife SPTM – syringe pump, oxylifeTM – oxygen concentrator and Invocare HDTM – state of the art dialysis chairs and beds .All designed to offer convenience, comfort and ease of use.

INTERNATIONAL OPERATIONS

The company has a presence in more than 30 countries including Latin America, Europe, CIS, Asia Pacific and Africa through its own sales force and local teams in various countries. This presence is slated to go up to 70 countries and plans for the U.S.A., Australia, and U.K., is in place.

Subsidiaries and its own offices in various countries are involved in grass root marketing products. Almost 70% of the Company’s revenues come from international operations, and several major brands like proviveTM (Propofol) are widely recognized and accepted globally.

The teams in international markets include sales, marketing and support people, ably complemented by a strong network of distribution partners. This level of infrastructure in international markets helps Claris meet the demands of its international customers including aid agencies, large corporate hospitals and institutions.

HOSPITAL CARE

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This division of Claris is recently launched to cater the needs of the hospital. Its product range comprises common IV fluids, antibiotics and antiamoebic drugs.

PROPOSED ONCO DIVISION

Claris is planning to launch a new division that is Onco division to save the lives of the patients suffering from various types of cancers. This division will be launched in the near future.

RESEARCH AND DEVELOPMENT

The company is actively involved in the area of Research and Development through Claris research Foundation.The Foundation’s is in the area of development of critical products and new drug delivery system.

CRF has developed some pioneering technologies in the last few years and has built its expertise in such fields. One example of this is parenteral fat emulsions (Lipid Drug Delivery System). Claris used this platform to manufacture Propofol, which was introduced in 1998 in India.Since then this product is sold in many countries world wide, and is benchmarked against international products in a large number of countries.

CRF has now developed expertise in Liposomal drug delivery systems. In both of these DDS, there are several drugs in the pipeline, which have reached a threshold for the next stage in development.

The research pipeline of Drug Delivery Systems for the next three years has been chalked out. The foundation has filed for respective patents. Its IPR Cell has the infrastructure to handle the short term and long term plans.

CRF has initiated its research program in the field of Biotechnology with a focus on R&D of Monoclonal Antibodies technology platform and to develop drugs for therapeutic application. CRF’s vision to do advanced research in Oncology fits in well with its Biotech vision.

Another area, in which CRF is working, is the recombinant Technology platform. Some specific, rare bulk drugs (API) have also been developed, which makes Claris one of the few manufactures of such drugs in the world today. Several more APIs are in the pipeline.

Claris has networking with German and Japanese laboratories for technical alliances are an outcome of the same. Claris continues to add up innovative research projects in its pipeline that have the potential to save human lives across the globe.

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PIPELINE

In the pipeline are several innovative research projects in the area of critical care and drug delivery systems. Our world class R&D center undertakes pioneering work in the development of recombinant products for critical care e.g. Erythropoietin, Heparen, Interferon, and Interlukins etc.

Liposomal systems are being developed with drugs in various therapeutic segments such an anticancer, anti-fungal agents and antibiotics.Biotechnology is an area of key interest, as one of the major platforms available for producing lead compounds with preselected properties.

CLARION

CLARION is a bimonthly news magazine of Claris, featuring issues and events at CLARIS.

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Research Design

Sample design

This design will consist of two different sample .One will be to understand demand pattern of narcotic analgesic drugs and the other one to understand the supply pattern.

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Sample to understand the demand pattern of narcotic analgesic drugs

Population:- All anesthesiologists of Ahmedabad city.

Sample type:-Convenient sample

Sample size:-15

(The anesthesiologist doctors will be selected randomly from private hospitals like Sterling, SAL, Medisurg and the government hospitals like Vadilal Sarabhai , Shardaben , Rajasthan and LG.

Sample to understand the supply pattern of narcotic analgesic drugs

Population:-All retailers having the permit to sell narcotic analgesic drugs.

Sample type:- Probability sample

Type of the probability sample:-Random sample

Sample size:-2

Scheduling:-

The research is completed within the time span of eight weeks starting from 19 th

May .The schedule is presented here week wise.

Weeks Starting date Work done

1st 19th May Preparing research methodology

2nd 26th May Designing the questionnaire

3rd 2nd June Revising the questionnaire

4th 9th June Revising the questionnaire

5th 16th June Survey

6th 23rd June Survey

7th 30th June Analysis of the data

8th 7th July Presenting the results

Research instrument:-

The instrument for the research will be a self administered questionnare.There will be two different questionnares for the two different samples. One questionnaire will be for the sample of anesthesiologist (to understand the demand of narcotic analgesic drugs) and the other questionnaire will for the sample of retailers( to understand the supply pattern of narcotic analgesic drugs).

The two different questionnaires for two samples were:-

o Questionnaire for the sample of anesthesiologist

o Questionnaire for the sample of retailers

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Data Analysis

First of all I will present the analysis of the sample of anesthesiologist.

Preference of narcotic analgesics (opioids) over non narcotic analgesics (NSAIDs)

In the sample of anesthesiologist that was selected 94% of the doctors prefer narcotic analgesics (opioids) while only 6% of the doctors prefer non-narcotic analgesic drugs.

PREFERENCE OF NARCOTIC ANALGESICS OVER NON NARCOTIC

ANALGESICS

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Narcotic analgesics Non narcoticanalgesics

PE

RC

EN

TA

GE

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• The number of surgeries in which doctors use narcotic analgesic drug

Percentage of surgeries No.of doctors using narcotic analgesics

0% to 20% 6.6%

21% to 40% 0%

41% to 60% 13.3%

61% to 80% 46.7%

81% to 100% 26.6%

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Percentage of surgeries in which doctors use narcotic analgesic drugs

0.00%5.00%

10.00%15.00%20.00%25.00%30.00%35.00%40.00%45.00%50.00%

0% to

20%

21%

to 4

0%

41%

to 6

0%

61%

to 8

0%

81%

to 1

00%

Percentage of surgeries

Pe

rce

nta

ge

of

do

cto

rs

us

ing

na

rco

tic

an

alg

es

ic

dru

gs

No.ofdoctorsusingnarcoticanalgesics

Preference of following narcotic analgesic drugs .

o Morphine

o Fentanyl

o Pethidine

In preference level for morphine, fentanyl and pethidine

o Rank 1

100% doctors gave rank1 to fentanyl in preference.

o Rank 2

87% of doctors gave rank2 to pethidine in preference.

13% of doctors gave rank2 to morphine in preference.

o Rank 3

87% of doctors gave rank3 to morphine in preference.

13% of doctors gave rank3 to pethidine in preference.

Morphine Fentanyl Pethidine

Rank 1 0% 100% 0%

Rank 2 13% 0% 87%

Rank 3 87% 0% 13%

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• Preference of Sufentanyl

(In the selected sample 67% of the anesthesiologists replied that they would prefer Sufentanyl even if the cost is high while 33% of the doctors gave negative answer)

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Preference level of Sufetanyl

Would prefersufentanyl

Would not prefersufentanyl

• How many doctors use narcotic analgesics in pre-surgery, peri-surgery, post-surgery.

Do prefer narcotic analgesics

Do not prefer narcotic analgesics

Pre surgery 46% 54% 100%

Peri surgery 94% 6% 100%

Post surgery 26% 74% 100%

When the drug is used

0%10%20%30%40%50%60%70%80%90%

100%

Presurgery

Perisurgery

Postsurgery

Do prefer narcoticanalgesics

Do not prefernarcoticanalgesics

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• Hurdles faced in using narcotic analgesic drugs

o 53% felt legal formalities is a hurdle.

o Avaibility is not a hurdle.

o 13% felt that cost is a hurdle.

o 34% felt that they don’t face any hurdles in using these drugs.

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HURDLES FACED IN USING NARCOTIC ANALGESIC DRUGS

0%

10%

20%

30%

40%

50%

60%

Lega

l form

alitie

s

Avaib

ility

Cost

No hur

dle

HURDLES

PE

RC

EN

TA

GE

Series1

• Short supply of this drugs

The sample was asked that how frequently they face short supply of these drugs and the options given to them were very frequently, frequently, sometimes, rarely, never. The results are as under.

Very frequent Frequent Sometimes Rarely Never

0% 0% 46% 27% 27%

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Short supply of Narcotic analgesic drugs

Very frequently

Frequently

Sometimes

Rarely

Never

• Comparison between narcotic analgesics and non narcotic analgesic

According to the doctors the benefits of narcotic analgesics over non-narcotic analgesic were as follows:-

o They are potent analgesic.

o They decrease the volume of the anesthetic agent required.

o Drugs like fentanyl have shorter duration of action .So they can be used for short duration surgeries.

o They prevent much variation in haemodynamic changes.

o These drugs can easily be used on the patient having bleeding tendencies.

o Provides better pain control

o Cardiovascular stability

Thus overall Narcotic analgesic (opioids) are potent analgesic,have short duration of action.,provide haemodynamic stability and cardiovascular stability, decrease the requirement of anesthetic agents compared to non narcotic analgesic drugs(NSAIDs).

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• Data analysis of sample retailers (to understand the supply of narcotic analgesic drugs).

As morphine, fentanyl and pethidine are the prohibited drugs the retailers need to get permit from narcotic department to sell this drugs. Also they need permit to transport this drugs .The retailers having the permit to sell this drugs are needed to maintain a record of prescriptions, record of person to whom they have sold this drugs. Due to all this legal formalities involved in selling this drugs there are few retailer who have license to sell the drugs in Ahmedabad.I could meet two retailers who keep this drugs.

Here is the analysis of the data, which I could get from the two retailers through the questionnaire.

o Which narcotic analgesic drugs do they keep?

The three main narcotic analgesic drugs are morphine, fentanyl, pethidine and as can be seen from the analysis of the sample of anesthesiologist fetanyl is widely used and most preferred narcotic analgesic drug. Out of two retailers I met:-

One of the retailers kept two drugs fentanyl and pethidine.

The other retailer kept only fentanyl.

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o Amount of morphine , fentanyl and pethidine kept by the retailers in units

Out of the two retailers one retailer kept only fetanyl while the other kept fetanyl and pethidine. The amount in which they kept these drugs is as follows.

Morphine Fentanyl Pethidine

Retailer 1 Does not keep this drug.

2ml x 5000 amp and 10ml x 100 amp

1ml x 500 amp

Retailer 2 Does not keep this drug

2000 amp Does not keep this drug

The retailers on monthly bases reorder these drugs.

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o The factors kept in mind while the purchase of these drugs.

As mentioned earlier there are many legal formalities involved in selling of this drugs. Because of this reason there are few retailers who sell these drugs. From this sample of retailers I tried to find that what are the factors that these retailers keep in mind while selling of this drugs inspite of the legal hurdles faced in selling of these drugs.

The options given to them were:-

Higher margin they get in selling of these drugs.

Lack of competition (because only few retailers have license to sell this drugs)

High consumption of these drugs.

The results derived were

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Factors that prompt retailers to sell this drugs

0%

20%

40%

60%

80%

100%

120%

Lack ofcompetition

High margin Highconsumption

Factors

Series1

o The hurdles faced in selling of this drugs

As morphine, fentanyl and pethidine are prohibited drugs retailers face some hurdles in selling of this drugs. The hurdles faced by the retailers are legal formalities, storage, slow moving product etc. The results were.

Rank 1 Rank 2 Rank 3

Legal formalities 100% 0% 0%

Storage 0% 100% 0%

Slow moving product

0% 0% 100%

Thus legal formalities involved in selling these drugs are the biggest hurdle.

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Hurdle faced in using this drugs

0%

20%

40%

60%

80%

100%

120%

Rank 1 Rank 2 Rank 3

Ranks

Legal formalities

Storage

Slow movingproduct

• In case of margin fluctuations between two companies preference of the retailers

The options given to the retailers in this case were as follows.

o Company giving higher margin.

o Drugs of the company that doctor prefer.

o Stockist relationship.

Here the retailers feel that that they would prefer the drugs of the company which the doctors prefer more.

Company giving higher margin

Drugs of the company that doctors prefer more

Stockist relationship

0% 100% 0%

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Conclusions

Conclusions from the sample to understand the demand pattern (anesthesiologist) of narcotic analgesic drugs.

Preference of narcotic analgesic over non narcotic analgesic –About 94% of the doctors prefer narcotic analgesics during surgeries compared to non narcotic analgesic.

About 26% of the doctors prefer narcotic analgesics in 80% to 100% of surgeries they perform. While about 46% of the doctors prefer this drugs in 60% to 80% of surgeries they perform.

Out of the three narcotic analgesic drugs Fentanyl is the most preferred drug by the doctors. The second preferred drug is pethidine and then morphine.

For the new molecule sufentanyl 67% of anesthesiologist responded that they would use this drug even if the cost is high while 33% responded that they would not use it.

Out of the total sample 46% of the doctors prefer these drugs in pre surgery, 96% of the doctors prefer it in pre surgery and 26% of the doctors prefer it in post surgery.

53% of the doctors felt legal formalities are hurdle in using these drugs. Avaibility is not a hurdle.13% felt that cost is a hurdle.34% felt that they don’t face any hurdles in using these drugs.

46% of the doctors felt that sometimes they faced short supply of this drugs,27% felt that they faced the short supply rarely and 27% felt that they never faced short supply of this drugs.

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Conclusions from the sample to understand the supply pattern of narcotic analgesic drugs (retailers).

Fentanyl is kept by all the retailers. While only one retailer kept pethidine.

Retailers reorder this drugs on a monthly bases

Lack of competition is the factor that retailers keep in mind in selling of this drugs.

Legal formalities are the biggest hurdle is selling of these drugs. The second hurdle is the storage as these drugs have to be kept in a locked place.

In case of margin fluctuations between two companies retailers would prefer the drugs of the company, which doctors prefer.

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BIBLIOGRAPHY

Books

Kotler, Marketing management, Pearson education, eleventh edition

Cooper, D.R. and Schindler,P.S.,Business research method,eigth edition

Rao, S.S, Handbook for writers and editors,AMA

28

Annexure

Annexture 1

Anesthesia

Anesthesia has an effect on a part of nervous system which results in depression or numbing of nerve pathways.Anesthsia is devided into three basic catogeries.

29

G e n e r a l A n e s t h e s i a R e g i o n a l A n e s t h e s i a L o c a l A n e s t h e s i a

A n e s t h e s i a

General Anesthesia:-General anesthesia affects the brain cells which causes a person to lose consciousness. General anesthetics produce an unconscious state. In this state a person is:

• unaware of what is happening

• pain-free

• immobile

• free from any memory of the period of time during which he or she is anesthetized

General anesthetics affect the spinal cord (resulting in immobility), the brain-stem reticular activating system (resulting in unconsciousness) and the cerebral cortex (seen as changes in electrical activity on an electroencephalogram).

General anesthesia can be administered as an inhaled gas or as an injected liquid. There are several drugs and gases that can be combined or used alone to produce general anesthesia. The potency of a given anesthetic is measured as minimum alveolar concentration (MAC). This term describes the potency of anesthetic gases. (Alveolar is the area in the lung where gases enter and exit the blood stream via the capillary system). Using MAC as a guideline, the amount of anesthetic given to a patient depends on that particular patient's needs.

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Regional Anesthesia:- Regional anesthesia is so named because a "region" of the body is anesthetized without making the person unconscious.Regional anesthesia techniques can be used to block very specific areas such as one foot, one leg, one arm, or one side of the neck. One example of this is spinal anesthesia, which is often used on women during childbirth. A local anesthetic is injected into the spinal fluid and causes a loss of sensation of the lower body. Spinal anesthesia can be used for surgery on the legs or lower abdomen (below the bellybutton).

Local Anesthesia:- Local anesthesia involves numbing a small area by injecting a local anesthetic under the skin just where an incision is to be made. When used alone, this type of anesthesia has the least number of risks. Local anesthetics are thought to block nerve impulses by decreasing the permeability of nerve membranes to sodium ions. There are many different local anesthetics that differ in absorption, toxicity, and duration of action. There are many different local anesthetics that differ in absorption, toxicity, and duration of action.

Annexure 2

Analgesics

Analgesics(pain killers) are of two types based on intensity of pain.

• Non-Narcotic Analgesics (NSAIDs).• Narcotic analgesics (Opioids)

In 1982, a WHO experts panel established a relatively inexpensive, easily applicable approach for pain treatment, known as the 'Three-step Analgesic Ladder', this approach has become accepted worldwide and is being implemented in several countries.

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• NSAIDs- They are used for slight to moderate pain. They include Salicylic Acid (Aspirin), acetaminophen (Tylenol), Ibuprofen (Motrin), Aleeve (Naproxen) and many others. As they have anti-inflammatory effect they are often referred to as non-steroidal anti-inflammatory drugs (NSAID).

• Opioids- They are used in case of severe pain.They act on the nervous system, altering pain perception and awareness, they make the person drowsy, sleepy, and they may be addictive. Narcotics require a prescription to be dispensed.

WHO STEP-1 The first step is the use of acetaminophen, aspirin, or other non-steroidal anti-inflammatory drug (NSAID) for mild to moderate pain.

WHO STEP-2 When pain increases or persists, a mild opioid such as codeine or hydrocodone should be added to the NSAID.It should only be used in cancer patients in special situations such as difficulties in providing morphine or the patient refusing to use opioids

WHO STEP-3 When higher doses are needed and the maximum therapeutic dose has been reached, they should be replaced with potent opioids such as morphine, hydromorphone or fetanyl.

( Adjuvant drugs may be used at any time to enhance analgesic efficacy for specific types of pain )

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Annexture 3

Major narcotic analgesic drugs

Morphine:-( C 17H19NO3 285.37)

Morphine is naturally occurring substance in the opium poppy, Papaver Somniferous. It is a potent narcotic analgesic, and its primary clinical use is in the management of moderately severe and severe pain. After heroin, morphine has the greatest dependence liability of the narcotic analgesics in common use. Morphine is administered by several routes (injected, smoked, sniffed, or swallowed); but when injected particularly intravenously, morpine can produce intense euphoria and a general state of well-being and relaxation. Regular use can result in the rapid development of tolerance to these effects.

Medical Uses

* symptomatic relief of moderately severe to severe pain;

* relief of certain types of difficult or labored breathing;

* suppression of severe cough (rarely);

* suppression of severe diarrhea (e.g., that produced by cholera).

Routes Of Administration

Morphine may be taken orally in tablet form, and can also injected subcutaneously, intramuscularly, or intravenously; the last is the route preferred by those who are dependent on morphine.

Fentanyl

Fentanyl belongs to the group of medicines called narcotic analgesics . The transmucosal form of fentanyl is used to treat breakthrough cancer pain. Breakthrough episodes of cancer pain are the flares of pain which “breakthrough” the medication used to control the persistent pain. Transmucosal fentanyl is only used in patients who are already taking narcotic analgesics. Fentanyl acts in the central nervous system (CNS) to relieve pain. Some of its side effects are also caused by actions in the CNS. When a narcotic is used for a long time, it may become habit-forming (causing mental or physical dependence). However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve their pain. Mental dependence (addiction) is not likely to occur when narcotics are used for this purpose. Physical dependence may lead to withdrawal side effects if treatment is

33

stopped suddenly. However, severe withdrawal side effects can usually be prevented by reducing the dose gradually over a period of time before treatment is stopped completely.This medicine is available only with doctor’s prescription.

Pethidine

Pethidine is an analgesic (a painkiller) but also an anti-spasmodic, which is a drug that helps you relax. It's a drug rather similar to morphine — in fact, a synthetic version of morphine . . It is given as an injection and often combined with another drug — an anti-emetic — to control sickness because pethidine often causes sickness.It’s been around a long time-sixty years and more.It helps a person to relax.Sideeffects of this drug are that it makes the person depressed and sick even if you have an anti-emetic.

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Annexure 4

Questionnaires

35

Questionnaire for the doctors

(Information of the doctor)Name: ___________________Qualification: ___________________Hospital: ___________________Sign: ___________________

(Note: I assure you that the information given by you will be used purely for the academic purpose and will not be passed on to any unauthorized person.)

1.How many anesthesia do you perform per month?____________

2.Please write the number of different type of anesthesia you perform. General Anesthesia

Regional Anesthesia

Local Anesthesia

3.State your preference for narcotic analgesic drugs over non-narcotic analgesic drugs.

Narcotic analgesic drugs

2 3 4 Non-narcotic analgesic drugs

4.In how many surgeries do you use narcotic analgesic drugs?___________

5.Which of the following narcotic analgesic drugs you prefer.(Please rank your preferences)

Morphine Fentanyl Pethidine

6. How many units following narcotic analgesic drugs do you prescribe per month. Morphine- _______ Fentanyl- _______ Pethidine- _______Yes

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7.If new drug like Sufentniyl is introduced in the market would you prefer it if the cost is high.

Yes No

8.Please tickmark where you use narcotic analgesic drugs.

Pre surgery Peri surgeryPost surgery

9.Which molecule do you use in the followi ng cases.

A) Pre surgery1 Hr surgery

2 Hr Surgery

More than 2 hr surgery

MorphineFentanylPethidine

B) Peri surgery1 Hr surgery

2 Hr Surgery

More than 2 hr surgery

MorphineFentanylPethidine

C) Post surgery

1 Hr surgery

2 Hr Surgery

More than 2 hr surgery

MorphineFentanylPethidine

10.Please tickmark the drugs used in following surgeries

Morphine Fentanyl PethadineCardiac surgeryOnco surgeryNephro surgeryOrtho surgeryNeuro surgeryGastroentero surgery

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11.Rank the hurdles that you face in using narcotic analgesic drugs.

Legal formalitiesAvaibilityCost

12.How frequently do you face short supply of this drugs.

Very frequent Frequent Sometimes Rarely Never

13.According to you what benefits narcotic analgesic drugs have over NSAIDs

1._______2._______3._______4._______5._______

Date:

Place: Signature:

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Questionnaire for the retailers

(Information of the retailer/Pharmacy)

Name: ___________________________Hospital/Shop: ___________________________Sign: ___________________________

(Note:I assure you that the information given by you will be used purely for the academic purpose and will not be passed on to any unauthorized person)

1.Which of the following narcotic analgesic drugs do you keep?

MorphineFentanylPethidine Others

2.In how many units following narcotic analgesic drugs are sold/consumed/used?

Morphine- _______Fentanyl- _______Pethidine- _______

3.Tick mark the frequency in which you reorder this drugs.

Morphine Fentanyl PethidineMonthlyBimonthlyQuaterlyAs per the need

4.Rank the factors kept in mind while purchase of this drugs.

High marginLack of competitionHigh consumption

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Continued

5.Rank the hurdles that you face in selling this drugs.

Legal formalitiesStorageSlow moving product

6.What is the permitted stock that you can keep of this drugs.__________

7.What amount of stock do you keep.__________

8.What are the legal requirement you need from the person purchasing this drugs .

Yes No FormPrescriptionLicense

9.What is the procedure you adopt to purchase narcotic analgesic drugs from the stockiest?__________________________

10.In case of margin fluctuations between two companies rank your preferences.

Company giving higher marginDrugs of the company which doctors prefer moreStockist relationship

11. If new drugs come in the market what will be the procedure to include the drug in the license?_________________________________

Date:

Place: Signature: