Project title- Pharmacoinvasive management of STEMI patients & the perception of

the doctors.

Project Guide- Mr. Prashant Agrawal

(General Manager)
Emcure Pharmaceutical Ltd.

Project by- Anant Kumar

MBA (Hospital & Health Care Management)
Symbiosis Institute of Health Sciences
Pune
 Executive Summary
• The purpose of the study was to get acquainted with the perception
of doctors regarding the treatment of AMI (Acute Myocardial
Infraction) & the strategy followed in the treatment of STEMI
patient.
• The survey was carried in Delhi particularly south Delhi & was
categorized in two category A & B .
• Category A consist of Cardiac hospital where there was 24 hrs CATH
lab available & highly experienced doctors available round the
clock.
• Category B Consist of General Physician and other hospital where
heart patient visit.
• The study identified the awareness of 3rd generation thrombolytic
drug among the two categories & also the perception of doctors
with regard to the strategy followed in treatment of STEMI patients
in Indian Scenario.
• The project further aims in identifying the insight of doctors on the
subject of ideal characteristics of thrombolytic drug on rank basis in
both the category A & B.
 Introduction
• Potentially carved with attributes like fastest bolus administration,
proven clinical effectiveness, ease of administration, and with best
safety profile, tenecteplase (Elaxim) has remarkably poised it presence
for its use in ST-Segment Elevation Myocardial Infarction (STEMI).

• It has been observed that timely delivered bolus injection of Elaxim can
make a sea face change in outcome of Heart attack victims.

• The project paddles around identifying the awareness of third

generation thrombolytic drug among the Cardiologists & General
physician & also the perception on Pharmacoinvasive strategy in STEMI
cases.

• The project further aims to identify the present trend of use of

tenecteplase in AMI cases with regard to Pharmacoinvasive strategy in
Indian scenario.
 Research Methodology
• Number of samples n=92
» Number of Cardiologist= 36
» Number of General Physician=56

• Number of days of Survey= 17 days

• Survey Methodology= Interviewing method.
• Survey area covered-
» Category A- Cardiologist M.D., D.M (Cardio).
» Category B- General Physician M.D.
 Doctors Speciality
Following graph shows categorization of Doctors specialty wise who
were surveyed for the Study.

39%

D.M. (Card)
61%
M.D.
Average no. of AMI patients visiting

100%
21%
80%
68% Above 20
34%
60% 11 to 15

40% 6 to 10
21% 34% 1 to 5
20%
12% 11%
3%
0%
Category A Category B

It is well evident from the bar diagram the AMI patients visiting the category A
doctors were more than category B doctors.
 First line of treatment given to STEMI patient
Category A Category B

9% 1% 6%
P.C.I. 10%
22%
Thrombolysis
17%
74% Depends on 62%
the case
Referred cases

Category A - 74% of doctors preferred P.C.I as first line of treatment rather than opting
thrombolysis, if presented within 3 hrs of symptom onset, as there were 24 hrs CATH lab
available & also suggested that affordability of the patient is one of the important factor
that help them to decide the line of treatment.

Category B- 62% of doctors preferred thrombolysis as the first line of treatment if

presented within 3 hrs of symptom onset & 22% preferred PCI on CATH lab availability
followed by 10% of doctors who suggested that it depends upon the case .
• Both the Category A & B doctors agree for
pre-hospital thrombolysis if pain to door time
exceed more 3 hours.
• Super speciality cardiac hospital where there is
24 hrs Cath lab availability they prefer PCI than
thrombolysis or pre-hospital thrombolysis is
done.
• General physician and the hospital where
there is no Cath lab availability prefer going for
thrombolysis and refer the patient where the
Cath lab is available.
 Reason for referring the STEMI patients

Others 5%

Lack of avalibility of thrombolytic drug 6%

Lack of specialized doctors 11%

No CATH lab avalibility 78%

0% 20% 40% 60% 80%

78% doctors mentioned the reason for referring the patient was non availability of
CATH lab and 11% mentioned lack of specialized doctors.
Certain hospitals refer the patient as no thrombolytic drug available.
 Reason for primary PCI
72%
11%
Category B Contraindicated
9% patient
8%
Less Mortality

36% To prevent re-

8% occlusion
Category A
14% To cut down
42% unnecessary cost

0% 20% 40% 60% 80%

42% doctors in Category A prefer going for PCI rather than thrombolysis as to cut
down the unnecessary cost as them PCI has to be done to prevent re-occlusion.
In Category B the 72% doctors prefer going for PCI if the patient is contraindicated to
the thrombolytic drug .
 Awareness of 3rd generation thrombolytic drug

100% 91%
90%
80%
70%
60% 51%
50% 41%
40%
30% Category A
20% 4% 5% 8% Category B
10%
0%

Category A- 91% of doctors are well known of 3rd generation thrombolytic drug ,
Where as in Category B-only 55% are well aware & 41% are partially aware.
 Preference of thrombolytic Drug
Total (n=92) 100% 83%
80% 71%
Urokinase 1% Streptokinase
60%
Reteplase 3% Tenecteplase
40% 27%
Streptokinase 55% 20% 12% Reteplase
2% 4%
0% Urokinase
Tenecteplase 41%
Category 1 Category 2
0% 20% 40% 60%

A high preference of tenecteplase (71%) is seen in category A , while in category B

Streptokinase is more preferred (83%)

A high preference for Streptokinase as Thrombolytic (55%) is seen due to following

reasons:
1.Widely available
2.Cheaper in price
3.Cost effective results
4.Good past experience
5.Affordable by patient.
Preference of the Tenecteplase brand
% of brand preference

4%
8%

Elaxim
Metalyse
Don’t remember

88%

Elaxim is the most preferred brand. 88% of doctors prefer Elaxim than
Metalyse.
Few of the doctors find difficult to recapitulate the name of brand as the
drug is issued by the hospitals pharmacy.
 Reason for not prescribing Elaxim

5%
High price
21%
Affordability of patient

Good past experience of

56% Streptokinase
No information
18%

56% Doctors Don’t Prescribe Elaxim because of its high cost.

Whereas 18% Doctors mentioned the affordability of the patient as the limiting
factor. And 21% doctors said that streptokinase has shown better result
throughout their experience.
 Rating of the attributes while selecting a thrombolytic for patient
with STEMI
20
18
16
14
12
10
8
6
4
2
0

Category A Category B

It is evident from the above graph that, doctors while selecting a drug for patients
with STEMI preferably look for a molecule which is rapid acting with single bolus
administration & should possess no re-occlusion.
 Ranking of the attributes

Attributes Category 1 Category 2 Total

Single dose 2 2 2

Rapid Action 1 1 1

Fibrin Specific 10 5 7

No Re-occlusion 3 4 3

Resist to PAI 1 6 10 8

Longer half life 9 8 9

Reduction in 30 days mortality 4 6 4

Compatibility 5 3 6

No Antigenicity 7 3 5
No effect on B.P. 8 9 10
 Graph Showing the preference of Ideal
thrombolytic drug
12
10 10
9
8 8
Ranking

7
6 6
5
4 4
3
2 2
1
0

Overall rapid action of the drug is ranked as the most important attribute while
selecting a drug for STEMI case ,Single dose admin as bolus is the second most
important factor ,followed by No Re-occlusion in STEMI cases.
 Average effective time for thrombolytic to be
administered
160%
140% 61%
120%
100%
80% 77%
60% 34%
40%
20% 20%
0% 0% 0%
0%
0-1 hrs 2-4 hrs 4-6 hrs More than 6
hrs
Category A Category B
Approximately 77% of doctors in Category A said that 0-1 hr. (golden hour) is the most
effective time for Thrombolytic to be effective & 61% in case of Category B.
Where as many suggested that if thrombolytic can’t be administered in golden hours
then it can be administered up to 3 hrs. Both Category suggested that thrombolysis
should not be preferred after 3 hours & alternative therapy should be adopted.
 Awareness of Pharmacoinvasive Management of
STEMI patient

5%
Don’t No
3%

53%
Partial Knowledge Category B
18%
Category A

42%
Yes
79%

0% 20% 40% 60% 80% 100%

79% of the doctors are well aware of Pharmacoinvasive management of STEMI

patient in Category A. Where as only 42% of doctors are aware in Category B.
18% of doctors have partial knowledge in category A & 53% in case of category B.
 Information of Pharmacoinvasive
management received from
Others 7%

Medical Journal 18%

Conference 33%

Company representative 42%

0% 10% 20% 30% 40% 50%

Medical Representatives (42%) and Conference (33%) were referred as major

source of Information through which doctors got familiar about the
Pharmacoinvasive management in STEMI patient.
 Pharmacoinvasive approach in Indian
scenario
140%
120%
100% 58%
80%
60%
39%
40% 68% 3% 0%
20% 24%
6% 2%
0%
Strongly Agree Disagree Strongly
Agree disagree

Category A Category B

In category A 68% of the doctors agree to the Pharmacoinvasive approach in Indian

scenario & 24% strongly agree. Where as 58 % of doctors in category B agree to it &
39% strongly agree to pharmco-invasive strategy .
 Ideal time for P.C.I after thrombolysis

More than 12 hrs 8% 14%

9-12 hrs 11% 64%

6-9 hrs 22% 13%

3-6 hrs 59% 9%

0% 20% 40% 60% 80%

Category A Category B

In category A 59% of doctors preferred the ideal time for PCI after thrombolysis is
between 3 to 6 hrs. Where as in category B 64% prefer between 9-12 hrs .
Management of the patient during off time (6 PM to 8AM)
100%
90% 89%
80%
70%
60%
50% Category A
40% 41% 49% Category B
30%
20%
10%
10% 11%
0% 0%
Thrombolysing P.C.I Depends on case
49% of doctors prefer for the PCI in category A as there is 24 hrs CATH lab available &
41% suggested to go for thrombolysis as availability of specialized doctor is a major
problem during off time.
Where as in Category B 89% prefer for thrombolysis & 11% suggested that it may depend
upon the case.
 Overall Tenecteplase rating

0.6
56%
0.4

0.2
0 14% 23%
0 0 7%
0
1 2 3 4
5
6
7

56% of doctors rated the tenecteplase as 6 out of 7 rest 23% rated it 7

out of 7.
 Findings
• Though the tenecteplase is potentially carved with attributes like fastest
bolus administration, proven clinical effective, ease of administration, and
with best safety profile etc, the tenecteplase is still do not hold a good
market share in Indian scenario.
First Line of Treatment Given to STEMI Patients-
• 74% of Category A doctors DM (Cardio) prefer PCI rather than
thrombolysis if presented within 3 hrs of onset of action as there is 24 hrs
Cath lab availability or they prefer pre hospital thrombolysis rather than in
hospital thrombolysis
• 62% of Category B prefer for thrombolysis during first 3 hrs of symptom
onset to start timely reperfusion and further refer the patient where Cath
lab is available.
Reason for Referring the STEMI Patients-
• 78% doctors mentioned the reason for referring the patient was non
availability of CATH lab and 11% mentioned lack of specialized doctors.
• Certain hospitals refer the patient as no thrombolytic drug available.
 Reason for Primary PCI-
• 42% doctors in Category A prefer going for PCI rather than thrombolysis as
to cut down the unnecessary cost as them PCI has to be done to prevent
re-occlusion.
• In Category B the 72% doctors prefer going for PCI if the patient is
contraindicated to the thrombolytic drug .

Awareness of 3rd generation thrombolytic drug-

• Category A- 91% of doctors are well known of 3rd generation thrombolytic
drug
• Where as in Category B-only 55% are well aware & 41% were having
partial knowledge of the it.
Preference of Thrombolytic Drug-
• 71% Category A doctors prefer tenecteplase while 83% in Category B
Streptokinase is preferred.
•Most of the doctors (55%) prefer Streptokinase as because of –
1.Widely available
2.Cheaper in price
3.Cost effective results
4.Good past experience
5.Affordable by patient.

Preference of the Tenecteplase Brand-

•Elaxim is the most preferred brand, 88% of doctors prefer Elaxim than
Metalyse.
•Few of the doctors find difficult to recapitulate the name of brand as the drug is
issued by the hospitals pharmacy.
 Reason for not prescribing Elaxim
• 56% Doctors Don’t Prescribe Elaxim because of its high cost.
• Whereas 21% doctors said that streptokinase has shown better result
throughout their experience followed by 18% doctors who mentioned the
affordability of the patient as the limiting factor.

Ranking of Ideal Thrombolytic Drug-

• While ranking the attribute of ideal thrombolytic drug, doctors while
selecting a drug for Patients with STEMI preferably look for a molecule which
is rapid acting with single bolus administration & should possess good safety
profile at affordable price with no re-occlusion.

Average effective time for thrombolytic to be

administered
• Approximately 77% of doctors in Category A said that 0-1 hr. (golden hour) is
the most effective time for Thrombolytic to be effective & 61% in case of
Category B.
• Where as many suggested that if thrombolytic can’t be administered in
golden hours then it can be administered up to 3 hrs.
• Both Category suggested that thrombolytic should not be preferred after 3
hours & alternative therapy should be adopted.
 Awareness of Pharmacoinvasive Management of STEMI
patient
• 79% of the doctors are well aware of Pharmacoinvasive management of
STEMI patient in Category A. Where as only 42% of doctors are aware in
Category B.
• 18% of doctors have partial knowledge in category A & 53% in case of
category B.

Information of Pharmacoinvasive management received

from-
• Medical Representatives (42%) and Conference (33%) were referred as
major source of Information through which doctors got familiar about the
Pharmacoinvasive management in STEMI patient.

Pharmacoinvasive approach in Indian scenario-

• In category A 68% of the doctors agree to the Pharmacoinvasive approach
in Indian scenario & 24% strongly agree. Where as 58 % of doctors in
category B agree to it & 39% strongly agree to pharmco-invasive strategy .
 Management of the patient during off time (6 PM to 8AM)
• 49% of doctors prefer for the PCI in category A as there is 24 hrs CATH lab
available & 41% suggested to go for thrombolysis as availability of
specialized doctor is a major problem during off time.
• Where as in Category B 89% prefer for thrombolysis & 11% suggested that
it may depend upon the case.

Overall Tenecteplase rating-

• Most of the doctors who had used the Tenecteplase in their clinical
practice have rated the Tenecteplase as an ideal thrombolytic drug.
• Doctors who have not used the Tenecteplase in their clinical practice &
have the knowledge about the drug have rated above 5 out of seven.

Cost of Tenecteplase in Indian Scenario-

• Though most of the doctors could not answer as they only know the cost
of tenecteplase is much more than any other thrombolytic drug and is not
affordable by patient in Indian scenario.
• Rest of doctors who answered suggested the price should be between
12000 to 15000 on an average.
 SWOT Analysis
Strengths
• Attributes of Elaxim such as rapidity of action, single dose administration, no re-
occlusion etc.
• Less 30 days mortality reported in cases of facilitated PCI using adjunctive Elaxim.
• Lesser complication of hemorrhage ,as it is fibrin specific drug.
Weakness
• High cost of drug in the market.
• Partial or less knowledge about the trials & research models relating with the
Tenecteplase especially in Category B.
• No clinical experience with Elaxim.
• Affordability of the patients in Indian scenario.
Opportunities
• As there is bigger cardiac market in India ,Elaxim can be promoted to doctors in both
the categories who do not have a clinical experience of Elaxim.
• As possessing the ideal characteristics of thrombolytic drug, trials & research model
can be well adopted in explaining the advantages over the other thrombolytic drugs
especially the use of drugs in pre hospital thrombolysis & reduction in thirty days
mortality in Pharmacoinvasive management.
Threats
• Preference of Streptokinase, as widely available & affordability by patients in India.
• Good past clinical experience of doctors using Streptokinase.
• Preference of doctors for PCI in category A rather than thrombolysis if specialized
doctors are available & there is 24 hrs Cath lab available.
 Recommendations
• Aggressive field forces-
– Building good field members with the update
knowledge of recent trials & research models in
explaining the benefits of benefits of Tenecteplase
& make doctors help to decide the strategies
(Pharmacoinvasive) to be followed in treatment of
STEMI cases which had shown reduction in 30
days mortality in Indian population.
– Regular follow ups to be maintained especially for
the doctors not prescribing Tenecteplase.
– Regular SMS reminders to be sent to the doctors
for updates in research.
– CME’s to be established on regular basis.
• Identifying key opinion leaders (KOL’s)
– The doctors who have used the tenecteplase in their
practice can be the KOL’s in promoting the drug.

– Dr. Pramod Joshi, Dr. Vivek Tondon, Dr. Sanjeev

Bharadwaj
(Fortis Escort Heart Institute, New Delhi )
– Dr. Harkrishan Lal Kher, Dr. Ashwani Metha
(Sir Ganga Ram Hospital,New Delhi)
– Dr. Sumit Khenderwal (Bhatra Hospital,New Delhi )
– Dr. Anupam Goel (MAX Super Speciality
Hospital, Saket , New Delhi )
 Other recommendations-
• Providing free subscription of National &
International Journals to the doctors and providing
the updates regarding the trials & benefits of drug.
• Publishing the product monograph in leading
medical journals.
• Organizing seminars & conferences, and briefing the
doctors about various strategies followed in
treatment of STEMI and to persuade them to adopt
the strategy (pharmacoinvasive) on the basis of
recent trials which has shown less mortality with
Tenecteplase as compared to other drugs.
• To increase awareness among the doctors about
additional benefits conferred by Tenecteplase as
compared to its completive products.
• Providing free post diagnostic tests to the patients who
had used Tenecteplase, would reassure the doctors and
patients of the high clinical efficacy of the drug.
• Tie ups could be made with the leading corporate &
public hospitals were STEMI patients visits regularly, so as
to focus strategies for increased penetration in the
selected target population segment.
• Reviewing the price of elaxim-
– The current price of the Elaxim could be reviewed with the
view to decrease the costs incurred in value addition process
that extends from development of the molecule to the point
at which it is made available to the customers and finally the
customers.
 Conclusion
• Even though tenecteplase is potentially carved with
attributes like fastest bolus administration, proven clinical
effective, ease of administration & best safety profile etc, it
still does not hold a good market share in Indian scenario
due to various reasons like high price, lack of awareness
among doctors, and lack of clinical experience of
Tenecteplase among the doctors and last but not the least
its competitor Streptokinase which has got a well
established market due to its affordability and good
experience with this drug.
• Lack of awareness about the Pharmacoinvasive
management of STEMI mainly among primary physicians.
And to overcome this problem various strategies should be
followed like aggressive field force, regular reminders to
the doctors, increasing the visibility of drug in print media
and CMEs with the update trials & research model
explaining the benefits & mortality ratio.
Thank you