Re: new topic for discussion

[Guest guest]

Hello all, I think this is the first posting on this topic. With greetings to Dr. Mira madam, I will start my post about history of ethics in medicine. The Greek word "Ethos " means gathering of good hearted people> Now adays Ethics can be defined as' Systemic study of what is good with respect to Conduct and Charecter' but in curent era of arguments we can also say it as "a desicion which can be justified." There have been various regulations in our fraternity concerned with Ethics. 1) Hippocratic oath- It consisted of two parts.... Inward looking- deals with our Intrafraternity behaviour Outward Looking- deals with our relation with our clients. 2) Declaration of Geneva- written in 1948....Revised in 1968,1983. 3) International code of medical ethics- written

in 1949 Revised in 1968 4) Nuremberg code- written in 1947....Revised in 1966. ( Universal code) 5) Helsinky declaration- written in 1964 coming to resent past 6) Icmr guidelines- written in 1982....Revised in 2000 7) Shedule Y - latest came in 2005. The interesting thing behind this history is that " Most of the writings and amendmends were followed after a BIG medical Mishap" Even we see large niumber of regulations, the basic principles remain the same 1] Autonomy 2]beneficeince 3] Non-maleficience 4] Justice But in current situation we all follow ICMR guidelines and Shedule Y. particulary ICMR gives the twelve basic principles to be followed in a clinical trial. Both these regulations are based on " Institutional ethics comittee' and " protocol along with

written informed consent form" This is for now in my next posting I will give general Info about the above two. Till then I hope a huge responce from other members Regards Dr. Narendra GMC, Nagpur. Mira Desai <desaimirak@...> wrote: Dear Netrumians, Hello !! After a break , lets gear up for the discussion on next topic.......... '' Ethical

issues in medicine development" which will be open from 18th - 28th Nov.2006. Medicine development is a highly technical, time consuming and expensive process involving animal studies and clinical trials.Animal rights activists protest to the use of animals which has become a major concern.It is also a fact that India has become a major hub for the clinical trials.In spite of code of ethics, reports of unethical practices keep coming.Pharmacologists are involved in the medicine research, animal studies and clinical trials. Further,lot of interest and enthusiasm has been observed in topics of clinical research among our members from the previous discussion.Hence, it is felt that we should discuss "Ethical issues in medicine development" on NetRUM.It is my privilege to moderate .We look forward to your active participation and valuable inputs. Best inputs will fetch the participant a

certificate /memento/ both from NetRUM. So happy posting and best luck. Dr Mira DesaiB.J.Medical College,Ahmedabad.Moderator Find out what India is talking about on - Answers India Send FREE SMS to your friend's mobile from Messenger Version 8. Get it NOW

Find out what India is talking about on - Answers India Send FREE SMS to your friend's mobile from Messenger Version 8. Get it NOW

[Guest guest]

Hi

Honoured to have Pof Mira Desai as moderator on NetRUM.

Here are some areas which need discussion in the ethical issues in

medicine development:

1. New medicine development for prevalent diseases in the country

and National health programmes.

2. Are new medicines needed for the diseases where the market is

flooded with too many " me too " medicines?

3. Medicines for orphan diseases and availability of financial

subsidies for their development.

4. Participant enrolment, trial information and consent in clinical

trials.

5. Conflict of interest in clinicals.

6. What should be the capping on the margins of profit in the sales

chain for new medicines?

7. When should the new medicines be allowed to be sold in Indian

market for the special groups like children, geriatric population?

I am starving to see the topic picking up.

Vijay

>

> Dear Netrumians,

> Hello !!

>

> After a break , lets gear up for the discussion on next

topic..........

> '' Ethical issues in medicine development " which will be open

from 18th - 28th Nov.2006.

>

>

> Medicine development is a highly technical, time consuming and

expensive process involving animal studies and clinical

trials.Animal rights activists protest to the use of animals which

has become a major concern.It is also a fact that India has become a

major hub for the clinical trials.In spite of code of ethics,

reports of unethical practices keep coming.Pharmacologists are

involved in the medicine research, animal studies and clinical

trials.

> Further,lot of interest and enthusiasm has been observed in

topics of clinical research among our members from the previous

discussion.Hence, it is felt that we should discuss " Ethical issues

in medicine development " on NetRUM.

>

> It is my privilege to moderate .We look forward to your active

participation and valuable inputs.

> Best inputs will fetch the participant a certificate /memento/

both from NetRUM.

> So happy posting and best luck.

>

> Dr Mira Desai

> B.J.Medical College,Ahmedabad.

> Moderator

>

>

>

>

> ---------------------------------

> Find out what India is talking about on - Answers India

> Send FREE SMS to your friend's mobile from Messenger

Version 8. Get it NOW

>

[Guest guest]

Hi all

Drs Mira and Vijay..nice topic, I am sure we will have many fingertips itching to hit the keyboard!!

Many areas of discussion have been suggested by vijay. Me too medicines have been a sore point for all rationalists.

It's expensive to produce an innovative drug. On average, the bill runs to more than $400 million. So drug companies often take a less costly route to create a new product. They chemically juggle an old drug, package it nicely and market it aggressively as "new better drug".

The U.S. FDA classified three-fourths of the 119 drugs it approved last year as similar to existing ones in chemical makeup or therapeutic value. UNDP reports that less than 5% of drugs introduced by industry in USA are true innovations and these too have developed with Government involvement. A study published in Lancet shows that 68% drugs marketed in the past 25 years are me too drugs. Surprisingly even the so-called qualified and informed prescribers fall for this ploy. Often when the patent of a drug is to expire, the company is ready with its "me too"!

The FDA approves drugs on the basis of their superiority to placebo, not their superiority to existing drugs. This gives a lot of leniency to me too drugs.

Any solution to this? Maybe. First consumers need to be educated. Second the regulators need to be choosier in approving drugs. Free public sharing of newer innovations also helps. We also need to realize that me too drugs come at a sacrifice…a sacrifice of innovation and better ideas in drug development.

More in next post

Chetna Desai

On 20/11/06, Vijay <drvijaythawani@...> wrote:

HiHonoured to have Pof Mira Desai as moderator on NetRUM.Here are some areas which need discussion in the ethical issues in medicine development:1. New medicine development for prevalent diseases in the country and National health programmes.2. Are new medicines needed for the diseases where the market is flooded with too many " me too " medicines?3. Medicines for orphan diseases and availability of financial subsidies for their development.4. Participant enrolment, trial information and consent in clinical trials.5. Conflict of interest in clinicals.6. What should be the capping on the margins of profit in the sales chain for new medicines?7. When should the new medicines be allowed to be sold in Indian market for the special groups like children, geriatric population?I am starving to see the topic picking up.

Vijay

>> Dear Netrumians,> Hello !!> > After a break , lets gear up for the discussion on next topic..........> '' Ethical issues in medicine development " which will be open

from 18th - 28th Nov.2006.> > > Medicine development is a highly technical, time consuming and expensive process involving animal studies and clinical trials.Animal rights activists protest to the use of animals which has become a major concern.It is also a fact that India has become a major hub for the clinical trials.In spite of code of ethics, reports of unethical practices keep coming.Pharmacologists are involved in the medicine research, animal studies and clinical trials.> Further,lot of interest and enthusiasm has been observed in topics of clinical research among our members from the previous discussion.Hence, it is felt that we should discuss " Ethical issues in medicine development " on NetRUM.> > It is my privilege to moderate .We look forward to your active participation and valuable inputs.> Best inputs will fetch the participant a certificate /memento/ both from NetRUM. > So happy posting and best luck.> > Dr Mira Desai> B.J.Medical College,Ahmedabad.> Moderator> > > > > ---------------------------------

> Find out what India is talking about on - Answers India > Send FREE SMS to your friend's mobile from Messenger Version 8. Get it NOW>

-- Chetna Desai

[Guest guest]

Dear Barna Madam and Vijay Sir, It is really a shame for India that despite there being a plenty of ADRs, none is being reported to WHO. Why is this carelessness? There is a good brain here in India, it should be put to good use. Regarding Nimesulide, it is well prescribed by private practitioners here also. They defend this by saying that one or two doses will not cause harm- the harm comes after prolonged use.Anupama From: Vijay <drvijaythawani@...>Subject: Re: New topic for discussionTo:

netrum Date: Tuesday, 18 August, 2009, 9:04 AM

Hi,

If medicines are banned elsewhere in the world but not in India, does that not mean that :

- Indians are fitter to sustain and live ADRs and toxicity

- If they suffer, it goes unreported (reminds that while we were in WHO HQ for TBS, we were sarcastically cajoled with the nil data on ADRs from India for one calender year. Can you take it that not a single ADR was reported to WHO ADR monitoring centre by our great pharmacovigilance machienery?)

- The deaths due to drugs are considered natural deaths

So finally it narrows to the fact that Indians are smarter than the whole world. While the world may ban Nimesulide, but our five private practioners from Delhi certify it to be safe! If this was not enough, the regulators harp on this statement and even allow pediatric formulations, FDCs of nimesulide to be sold in the country. Their tenacity can be realised that when questioned why this is being allowed - they reply that where is it written on the liquid formulation that it is for pediatric use? Anyone can drink it!

If there is heaven for irrational manufacture of drugs, it is here, in India.

Vijay

>

> Dear All

> Let me first express my thanks to Dr.Vijay and his team for giving me chance to moderate the discussion on a new topic.... " Banned medicines in India".

> This is not a new topic to know, rather should I say an old topic carrying a bag full of never ending arguements. Lets gather a few of such questions, and see whether we can find a few strongly recommendable answers which can be followed by various stakeholders! !!!

>

> OPENING STATEMENT FOR DISCUSSION ON BANNED MEDICINES

>

> • A number of medicines(phenylpro pralamine, cisapride, nimesulide,Furazoli done, oxyphenbutazone, nitrofurazone, phenophthalin etc) which are banned internationally are available in India.

> • It is not necessary that the medicines which are banned in other countries should automatically banned here also…… opined by DCGI

> • OTC medicines contain banned drugs

>

> Common queries of above statements are:

> 1. Why?

> 2. How are they made available?

> 3. At what cost?

>

> Therefore Friends! I am inviting opinions from you based on which we can further look into various aspects of this area.

> Looking forward for a warm towards hot response

>

> Regards

>

> Barna Ganguly

> Professor and Head

> Dept of Pharmacology

> P.S.Medical College

> Karamsad, Gujarat

>

Looking for local information? Find it on Local

[Guest guest]

Dear Dr Srisailam, The names of these drugs are engraved in minds of the public who had been using them for a long time. Ignorance of the public that these medicines are banned makes them purchase such medicines as OTCs. There are no strict rules and regulations for banning prescription and sales of such drugs. There are some doctors also who continue to prescribe these banned drugs. Communication gap and profit motives of pharma companies are the key factors for availability of banned drugs.Anupama

From: BARNA GANGULY <barnaganguly@ rediffmail. com>Subject: New topic for discussionnetrumgroups (DOT) comDate: Monday, 17 August, 2009, 11:52 PM

Dear AllLet me first express my thanks to Dr.Vijay and his team for giving me chance to moderate the discussion on a new topic.... " Banned medicines in India".This is not a new topic to know, rather should I say an old topic carrying a bag full of never ending arguements. Lets gather a few of such questions, and see whether we can find a few strongly recommendable answers which can be followed by various stakeholders! !!! OPENING STATEMENT FOR DISCUSSION ON BANNED MEDICINES• A number of medicines(phenylpro pralamine, cisapride, nimesulide,Furazoli done, oxyphenbutazone, nitrofurazone, phenophthalin etc) which are banned internationally are available in India.• It is not necessary that the medicines which are banned in other countries should automatically banned here also…… opined by DCGI• OTC medicines contain banned drugsCommon queries of above statements are:1. Why? 2. How are they made

available?3. At what cost?Therefore Friends! I am inviting opinions from you based on which we can further look into various aspects of this area.Looking forward for a warm towards hot responseRegardsBarna GangulyProfessor and HeadDept of PharmacologyP.S.Medical CollegeKaramsad, Gujarat

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[Guest guest]

Dear Dr. Anupama

Yes, it is true that many of us are careless about reporting the ADRs

Most of the doctors in India are busy to serve the large number of patients and they dont find time to report the ADRs

This can be understood from the journal publications from our doctors. Negligible number of doctors publish manuscripts in journals. Even case studies are also not published in journals

India, being high populated, is a good center for research and learning in medicine and health aspects

If you see some US hospitals, like Hopkins, they publish even small case studies in journals

The number of medical journals published from India are also very less.

The lack of publication interest will reflect in treatment aspects too

The final losers are our own population. Because our genetic makeup is different from western people and we cannot rely on the ADRs and efficacies particularly doses of drugs reported based on studies on western population

Our patients' mentality addsup to this problem. Most of our patients dont report their progress to the doctors. If the ailment is not cured, our people consult a second doctor.

For proper reporting of ADRs, our patients have to be educated to report the ADRs to their respective doctors. Then the doctors are advised to report the same to WHO and publish in a journal or magazine.

Dr. Srisailam

From: Vijay <drvijaythawani@ .co. in>Subject: Re: New topic for discussionnetrumgroups (DOT) comDate: Tuesday, 18 August, 2009, 9:04 AM

Hi,If medicines are banned elsewhere in the world but not in India, does that not mean that :- Indians are fitter to sustain and live ADRs and toxicity- If they suffer, it goes unreported (reminds that while we were in WHO HQ for TBS, we were sarcastically cajoled with the nil data on ADRs from India for one calender year. Can you take it that not a single ADR was reported to WHO ADR monitoring centre by our great pharmacovigilance machienery?)- The deaths due to drugs are considered natural deathsSo finally it narrows to the fact that Indians are smarter than the whole world. While the world may ban Nimesulide, but our five private practioners from Delhi certify it to be safe! If this was not enough, the regulators harp on this statement and even allow pediatric formulations, FDCs of nimesulide to be sold in the country. Their tenacity can be realised that when questioned why this is being allowed - they reply that where

is it written on the liquid formulation that it is for pediatric use? Anyone can drink it! If there is heaven for irrational manufacture of drugs, it is here, in India.Vijay>> Dear All> Let me first express my thanks to Dr.Vijay and his team for giving me chance to moderate the discussion on a new topic.... " Banned medicines in India".> This is not a new topic to know, rather should I say an old topic carrying a bag full of never ending arguements. Lets gather a few of such questions, and see whether we can find a few strongly recommendable answers which can be followed by various stakeholders! !!! > > OPENING STATEMENT FOR DISCUSSION ON BANNED MEDICINES> > • A number of medicines(phenylpro pralamine, cisapride, nimesulide,Furazoli done, oxyphenbutazone, nitrofurazone,

phenophthalin etc) which are banned internationally are available in India.> • It is not necessary that the medicines which are banned in other countries should automatically banned here also…… opined by DCGI> • OTC medicines contain banned drugs> > Common queries of above statements are:> 1. Why? > 2. How are they made available?> 3. At what cost?> > Therefore Friends! I am inviting opinions from you based on which we can further look into various aspects of this area.> Looking forward for a warm towards hot response> > Regards> > Barna Ganguly> Professor and Head> Dept of Pharmacology> P.S.Medical College> Karamsad, Gujarat>

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[Guest guest]

Dear Dr.Srisailam

Yes I agree to some extent about the busy schedule of doctors......but what about carelessness?

India being a vast country with multi-ethnic population, problems are also large and multifaceted. As Dr. Vijay mentioned that the surcasting comments from experts from WHO during his visit that there was no ADR reporting in some particular 1 year. Just think of the situation or I should say the problem! Is there only 1 cause of that? Absolutely NO!!!

It was therefore necessary to have a viable Adverse Drug Reaction (ADR) data capturing system. A vibrant pharmaco-vigilance programme in the country was set up. Even then how many were reported? Is it carelessness or negligence?

One of the functions of the programme is to assess the benefit, harm, effectiveness and risk of medicines; encourage their safe, rational and proper use; and improve patient care and safety in relation to the use of medicines and all medical and para-medical interventions. What we understood that the pharmacovigilance programme has experts on board to decide whether a particular drug should be banned or not.

How much was their role in India? Can we in any way point out in a larger scale?

Warm regards

Barna

On Tue, 18 Aug 2009 12:38:05 +0530 wrote

>

Dear Dr. Anupama

Yes, it is true that many of us are careless about reporting the ADRs

Most of thedoctors in India are busy to serve the large number of patients and they dont find time to report the ADRs

This can be understood from the journal publications from our doctors. Negligible number of doctors publish manuscripts in journals. Even case studies are also not published in journals

India, being high populated, is a good center for research and learning in medicine and health aspects

If you see some US hospitals, like Hopkins, they publish even small case studies in journals

The number of medical journals published from India are also very less.

The lack of publication interest will reflect in treatment aspects too

The final losers are our own population. Because our genetic makeup is different from western people and we cannot rely on the ADRs and efficacies particularly doses of drugs reported based on studies on western population

Our patients' mentality addsup to this problem. Most ofour patients dont report theirprogress to the doctors. If the ailmentis notcured, our people consult a second doctor.

Forproperreporting of ADRs, our patients have to be educated to report the ADRs to their respective doctors. Thenthe doctors are advised to report the same to WHO and publish in a journal or magazine.

Dr. Srisailam

>

>

>

>From: Vijay

>Subject: Re: New topic for discussion

>netrumgroups (DOT) com

>Date: Tuesday, 18 August, 2009, 9:04 AM

>

>

Hi,

>

>If medicines are banned elsewhere in the world but not in India, does that not mean that :

>- Indians are fitter to sustain and live ADRs and toxicity

>- If they suffer, it goes unreported (reminds that while we were in WHO HQ for TBS, we were sarcastically cajoled with the nil data on ADRs from India for one calender year. Can you take it that not a single ADR was reported to WHO ADR monitoring centre by our great pharmacovigilance machienery?)

>- The deaths due to drugs are considered natural deaths

>

>So finally it narrows to the fact that Indians are smarter than the whole world. While the world may ban Nimesulide, but our five private practioners from Delhi certify it to be safe! If this was not enough, the regulators harp on this statement and even allow pediatric formulations, FDCs of nimesulide to be sold in the country. Their tenacity can be realised that when questioned why this is being allowed - they reply that where

is it written on the liquid formulation that it is for pediatric use? Anyone can drink it!

>

>If there is heaven for irrational manufacture of drugs, it is here, in India.

>

>Vijay

>

>>

>> Dear All

>> Let me first express my thanks to Dr.Vijay and his team for giving me chance to moderate the discussion on a new topic.... " Banned medicines in India".

>> This is not a new topic to know, rather should I say an old topic carrying a bag full of never ending arguements. Lets gather a few of such questions, and see whether we can find a few strongly recommendable answers which can be followed by various stakeholders! !!!

>>

>> OPENING STATEMENT FOR DISCUSSION ON BANNED MEDICINES

>>

>> A number of medicines(phenylpro pralamine, cisapride, nimesulide,Furazoli done, oxyphenbutazone, nitrofurazone,

phenophthalin etc) which are banned internationally are available in India.

>> It is not necessary that the medicines which are banned in other countries should automatically banned here also opined by DCGI

>> OTC medicines contain banned drugs

>>

>> Common queries of above statements are:

>> 1. Why?

>> 2. How are they made available?

>> 3. At what cost?

>>

>> Therefore Friends! I am inviting opinions from you based on which we can further look into various aspects of this area.

>> Looking forward for a warm towards hot response

>>

>> Regards

>>

>> Barna Ganguly

>> Professor and Head

>> Dept of Pharmacology

>> P.S.Medical College

>> Karamsad, Gujarat

>>

>

>

>

Looking for local information? Find it on Local

Get your new Email address!

Grab the Email name you've always wanted before someone else does!

[Guest guest]

Hello All,

This is to clear the confusion and clarify the matter.

I dont understand how but my earlier post mentions sender's name as 'Chaitali Bajait' in the mail box. I dont know how this happened.

But let me make it clear that I, Dr. Smita Sontakke, am the moderator of the current discussion.

Dr. Smita Sontakke

Moderator

From: chaitali_bajait <chaitali_bajait@...>Subject: New topic for discussionnetrum Date: Thursday, 3 September, 2009, 6:29 AM

Thank You Sir for the invitation.

Hello Friends,

Good Morning and

Welcome to this new discussion on `Safe medicine use in Pregnancy'.

This is an issue which is very commonly talked of and has assumed widespread importance particularly after the Thalidomide disaster.

There are major concerns of permanent harm to the baby whenever any drug is administered to pregnant women .

Birth defects induced by maternal exposure to exogenous agents during pregnancy are preventable, if the agents themselves can be identified and avoided.

But the problem is further complicated due to the fact that the data obtained from teratogenicity tests in animals cannot always be reliably extrapolated to humans.

More than 800 chemicals have been defined as teratogens in laboratory animals, but only a few of these, approximately 20, have been shown to be teratogenic in humans. This discrepancy can be attributed to differences in metabolism, sensitivity and exposure time. Schmid, Trends in Pharmacological Sciences, vol 8, p 133.

Therefore, prescribing for pregnant women requires a lot of skill and restraint. Possible harm to the foetus by the administered medicine has to be weighed against harm to both mother and the baby due to untreated disease. There is paucity of data about safety of majority of medicines during pregnancy; largely because prospective drug trials in pregnant women are associated with ethical, legal, emotional and practical difficulties. Information is mostly derived from anecdotal reports and retrospective studies.

Keeping these facts in mind let's start our discussion in which we'll discuss the following issues and others which come up as the discussion progresses.

Why is it necessary to be careful while prescribing medicines during pregnancy?

What are the various factors on which prescribing medicines during pregnancy depends?

Is it safe to take medicines during pregnancy?

Which medicines are safe for use during pregnancy?

Which medicines are not safe during pregnancy?

Is it safe to take OTC medicines in pregnancy?

What are the environmental factors that can cause foetal damage?

What are the conditions which indicate use of medicines during pregnancy inspite of there known teratogenicity?

So, my dear friends I invite you all to share your valuable opinions, suggestions , comments, criticisms, additions and anything else concerning the topic to make this discussion lively and interesting.

Kind Regards,

Dr. Smita Sontakke

Associate Professor

Dept. of Pharmacology

Govt. Medical College

Nagpur

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[Guest guest]

No Medicine is absolutely safe in early pregnancy.That said, only life saving medicines could be given, if at all.Morning sickness could be managed without drugs.Even vitamines are not safe, thanks to their preservatives.This has been my practice for nearly half a decade.I did not have to regret it.love,bmhegdeProf. B. M. Hegde, MD, FRCP, FRCPE, FRCPG, FRCPI, FACC, FAMS.Visiting Professor of Cardiology, The Middlesex Hospital Medical School, U'sity of London,Affiliate Professor of Human Health, University of Northern Colorado in Greeley,Visiting Professor, Indian Institute of Advanced Studies, Shimla,Retd. Vice Chancellor. Manipal, India From: chaitali_bajait <chaitali_bajait@...>Subject: New topic for discussionnetrum Date: Thursday, 3 September, 2009, 6:29 AM

Thank You Sir for the invitation. Hello Friends,

Good Morning and Welcome to this new discussion on `Safe medicine use in Pregnancy'. This is an issue which is very commonly talked of and has assumed widespread importance particularly after the Thalidomide disaster. There are major concerns of permanent harm to the baby whenever any drug is administered to pregnant women . Birth defects induced by maternal exposure to exogenous agents during pregnancy are preventable, if the agents themselves can be identified and avoided. But the problem is further complicated due to the fact that the data obtained from teratogenicity tests in animals cannot always be reliably extrapolated to humans. More than 800 chemicals have been defined as teratogens in laboratory animals, but only a few of these, approximately 20, have been shown to be teratogenic in humans. This discrepancy can be attributed to differences in metabolism, sensitivity and exposure time. Schmid, Trends in Pharmacological Sciences, vol 8, p 133. Therefore, prescribing for pregnant women requires a lot of skill and restraint. Possible harm to the foetus by the administered medicine has to be weighed against harm to both mother and the baby due to untreated disease. There is paucity of data about safety of majority of medicines during pregnancy; largely because prospective drug trials in pregnant women are associated with ethical, legal, emotional and practical difficulties. Information is mostly derived from anecdotal reports and retrospective studies. Keeping these facts in mind let's start our discussion in which we'll discuss the following issues and others which come up as the discussion progresses.

Why is it necessary to be careful while prescribing medicines during pregnancy? What are the various factors on which prescribing medicines during pregnancy depends? Is it safe to take medicines during pregnancy? Which medicines are safe for use during pregnancy? Which medicines are not safe during pregnancy? Is it safe to take OTC medicines in pregnancy? What are the environmental factors that can cause foetal damage? What are the conditions which indicate use of medicines during pregnancy inspite of there known teratogenicity? So, my dear friends I invite you all to share your valuable opinions, suggestions , comments, criticisms, additions and anything else concerning the topic to make this discussion lively and interesting. Kind Regards, Dr. Smita Sontakke Associate Professor Dept. of Pharmacology Govt. Medical College Nagpur

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[Guest guest]

Dear Hegde Sir,

I am sure everybody will agree to what you have said.

Usually it is said that no medicine is 100% safe during pregnancy and hence medicines should be used during pregnancy only when it is very essential.

When we talk about safety of a medicine – probably in general, but certainly during pregnancy –we can’t talk in terms of absolute safety because we really can’t do the type of studies to prove that. When deciding whether or not to use a medicine in pregnancy, we need to talk about the medicine's benefits and risks.

Benefits: what are the good things the medicine can do for the mother and the baby?

Risks: what are the ways the medicine might harm the mother and the baby?

But then there are some medicines the use of which is a must during pregnancy. What are those medicines and why should they be used? I would like to know about these from our esteemed members.

Dr. Smita Sontakke

From: chaitali_bajait <chaitali_bajait>Subject: New topic for discussionnetrumgroups (DOT) comDate: Thursday, 3 September, 2009, 6:29 AM

Thank You Sir for the invitation.

Hello Friends,

Good Morning and

Welcome to this new discussion on `Safe medicine use in Pregnancy'.

This is an issue which is very commonly talked of and has assumed widespread importance particularly after the Thalidomide disaster.

There are major concerns of permanent harm to the baby whenever any drug is administered to pregnant women .

Birth defects induced by maternal exposure to exogenous agents during pregnancy are preventable, if the agents themselves can be identified and avoided.

But the problem is further complicated due to the fact that the data obtained from teratogenicity tests in animals cannot always be reliably extrapolated to humans.

More than 800 chemicals have been defined as teratogens in laboratory animals, but only a few of these, approximately 20, have been shown to be teratogenic in humans. This discrepancy can be attributed to differences in metabolism, sensitivity and exposure time. Schmid, Trends in Pharmacological Sciences, vol 8, p 133.

Therefore, prescribing for pregnant women requires a lot of skill and restraint. Possible harm to the foetus by the administered medicine has to be weighed against harm to both mother and the baby due to untreated disease. There is paucity of data about safety of majority of medicines during pregnancy; largely because prospective drug trials in pregnant women are associated with ethical, legal, emotional and practical difficulties. Information is mostly derived from anecdotal reports and retrospective studies.

Keeping these facts in mind let's start our discussion in which we'll discuss the following issues and others which come up as the discussion progresses.

Why is it necessary to be careful while prescribing medicines during pregnancy?

What are the various factors on which prescribing medicines during pregnancy depends?

Is it safe to take medicines during pregnancy?

Which medicines are safe for use during pregnancy?

Which medicines are not safe during pregnancy?

Is it safe to take OTC medicines in pregnancy?

What are the environmental factors that can cause foetal damage?

What are the conditions which indicate use of medicines during pregnancy inspite of there known teratogenicity?

So, my dear friends I invite you all to share your valuable opinions, suggestions , comments, criticisms, additions and anything else concerning the topic to make this discussion lively and interesting.

Kind Regards,

Dr. Smita Sontakke

Associate Professor

Dept. of Pharmacology

Govt. Medical College

Nagpur

Love Cricket? Check out live scores, photos, video highlights and more. Click here.

Love Cricket? Check out live scores, photos, video highlights and more. Click here.

[Guest guest]

In a healthy woman, pregnancy is NOT a disease. I wonder why some medicines are a MUST in pregnancy?I know of no such medicine.love,bmhegdeProf. B. M. Hegde, MD, FRCP, FRCPE, FRCPG, FRCPI, FACC, FAMS.Visiting Professor of Cardiology, The Middlesex Hospital Medical School, U'sity of London,Affiliate Professor of Human Health, University of Northern Colorado in Greeley,Visiting Professor, Indian Institute of Advanced Studies, Shimla,Retd. Vice Chancellor. Manipal, India

From: chaitali_bajait <chaitali_bajait>Subject: New topic for discussionnetrumgroups (DOT) comDate: Thursday, 3 September, 2009, 6:29 AM

Thank You Sir for the invitation.

Hello Friends,

Good Morning and

Welcome to this new discussion on `Safe medicine use in Pregnancy'.

This is an issue which is very commonly talked of and has assumed widespread importance particularly after the Thalidomide disaster.

There are major concerns of permanent harm to the baby whenever any drug is administered to pregnant women .

Birth defects induced by maternal exposure to exogenous agents during pregnancy are preventable, if the agents themselves can be identified and avoided.

But the problem is further complicated due to the fact that the data obtained from teratogenicity tests in animals cannot always be reliably extrapolated to humans.

More than 800 chemicals have been defined as teratogens in laboratory animals, but only a few of these, approximately 20, have been shown to be teratogenic in humans. This discrepancy can be attributed to differences in metabolism, sensitivity and exposure time. Schmid, Trends in Pharmacological Sciences, vol 8, p 133.

Therefore, prescribing for pregnant women requires a lot of skill and restraint. Possible harm to the foetus by the administered medicine has to be weighed against harm to both mother and the baby due to untreated disease. There is paucity of data about safety of majority of medicines during pregnancy; largely because prospective drug trials in pregnant women are associated with ethical, legal, emotional and practical difficulties. Information is mostly derived from anecdotal reports and retrospective studies.

Keeping these facts in mind let's start our discussion in which we'll discuss the following issues and others which come up as the discussion progresses.

Why is it necessary to be careful while prescribing medicines during pregnancy?

What are the various factors on which prescribing medicines during pregnancy depends?

Is it safe to take medicines during pregnancy?

Which medicines are safe for use during pregnancy?

Which medicines are not safe during pregnancy?

Is it safe to take OTC medicines in pregnancy?

What are the environmental factors that can cause foetal damage?

What are the conditions which indicate use of medicines during pregnancy inspite of there known teratogenicity?

So, my dear friends I invite you all to share your valuable opinions, suggestions , comments, criticisms, additions and anything else concerning the topic to make this discussion lively and interesting.

Kind Regards,

Dr. Smita Sontakke

Associate Professor

Dept. of Pharmacology

Govt. Medical College

Nagpur

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[Guest guest]

Dear Dr. Hegde Sir,

All of us are very well aware that pregnancy is not a disease. Of course, at times pregnancy is associated with other diseases. That is a different matter and we’ll discuss about that in the coming days.

Though pregnancy is not a Pathological state there occur certain physiological changes during pregnancy and there is increased maternal nutritional requirement to meet the increased demand that cannot be satisfied by normal dietary sources.

This necessitates the use of certain medicines which are routinely administered during pregnancy. Its not that if these medicines are not given the pregnancy cannot proceed along its normal course. We are aware about pregnant women from low socio economic background who never visit the doctor thruout pregnancy, do not take any medicines but still deliver a normal baby.

The use of medicines which I mentioned certainly helps to improve the pregnancy outcomes and lower the chances of complications.

Adequate folic acid intake during the periconceptual period, the time just before and just after a woman becomes pregnant, reduces the chance of a baby having a neural tube defect, like spina bifida. Women who are pregnant or trying to get pregnant should take at least 400 micrograms of folic acid daily.

Iron requirement becomes quite large during 2nd half of pregnancy. In the absence of supplemental iron, the hemoglobin concentration and hematocrit fall appreciably, as the maternal blood volume increases. Anemia has been associated with increased risk of preterm delivery.

The developing fetus imposes a significant demand on maternal calcium homeostasis. During the 3rd trimester approximately 200mg of calcium are deposited in the fetal skeleton per day. Dietary intake of sufficient calcium, therefore, is necessary to prevent excess depletion from the mother.

Kind Regards,

Dr. Smita

From: chaitali_bajait <chaitali_bajait>Subject: New topic for discussionnetrumgroups (DOT) comDate: Thursday, 3 September, 2009, 6:29 AM

Thank You Sir for the invitation.

Hello Friends,

Good Morning and Welcome to this new discussion on `Safe medicine use in Pregnancy'.

This is an issue which is very commonly talked of and has assumed widespread importance particularly after the Thalidomide disaster. There are major concerns of permanent harm to the baby whenever any drug is administered to pregnant women .

Birth defects induced by maternal exposure to exogenous agents during pregnancy are preventable, if the agents themselves can be identified and avoided. But the problem is further complicated due to the fact that the data obtained from teratogenicity tests in animals cannot always be reliably extrapolated to humans. More than 800 chemicals have been defined as teratogens in laboratory animals, but only a few of these, approximately 20, have been shown to be teratogenic in humans. This discrepancy can be attributed to differences in metabolism, sensitivity and exposure time. Schmid, Trends in Pharmacological Sciences, vol 8, p 133.

Therefore, prescribing for pregnant women requires a lot of skill and restraint. Possible harm to the foetus by the administered medicine has to be weighed against harm to both mother and the baby due to untreated disease. There is paucity of data about safety of majority of medicines during pregnancy; largely because prospective drug trials in pregnant women are associated with ethical, legal, emotional and practical difficulties. Information is mostly derived from anecdotal reports and retrospective studies. Keeping these facts in mind let's start our discussion in which we'll discuss the following issues and others which come up as the discussion progresses..

Why is it necessary to be careful while prescribing medicines during pregnancy?

What are the various factors on which prescribing medicines during pregnancy depends?

Is it safe to take medicines during pregnancy?

Which medicines are safe for use during pregnancy?

Which medicines are not safe during pregnancy?

Is it safe to take OTC medicines in pregnancy?

What are the environmental factors that can cause foetal damage?

What are the conditions which indicate use of medicines during pregnancy inspite of there known teratogenicity?

So, my dear friends I invite you all to share your valuable opinions, suggestions , comments, criticisms, additions and anything else concerning the topic to make this discussion lively and interesting.

Kind Regards, Dr.. Smita Sontakke Associate Professor Dept. of Pharmacology Govt. Medical College Nagpur

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[Guest guest]

dear all, now a days has come to have one or two childs.hence we r thinking pregnancy is importennt.care reqd. SAFE MEDICINES R REQD.pl. clear our concept define medicine or drug.i have taken tommato in my diet, it is medicine? or i have to take phytochemical tab of lycopene from tomamato, a beta carotine then it wiil be medicine? new research tells tommato is importent call it as medicine.=============================== during pregnancy and after delivery, women may suffer from several ailments. common complaints are nausea, vomiting, gas in abdomen , tiredness, constipation, in digestion, urinary complaints, odema, sleeplessness, fever specially after delivary, weakness, and not having sufficient breast milk.================management Nausea and Vomiting during early pregnacy give 5 ml of lemmon juice with pinch of salt two or three times per day. also ask the women to chew cardamom three to four times per day. =====================for indigestion give 5 ml of ginger juice with honey in equal quatity.===================for insufficint breastmilk give 5 gram of the poeder of SHATAVARI twice daily with milk.===========================for general weakness give one teaspoonful of the powder of ginger, fenugreek with milk.==========diet shold be nourishing, but easily digestable, food including milk, cheese, vegetables,fruits. avoid curd and fried food. garlic, ginger, turmeric, and cumini seeds are useful.========================and that there should be a gap of at least 4 years between two pregnancies.===================and so many advices and suggesstions from world health organisation based on research of traditional medicine. dr surendra 07232 252129 yavatmal.

On Fri, 04 Sep 2009 15:10:25 +0530 wrote

>

Dear Dr. Hegde Sir,

All of us are very well aware that pregnancy is not a disease. Of course, at times pregnancy is associated with other diseases. That is a different matter and well discuss about that in the coming days.

Though pregnancy is not a Pathological state there occur certain physiological changes during pregnancy and there is increased maternal nutritional requirement to meet the increased demand that cannot be satisfied by normal dietary sources.

This necessitates the use of certain medicines which are routinely administered during pregnancy. Its not that if these medicines are not given the pregnancy cannot proceed along its normal course. We are aware about pregnant women from low socio economic background who never visit the doctor thruout pregnancy, do not take any medicines but still deliver a normal baby.

The use of medicines which I mentioned certainly helps to improve the pregnancy outcomes and lower the chances of complications.

Adequate folic acid intake during the periconceptual period, the time just before and just after a woman becomes pregnant, reduces the chance of a baby having a neural tube defect, like spina bifida. Women who are pregnant or trying to get pregnant should take at least 400 micrograms of folic acid daily.

Iron requirement becomes quite large during 2nd half of pregnancy. In the absence of supplemental iron, the hemoglobin concentration and hematocrit fall appreciably, as the maternal blood volume increases. Anemia has been associated with increased risk of preterm delivery.

The developing fetus imposes a significant demand on maternal calcium homeostasis. During the 3rd trimester approximately 200mg of calcium are deposited in the fetal skeleton per day. Dietary intake of sufficient calcium, therefore, is necessary to prevent excess depletion from the mother.

Kind Regards,

Dr. Smita

>

>

>

>From: chaitali_bajait

>Subject: New topic for discussion

>netrumgroups (DOT) com

>Date: Thursday, 3 September, 2009, 6:29 AM

>

>

Thank You Sir for the invitation.

Hello Friends,

Good Morning and

Welcome to this new discussion on `Safe medicine use in Pregnancy'.

This is an issue which is very commonly talked of and has assumed widespread importance particularly after the Thalidomide disaster.

There are major concerns of permanent harm to the baby whenever any drug is administered to pregnant women .

Birth defects induced by maternal exposure to exogenous agents during pregnancy are preventable, if the agents themselves can be identified and avoided.

But the problem is further complicated due to the fact that the data obtained from teratogenicity tests in animals cannot always be reliably extrapolated to humans.

More than 800 chemicals have been defined as teratogens in laboratory animals, but only a few of these, approximately 20, have been shown to be teratogenic in humans. This discrepancy can be attributed to differences in metabolism, sensitivity and exposure time. Schmid, Trends in Pharmacological Sciences, vol 8, p 133.

Therefore, prescribing for pregnant women requires a lot of skill and restraint. Possible harm to the foetus by the administered medicine has to be weighed against harm to both mother and the baby due to untreated disease. There is paucity of data about safety of majority of medicines during pregnancy; largely because prospective drug trials in pregnant women are associated with ethical, legal, emotional and practical difficulties. Information is mostly derived from anecdotal reports and retrospective studies.

Keeping these facts in mind let's start our discussion in which we'll discuss the following issues and others which come up as the discussion progresses..

Why is it necessary to be careful while prescribing medicines during pregnancy?

What are the various factors on which prescribing medicines during pregnancy depends?

Is it safe to take medicines during pregnancy?

Which medicines are safe for use during pregnancy?

Which medicines are not safe during pregnancy?

Is it safe to take OTC medicines in pregnancy?

What are the environmental factors that can cause foetal damage?

What are the conditions which indicate use of medicines during pregnancy inspite of there known teratogenicity?

So, my dear friends I invite you all to share your valuable opinions, suggestions , comments, criticisms, additions and anything else concerning the topicto make this discussion lively and interesting.

Kind Regards,

Dr.. Smita Sontakke

Associate Professor

Dept. of Pharmacology

Govt. Medical College

Nagpur

>

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Love Cricket? Check out live scores, photos, video highlights and more. Click here.

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