Life is going to get even more exciting for Anthony Zammit
The Times, Saturday, 15th November 2008
Anthony Zammit steps into Karl Chircop’s shoes
Surgeon Anthony Zammit will become the Labour Party’s main spokesman for health following the death of Karl Chircop last month, MLP leader Joseph Muscat announced yesterday.
Relatively unknown in the political field, Dr Zammit had skyrocketed to fame after operating on former MLP leader Alfred Sant last December. Mr Zammit gave regular bulletins about Dr Sant’s health while the latter was in hospital being treated for colon cancer.Just a month later, Mr Zammit received a standing ovation during the first session of the MLP’s annual general conference, with delegates applauding and cheering even before he started his address.
During the March 8 election, he was elected from the seventh district with 2,737 votes. In his address at the Labour conference following Dr Sant’s operation, the surgeon had said the Labour leader had emerged victorious from his big medical test and would do the same in the general election. In a clear reference to President Eddie Fenech Adami, he had said Dr Sant had sought treatment in Malta while others had gone to the US.
Reacting to criticism of Labour’s initial coy approach to Dr Sant’s condition, he had said: “The Nationalists were offended when we told them he is there and he will be there… They described my bulletins as similar to Fidel Castro’s… Where is the professional ethic? They threw mud, cast doubts, created uncertainty. He is there and he will be there.”
In August, he was again catapulted into the headlines after going through the trauma of a hold-up in which he was bound and beaten at his residence in Żebbuġ by three hooded and armed men who made away with about €1,200, some wristwatches and a signet ring with diamonds.
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apparently ‘exciting’ is the operative word for Zammit. From what I’ve heard, he’s into thrills.
God help us then! What with MUMN, and now Prof Zammit as spokesperson for health, God help all patients at Mater Dei, and the other hospitals. At least it is not Dr. Farrugia, who is spokesperson. There is a God in heaven!
God help us with the difficult situation in Mater Dei. It is neither the MUMN not the opposition who is responsible for the shortage in staff at this hospital. Now we have been told that another hospital is being build on the same land. I wonder who the building contractor is going to be. Apparently this government solves all problems by constructing what he calls state of the art buildings. Then never bothers about services rendered.
[Daphne – Ho.Hum. And governments are ‘it’ not ‘he’ – or at a pinch, ‘they’.]
Why is it that spokespersons on health are nearly always doctors? With John Dalli as minister I am hoping to see more ‘managerial’ decisions to increase the efficiency in the health sector.
For example he is in a better position to tackle the problem of the high cost of medicines which finances the commissions and perks doctors take from renowned pharmaceutical companies.A case in point is the ‘anti inflammatory ‘ medicine Au******tine. If one cuts his finger, or has a soar throat be sure that the doctor prescribes a coarse of this magic broad spectrum pill. And please note that as soon as you stand up to leave, your doctor will put a little mark on a small paper so that at the end of the day he will count the amount of branded medicines he ‘sold’, for which he will get a commission for pushing that brand.
When we where young the doctor used to prescribe a medicine in its chemical name and the pharmacist supposed to offer the client medicines of different brands.
As things stand pharmacists aren’t performing their real job .
BTW one can always ask the pharmacist for equivalent generic medicines, but few people know about this.
The MUMN is in no way helping with the situation……..anzi MUMN is only worsening the situation. Many nurses ta’ stoffa are ignoring the union’s directives. The shortage is not really there………what needs to be done is some redeployment, like for example, the waste of so many nurses doing clerical work at out patients………..they are just happy to act as messengers, calling people, to attend to the consultants’ rooms, prepaaring coffee for the doctors.
Nurses are trained for 4 years to do more than that.
Grace
“Apparently this government solves all problems by constructing what he calls state of the art buildings.”
For the record, the term “state of the art”, referred to Mater Dei hospital, was used by Alfred Sant.
What do you mean, “another hospital is being built on the same land” ? Is it being built within the grounds of the existing hospital or literally over it (as additional storeys)?
Dear Grace
Mater Dei was not originally planned to be what it is to day. Dr Edward Fenech Adami, and his team had thought of building a reserach hospital on the same ethos of San raffaelle Hospital. In the 18 months that Dr Alfred Sant was Prime minister he turned upside down all plans, and decided that that new building will become a huge acute main hospital. The money spent there is all thanks to the man without vision.
Dr Joseph Cassar Parliamentary Secretary for Health stated that the new oncology hopsital will not go to Zammit Clapp, but will be erected in the grounds of Mater Dei, a good move, since over there there are the radiology department, and the foundations for a bunker. I do believe that Hon John Daalli, together with his two junior ministers knows exactly what they are doing.
Daphne, can you start something on the rather sad situation that MUMN has placed all nurses please?
[Daphne – MUMN: I don’t know enough about it as I haven’t been following it closely, but I’ll read up.]
Dear Daphne
MUMN is saying that there is a shortage of nurses. It has issued directives for nurses not to answer telephones and the new IT thingies that Mater Dei has, not to collect pharmaceuticals from the pharmacy dept. At SVPR, nurses cannot be moved from one ward to another, they are instructed not to lift and handle elderly patients. The president Mr Paul Pace doesn’t it seems have a clue what nursing ethics are.
@ John – if you have definite proof – then put up a report to the Medical Council (this could also be in the form of an anonymous letter). If on the other hand you have no proof of what you are saying then please shut up!
Though some GP’s still get a cut from the consultant’s home visit fee without informing the patient (they can get a cut but have to inform the patient) – I think that direct commissions from the pharmaceutical companies are not as common as you are making it sound. The drug that you have mentioned is a widely used braod spectrum antibiotic and though it is heavily overused (by patients, compliant pharmacists and doctors), from a GP perspective it is not overused for the reasons that you mention but most likely direct (or more likely indirect) patient pressure and fear of medical litigation.
On the other hand, the one that makes a profit (and this is known) is the pharmacist. So whilst they stopped the pharmaceutical firms from supplying flu vaccines to doctors directly citing the fact that doctors can prescribe but not supply medicinals, they (the pharmacists) still administer injections (the flu vaccine in particular) as well as supply drugs over the counter – both in contravention of the law.
As for the price of medicines, these are decided on a regional basis by the company and in actual fact most of the drugs in Malta fall within the cheaper bracket within the EU.
I would have thought that you should complain at the way a large number of drugs have disappeared from the market, as the pharmaceutical companies consider the Maltese market too small – basically economically unfeasible.
“On the other hand, the one that makes a profit (and this is known) is the pharmacist. So whilst they stopped the pharmaceutical firms from supplying flu vaccines to doctors directly citing the fact that doctors can prescribe but not supply medicinals, they (the pharmacists) still administer injections (the flu vaccine in particular) as well as supply drugs over the counter – both in contravention of the law.”
CHRIS II – Its obvious that you are a doctor, isnt it/ THe law states that doctors CANNOT supply flu vaccines, only pharmacists can do that.Thats why they were stopped. They were selling the medicine, something that they cannot do. Thats why there is a law.
There are pharmacists who have undergone the necessary CPR training in order to be able to inject patients. And OTC drugs are clearly labelled as so and Pharmacists are will within their profession to issue them. The name says it all . OTC = OVER THE COUNTER.
If the pharmacy didnt make a profit, then they would start charging a dispensing fee, as a pharmacy in the rest of the EU can do. The sooner it happens, the better. The average presciption fee in the EU is around 11 Euros.
@John Schembri
For example he is in a better position to tackle the problem of the high cost of medicines which finances the commissions and perks doctors take from renowned pharmaceutical companies.A case in point is the ‘anti inflammatory ‘ medicine Au******tine. If one cuts his finger, or has a soar throat be sure that the doctor prescribes a coarse of this magic broad spectrum pill.
Augmentin is a beta lactam antibiotic that costs money wherever you go, because you are buying the brand, and because its expensive to make. There is a parallel Imported version that is cheaper, plus there is an ever cheaper generic. Needless to say, the generic is mostly unsold because people want the brand. It is NOT supposed to be prescribed for cut fingers, unless the wound is great, and its not the antibiotic of choice for that. Cefuroxime or Ciprofaxin are usually prescribed for that. Suggest you change your doctor if he gave you that. Augmentin however, is over prescribed in Malta.
“And please note that as soon as you stand up to leave, your doctor will put a little mark on a small paper so that at the end of the day he will count the amount of branded medicines he ’sold’, for which he will get a commission for pushing that brand.”
This is illegal according to the Medicines Act 2003. It is a criminal act, and goes against doctor’s ethics. But it happens, I’m not denying it. If you have any tangible proof, please contact the Medicines Authority on 23439000.
“When we where young the doctor used to prescribe a medicine in its chemical name and the pharmacist supposed to offer the client medicines of different brands. As things stand pharmacists aren’t performing their real job .BTW one can always ask the pharmacist for equivalent generic medicines, but few people know about this.”
That is a really fatuous accusation. Pharmacists do their job in Malta excellently, and the standards are very very high. Their JOB is to dispense what the doctor prescribes, and you JOB is to ask if any alternatives exist, and buy them, John.
I was involved in the writing of the Medicines Act 2003. In it the Pharmacist can substitute a brand with a generic, but doctors have always opposed this, to the extreme of telling their patients to shun the pharmacy that did offer that choice. You will be surprised by the amount of vile accusations and other unseemly words thrown at me whenever I pushed for generic substitution and this by Doctors who are in leading positions at the Ministry. Not all doctors are like this. Government refuses to legislate so that doctors prescribe using generic names because it would limit doctors’ choice. There is some merit in that argument if we had to be a third world country, but not today.
However all of you think we as medicines importers and retailers run charities. I am proud to be one, but i will not be called a thief. Medicines cost more in Malta because the expenses for us to import, store, and deal with the plethora of documents and standards are the same as anyone in any other EU country. The market, however, is not the same sized one. We actually have minimum quantities we need to import and have to throw away at least 25% yearly in expired medicines, for example. It’s a simple fact of life that our buying power in Malta is the same as a small town in the UK. It’s take it or leave it. Everyone complains about medicines prices because we have to pay out of pocket, when in fact in the rest of the EU they are REIMBURSED by either Govt. Or the Insurances called Sick Funds. Reimbursement would be ideal for Malta, but it would make the Government’s medicine bill shoot up astronomically, plus it would also entail that pharmacies charge a prescription fee, something that they don’t do as yet, but is theirs by right.
By the way, the decision to site the new Oncology department at Mater Dei is the correct one. There is plenty of land and plenty of space. And it would be cheaper in the long run.
As for MDH being state of the art, it is. There is no other PUBLIC hospital of the same standards and levels of equipment in all of the EU, except maybe Sweden. Be thankful, we are well served.
I think it is about time that doctors should be made to precribe medicines using the generic name.
@ Mario Debono:
WOW! I’m impressed! Chris II must’ve really got your goat there, Mario – or is it simply a chip on the shoulder? A clear case of the coal scuttle calling the kettle black!
But back to some serious talk now….
@ Antimony:
Couldn’t agree with you more, Antimony. And irrespective of what the good doctor prescribes for me and mine, I’ll be asking for the generic alternative next time round.
Mario Debono – I was not referring to OTC’s but to antibiotics and other POM’s.
And yes, I had no problem in the vaccine issue but on the same level pharmacists should not administer any type of injections (vaccines or otherwise).
As for what is better Augmentin or the other two drugs mentioned – they are all the three on the same level – all are effective against beta-lactamase. In actual fact augmentin is most probably the cheapest of the lot.
Restricting doctors to prescribe generics (in the private practice as opposed to NHS) is both counter-productive and as far as I know is not practiced anywhere in the world (though the practice that pharmacist advice their clients about the availability of generics is a normal practice especially in Germany).
One has to understand that for every drug a Pharma company introduces to the market, 9 others have been discarded ( with usually a huge a financial loss). Thus if they are not allowed to recuperate these losses, none would be able to continue in its research efforts and we might end up without novel drugs and in the long term one would end up without any generics.
And, as you are an importer, the initial accusations were also mainly directed to you i.e. that importers are illegally giving commissions to doctors for prescribing certain drugs – something that I have still to meet in my 30 years or so of medical practice.
@ Mario Debono
Yes true we are well served if you can afford to wait for the treatment. I have to wait 2 to 3 years for a knee operation. I waited 10 months to have an MRI scan too. And yes I do not afford treatment in a private clinic and nor do I afford a health policy for the time being.
Please note also that the original plan for the MDH had the Oncology Department together with the Medical School planned as part of the initial setup. I guess lack of funds or time had forced the Government to let go of them for the time being. It is obviously the wisest decision to have the Oncology Department within MDH.
@Chris II
“And, as you are an importer, the initial accusations were also mainly directed to you i.e. that importers are illegally giving commissions to doctors for prescribing certain drugs – something that I have still to meet in my 30 years or so of medical practice.”
I am known for NOT giving commissions to doctors because my business model does not allow it . Ask anyone. My reputation is pristine on that one, and I plan to keep it that way.As such i resent the accusation.Dont lump me with everyone else.
“And yes, I had no problem in the vaccine issue but on the same level pharmacists should not administer any type of injections (vaccines or otherwise).”
So what you are saying is that no one except doctors can administer parenterals? If that was so, all hospital would stop. Nurses are trained in this. And so are some pharmacists. I dont agree that someone without the proper training, and as you know the training is basic CPR, should do it.
Restricting doctors to prescribe generics (in the private practice as opposed to NHS) is both counter-productive and as far as I know is not practiced anywhere in the world (though the practice that pharmacist advice their clients about the availability of generics is a normal practice especially in Germany).
This is the practice in ALL of the EU except Malta and the UK
“One has to understand that for every drug a Pharma company introduces to the market, 9 others have been discarded ( with usually a huge a financial loss). Thus if they are not allowed to recuperate these losses, none would be able to continue in its research efforts and we might end up without novel drugs and in the long term one would end up without any generics.”
This is not true. All funding the drig companies get are either from Governments or by issuing more stock on the stock market. Thats how they make most of their money.And thats why their profits are huge.
@Mixx. Yes he got my goat there. I’m no virgin, but I’m far away from being a coal scuttle. If you want to see coal scuttles in action, read yesterday’s Malta today.
@Antimony. Thats the spirit. Do that. If you ask me, I can tell you what generic alternatives there are.
@IM Dingli. _ all the private hospitals are suffering from lack of sales. Now your wait tells you why. Everyone is going to MDH. The systems there are simply the latest.As to the oncology dept being at MDH, i couldnt agree with you more.
Mixx,
I am sure the pharamacist will be happy to oblige you and then of course be ready to answer for the legal consequences should you end up with a serious allergy caused by the generic alternative you insisted on getting rather then what the doctor prescribed.
@ Mario – please note that I was not the one that made the initial accusation – this was written by John – so when referring to you as an importer, it was not meant at you personally though John had put everyone in the same basket, i.e. all doctors and importers – as I said I have never come across a case of commissions being offered by importers to doctors – so please read the posts well as I have also a reputation to safeguard.
“So what you are saying is that no one except doctors can administer parenterals? If that was so, all hospital would stop. Nurses are trained in this. And so are some pharmacists. I dont agree that someone without the proper training, and as you know the training is basic CPR, should do it.”
I was not referring to nurses, these are all trained and this is part of their job, but in the case of pharmacists, and taking your cue, only “some” are trained i.e. the majority are not and patients cannot know that.
“This is the practice in ALL of the EU except Malta and the UK”
Again I believe that you are only referring to National Health Schemes. One can legislate to the effect that only generics can be prescribed within the NHS but when it comes to private practice (where the patient and not the national insurance pays), then it is very difficult to legislate (and I believe goes against one of the main principles of professional freedom). So in most countries there are moves to encourage doctors to prescribe generics, which is laudable. If you have more and direct information of such legislation, I would be very happy to know about them. Do not take my arguments to mean that I am not in favour of generics – the truth is diagonally opposite and I tend to prescribe generics whenever it is possible, safe and of equatable pharmaceutical quality to the branded type.
“This is not true. All funding the drig companies get are either from Governments or by issuing more stock on the stock market. Thats how they make most of their money.And thats why their profits are huge.”
Government funding is in fact a very small proportion, most pharmaceutical companies (as you have pointed out) issue stock. But the take up of stock depends on the how confident investors are in investing within that particular market. In fact, in the past few years, the pharmaceutical industry’s stock market performance has been declining when compared to other areas. The reason for this decline has been mainly pegged down to the industry’s failure to discover and develop a sufficiently high number of high-value and innovative products to the market, to replace the drugs facing patent expiry. Thus, the industry has not maintained its historical growth rates.
Just to give an example, it is envisaged that between 2007 and 2012, the top 50 pharmaceutical companies will face patent expiries on $115 billion worth of drugs, whilst on the other hand, in 2007 the FDA approved only 19 new drugs which is the lowest number in 20 years. This is compounded by the fact that the cost of developing new therapies has risen (and is still rising) with an average of $800m to bring a drug to the market (15 times as high as in the 70’s and 3 times as high as in the 80’s)
Issuing stock is an indirect way of taking loans – the only way that they can make money out of stock is to make a profit that is higher than the amount paid as interest to the stock holder – and this means actual production of pharmaceuticals.
This is reality, we live in a world where business (and profit) are the key towards the promotion of innovation and research – without the possibility of an industrial application, even government funding is not available – just see the regional and national R&D funding regulations as well as the EU’s Framework 7 funding programme). In all, the recurrent terms are patents, copyrights and applied research.
@Mixx – Though it is generally safe and cheaper to go for generics in a tightly regulated market such as Malta, be advised that in some cases it is medically not advisabel to change brand let alone go for generics. The main diference between brands and generic is usually bioavalability issues and in some cases where the therapeutic dose is very near the toxic dose or where the therapeutic limits are very thight, then changing your brand might cause you sever problems (three cases that come to my mind are Lithium, anticoagulants and epilepsy drugs.
The physician/patient relationship is one built on trust, if you lose you trust in him/her, then change your physician. Thus, whilst you can discuss the use of generics with him/her, you are finally free to take his/her advice or not.
@ Sybil
One of the major problems is in fact that of liability. If a physician prescribes branded drug A and the pharmacist offers the generic drug B, who is liable and how can liability be proven, if the person reacts badly to the drug?
What is the liability of the pharmacist? How can the physician protect himself/herself? These are questions that need to be asked and a reasonable answer identified.
http://www.consumerwarningnetwork.com/2008/09/18/warning-generic-drugs-not-always-equivalent-to-name-brands/
After carefully considering the content of the above website, remember this:
Your doctor is RESPONSIBLE for what he prescribes (and only that), and does so with your interest at heart. When he/ she prescribes a drug he/ she is doing so because he/ she knows it is a good drug, which one can depend on. He/ she has experience using that drug, and knows it to be effective, safe and good, and is comfortable prescribing it. These do not only include drugs with a brand name, but also some of the better generics.
When one considers different drugs which contain the same active ingredient, one must keep in mind that two drugs (branded and generic) may not be totally identical. There may be differences in absorption of the two drugs, and hence in their bioavailibility. Besides the active ingredients, a drug also contains other ingredients which may differ in the two drugs.
As Sybil implies, once a doctor’s prescription is not followed, the doctor loses any liability, should anything happen as a side-effect, following the self-administration of any other drug.
@ Mario Debono: nurses do not administer parenterals in hospital, and have not done so for years. A doctor is called to do so. Nurses do not even take blood samples in hospital, and a doctor must do so.
Also, if certain doctors are receiving commissions from certain companies, and you know so, then maybe it’s about time you reported the fact. It is illegal and reprehensible, but I doubt that it is particularly wide-spread.
“Chris II
@ Sybil
One of the major problems is in fact that of liability. If a physician prescribes branded drug A and the pharmacist offers the generic drug B, who is liable and how can liability be proven, if the person reacts badly to the drug?
What is the liability of the pharmacist? How can the physician protect himself/herself? These are questions that need to be asked and a reasonable answer identified.”
I belive that when the pharmacist despenses a mediciation that is not the exact one prescribed by the doctor, then the pharmacist is shouldering a legal resposability that he is not supposed to shoulder by law. It is easy to say that “u iva, mhux xorta Xyz-tine jibqa wether it is a brand medicine or a generic one”. But what happens then if, the patient gets a fatal allergic reaction to the medicine despensed by the pharmacist(which was not the same one as thatprescribed by the doctor) because of, for example, the components of the different coating of the pills or capsules or the dodgy provenience of the medicine itself? The doctor in that case will simply point out that the medication dispensed by the pharamacist was not the one prescribed by him and he is not to blame for the consequences of any bad side effects caused by the medication dispensed by the pharmacist. So I do belive that one has to be very careful when saying that he will demand of the pharmacist a cheaper version of the medicine prescribed by his doctor.He should stop and think of the consequences first.I know of pharmacists who ended up having quite a few bad legal headaches when they ended up dispensing medicines that were not the exact ones prescribed by the doctor and then had to answer for themselves to very irate patients for the serious side effects that cropped up.
Re commissions, I was led to believe that Pharmacists themselves are offered “commissions” in the form of bonuses to encourage them to dispense certain over-the-counter medicines and not others. I think this goes under the name of “bonuses”. I may be mistaken though.
@ Sybil – the bonuses issue is real and not only on the Over-the-counter medicines. It is basically a way of increasing the profit to the pharmacist without going against the ethical regulations of discounting pharmaceuticals (pharmacists and pharmaceutical wholesalers are prohibited from giving discounts). So if a pharmacy buys in bulk, the wholesaler gives bonuses. I think that as long as this is not artificially increasing the price of the product, this is an acceptable situation – after all pharmacists (like doctors and importers) are not running a charity.
As for liability, I agree with you but my worry is the fact that the bad habit of not keeping proper records and copies of prescriptions (by most doctors and pharmacists) complicates the question of liability. How can a doctor prove that he/she has prescribed a different drug from the one that the pharmacist dispensed without the proper filing of the prescription?
I think that the Medical Association should tackle these issues and not waste their time on petty issues (e.g. food allowances).
Agree completely with Sybil. If a patient gets a reaction to, or reacts unfavourably to, any medication which is not prescribed by the doctor, then it cannot be the doctor who is liable any more, but whoever dished out the different drug. If the case comes to Court, the latter will not have a leg to stand on, and the patient will definitely not have a case against a doctor if he chose not to take the medicine prescribed, but something else instead.
There are already many generics on the Government formulary, and these are used within the Health system (in hospitals and free drugs) instead of branded drugs. However, I agree with Chris II that it is difficult, and maybe even unethical, to oblige a doctor to prescribe generics in private practice. I believe that once a doctor is taking responsibility for prescribing a drug, then he/she has every right to choose the drug he/she believes to be the best. If not, then he/ she cannot be held liable for any misadventure resulting from the administration of a drug which is being promoted, and which is different from the one which the doctor wishes to prescribe.
“Chris II Tuesday, 18 November 1307hrs
@ Sybil –
As for liability, I agree with you but my worry is the fact that the bad habit of not keeping proper records and copies of prescriptions (by most doctors and pharmacists) complicates the question of liability. How can a doctor prove that he/she has prescribed a different drug from the one that the pharmacist dispensed without the proper filing of the prescription?”
Quite simple actually. I can prove that I was seen by a particular doctor and prescribed a paticular medicine by hanging on to my prescription together with the box of medicine that I was actually dispensed by the pharmacist and the receipt.
@Chris II and Moggy:
I did not say that doctors should be made to prescribe generic drugs but prescribe drugs using their generic (non-proprietry) name, which is a different thing.
@Mario Debono
Are pharmacists allowed to dispense a generic version if the doctor have prescribed a branded version of the drug?
@ Chris II – Hence the importance of keeping accurate medical records.
@ Antimony – If a doctor prefers a particular brand name for the reasons explained above, who is to oblige him to use another one? If this is done, should a doctor remain liable if the patient reacts badly to the generic drug, or if it does not have the desired effect (see the link I posted – two similar drugs may not have the same bioavailibity, or be absorbed at the same rate)? If a doctor is to shoulder the responsibility of what he prescribes, then he should be allowed to make the choice. It is only fair.
@Antimony
If a doctor prescribes the drug with its generic name, then the pharmacist is free to dispense any brand – hence whilst the doctor is stil liable (he is the one who has prescribed the generic drug) whilst the pharmacist is not liable at all.
@ Moggy – agreed 100% on the need to keep complete records – unfortunately most doctors do not.
@ Sybil – to be fair, a copy of the prescription, together with some proof of the item dispensed, should also be kept by the pharmacist, so that he/she can be covered. I think that prescriptions should be written on a three copy basis – one to be kept by the doctor, the other by the pharmacist and a third would be the patient’s copy. The pharmacist should then put in both copies (his and the patient’s) in a system where the brand name of the drug and maybe even the lot number, is clearly printed on both his and the patient’s copy. I have seen this system at work in Finland (in this case they even go a step further, the doctor asks you for your preferred pharmacy, and the prescription is sent through the system to the pharmacy and one fidns the medicien ready and packed when he/she goes to pick it up).
We are now in EU and the generics presently in the market are all of EU origin. For a medicinal product to reach the market in the EU a dossier must be submitted.
In this dossier the manufacturer has to demonstrate quality safety and efficacy. Quality and safety standards are the same be it for branded products as well as generic drugs. the story is a bit different with regards to efficacy whereby branded drug manufacturers submit the clinical trial data while generic manufacturers submit a bioequivalnce study to demonstrate that the generic product is bioequivalent to the branded one.
While it is granted that a doctor should be left free to choose between a generic and a branded product; IT IS VERY SORRY AND MISCHIEVOUS TO CAST DOUBTS OVER THE QUALITY OF GENERIC DRUGS given the present scenario that generics all originate from the EU.
I hope that this is a genuine misconception and not fuelled by someone to please originator companies.
[Daphne – This is not something I know much about, so I’ll leave you to thrash it out between you.]
According to Wikipedia: The United States Food and Drug Administration (FDA) has defined bioequivalence as, “the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study.”
So I cannot see how a generic which has been deemed as bioequivalent can have a different rate of absorption.
[Mario Dalli – The story is a bit different with regards to efficacy whereby branded drug manufacturers submit the clinical trial data while generic manufacturers submit a bioequivalnce study to demonstrate that the generic product is bioequivalent to the branded one.]
Which is because the branded drug manufacturers are the ones who carry out research on, and develop, the drugs in the first place, leading to their products being more pricey.
@ Mario and Antimony
If two drugs are bioequivalent, then they should have the same therapeutic effect and basically can be considered the same drug.
There are only two potential problems:
1. A large portion of the drug (i.e. oral drug) are excipients, basically inactive substances usually used to bulk up the drug (e.g. a 50 microgram dose is usually too small to packed into a tablet, so an inert compound is added to make it larger). There are persons that can be either allergic or intolerant to some e.g. gluten in wheat starch. So whilst the bioequivalence is the same, one drug might produce an allergic reaction whilst the other no.
2. Bioequivalence is taken with a confidence interval of 90% that is one can have a difference of +/-10%. Whilst this is acceptable in most cases e.g. antibiotics in some e.g. epileptic drugs, lithium (used in manic depressive disorders) and anticoagulants, the difference between the therapeutic dose and the toxic dose can be less than 10% and thus there is the risk of either an over or under dose. That is why in these cases it is recommended not to change brands – so it is not the same as saying not to use generics but to use the same brand of generics.
Daphne
What about writing something about MUMN
[Daphne – I’ve set it aside for Sunday.]
Thank you so much
Moggy “Which is because the branded drug manufacturers are the ones who carry out research on, and develop, the drugs in the first place, leading to their products being more pricey”
Agreed and granted.
That is why there is a patent which gives a temporary monopoly so that the comapny can recoup the money it invested in the research and in getting a product to the pharmacy shelves.
I do however beleive that after the patent expires, patients have a right to have their medicine at a better price. It is also a means of social justice otherwise medicines would only be available for people who can afford them even in the western world.