'Battle of the Drugs'

To prescribe or not to prescribe.....? - Doctor's dilemma

by Umangi de Mel

The 'Battle of the Drugs' is apparently pretty much on. People are surprisingly interested probably for obvious reason such as dear life. According to the Health Ministry, doctors in the government sector must prescribe generics and explain to the patient about other brand alternatives available, before prescribing the latter if the former prefers it while doctors in the private sector are permitted to write both generic and the brand name.

The Act has given rise to opinions that are poles apart. Thus, the Sunday Observer presents a cross section of opinions. "This is not a new law. It's been in existence since 1980. Under Mahinda Chinthanaya this Act will be enacted and nobody can find fault with me," says Nimal Siripala de Silva, Minister of Healthcare and Nutrition making a statement.

"There were many people from the general public who questioned why the law was not implemented. There are certain doctors who write the trade name and write 'no substitutes'. This is unfair by certain patients who might not be able to afford. Instead he's supposed to explain the procedure to the patient. If the doctors don't comply with the regulation they could be penalised under the Act.

Pharmacies should stick to the rule and dispense the generics unless a patient demands he wants a more expensive trade drug. There's no need to worry about quality, as all the drugs are registered with the Cosmetics, Devices and Drugs Act (CDDA). We won't import drugs without a proper registration. We've been using generics to treat patients in the hospital from time immemorial, has anybody complained or died? And multinational companies spend millions to market or sell other branded drugs."

On the contrary, Shirantha Peiris MD/Chairman of Mega Pharma says that the brand drugs have what they call a 'brand responsibility' where it assures its effectiveness. "Most drugs have a brand and pure generic. When a drug is called a branded original, it's a drug that is put out by the company that spends billions of dollars on research to discover a molecule of a substance. A branded generic is a drug which is produced by other companies which are given the right to manufacture a similar alternative with the same component after the patency of the branded original is expired.

"All products containing generics have the same curative quality. And there's certainly a big difference between a brand and a generic drug available in the market, in the pharma parameters, such as, desolution absorption and shelf life. The potency of most generic products that are available in the market (that claim to last 3 years) is reduced up to about 25% if you do a random batch test after 1 1/2 years.

The doctor is the person who sees the efficacy of certain brands. The stuff that work on patients, he prescribes. He's the one who utilises brand responsibility for the effect it shows on his patient. Now, the pharmacist will dispense the generic that he has the biggest margin. As for the companies, they'll import the cheapest possible product and will give massive bonuses for those. True, the pharmaceutical companies make profit out of which 25% is ploughed back to the well being of the patient by having doctor conferences where doctors are updated with the latest techniques and equipment, foreign training to the doctors and refurbishing government hospitals. The entire cycle is going to break down.

We, as pharmaceutical companies, take from the rich who can afford the branded drugs and facilitate the poor. It's going to be shattered and the poor man is going to be at the mercy of a failed medical system."

"This is not a new regulation. It has been there since 1980, under the Cosmetic, Devices and Drugs Act, No. 27 but it wasn't carried out for some reason. Now prescribing drugs under their generic name has been made a compulsion due to major reasons, such as patients being overcharged by the drug companies for the same quality drugs, and the mushrooming brands that tend to confuse the pharmacist," says W.M.D Wanninayke, Media Secretary, Ministry of Healthcare and Nutrition, commenting on the issue.

"For many years, the drug companies have overburdened patients with the ever increasing drug prices. For example, the Cestriasone 1g injection (generic) which is available for Rs. 100 is sold by the trade name of Rocephin for Rs. 962.50.

An Anti diabetic 5mg tablet called - Glibenclamide which is available for six cents is sold by the trade name of Euglucom for Rs. 9.73. Salbutamol is Rs. 190 but is sold for Rs. 375 in its brand name which is Ventolin. Medendazola 100mg which is available for 43 cents, will cost you Rs. 17.12 to purchase by its brand name Wormox. Also Gentamycin, an eyedrop is Rs. 35 and is sold by its brand name Garamycin for Rs. 360.20.

There's absolutely no question about the quality of the generic drugs as any drug or equipment that's to be sold must first be registered by the Health Ministry. The approval is given by, (a) a Council which comprises high profile professors and doctors in the field, (b) Centre for Drugs Quality, (c) Medical Supplies Division or (d) Drug Regulatory Authority.

All the drugs and equipment are tested and checked by these bodies before distributing them to the pharmacies or hospitals. Later on we conduct random sample tests to ensure the quality of products already available in the market."

He points out that pharmacists get confused dispensing a branded drug since he or she may not be literate enough to even read the prescription properly, "Whereas it's easy if it's in its generic name. Some of our pharmacists don't even have a proper training which is why we are training 4000 pharmacists and MLTs and after two years, they'll be able to start on their own.

There is absolutely no difference between a generic and branded drug. The only difference is the price and the name. Ingredients are the same and so is the efficacy.

People are making a big fuss about nothing, they'll get used to it. The Act will ensure that poor people are not burdened by costly drugs that are also available for less in another name. Doctors should think about the public first and not the drug companies.

A doctor is supposed to take time and explain to the patient about the price difference and let the patient decide. If the doctor doesn't do that, the patient can complain to the provincial director or the Health Ministry and we will do the needful."

He also states that a doctor could be penalised if they don't carry out the instructions, "they could be fined or imprisoned. True, the import of brand drugs is higher than that of, the generic, but we bring down 7000 generics which will now be increased. Just that the ministry wants people to benefit and get the best for their money. We won't stop importing brand drugs either. All the drugs are available in its generic thus the pharmacist doesn't have to be confused as to which they should give the patient.

Government doctors can't prescribe brand drugs as we believe only poor people who can't afford the costly brands go to govt. hospitals.We should educate the poor people about drugs. Only the media can do it but they're only interested in themselves. Also, the drug regulation has become a big issue because most journalists get freebees and are sponsored by big drug companies. Papers are run thanks to the advertisements given by companies, so journalists are obliged by those organisations to put what the latter want. Anybody is free to purchase brand drugs but please don't put the blame on us, the ministry or the president about the high prices.

The bottom line's that the brand drug's are costly not because they are better in quality but they need to cover the publicity and packaging cost."

Sharing his view on the issue, Dr.Anuruddha Padeniya, Secretary, Government Medical Officers Association (GMOA) says that there's no such regulation, "when I spoke to Dr. Athula Kahandaliyanage, he said that it's merely the Minister's statement and that there's no such act.

Actually Senaka Bibile was an intelligent doctor who introduced the concept of rational prescription. His vision was to introduce the national drug policy which is implemented in many countries but ours. So, we are still without a national drug policy, being the very country that gave birth to it.

Without introducing a drug policy, the ministry wants to agitate the doctors against a totally different issue so that the former's action could be misinterpreted. Irrespective of what the government doctor prescribes, the hospital will only give what's available, purchased by the health ministry. For each generic, the ministry has registered over 200 brands. If concerned, they should restrict the amount of drugs that are registered.

Once you prescribe a generic, the pharmacist has the liberty to give any drug out of those 200. Out of 20,000 pharmacies, less than 300 pharmacies are registered. Most pharmacists are not qualified. So it's in the hands of the sales person at the counter. The tendency to give a high priced drug where they'll have a high profit margin is very high."

He also states that Sri Lanka does not have a drug information centre. "GMOA proposed one about three years back after which the government appointed five medical officers to run the centre which suddenly came to a halt.

When it comes to drug quality, Sri Lanka only analyses the sample at the registration. In other countries, they conduct post marketing surveillance where they'll assure the drug quality on a regular basis.

The motive behind the so called act is to tarnish the image of doctors. What we need is a national drug policy and a drug information centre. Plus, it's absurd when the very people who want to implement these laws, come to us when sick, asking the very best of drugs irrespective of it being generic or brand."

"There's no new circular or no new gazette notification to this effect. Though an extra-ordinary gazette notification was issued on July 6, 1992 giving a new regulation," says Adrian Basnayake, President, Sri Lanka Chamber of the Pharmaceutical Industry - (SLCPI).

"Basically the current situation is that a doctor is well within his/her right to write a brand provided he/she includes the generic in the prescription. That's the legal stand point.

But the media has a different story which says that the government has banned prescribing brand names. However, it's incorrect to communicate to the doctors and the public at large that all the generics are the same.

Because you have to conduct tests to prove that two drugs are the same. The method to do this is the bio-equivalence test which is not conducted routinely for the products that are available in the market. Thus there's no evidence to prove that all drugs are the same. Secondly, the national drug quality assurance lab conducts other tests to assure the quality of the imported drugs used in the government hospitals. The best way to prove their point is to release the test results for the last five years in the public domain for everyone to see.

But the reality is that a large number of drugs have failed in quality.

The next point is not all the generic quality's the same. A doctor chooses a product because he has faith in that particular brand as he's experienced the efficacy over the years.

If he's to write in generics, he doesn't know what his patient is getting as the pharmacy gets to decide which particular manufacturer the patient gets. Most of the pharmacies in our country are manned by unqualified pharmacists. Eventually the doctor loses the faith and trust he maintains with the patient to ensure that the latter gets the quality product. Even if it's a qualified pharmacist, he can't conduct quality tests in the pharmacy. Ultimately the patient will end up getting a drug of poor quality.

Also, the WHO/Health Action International report published in 2002, conducting a price analysis of pharmaceuticals in a number of developing countries, has shown that Sri Lanka has the lowest pharmaceutical price and it also says if the prices were to come down anymore, the price reduction will come down at the cost of quality, which means Sri Lanka already has a very good drug supply system.

Thus, this kind of upheaval is unnecessary. Anyway our doctors in most instances, use lower priced branded generics. The quality won't be ensured if you try to make it pure generic."

How does a conception occur
 

Dr. Vijith Vidyabhushana

Consultant Obstetrician and Gynaecologist, Colombo North Teaching Hospital, Kalubowila

The basic requirement for a conception to occur is the egg (Ovum) meeting the sperm in the outer portion of the Fallopian tube. This process is called Fertilization. The man should have healthy viable and normal sperms which are moving forward. Once sperms are deposited in the vagina, they travel through the neck of the womb to the cavity of the womb and then to the Fallopian tubes. Although sperms die within hours after ejaculation they can survive up to a maximum of seven days once they are inside the womb.

Once the egg is released from the ovary, it is caught up by the outer part of the Fallopian tube which is called fimbrial end. As soon as the egg is caught by the fimbria, it is transported to the part of the Fallopian tube where fertilization is taking place. Movement of fine hair like structure of the lining of the Fallopian tube helps this movement of the egg. Therefore any damage to the lining of the tube will affect this movement and a block of the Fallopian tube will prevent the egg meeting the sperm. As the lifespan of the human egg is about 24 hours, the sperms should meet the egg before it dies.

Out of the millions of sperms deposited in the vagina only a few sperms approach the part of the Fallopian tube where they meet the egg and only one sperm is able to fertilize the egg. Although only one sperm is necessary for a 'new life' to begin the male should have several millions of sperms to have normal fertility.

According to medical evidence, about 84 out of 100 couples who are trying for a pregnancy would get pregnant at the end of one year of trying. This figure rises to 92 out of 100 at the end of two years. Therefore you do not have to worry if you find it difficult to get conceived within few months of trying and allow time to solve the problem.

However if there is any concern especially if your menstrual cycles are irregular, you may seek your gynaecologist's help if you wish. General consensus is that a couple should seek medical advice after one year of trying for a pregnancy. Fifteen out of hundred couples trying for a pregnancy can have fertility problems.Ovum is the female counterpart which contains all the genetic material required for the beginning of a new life.

Therefore the egg contains half of the genetic material that we inherit from our parents. Eggs are produced from a structure called ovaries which are situated in the lower part of your cavity of tummy. The other half of the genetic material will come from the male sperm, which make the full genetic composition of the new life. These special cells required for reproduction (Egg and the sperm) have half of the genetic material of a normal cell. There has to be a process of division of those special cells to give half of the material into this special cells.

Do you know that the ovum or the egg you release every month starts its division even before your birth? By the end of the 12th week of life inside the womb early eggs are formed. And then they multiply in number, and at about 20th week inside the womb there are about seven million eggs in the ovary.

Thereafter, these cells die spontaneously and number goes down steadily. At the time of birth it reaches seven hundred thousand to two million. Approximately at the time of birth , these eggs start dividing in order to give half of the genetic material in to future eggs destined to make a new life. These dividing cells then enter a resting phase until puberty.

During childhood majority of eggs dies spontaneously and at the time of puberty a female has about four hundred thousand eggs in both ovaries.

During entire reproductive life fewer than five hundred eggs will be released and the number of children in a family would be the number of eggs used.

The first day of menstrual bleeding is the first day of your menstrual cycle. Under the influence of hormones released by the brain, few eggs start to mature from day one (these growing eggs are known as "Follicles"). After few days one follicle becomes dominant and on the 14th day of the menstrual cycle this dominant follicle in the ovary will rupture and release the egg into the cavity of the tummy. This egg will be caught by the "Fimbria" (Finger like projections at the end of the fallopian tube) and transported in to the fallopian tube. Since the lifespan of an egg is 24 hours it has to be fertilized before it dies. Therefore you would understand that a 35-years-old lady releases an egg which has been arrested in division 35 years ago.