by Jawaid Tariq Khan
Patients must never be allowed to purchase drugs without a prescription with the exception of pain killers like aspirin and paracetamol. Professor Tariq Bhutta's efforts in this regard are, therefore, laudable. His point that many drugs still in use in Pakistan are no longer in use in other countries because of their known side effects is very valid for the health of our people. It is true to say that for each disease there are several drugs. However, equally accurate is the statement that doctors carefully choose a drug for a patient based on his medical history. Hence even if two people have blood pressure yet one also suffers from kidney disease then he cannot be given the same drug.
The total number of drugs in Pakistan is very large. The matter has been explained by the Ministry of Health (MOH), Government of Pakistan, Pakistan Pharmaceutical manufacturers' association (PPMA) and many other knowledgeable persons time and again. It is true that in many countries of the world, including the developed world, registered drugs are no more than 2000 to 3000 in number. In Pakistan the number of medicinal chemical entities registered are actually no more than 1000. It is the system of the allocation of Registration Number by MOH which gives a false impression about the numbers. The prevailing system at MOH is that each and every company for each and every medicine and for each and every formulation of the dosage form is allotted a different number. For instance, paracetamol, 500 mg tablets, made by one company is allotted a certain registration number. When the same company comes up with a paracetamol, say in elixir formulation it will be given a different number. If it again comes up with a paracetamol syrup it will get yet another number. The company will, therefore, get three registration numbers for one product. If the same product is made by 50 companies in three formulations each the registration numbers allotted to paracetamols will be 150 instead of 50 while the product is, actually one. Similarly different dosage forms of each drug are also given different numbers. That explains the registration numbers going up to 1400 while the drug entities represented are actually not more than one thousand. We have been persistently impressing upon the government to rationalize the system so that there is one number for each main drug entity.
Me-too Drugs
Then there are the me-too drugs. I am not against "me-too" drugs it it means made in the original formulation after the latter's patient expires. The raw materials of the same drugs are available from various competitive sources enabling the same drug to be made at far lower cost than the one made by the erstwhile patent holder. This cost factor is important especially in developing countries like Pakistan. But factors like quality of material, the dependability of the source of material whether the drug is approved by the regulatory authorities in its country of origin or not must be seriously considered while importing a "me-too" drug or raw material for local manufacture of these drugs. Also, these drugs should maintain a scientific criterion of validation under a reassessment procedure based upon local conditions and requirements which should be carried out by at least three specialists in the respective relevant therapeutic categories.
Spurious and Fake Drugs
One hears a lot about spurious drugs. It is being said all over the country that fake, substandard and spurious drugs are being sold mainly in small towns and rural areas where there are no checks. The number of drug inspectors, drug controllers who effectively watch or monitor thousands of retail chemist shops are limited and hence small towns and rural areas are ignored. Unfortunately, in Pakistan there are far more chemist shops per number of people than there are in Europe or the United States. The reason for this mushroom growth of chemist shops in Pakistan is the lack of prerequisites like compulsory employment of a full time qualified pharmacist and lack of ethics that no drug, be it a brand name in a prepacked form or a mixture formulated in the chemist shop, be allowed to be sold by any one other than a qualified pharmacist and then too only if there is a prescription for it. To keep tabs on all the existing chemist shops we would require thousands of Drug Inspectors so that each one should be made responsible for at the most 20 outlets. Given the present number of outlets per inspector there is no way he/she can do justice to his job. Both, Pakistan Medical Association (PMA) and Pakistan Pharmaceutical Manufacturers' Association (PPMA) have been at loggerheads on many issues but both are agreed on this one issue, i.e., that each outlet for pharmaceutical products in any form, be it a hospital pharmacy or a wholesaler or a retailer of medicines, must have a qualified pharmacist. That is the only answer.
In Pakistan unfortunately the manufacturer has no control over the drug once it leaves the factory. The warehouses of the wholesalers are usually not properly maintained, temperature therein is not controlled as required and medicines are stored in cupboards fitted with glass shutters exposing the products to sunlight, in many instances, direct sun rays, during the day, which raise the temperature by as much as 50 per cent inside the cupboard. Thus product deterioration occurs. Drug delivery system is virtually non-existent in Pakistan. The authorities, however, seem oblivious of these factors and invariably penalize the manufacturer. A drug can change color, can be transformed into crystals, or whose quantity can become less than ordered due, most likely, to evaporation because of the heat, one must not take chances with the health of the people. Greater vigil should be exercised by the authorities to maintain at least a passable level of drug delivery system in the country. If qualified pharmacists are employed by the drug stores they would know how to store the drugs. There should be qualified pharmacists at each international airport and seaport where cargo is received to ensure that drugs are kept under specified conditions during process of custom clearance, etc.
Vaccination
Pakistan is a developing country and under-development generates a lot of pollution and harbors conditions which, may figuratively be called cradles of diseases carrying micro-organisms. Thus it is essential to immunize our people, especially children, against disease which can thus be prevented. All necessary vaccines must be made available to immunize each and every Pakistani citizen free of cost. This is an area where only government can take action. One can laud the present efforts of the government in this regard, i.e. to immunise the people against polio free of cost. But this program must be extended to include other diseases as well.
Sale Outlets of Drugs
In Pakistan there is practically no distinction between prescription and OTC products. We have been impressing upon the MOH that like in UK, USA and other developed countries or even in any developing country separate lists of OTC products and prescription products should be maintained. Under our Drug Act all drugs are meant to be prescribed. But, unfortunately, it is not uncommon that a housewife tears a portion from a used envelop and writes her groceries: potatoes 1 kg; onion 1/2 kg; dhaniya 1/4 kg; Velosef 500 mg one pack. And the servant brings these. The law is there. But no one to enforce it. Anyone can just go to a chemist shop and buy whatever medicine he wants; and the chemist would not say no, because there is no check. Again, if there was a qualified pharmacist he would insist on a prescription. His education and qualification would condition him to observe the code of ethical dispensation. Thus there is a need for law to be enforced. Any violation there of should be strictly dealt with. In addition, vigorous public awareness campaign must be launched.
Drugs for Infants and Children
Infants and children should preferably not be given toxic drugs or antibiotics. There is no denying that while medicines do play a part in improving health yet they are not a substitute for adequate nutrition, sanitation, clean water and other such necessities. Priorities have to be set by the government based on existing resources and limitations of a child's socio-economic status. Ideally the diet that will be recommended for a malnourished child would, more often than not, be beyond the economic means of the concerned family. So a doctor has to keep all these things in mind. Often doctors have no choice but to prescribe drugs.
Multi-Drug Therapy
In certain situations multi-drug therapy is the standard regime of treatment., But not in all forms of illness. If a patient visits a doctor and the doctor gives him a list of tests before he starts the treatment the patient gets unhappy. To him the doctor has wasted his time and money. He will have to come next day with the tests, an exercise which is not treatment as he knows it. Literacy level being very low in Pakistan, people f eel very happy if doctor gives them five or six drugs of different colors and sizes and shapes, i.e. tablets, capsules, syrup, etc. They feel deprived if the doctor does not give them an injection and form a low opinion of the doctor. I have seen instances like a normal healthy lady requesting to be taken to the doctor to get a drip because she feels weak. A drip or injection is given when for some reason a drug cannot be taken orally. If a patient is able to drink 10 to 12 glasses of water of ORS a day he or she doesn't need an infusion of dextrose or things like that. But somehow drip has acquired an aura of being a source of nourishment. So one wants a drip no matter if one needs it or not. It has become a kind of snobbery or a social norm which compels the doctor to adopt multi-drug therapy. Otherwise they lose their credibility, their business and their customers or patients. What is needed in this respect in an uplift in overall public awareness. Responsible and reputed pharmaceutical companies and PPMA should join hands to institute patient education programmes so that patients learn to question the doctor about his prescription. This would also motivate the doctors to adopt ethical prescribing practices and demotivate unethical promotion of drugs.
Respiratory Tract infections
Promotion of Drugs for Indications other than What it is Supposed to Cure
That is a most unethical practice if adopted by any company in Pakistan. Mostly, the research products are developed by international companies where these have to undergo rigorous trials before being approved for human use. I believe that a responsible pharmaceutical company will only promote such a product for indications duly supported by proper clinical data and approval of the regulatory authority of the country of origin to support the claim. I believe it is also the responsibility of the prescribing or dispensing doctor t check and make sure that th provided by the company is well documented. Also to ascertain that the company which is promoting a drug is ethically reliable.
Doctor-Patient Relationship
It is commonly said that the overwhelming majority of our doctors are paid for the drugs they sell to patients and not for advice and consultation. This gives them incentive to prescribe as many drugs as possible. Instead of giving a value judgement on this trend I would like to point out a few more trends. In Pakistan, we have shortage of doctors and consequently we see too many patients chasing each doctor, especially the doctors of some standing, i.e. Professors, Associate Professors and assistant professors or the retired consultants engaged in private practice. The number of patients they have to cope with every day is astronomical. It is humanly beyond them to handle so many patients properly: to give proper attention, to give due time for examination to each and every patient and to maintain proper record of the cases. If they tried to do so they would be in their clinics 24 hours a day and quite a few of them would drop dead on spot. This anomaly in supply and demand has driven them to treat their profession as a business instead of a health service. When I have to visit a doctor I feel sorry for him while sitting in his waiting room along with other 50 to 60 patients knowing that he has hardly three to four hours to see them all. He cannot spare more than four minutes for each patient. By contrast, in the developed countries a consultant doesn't see more than four or five patients a day, four days a week. Thus they have time to study, relax and attend to personal needs which is unfortunately not the case in Pakistan. The pattern has to change with better training for the doctors creating awareness in the general public about the scarcity of doctors in this country and ensuring that pharmaceutical companies become more ethically restrained. Another notable trend is the belief that doctors can only practice when affiliated with a hospital. The result is that we have so many FRCP and FRCS doctors without jobs or without flourishing practices. The belief that one has to be a professor or a hospital consultant to be a real doctor is highly erroneous. Postgraduate doctors repatriating from abroad have undergone lots of experience as part of their postgraduate education and afterwards when they were working in hospitals abroad. But they are side tracked and have to content with unemployment and low demand. Yet another trend that merits serious thought is the absence of facilities in our rural are as for medical practice which makes the doctors hesitate to serve there. Not only doctors but professionals in any walk of life would rather stay in cities whether their services are wanted there or not.
Charges Against Pharmaceutical Co's
Pharmaceutical companies are blamed for influencing doctors to prescribe drugs by using many non-education inducements, i.e. gifts, sponsored trips etc. A pharmaceutical company has a set of diverse responsibilities say, towards its shareholders, towards its customers or prescribers, towards the end-users, the patients and towards society as a whole. Take the example of Highnoon. On the one hand it pays its taxes and fulfills its legal requirements. On the other hand it donates medicines to charitable hospitals.
Here it fulfills a social responsibility. Highnoon's very existence in a society, in which there are patients who cannot afford to meet their health care needs places this responsibility on its shoulder. Highnoon and, for that matter many other run considerable expense sponsoring visits of renowned scholars from abroad to share their latest knowledge with Pakistani doctors in conferences and seminars. This too is discharging a social responsibility. Similarly, Highnoon sponsors visits of local doctors to conferences abroad where they learn new ideas and bring scientific advances for the benefit of the profession in our country. Selections for such sponsorships are purely on merit and without any strings attached. I see nothing wrong in it. This is not the same as presenting expensive ornaments to the wives of the doctors or gold watches or video sets to the doctors, which to my mind would be wrong and objectionable. Highnoon along with other companies also contribute to HEJ Institute of Chemistry in Karachi.
Prices of Drugs
It has been a disinformation propaganda that prices of drugs have increased by 300 to 500 per cent in the recent past. That is simply not true. Its part of a propaganda sponsored by some people within the MOH who do not like the prospect of losing their power to control drug prices because of the recent momentum towards decontrol. But the main sponsors of drug price hike are the big importers of drugs. What actually happens is that the price of essential and life-saving drugs are allowed to increase only once by five percent. 15 days later when the budget was announced the rupee was devalued by five per cent. Then, came the caretakers who again devalued the rupee. Though cost increased by more the price stayed the same.
The three years long work of the price committee of MOH consisted of the best brains in the country thus came to naught. People like Dr. Tariq Siddiqui, Mr. A. R. Siddiqhui, Mr. A.G.N. Kazi, the DG Health, even the Minister of Health himself was involved. This 5 per cent increase covered 70 percent of the market. It was the balance 30 per cent of the total pharmaceutical market which was decontrolled. That too with the proviso that each product should not cost more than the leader price. It worked like this: previously, if you brought a patented product you could sell it at any price you liked. After the patent expired many local companies wanted to make that product. The price of your product was, say, Rs. 100 for 10 tablets. This was termed as the leader price. You continue to sell it at the same price. Then, say, I went to the MOH and offered to sell the same product at Rs. 20. Then another party went with price of Rs. 15 and so on. Panadol which is paracetamol was Re 1 a tablet. But 50 other companies made equally good paracetamol selling at quarter of this cost. They could fix any price but not more than Panadol, the leader product. Please name anything in Pakistan which has not witnessed an increase in price of nearly 300 to 400 per cent during the last five years. Consider then the question: is it legally, morally and ethically right to control price of end product when the prices of inputs cannot be controlled? Our story is like that of a meat seller who cannot get a goat of 20 kg. for less than Rs. 1300 or Rs. 1400, i.e. Rs. 65 to 70 a kg. and after slaughtering and getting rid of skin and other rubbish he is asked to sell meat at Rs. 70 per kg. From where will he make his livelihood?
COPYRIGHT 1994 Economic and Industrial Publications
COPYRIGHT 2008 Gale, Cengage Learning
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