For Quality, Essential, Generic Medicines
Chapter 3: Rationality of Drugs    
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Hazardous Drugs

Drugs are hazardous when their risks far outweigh their benefits
Some are toxic and should be used only in life-threatening conditions. Quite a few of them are used in combination and are potentially hazardous.
Analgin or dipyrone is an analgesic pain killer with anti-inflammatory and anti-pyretic (fever-reducing) properties. Its side-effects are severe allergic reactions or with life-threatening blood disorders called "aplastic anaemia". It has caused the death of 94 people in Germany between 1981 and 1986. Because of these deaths, the German drug regulatory authority has placed all Dipyrone products under prescriptions and severely restricted their use to post surgical conditions (8). Yet analgin, commonly available as Novalgin and Baralgan, is one of the more popular over-the-counter drugs among consumers than its safer and cheaper alternative, aspirin. (At the time of writing, the Supreme Court of India has banned combinations of analgin with drugs other than anti-spasmodics, including the top-selling Baralgan brand.).
Anabolic Steroids (synthetic male hormones) are often used to treat conditions for which they are not only useless but very dangerous. They are useful as supportive therapy in treating rare conditions such as aplastic anaemia (bone marrow shut down) where the patient is very ill. Instead, anabolic steroids are sold over the counter as appetite stimulants and tonics in the developing countries. These drugs can stunt growth in children by prematurely closing the epiphyses (the growing ends of the bones). They also disturb the sexual development of adolescent children. Young girls can develop masculine characteristics such as deep voice and growth of facial hair, while young boys can develop breasts. These changes are irreversible
Chloramphenicol is an effective and cheap drug to treat typhoid. It should not be given to treat patients with less serious bacteria infection. Chloramphenicol when used in diarrhoea only prolongs the disease. A child with diarrhoea who is given chloramphenicol faces the risk of possible fatal side effects while not gaining any benefits. Streptomycin is not absorbed when given by mouth. Hence the drug is not effective in diarrhoea. The combination of chloramphenicol and streptomycin (banned since 1988) would cause diarrhoea because of infection due to change in gut flora. Commonly available brands of combined chloramphenicol and streptomycin used to be Chlorostrep, Enterostrep, Streptoparaxin, Lifstrep, Streptchlor, Intestotrep. Most diarrhoeas can be treated effectively by means of oral rehydration therapy. It is simple and inexpensive. If drugs need to be used, cotrimoxazole or ampicillin is safer and effective alternative.
Clioquinal was used widely to treat diarrhoea.  Marketed as Entero Vioform and Mexaform, it was available over-the counter for the common ailment, "traveller's diarrhoea". It damages the central nervous system resulting in paralysis, blindness and loss of bladder control.  About eleven thousand people in Japan were victims of these side effects caused by the drug.  The Swiss drug company, Ciba Geigy, was found guilty of marketing this drug without revealing its hazards.  It is now available and sold as prescription drug.

Depo Provera is an injectable contraceptive for use by women manufactured by the American multinational, Upjohn. This drug is not allowed for use as contraceptive in USA, but may be prescribed by a doctor after the woman gives her informed consent. Yet the drug is sold in the Third World for contraceptive use. The drug is associated with breast and endometrial cancers, osteoporosis, lowered life expectancy and lowered resistance to infection. In addition, the drug causes severe birth defects if a woman who is unaware of her pregnancy, takes the drug. The effect of the drug on babies when it passes through breast milk is not well documented, but it could interfere with the babies' normal development and inhibit the transmission of immunities. Despite this knowledge, Upjohn promotes this drug for nursing mothers because the drug does not stop the flow of breast milk. Depo is also known to cause depression, hair loss, headaches, weight gain/loss, menstrual spotting, heavy bleeding, skin changes, nausea and loss of libido. Though the drug dosage was originally designed for the larger western women, it has not been decreased proportionately for the smaller Asian women who are now the target for this drug (9).

Oxyphenbutazone and Phenylbutazone has caused over a 1000 deaths worldwide. It is recommended by the Drug Controller of India only for ankylosyting spondylitis and acute gouty arthritis, and that too only as drugs of second choice. Because of its severe side-effects, Ciba-Geigy has withdrawn this drug marketed as Tanderil. Yet the drug is prescribed widely. (The Supreme Court Of India however has banned only fixed dose combinations of Phenylbutazone and Oxyphenbutazone but the individual drugs themselves are still available with potential for continued misuse.)
Guidelines for Rational Use of Drugs are as follows:
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Prescribing a drug only when genuinely indicated
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Choosing drugs which are effective
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Using single-ingredient drugs
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Using drugs indicated for specific conditions
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Choosing drugs which are relatively safe
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Choosing cheaper alternatives
Some of the steps needed to rationalise the use of drugs in the market are:
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Elimination of new drugs which are expensive and not necessary because other drugs with proven efficacy already exist in the market.
 
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Elimination of useless, hazardous and harmful drugs which have irrational combinations.
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Use of Essential Drugs List.
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Marketing of drugs by their generic names
       
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