For Quality, Essential, Generic Medicines
Chapter 3: Retionality of Drugs    
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Another concern is misprescription, such as the prescribing by gastroenterologists and other specialists pancreatic enzyme (brand names Festal, from Hoechst, nad Zymet, from Beximco) and oxiphenomonium bromide (brand name Antreny1, from Ciba -Geigy) for indigestion. Some brands are more misused than others in the same category of drugs, obviously because of heavy promotion. Interestingly, drugs of doubtful efficacy are highly priced. A 250 mg tablet of ciprofloxacin, a useful drug but wrongly prescribed for ordinary fevers of two to three days' duration and for diarrhea, cost Taka 12 in 1994, whereas cotrimoxazole cost just over Taka 1 per tablet, Similarly a 300 mg ranitidine tablet was priced at Taka 4, while 20 mg of omeprazole cost Taka 14, Not only do bribes in the form of gifts, or travel and per diem expenses for attendance at seminars, increase the irrational prescription of drugs, they also add to the cost of these unnecessary drugs.

An extensive study of prescribing habits of GPs paediatricians in Indonesia, undertaken in 1988 by the Indonesian Consumer Federation found that GPs wrote fewer drugs per prescription than paediatricians. paediatricians also often wrote two or more antibiotics in the same prescription (in 21.1 per cent of cases compared with 12.4 per cent for GPs). GPs prescribed two or more vitamins (15.8 per cent) and two or more antidiarrhoeal drugs (31.6 per cent ) in the same prescription, a higher incidence than for paediatricians. But oral rehydration therapy (ORT), generally acknowledged to be the most important and effective form of treatment for diarrhea, had been prescribed in only 16.03 percent of all the cases.

Source: Chowdhary, zafrullah. The politics of Essential Drugs, op.cit.,pp.124-126.


Combination Drugs

According to the WHO Expert Committee (2) combination drugs should not be used unless there are no alternative single drug available for treatment or no alternative single drug was cost-effective for the purpose. Expert recommended that patients be individually evaluated and those patients requiring more than one drugs should be prescribed separately. Combination drugs "increase the risk of side effect and may also needlessly increase cost while encouraging irrational miss and hit' therapy" (3). When a combination drug is used it is difficult to identify a which drug is the cause of a drug reaction. Combination drugs are irrational also because their stability is doubtful, reducing the efficacy in many reparations. Moreover, drug companies frequently change the ingredients making is difficult to keep track of the changes.

Injections with combinations of streptomycin ( for the treatment of T.B.) and penicillin since banned have been widely used in the treatment of fevers, infections and other minor illnesses. This is irrational because it masks the occurrence of T.B. and leads to the development of resistance to streptomycin by T.B. Bacilli (mycobacterium tuberculosis). Similarly, streptomycin in combination with chloramphenicol
was widely (mis )used in the treatment of diarrhoes ( the combination has been banned since 1988 after attempts by affected drug companies to thwart a ban). This used to be a sheer waste as 60 per cent of diarrhea is viral and can be controlled by Oral Rehydration Therapy and do no need anto-bacterials. Indiseriminate use of chlormphenicol itself is hazardous because it unnecessarily exposes people to the risks of chloramphenicol, for example fatal blood discorders like agranulocytosis, a drug which should be reserved for typhoid fevers. Used in combination, it causes resistance of typhoid to the drug.

Irrational drug combinations include

*   Antibiotics combined with other antibiotics or with cortico- steroid or other active substances such
    as vitamins.
*   Combination of antipyretics and analgesics, e.g. ibuprofen + paracetemol or analgin
    + paracetemol.
*   Analgesics combined with iron, vitamins or alcohol. Combination painkillers increase
    the risk of toxicity and other side-effects, especially kidney damage. Analgesics
    combined with iron or vitamins are irrational and wasteful; analgesics combined with
    alcohol are wasteful and potentially dangerous.
*   Codeine in combination with other medicines; since codeine is a habit forming drug
    and using it in combination medicines increases the risk of addiction.
*   "Multi" and liquid vitamin preparations, with the exception of combination vitamins
    supplied in small bottles, with droppers for babies.

The guidelines as per the WHIO recommendations for acceptability of Fixed Dose Combinations are :

1.
  Clinical documentation justifies the concomitant use of more than one drug.
2.
  Therapeutic effect is greater than the sum of the effect of each.
3.
  The cost of combination product is less than the sum of individual products.
4.
  Compliance is improved (the is when two or more medicines are to be taken separately,
    as in the case of TB, the user tends to avoid one or two medicines aftersometime. This
    can be avoided if all three medicines are combined into one).
5.
  Sufficient drug ratios are provided to allow dosage adjustments satisfactory for the
    majority of the population.

Any fixed dose combination which does not satisfy the above mentioned guidelines is considered irrational (5). (See also Appendix 2: Why some leading drug combinations in the Indian market should not be sold- but are still sold).

When Drug Combination are Rational

Drug combinations in some cases are not only rational but are sometimes even necessary. The scientific rationale of few selected drug combinations is given below::

1.
  When it allows synergistic action, i.e., it facilitates each other's pharmacological action, thereby
    producing greater effects..
     
2.
  Where it allows enhanced efficacy without linking of each other's pharmaco-chemical actions.
     
3.
  Combined doses are given in cases of general under-nourishment or simultaneous deficiency of all
    vitamins in famine conditions, e.g., Vitamin B complex, multivitamin,ferrous sulfate + folic acid,
    Vitamin A + Vitamin D.
     
4.
  Where it is necessary to reduce side-effects or toxicity, e.g., isonex + Vitamin B6 (Vitamin B6
    prevents peripheral neuritis caused by prolonged use of isonex).
There are also some simple ways of monitoring drug use. See for example the box below on Core Drug Use Indicators. (See also Phadke, et.al. op.cit. for a critique of these criteria).
   
Core Drug Use Indicators
  Prescribing indicators
  1. Average number of drugs per encounter
  2. Percentage of encounters with an antibiotic prescribed
  3. Percentage of drugs prescribed by generic name
  4. Percentage of encounters with and injection prescribed
  5. Percentage of drugs prescribed from essential drugs list or formulary
  Patient care indicators
  6. Average consultation time
  7. Average dispensing time
  8. Percentage of drugs actually dispensed
  9. Percentage of drugs adequately labeled
  10. Patient's knowledge of correct dosage
  Facility Indicator
  11. Availability of copy essential drugs list or formulary
  12. Availability of key drugs
  Source: How to Investigate Drug Use in Health Facilities: Selected Drug Use of Indicators. Action Programme of Essential Drug, WHO, Geneva, 1993.

Vitamins and Tonics
These are some of the most highly selling and highly-priced products in India.

Vitamin and tonics are in many cases a mixture of Vitamin B-complex or vitamins in solutions of sugar and alcohol. Tonics or health restoratives are prescribed for debilitating conditions usually for convalescents, chronic diseases, loss of appetite, weight loss, and fatigue.

Vitamin and tonic preparations are irrational because what is actually needed is an adequate mixed diet containing leafy vegetables. Vitamin deficiency should be treated with specific vitamins in dry tablet form.

Tonics are hazardous when substances like caffeine, strychnine, leptazol are combined with vitamins. Regular intake of Vitamin A and D will be excessive and hence hazardous.

Bangladesh has banned tonics, enzyme mixtures/preparations and restorative product because such products "flourish on consumer ignorance..., most are habit-forming and with the exception of pancreatin and lactase (which are allowed as single ingredient products) of no therapeutic value." (6). United Kingdom does not recognise tonics as drugs.

Most of the tonics are grossly advertised with many tall claims as health restoratives. However they often contain inadequate doses of vitamins, useless ingredients and lot of alcohol. A well known tonic, Waterbury's Yellow Label tonic, contains about 3 mg of Iron per teaspoon of which only one-tenth is absorbed by the body. The Indian Council of Medical Research recommends at least a daily intake of 10 mg for men and 20-30 mg for an average woman.

Some tonic preparations contain more vitamins than what is actually needed. High-potency multivitamin formulations are sheer waste of resources as they are almost wholly rejected by the body, particularly in the case of well-fed consumers. The daily requirement of the human body of Vitamin C is about 50 milligram, of Vitamin B1 one milligram and some others in minute quantities of few milligrams. Yet tonic preparations, apart from being extremely expensive, contain between 10 to 50 times the minimum requirements which are simply excreted by the body. Moreover, most vitamins are needed in small amounts to stimulate metabolism, they are not energy-enhancers.

The daily requirements of Vitamin C can be obtained from regular use of fruits or fresh vegetables and salad helpings. Vitamin A, supplied by green leafy vegetables, is stored in large amounts by the body for proper vision. Vitamin D is naturally synthesized by the skin from daily sunlight. Despite the availability of inexpensive, fresh fruits and vegetables, tonics are a craze among people. Over 15, 000 tonnes of health drinks are produced every year in India. Manufacturers spend large amount of money on advertisement. Television advertising is a very effective way of getting credulous consumers hooked on these expensive junk. And the current trend is to recommend tonics for healthy adults and growing children.

The production of the high-potency or Forte preparation of multivitamins is a sheer economic waste. It is a drain on the consumers and government dispensaries. It would benefit more number of patients if the preparation was made available in smaller but adequate quantities so that more tablets could be produced at cheaper price. High-potency preparation is also a drain on the country's foreign exchange as most of the raw materials have to be imported.

Cough Syrups and expectorants are mixtures of drugs which stimulate coughing (ammonium chloride, ipecac) as well as those which suppress coughing (codeine, noscapine) and antihistamines that dry the secretions (some common brand names are Benadryl Expectorant, Piriton Expectorant, Avil Expectorant).

Prolonged use of cough syrup is habit-forming, it may cause stomach upsets, reduce food intake and cause drowsiness.
Coughing is a protective activity of the body. It should not be suppressed except in certain conditions. Simple steam inhalation is advised. If it is necessary to use drugs, use only a single ingredient cough suppressants such as codeine, dextromethorphan. There is no scientific basis for using cough suppressants and cough stimulants together.

The WHO List of Essential Drugs does not include cough syrups and lozenges. Bangladesh has banned them on the grounds they are "of little or no therapeutic value and amounts to great wastage of meager resources"(7).

     
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