Rational Drugs

What is Rational Therapy?

Rational drug therapy means the use of drugs, which are efficient, safe, low-cost and easy to administer. It requires that health practitioners have adequate medical knowledge and appropriate skill for correct diagnosis and treatment. They would also be required to have time and concern for their patients.

Rational drug therapy thus is only part of the larger issue of rational treatment – which in turn is a subset of the large issue of rational health services. Rational health care implies rational diagnosis and treatment. Rational diagnosis means ordering the appropriate amount of procedures, laboratory test, X-ray, etc., not more, not less. Rational treatment also assumes rational behaviour by the patient after a medicine is prescribed provided he/she can afford it.

Rational means also appropriate

The Oxford English Dictionary defines “rational” as that which is based on reason, which is sensible, sane or moderate. Rational drug therapy may be used interchangeably with the concept of appropriate therapy, which may be described as ordering the appropriate right medicine for the right / appropriate indication, for the appropriate / right patent at the right time and in the right dose, route and duration, with due consideration of costs.

An appropriate Indication for the Use of Drugs should Exist.

·        A1 – year old with low body weight for age is seen in the OPD, because the parents noticed a pot belly. This is clearly due to under nutrition. The family is poor but the child not been weaned and given solid food till now. Should the child receive advice on feeding or an alcohol based ‘tonic’?

·        A chronic smoker comes with cough off and on, especially in the morning. There is no shortness of breath. The clinical examination is normal. Should he receive a cough suppressant, an antibiotic or advice and support for stopping smoking?

·        A child comes with viral upper respiratory infection (rather long and impressive name for a common cold) with a fever, running nose and a mild cough. Should he receive antibiotic like amoxicillin which would be useful only in bacterial infections, a syrup which has a combination of cough suppressant and cough expectorant (such preparations which are neither fish nor fowl but both abound in the market), or advice that the illness is a mild, a self-limiting one, where paracetamol can be used if the fever is significant?

·        A 2-year child comes with diarrhea with passage of 5-6 loose stools without significant abdominal pain or any blood. This is again likely to be only viral diarrhea, which like viral upper respiratory infection is self-limiting. Should he receive oral rehydration solution (even home-made ORS which is rice-based would be appropriate), or a combination of ciprofloxacin (a drug to be avoided in children under 14 years of age) and metronidazone (which is effective only in amebiasis, giardiasis)?

·        A computer professional has low-backache of long hours of sitting at the desk in a faulty posture on a faulty chair. Should he receive long term pain killers or advice on posture, exercises and a proper chair which supports the lower back?

·        A 24-year old married woman complaints of mild nausea in the morning. On enquiry her periods are overdue by 15 days. Should she receive drugs for nausea or an evaluation for pregnancy?

In each of the above examples which are very common in our experience, the use of drugs like tonics in under nutrition, cough suppressants in a chronic smoker without advice on smoking cessation, a drug for bacteria like amoxicillin in a viral infection, and use of irrational medications like combinations of antibiotics (ciprofloxacin and metronidazole) or combinations of cough suppressants and cough expectorants, are not indicated at all. The use of such drugs is in appropriate, leading to sub-optimal a care, a waste of resources, and endangering the health of the patients. The use of drugs like ORS, and simple antipyretics like paracetamol would however be termed appropriate or rational.

Not only do many conditions require No Drugs or Very few drugs, but Non-drug treatment is an important complementary treatment with drugs for many common diseases, e.g. weight reduction, smoking cessation, going low on fats in diet, is an important part of the management of diabetes, hypertension, and angina. Similarly eating high fibre diet, drinking lots of fluids, and exercising is important in treating constipation. And in many conditions some form of surgical intervention is indicated from bleeding piles, to gall-stones which are causing symptoms and complications, to cataracts. In all these conditions, drug therapy has no or a very limited place as a primary treatment.

Appropriate Medicine Should be Used: Is it the Right Drug for the Right Patient?

The drug to be used should be efficacious, safe and cost-effective, and suitable for use in a patient. Which are these drugs that we can rely on? Fortunately there is broad international and even national consensus on a limited number of essential drugs, which are efficacious, safe and cost-effective. These are the drugs contained in the lists of essential medicines. It is from these lists of essential medicines we can choose the right drugs for our patients. When we choose drugs from these lists, we are automatically choosing drugs with demonstrated efficacy, safety and cost-effective and practicing evidence drug therapy.

The list of essential medicines covers the right drugs of choice for treatment of priority disease conditions be it anemia, asthma, or diabetes, hypertension or epilepsy. How these drugs are to be used is described in textbooks of medicine, pharmacology. Also an increasing number of professional and public health related organizations bring out Standard Treatment Guidelines for treatment of particular disease conditions. Guidelines from WHO exist for treatment of TB, Leprosy, and other communicable and non-communicable diseases. In India, State level and National level guidelines for treatment of common disease conditions have been compiled, and need to be disseminated and used widely to realize their potential for providing rational, safe and cost-effective care.

Apart form making the correct diagnosis, choosing the right drug from the list of essential medicines and standard treatment guidelines, the suitability of the drug for the individual patient has to be assessed before starting the treatment. The drug should not only be right but be right for our patient. There are a number of factors which need to be taken into account by the prescriber. In fact all patients can draw the attention of their doctors to these factors while they receive their prescriptions.

There are three things which are absolutely essential to bring to the attention of the doctors. The first is any history of a possible reaction in the past. The second is the possibility of pregnancy in all women of child bearing age. Before accepting a prescription for any illness, a woman should keep this in mind. It is better to rule out pregnancy if monthly periods have been delayed, rather than take a drug unknowingly which can affect the development of a child permanently. The third is any   other illness that the patient has and the treatment that he is taking for the same.

Age is important consideration. Some drugs like tetracyclines are not safe in children. In the elderly the rate of breakdown of drugs is lower so that doses have to be lower and one has to be on the look out for side effects which are more frequent in this group. Pregnancy and lactation affect the choice of drugs in a major way, and women who are pregnant need to exercise particular caution about taking drugs. The individual patient may have allergy to certain commonly used drugs like pencillins and sulfonamides, which have to be therefore avoided. Coexisting illness often dictate the choice of drugs, e.g. a patient with hypertension and asthma should not be given a beta-blocker like propranolol which can worsen the asthma, which can otherwise be used in other patients with hypertension. Patients with diseases of liver and kidney need to be particularly cautious while using drugs, because most drugs can potentially cause side effects on the liver and kidney and worsen their condition. Even the occupation of the patient has to be taken into account. A drug for sneezing due to nasal allergy which can cause some drowsiness, would be completely unacceptable in an airline pilot or the driver of a super fast train.

We have discussed in the above paragraphs the selection of drugs from the list of Essential Medicines. What about the drugs which are available in the market and fall outside this list? Some of the drugs which are outside this list are of complementary drugs which are to be used in selected patients, under specific situations, in a specific healthcare setup, e.g. certain antibiotics for use in antibiotic resistant infections, or anti-cancer drugs to be used in a hospital setup for use in certain cancers. But a large number of drugs which are outside the list of Essential Medicines are simply more expensive alternatives for essential drugs, e.g. ramipril works on the same principle and to the same extent as enalapril which is an essential medicine for use in hypertension and heart failure, but is more than five fold in terms of cost tot patient. In fact a huge number of drugs, which do not figure in the list of Essential Medicines are in fact of dubious efficacy, rationale, safety, but are money-spinners for their companies. E.g. most preparations for iron deficiency anemia in this country do not conform to the criteria mentioned in the list of Essential Medicines.

Drugs have to be Administered in an Appropriate Dose at an Appropriate Interval through an Appropriate Route for an Appropriate Duration.

Sample the following:

·        A patient pneumonia admitted in a private hospital does not improve after 3 days of therapy with a “higher antibiotic”. He is receiving injection Cefotaxime 1g once a day.

·        A woman with high fever, discomfort while passing urine and flank pain was diagnosed as having an upper urinary tract infection. She was given an antibiotic in the correct dose and dosing interval but for 5 days. Improving initially, she developed recurrence of the same problem two weeks later.

·        A patient in a village in Chattisagarh has had recurrent episodes of malaria over the past months. During each such episodes the patient was administered injection Chloroquine 2 ml by an intramuscular injection daily for 3 days.

·        A patient suffering from persistent asthma of moderate severity has been on long-term oral medication with salbutamol and prednisolone.

Apart from selection of the appropriate drugs it is critical to ensure that the drugs are used in the proper dose, interval, and duration through an appropriate route. This is one area where there is a rampant anarchy in India of which the above is a small sample. The patient with pneumonia received an improper dose. The antibiotic given as 1 dose/day of a drug should have been administered 3 times in a day. The woman with the upper urinary tract infection was given the wrong duration of therapy. She needed to be treated for 14 days to eradicate the infection, yet was treated only for 5 days, which was the reason for the recurrence of the infection. The villager with malaria received the right drug through the wrong route. Chloroquine should have been administered through the oral route an in an appropriate dose 10 tables for 3 days.  The choice of injections was particularly inappropriate as chloroquine is one drug which is very well absorbed when taken  by mouth, and giving the injection led to massive under dosing as shown below.

Use of Injections of Chloroquine in Uncomplicated Malaria: An example of Massive Under Dosing.

An adult patient with malaria needs to be given a total of 1500mg of Chloroquine over 3 days.  Therefore the appropriate dose in terms of tablets is 10 tablets which is given in the schedule of 4-4-2, in the national antimalaria program. (4 tablets on day 1, 4 on day 2, 2 on day 3).

1 ml of Chloroquine injection on the other hand contains only 40mg of Chloroquine, which is nearly a quarter of the content of table. Therefore a patient who received 2ml injection daily for 3 days, received a total of 40 x 2 x 3 i.e. 240mg of Chloroquine, which is less than a total 2 tablets of Chloroquine and only 1.6 of those dose required for malaria.

Lastly the patient with persistent asthma received the improper dosage form of medication. The treatment of asthma requires not only treatment for relief of spasm, with drugs like salbutamol, but also drugs like steroids to prevent spasm from occurring by decreasing the allergy in the airways. However the long term use of oral steroids is marked by high risks of side effects like decreased

Immunity, diabetes, hypertension and bone disease, and is therefore inappropriate. The beneficial effects of steroids in prevention of attacks of asthma can be gained from taking steroids through inhalation route through inhalers have made their long term use a very safe option, and have revolutionized the treatment of asthma. Even salbutamol offers the advantage of rapid onset of action, lesser side effects and flexibility of dosing.

The Patient should also Receive Appropriate Information.

The concept of rational use of medicines also implies that the patients should receive the appropriate information about their disease and the medicines prescribed and are appropriately evaluated for the anticipated effects and side effects. For example a patient with diabetes who is prescribed an oral pill for lowering blood sugar, needs to be explained how to take them, what not to do while taking them (missing meals, going on a fast), the possible side effects in the form of development of low blood sugar (hypoglycemia), how to recognize the symptoms of low blood sugar, and how to treat the problem of low blood sugar. If the patient does not have this basic information, he may pay for it with his life. There are numerous instances when patients have developed low blood sugar, have not responded by taking sugar in some form because of lack of information, and have ultimately died into irreversible coma.

In the current situation of medical practice in India, the patient’s Right to Information is given short shrift, and any explanation on the drugs mentioned in the prescription is often perfunctory. This lack of information given by the doctors is compounded by the lack of information provided by the companies.

Rational Across Systems.

Rationality across systems is a poorly studied issue. Doctors across systems, and their various protagonists, tend to taken positions: if you are qualified in one system you cannot practice other system, unless you are qualified for it also. Some Allopaths, that is practitioners of Modern Western medicine, feel that there is no rationality, and therefore science, in other non-allopathic systems: a position hotly contested and one that soon gets us into issues of privileging one knowledge system over the other. But certainly we can ask for rationality within a particular medical system.

In this book, we are concerned with rationality within the allopathic (modern, Western Medicine) system only. A decision of the Supreme Court (Poonam Verma Vs. Drugs. Ashwin Patel in Cp No.8856 of 1994) prohibits cross practice: that is no medical practitioner will use medicines that do not belong to the system in which he is not educated and registered. See box below: In Violation of clear SC Ruling “Quacks” Continue to Conduct Clinical Trials.)

In Violation of clear SC Ruling “Quacks” Continue to Conduct Clinical Trials.

No practitioner of modern medicines is taught either during the course at the medical college or hospital training about the contents and properties of Pippalyadi Yoga. Yet believe it or not, it is being tested on humans, that too young females, to test if this product has any anti-fertility role.

In Poonam Verma Vs. Drugs. Ashwin Patel in Cp No.8856 of 1994), the  Supreme Court had outlawed “cross-border” practice and ruled  that n medical practitioner will use medicines that belong to the system in which he or she is educated and registered. In other words, allopaths are not permitted to use modern medicines.

The apex court had pronounced that a person holding, say MBBS, was a doctor in allopath but a “quack” in other systems  just like any lay person and will be “deemed” to be negligent per se without any further proof or argument” if found to be administering medicines belonging to other streams.

Pippalyadi oga has been developed by the Central Council for Research in Ayurveda and Sidddha and claims to contain Pippali, Vidanga a nd Tanakana. These substances are strange words for medical practitioners because they do not find any mention in the standard textbooks of pharmacology.

Strangely, the unauthorized and illegal  clinical trials are taking place at  the All India Institute of Medical Sciences (AIIMS), New Delhi; Post Graduate Institute (PGI), Chandigarh; JIPMER, Podicherry and King Edward Memorial Hospital, Mumbai, all managed by the government. Thus state-run institutions are violating Supreme Court Orders.

Because of their prescription powers, allopathic doctors are bombarded with promotional material Ayurvedic products even though it is unethical and illegal. Since doctors demand evidence of safety and efficacy, some manufacturers of Ayurvedic medicines go to the extent of sponsoring clinical trials of their products in medical colleges where unwittingly investigators are roped in for illegal trials.

In the past year alone, just two companies have conducted over a dozen clinical trials of Ayurvedic products at medical colleges in violation of Supreme Court ruling. Some examples:-

·        Safety and efficacy of branded Septilin by Drugs.Bharat J. Parmar at Department of Paedaitrics, B.J. Medical College, Ahmedabad.

·        Safety and efficacy of branded Opthacare by Drugs. Ulka Srivastava, Professor of Opthalmology, M.G.M. Medical College, Indore.

·        Safety and efficacy of branded Himocospaz by Drugs. Shakuntala Prabhu, Associate Professor of Bai Jerbai Wadia Hospital for Children, Mumbai.

·        Effct of branded Calcurosin in the management of urolithiasis by Dr. Lokesh Upadhyay at Institute of Medical Sciences, Varanasi.

·        Safety and efficacy of branded Diabecon in diabetes by Drugs. K.R. Kohli at R.A. Podar Medical College, Mumbai.

Unlike allopathic molecules, all these trials are conducted on formulations with trade names thus directly helping the manufacturers to increase their sales. Once the results of such trials are available, they are misused to induce practitioners to modern medicines to prescribe, an illegal act. Despite claims to the contrary, Ayurvedic products are not always safe. Many contain minerals and metals such as lead, mercury, arsenic etc. and have side effects. They can interact with ingredients of modern medicines about which allopaths are blissfully ignorant. The Medical Council of India should discharge its statutory duty and take urgent steps to ensure that the Supreme Court ruling is obeyed in letter and spirit.

(MMS India, Editorial, May 2005)

Guidelines for Rational Use of Drugs.

·        Prescribing a drug only when genuinely indicated.

·        Choosing drugs which are effective.

·        Using single-ingredient drugs.

·        Using drugs indicated for specific conditions

·        Choosing drugs which are relatively safe.

·        Choosing cheaper alternatives.

Some of the Steps needed to rationalize the use of drugs in the Market are:

·    Elimination of new drugs, which are expensive and not necessary because other drugs with proven efficacy already exist in the market.

·    Elimination of useless, hazardous and harmful drugs which have irrational combinations.

·    Use of essential drugs list.

·    Marketing of drugs by their generic names.

Causes of Irrationality

Irrationality in prescription of medicines is of two broad types: Using irrational drugs prevalent in the market, and irrational use of rational, essential drugs available.

Some of the common irrational prescription and treatment practices include:-

·        Prescribing antibiotics for ailments like diarrhoea or viral infection where they are useless, thus causing antibiotic resistance by the body when needed for dangerous diseases.

·        Prescribing combination products where one medicine is sufficient.

·        Prescribing unnecessary expensive vitamins or tonics, virtually regardless of the condition being treated.

·        Prescribing expensive new drugs in preference to established, less expensive ones.

·        Ordering of unnecessary investigations.

Who is responsible for allowing irrational drugs and irrational prescriptions? Government firstly, and then the drug companies, and then the medical profession and their professional associations for not being disciplined enough.

The reasons for irrational Prescribing.

1.      The belief of a pill for every ill.

2.      The more the merrier, combinations work better, and the belief in shotgun therapy.

3.      I have to cover all possibilities.

4.      The latest is the best (latest antimalarials, antibiotics, analgesics etc)

5.      Costlier is better, especially with poor quality drugs in the market.

6.      My professor said society…..

7.      The MR (medical representative) said society…..

8.      The patients demand it (or I will lose my practice)

9.      In my experience….

10.  The more I write the more I earn…

Some frequently Abused Drugs in India, Thanks to their Large-scale Prescription.

1. Vitamins   2. Digestives   3. Cough expectorant   4. Antibiotics   5. Injections

of all kinds    6. Analgesics

— Observations of a practicing physician doing rational practice.

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