Essential Medicines

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Presented by: Reena Tayde M. Pharm.- Sem III Roll No: 20 Department of Pharmacology L.M.COLLEGE OF PHARMACY Concept of Essential Medicines And Rational Drug Use

Rational means:

Rational means Endowed with Reasoning Sensible Sane Moderate Not foolish ,absurd or extreme

What is Rational Drug Use?:

What is Rational Drug Use? Use of drugs which are efficient, safe, low- cost and easy to administer Use of right medicine for right indication to right patient at right time in right dose, route of administration and duration

Essential medicines :

Essential medicines The drugs to be used should be efficacious, safe, cost effective and suitable for use in a patient. These are the drugs contained in the list of essential medicines Essential medicines are those that satisfy the priority health care needs of the population

Criteria for selection of essential medicines:

Criteria for selection of essential medicines Selected with due regard to: Disease prevalence Evidence on efficacy and safety Cost-effectiveness These are intended to be available within the context of functioning health systems at all times in adequate amount, In appropriate dosage form, With assured quality and At price that individual and community can afford

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Continue…. WHO list of ED: 312 items and 518 formulations 21 FDCs and 36 formulations India: The National Essential Drug list: 279 items, 489 formulations, 11 FDCs Market: >1 lakh formulations, 70% FDCs Many are non-essential, useless, irrational and harmful.

Causes of irrationality:

Causes of irrationality Irrationality of 2 broader types: Irrational drug combinations prevalent in the market Irrational use of rational, essential drugs available

Some common irrational prescription & treatment practices:

Some common irrational prescription & treatment practices Prescribing antibiotics for ailments like protozoal or viral infection-antibiotic resistance Combination products where one drug is sufficient Prescribing unnecessary expensive vitamins or tonics, virtually regardless of condition being treated

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Continue…. Prescribing expensive drugs in preference to established less expensive ones Ordering for unnecessary investigations

Who is responsible?:

Who is responsible? Patient pressure: You must give instant relief A belief of pill for every ill Changing physician/ hosp, simultaneous treatment from different system of medicines Injections are more efficatious Social taboos- fasts Non- compliance

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Continue…. Practice pressure I must succeed(as may be the deal with pharma companies) The latest is the best Costlier is better The patient demand it(or I lose my practice or patient will go to other doctor) The more I write the more I earn Too many patients, too little time

Above all….:

Above all…. The Pharmaceutical companies and Government The amendment of D & C act,1982 had given the govt. enough power to prohibit mfg and sale of Irrational FDCs. Most irrational FDCs marketed by companies are permitted by State Drug Authorities--- clear violation to the LAW

Steps to improve rational drug prescribing:

Steps to improve rational drug prescribing Step 1 Identify the patient’s problem based on symptoms & recognize the need for action Step 2 Proper diagnosis of the disease. Step 3 List only possible intervention or treatment

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Continue…. Step 4 Start the treatment by writing an accurate & complete prescription: name of drugs with dosage form, dosing schedule & Total duration of action

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Continue…. Step 5 Give proper information, instruction & warning w.r.t treatment given side effects & Potential benefits Action to be taken in case of missed dose Danger/risk of stopping therapy suddenly ‘To do’ and ‘not to do’ during therapy

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Continue… Step 6 Monitor the treatment to check, if particular treatment has solved the patient’s problem: Passive monitoring:- by patient himself Active monitoring:- by physician

FDCs: Rational or irrational:

FDCs: Rational or irrational Basis of rationality of FDCs: The drugs in combination should act by different mechanism. The pharmacokinetics must not be widely different The comb. should not have supra-additive toxicity of the ingredients. Special benefit with cost-effectiveness.

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Continue…. Irrational FDCs introduced in India: Paediatric formulation of nimesulide + paracetamol Diclofenac + serratopeptidase Quinolones & nitroimidazoles e.g. norfloxacin + metronidazole ciprofloxacin + tinidazole ofloxacin + ornidazole To cover up diagnostic imprecision& the lack of access to lab facilities

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Continue… CIMs,2006:- >100 irrational combination brands The monthly index of medical Specialties, june2007:- 136 irrational combinations

Irrational combination as listed by CIMs in 2006:

Irrational combination as listed by CIMs in 2006 FDCs Irrationality NO. of brands available Nimesulide + Paracetamol Enalapril + Losartan Nimesulide banned No evidence that combination is more effective than single Increased side – effects Both affecting same pathway do not add to efficacy 21 3

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Continue…. FDCs Irrationality No. of brands available Norfloxacin + Tinidazole Atorvastatin + Nicotinic acid Cetrizine + Phenylpropanolamine + Paracetamol Patient suffer from only one type of diarrhoea (bacterial or protozoal ), may encourage resistance Probability of myopathy may increase PPA is banned due to its potential to cause Stroke, Glaucoma & Prostate enlargement 47 4 6

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Continue…. FDCs Irrationality No. of brands available Amoxicillin + Cloxacillin Amoxicillin is inactive against Staphylococci & cloxacillin is not very active against streptococci, One of the components is useless for any given infection Amount of each drug is halved & chances of resistance increases. 27

Irrational Combinations And Banned Drugs:

Irrational Combinations And Banned Drugs The DCGI has allowed so many drugs having serious ADR after considering their therapeutic justification but those drugs are allowed with an indication to be printed on label of product i.e. Erythromycin, Chloramphenicol , Metronidazole , Iodo-chlorohydroxy quinoline etc.

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1. Amidopyrine 2. Phenacetin 3. Sulphanilamide 4. Practolol 5. Methapyrilence and its salts 6. Penicillin skin/ eye ointment 7. Tetracycline liquid 8. Oxytetracycline liquid oral preparation 9. Demeclocycline liquid oral preparation 10. Methaqualone 11. FDC of chloramiphericol with other drugs for internal use 12. FDC of Ergot with any drugs 13. FDC of Vitamins with anti-inflammatory agents and tranquilisers 14. FDC of Atropine with analgesics and antipyretics 15. FDC of Yohimbine and strychnine with Testosterone and vitamins. 16. FDC of iron with Strychnine, Arsenic and Yohimbine . 17. Chloral hydrate 18. FDC of sodium bromide with other drugs. 19. FDC of Tetracycline with vitamin C. 20. FDC of antihistamins with antidiarrhoeals . Continue….

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21. FDC of Penicillins with Sulfonamides 22. FDC of vitamins with analgesics 23. FDC of prophylactic vitamins with Anti TB drugs except isoniazid with Pyridoxine Hydrochloride (Vitamin B6). 24. FDC of Strychnine and Caffeine in Tonic. 25. FDC of Hydroxy Quinolines groups of drugs with other drugs and liquid oral antidiarroheal or any other dosage form for paediatric use except for external use. 26. FDC of corticosteroid for internal use 27. FDC of Anabolic steroid with other drugs. 28. Combination of high dose of Estrogen and Progesterone (low dose combination is allowed for its use as contraceptive) 29. FDC of Sedatives/ hypnotics/ anxiolytics with analegesic and antipyretics. 30. FDC of anti-TB drugs except the under-stated combinations. I II (a) (I) Pyrizinamide 1000mg; 1500mg (II) Rifampicin 450mg; 600mg (III) Isoniazid 300mg; 300mg (b) (I) Ethambutol 600mg; 800mg (II) Isoniazid 200mg; 300mg. Continue….

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Continue…. 31. FDC of Histamin H2 receptor antagonists with antacid except any combination approved by DCGI. 32. Patent and proprietary medicines having alcohol more than 20% except preparation listed in IP. 33. All preparations containing chloroform exceeding 0.5% w/w or v/v whichever is appropriate. 34. FDC of anthelmintics with cathartics or purgatives except for piperazine . 35. FDC containing more than one antihistaminic drug. 36. FDC of Salbutamol or any other bronchodilator with central acting antitussives and/ or antihistamines. 37. FDC of Laxatives and/ or antispasmodic drugs in enzyme preparations. 38. FDC if metoclopramide with other drugs except with Aspirin/ Paracetamol . 39. FDC of centrally acting antitussives with antihistamin as having atropine like activity in expectorent . 40. Preparations claiming to combat cough associated with asthma that contain a centrally acting antitusive and/ or antihistamine. 41. Liquid oral tonic having glycerol phosphates and other phosphates and/ or CNS stimulants and such preparations having alcohol more than 20%. 42. FDC containing Pectin and/ or Kaolin with any drug which is systemically absorbed through GI tract .

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Continue…. 43. Toothpaste/ toothpowder containing tobacco. 44. Dovers powder IP Dovers Powder IP Tablets. 45. Antidiarrohoeal preparations containing kaolin/ pectin/ attapulgite / activated charcoal. 46. Antidiarrohoeal preparations having phthalye sulphathiozole , Sulphaguinidine , succinic sulphathiozole , Neomycin, streptromycin , dihydro streptomycin or their salt. 47. Antidiarrhoeal formulation in any form for Pediatric use containing Diphenoxylate or Loperamide or Atropine or belladonna including their salts, esters or metabolites or their extracts or alkaloids. 48. FDC of antidiarrhoeals with electrolytes, 49. Oral Rehydration salts (ORS)-other than conforming to WHO formula or Pharmacapoeial preparation. 50. FDC of Analgin with any other drugs. 51. FDC of Dextropropoxyphene with any other drug except with antispasmodics and or NSAID 52. FDC of Phenylbutazone or Oxyphenbutazone with other drugs. 53. FDC of allopathic drugs with Ayurvedic , Siddha or Unani drugs. 54. Mepacrine Hydrochloride ( Quina-crine and its salts) in any dosage form for use for female sterilization or contraception. 55. Fenfluramine and Dexfenfluramine.

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Continue…. 56. FDC of streptomycin with penicillin. 57. FDC of Vitamin B1, B6 & B12. 58. Fixed dose combination of Nitrofuratoin and Trimethoprim . 59. Fixed dose combination of Phenobarbitone with any antiasthamatic drugs. 60. Fixed dose combination of Phenobarbitone with Hyoscin and/or Hyoscyamine . 61. Fixed dose combination of Phenobarbitone with Ergotamine and/or Belladona . 62. Fixed dose combination of Haloperidol with any anti-cholinergic agent including Propentheline Bromide. 63. Fixed dose combination of Nalidixic acid with any antiramoebics including Metronidazole . 64. Fixed dose combination of Loperamide Hydrochloride with Furazolidone . 65. Fixed dose combination of Cyproheptadine with Lysine or Peptone. 66. Fixed dose combination of Diazepam and Diphenhydramine Hydrochloride. 67. Cisapride - Only qualified gastro- enterologists such as super specilists holding DM in gastro- enterology are permitted to prescribe cisapride . 68. Astemizole 69. Terfenadine 70. Sildenafil citrate. To be prescribed by endocrinologists, Urologists and Psychiatrist only.

FDCs in WHO’s EDL:

FDCs in WHO’s EDL Neomycin + Bacitracin (O) 5 mg + 500 IU Amoxicillin + Clavulanic acid (T) 500 mg + 125 mg Imipenem + Cilastatin (I) 250 mg + 250 mg Sulfamethoxazole + Trimethoprim (T) 100 mg + 20 mg 400 mg + 80 mg Sulfamethoxazole + Trimethoprim (I) 80 mg + 16 mg/ml (in 5 ml ampule) Isoniazid + Ethambutol (T) 150 mg + 400 mg Rifampicin + Isoniazid (T) 150 mg + 75 mg 300 mg + 150 mg Rifampicin + Isoniazid + Pyrazinamide (T) 150 mg + 75 mg + 400 mg Thiacetazone + Isoniazid (T) 50-150 mg + 100-300 mg Benzoic acid + Salicylic acid (O) 6% + 3% (w/w) Ethinylestradiol + Levonorgestrel (T) 30 μg + 150 μg

FDCs in WHO’s EDL:

FDCs in WHO’s EDL Ethinylestradiol + Levonorgestrel (T) 50 μg + 250 μg (Pack of four) Ethinylestradiol + Norethisterone (T) 35 μg + 1 mg Levodopa + Carbidopa (T) 100 mg + 10 mg 250 mg + 25 mg Ferrous salt + Folic acid (T) 60 mg + 400 μg Sulfadoxine + Pyrimethamine (T) 500 mg + 25 mg Lidocaine + Epinephrine (I) 1 or 2% + 1:200,000 Oral Rehydration Salts: Sodium chloride 3.5 g/L + Trisodium citrate dihydrate 2.9 g/L + Potassium chloride 1.5 g/L + Glucose 20.0 g/L (P) O = Ointment, T = Tablet, I = Injection, P = Powder

Guidelines for Rational use of drugs:

Prescribing a drug only when genuinely indicated Choosing drugs which are safe and effective Using single-ingredient drug, if FDCs then it should be rational Using drugs indicated for specific conditions Avoid using more than one drug of same chemical class at same time Guidelines for Rational use of drugs

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Formulations with apt dosage form and dose Minimum no. of drugs with assured quality Choosing cheaper alternatives ADR-anticipation, monitoring and management Monitor the effect of treatment Continue…

Steps to rationalize drug use in Market:

Steps to rationalize drug use in Market Elimination of useless, hazardous & harmful drugs having irrational combinations Use of Essential Drug list Marketing of drugs by their generic names Elimination of new drugs-expensive & unnecessary as other drugs with proven efficacy already exist in market

WHO Resolution Goals and Objectives:

WHO Resolution Goals and Objectives Overall goal Establish national programs for rational use of medicines run by mandated, resourced, multi-disciplinary, national bodies to coordinate monitoring of use and implementation of interventions

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Continue… WHO Objectives 1. Develop global WHO team dedicated to support countries to develop national programs to promote RUM (& contain AMR) 2. Establish internat. steering committee to guide global program 3. Undertake situational analysis in selected countries per region 4. Establish national programs in selected countries 5. Review progress after 5 years and plan for next 6 years 6. Develop model on how to promote RUM (& contain AMR) at the national level based on experience gained

Appropriate indication for the use of drugs:

Appropriate indication for the use of drugs A 1-year old with low body weight for age is seen in the OPD, because 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

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Continue…. A child with a fever, running nose and mild cough. Should he receive antibiotic like amoxicillin or a syrup with cough suppressant and cough expectorant If it would be a viral infection then it will be a self-limiting one.

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

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Continue…. Non drug treatment – important complementary treatment with drugs for many conditions E.g. weight reduction smoking cessation, going low on fats in diet- for management of diabetes, hypertension and angina. Eating high fiber diet, drinking lots of fluids and exercising is important in constipation.

Right drug for Right patient:

Right drug for Right patient Any history of possible reaction in the past Possibility of pregnancy in women of child bearing age Coexisting illness/disease present and the treatment that he is taking for the same Age and gender of the patient Occupation of the patient

Right Dose, Interval, Route And Duration :

Right Dose, Interval, Route And Duration A patient with pneumonia admitted in a private hospital does not improve after 3 days of therapy with “higher antibiotic”. He is receiving injection Cefotaxime 1g once a day A women with high fever, discomfort while passing urine and flank pain was diagnosed as having upper UTI. She was given an antibiotic in the correct dose and dosing interval but for 5days.Improving initially, she developed recurrence of the same problem two weeks later

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Continue…. A patient in a village had recurrent episodes of malaria over the past months. During each such episodes patient was given injection chloroquine 2ml by I.M. daily for 3days.

Patient be given appropriate information:

Patient be given appropriate information Information about their disease and prescribed medicines Patient’s right to information is given short shrift Lack of information by doctors and pharma companies patient education is often superficial

References::

References: 1. WHO Technical Report Series No. 867,World Health Organization, Geneva, 1997. 2. WHO Model List (revised March 2010);available at http://whqlibdoc.who.int/hq/2009/a87017_eng.pdf 3. Tiwari , P. and Panda, Jayanti , Pharmabiz ,13 July 2005. 4. Sreedhar , D., Subramanian, G. and Udupa,N ., Curr . Sci. , 2006, 91 , 406. 5. Current Index of Medical Specialties, June 2006. 6. Monthly Index of Medical Specialties,June 2007, vol. 27, No. 6: 18.

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Reena Tayde Thank You