Rational drug, Essential drugs.pptx
- 1. RATIONAL DRUG, ESSENTIAL DRUGS FDC, OTC, ORPHAN DRUGS USE presented By Dr. Manoj Kumar Assistant Professor Department of Pharmacology Adesh Medical College & Hospital Ambala Can’t
- 2. BY THE END OF THE SDL SESSION You would be able to Know about Rational drug use Essential drugs FDC OTC ORPHAN DRUGS Fast-track drug designation 2
- 3. RATIONAL DRUGS USE (RDU) Use of the drugs for the best possible effect in the shortest possible period and at a reasonable cost Right drug in Right dose in the Right dosage form by the Right route at the Right cost to the Right patient for the Right diagnosis 3
- 4. ESSENTIAL DRUGS Satisfy the priority health care needs of the population Must be available at all times, in adequate supply Available with assured quality, at a price the individual/ community can afford Intended to be flexible & adaptable to different situations Exactly which medicines are regarded as essential remains a national responsibility 4
- 5. ESSENTIAL DRUGS Selection criteria: Selected with due regard to Disease prevalence Evidence on efficacy & safety Comparative cost-effectiveness 5
- 6. ESSENTIAL MEDICATION LIST (EML) Minimum number of rational drugs and their dosage forms which are necessary to cover preventive, symptomatic and curative health needs of a majority of population of that geographical area. WHO 1st in 1977: 208 drugs 2019: 21st edition: 460 drugs Core list & complementary list 6
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- 8. NLEM (2015) 1st in 1996 376 medicines listed in NLEM 2015 3 category included P→ Primary S → Secondary T → Tertiary 9
- 9. CRITERIA FOR INCLUSION OF A DRUG IN NLEM Approved/licensed in India. Useful in disease which is a public health problem in India. Have proven efficacy & safety profile based on valid scientific evidence. Cost effective. Aligned with the current treatment guidelines for the disease. Stable under the storage conditions in India. When more than one medicine are available from the same therapeutic class, preferably one prototype/ medically best suited medicine & careful evaluation of their relative safety, efficacy, cost-effectiveness. 10
- 10. . Price of total treatment to be considered and not the unit price of a medicine. Fixed Dose Combinations (FDCs) are generally not included unless the combination has unequivocally proven advantage Over individual ingredients administered separately, in terms of increasing efficacy, reducing adverse effects and/or improving compliance. The listing of medicine in NLEM is based according to the level of health care, i.e. Primary (P), Secondary (S) and Tertiary (T) because the treatment facilities, training, experience and availability of health care personnel differ at these levels. 11
- 11. PURPOSE OF THE NLEM Guide safe & effective treatment of priority disease conditions of a population Promote the rational use of medicines Optimize the available health resources of a country 12
- 12. ALSO BE A GUIDING DOCUMENT FOR: State governments to prepare their list of essential medicines Procurement & supply of medicines in the public sector Reimbursement of cost of medicines by organizations to its employees Reimbursement by insurance companies Identifying the ‘MUST KNOW’ domain for the teaching & training of health care professionals 13
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- 14. EDL: HARYANA 15
- 15. FIXED DOSE COMBINATIONS (FDC) Product containing two or more active ingredients used for a particular indication Combination of two different drugs in a single pharmaceutical formulation Should have approximately equal t1/2 & the ratio of doses of each component should depend on aVd & plasma concentration 16
- 16. EXAMPLES Levodopa (t1/2: 1.7 hr) & Carbidopa (t1/2: 2 hr) Sulfadoxine (t1/2: 160 hr) & Pyrimethamine (t1/2: 112 hr) Amoxycillin (t1/2: 1-2 hr, aVd: 0.21 L/kg) & Clavulanic acid (t1/2: 1- 1.5 hr, aVd: 0.2 L/kg) Amoxycillin 500mg + Clavulanic acid 125mg can be administered as 1 to 2 tab 8hrly Sulfamethoxazole (t1/2: 11 h, aVd: 0.2 L/kg) & Trimethoprim (t1/2: 10 h, aVd: 1-2 L/kg) Can be combined in their standard dose regimen 17
- 17. ADVANTAGES Convenient, Improves patient compliance Reduction in numberof pills Simplifies dosing Enhanced effect Allows for synergistic combinations Cotrimoxazole, Levodopa + carbidopa Reduced dose & adverse effects Prevents and/or slows attainment of antimicrobial resistance Treatment of chronicinfectious diseases.eg- treatment ofTB,HIV Less expensive 18
- 18. DISADVANTAGE Dosing is inflexible & cannot be regulated to patient’s needs May showmore adverse effects Nimesulide + Paracetamol, Ramipril + Losartan It becomes difficult to identify one particular drug which is causing harmful/beneficial effects FDC must be stopped & replaced by separate tablets More expensive May require bio-availability testing Potential quality problems, especially with rifampicin in FDCs for TB 19
- 19. DISADVANTAGE CONT.. Incompatible pharmacokinetics is irrational Different elimination t½ of individual components Incompatible pharmacodynamics Combination of antihistaminic & antidiarrhoeal is dangerous as antihistaminic action may mask other symptoms Reaction of one of the components (e.g., a rash to sulfamethoxazole in cotrimoxazole) may result in patient avoiding the “innocent” trimethoprim in the future Drug interactions may lead to alteration of the therapeutic effect 20
- 20. DISADVANTAGE CONT.. One of the drugs in the combination maybe wasteful Vitamin + iron There will be increase in price if unnecessary drugs are included. Ibuprofen + paracetamol + caffeine The dose of any component cannot be adjusted independently Individual medicines may not be present in adequate amounts e.g-multivitamins 21
- 21. OTC DRUGS Drugs that are safe & effective for use by the general public without a prescription Considered as minimally effective & safe Do not require approval by the physician Prescription drugs considered more potent & frequently dangerous.
- 22. OTCS Indicated for Cough Diarrhoea Influenza Vomiting Allergy Gastric hyper-acidity 23
- 23. MOST COMMONLY USED FOR • Aches & Pain (78%) • Cough, cold (52%) • Heartburn (45%) • Constipation, diarrhea (37%) • Skin care (10%) • Multivitamins 24
- 24. OTCS Adverse effects: Generally mild Nausea, vomiting, diarrhea, dizziness, drowsiness ADVANTAGES • Allows the patient to have greater access to a variety of drugs available in the market to treat some medicinal conditions e.g. Cough Allergy Gastric hyper-acidity Pain 25
- 25. ADVANTAGES OF OTC DRUGS Benefits outweigh risks Low misuse & abuse potential Consumers are able to Self diagnose Self treat Self manage health practitioners are not needed. adequately labeled 26
- 26. ADEQUATELY LABELED Active ingredient Inactive ingredients Uses "indications" Warnings Directions Other information Questions or Comments Expiry date 27
- 27. DISADVANTAGES o Poorer compliance o More difficult to study drug effects o Misdiagnosis may occur o Risk of abuse o Reduced opportunities to receive counseling about possible lifestyle therapies (e.g. exercise & diet), 28
- 28. ORPHAN DISEASES All pathological conditions, affecting 0.65-1% out of every 1000 population. Usually not studied for their patho-physiology or for newer therapeutic options, as these are not economically viable Orphan Drug Act, passed in 1983 by USA, to stimulate the research, development, & approval of those products that treat orphan diseases 29
- 29. ORPHAN DRUGS Incentives for ODS Tax incentives for clinical research, Study design assistance from FDA , Rebate from application-filing fees, Grant for Phase I and II clinical trials, and Seven years of marketing only after the approval of the drug or biological product 30
- 31. ESSENTIAL VS ORPHAN DRUGS . 32
- 32. FAST-TRACK DRUG DESIGNATION No therapy must exist for that specific condition, The new therapy must demonstrate an improved effect, Affect alternative outcomes other than the current therapy, Benefit patients unresponsive to current therapy, Avoid serious toxicities associated with current therapy, or Offer improved compliance and convenience compared to current therapy. 33
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