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FDC STG NLEM

Fixed dose combination Standard treatment guideline and NLEM related general useful for MBBS students

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FDC STG NLEM

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  1. FDC STG NLEM Dr. Chandane R. D. Professor Dept of Pharmacology Lady Hardinge Medical College, New Delhi Dr. R. D. Chandane

  2. FIXED DOSE COMBINATIONS/ FDCs FDC: When two or more than two drugs are used in a fixed ratio of doses these are called fixed dose combinations (FDCs). These may be • Rational or • Irrational The Indian laws are not properly defined to grant marketing approvals of FDCs by State or Central Drug Controlling Authorities. Hence the rationality of a FDC has become one of the most controversial and debatable issues in general practice. Dr. R. D. Chandane

  3. BASIS OF FDCs Two or more drugs can be combined but while doing so following points should be kept in mind. • Efficacy should be increased and they should preferably act by different mechanisms e.g. trimethoprim and sulphamethoxazole. • Pharmacokinetic similarity e.g. should have similar half lifeeg. same as above (t ½ of both is 12 h). • Both should be metabolized or excreted unchanged, so the combination is suitable in poor renal or poor hepatic function. Dr. R. D. Chandane

  4. BASIS OF FDCs…….. • Amount of drug ratio in which two drugs are combined also depend on aVdand peak plasma concentration of individual drug in order to achieve the same plasma concentration, e.g. ratio of trimethoprim and sulphamethoxazole is based on their aVd. • Both should have different side effect profile and it is better if the side effect of one may counter the other e.g. potassium losing and potassium sparing diuretics and another example is combination of atenolol (bradycardia) with amlodipine tachycardia). Dr. R. D. Chandane

  5. BASIS OF FDCs…….. • Convenience of administration and thus better patient compliance, particularly when treatment is prolonged or life long as patient may forget to take all the drugs. • Those FDCs which do not conform to above guidelines are irrational. Sometimes FDCs are rational but their use is irrational. e.g. if FDCs of antihypertensive drugs or antidiabetic drugs are used to start the treatment it is irrational use but once it is established that two drug are required to control such condition, then the use of combination in appropriate doses for the maintenance of therapy is rational as it greatly increases the patient compliance due to convenience of use. Dr. R. D. Chandane

  6. Advantages • Enhanced efficacy e,g. drugs for tuberculosis, antidiabetic drugs, antihypertensive drugs. • With certain FDC efficacy is not increased but adverse effects are antagonized e.g. tachycardia due to amlodipine is counteracted by atenolol that causes bardycardia when they are used as FDC as antihypertensive. • Synergistic effect e.g. trimethoprim + sulphamethoxazole, levodopa + carbidopa. • Prevent the development resistancee.g tuberculosis Dr. R. D. Chandane

  7. Reduced the adverse effects eg. combination of potassium loosing with potassium sparing diuretics and combination of levodopa with carbidopa. However adverse effects may be enhanced as well e.g. enhanced hepatotoxicity when FDCs of antitubercular drugs such as INH, rifampicin and pyrazinamide is used. • Reduced the cost of treatment (not alwave true). • Convenient and so better patient compliance particularly for those diseases where treatment is prolonged e,g. tuberculosis or life long such as antiHIV, antihypertensive and antidiabetic drugs In such diseases, it is ascertained that single drug will not be administered Dr. R. D. Chandane

  8. One of the ingredients is intended to minimize abuse of the other ingredient (e.g. the combination of diphenoxylate with atropine, or buprenorphine with naloxone) • One drug acts as a booster for another (for example Lopinavir + Ritonavir). Compliance:  Dr. R. D. Chandane

  9. Rational point • The main advantage often emphasized of any FDC is only convenience and better patient compliance. If two or more drugs are combined as FDCs merely for convenience then it is not considered rational except certain FDCS Such as FDCs of antitubercular and antiHIV drugs. Dr. R. D. Chandane

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  13. Disadvantages • Difficulty in dose adjustment or flexibility in dose. • Subtherapeutic dose of individual drug. • Difficulty to detect side effect. • Pharmacokinetic incompatibility and pharmacokinetics of different component may be affected differently in altered hepatic or renal function. • Allergy to one drug contraindicates the FDC. • Increased cost of treatment Dr. R. D. Chandane

  14. Disadvantages….. • Enhanced side effects e.g. the combination of INH, rifampicin and pyrazinamide may cause more hepatotoxicity as all the three are hepatotoxic, so ideally should not be combined but main reason is patient compliance. WHO also approves antitubercular FDCs in different proportions. • Sometimes there is no clear indication of FDC. Dr. R. D. Chandane

  15. Condition to use FDC FDCs should only be used when there is good reason with clear cut therapeutic objectives and when patient needs all the drugs in a FDC. Doses of all the drugs should be appropriate and there is no need to adjust the dose of any drug. Dr. R. D. Chandane

  16. EXAMPLES OF IRRATIONAL FDC • Nimesulide+pcm- • FDC of analgesi, anti inflammatory and antipyretic results in increased hepatotoxicity • Ampicillin+cloxacillin- • ampicillin is effective against Gram negative bacilli but Cloxacillin is an antistaphylococcal penicillin and not effective againt Gram -ve and Staphylococcal(Gram +ve) infection rarely coexists. Dr. R. D. Chandane

  17. The 17th essential medicines list of WHO has 351 essential medicines, including 25 FDCs whereas the National list of essential drugs of India NLEM(2011) has 354 essential drugs including 14 FDCs. Despite of this, hundreds of irrational FDCs are being marketed in India under more than 1,000 brand names. Dr. R. D. Chandane

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  20. FDC • FDCs with their advantages have great potential to revolutionize the therapeutic scenario in many medical conditions. • But the ever increasing number of irrational FDCs is an alarming concern. • Regulatory authorities, Pharmaceutical industries & Clinical practitioners must work collectively to change the scenario for the better, promising & economical health care. Dr. R. D. Chandane

  21. Standard treatment Guidelines • Definition: A systematically developed statement designed to assist practitioners and patients in making decisions about appropriate health care for specific clinical circumstances • The Drug and Therapeutics Committee (DTC) is responsible for numerous important pharmaceutical management functions. • evaluatingnew medicines for the formulary, identifying and correcting medicine use problems, assessing and controlling adverse drug reactions. Dr. R. D. Chandane

  22. Need for STG • Treatment of diseases may have many different approaches. • Many practitioners will not remember the best method of treatment. • Applying the most effective treatment benefits both the patient and the health care system. • Formulary management will have only limited impact if medicines are used incorrectly. The development and implementation of STGs is a necessary task in a health care system where numerous treatments may be available. Dr. R. D. Chandane

  23. The Need: A Solution to Therapeutic Anarchy • Casual observation, as well as more systematic study of prescribing practices, frequently reveals a pattern of tremendous diversity among prescribers in the treatment • Polypharmacy is one problem • Problem - making incorrect medicine choices, overdosing, underdosing, and choosing a more expensive medicine when less expensive ones would be equally or more effective. Dr. R. D. Chandane

  24. STGs—also known as standard treatment schedules, standard treatment protocols, therapeutic guidelines, and so forth—list the preferred pharmaceutical and nonpharmaceutical treatments for common health problems experienced by people in a specific health system. • Pharmaceutical treatment: name, dosage form, strength, average dose (pediatric and adult), number of doses per day, and number of days of treatment • Diagnosis and advice to the patient may also be included. Dr. R. D. Chandane

  25. Advantages of STG : Health care providers • Provides standardized guidance to practitioners • Encourages high quality care by directing practitioners to the most appropriate medicines for specific conditions • Provides valuable assistance to all practitioners, especially to those with lower level skills • Enables providers to concentrate on making the correct diagnosis because treatment options will be provided for them Dr. R. D. Chandane

  26. Advantages of STG : Health care officials • Provides a basis for evaluating quality of care • Provides the most effective therapy in terms of quality • Provides a system for controlling cost by using funds more efficiently • Provides information for practitioners to give the institution’s standards of care to patient • Can be a vehicle for integrating special programs (e.g., diarrhea disease control, acute respiratory infection (ARI), tuberculosis control, malaria) at the primary health care facilities using a single set of guidelines Dr. R. D. Chandane

  27. Advantages of STG : Supply management • Utilizes only formulary or essential medicines, therefore the health care system needs to provide only medicines in the STGs • Provides information for forecasting and ordering (because medicines and quantities for common diseases will be known) • Provides information for purchase of prepackaged medicines Dr. R. D. Chandane

  28. Advantages of STG : Patients • Patients receive optimal pharmaceutical therapy • Enables consistent and predictable treatment from all levels of providers and at all locations within the health care system • Allows for improved availability of medicines because of more consistent use and ordering • Helps provide improved outcomes because patients are receiving the best treatment regimens available • Lowers cost Dr. R. D. Chandane

  29. Disadvantages of STG • Inaccurate or incomplete guidelines will provide the wrong information for providers and therefore do more harm than good. Guidelines may not be based on the most reliable information. • Developing and updating guidelines is difficult and time-consuming and must be done on a regular schedule or they will become obsolete very quickly. • Guidelines provide a false sense of security; that is, many providers will limit their evaluation of a particular patient as soon as it fits into a particular standard treatment. Dr. R. D. Chandane

  30. Steps for Establishing STGs • Establish a committee to address the development of the guidelines. • Develop an overall plan for guidelines. • Identify the diseases that the STGs will cover. • Determine appropriate treatment options:-- • Determine what information should be included in the STG:-- • Draft the STGs for comments and pilot testing. • Publish and disseminate. • Revise and update. Dr. R. D. Chandane

  31. Determine appropriate treatment options Experts and clinical specialists should be consulted. Evidenced-based information must used • Use the fewest medicines necessary to treat the medical condition • Choose cost-effective treatment • Use formulary medicines (from local and national formularies) • Give first-, second-, and third-line treatment options, when appropriate • Provide dose, duration, contraindications, and side effects Dr. R. D. Chandane

  32. Determine what information should be included in the STG • Clinical condition • Diagnostic criteria and exclusions • Treatment objectives (e.g., elimination of plasmodium parasites from a blood smear) • Nonpharmaceutical treatment • Medicines of choice (and alternatives) for the medical condition • Important prescribing information—dose, duration, contraindications, side effects, warnings, medicine interactions • Referral criteria • Patient education information • What to do when clinical response is poor Dr. R. D. Chandane

  33. Implementing the Guideline • Printed reference materials • Official launch • Initial training • Reinforcement training • Monitoring • Supervision Dr. R. D. Chandane

  34. Essential drug • 1975, the World Health Assembly requested the Director-General to advise Member States on “the selection and procurement, at reasonable cost, of essential drugs of established quality corresponding to their national health needs” • 1st WHO model list of essential drugs- 1977 contained 208 medicines. • It stated that essential drugs were “of utmost importance, basic, indispensable and necessary for the health and needs of the population”. • 2007, a separate list for children up to 12 years Dr. R. D. Chandane

  35. Definition Essential medicines are those that satisfy the priority health care needs of the population. They are selected with due regard to public health relevance, evidence on efficacy and safety, and comparative cost-effectiveness. They are intended to be available within the context of functioning health systems at all times in adequate amounts, in the appropriate dosage forms, with assured quality and adequate information, and at a price the individual and the community can afford. Dr. R. D. Chandane

  36. NATIONAL LIST OFESSENTIAL MEDICINES (NLEM) • The current WHO "Model List of Essential Medicines“ is revised in 2019 and it is the 21st edition adults and 7th edition for children. • Similar to WHO model list every member country has modified this list as per their local requirement (need) mainly the prevalent diseases and available financial resources, the NLEM. • By MOHFW, GOI, first list 1996- 279 medicines • Revision in 2003, 2011, 2015 • The current NLEM is revised in March, 2015 and it is the 4th edition and contains 376 drugs and 23 FDCs. Dr. R. D. Chandane

  37. NLEM 2015 • The NLEM 2015 has been prepared adhering to the basic principles of Efficacy, Safety, Cost-Effectiveness; consideration of diseases as public health problems in India. The list could be called as a Best-Fit List. • NLEM 2011- 348 medicines. 106 medicines –added 70 medicines -deleted • NLEM 2015- 376 medicines. • Coronary stents included in NLEM- to increase affordability • Medicines used in dementia and neonatal care added • Any medicine/ vaccine, under a National Health Programme will be deemed to have been included in NLEM. Dr. R. D. Chandane

  38. NLEM 2015 • Essentiality considered in terms dosage form and strength also. • Oral solid dosage form (tablet/capsule)- two aspects considered 1) dosage form that is commonly available 2) dosage form that is mentioned in Indian Pharmacopoeia • Active moiety available as different isomers/ analogues / derivatives, considered as separate entities, and inclusion of one does not imply inclusion of all isomers/ analogues/ derivatives. Dr. R. D. Chandane

  39. NLEM 2015 • Fixed Dose Combinations (FDCs) not included unless, combination has unequivocally proven advantage over individual ingredients administered separately, in terms of increasing efficacy, reducing adverse effects and/or improving compliance. • Formulations developed through innovation/ novel drug delivery systems considered as included only if specified in the list against any medicine. Dr. R. D. Chandane

  40. LEVELS OF HEALTHCARE IN NLEM • Medicines in NLEM are listed with reference to the levels of healthcare, i.e., Primary (P), Secondary (S) and Tertiary (T) as the treatment facilities, training, experience and availability of health care personnel differ at these levels. • 209 medicine formulations- all levels (P, S, T), • 115 medicine formulations- secondary and tertiary levels (S, T) • 79 medicine formulations- the tertiary level (T). • Formulations of certain medicines are listed at different levels but as item, they are counted as one. Dr. R. D. Chandane

  41. INCLUSION CRITERIA OF MEDICINE IN NLEM 2015 • Medicine has to be licensed and approved in the country by DCGI • Useful in disease which is a public health problem in India • Proven efficacy and safety profile based on valid scientific evidence • Comparatively cost effective • Aligned with current treatment guidelines for the disease • Stable under storage conditions in India • considered, not the unit price of medicineTotal treatment price Dr. R. D. Chandane

  42. CRITERIA FOR DELETION OFMEDICINE IN NLEM 2015 • Medicine banned in India • Reports of concerns on the safety profile • Medicine with better efficacy or safety profile and better cost effectiveness is available • Disease burden for which medicine is indicated is no longer a national health concern • In case of antimicrobials, resistance pattern has rendered the medicine ineffective Dr. R. D. Chandane

  43. PURPOSE OF NLEM • Guide safe and effective treatment of priority disease conditions of a population • Promote the rational use of medicines • Optimize the available health resources of a country • Guiding document for: - State governments to prepare their list of essential medicines - Procurement and 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 and training of health care professionals Dr. R. D. Chandane

  44. Thank You Dr. R. D. Chandane

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