Clinical Establishment act.pptx

About clinical establishment act and National List of Essential Medicine.

1. CLINICAL ESTABLISHMENT ACT DR VANDANA VERMA, ASSOS. PROF, DEPT. OF COMMUNITY MEDICINE, CIMS&H

2. Introduction The Clinical Establishments Act was passed by Parliament of India on 17 th August 2010 The Ministry of Health and Family Welfare has notified the National Counci l for Clinical Establishments and the Clinical Establishments (Central Government) Rules , 2012 under this Act vide Gazette notifications dated 19th March, 2012 and 23rd May, 2012 respectively. NSSO estimates, as much as 40% of the private care is likely being provided by informal unqualified providers.

3. Objectives of the Act To prevent quackery by unqualified practitioners by introducing registration system, which is mandator y. To establish digital registry of Clinical Establishments at National, State and District level. To improve quality of health care through standardization of healthcare facilities by prescribing minimum standards of facilities and services for all categories of health care establishments.

4. Definition Clinical establishments defined as health care / establishments by any name, engaged in diagnosis, treatment or care of injury, illness, pregnancy, disability, or abnormality in any recognised sysytem of medicine established and adminstrated.

5. Clinical Establishment.. A clinical establishment owned, controlled or managed by a Government or department of the Government; a trust, whether public or private; a corporation (including a society) registered under a Central, Provincial or State Act, whether or not owned by the Government; a local authority; and a single doctor ( Exception : establishments of the Armed Forces)

6. Authority National Council for clinical establishments DGHS, Ex-officio, Chairperson 4 elected representatives, out of which Medical Council of India ( one representative), Dental Council of India ( one representative), Nursing Council of India ( one representative), Pharmacy Council of India( one representative), Indian Medicines representing the Ayurveda,Siddha,Unani ( three elected representatives), Central Council of Homoeopathy ( one elected representative) ,

7. At State Level State shall set up, District Registering Authority District collector - Chairperson District Health Ofiicer - Converner Three Members

8. Powers & Responsibilities: DRA Grant/Renew provisional (within 10 days)/permanent registration. May issue a notice to Clinical Establishment to show cause within 3 months, if condition(s) of registration are not met . To enter and search unregistered CE (after due notice), inspection and inquiry of registered Clinical establishments May cancel registration (after giving reasonable opportunity) and giving reasons . After cancelling registration, immediately restrain Clinical Establishment if imminent danger to the health and safety of patients Recover p enalties . Maintain District register of Clinical establishments .

9. Minimum required standards Clinic / Polyclinic only Consultation ( level 1A) S pace : 2. Human Resource: One Doctor – MBBS / BDS registered in any MCI One Support staff – registered in any nursing council Common area Consultation area Reception Waiting Room 35 sqft 35 sqft 70 sqft

10. Essential Equipment Equipment Minimum specification Number Stethoscope 1 Thermometer Digital 1 Torch (flash lights) 1 Sp h y gm oma n om e t er ( B . P . Apparatus) Digital 1 Weighing machine( Op t i onal) Adult 1

11. Eme r g enc y E quipme n t Equipment Minimum specification Number Resuscitation Equipment Ambu Bag/Air Way Adult P e d i a t r i c 1 1 Oxygen Concentrator/ Cylinder . Portable 1 Fire Extinguisher 1

12. Emergency Drugs Name of the Drug No of ampule Inj Adrenaline 2 A Inj Hydrocortisone 1 vial Inj Atropine 1 Ampoule Inj Avil 1 Ampoule Inj Phenargan 1 Ampoule Inj. Deryphyline 1 Ampoule Inj. Frusemide 1 Ampoule Inj. Metoclopramide 1 Ampoule

13. Emergency Drugs Name of the Drug No of ampule Inj. Dexamethasone 2 A Inj. Diazepam 1 vial Inj. Dicyclomine Hydrochloride 1 Ampoule Inj. 5% dextrose infusion 1 Vac Inj. Normal saline 1 Vac

14. Penalties under the Act Offences penalties FIRST ATTEMPT SECOND ATTEMPT SUBSEQUENT ATTEMPT Running Clinical Establishment without registration 50,000 2,00,000 5,00,000 Contravention of any other provision of the Act 10,000 50,000 5,00,000 Whoever knowingly serves in an unregistered Clinical Establishment 25,000 Minor deficiencies which do not pose imminent danger 10,000

15. ESSENTIAL MEDICINE LIST

16. DEFINITION Essential medicines are those that satisfy the priority health care needs of the population at all time.

17. Essential medicines are selected with due regard to: Disease prevalence Public health relevance Evidence on efficacy and safety Comparative cost- effectiveness

18. HISTORY OF THE WHO MODEL LIST OF ESSENTIAL MEDICINES Tanzania was the first country in the world to compose Essential Medicine List 1977 First Model list published by WHO, ± 200 active substances List is revised every two years by WHO Expert Committee 21 st WHO model EML published in June 2019, is proof that the concept is still valid after nearly 43 years and continues to have many advantages when it is used appropriately and in conjunction with standard treatment guidelines.

19. NATIONAL LIST OF ESSENTIAL MEDICINES INDIA (NLEM) Introduced & controlled by Ministry of Health & Family Welfare (MOHFW), GOI First NLEM 1996 (Revised in 2003) NLEM 2011 (348 Drugs) NLEM 2015 [376 Drugs (106 added & 70 deleted)] Category of Drugs (On basis of health care and disease burden) P→ Primary (206) S → Secondary (115) T → Tertiary (79)(106 additions and 70 deletions) Medicines deleted from NLEM- 2003 (47 Drugs)

20. CRITERIA FOR INCLUSION OF A MEDICINE IN NLEM 2015 The medicine should be approved/licensed in India. The medicine should be useful in disease which is a public health problem in India. The medicine should have proven efficacy and safety profile based on valid scientific evidence. The medicine should be cost effective. The medicine should be aligned with the current treatment guidelines for the disease. The medicine should be stable under the storage conditions in India.

21. WHAT IS CORE LIST AND COMPLEMENTARY LIST? Core list – List of minimum medicine needs for a basic health care system, listing the most efficacious , safe and cost effective medicines for priority conditions. Complementary list – Essential medicines for priority diseases , for which specialised diagnostic or monitoring facilities and or specialist medical care and or specialist training are needed.

22. PURPOSE OF NLEM Guides safe and effective treatment of priority disease conditions. Promote the rational use of medicines Optimize the available health resources of a country NLEM- a 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

23. TAKE HOME MESSAGE E – Efficacy S – Safety and suitability S - Storage and stability E - Ease of administration (dosage form) N - Need of population T - Total cost I - Irrational combination to be avoided A - Availability, Affordability L - Listing regularly (updating)

24. MCQ 1.Which Clinical establishments not covered under the Act ? a) Clinic owned by single doctor. b) Clinics owned, controlled or managed by the Armed Forces. c) Government medical college. d) Corporation / municipality – dispensaries

25. 2.According to National Sample Survey 60th round % of the private care is likely being provided by informal unqualified providers? a) 20% b) 30% c) 40% d) 50%