Indian Pharmacological Society
Bangalore Chapter
Pre Conference Workshop: Wed 05 Aug 2015
•Start, implement and lead the q...
1941
2
Module - 1
• The Pharmacological Basis for
Establishment and Implementation of
a Quality Managagement System for
Pharmacol...
WHAT is Quality ?
• The totality of characteristics of a medical
service that bear on its abilities to satisfy patient
nee...
H O W ?
• M ANAGEMENT: commitment, laws, rules
• M ETHODS : policies, procedures, registers,
• M EDICINES & other material...
Only 5 points to the
Quality Approach
• LEGAL requirements
• PATIENT needs
• EMPLOYEE needs
• DOCUMENTATION requirements
•...
Ignorantia Juris NON Exclusat
• Council Registration: Medical, Pharmacists,
Nursing, Rehabilitation, Dental…
• Building sa...
5 points… ( repeated )
• LEGAL requirements
• PATIENT needs: stated & implied, families
• EMPLOYEE needs: training, safety...
Documentation needed to
establish a quality management
system
9
At minimum :
• Quality Manual (Apex Manual), institutional level
• List of applicable laws, list of abbreviations
• Organo...
What is a policy?
Plan of action, statement of aims and ideals,
standing instructions applicable to all
• "Oral Contracept...
What is a procedure?
The regular order of doing things, especially 'how
to' follow the steps leading to implementation of
...
Committees for implementing the QMS
• Pharmacy services
• Preparation of formulary
• Look Alike – Sound Alike meds
• High ...
Tool for Improving the QMS
14
INTERNAL AUDIT: a QMS tool
( Find the problems before TV/Newspapers/Goondas ! )
• Safety Audits, rounds, hazard analysis &...
ERRORS will occur
• Correction : patient must never suffer, no
compromise on safety and legal requirements
• Corrective Ac...
Module - 2
The N A B H Approach
13 Requirements for
QUALITY MANAGEMENT
OF MEDICATION (MOM)
This is NOT the 14th requirement !
18
19
Dr. VIKRAM KASHYAP
CONSULTANT NEUROSURGEON & LEAD AUDITOR, ISO 9001.
PRINCIPAL ASSESSOR, NATIONAL ACCREDITATION BOARD F...
NABH requirements : Intent
Patient safety, above all else
Integrate pharmacy: hospital & patient care
Storage practices...
1 st MOM std : MEDICATION
Documented policies & procedures guide
the organisation of pharmaceutical,
pharmacological, disp...
2nd MOM std : FORMULARY
Establish and document a hospital formulary
• Prepared by pharmacists, pharmacologists,
clinicians...
3rd MOM std : STORAGE 1st of 3
Documented policies and procedures govern
storage of medication.
23
Contd...3rd Std: Storage 2nd of 3
• Temperature & humidity : monitoring,
calibration issues
• Light & Ventilation ( magnif...
Storage…Contd...3rd of 3
Sound alike and look alike medications are stored
separately: fool - ......... proofing
EXAMPLES:...
4th MOM std. PRESCRIPTIONS
• Documented policies and procedures : who,
where, when (repeat orders), what (particularly
hig...
5th MOM std. DISPENSING
SAFE dispensing : concerns the PHARMACIST
Prepare a procedure ( SOP ) to address :
• Recall. Anywa...
6th MOM std ADMINISTRATION 1st of 2
Documented policies and procedures for
medication management
• Administration of medic...
6th ...2nd of 2 Administration ..... Contd.
VERIFY THE ORDER
• Patient
• Drug, cross verified
• Dosage
• Route
• Timing
• ...
7th MOM std : MONITORING
• Documented policies and procedures to
MONITOR the patient after drug
administration.
• When is ...
8th MOM std : ERRORS
• Procedure to define what is a near miss, an
error and an adverse drug event (more about
this in a l...
9th MOM Std : NARCOTICS
• Narcotic & Psychotropic Substances Act
( NDPS ) 1985 amended upto 2015
• Excise law, not drug la...
10th MOM std CHEMO drugs
• Policies and procedures for chemotherapeutic
drugs : who can prescribe, who can prepare,
who ca...
11th MOM std RADIO-pharmaceuticals
• Policies and procedures for radio-
pharmaceuticals: who can prescribe, who can
prepar...
12th MOM std: Prostheses, implants
• IOLs, Ortho implants, Cardiac Stents, Neuro shunts
• Quality criteria: CE mark, ISO 1...
13th MOM std : CONSUMABLES
• Purchase procedure : remember vendor
requirements ?
• Quality criteria for purchase
• Resourc...
Take Home Messages
• Know the applicable laws
• Establish, document & monitor the QMS
• Errors WILL occur: try to ELIMINAT...
Thank you very much
of 38

NABH overview

Presentation @ IPS Bangalore Chapter Preconference workshop
Published on: Mar 3, 2016
Published in: Health & Medicine      
Source: www.slideshare.net


Transcripts - NABH overview

  • 1. Indian Pharmacological Society Bangalore Chapter Pre Conference Workshop: Wed 05 Aug 2015 •Start, implement and lead the quality initiative •Management of medication, the NABH approach 1
  • 2. 1941 2
  • 3. Module - 1 • The Pharmacological Basis for Establishment and Implementation of a Quality Managagement System for Pharmacology, Pharmaco- Therapeutics & Dispensing Pharmacy 3
  • 4. WHAT is Quality ? • The totality of characteristics of a medical service that bear on its abilities to satisfy patient needs : stated and implied • RIGHT: patient, drug, route, dose, time, recording, rationale, response To practice quality you have to MANAGE quality To manage quality, you need a Quality Management System ( QMS ) 4
  • 5. H O W ? • M ANAGEMENT: commitment, laws, rules • M ETHODS : policies, procedures, registers, • M EDICINES & other material • M ACHINES : refrigerators, UPS, generators • M ANPOWER : staff, training : motivation • M ILIEU : environment, storage, safety, waste • M ANAGEMENT : money, review, improve 5
  • 6. Only 5 points to the Quality Approach • LEGAL requirements • PATIENT needs • EMPLOYEE needs • DOCUMENTATION requirements • ( NABH ) requirements JCAHO, JCI (USA), AC (Canada), NHS (UK), DAC (Dubai), MSQH (Malaysia) 6
  • 7. Ignorantia Juris NON Exclusat • Council Registration: Medical, Pharmacists, Nursing, Rehabilitation, Dental… • Building sanctioned plans from municipality • Rule by Hon'ble Supreme Court of India: Visakha vs State of Rajasthan 1997 • Karnataka Shops & Other Est. Act 1963 • IP 2014 • Pharmacy Act 1948, I.P. 2014 , NDPS 2015, D & C Act 2013, Factories Act 1948…. 7
  • 8. 5 points… ( repeated ) • LEGAL requirements • PATIENT needs: stated & implied, families • EMPLOYEE needs: training, safety, duties... • DOCUMENTATION requirements • STANDARD ( NABH ) requirements 8
  • 9. Documentation needed to establish a quality management system 9
  • 10. At minimum : • Quality Manual (Apex Manual), institutional level • List of applicable laws, list of abbreviations • Organogram: institutional & dept. levels • Formulary (list of approved drugs for a hospital) • Antibiotic Policy • S O P s where required • Formats, Forms, Registers, Records, stock-outs, errors…. • Documented Procedures, ("Policies & Procedures") that are common to all standards for accreditation >>>> 10
  • 11. What is a policy? Plan of action, statement of aims and ideals, standing instructions applicable to all • "Oral Contraceptives are not dispensed here" • "Prescriptions of outside drs are not accepted" • "Errors & Omissions Excepted" • "Payment shall be made only after verification of the invoiced goods on Purchase Order" 11
  • 12. What is a procedure? The regular order of doing things, especially 'how to' follow the steps leading to implementation of a policy • Purchase Procedure for Vendor Approval • Procedure for Safety Precautions during 6th Semester lab experimentation in Pharmacology Lab • Procedure to obtain drugs during 'stock out' • Procedure to be followed in the event of a reported drug reaction >>>> committees >>> 12
  • 13. Committees for implementing the QMS • Pharmacy services • Preparation of formulary • Look Alike – Sound Alike meds • High risk meds • Analysis of adverse drug events • Procedure for purchase (vendor control) • Infection control & Antibiotic policy • Safety, Research, Quality IMPROVEMENT…… 13
  • 14. Tool for Improving the QMS 14
  • 15. INTERNAL AUDIT: a QMS tool ( Find the problems before TV/Newspapers/Goondas ! ) • Safety Audits, rounds, hazard analysis & risk assessment: walk around, 5 senses, cybersafety • Clinical Audits • Prescription Audits • Medical Record Audits • Accounting Audits • Internal Quality Audit of the entire QMS 15
  • 16. ERRORS will occur • Correction : patient must never suffer, no compromise on safety and legal requirements • Corrective Action : prevent the same problem from occurring again and again • Root Cause Analysis : WHY, why …….. • Preventive Action : Look around, prevent similar problems from occurring • Follow up, confirm elimination, strengthen the QMS, make friends not enemies 16
  • 17. Module - 2 The N A B H Approach 13 Requirements for QUALITY MANAGEMENT OF MEDICATION (MOM)
  • 18. This is NOT the 14th requirement ! 18
  • 19. 19 Dr. VIKRAM KASHYAP CONSULTANT NEUROSURGEON & LEAD AUDITOR, ISO 9001. PRINCIPAL ASSESSOR, NATIONAL ACCREDITATION BOARD FOR HOSPITALS Telephones (080) 2657 4909, & - 4949 Residence: Clinic : (080) 40800102 1, Church Road, "Shambhavi", Cell : (0) 98440 17490 Home School Circle, Basavangudi, E-mail: kashyapdrs@gmail.com Bangalore – 560 004 Prescription Name of the patient : Mr S..........., aged 31 years Diagnosis : Post traumatic late onset seizures with post contusion brain gliosis On LIFE - LONG anti convulsion prophylaxis, at minimum 5 more years i.e. until 2020. 1. CARBAMAZEPINE tab 200 mg 2-0-2 i.e. 400 mg twice daily morning and night 2. LEVETIRACETAM tab 500 mg 2-0-2 i.e. 400 mg twice daily morning and night 3. LAMOTRIGINE tab 100 mg 2-0-1 i.e. 200 mg in the morning ans 100 mg at night  All medication to be taken continuously until otherwise changed  All medication may be dispensed for about 3 months at a time in the interests of convenience  This prescription may be renewed from time to time  Pharmacist may seek clarification from me in case of doubts, contact numbers as above.  All medication to be taken after food. Dr. Vikram Kashyap. Dated: dd.mm.2015 .... end of prescription.....page 1 of 1 ..COME 2002 compliant.. Some improvement ? hh mm
  • 20. NABH requirements : Intent Patient safety, above all else Integrate pharmacy: hospital & patient care Storage practices, Inventory control Narcotics control Includes: blood, implants, devices & gases. Applicable laws 20
  • 21. 1 st MOM std : MEDICATION Documented policies & procedures guide the organisation of pharmaceutical, pharmacological, dispensation & administration of all medication Must cover : • Procurement, Storage, Prescription, Dispensing, Administration, Monitoring. Addendum : Formulary, Antibiotics • Ensure legal compliance • Roles & responsibilities of Committees & Members 21
  • 22. 2nd MOM std : FORMULARY Establish and document a hospital formulary • Prepared by pharmacists, pharmacologists, clinicians, nurses & other users • Approved by management: vendor issues, cost & brand considerations, generics…. • Available at all points of use • Periodical review & update 22
  • 23. 3rd MOM std : STORAGE 1st of 3 Documented policies and procedures govern storage of medication. 23
  • 24. Contd...3rd Std: Storage 2nd of 3 • Temperature & humidity : monitoring, calibration issues • Light & Ventilation ( magnifying glass ! ) • Rodent & pest control (monitor if outsourced) • Inventory control, replenish after emergency • Everything in its place • A place for everything • FIFO, ABC, good practices • Near expiry • Quarantine 24
  • 25. Storage…Contd...3rd of 3 Sound alike and look alike medications are stored separately: fool - ......... proofing EXAMPLES: Fortum(ceftazidime) / Fortwin(pentazocine) Methycal(calcium)/Methycobal(methcobalamine) Adrenor (noradrenaline) / Adenocor (adenosine) ( End of 3rd NABH requirement ) 25
  • 26. 4th MOM std. PRESCRIPTIONS • Documented policies and procedures : who, where, when (repeat orders), what (particularly high risks, to be identified) and how to write • Check for allergies before writing prescription • List of abbreviations commonly used. • Remember the 'R's : also rational use • Code of Medical Ethics: reg. number, name date, sign time, legible • Verbal orders : general rule – discourage • Prescription audit : corrective & preventive actions 26
  • 27. 5th MOM std. DISPENSING SAFE dispensing : concerns the PHARMACIST Prepare a procedure ( SOP ) to address : • Recall. Anyway conduct a 'mock recall' test • Check expiry date, also 'near expiry' • Check high risk meds • Correct LABELS, in particular for tablets or ampoules dispensed loose, and 'cut strips' 27
  • 28. 6th MOM std ADMINISTRATION 1st of 2 Documented policies and procedures for medication management • Administration of medicines only by those permitted by law : nurses, doctors..... • Second drug prepared only AFTER first drug labelled 28
  • 29. 6th ...2nd of 2 Administration ..... Contd. VERIFY THE ORDER • Patient • Drug, cross verified • Dosage • Route • Timing • Record • Self Administration • Outside drug 29 RIGHT Discourage
  • 30. 7th MOM std : MONITORING • Documented policies and procedures to MONITOR the patient after drug administration. • When is close monitoring required ? (GA, sedation, restraints of any sort, suicidals...) • Monitoring is done in a collaborative manner. • This is so that drug may be changed if needed (typically: Ischaemic Heart Disease with Sub Dural Haematoma....) 30
  • 31. 8th MOM std : ERRORS • Procedure to define what is a near miss, an error and an adverse drug event (more about this in a later module) • Pro-active culture of reporting problems: near miss, errors, adverse drug events are reported. NON punitive. NO blame games, salary cut....! • Raw data collection, realistic approach, proper analysis, corrective & preventive actions 31
  • 32. 9th MOM Std : NARCOTICS • Narcotic & Psychotropic Substances Act ( NDPS ) 1985 amended upto 2015 • Excise law, not drug law ! • Storage, prescription, handling, administration, discard, breakage, record keeping: strictly as per law, prevent misuse 32
  • 33. 10th MOM std CHEMO drugs • Policies and procedures for chemotherapeutic drugs : who can prescribe, who can prepare, who can give • ( chemo drugs are toxic to the nursing staffs preparing the drugs, LAFU required ! ) • Std says : Chemotherapy is prescribed by " those who have the knowledge " to monitor and treat the adverse effect of chemotherapy. • Disposed of: BMWM 1998 Category 5 33
  • 34. 11th MOM std RADIO-pharmaceuticals • Policies and procedures for radio- pharmaceuticals: who can prescribe, who can prepare ( need for 'hot lab' ) , who can administer, how to administer • Examples: I-131, Tc 99 m, Sr 90, Y 90, Cs 37 • Radiation Safety : strictly as per A E R B rules (Office of the Prime Minister), TLD badges, Radiation Safety Officer approved by AERB. • Disposal : Atomic Energy (Safe Disposal of Radioactive Wastes) Rules, 1987 34
  • 35. 12th MOM std: Prostheses, implants • IOLs, Ortho implants, Cardiac Stents, Neuro shunts • Quality criteria: CE mark, ISO 13485:2003 (2015 version in draft stage for release by Dec 2015); US- FDA Code of Federal Regulations (CFR) • Counseling, implants: log book • Batch, serial no., sticker: for traceability and recall. Mock recall test to be done. De Puys : RECALL of Hip Implants, 2004 - 2010 35
  • 36. 13th MOM std : CONSUMABLES • Purchase procedure : remember vendor requirements ? • Quality criteria for purchase • Resources to be provided by management including consumables for infection prevention and control • Storage criteria • Inventory control 36
  • 37. Take Home Messages • Know the applicable laws • Establish, document & monitor the QMS • Errors WILL occur: try to ELIMINATE ( or at least minimise ) • Focus on prevention: identify hazards, analyse risks: ONLY by walking around the hospital • AUDITS: safety, clinical, prescription, research, medical records, entire quality system • NABH std: tried & tested quality system for hospitals 37
  • 38. Thank you very much

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