Presentation @ IPS Bangalore Chapter Preconference workshop
Published on: Mar 3, 2016
Transcripts - NABH overview
Indian Pharmacological Society
Pre Conference Workshop: Wed 05 Aug 2015
•Start, implement and lead the quality initiative
•Management of medication, the NABH approach
Module - 1
• The Pharmacological Basis for
Establishment and Implementation of
a Quality Managagement System for
Therapeutics & Dispensing Pharmacy
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
To manage quality, you need a Quality
Management System ( QMS )
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
Only 5 points to the
• LEGAL requirements
• PATIENT needs
• EMPLOYEE needs
• DOCUMENTATION requirements
• ( NABH ) requirements
JCAHO, JCI (USA), AC (Canada), NHS (UK),
DAC (Dubai), MSQH (Malaysia)
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….
5 points… ( repeated )
• LEGAL requirements
• PATIENT needs: stated & implied, families
• EMPLOYEE needs: training, safety, duties...
• DOCUMENTATION requirements
• STANDARD ( NABH ) requirements
Documentation needed to
establish a quality management
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 >>>>
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"
What is a procedure?
The regular order of doing things, especially 'how
to' follow the steps leading to implementation of
• 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
>>>> committees >>>
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……
Tool for Improving the QMS
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
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
Module - 2
The N A B H Approach
13 Requirements for
OF MEDICATION (MOM)
This is NOT the 14th requirement !
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: email@example.com Bangalore – 560 004
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.
.... end of prescription.....page 1 of 1 ..COME 2002 compliant..
Some improvement ?
NABH requirements : Intent
Patient safety, above all else
Integrate pharmacy: hospital & patient care
Storage practices, Inventory control
Includes: blood, implants, devices & gases.
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
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
3rd MOM std : STORAGE 1st of 3
Documented policies and procedures govern
storage of medication.
Contd...3rd Std: Storage 2nd of 3
• Temperature & humidity : monitoring,
• 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
Storage…Contd...3rd of 3
Sound alike and look alike medications are stored
separately: fool - ......... proofing
Fortum(ceftazidime) / Fortwin(pentazocine)
Adrenor (noradrenaline) / Adenocor (adenosine)
( End of 3rd NABH requirement )
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
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'
6th MOM std ADMINISTRATION 1st of 2
Documented policies and procedures for
• Administration of medicines only by those
permitted by law : nurses, doctors.....
• Second drug prepared only AFTER first drug
6th ...2nd of 2 Administration ..... Contd.
VERIFY THE ORDER
• Drug, cross verified
• Self Administration
• Outside drug
7th MOM std : MONITORING
• Documented policies and procedures to
MONITOR the patient after drug
• 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
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,
• Raw data collection, realistic approach,
proper analysis, corrective & preventive
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
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
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
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 :
2004 - 2010
13th MOM std : CONSUMABLES
• Purchase procedure : remember vendor
• Quality criteria for purchase
• Resources to be provided by management
including consumables for infection
prevention and control
• Storage criteria
• Inventory control
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
Thank you very much