ISO 15189 2022 standards for laboratory quality and competence
J. SUBRAHMANYAM
1. SUBMITTED BY UNDER THE GUIDANCE OF
J. SUBRAHMANYAM Dr. G. RAMESHPHARM. D
15AB1T0009 DEPARTMENT OF
IV PHARM. D PHARMACY PRACTICE
VIGNAN PHARMACY COLLEGE
(Approved by AICTE & PCI Affiliated to JNTU KAKINADA)
VADLAMUDI, GUNTUR DIST, ANDHRA PRADESH, INDIA, PIN: 522 213
2. DEFINITION
THE PHARMACYAND THERAPEUTICS
COMMITTEE IS A POLICY FAMING AND
RECOMMENDING BODY TO THE MEDICAL STAFF
AND THE ADMINSTRATION OF HOSPITAL ON
MATTERS RELATED TO THERAPEUTIC USE OF
DRUGS.
3. OBJECTIVE OF PHARMACY AND THERAPEUTIC
COMMITTEE
The pharmacy and therapeutics have three major roles
to play. These are:
ADVISORY
EDUCATIONAL
DRUG SAFETY AND ADVERSE DRUG MONITIORI
NG
4. COMPOSITION
Composition of pharmacy and therapeutics committe
e (PTC) might vary from hospital to hospital. The foll
owing scheme is suggested for general adoption:
The PTC may be composed of:
•At least three physicians from the medical staff
•A pharmacist
•A representative of the nursing staff
•An hospital administrator with his/her designated an
ex‐officio member of the committee one of the physici
ans may be appointed as the chairman of PTC
8. OPERATIONS OF PTC
This committee should meet regularly at least six time
s in an year and also when necessary.
The agenda and the supplementary materials should
be prepared by the secretary and furnished to the com
mittee members well in advance so that the members
can study them properly before meeting.
A typical Agenda may consists of following:
Minutes of the previous meeting
Review of the contents of the Hospital Formulary for t
he purpose of bringing it up to date, and deleting of p
roducts not considered for use
9. Information regarding new drugs which may have bec
ome commercially available.
Review and/or adoption of investigational drugs curre
ntly under processing in the hospital.
Review of side effects, adverse drug reactions, toxic eff
ects, drug interactions of drugs reported by various un
its of hospital.
Review of “Drug Safety” in the hospital.
Reports of various sub‐committees.
Report of medical audit.
Any other matter with the permission of chair.
Vote of thanks
10. ROLE OF PHARMACY AND PTC IN DRUG SAFETY
Drug safety is the moral, legal and professional obliga
tion of pharmacist in western countries.
It includes responsibility from dispensing of drugs to
drug administration.
Following guidelines may sub serve
the committee in ascertaining the adequate safety fact
or of hospital pharmacy:
• The hospital must employ a qualified, at
least, a registered pharmacist with at least B. Pharm
degree as ‘Chief Pharmacist’ and the rest are may be a
t least Diploma holders in pharmacist
11. • Should not permit non‐pharmacist personnel to dispe
nse drugs and allied materials.
• Must employ a sufficient members of qualified consid
ering the work load of a pharmacist and allow for ade
quate coverage(7days/week).
• Must provide adequate safe, work space, and storage
facilities
• Should have equipment necessary to safely and adequ
ately carry out the modern practice of pharmacy.
• Must have an automatic stop order regulation for dang
erous drugs. eg: narcotics, anticoagulants etc.
• Should have a drug formulary which periodically revis
ed and kept up to date.
12. • The poisonous materials are separated from non‐pois
onous materials in the pharmacy.
• The external used preparations should be separated fr
om internal used medications.
• Must have adequate quality control measures and foll
ow good manufacturing practices.
• Should provide a teaching program to teach students,
nurses the basic course of pharmaceutical mathemati
cs and pharmacology.
• Should be periodically inspected in order to remove
deteriorated and outdated drugs as well as to check all
labels for legibility.
13. Should have an adequate reference library which contains t
exts on pharmacology, toxicology, posology, and journals
containing information on newer developments in the pha
rmaceutical world
ROLE OF PTC IN ADR MONITORING:
An adverse drug reaction is defined as any usual of unexpe
cted harmful reaction including acute poisonings by narco
tics, barbiturates, and ampheteminesas well as industrial p
oisonings.
There is a proportionate increase in the drug reactions. In
order to gain an understanding of these problems and to f
ormulate competent opinions as to the best type of preven
tion and treatment, the PTC must assume the responsibili
ty for the developing and instituting a procedure for the
purpose of committee
14. AUTOMATIC ORDERS FOR
DANGEROUS DRUGS
“All Drug orders for narcotics, sedatives, hypnotic antico
agulants, and antibiotics (adminstered orally or
parenterally) shall be automatically discontinued after 48
hours unless the order indicates an exact number of doses
to be adminstered, or the attending physician, re‐orders t
he medication”.
All orders for narcotics, sedatives and hypnotics must be
re‐written every 24 hours
15. ROLE OF PTC IN EMERGENCY DRUG
LIST
The Time Factor is necessary for the Pharmacy and
Therapeutics Committee of a hospital to get prepared boxe
s containing emergency drugs which should be
always available readily for use at the bed‐side. List of suc
h drugs and other supplies should compiled by Committee
, and it should find their place in “Emergency Kits”.
After the emergency boxes have been placed in the wards,
it is very essential and compulsory that a system is
developed where by they checked daily either by the
hospital pharmacists or by nursing supervisor responsible
for the ward.
16. Following is the list of suggested drugs and other artic
les maintained in Emergency Box:
SUPPLLIES TO BE MAINTAINED IN EMERGENCY
BOX :
Syringes of various range
Needles
Files for breaking the ampoule
Airway equipment
17. These may be selected in consultation with the physician:
Atropine sulphate 0.4 mg/ml
Digoxin0.25 mg/ml
Heparin 10.000 units/ml
Neostigmine methyl sulphate 0.25 mg/ml
Mannitol injection 25%
Saline for injection 09% 30 ml
Water for injection 20 ml
SUPPLIES FOR CABINET UTILITY ROOM
Oxygen catheters
Razor with blades
Resuscitation tube.
18. OTHER EMERGENCY SUPPLIES
Burn sheets
Dextran and tubing
Resuscitation carts.
ROLE OF PTC IN DRUG PRODUCT DEFECT
REPORTING PROGRAMME:
•The drugs purchased by hospital may be defective in quality.
•It is for the committee to get information about the defectiv
e drug products and to inform it first to the manufacturer f
or appropriate action.
•If satisfactory answer is not obtained from the manufacturer
it should be reported to the Food and Drug Control
Adminstration.
19. ROLE OF PTC IN DRUG UTILISATION
REVIEW
•Drug utilisation includes prescribing, dispensing, ad
minstering and ingesting of prescription of drugs.
•Hospital pharmacist should take medication history t
hat should include following information:
o Medication being taken at the time of admission,
during admission, home remedies (OTC)
o Drug allergies and idiosyncrosytowards food products
etc.
Patent medication profile to be maintained for each p
atient. This will serve the following purposes:
20. To help improved drug prescribing practices by promoting
the safe and rational use of drugs.
To detect and help prevent drug‐interactions.
To detect and prevent adverse drug reactions in sensitive p
atients.
To detect and prevents IV additive incompatibilities
To detect drug‐induced diseases.
To help detect and potential drug‐toxicities.
REFERENCES:
https://www.scribd.com/document/340771098/Pharmacy-
and-Therapeutics-Committee-Policies-and-Procedures
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3724438/.
http://www.authorstream.com/Presentation/usha.eatakot
a-1248234-pharmacy-therapeutic-committee/.