good practice in compounding
Post on 03-Apr-2018
220 Views
Preview:
TRANSCRIPT
-
7/28/2019 Good Practice in Compounding
1/53
PHARMACY PRACTICE
MPHA 2501
GOOD PHARMACEUTICALPRACTICE IN COMPOUNDING
AND DISPENSING
NURULUMI AHMAD
1
-
7/28/2019 Good Practice in Compounding
2/53
2
Learning Outcomes
At the end of the session, students shouldbe able to:
Identify theresourcesneeded in
compounding and dispensing. Know theequipment used and choose the
appropriate equipment to be used in
extemporaneous compounding anddispensing.
Apply the knowledge in practical session.
2
-
7/28/2019 Good Practice in Compounding
3/53
3
Resources
The resources that are required forgood compounding and dispensingpractice include:
1. Suitable, well-maintainedpremises,2. An adequate supply ofequipment,
3. Well-trainedpersonnel,
4. Strictcontrol procedures,
5. Readily accessibleinformationsources.
3
-
7/28/2019 Good Practice in Compounding
4/53
4
1. The Premises
The premises from which a pharmaceuticalservice is provided should inspire confidence
in the users of the service.
Cleanand hygienic,well-organized,tidy,accessibleand secure.
Provide suitable environmental conditions for
both personnel and products (medicines,etc.) e.g. controlled temperature,
acceptable noise level for concentration.
4
-
7/28/2019 Good Practice in Compounding
5/53
5
-
7/28/2019 Good Practice in Compounding
6/53
6
2. The Equipment
The equipment in the pharmacy should be
suitableandadequatefor the work to beundertaken.
The equipment required includea means of
counting tablets and capsules,a suitable rangeoflabels, working surface of adequate size,sink,refrigerator,suitablebalanceandweights,mortars and pestles,etc.
All equipment must bemaintainedin accurateworking order (calibration!!!) and checked forcleanliness prior to each use. Log books anduser manuals attached if appropriate.
6
-
7/28/2019 Good Practice in Compounding
7/53
Tablet counting tray
77
-
7/28/2019 Good Practice in Compounding
8/53
8Pharmaceutics 1: GDP
Tablet Counting
Machine
8
-
7/28/2019 Good Practice in Compounding
9/53
9
A. Weighing and Measuring
Balance: Electronic Balances
9
-
7/28/2019 Good Practice in Compounding
10/53
10
Balance: Triple Beam Balances
Learn how to use the balance at:http://www.wisc-online.com/Objects/ViewObject.aspx?ID=GCH202
10
http://www.wisc-online.com/Objects/ViewObject.aspx?ID=GCH202http://www.wisc-online.com/Objects/ViewObject.aspx?ID=GCH202http://www.wisc-online.com/Objects/ViewObject.aspx?ID=GCH202http://www.wisc-online.com/Objects/ViewObject.aspx?ID=GCH202 -
7/28/2019 Good Practice in Compounding
11/53
Weighing: Balances
Important equipment in pharmaceutical
formulation.
Torsion and electronic balances.
Recognize maximum capacity (including the
weight of tares weighing boat/paper/beaker
used) and sensitivity requirement.
Use balance that is appropriate for a
particular task.
11
-
7/28/2019 Good Practice in Compounding
12/53
Sensitivity Requirement (SR) and Min.
Weighable Quantity (MWQ) of a Balance
All balances have a point below which they cannotmeasure accurately, e.g. 6 mg for a standardprescription balance.
Fancy electronic balances can measure as little as 10
mg, 1 mg, or even 0.1 mg (100 micrograms). Thenumber below which they cannot measure reliably isusually inversely proportional to the price of thebalance!
This cut off point is called the sensitivity requirement(SR).
The sensitivity requirement will tell two things: theminimum amount of drug that can be weighed on that
balance and the increments of the balance measure.12
-
7/28/2019 Good Practice in Compounding
13/53
Sensitivity Requirement (SR) and Min.
Weighable Quantity (MWQ) of a Balance
In pharmacy, weighing error of 5% or less isacceptable (some potent drugs require up to98% accuracy in weighing).
Therefore, to keep the error below 5%, theminimum amount of substance that can beweighed using a balance should be 20 timesits SR.
i.e. MWQ = (SR 0.05) or, (SR 20).
Any amount smaller than MWQ should beobtained by aliquot method.
13
-
7/28/2019 Good Practice in Compounding
14/53
14
B. Volumetric Apparatus
Graduated cylinders, beakers, burettes, pipettes. As general rule, choose graduates with capacity equal or just
exceeding the volume to be measured higher accuracy.
14
-
7/28/2019 Good Practice in Compounding
15/53
Measuring equipment for small volumes.
Pipettes
Syringe
Micropipette
15
-
7/28/2019 Good Practice in Compounding
16/53
Meniscus reading technique.
16
-
7/28/2019 Good Practice in Compounding
17/53
17
C. Mortar and Pestle
Forparticle sizereduction, mixing &
makingemulsions.
Made of porcelain or
glass.
Porous, unglazed interiors
(porcelain) shearing
action for makingemulsion, should not be
used for drugs that stain.
17
-
7/28/2019 Good Practice in Compounding
18/53
18
D. Pellet Knives
Stainless steel spatulawith wooden or hardplastic handles.
Hard rubber or Teflon-
coated stainless steelspatula.
Flexible rubber spatulasor rubber scrapers.
Used forlevigationandspatulationincompounding ointment.
18
-
7/28/2019 Good Practice in Compounding
19/53
E. Spatulas
Spatula and micro spatula.
19
-
7/28/2019 Good Practice in Compounding
20/53
20
-
7/28/2019 Good Practice in Compounding
21/53
21
F. Glass and Plastic Funnels
Used to transfer
solutions from one
vessel or bottle to
another.
Also used with
filter paper in
filtering solution.
21
-
7/28/2019 Good Practice in Compounding
22/53
22
G. Ointment Slab
Used as a surface forlevigation and
spatulation in
compounding
ointment. Also be used as a
clean, hard surface for
rolling semisolid
material when makinghand rolled
suppositories or
lozenges.22
-
7/28/2019 Good Practice in Compounding
23/53
23
H. Glass Stirring Rods
Useful for stirring liquid
preparations. Spatulas are not to be
used as stirring rods.
23
-
7/28/2019 Good Practice in Compounding
24/53
24
I. Heating Devices
1. Hot Plate Offer fast and direct
sources of heat, but
required careful monitoring
to avoid overheating ofingredients.
Must have a carefully
controlled temperature.
2. Water Bath
For desired temperature at
100oC or less.
24
-
7/28/2019 Good Practice in Compounding
25/53
25
3. The Personnel
Most defects in manufactured medicinal products
arise through human error or carelessness!!! There should be anadequate numberoftrained
personnel i.e. pharmacists and technicians togetherwith appropriate support staff.
Standards ofpersonal hygiene should be high andappropriate clothing worn.
Personnel with potentially infectious disease or
open wounds should NOT be involved incompounding process.
Eating, drinking and smoking should not bepermitted in any area where medicines are
prepared or supplied. 25
-
7/28/2019 Good Practice in Compounding
26/53
26
4. Strict Control Procedures
In order to assure the quality of all medicines prepared
or supplied, stringent control procedures arenecessary.
Supervision:
The compounding and dispensing of medicines should
be carried out by a pharmacist or by other suitablepersonnel under the personal supervision of apharmacist.
Packaging and labeling:
Suitable containers should be used. Containers shouldbe labeled immediately after filling.
Storage and expiry date:
Appropriate storage conditions should be maintained
and out-of-date stock safely disposed. 26
-
7/28/2019 Good Practice in Compounding
27/53
27
4. Strict Control Procedures
Documentation
Good documentation of the procedures
involved in production of pharmaceutical
products is essential. All documents must be clearly written.
Do what you document, document what
you do
27
-
7/28/2019 Good Practice in Compounding
28/53
28
5. Information Sources
United States Pharmacopoeia (USP) British Pharmacopoeia (BP)
British National Formulary (BNF)
Medical Information Management System(MIMS)
Martindale: The Extra Pharmacopoiea
British Pharmaceutical Codex (BPC)
28
-
7/28/2019 Good Practice in Compounding
29/53
29
-
7/28/2019 Good Practice in Compounding
30/53
3030
-
7/28/2019 Good Practice in Compounding
31/53
31
British Pharmacopoeia (BP) Pharmacopoiea is a book
containing directions for theidentification of samples and the
preparation of compound
medicines,and published by the
authority of a government or amedical or pharmaceutical
society.
The British Pharmacopoeia (BP)
is the authoritative annual
published collection of standards
for UK medicinal substances and
the official source of all UK
pharmaceutical quality
standards. 31
-
7/28/2019 Good Practice in Compounding
32/53
32
British Pharmacopoeia (BP)
Essential reference for anyone involved inpharmaceutical research, development,manufacture and testing, and plays a vital role inensuring that all medicinal substances on theUK market (and other countries market using the
title BP, e.g. simple syrup BP) meet standards ofsafety,qualityandefficacy.
The BP comprisesmonographs,which set out themandatory standards foractive substances,
excipients andformulated preparations,togetherwith supporting General Notices, Appendices (testmethods, reagents, etc) and Reference Spectra.
32
-
7/28/2019 Good Practice in Compounding
33/53
33
-
7/28/2019 Good Practice in Compounding
34/53
34
-
7/28/2019 Good Practice in Compounding
35/53
35
-
7/28/2019 Good Practice in Compounding
36/53
36
-
7/28/2019 Good Practice in Compounding
37/53
37
Other Pharmacopoieas include:
European Pharmacopoeia (EP),
United States Pharmacopoeia (USP), Indian Pharmacopoeia (IP),
International Pharmacopoeia (Ph.Int.)
etc.
British Pharmacopoeia (BP)
37
-
7/28/2019 Good Practice in Compounding
38/53
38
British National Formulary (BNF)
A very useful and widely used reference.
The British National Formulary (BNF)
contains a wide spectrum of information on
prescribing and pharmacology, among
othersindications, side effects andcosts of
the prescription of all medications available
on the National Health Service.
38
-
7/28/2019 Good Practice in Compounding
39/53
39
British National Formulary (BNF)
It is used by general practitionersand specialist practitioners, and byother prescribers (such aspharmacists, nurses and
paramedics) to help them selectappropriate treatments for theirpatients; as a general referencebook on the wards by nurses whoadminister medications; and by
patients and others seeking anauthoritative source ofpharmacological advice.
39
-
7/28/2019 Good Practice in Compounding
40/53
40Pharmaceutics 1: References 40
-
7/28/2019 Good Practice in Compounding
41/53
41Pharmaceutics 1: References 41
-
7/28/2019 Good Practice in Compounding
42/53
42Pharmaceutics 1: References
42
-
7/28/2019 Good Practice in Compounding
43/53
43Pharmaceutics 1: References
43
-
7/28/2019 Good Practice in Compounding
44/53
44Pharmaceutics 1: References
44
-
7/28/2019 Good Practice in Compounding
45/53
45Pharmaceutics 1: References
45
M di l I f i M
-
7/28/2019 Good Practice in Compounding
46/53
46
Medical Information Management
System (MIMS)
MIMS is a pharmaceutical prescribing reference guidecontaining information about all drugs in the UKformulary.
The title is published monthly, being sent gratis to all
UK general practitioners and on a paid basis tosubscribers. An electronic version, eMIMS, is part ofthe Healthcare Republic website.
MIMS also serves as a medical advertising mediumand has been published in various forms since the1960s by unrelated organizations in China, Europe,Hong Kong, India, the Middle East, Ireland, Australia,New Zealand and Malaysia (MIMS Malaysia).
46
-
7/28/2019 Good Practice in Compounding
47/53
47
MIMS Malaysia contains information (brand
and generic names, indications, dosages,
contraindications, special precautions,adverse reactions, drug interactions,
presentations and packings, and prices)
about drugs available in the Malaysianmarket.
47
-
7/28/2019 Good Practice in Compounding
48/53
THANK YOU
48
-
7/28/2019 Good Practice in Compounding
49/53
-
7/28/2019 Good Practice in Compounding
50/53
-
7/28/2019 Good Practice in Compounding
51/53
Discussion
Explain why using proper techniques
and weighing ingredients with
accuracy are important whilepreparing special compounds in the
pharmacy.
-
7/28/2019 Good Practice in Compounding
52/53
QUESTIONS
1. Define compounding.
2. Define dispensing.
3. List factors required for good pharmacy
practice in compounding.
4. List factors required for good pharmacy
practice in dispensing.
52
-
7/28/2019 Good Practice in Compounding
53/53
QUESTIONS
5. You are the new pharmacist incharge of
the in patient pharmacy department. Your
head of pharmacist asked you to prepare
standard operating procedures forcompounding and dispensing. With relevant
examples, discuss the important points
necessary to produce the document.
53
top related