4. ABSTRACT:
Extemporaneous dispensing is a manual process where a manufactured
product undergo modification performed by a dispenser.
Dermatological dosage forms were the major types of extemporaneous
compounding products
Reasons behind compounding practice were to make customized
products which are not available commercially.
Extemporaneous compounding is not without risk.
In Pakistan, pharmacists in hospitals are not appropriately engaged in
clinical services and pharmaceutical care due to the monopoly of the
physicians.
Federal and provincial governments should provide funds to
facilitate good pharmacy services and the required number of
pharmacists in hospitals.
5. Hence Extemporaneous compounding practice are an
essential part of pharmacist’ competency and it is an
important component in pharmacy practice allowing
pharmacists to supply dosage forms or strengths that are
commercially unavailable. The goal of this review was to
work out the scope and frequency of extemporaneous
compounding practice among pharmacists,
6. INTRODUCTION:
Pharmaceutical compounding is an important component in pharmacy
practice allowing pharmacists to supply dosage forms or strengths that are
commercially unavailable.
Extemporaneous compounding describes the utilization of traditional
compounding techniques to control chemical ingredients to
supply appropriate dosage forms when no commercial medicines form is out
there.
Pharmacists providing compounding services can assist the patients with the
access to special medications and dosage forms which will be helpful in
providing an appropriate therapeutic plan for the patients.
Most available medicines are formulated as solid dosage forms like tablet
and capsules.
The powder content of tablet or capsule could also be dissolved or suspended
with various excipients to supply an oral liquid medicine or could also
be reformulated during a smaller dosage strength with lactose.
Tablets are sometimes dig halves or quarters within the pharmacy to
get appropriately sized dosage unit for youngsters.
7. in several Western countries, compounding practice was dramatically
decreased.
Data on the present status of compounding in are lacking.
Thus, effort at increased regulation of pharmaceutical compounding
are apparently supported assumptions that the practice represents a
big , increasing, fraction of pharmaceutical services which the
standard of compounded products can't be assured.
8. TYPES OF EXTEMPORANEOUS COMPOUNDING:
Major types of unmixed compound products were dermatological dosage forms and
were followed by oral solutions and oral suspensions.
Active herbal ingredients include
creams
eye drops
nasal sprays
oral dosing forms
intravenous injections.
In Australia, products could also be classified into
Simple compounding
complex compounding .
o By comparing the trend of compounding across the countries:
Brion et al. found that in England, Ireland, Norway……… prepared mainly 60%
oral solution .
Finland, Italy, and Scotland…… prepared mainly powder.
Belgium, Croatia, France, and Switzerland …..prepared mainly capsules.
9. ENVIRONMENT FOR EXTEMPORANEOUS
COMPOUNDING:
The compounding pharmacist needs a tidy, well-lit, and quiet working
environment.
A clean air atmosphere should be used if aseptic compounding is being
considered.
A designated area or temporarily designated area is permissible for
pharmacies preparing small amounts of a limited range of items for
immediate dispensing.
There must be safeguards in place to prevent cross-contamination.
At any given time, only one substance should be dealt.
After any maintenance or repairs, a thorough cleaning and, if
necessary, disinfection should be performed.
10. To prevent ingredient degradation, the environment, including temperature, humidity,
and lighting, must be suitable for the safe and comfortable preparation of medicinal
products.
To include individualised dosing or commercially unavailable formulations, both
public and private hospitals operate broad aseptic compounding facilities.
Before and after use, areas and facilities should be thoroughly washed with a suitable
detergent After cleaning, the equipment should be rinsed with a suitable grade of
water (potable or sterile water for irrigation/injection) and then cleaned.
Until using, critical surfaces should be effectively sanitised with a suitable agent such
as 70% alcohol.
Equipment should be washed in sinks, with handwashing facilities available
separately.
The chance of microbial contamination from water splashes, sinks should be placed a
reasonable distance away from the preparation areas.
Ensure that all cleaning agent traces have been eliminated.
Before using containers and lids, double-check that they are clean and dry. Adequate
pest management should be implemented.
11. EQUIPMENTS FOR EXTEMPORANEOUS
COMPOUNDING:
Many state boards of pharmacy have a registry of equipment that must
be used when compounding medications. .
Many pharmacies now have clean air environments for aseptic
compounding of sterile solutions
It is essential to have a balance, ideally electronic.
Purchase ointment slabs (also known as pill tiles) as well as various
sizes and materials of spatulas.
A few mortars and pestles (glass, ceramic, or plastic) should be kept on
hand, as well as some glassware.
To demonstrate satisfactory results, equipment should be calibrated
and validated.
12. Measures should have levelling lines and be optimised for particular
volumes.
Glassware should be inspected for chips and cracks before and after
each use
Stainless steel of a reasonable grade is a safe material, but certain
agents must be handled with caution because it is prone to oxidation.
Plastics are prone to scratches and stains on the surfaceElectronic
balances are now more common than torsion balances, micro-pipets
are common, and ultrafreezers are sometimes needed in addition to
regular refrigerator freezers.
This field is continually evolving, and compounding pharmacists must
stay up to date with the latest technologies in order to prepare accurate
and reliable prescriptions. It's beneficial to get to know the local
representative for a laboratory supply company
13. REASONS OF EXTEMPORANEOUS COMPOUNDING:
The reason for extemporaneous compounding is to fulfill the special needs of the
patient.
The motive for the compounding practice was that there was no suitable preparation
or strength available.
Another excuse for compounding was patient preference. Based upon pharmacists’
perspective, using more extemporaneous prepared products could also make sense
economically. ‘
The significant therapeutic improvement and a few cost savings is also gained’ by the
rational use of extemporaneously prepared medicines.
In most of the studies, major reasons stated by physicians for prescribing
extemporaneous products was that they worked well in many conditions when the
product wasn't available commercially. Most responding doctors don't prescribe
medications that need compounding because they lack trust within the quality of the
compounded formulations.
However, most of the doctors want to learn about the usefulness of extemporaneous
products.
14. RISKS AND ERRORS IN EXTEMPORANEOUS
COMPOUNDING:
Studies in this review highlight that issues about the stability of
compounded products, accuracy in dose strength and lack of
standardized protocol in extemporaneous compounding were needed to
be acknowledged.
In Dutch community pharmacies, pharmacists did not use a
standardized protocol in 42% of cases.
Segments from tablets are quick to cut and probably have similar
stability to the original tablet, but cannot be cut with a great accuracy
of dose.
Oral liquid are comparatively quick to prepare and allow flexibility in
the dosage form in a single strength preparation by accurately
measuring the volume required using a spoon designed for oral
administration but oral liquids may be difficult to formulate to ensure
palatability, and physical, chemical, and microbial stability
15. Pharmaceutical companies should have appropriate facilities and
should be encouraged to make modern dosage forms available
for children.
Extemporaneous preparation may be in accordance with a
formulation published in a pharmacopoeia or some other
published work of reference, or the formulation may have been
developed locally.
Extemporaneously prepared medicines should be rationalized for
formulation and strength and their standards assured by
monographs in official publications such as European
Pharmacopeia.
Data, once available, should be published in all countries and
should lead to a monograph in a pharmacopoeia.
16. HOSPITAL PHARMACY SERVICES IN PAKISTAN:
In 2000, Pakistan launched the National Drug Policy as an important
element of the National Health Policy to accomplish ‘health for all’.
According to NDP for each 50 beds in a hospital facility, one hospital
pharmacist should be appointed.
In 2009, the Supreme Court of Pakistan assisted the health department
to ensure that the no of pharmacists in hospitals met the intelligible
criteria.
Annually in Pakistan around 2700 pharmacists graduate .Despite the
number of pharmacists, only 15% are engaged in hospitals, technical
and administrative jobs in the public sector as more than 15000
pharmacists do not have appropriate jobs .
17. Due to lack no of funds and financial resources, there is shortage of
pharmacists in public sector .Also in private hospitals the number
of pharmacists and pharmacy services are inadequate.
Additionally, due to the monopoly of the physicians pharmacists in
hospitals are not properly engaged in pharmaceutical care and clinical
services
Doctors interact with pharmacists only to inquire about the availability
of medicines.
After that, provincial and federal governments must provide funds to
encourage the required number of pharmacists and good pharmacy
services in hospitals.
There should also be an good interaction between doctors and
pharmacists to empower clinical outcome
18. CONCLUSION:
Extemporaneous preparations are made when there is non- availability of suitable
dosage
This is an unmet pharmacy practice that requires having a data maintained on the
shelf life of the extemporaneous preparations.
Medicine regulatory agency and National Drug Policy efforts in creating appropriate
standard needs to have its inception and implemented.
pharmacists need to have access to stability, compatibility, and formulation
information as well as appropriate training to ensure patients are supplied with high
quality, safe, and effective preparations.
Extemporaneous compounding practice can build a strong pharmacist patient
relationship in the healthcare sector intended for higher quality therapeutic efficacy.
The data of extemporaneous preparations should have a monograph in pharmacopeia
as an official standard. Since we don’t have any official standards for
extemporaneous preparations so they are not without the risk.
Incidence of extemporaneous prescribing and compounding is very low though it
should be a collaborative work of a pharmacists and a physician.