Compounding in Community pharmacy

What is compounding?

Compounding is “the preparation and supply of a single unit of a product intended

for immediate use by a specific consumer”.It is also known as extemporaneous
dispensing, and may involve modification of a manufactured product or preparation
from the raw ingredients. Although most often associated with the pharmacy
profession,compounding is also practiced by other health practitioners including
doctors, naturopaths,herbalists and veterinarians.

All medicines were compounded until the expansion of the pharmaceutical industry
and the availability of manufactured drugs.Although now practised to a lesser
extent by most pharmacists,it is still taught as part of undergraduate pharmacy
degrees and all community pharmacies are required to maintain basic compounding
equipment for the provision of this service.

Based on the United States experience, where the service is widely promoted,the
requests for individualised dosage will be requested more frequently to meet the
specific needs of individual patients.

What medicines are compounded?

Registered manufactured products are preferable since they have been produced
according to the Code of Good Manufacturing Practice and undergone evaluation by
the Therapeutic Goods Administration (TGA). However,many products are unavailable
in suitable forms for reasons other than safety. The size of the Australian market
precludes registration of products required for small but significant patient
populations and many products are discontinued or unavailable for economic rather
than safety reasons.For example, paediatric patients are a group dependent on
pharmacy compounding. Tan et al reported that in a review of all products with
approved indications for use in children, around 24% were not available in a form
suitable for administration to children such as an oral liquid. Balancing vitamin D
deficiency and exposure to sunlight is increasingly recognised as a problem and
with commercially available products containing insufficient amounts of vitamin D
for high dose oral therapy, compounded capsules have been prescribed.Metronidazole
vaginal gel for the treatment of bacterial vaginosis is an example of a
manufactured product available in other countries that must be compounded by a
pharmacist if required by a patient in this country.More controversially, there has
been an increase in the prescribing of so called bio-identical HRT.The issue is
complicated and beyond the scope of this article.

Compound medication is provided to the patients who need special treatment that is
not readily available through commercially prepared drugs.For this purpose, a
compound Pharmacy serves the function.Compounding pharmacy definition describes
itself as a well-purposed place that formulates the customized compound medications
for the patients to meet their specific needs of product involved in their
treatment.

The compound medications are endless. If you cannot take oral pills,compound
pharmacies plan the same medicine differently so that you can still take the
medicine for your treatment. A compound medication list involves a variety of
delivery options.Following are some famous compound medicine examples:

Capsules
Injectables
Syrups
Creams
Serums
Ointments
Supplements
Gels
Typically,the pharmacists at the compounding pharmacy customize the medicine from
scratch. There are several compound medication examples like compounded pills and
tablets that are rarely compounded but creams,liquids, ointments and suppositories
fall under the regular compound medication list.

WHAT IS THE MOST COMMON COMPOUNDED PRODUCT?

The compound medication list is surely a lengthy one having extra-ordinary health
benefits.The most common examples of compound medication include compounded topical
medications,sublingual medications and oral medications.Injectable medications and
suppositories are also novels compound medication examples.

Topical medicines are applied on the skin or mucous membrane to get relief from
pain.The advantage of using a topical medication is that it provides local
treatment and it is a prominent way of treatment by drug absorption.

Topical medication products are helpful because they can bypass the first-pass
metabolism that is liver metabolism,bypass gastrointestinal sensitivity and
degradation from stomach acid. Another benefit of using topical medication is that
the combined effect of two or more active ingredients enhances patient
compliance.There is a compounded medicine list which includes:

Gels
OPL gels
Creams
Ointments
Solutions
Lotions
The most common formulated drugs at a compounding pharmacy for topical medications
include:

1.DHEA 1.3% (13mg/gm) Vaginal Cream

2.Estradiol 0.05% (0.5mg/gm) Cream
3.Retinoic Acid 0.4% Topical Solution
4.Gabapentin 6% Ointment
5.Trichloroacetic Acid 7%, Salicylic Acid 2% Topical Solution

Ketoprofen/Cyclobenzaprine topical gel is another most common product that is

formulated combining various active ingredients in calculated amounts.

COMPOUNDED SUBLINGUAL MEDICATIONS

Lab testing sublingual medication

A sublingual medication is defined as a drug that is administered under the tongue
where it is absorbed into the bloodstream through the mucous membrane.Sublingual
medicines are prescribed to blood pressure patients as it is the fastest way of
delivering the drug to the body.

Several advantages of using sublingual drugs include bypass to the liver metabolism
and gastrointestinal degradation of the drug. It is also helpful for patients who
have difficulty swallowing the pills. Moreover, their on-set of action is faster
because of direct administration.

COMPOUNDED STERILE INJECTIONS

Pharmacist injecting a compound medication

Compounded sterile injections include aqueous and oil vehicles that are sterile
drugs to be administered in the patient’s body using a needle and syringe.Several
routes are commonly used for drug delivery which includes:
• Intravenous drug delivery
• Intramuscular drug delivery
• Subcutaneous drug delivery

COMPOUNDED ORAL MEDICINES

Doctor writing prescriptin for compounded oral medication

Oral medicines are also available as compounded drugs.These are taken into the body
via mouth for digestion and absorption. Compounded oral medicines are available as:

• Tablets
• Capsules
• Suspensions
• Solutions and formulations

Sugar-free, dye-free and lactose-free formulations are also available that are
customized for diabetic patients and patients who have lactose intolerance. Table
triturate provides rapid onset for various issues including migraine headaches,
emesis and erectile dysfunction. Tablet triturates are cheap and they provide a
variety of benefits.

SUPPOSITORIES

Man holding compound suppository

Suppositories are advanced compounded drugs that come in a solid molded medication
inserted rectally or vaginally. It is absorbed locally and systemically when it is
dissolved inside the body. Putting medicine by suppositories allows the patient who
can’t swallow pills and tablets to receive the required concentration of the drug.

A suppository is helpful for patients who have symptoms of nausea and vomiting and
feel difficulty taking oral medication.Suppositories have rapid local effects for
Hemorrhoids, Irritable Bowel Syndrome (IBS) and other diseases.

Various types of suppositories include:

• Rectal suppositories
• Vaginal suppositories
• Rectal enemas
• Vaginal creams

Compounding problems
The Therapeutic Goods Regulations 1990 exempt compounded products from registration
by the TGA on the condition that they “are dispensed, or extemporaneously
compounded, for a particular person for therapeutic application to that person” and
they are prepared in a pharmacy “for supply (other than by wholesale) on or from
those premises”. Due to this exemption,extemporaneously dispensed medicines are not
subject to evaluation by the TGA.Professional practice is governed by state
Pharmacy Boards in each state or territory. Although there have been few confirmed
incidents of harm from compounded products in Australia the potential is great in
the absence of quality control measures. There have been reports of serious adverse
events in the United States, in most cases associated with improper compounding of
sterile parenteral products. 7 In the US, pharmacy compounding is also regulated by
state Pharmacy Boards however the Food and Drug Administration (FDA) has initiated
enforcement action against companies that have embarked on large scale manufacture
and supply of unapproved drugs under the guise of compounding.

The United States Pharmacopeia has published specific chapters pertaining to

sterile and non-sterile compounding which are being used in conjunction with an
accreditation system in that country to ensure patients and doctors are able to
identify compounding pharmacies that comply with the USP standards. The
Pharmaceutical Society of Australia has developed Professional Practice Guidelines
for Compounding as well as a specific compounding chapter in the Australian
Pharmaceutical Formulary and Handbook.These guidelines are regularly reviewed and
in addition, the TGA is currently working with pharmacy professional
bodies,regulators,state health departments and other stakeholders to review and
improve compounding standards in Australia.

A particular concern of the TGA is the multiple preparation of compounds called

batch production.Until recently this was mostly undertaken by hospital pharmacies
but now has increased in other areas.

As for all dispensed medicines, pharmacists are required to provide patient

counselling on the appropriate use of compounded medicines. Since there is no
approved consumer medicines information available,prescribers and pharmacists must
ensure that the patient is aware of this status and of the correct use,
storage,expiry date and possible adverse effects and interactions.This
counselling,information and education has to be communicated on an individual
basis.

The way forward

Application and enforcement of practice standards has been inconsistent and a
uniform approach to the current regulations and guidelines would help to address
many of the concerns raised in recent years about the practice.Since there is
infrequent demand for extemporaneously prepared products in most
pharmacies,maintenance of compounding skills, equipment, formularies and standard
procedures can be difficult and costly and may result in the development of
specialised compounding practices.

Pharmacy compounding is an important professional practice and has a role in the

effective treatment of patients with specific needs.The pharmacy profession and
regulators need to collaborate to ensure that there is uniform compliance with
existing standards and regulations and on the development of more comprehensive
compounding practice standards which are critical to ensure that only the highest
quality products are prepared for our patients.

All compounding activity by any health professional should be undertaken to the

same standard and enforcement to ensure

Reasons for compounding medicines

Different dosage form required eg liquid form required but only tablets available,
ointment required instead of cream
Sensitivity/allergy to excipients and preservatives
Discontinued medicine
Different dose or concentration required
Different route of administration required
Palatability/compliance problems