HISTORY

What Do You Know
About Pharmacy
Compounding?


In the past, compounding was pharmacy! Throughout history, pharmacists have had to compound drugs for individualised dosages for patients when they were prescribed by physicians. In the early 1900s, however, the pharmaceutical industry began manufacturing a myriad of drugs and dosage forms for patients and the need for compounding diminished. Since the late 1900s, however, a lot has changed and the pharmaceutical industry no longer supplies all the medications needed by patients.

The Australian Society of Compounding Pharmacists

In Australia at the end of the 1900’s there were only a handful of compounding only pharmacies operating in a largely unregulated environment with the Australian Pharmaceutical Formulary as the primary reference for the dispensing of extemporaneously prepared medicines.  But with growing interest in compounding since 2003 the TGA began consultations with the industry for greater regulatory oversight. 

In March 2015 The Pharmacy Board of Australia published the first Guidelines for Compounding Medicines. These guidelines were designed to provide guidance and clarification to Pharmacists on specific issues regarding the compounding of medicines.  The aim was to minimise the associated risks of compounded medicines for patients, pharmacists and other pharmacy staff, and improve patient outcomes and patient safety. Now in 2018 as a result of the growing demand from Doctors and Patients for personalised medicines which are not commercially available there are approximately 500 pharmacies offering some form of compounding capability – with that number growing all the time. There is now greater uncertainty among compounding Pharmacists regarding how to ensure they remain compliant with the tightening of the regulatory environment.

To fill this gap the ASCP was incorporated as a not-for-profit, peak pharmacy industry body comprising expert stakeholders from all facets of the Compounding Pharmacy Industry. It represents an expert body formed to assist compounding pharmacists, regulators and other industry stakeholders to understand the concepts involved in modern, simple and complex compounding. The mission of ASCP is to act as an industry stakeholder representing pharmacy compounders and to advance the compounding profession by providing support to help ensure that patients receive compounded medicines that are safe, effective and of high quality.

By promoting good compounding practices in the interest of public health and safety and representing the interests of the pharmacy compounding industry in Australia as an expert resource the ASCP will strive to achieve the following goals;

  1. Actively promote the ASCP as the go-to advisory group for all compounding industry matters

  2. Approach regulators e.g. Pharmacy Board, TGA, Government Health Departments and Pharmacy Councils to assist in the development of the regulatory framework for compounding non-ARTG medicines and discuss the current published guidelines for compounding with a view to help clarify these for all stakeholders

  3. Communicate to Pharmacy educators the need for appropriate training for compounding Pharmacists and their staff and the need for ongoing continuous education in order to meet professional practice standards

  4. Create a platform for exchanging knowledge and information for the benefit of compounding pharmacists and their patients in Australia.

Pharmacy Compounding is now more important for the following reasons:

1. LIMITED DOSAGE STRENGTHS
The pharmaceutical industry supplies only limited strengths of drugs. One size does not fit all and it is often necessary to change the strength of a drug for patients, through compounding.

2. LIMITED DOSAGE FORMS
The pharmaceutical industry supplies only limited dosage forms; generally only an oral solid (tablet or capsule) and/or injection are manufactured. This does not address the needs of children, premature infants, the elderly, and special needs patients. 

3. HOME HEALTH CARE
A significant percentage of the needs of home healthcare patients are satisfied by compounded medications, including, as an example, total parenteral nutrition (intravenous fats, sugars, and amino acids) necessary for the healing of colon disorders post-operatively. These patients cannot be satisfactorily medicated or sustain a nutritional status needed for healing with manufactured dosage forms.

4. HOSPICE and PALLIATIVE CARE PATIENTS
End-of-life therapy involves the compounding of many, many different and unique dosage forms to allow patients to live out their lives free of pain and discomfort. Many combinations of drugs are used for these patients who cannot swallow medications and who don’t have the muscle mass that is required to receive multiple injections each day. Other methods include compounded medications for oral inhalation, nasal administration, topical/transdermal, and rectal use.

5. DISCONTINUED DRUGS
The pharmaceutical industry has discontinued thousands of drug products over the past 25 years, many due to economic considerations. These were very effective and important medications. The only way they are now available is through pharmacy compounding.

6. DRUG SHORTAGES
With over 70% of all bulk drug chemicals being imported from China or India for the U.S. and EU pharmaceutical industries, and these industries then supplying Australia, commercially manufactured drugs become unavailable for various reasons. In many cases, these can be compounded to help “bridge the gap” until the commercial product comes back on the market.

7. INTRAVENOUS ADMIXTURES IN HOSPITALS
Many, if not most, of the lifesaving intravenous drugs given in hospitals and clinics are compounded. This saves the hospital personnel time and the patient multiple injections or administrations. It is hard to imagine being in the hospital without intravenous admixtures being available.

8. ORPHAN DRUGS
When physicians prescribe drugs that are not on the market, they may be available as orphan drugs, either commercially or compounded.

9. SPECIAL PATIENT POPULATIONS
Included here would be pain management patients, bioidentical hormone replacement therapy (BHRT) patients, sports injury patients, dental patients, dermatological patients, environmentally and cosmetic sensitive patients, and other patients who are being treated successfully with compounded medications prescribed by physicians. In fact, cancer treatment often involves compounded “cocktails”, or mixtures of cancer drugs that would be unavailable if they could not be compounded. Specialty compounded drugs for eye surgery, bone surgery, etc. would not be available.

10. NEW THERAPEUTIC APPROACHES
If a physician desires to use a medication that is successfully used in other countries but is not commercially available here, that physician can prescribe a compounded formulation of the medication for patients. An TGA-approved oral therapy prescribed as a topical gel for arthritis treatment to avoid gastric bleeding could reduce the overall cost of healthcare by avoiding hospitalisation from a gastric bleed.

11. VETERINARY COMPOUNDING
Animals can be grouped into various categories, including small, large, herd, exotic, and companion groups. There are actually relatively few medications available for animals, and those medications that are available are for specific species and diseases. In most cases, for an animal to be satisfactorily treated, a compounded medication may be necessary.

12. CLINICAL STUDIES
Pharmacists compound drugs that are not commercially available that are used in various clinical studies.


Disclaimer: The information contained on this website, which may include instructions related to regulatory guidelines and current standards of practice, treatment modalities, diagnostic and therapeutic information for pharmacy compounding is for general reference purposes only and should not be taken as suggested standard of practice, a treatment regimen, product indication or suggested treatment modality. Pharmacists must always ensure compliance to Pharmacy Board of Australia requirements and all relevant State/Territory and Commonwealth laws. Any regulatory, practice or treatment standard must be fully investigated by a registered pharmacist in accordance with accepted professional practice standards and compendia.