The Australian Pharmacy Board has released an updated set of guidelines for compounding medicines. Definitely a must-read for all compounding pharmacists.
The New Set of Guidelines on Compounding Medicines in Australia
1. As of the second day of March, 2015, the Australian Pharmacy Board released
some updated guidelines for compounding pharmacies and pharmacists as well.
These guidelines are also published on the website for the Pharmacy Board of
Australia and all pharmacists are strongly urged to read and understand them.
Those with questions are welcome to contact the board through the details
provided in the website.
The New Set of Guidelines
on Compounding Medicines
in Australia
2. To better understand these rules, it might also be helpful to read this simplified
summary first. The publication includes new guidelines for compounding
medicine and an update on the history and reasons for the new rules. In addition,
there is a practice profile that can be used by pharmacists who perform complex
medicine compounding.
These rules were developed after extensive consultations with professionals in
the industry. They have become effective on the twenty-eighth day of April of
2015. They will stay effective until another update gets released. The guidelines
were published before they became effective to give pharmacists a chance to
familiarise themselves with the new regulations, ask questions, and submit
feedback.
As noted on the website, these new rules will replace the 2010 version. This
version was published under the name of "Guideline 5." The old guidelines will no
longer be valid after the new rules are implemented.
The Updated Pharmacy Compounding
Rules in Australia
3. The purpose of these new rules, according the Stephen Marty, the Pharmacy
Board's chairperson, is to ensure that all pharmacists have access to the same
guidelines and procedures. These consistent rules will help make sure that
compounding pharmacies will provide the maximum quality, effectiveness, and of
course, safety.
The new rules have a second purpose of outlining the right procedures for
making more complex compounding medications. These are defined as those
medicines that may require specialised training, equipment, facilities, or
processes. They may also be associated with a higher risk because of the
additional complexity, the nature of the medication involved, or even the
complexity of dispensing them.
These new rules have been called a significant improvement over the older
guidelines. The purpose is to minimise risks to patients, registered pharmacists,
and pharmacy staff. Other goals of these changes are to improve patient safety
and patient outcomes.
What is The Purpose of the New
Pharmacy Rules?
4. Compounding medications has sometimes been called both a science and an art.
It is the practice of mixing different medicines and inactive ingredients together
to offer patients a customised and personalised medication. These days, the vast
majority of Australian prescriptions are not compounded but are mass-produced
in factories.
Half a century ago, most medications were prepared by pharmacists in their own
workspaces. These days, pharmacists usually tend to act as the dispensers of
prepared medicines. And the sad truth is, many pharmacists lack the training
needed to properly compound medicine.
Modern technology has also helped ensure accuracy and efficiency when
providing these specialised compounds. Still, using this technology may require
special training, so not all pharmacists are authorised to work as compounding
pharmacists
Background of the Compounding
Pharmacy Regulations
5. Who Should Read the Updated
Rules?
All pharmacists who deal with compounding medications should familiarise
themselves with the 2015 regulations. Mass-produced drugs require approval,
but the rules allow compounded medications to be produced with only a
prescription. This makes it especially important be cautious when producing
them in order to ensure a safe product and the best possible patient outcome.
However, mass-produced prescription drugs might not meet the needs of every
patient. Thus, there has been a resurgence in requests for compounded
medications.
Compounding Pharmacy - Sydney Compounding Chemist | Fresh Therapeutics
Compounding Pharmacy
Address: 3102 Westpoint Blacktown 17 Patrick Street,
Blacktown, Sydney, NSW 2148
Tel: 02 9621 2168
Website: http://www.freshtherapeutics.com.au/compounding/