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Cannaceuticals coined
Pharmacys lexicon has just
Compounding feedback Black Triangle plan
The Therapeutic
expanded with a new term hitting The Pharmaceutical Society of documentation Goods Administration
the pages of Pharmacy Daily: Australia is seeking submissions on facilities and equipment (TGA) has invited
Cannaceuticals. its revised Compounding Standard, storage, stability and disposal comment on a new
The term refers to pharmaceutical yesterday releasing a consultation dispensing and other supply consultation relating
grade cannabis made under the paper which is open to feedback arrangements to Strengthening monitoring of
conditions of good manufacturing until 18 Apr 2017. compounding practice medicines in Australia - including
process (GMP), and was coined The consultation is part of a counselling and the proposed introduction of a
by CannRx announcing its joint wider review of PSAs Professional monitoring, review & follow-up. new Black Triangle Scheme to alert
venture with iCAN: Israel-Cannabis Practice Standards, and outlines The review also highlighted the health professionals and consumers
at CannaTech, a medical cannabis the requirements for pharmacists requirement for compounding about newly available medicines.
conference in Tel Aviv. to enable patients to have timely activities to be guided by One of the recommendations of
Together, the companies will access to safe, efficacious and appropriate risk assessments. the Medicines and Medical Devices
bring to market ican.sleep, the quality compounded medicines. The project was funded as part Review was the improvement to
first advanced sleep cannabis A key outcome of the review has of the governments PBS Access the safety monitoring of medicines,
formulation utilizing the CannTrap been to ensure consistency of the and Sustainability Package which with the proposal aiming to
platform developed by CannRx. PSA standard with the Pharmacy includes the Sixth Community improve communication and
ican.sleep is the first Board of Australias Guidelines Pharmacy Agreement. collaboration, use of data and the
Cannaceutical (GMP, on compounding of medicines, in The consultation paper and a collection of adverse events.
pharmaceutical grade cannabis particular relating to the difference survey are online at psa.org.au. Black Triangle Schemes are
product) available to the tens of between simple and complex already in use in the EU, with the
millions of adults suffering sleep compounding activities. symbol displayed on PI and CMI
disorders, the companies said, The PSA Standard is intended
Swisse self-regulation documents with an explanation
with a global launch planned after to apply to all compounding, but Complementary products that the product is subject to
patient trials later this year. also identifies additional actions maker Swisse has made a pre- additional monitoring and a request
The pharmaceutical grade that need to be undertaken budget submission urging the to report suspected adverse events.
delivery system is said to provide when compounding complex government to implement a self- Other changes proposed include
a stable, controlled dose of the preparations. regulation model for advertising of reformatting Product Information
cannabis formulation. It details twelve criteria, under complementary medicines. to ensure indications, precautions
CannRx said it had developed the following headings: Swisse said the existing TGA and adverse event information is
highly accurate quantitative and patient-centred care complaints resolution process is easily accessible to prescribers.
qualitative analytical chemical quality assurance complex, obscure and insufficient The TGAs plans to enhance safety
assays as well as disease-specific policy and procedures and suggested the ACCC would be monitoring of medicines would
bioassays to determine the activity training and education a better body to handle complaints take effect from late 2017 onward.
of specific cannabinoids. risk management & evaluation under Australian Consumer Law. See tga.gov.au.
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