PSA seeks consensus document on biological medicines


white pills and tablets: GMiA

The PSA has released its position statement on biologics, stating that it believes a consensus Australian document on terminology and definitions relating to biological medicines, including biosimilar medicines, should be developed as a priority to promote accurate and common understanding of this subject.

In its Biosimilar medicines position statement, released today, PSA says patient safety is a prime concern of the pharmacy profession and risk assessment in relation to biosimilars includes assessment of safety and efficacy by the TGA, consideration by the Pharmaceutical Benefits Advisory Committee, and clinical assessment by the prescriber.

National President of the PSA, Joe Demarte, says pharmacists currently follow substitution principles which respect the choice of prescribers and patients, in accordance with PSA’s Professional Practice Standards, and Guidelines for Pharmacists on PBS Brand Substitution.

“In consideration of possible long-term impacts of biological medicines generally, but biosimilar medicines in particular, PSA believes a holistic, nationally-coordinated and outcomes-focussed approach is essential for a strong pharmacovigilance program,” Demarte says.

“PSA suggests a stakeholder group should be established to determine appropriate parameters which may include an extension of routine pharmacovigilance requirements.

“Pharmacists have a fundamental role in pharmacovigilance activities.

“There is an imperative to capitalise on the pharmacist’s medicines expertise and frontline health professional role.

“PSA believes it is vital that a national awareness campaign on biosimilar medicines is based around clear and consistent communication messages to support prescribers, pharmacists and patients,” he says.

“PSA would welcome the opportunity to assist through the provision of expertise on developing high quality education, practice support and communication materials appropriate for the pharmacy profession.

“PSA offers its unique medicines expertise to assist the Australian Government in this regard and work closely with consumers, other health professionals and the pharmaceutical industry.”

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