Pharmacy Daily | Harvey ‘s MIMS complaint

IF MIMS continues to publish information from Listed medicine product sponsors that is “potentially erroneous and harmful” then a prominent disclaimer should be attached to each information page, according to Adjunct Senior Lecturer, Dr Ken Harvey, from the School of Public Health at La Trobe University. Speaking to PD Harvey tendered his comments following a complaint he made to the Therapeutic Goods Administration regarding the promotion of Ethical Nutrients’ ‘Urinary Tract Support’ herbal supplement in a number of publications. According to Harvey, the product claims made in the promotions had a lack of verifiable evidential support. “Promoting this product for urinary tract infections (an infectious disease best treated with antibiotics) is a breach of Section 42DL(1)(c) of the Therapeutic Goods Act 1989,” Harvey said in his complaint letter to the TGA. In response to his complaint Harvey was told that a portion of the information cited in some of the Urinary Tract Support promotions was sourced from MIMS. “MIMS then confirmed that their product information (PI) on Listed complementary medicines was provided by the company concerned and received no independent validation,” Harvey told PD. A MIMS disclaimer also states that it ‘reproduces information as provided by pharmaceutical companies and approved by the Therapeutic Goods Administration’. “I have pointed out to MIMS that this statement does not accurately reflect the difference between TGA “approved prescribing information” (provided for prescription products) and information on Listed medicines that is not routinely checked by the TGA,” Harvey said. “The TGA have admitted (after an FOI request) that, the high level of regulatory compliance irregularities (found on monitoring 26% of newly listed medicines) presents a major risk to confidence in the Australian Government’s regulatory framework for complementary medicines and the complementary industry itself,” he added. At the time of publication representatives for MIMS had not yet responded to PD’s questions regarding their Listed medicine product information.

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