DocWire News Editors

DocwireNews

Citing a lack of evidence regarding the determination of readability of biosimilar package leaflets sold in the European Union, authors for this cross-sectional, analytical study examined the readability and length of package leaflets of biosimilars downloaded from the European Medicines Agency (EMA) website.&ldquo;Taking into account the forecast growth in the market of biosimilars in the coming years, studying the readability of the package leaflets of biosimilars that are currently on the market is an important task,&rdquo; they wrote.The study sample included leaflets written in English for all biosimilars authorized by the EMA through August 31, 2017, an about which information could be obtained on the internet (n=35). Biosimilars included in the analysis included human growth hormones (n=2), insulins, granulocyte-colony stimulating factors (n=7), erythropoietins (n=5), low-molecular-weight heparins (n=2), parathyroid hormones, and monoclonal antibodies (n=12). The also examined six different sections of the package leaflet:<ul>
<li>What X is and what it is used for</li>
<li>What you need to know before taking it</li>
<li>How to take/use</li>
<li>Possible side effects</li>
<li>How to store</li>
<li>Annex/handling instructions</li>
</ul>The authors used two readability indices, the Flesch Index (FRE) and the Flesch-Kincaid Index (FKGL). The indices are inversely proportional, meaning that as a text becomes easier to read, its FKGL value decreases while its FRE increases. The authors did note that&nbsp; all of the leaflets were more difficult to read than recommended for health-related texts, according to the FKGL (all the averages were &gt;6). There were statistically significant differences between the leaflet sections in readability and in length, with the most difficult sections to understand being related to therapeutic indications and of possible side effects.&ldquo;Our results show that the package leaflets analyzed are longer than those of non-biological medicines, and of non-biosimilar biological medicines,&rdquo; the authors wrote in their discussion. &ldquo;Excessive information in the package leaflets does not meet the requirements of patients.&rdquo;This could potentially lead to harm down the road, the authors said.The lack of readability that the package leaflets may exhibit could lead to not all patients reading them, and even to a certain degree of alarm in patients who do read them, which could reduce adherence to the treatment,&rdquo; they wrote.Study limitations included the patients not being contacted, which the authors explained could frame the current study as a first step in the identification of readability problems independent of study patients.In their conclusion, the researchers did note that the European Commission has made an effort to contribute to proper package leaflet writing and issued guidelines in 2009. Biosimilar manufacturers have had time to make the necessary adjustments.&ldquo;To that end, it would always be possible, before publication of the package leaflet, to perform readability tests directly with the target patients (as is recommended in the guideline), and to apply readability formulas and assess the results as a prior step,&rdquo; they wrote. &ldquo;The competent organizations could be informed about package leaflets for authorized biosimilar medicines may not fulfil the function for which they were designed, which could have a negative effect on the use of the medicines by the user or patient.&rdquo;Read more at BMJ Open (<a href="https://bmjopen.bmj.com/content/9/1/e024837">https://bmjopen.bmj.com/content/9/1/e024837</a>)

Bradley Marder, MD

Joel M. Topf, MD, FACP

Gout Studies: Transplant Waitlisting and Bone Erosion

NKF Spring Clinical Meetings 2025

Jayme Locke, MD, MPH

The Promise of Xenotransplantation

Leah Lawrence

Real-World Data Backs Invasive DFS as Surrogate Endpoint for OS in EBC

HR Breast Cancer

Latest News

Readability Assessment of Package Leaflets of Biosimilars

Oncology

Citing a lack of evidence regarding the determination of readability of biosimilar package leaflets sold in the European Union, authors for this cross-sectional, analytical ...

About Us

Editorial Policy

Advertising

Contact Us

eNewsletters

Contribute

Career Center

MashupMD

Blood Cancers Today

Cancer Nursing Today

GU Oncology Now

Urban Health Today

Bile Duct Cancer

Colorectal Cancer

Gastroesophageal Cancer

Gastric Cancer

GEP-NETs

GIST

Liver Cancer

Pancreatic Cancer

GI Oncology Now

Anemia

Deep Vein Thrombosis

Essential Thrombocythemia

Hemophilia

Immune Thrombocytopenic Purpura

Myelodysplastic Syndromes

Myelofibrosis

Myeloproliferative Neoplasms

Polycythemia Vera

Pulmonary Embolism

Sickle Cell Disease

Thrombocytopenia

Thrombophilia

Thrombosis

Thrombotic Thrombocytopenic Purpura

Venous Thromboembolism

von Willebrand Disease

Heme Today

Acute Kidney Injury

ADPKD

Anemia and Kidney Disease

Chronic Kidney Disease

COVID-19 and Kidney Disease

Diabetes and Hypertension

End-Stage Renal Disease

Gout

Hyperkalemia

IgAN

Kidney Transplantation

Metabolic Acidosis

Nephrology Times

HER2 Breast Cancer

Triple-Negative Breast Cancer

Genetics & Breast Cancer

Breast Cancers Today

Atherosclerotic Disease

Atrial Fibrillation

Heart Failure

Hypertension

Interventional Cardiology

Lipid Management

Practice Tips With Dr. Lichaa

Preventive Cardiology

Stroke

Cardiology

Breast Cancer

Gynecologic Cancer

Head and Neck Cancer

Skin Cancer

Sleep

Urology

Diabetes

Ophthalmology

— Demodex Blepharitis

Neurology

Rheumatology

Gastroenterology

Pulmonology

Infectious Diseases

— HIV

Health and Wellness

Lupus

Future of Medicine

Orthopedics

Pharmacology

Career News

More

Conferences

CardioNerds

The Sleep Source With Dr. Morse

Rheumatology Rounds With Dr. Maheswaranathan

Partners

Expert Interviews

Subscribe