Abstract
Complementary medicines (CMs) available on the South African market are sold to the public in stores, pharmacies and online. Products are regulated according to the guidelines of the South African Health Products Regulatory Authority (SAHPRA). A CM is categorised based on its content and use. Silybum marianum (L.) Gaertn. (S. marianum) or Milk Thistle forms part of the Asteraceae family and contains compounds that provide the plant with its properties.
This non-experimental quantitative study aimed to assess the degree to which medicines containing Milk Thistle on the South African market were compliant with regulatory requirements of the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965) and the SAHPRA Guidelines by assessing product indications, labelling and verifying them.
24 products were included in the study. The inclusion criteria: products contained S. marianum as only active ingredient and products available for sale in South Africa. The exclusion criteria: the products did not classify as CM or the products had other active ingredients. The method assessed and reviewed the indications on the labels. The data was collected, analysed and followed by an evaluation report.
All products had labels, 33.3% of products had Professional Information (PI), and 45.8% of the products had Patient Information Leaflets. 45.8% of the products use English and another language. 16.7% of the products had no indications, 67.7% had low-risk indications, and 16.7% had high-risk indications. All products (24) were unregistered. Imported products had no PI present. Nine products had a Silymarin content above the recommended dose.
All products had one or more regulatory compliance deficiency. A deficiency in compliance could possibly put consumers at risk, the implementation of regulations could be re-evaluated to address the situation. One-third of products had a higher dosage than recommended. Four unregistered products with high-risk claims were identified, this poses a potential risk to the public. Lack of regulation compliance among imported products was noted.
The study should be repeated to determine regulatory compliance for other CMs. Non-compliant products will be reported to SAHPRA. Immediate registration or withdrawal should be considered for high-risk products. Content analysis studies can establish compliance with the label content claim. Imported products should be checked for compliance upon entry into South Africa. Public campaigns to inform them about the labelling of medicines (especially CMs) could be considered.
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DEDICATION
I dedicate my dissertation work to my Creator. He has been my strength throughout this project and it is by His grace that I have made it through. His wisdom, knowledge, presence and love have been my constant inspiration during this time.
I also dedicate this work to my family and friends. My beloved parents, Dirk & Anina, your encouragement and support have meant the world to me. I am forever grateful to both of you for making my education possible and for being there with me through it all.
My dearest husband, Quinton, you have been a constant source of unconditional love and patience. My biggest inspiration and motivator. Your words of support truly carried me through. Thank you for always being there, I would not have been able to do this without you.
My sisters, Hanneke, Joke and Anne, thank you for the laughs and hugs on the difficult days. You are my joy. I would like to thank the rest of my family and friends. The support and love were constant and I appreciate each and every one of you.