Evaluation of the level of compliance of Veterinary medicine package inserts with Regulatory authority guidelines
| dc.contributor.advisor | Coetzee, Renier | |
| dc.contributor.author | van der Riet, Estelle | |
| dc.date.accessioned | 2021-08-03T14:02:09Z | |
| dc.date.accessioned | 2024-10-30T11:28:12Z | |
| dc.date.available | 2021-08-03T14:02:09Z | |
| dc.date.available | 2024-10-30T11:28:12Z | |
| dc.date.issued | 2021 | |
| dc.description | Magister Scientiae (Medical Bioscience) - MSc(MBS) | en_US |
| dc.description.abstract | Background: Veterinary medicines play an imperative role in the diagnosis, prevention and treatment of animal diseases. Many veterinary stock remedies in South Africa are available to the public without the intervention or supervision of a veterinarian or healthcare worker. Therefore, the accompanying package insert with product information and directions for use is central in promoting the safe and effective use of stock remedies. Information such as the dosage, warnings, precautions and storage instructions are essential to assist the user in their treatment decision-making. While local regulatory authority guidelines prescribe and control the minimum information that should be available in the package insert or product label, it is questioned whether the information contained in package inserts of products on the market complies with these regulatory requirements. Methodology: Using simple random sampling of veterinary stock remedies, 159 package inserts or product labels from various animal health companies were selected and evaluated against the prescribed labelling guidelines of the local regulatory authority responsible for the registration and control of stock remedies. The contents of each package insert or label in the sample were assessed for the presence of the prescribed information statements and were accordingly classified as non-compliant, partially compliant or compliant. Results: Among the 159 package inserts, 48 were for antimicrobials, 49 for ectoparasiticides, 44 for anthelmintics and the remaining 18 for endectocides. It was observed that none of the package inserts met all of the criteria and that the package inserts were inadequate in many aspects. The average percentage of compliance was 69.43%, with a range of 36.21% to 87.93%. Conclusion: The study indicated that many package inserts do not fully comply with the prescribed regulatory guidelines and that information related to the safe and appropriate use of stock remedies is insufficient. | en_US |
| dc.identifier.uri | https://hdl.handle.net/10566/16755 | |
| dc.language.iso | en | en_US |
| dc.publisher | University of the Western Cape | en_US |
| dc.rights.holder | University of the Western Cape | en_US |
| dc.subject | Patient information | en_US |
| dc.subject | Package insert | en_US |
| dc.subject | Product labelling | en_US |
| dc.subject | Veterinary medicine | en_US |
| dc.subject | Medicine labelling | en_US |
| dc.subject | Regulatory requirements | en_US |
| dc.subject | Stock remedies | en_US |
| dc.subject | Patient compliance | en_US |
| dc.title | Evaluation of the level of compliance of Veterinary medicine package inserts with Regulatory authority guidelines | en_US |