A review of adverse events in animals and children after secondary exposure to transdermal hormone-containing medicinal products.

Background: Hormonal replacement therapy is widely used to treat conditions in humans, the most well-known indication being the relief of menopausal symptoms in women. Many of the hormone-containing products (HCP) are applied to the skin. This transdermal delivery poses a risk to animals and humans through secondary exposure, especially when product information is not strictly followed. The aim of this article is to raise awareness among veterinarians and human healthcare providers of this risk; based on evidence from spontaneous reporting of suspected adverse events (AEs) in animals and humans. Interventions are also explored to mitigate the risk of secondary exposure to transdermal HCP (THCP). Review of spontaneously reported suspected AEs: The Swedish Medical Products Agency has received several, mainly serious, AE reports in animals and children following secondary exposure to THCPs. The AE reports were reviewed together with worldwide data from the EudraVigilance Veterinary database and human EudraVigilance Data Analysis System. The clinical signs reported in animals included persistent signs of oestrus, poor growth rate and birth defects. In humans, reported clinical signs included precocious puberty, unresolved virilisation, accelerated growth rate and female infertility. Conclusions: It is important that THCP are used according to manufacturer's instructions and users are made aware of risks and mitigating measures. This review of AEs in animals and children provides evidence to show that the use of THCP poses a risk for secondary exposure. Efficient communication strategies that stretch across veterinary and human medicinal disciplines are required to raise mutual awareness and minimise the risk of AEs in animals and humans.

A survey of veterinary professionals in Sweden: Adverse event reporting and access to product safety information.

BACKGROUND: Pharmacovigilance based on spontaneously reported suspected adverse events (AEs) from veterinary professionals is a powerful tool for detecting potential risks of using medicinal products. However, it is heavily dependent on the voluntary participation of veterinary professionals. Estimates suggest that over 90% of suspected AEs remain unreported. This survey was conducted to accumulate information on current practices and attitudes of Swedish veterinary professionals in relation to AE reporting and their perceptions of the accessibility of updated product safety information. METHODS: Swedish veterinary professionals were surveyed using a web-based questionnaire prepared by the Swedish Medical Products Agency (SMPA). The survey included three sections with 13 questions and was distributed via several communication channels, including the Swedish Veterinary Association. RESULTS: The survey was answered by 412 veterinary professionals, including veterinarians and licensed veterinary nurses. The survey identified that most veterinarians comply with national legislation by reporting directly to the SMPA, but not all observed AEs are reported. Veterinary professionals indicated that it is important to have an easy and efficient reporting system, preferably directly from an electronic medical records system. Feedback is considered important. Veterinary nursing staff could potentially improve the reporting rate of suspected AEs in Sweden. The degree of knowledge relating to the reporting of AEs varies among professionals, thus impacting on reporting frequency. A single source of product safety information is mainly used, and improvements are required to enhance accessibility and distribution of updated product safety information. CONCLUSIONS: The insight gained from this survey will be used to influence attitudes and facilitate adaptations needed to fulfil the requirements of the European Union regulations. To reduce underreporting of AEs and facilitate access to updated product safety information, various approaches are required including educational interventions, new digital reporting tools and adaption of communication strategies.

Group and Single Housing of Male Mice: Collected Experiences from Research Facilities in Sweden.

Animals used for scientific purposes are protected by EU legislation. Social animals should be kept in stable groups that enable species-typical social behavior and provide individuals with social comfort. However, when group-housing male mice, aggression within the homecage is a common husbandry and welfare problem. Excessive fighting and injuries due to aggression can cause pain and stress, resulting in individuals being euthanized or housed individually. In addition, stress can alter physiological parameters, risking scientific validity and generating larger sample sizes. Mouse aggression, and the consequences thereof, thus opposes the 3R goals of Refining the methods to minimize potential pain and suffering and Reducing the number of animals used. Animal technicians, veterinarians, and scientists using animals have valuable information on how these problems are experienced and handled in practice. We assembled these experiences from laboratory animal facilities in Sweden, mapping problems observed and identifying strategies used to prevent mouse aggression. In line with current literature, less aggression was perceived if mice were grouped before sexual maturity, re-grouping avoided and nesting material transferred at cage cleaning. Preventing aggression will minimize pain and suffering and enable housing of stable groups, leading to more reliable scientific outcomes and is thus of high 3Rs relevance.