Safety

In the pharmaceutical industry, the Change Control process typically occurs when any change is proposed or required to a product, process, equipment, or system that could potentially affect the quality, safety, or compliance of the product. This paper includes a study to ensure the quality and safety of drugs and also avoids the future risks. This research investigates the root causes of incidents within the change control process in the pharmaceutical industry, analyzing the patterns and trends that lead to non-conformances and quality deviations. It ensures that any modifications, whether planned or unplanned, are thoroughly evaluated, authorized and executed in a controlled manner to minimize disruption, risk and inefficiencies. Changes may occur at any time during the product life cycle, leading to changes in the manufacturing process, the number of materials, and  the manufacturing Location . An effective change control process is critical in the pharmaceutical industry to ensure ongoing compliance with regulatory standards, maintain product quality, and safeguard patient safety, while minimizing potential risks associated with any changes to processes, materials, or systems.

Epilepsy is a common and non-communicable disorder of the brain affecting people of all ages. While epilepsy may cause complications in women during pregnancy, women can still enjoy healthy pregnancy with proper medical care. This study was aimed at identifying factors associated with enhancing pharmacotherapy care of pregnant women with epilepsy in Khartoum State, Sudan. This research was conducted using survey method to gather cross-sectional data from 30 pregnant women who are using prescribed antiepileptic drugs (AEDs), 30 doctors and 30 pharmacists. Structured Interview Schedule was used to collect data from study subjects. Sixty percent of sampled pharmacists contain AEDs prescribed by  physicians. In addition, only 23% of the women respondents were able to afford the prices of AEDs prescribed for them, and 63% of them purchased their prescribed AEDs from private pharmacies where prices are higher. Moreover, the difference in the level of effort by pregnant women to ensure compliance and safety in use of AEDs prescribed is not associated with differences in age, educational level  and source of income of the women respondents, as well as availability and affordability of AEDs to the women. No association was found between the compliance and safety among respondents and age group, educational level and sources of income of the women respondents as well as availability and affordability of AEDS. Moreover, there is need for more on-the-job training for pharmacists in order to develop their knowledge and skills to ensure patient compliance and safety.

Glaucoma is an optic neuropathy associated with retinal ganglion cell death that results in visual field loss. Elevated intraocular pressure (IOP) is a primary risk factor for the disease. Glaucoma is the second leading cause of blindness worldwide. Primary open angle glaucoma alone accounts for about 75% of all primary glaucoma. Timolol maleate (non selective β adrenergic antagonist) and Latanoprost (prostaglandin analogue) are commonly used drugs. Our aim of study is to compare the ocular hypotensive effect and safety of topical Timolol maleate (0.5%) and Latanoprost (0.005%) in patients of primary open angle glaucoma. A total of 60 patients with primary open angle glaucoma were included and studied for 6 months. One group of patients were given 0.5% timolol maleate eye drops twelve hourly and other group were given 0.005% latanoprost eye drops once a day. In our study both drugs were significantly effective in lowering the intraocular pressure. The mean fall in IOP in Timolol group was 6.69mmHg (26.10%) and in Latanoprost group was 7.20mmHg (28.5%) from pretreatment values. The difference between the values of mean of reduction in IOP from baseline IOP of the two groups was 0.512 mmHg that was statistically insignificant. The systemic and ocular side effects observed in two groups were comparable and both groups were well tolerated. Timolol maleate and Latanoprost both drugs are effective significantly in lowering the IOP, well tolerated and safe with negligible systemic side effects and comparable ocular side effects.