Compliance

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 disorder that is best viewed as symptoms of disturbed electrical activity in the brain, which may be caused by a wide variety of etiologies. It is a collection of many different types of seizures that vary widely in severity appearance, cause, consequence an management. The present study was done to evaluate, which drug is more effective than the other AED, used in tertiary care hospital. We studied and analyzed the pattern usage of AED in tertiary care hospital.  And evaluated the incidence of side effects of these drugs on the subjects in the study, studied the compliance to various recommendations/protocols for usage of AED in neurology intensive care unit, and also compared the commonest and least common anti epilepsy drugs in neurology care unit. Commonest drugs use in TBI, CVA, SAH, average age of patients having seizures. The required information was collected from the case sheets of individual patients in the designed data collection form. Patient details were collected through self designed, by patient interview, by prescriptions or by medication charts. The efficacy study conducted and was evaluated according to the declaration of ”HELNSIKI” (as embedded 1996) an by the incidence of adverse event reported by the patients.

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.

For more patient compliance there is a great demand for novel dosage form. Fast dissolving drug delivery system offers a solution for the patients who prefer oral route of drug administration without difficulty in swallowing. Fast dissolving films offers the simplest route of administration which is not painful and which do not require water for swallowing. Chlorpheniramine maleate is the First Generation alkyl amine antihistamine and used to relieve symptoms of allergy, hay fever, and common cold. These symptoms include rashes, watery eyes, itchy eyes/nose/throat/skin, cough, runny nose, and sneezing. In present study the aim was to formulate and evaluate fast dissolving films of Chlorpheniramine maleate. The films was prepared by solvent casting method, the superdisintegrants Crospovidone (2,4,6,8,10% w/w) and Microcrystalline Cellulose (5,10,15,20,25% w/w) were used in different concentrations with HPMC & PVA as a film forming base. Along with polymers and superdisintegrants the plasticizer PEG, mint flavor and sucrose were used in preparation of films. The formulated films were evaluated for thickness measurement, weight variation, folding endurance, disintegration time, in vitro drug release. It was concluded that the films containing Crosspovidone shows better drug release and less disintegration time as compared to the films containing Microcrystalline Cellulose.