Commenced in January 2007
Frequency: Monthly
Edition: International
Paper Count: 3

Search results for: drug safety

3 Patient Support Program in Pharmacovigilance: Foster Patient Confidence and Compliance

Authors: Atul Khurana, Rajul Rastogi, Hans-Joachim Gamperl

Abstract:

The pharmaceutical companies are getting more inclined towards patient support programs (PSPs) which assist patients and/or healthcare professionals (HCPs) in more desirable disease management and cost-effective treatment. The utmost objective of these programs is patient care. The PSPs may include financial assistance to patients, medicine compliance programs, access to HCPs via phone or online chat centers, etc. The PSP has a crucial role in terms of customer acquisition and retention strategies. During the conduct of these programs, Marketing Authorisation Holder (MAH) may receive information related to concerned medicinal products, which is usually reported by patients or involved HCPs. This information may include suspected adverse reaction(s) during/after administration of medicinal products. Hence, the MAH should design PSP to comply with regulatory reporting requirements and avoid non-compliance during PV inspection. The emergence of wireless health devices is lowering the burden on patients to manually incorporate safety data, and building a significant option for patients to observe major swings in reference to drug safety. Therefore, to enhance the adoption of these programs, MAH not only needs to aware patients about advantages of the program, but also recognizes the importance of time of patients and commitments made in a constructive manner. It is indispensable that strengthening the public health is considered as the topmost priority in such programs, and the MAH is compliant to Pharmacovigilance (PV) requirements along with regulatory obligations.

Keywords: Drug Safety, Pharmacovigilance, Good Pharmacovigilance Practice, patient support program

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2 Adverse Drug Reactions Monitoring in the Northern Region of Zambia

Authors: Ponshano Kaselekela, Simooya O. Oscar, Lunshano Boyd

Abstract:

The Copperbelt University Health Services (CBUHS) was designated by the Zambia Medicines Regulatory Authority (ZAMRA), formally the Pharmaceutical Regulatory Authority (PRA) as a regional pharmacovigilance centre to carryout activities of drug safety monitoring in four provinces in Zambia. CBUHS’s mandate included stimulating the reporting of adverse drug reactions (ADRs), as well as collecting and collating ADR reports from health institutions in the four provinces. This report covers the researchers’ experiences from May 2008 to September, 2016. The main objectives are 1) to monitor ADRs in the Zambian population, 2) to disseminate information to all health professionals in the region advising that the CBU health was a centre for reporting ADRs in the region, 3) to monitor polypharmacy as well as the benefit-risk profile of medicines, 4) to generate independent, evidence based recommendations on the safety of medicines, 5) to support ZAMRA in formulating safety related regulatory decisions for medicines, and 6) to communicate findings with all key stakeholders. The methodology involved monthly visits, beginning in early May 2008 to September, 2016, by the CBUHS to health institutions in the programme areas. Activities included holding discussions with health workers, distribution of ADR forms and collection of ADRs reports. These reports, once collected, were documented and assessed at the CBUHS. A report was then prepared for ZAMRA on quarterly basis. At ZAMRA, serious ADRs were noted and recommendations made to the Ministry of Health of the Republic of Zambia. The results show that 2,600 ADRs reports were received at the pharmacovigilance regional centre. Most of the ADRs reports that received were due to antiretroviral drugs, as well as a few from anti-malarial drugs like Artemether/Lumefantrine – Coartem®. Three hundred and twelve ADRs were entered in the Uppsala Monitoring Centre WHO Vigiflow for further analysis. It was concluded that in general, 2008-16 were exciting years for the pharmacovigilance group at CBUHS. From a very tentative beginning, a lot of strides were made and contacts established with healthcare facilities in the region. The researchers were encouraged by the support received from the Copperbelt University management, the motivation provided by ZAMRA and most importantly the enthusiasm of health workers in all the health care facilities visited. As a centre for drug safety in Zambia, the results show it achieves its objectives for monitoring ADRs, Pharmacovigilance (drug safety monitoring), and activities of monitoring ADRs as well as preventing them. However, the centre faces critical challenges caused by erratic funding that prevents the smooth running of the programme.

Keywords: monitoring, Evaluation, Pharmacovigilance, assessments

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1 Chronic Patients- Prescription Refill Intentions

Authors: Ching - Yi Lee, I-Hsiung Tseng, Feng-Chuan Pan

Abstract:

Environment today is featured with aging population, increasing prevalence of chronic disease and complex of medical treatment. Safe use of pharmaceutics relied very much on the efforts made by both the health- related organizations and as well as the government agencies. As far as the specialization concern in providing health services to the patients, the government actively issued and implemented the divisions of medical treatment and pharmaceutical to improve the quality of care and to reduce medication errors and ensure public health. Pharmaceutical sub-sector policy has been implemented for 13 years. This study attempts to explore the factors that affect the patients- behavior intention of refilling a prescription from a NHIB pharmacy. Samples were those patients refilling their prescriptions with the case NHIB pharmacies. A self-administered questionnaire was used to collect respondents- information while the patients or family members visit the pharmacy for the refilling. 1,200 questionnaires were dispatched in 37 pharmacies that randomly selected from Pingtung City, Dongkang, Chaozhou, Hengchun areas. 732 responses were gained with 604 valid samples for further analyses. Results of data analyses indicated that respondents- attitude, subjective norm, perceived behavior control and behavior intentions toward refilling behavior varied from some demographic variables to another. This research also suggested adding actual behavior, either by a self-report or observed, into the research.

Keywords: Drug Safety, theory of planned behavior, Separation of dispensing and prescribing, prescriptions refill slip, NHIB contracted pharmacy

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