Compliance with good distribution practice guidelines for cold chain products among pharmaceutical wholesalers in South Africa
- Authors: Masebe, Zandisile
- Date: 2020
- Subjects: Pharmaceutical industry
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: http://hdl.handle.net/10948/46390 , vital:39581
- Description: Background: The South African pharmaceutical cold chain distribution industry is highly regulated. Cold chain pharmaceutical products require storage in a cold room, in a temperature-controlled environment between (2°C-8°C) and the cold chain must be maintained at all times throughout the distribution process. The incorrect handling, storage, transport and distribution of cold chain products may reduce the potency and therapeutic effectiveness of the product which in turn may result in treatment failure. The research was aimed at determining the level of compliance to current Good Distribution Practice guidelines for cold chain products among pharmaceutical wholesalers and distributors in South Africa. Methodology: The study made use of quantitative research techniques. A purpose designed online questionnaire was used as a data collection tool from the study participants. The judgmental sampling technique was used in this study as it was found to be the most appropriate method for the research question. Phase one of the study was to conduct a pilot study at two Port Elizabeth pharmaceutical wholesalers. The data was analysed using Microsoft Excel®, chi-square test for goodness of fit and content analysis. The data was further analysed using a descriptive and inferential statistics approach to determine the level of compliance to regulatory guidelines for cold chain products.Results:The results obtained from the empirical study revealed that less than 50% of the study respondents indicated compliance to the factors listed in the regulatory guidelines for cold chain products distribution.These factors include cold chain monitoring, alternative power sources, validation of cold chain boxes and route transport validation.Conclusion:The wholesale pharmaceutical industry is experiencing challenges to comply with factors necessary to ensure compliance with GDP guidelines for cold chain products. Through the study it was proven that there is evidence of commitment by the industry to implement the GWP and GPP amendment guidelines, despite less than 50% of the respondents reporting compliance to the guidelines. Recommendations were provided to improve the level of compliance to guidelines for cold chain products by pharmaceutical wholesalers in South Africa.
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- Date Issued: 2020
Evaluation of product x pre and post cpv implementation
- Authors: Killian, Christopher Grant
- Date: 2020
- Subjects: Pharmaceutical industry
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: http://hdl.handle.net/10948/46447 , vital:39577
- Description: Purpose: Stage 3 of the pharmaceutical process validation lifecycle, is called continued process verification (CPV). CPV is the final stage of lifecycle management and is intended to provide ongoing assurance that during routine production that a process remains in a state of control. Since CPV is a relatively new focus area for regulators, many legacy products will not have undergone Stage 3 process validation. Therefore, an opportunity existed to review the impact and challenges of implementing CPV on a legacy product. Methodology: This study employed quantitative analysis to evaluate the impact of CPV on process stability and end product quality for Product X, a legacy product manufactured at a generics manufacturing facility. Initial Stage 3a CPV was used to review historical process data and identify special cause variation. Corrective and preventative actions were taken to address these statistical outliers and the impact of these process changes were evaluated in Stage 3b. Results: CPV implementation appeared to have an effect on process control, stability and capability for Product X. In Stage 3b, an increase in statistical outliers along with significant changes to process mean and standard deviation were seen for the critical process parameters, average mass and hardness. An improvement in process capability for the critical quality attributes, assay and dissolution, was also seen. Conclusion: The largest benefit of CPV implementation, especially for a legacy product, is the process knowledge gained. This provided opportunities for process improvement and ultimately benefited patient safety.
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- Date Issued: 2020
Willingness to pay for pharmacist-provided services directed towards reducing risks of medication-related problems
- Authors: Mushunje, Irvine Tawanda
- Date: 2012
- Subjects: Pharmaceutical industry , Pharmacy -- Practice -- Finance , Pharmacist and patient , Prescription pricing
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: vital:10133 , http://hdl.handle.net/10948/d1008053 , Pharmaceutical industry , Pharmacy -- Practice -- Finance , Pharmacist and patient , Prescription pricing
- Description: Pharmacists as members of health care teams, have a central role to play with respect to medication. The pharmaceutical care and cognitive services which pharmacists are able to provide can help prevent, ameliorate or correct medication-related problems. There are however many barriers to the provision of these services and one of the barriers commonly cited by pharmacists is the lack of remuneration for their expert services. The aim of this study is to ascertain if patients in South Africa are willing to pay for pharmacist-provided services which may reduce medication related problems, and thereby determine the perceived value of the pharmacist-provided services, by patients. The study will also seek to determine factors that influence willingness to pay (WTP), including financial status, gender, race, age and level of education. In addition the perceived value of the pharmacist‘s role in patient care, by third party payers (SA Medical Aid providers) and their WTP for pharmacist-provided services (such as DSM) on behalf of patients through their monthly premiums will also be investigated. The study was conducted as a two-phase process: the first phase focused on the opinions of patients and the second phase on the medical aid companies. In phase-1 a convenience sample of 500 patients was recruited by fifty community pharmacies distributed throughout the nine South African provinces. Data collection, consisting of telephonic administration of the questionnaires, was conducted and the survey responses were captured on a Microsoft Excel® spreadsheet. All the captured information was analyzed using descriptive statistics, box and whisker plots, analysis of variance (ANOVA) and regression analysis. In phase-2, medical aid schemes that are registered with the Council of Medical Schemes (CMSs) of South Africa were included in this research. A fifteen point questionnaire was completed electronically via e-mail by willing medical aid participants. Data was analyzed using descriptive statistics only. Only 233 or 88.6 percent, of the 263 participating respondents, were willing to pay at least one rand towards pharmacist-provided services. On average respondents were willing to pay R126.76 as out-of-pocket expenses. Respondents‘ WTP increased as the risk associated with medication-related problems was reduced due to pharmaceutical care intervention. Of the 263 respondents who took part in this research, fifty percent were willing to pay at least R100 for a risk reduction of 30 percent, R120 for a 60 percent reduction and approximately R150 for a greater than 90 percent risk reduction. It was also found that the respondents‘ willingness to pay was influenced by their age, earnings, racial grouping, employment status, medical aid status and their level of satisfaction with pharmacist-provided care services. Of the thirty-one open medical aid schemes only eight (25.8 percent) participated in the study. Findings indicate that all the participating medical aid respondents were unwilling to pay for pharmacist-provided care services, although they perceived pharmacists as very influential healthcare providers and as having a significant role to play in reducing medication-related problems. In conclusion it was found that majority of participants were willing to pay for pharmacist-provided services directed towards reducing risks associated with medication-related problems. Until pharmacists are able to prove pharmaceutical care‘s utility and cost-effectiveness to third-party payers, pharmacists must look to the patient for reimbursement.
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- Date Issued: 2012