An assessment of African traditional medicines in pregnancy and on birth outcomes: pharmacists' perceptions of complementary medicines in pregnancy
- Authors: Mupfumira, Rudo
- Date: 2012
- Subjects: Traditional medicine -- South Africa Pharmacists -- Attitudes -- South Africa Medical ethics -- South Africa Medical anthropology -- South Africa Alternative medicine -- South Africa Prenatal care -- South Africa Pregnancy -- South Africa Abnormalities, Human -- South Africa
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: vital:3778 , http://hdl.handle.net/10962/d1003256
- Description: Increasing numbers of medicines are being used by pregnant South African women in the public sector during pregnancy, for the treatment of different biomedical and supernatural disease states and conditions. The motivation for the research is to support the development of more local pregnancy registries in order to strengthen evidence for the safety and efficacy of medicines used in pregnancy. A mixed methods approach was used. Women in their ninth month of pregnancy in a public sector setting, and four community pharmacists were identified. The women who met the inclusion criteria were recruited. One in-depth semi-structured interview was conducted with each woman before giving birth and data on their pregnancy outcomes were collected after labour. Coincidentally, the mother of one of the participants was found to be a traditional healer. She was also interviewed on the topic. A structured questionnaire was administered to the pharmacists. Ten pregnant women between the ages of 19 to 39 who had used or were using a traditional medicine during the pregnancy were recruited. All the participants had had at least one antenatal check up during their pregnancy with one having attended five times. No abnormal results were reported from any of the check ups or tests done during the visits. All of them had been to school and had at least Standard 8/Grade 10 education. Ten babies were seen between one and four days postpartum and no birth defects were obvious or were reported for any of them. The traditional healer did not provide additional information to what the women had said and confirmed that some of the practices the women reported were known to her as traditional medicine practices. All four pharmacists indicated that they considered complementary and alternative medicines (CAMs) to be “somewhat effective” and sold them at their pharmacies although none of them were aware of whether or not they were registered with the MCC. None of the pharmacists appeared to have an in-depth knowledge of traditional, complementary and alternative medicines (TCAMs). All four pharmacists said that it is important to have a basic understanding of TCAMs before using them, although they did not agree on the reasons for this. All of them felt that pharmacists have a professional responsibility to provide information on TCAMs (especially herbal preparations) and two felt that providing this information is part of a medical doctors’ responsibility. No harm from taking TCAMs could be shown. However herbal medicines have numerous ingredients some of which are unknown and taking these medicines is risky. The pharmacists in this sample were unsure whether they were accessing unreliable CAM information. Reliable sources of information and reference materials on CAMs to assist pharmacists and other healthcare professionals are needed. The apparent widespread use of TCAM in pregnancy indicates a need for documentation about its efficacy and safety. The establishing of TCAM pregnancy registries should seriously be considered. Due to the increase in CAM use, CAM education during pharmacists’ training as well as continuing professional development (CPD) in CAM for pharmacists in practice should be encouraged.
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- Date Issued: 2012
Foreign reference products in the registration of generic medicines in South Africa a case study
- Authors: Hwengwere, Eldinah
- Date: 2012
- Subjects: Generic drugs -- Law and legislation -- South Africa Case studies Generic drugs -- South Africa Case studies Drugs -- Law and legislation -- South Africa Case studies Pharmacy -- Law and legislation -- South Africa Case studies
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: vital:3762 , http://hdl.handle.net/10962/d1003240
- Description: Introduction: Due to the increase in healthcare costs, generic medicines have been adopted for used in both developed and developing countries. When a generic or ‘multisource interchangeable medicine’ is to be registered, studies that prove that the generic is equivalent to the Innovator Product (IP) are used. The generic medicine is required to prove that it will mirror the IP in terms of safety, quality and efficacy and, in South Africa, the Medicines Control Council (MCC) ensures that generic medicines meet these requirements. Generic medicines may be registered using bioequivalence data obtained from comparison with a domestic reference product (usually the local innovator product) or in certain cases, a foreign reference product (FRP). The bioequivalence data can either be from in vivo or in vitro studies. The MCC guidelines require that for modified release preparations, in vivo bioequivalence studies are done for approval of registration; the exception being if a proportionally higher dose has already been registered. No information is currently given to prescribers and dispensers or to the public about whether a generic product was registered against a foreign or domestic reference product. Aims and Objectives: 1.) To determine the number of generic medicines in a predetermined sample registered using a FRP as comparator and to document the transparency of pharmaceutical companies when approached to disclose information regarding the registration of these products. 2.) To describe and document the use of the Promotion of Access to Information Act (Act 2 of 2000) [PAIA] from the perspective of a ‘layperson’ in the context of medicines’ regulation, in both private and public bodies. Methods: 20 modified release and Biopharmaceutics Classification System (BCS) class IV products were selected from the ‘generics dictionary’ – a commercial publication – and letters were sent to the manufacturers of the products requesting information about the tests done to prove equivalence and whether they were performed against a domestic or foreign reference product. The same information was also requested from the MCC. The requests were all made using the Promotion of Access to Information Act (PAIA). Results: Nine companies were represented by the 20 products chosen. Information was obtained about thirteen products. Ten of these products were registered using FRPs. Four products were registered based only on comparative dissolution studies. Four companies provided the requested information, two companies responded by refusing the requests and three did not respond at all. The MCC refused the request for information even after an internal appeal was lodged. Conclusions: The Promotion of Access to information Act was unsuccessful in obtaining information from the public body, and partly successful in obtaining it from the private bodies. While the title of the Act seems to indicate that the Act can be used to obtain information as such, it only provides for access to specified records. The MCC and the pharmaceutical companies involved in the study were under no obligation to provide the information as the request had not complied with PAIA requirements. The use of FRPs for registration is a reality in the pharmaceutical industry in South Africa. Neither the public nor healthcare professionals who prescribe medicines or who are involved in dispensing generic medicines as substitutes are aware of whether or not a FRP has been used to register a generic. Interchangeability cannot necessarily be guaranteed if the reference product was not proven equivalent to the local innovator product. It is debatable as to whether or not this information would be of any particular benefit to members of the public. Prescribers may choose to write ‘no substitution’ on their prescriptions if they were unconvinced that an FRP is acceptable. This could have consequences for healthcare costs. Dispensers are the most vulnerable in South Africa as they are obliged by law to substitute generic medicines when innovator medicines have been prescribed. Dispensers’ views on the acceptability of the use of FRPs can be seen as irrelevant. In the end, as this study demonstrates, the only option in the present situation is to rely entirely on the MCC’s rigour in assessing applications for registration of generic medicines.
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- Date Issued: 2012
Illustrated medicines information for HIV/AIDS patients: influence on adherence,self-efficacy and health outcomes
- Authors: Barford, Kirsty-Lee
- Date: 2012
- Subjects: AIDS (Disease) -- Treatment -- South Africa , HIV infections -- Treatment -- South Africa , AIDS (Disease) -- Patients -- South Africa , HIV-positive persons -- South Africa , AIDS (Disease) -- Study and teaching -- South Africa , Antiretroviral agents -- South Africa , Communication in medicine -- South Africa , Communication in public health -- South Africa
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: vital:3863 , http://hdl.handle.net/10962/d1015678
- Description: South Africa has an estimated 920 000 patients on antiretrovirals (ARVs), the largest number of patients in any country. ARV therapy demands adherence levels in excess of 95% to avoid development of drug resistance, but adherence to ARV therapy is estimated to be only between 50% and 70%. Poor medication adherence is acknowledged as a major public health problem, reducing the effectiveness of therapy and promoting resistance to ARVs. More than two thirds of the South African population have marginal reading skills and this significantly influences a patient’s ability to read and understand health-related information. Patient education materials tailored for the South African population could be a useful aid in facilitating communication with patients and perhaps impact positively on their medicine-taking behaviour. This behaviour is influenced by patient knowledge, beliefs, attitudes and expectations and includes self-management, self-efficacy and adherence. Self-efficacy, which refers to patient confidence in the ability to self-manage medicine taking, is a key factor influencing adherence. This study aimed to develop illustrated patient information leaflets (PILs) and medicine labels for all first-line ARV regimens used in the public health sector in South Africa and, using a randomised control study design, to investigate the impact of these illustrated information materials on knowledge, medication-taking behaviours and health outcomes in HIV/AIDS patients taking ARVs. To achieve this aim, the objectives were to assess HIV/AIDS and ARV-related knowledge, as well as self-efficacy and adherence to ARV therapy; to assess the influence of demographic variables on knowledge, adherence and self-efficacy; to assess the influence of the information materials on knowledge, self-efficacy and adherence and to assess the association of knowledge with health outcomes. Medicine labels and PILs, both English and isiXhosa, were developed for ARV regimens 1a, 1b, 1c and 1d. The 8-item Morisky Medication Adherence Scale (MMAS-8) and HIV Treatment Adherence Self Efficacy Scale (HIV-ASES) instruments for measuring respectively adherence and self-efficacy, were modified to optimize clarity, simplicity and cultural acceptability and were translated into isiXhosa using a multi-stage translation-back translation. The questions and the rating scales, for both the MMAS and HIV-ASES, underwent preliminary qualitative evaluation in focus group discussions. Patients were recruited from local Grahamstown clinics. A pilot study to evaluate applicability of the instruments was conducted in 16 isiXhosa AIDS patients on ARVs and the results from this study informed further modifications to the instruments. One hundred and seventeen patients were recruited for the randomised control trial and were randomly allocated to either control group (who received standard care) or experimental group (who received standard care as well as pictogram medicine labels and the illustrated PIL). Interviews were conducted at baseline and at one, three and six months. Data were analysed statistically using the t-test, chi-squared test and ANOVA (Analysis of Variance) at a 5% level of significance. Correlations were determined using Pearson and Spearman rho correlations. Approval was obtained from Rhodes University Ethical Standards Committee, Settlers Hospital Ethics Committee and the Eastern Cape Department of Health. The results of this research showed that illustrated PILs and medicine labels enhanced understanding of HIV/AIDS and ARV information, resulting in a mean overall knowledge score in the experimental group of 96%, which was significantly higher than the 75% measured in the control group. Variable knowledge scores were measured in three areas: baseline knowledge of general HIV/AIDS-related information was good at 87%, whereas knowledge scores relating to ARV-related information (60%) and side-effects (52%) were lower. These scores improved significantly in the experimental group over the 4 interviews during the 6 month trial duration, whereas in the control group, they fluctuated only slightly around the original baseline score. There was no significant influence of gender on knowledge score, whereas health literacy, education level and age tested (at one and three months) had a significant influence on knowledge. Self-efficacy and adherence results were high, indicating that the patients have confidence in their ability to adhere to the ARV therapy and to practice optimal self-care. Age, gender and education, in most cases, significantly influenced self-efficacy, but were found to have no effect on adherence. The CD4 count improved over the trial duration which may have been influenced by a number of factors, including better knowledge of ARVs and improved adherence. No significant parametric correlation was found between knowledge score and change in CD4 count, however, Spearman's rho showed significance (rs=0.498; p=0.022). Both patients and healthcare providers were highly enthusiastic about the illustrated labels and PILs, and indicated their desire for such materials to be routinely available to public sector HIV/AIDS patients. The isiXhosa version of the PIL was preferred by all the patients. These simple, easy-to-read leaflets and illustrated medication labels were shown to increase understanding and knowledge of ARVs and HIV/AIDS in low-literate patients, and their availability in the first-language of the patients was central to making them a highly useful information source.
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- Date Issued: 2012
Implementation of a standardised insulin protocol in a tertiary level referral hospital
- Authors: Smith, Charné
- Date: 2012
- Subjects: Diabetics -- Treatment -- South Africa Insulin -- Patients -- South Africa , Drugs -- Dosage forms Diabetics -- Care -- South Africa
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: http://hdl.handle.net/10948/18387 , vital:28632
- Description: In severely ill hospitalised patients with diabetes mellitus (type 1 and type 2) there is an increase in metabolic rate. Insulin requirements are increased and glycaemic control becomes more difficult to achieve. The insulin sliding-scale is a form of „top up‟ therapy used to supplement the patients existing hypoglycaemic medication. In 2002, research at Livingstone Hospital found that 14 different sliding scales were used in 38 patients (Du Plessis, 2002: 79). In 2006 the nurses and doctors working in the general medical wards at Livingstone Hospital indicated that they were willing to use a standardised insulin sliding scale protocol (Smith, 2006: 56). Thus the aim of this study was to assess whether a standardised insulin protocol can be effectively implemented. The objectives of the study were to: 1) assess insulin usage via insulin sliding scales prior to the implementation of the standardised insulin protocol; 2) implement the standardised insulin protocol; and 3) reassess insulin usage after the implementation of the standardised insulin protocol. As the study involved evaluating the use of insulin via the insulin sliding scale and the implemented insulin protocol, it occurred in four phases. The preliminary phase entailed obtaining ethical approval. The pre-intervention phase included data collection in the form of a nursing questionnaire and the auditing of patient medical records using a data collection tool. The intervention phase involved education sessions on the new insulin protocol for the nursing staff, and the implementation of a standardised insulin protocol, while the post-intervention phase comprised of post-intervention data collection, which included a nursing questionnaire, a prescribers questionnaire and the auditing of patient medical records using a data collection tool. The overall impression obtained from the comparison between the pre- and post-intervention nursing questionnaire was conflicting; in some aspects the educational intervention was successful in others not. Regardless the indication obtained was that the nursing staff require more in-service training on a more regular basis as a lack of knowledge regarding diabetes mellitus as a disease state may negatively affect patient outcomes. The overall response from the nursing staff towards the insulin protocol was positive. The prescribers‟ response to the insulin protocol was conflicted. The number of correct insulin sliding scale doses administered in the pre-intervention and post intervention phase improved by 5.25 percent. The number of incorrect insulin sliding scale doses administered during the pre- and post -intervention phase decreased by 5.25 percent. These results are positive and may be due to fewer sliding scales being prescribed in the post-intervention phase and the implemented insulin protocol. Only three (5.55%; n=54) inpatients with Type 1 diabetes mellitus were placed on the implemented protocol that is, the basal bolus regime, and rarely were dose adjustments to their insulin made rendering the effectives of the protocol undesirable. Only four (7.40%; n=54) inpatients with Type 2 diabetes mellitus were placed on the implemented protocol that is, an intermediate- to long-acting insulin (Protophane®). However all four patients experienced immediate improvements in their fasting blood glucose levels. These results indicated that by adding an intermediate- to long-acting insulin (Protophane®) to the therapy of a patient with Type 2 diabetes mellitus fasting blood glucose levels decrease. This would improve patient outcomes and decrease the risk of related diabetic complications. These limited results may indicate a clinical inertia on the part of the prescribers. Unfortunately overall the educational intervention was not successful and the implementation of the protocol was not successful and did not yield the desired results.
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- Date Issued: 2012
Treatment of Parkinson's disease in South Africa and investigation of risk factors causing dyskinesias
- Authors: Gaida, Razia
- Date: 2012
- Subjects: Movement disorders , Parkinson's disease , Drugs
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: vital:10159 , http://hdl.handle.net/10948/d1012466 , Movement disorders , Parkinson's disease , Drugs
- Description: Background: Levodopa is still thought of as the 'gold standard' symptomatic treatment for Parkinson’s disease. However, after four to five years of treatment, levodopa efficacy tends to decline even if there was a good initial therapeutic response. The ideal treatment of Parkinson’s disease is a much debated issue with a range of guidelines available. Objectives: This study was undertaken to analyse medication use and prescribing patterns as well as to determine the risk factors involved in causing dyskinesias in Parkinson’s sufferers. Methods: The study consisted of two parts, namely a drug utilisation review (DUR) and a questionnaire survey. There were 25 523 antiparkinsonian records consisting of 5 168 patients for the year 2010. The questionnaires were verbally administered to patients diagnosed with Parkinson’s disease. A total of 43 patients were interviewed. Results: The average age of the population was 70.74±10.37 years, with the oldest patient being 100 years. Females constituted 59.17percent (5 168: n = 3 058) of the total number of patients. The most common antiparkinsonian products dispensed were combination drugs containing levodopa with a decarboxylase inhibitor and some with a COMT-inhibitor as well (46.5percent; n = 11 875). Males represented 53.49percent (43: n = 23) of the patients included in the questionnaire survey. A review of the medical records showed that patients with dyskinesias were diagnosed with Parkinson’s disease at a younger age and had experienced longer disease duration. Conclusion: Parkinson’s disease is an under-recognised condition in South Africa. Treatment needs to be individualised and based on evidence-based guidelines. Further studies in South Africa, as well as SSA (sub-Saharan Africa), need to be conducted on both the prevalence as well as the treatment of Parkinson’s disease.
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- Date Issued: 2012
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