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Introduction: The main pharmacovigilance system in the United Kingdom is the ‘Yellow Card’ spontaneous reporting system which suffers from low reporting rate, and long lag time between drug launch and ADR recognition. Aim: The aim of this study is to develop a pharmacovigilance system to permit the early detection of adverse drug reactions using routinely acquired NHS health data with minimal cost and resources. Methods: There are 2 methods for this study; Phase 1: The extraction of drug persistence data from routinely acquired NHS health data, and Phase 2: Identifying the exact reason(s) for patient discontinuation of drug therapy within 6 months of the index prescription. Results: Phase1: During the study period 4243 patients were initiated on ramipril, 8849 patients on simvastatin, 3242 patients on ARBs, 3646 patients on amlodipine and 269 patients on lercanidipine. The 1, 2-3 and 4-6 month discontinuation rates were 9.9%, 4.9% and 4.2% respectively for ramipril, 9.5%, 3.4% and 3.2% for simvastatin, 8.7%, 2.9% and 2.5% for ARBs, 16.2%, 6.3% and 4.8% for amlodipine, and 17.8%, 3.7% and 3.7% for lercanidipine. Drug discontinuation rates determined agree closely with published data from trials and post marketing surveys in terms of the peak time at which ADRs and discontinuations occur (1 month), the populations most frequently affected (females and the young or elderly depending on drug), and the relationship between the frequency of ADRs and discontinuations relative to the drug of interest, especially for antihypertensive (CCBs>ACEIs>ARBs). Phase 2: Six (20%) of 30 participating primary care practices, contributing to the PTI database, agreed to be approached directly. Completed data was returned for 98% of patients whom discontinued amlodipine due to a specific ADR. Conclusions: Drug discontinuation rates obtained from health care databases is a good surrogate for ADR/E rates. Specific reasons for discontinuation, such as adverse drug reactions, can be identified directly from such electronic databases or more effectively from the primary care medical records held in primary care practices.

Class of 2009 Abstract / OBJECTIVES: To explore the viewpoints of physicians, pharmacists, and other healthcare professionals on the creation of a behind- the-counter class of drugs. METHODS: This was a descriptive study of testimony contained in public hearings that were held by the FDA regarding behind-the- counter availability of certain medications. A data collection form was created to classify the testimony into categories according to the list comprised of 14 general issues, 11 logistical issues, and 11 miscellaneous issues. Testifiers were divided into three groups: medical, pharmacy, and health care related. Testimonies were analyzed for issues addressed by each speaker and marked pro, con, or neutral next to the corresponding issue. Frequencies and percentages were derived from the count data and groups were compared using a Yate’s Chi-square test. RESULTS: The medical, pharmacy, and health care related groups had a significantly different number of responses (p<0.001). The responses of the medical testifiers were significantly more opposed to a BTC class than the pharmacy testifiers (p<0.001). The pharmacy testimony was also significantly more in favor of a BTC class compared to the health care related groups testimony (p=0.014). The medical testimony was not significantly different from the health care related testimony (p=0.064). CONCLUSIONS: Pharmacists supported and physicians opposed the creation of a BTC class of drugs. Other healthcare related professionals had mixed opinions as a group.

Introduction: In 2001, the Universal Coverage (UC) policy was introduced in Thailand. This policy aimed to provide equal access to health care regardless of socioeconomic status. There are now three different health care schemes serving Thai people including the Civil Servant Medical Benefit Scheme (CSMBS), the Social Security Scheme (SSS), and the UC Scheme. Soon after the introduction of the UC there was evidence of health inequalities among beneficiaries of different schemes. The purpose of this thesis is to explore the utilisation patterns of drugs and quality of prescribing across the different health insurance schemes in order to investigate whether there are any differences or inequalities in access to health care for people covered by the different schemes. Aims: 1. Investigate whether routinely collected data held by Thai hospitals can be used to examine the drug utilisation patterns and quality of prescribing. 2. Investigate the published criteria for assessment of prescribing quality and its applicability to apply to the Thai datasets. 3. Explore the patterns of drug utilisation for patients under the different health insurance schemes. 4. Determine the extent of potentially inappropriate prescribing across the different health insurance schemes. 5. Explore the UC patients' opinions of quality of health care and prescribing. Methods: The programme of work was grouped into two main studies: i) drug utilisation study; and ii) prescribing quality study. There are six sub studies which contribute to address the study aims. A national survey of routinely collected data held in Thai hospitals was conducted to gain information of the types of data collected and types of operating software employed. Also, the survey was used as a way to engage with hospitals to ask if they would be interested in participating in the main drug utilisation study. The drug utilisation study is the main study in this programme of work with aim to illustrate patterns of drug utilisation across the different health insurance schemes and trends of drug use in the years since the introduction of the UC. Drug use in patients with diabetes and hypertension were selected as a sample to show the utilisation of drug across the schemes. A purposive sample of four hospitals was selected with respect to geographical location (north, south, north east, and central) and hospital type (regional and general) and informed by a previous national survey. Separate drug utilisation studies were undertaken at each hospital for the fiscal year 2008 using routinely acquired data. A detailed analysis was undertaken for a subsample of patients with diabetes and hypertension. The Anatomical Therapeutic Chemical classification and the Defined Daily Dose (ATC/DDD) system were used to categorise and to quantify volume of drug prescribed. The findings from the four studies were then meta-analysed to provide additional information to give more insight about the national drug utilisation and comparison across the schemes. The meta-analysis was done for only year 2008 data, seven years after the introduction of the UC. The systematic review was undertaken to provide information of the published criteria for assessing quality of prescribing on theirs development, reliability and validity, applicability, association with health-related outcomes, as well as to identified published criteria to be applied to Thai electronic datasets. The relevant drugs were selected from the drug-to-avoid list from the most widely recognised criteria, to determine the extent of potentially inappropriate drug use in patients with diabetes and hypertension who aged 65 and older. The comparison between the schemes were analysed using the year 2008 data the seventh year after the UC introduction to provide additional information for the drug utilisation study. The qualitative interview study was considered to gain more in-depth understanding about UC patients' views on quality of health care and prescribing. Patients with diabetes or hypertension were included in the interview. The thematic framework approach was applied. This study provides additional information on patients' perspectives and clearer insight on access to health care and equality which is the ultimate goal of this thesis. Results: The findings from the national survey revealed that dispensing data and patient data were routinely collected in electronic format in all hospitals. Dispensing and patient databases could be linked in most hospitals. There were 20 different software used for computerised hospital information systems. Fifty four percent of hospitals indicated their interest in participating in the study of drug utilisation. The results of the drug utilisation study identified that the number of outpatient visits increased during the period, whilst the number of inpatient hospitalisations rose moderately. Female and older people were more likely to make hospital visits than male and younger people. People under the CSMBS were more likely to visit outpatient services at the hospital than those under the UC and SSS, whilst the UC people appear to have higher admission rates than that of the CSMBS. The mean cost of all drugs prescribed per patient per year for the CSMBS was the highest, while the mean drug cost per patient per year for the SSS and the UC was similar. The mean drug costs per patient per year for patients with diabetes and hypertension show similar patterns to general population; with a substantial increase in drug cost for the CSMBS and a slight increase for the SSS and the UC. The mean DDDs of dispensed antidiabetic drug per diabetic patient per year for the different schemes after adjustment were not significantly different throughout the year. Similarly, the DDDs of dispensed cardiovascular drugs for patients with hypertension under the three schemes were not significantly different during the period. The CSMBS patients were more likely to be prescribed the newer and expensive drugs such as glitazones, atorvastatin, and ARB, with very small amounts of those prescribed to patients under the SSS and UC. The SSS and the UC patients were more likely to receive older and cheaper drugs such as glibenclamide and beta blockers. The findings from meta-analysis of summary findings from four hospitals have confirmed the drug utilisation study. These findings suggest that variation in drug utilisation across the three schemes exist. The systematic review identified published criteria for assessing quality of prescribing. The Beers criteria have been proved valid through many consensus studies, and widely adopted in many countries and settings. The criteria also have been applied with electronic data in many studies. The STOPP criteria have been proved reliable and valid. The STOPP criteria also have used up-to-date evidence in the criteria development. The extent of potentially inappropriate drug use in people aged 65 and older identified according the published drug-to-avoid lists from the Beers and the STOPP criteria varied across the hospitals. The main problematic drug prescribed to elderly patients was glibenclamide ranging from 2.1%-6.1% of elderly people. The CSMBS patients were less often prescribed drugs to avoid than UC and SSS patients. Female, older, and patients with more hospital visits were more likely to receive the problematic drugs. Twenty nine patients were interviewed. The majority of participants was female, aged over 60 years old, had elementary school education, and worked in agricultural roles. Most interviewees felt the doctors treated them well, and they had great confidence in their doctors. They felt that the treatment they received was of high quality. They also believed that their prescribed medications were good and would control their diseases. Most participants perceived that the UC had reduced the financial burden of health care for them and led to an increase in accessible health care. They also believed that they received similar treatment and services compared to those who were under the alternative schemes. Only those participants with a higher socioeconomic status were dissatisfied with the service and medications under the UC and believed that it was worse than the services under the other schemes. Conclusion: The thesis has demonstrated the existence of inequalities in drug utilisation and prevalence of inappropriate drug use across health insurance schemes after the introduction of UC. The CSMBS members are the better-off with the highest drug cost and are more likely to receive the high-cost drugs. The drug utilisation and prevalence of potentially inappropriate drug use are similar for the UC and the SSS. A more indepth study to examine clinical outcomes of the differences in drug selection under different schemes should be conducted in the future. On another side, generally, people under the UC expressed their satisfaction with the quality of health care and prescribing. The hospitals and the doctors were reliable, responsive, and trustworthy. Policy or programmes at both hospital and national level in order to address the variation in drug prescribing should be implemented.

MSc(Med. Pharmaceutical Affairs), Faculty of Health Sciences, University of the Witwatersrand, 2009

A research report submitted to the Faculty of Health Sciences, University of the Witwatersrand, in fulfillment of the requirements for the degree of Master of Science in Medicine in Pharmaceutical Affairs Johannesburg, South Africa 2017 / In the Republic of South Africa codeine containing medicines are either sold as prescription only medicines or over the counter depending on the strength of codeine contained in the medicine. The analgesic properties of codeine are thought to be derived from the conversion of codeine to morphine. Codeine is often combined with nonsteroidal anti-inflammatory drugs (NSAIDs).Codeine is a relatively weak opioid analgesic that has seemingly addictive properties; the misuse of codeine-containing-medicines can cause morbidity in patients with known codeine addiction. The Regulation of codeine has been reviewed in a number of countries to try and curb the misuse of the product. This involves the reduction in the strength of codeine, reduction in the package size and duration of treatment of over-the-counter (OTC) codeine containing products and in some countries the OTC codeine containing products have been rescheduled into prescription only medicines. The study aims to monitor and describe trends in the sales of OTC codeine-containing medicines from Pick n Pay retail pharmacies in Gauteng, Western Cape and KwaZulu Natal provinces of South Africa from July 2011 to June 2014. Secondary data on the sales of OTC codeine-containing medicines from Pick n Pay Pharmacies database was obtained, which described the(1) pharmacy name, (2) the trade name of the medicine items sold, (3) the quantities of the medicines sold, (4) the purchase date of medicine, (5) the cost of the medicine, (6) the age of the purchaser, (7) the gender of the purchaser and (8) the mode of payment used when purchasing for the study period. A statistical software system, SPSS® version 20 was used to analyse the data. The study findings indicate a steady increase in the sales of the OTC codeine containing medicine over the years. Females were found to be the main purchasers of these products and the age group which purchased most of the products is the 40 to 45 years age group. The top three selling brands of the OTC codeine containing medicines were found to be Genpayne Capsules (30%), Myprodol Capsules (27%) and Mybuline Tablets (14%) of all the sales of these products in the three provinces combined. The mode of payment used for these purchases was mainly cash payment which accounted for sixty-five percent of the payments. There is a need to review the Codeine Car Initiative to monitor and audit the sales of these products so as to make an informed decision on their appropriate regulation. / MT2017