https://www.um.edu.mt/library/oar/handle/123456789/32024 2026-04-09T00:30:17Z 2026-04-09T00:30:17Z https://www.um.edu.mt/library/oar/handle/123456789/101282 2022-08-31T09:38:26Z 2003-01-01T00:00:00Z

Title: The price of medicines Abstract: Amongst the problems that challenge severely advances in health delivery is the question of finance. How much money should be allocated to health? And how much of this money should be earmarked for medicines? And finally, why carry out studies in pharmacoeconomics, and why study pharmacoeconomics? These questions are addressed in this work. Although one cannot expect to ever have definite answers to all of them it is hoped that this work will highlight some of the issues and suggest ways to address them. Issues considered range from aspects such as the balance between disposable income and the cost of healthcare through popular, industrial, governmental or institutional perceptions to consideration of fundamental principles such as human rights and the instinct for self-preservation. Factors impinging on healthcare, especially the cost of medicines, in relation to the three fundamental dimensions of healthcare, that is clinical, economic and humanistic, were also examined. "What is pharmacoeconomics" was the first question posed and to which an answer was sought. Equitable access to adequate healthcare and other principles were discussed using case examples such as a British pharmacist's expe1ience in delive1ing pharmaceutical care in Uganda. An attempt was also made to examine those factors which are taken in consideration by a manufacturing firm when it is about to fix a price for the launch of a new product into a particular market, the pharmaeconomic aspects of new therapeutic agents, such as patent life, and different treatment regimens. In order to put this in perspective, the rise of the pharmaceutical Industry, the development of generic products, the regulatory activities in the drugs market, the introduction of the single European currency, rates of exchange and ways to compare costs of drugs were examined. Factors that contribute to the cost of medicines that were considered included expected market share, availability and costs of raw materials, novelty of treatment class and of pharmaceutical dosage forms, prevalence of therapeutic indications as well as prices of competing products, including that of genetics. Aspects influencing costs such as the position of orphan drugs, sources of new therapies, costs of different treatment regimens, cost effectiveness and cost of controls were all considered in the light of sensitivity regarding one's state of health. Various scandals reported in the media are referred to and their impact on the public image of the pharmaceutical industry is considered. Examples included the monochloroacetic acid conspiracy case, the Bausch and Lomb contact lens incident, vitamin price fixing and the Poggiolini affair. The real needs as well as the exaggerated claims of the industry the costs of research and development are discussed. The impact and cost contribution of advertising, prescription versus non-prescription medication, the influence of the patient's quality of life efficacy and safety, ethical or generic presentation, distribution costs (including pharmacist services), the demand for the highest quality in medicine and the lack of transparency in p1icing were considered. Illogical real price, such as in the case of viagra and the presentation of the same pharmaceutical at enormously different prices (sometimes even those produced by the same manufacturer and marketed under different names), is used to point out the need for some standard in pricing. Gold is proposed as a possible universal standard to determine and compare prices of medicinals in terms of the equivalent weight of gold, prices so stated being easily converted to the various local currencies and enabling direct comparison of the price of the item in different countries. The subject of intellectual property rights as applied in the case of medicines leads to a consideration of the other side of the coin in defense of the industry by highlighting the significant costs incurred by the industry necessitated by research and development and the fact that regulatory constraints make patent life even shorter. Taxation such as VAT, applied in some countries but not in others lead to different prices which cannot be fairly laid at the door of the industry. Marketing departments, of pharmaceutical manufacturers in particular, do face problems in fixing prices according to affordability in various countries, leading to further problems through parallel importation and re-importing of drugs. In conclusion, a number of examples are used to demonstrate the problems arising from the cost of medicines, pointing out the need for pharmacoeconomic studies, notwithstanding their deficiencies, and giving reasons and concrete examples to support the argument for the teaching of pharmacoeconomics in a rational way without necessarily adding another subject to an already exhaustive curriculum of a pharmacy course. A number of projects carried out under supervision at the Department of Pharmacy of the University of Malta on various aspects of pharmacoeconomics ranging from the contribution and limitations of formularies to the cost effectiveness of glucose measuring machines, use of statins or treatment of acne as well as a summary of useful indicative data obtained from such studies conclude the case for pharmacoeconomic studies in determining the cost of medicines. Description: PharmD

2003-01-01T00:00:00Z https://www.um.edu.mt/library/oar/handle/123456789/100952 2022-08-31T07:03:11Z 1998-01-01T00:00:00Z

Title: Development and application of validation methods for community pharmacy Abstract: The concept of validation, which is today an essential procedure in the area of chemical analysis, was applied to the area of pharmacy practice. The aim of this research study was to develop validation tools which can be used by community pharmacists to monitor the standards of services provided and to measure the impact of the intervention of the pharmacist in a community setting. The validation process is divided into two parts namely the internal validation study where measurement of standards is undertaken from within the profession and the external validation study where measurement of standards is carried out by consumers and by non-pharmacist members of the health-care team. In order to develop internal validation tools, background studies were carried out to identify professional services for which measurement instruments had to be developed. The background studies consisted of a baseline study and of a field observation study. In the baseline study, data on the services provided from community pharmacies were collected from private community pharmacies (n=184) through a personal visit to all private community pharmacies in Malta (n=189). The field observation study was carried out in 10 community pharmacies selected using stratified random sampling. The investigator visited each pharmacy and in total 1800 minutes of pharmacist time were observed. Using the data obtained in the field observation study the Quantitative Community Pharmacy Model was developed from which the internal validation tools to be established were elicited. Five internal validation tools were developed namely The Setting of the Community Pharmacy, Dispensing a Prescription, Responding to Symptoms, Communicating with the Patient and Equipment and Professional Services available in a Community Pharmacy. Local systems and established international guidelines were used to identify indicators of good pharmacy practice which in tum were used to develop the tools. Face and content validity of the internal validation tools were assessed by setting up a group of expert judges with mixed expertise. Inter- observer reliability of the five internal validation tools was assessed. The five internal validation tools were applied by the investigator and another rater in the ten community pharmacies which were randomly selected for the field observation study. Factor analysis was carried out using Biomedical Data Package software version 7.0. Face and content validity of the five internal validation tools were found to be strong. The correlation coefficient for the overall score obtained by the two raters for each tool was high (rs >0.70) indicating consistency of scoring of the tools by different raters. Internal consistency was high (Cronbach's alpha >0.80) for the five internal validation tools. For the external validation process, two external validation tools were developed, namely the Consumer Services Tool directed at consumers and the Health Professionals Tool directed at non-pharmacist members of the health-care team. Face and content validity of the external validation tools were assessed using the same expert judges involved with the review of the five internal validation tools. The test-retest method was adopted to assess the reliability of the two external validation tools. The Biomedical Data Package Software version 7.0 was used to carry out factor analysis. Face and content validity of the two external validation tools were found to be strong. The correlation coefficient for the overall score for test 1 and 2 for each tool was high (rs >0.95) indicating reliability of the two tools. Internal consistency was found to be high (Cronbach's alpha >0.95) for both external validation tools. A standardised protocol for the implementation of the process of validation of community pharmacy was prepared. A pilot test was carried out in 50 community pharmacies selected using stratified random sampling. Areas where these pharmacies need to upgrade the professional services provided were identified. The study revealed that consumers had a good perception of the community pharmacist and that they are satisfied with the services provided while non-pharmacist members of the health-care team were aware of the need to improve professional services provided by the community pharmacist. This research project led to the development and to the psychometric evaluation of validation tools which can be used to monitor standards of professional services provided by the community pharmacist. The validation tools are intended to serve as benchmark procedures in different countries so that international harmonisation of instruments used to measure the effectiveness of the pharmacist in a community setting is achieved. Description: PharmD

1998-01-01T00:00:00Z https://www.um.edu.mt/library/oar/handle/123456789/32084 2021-02-18T10:37:59Z 1998-01-01T00:00:00Z

Title: Development and application of validation methods for community pharmacy Abstract: The concept of validation, which is today an essential procedure in the area of chemical analysis, was applied to the area of pharmacy practice. The aim of this research study was to develop validation tools which can be used by community pharmacists to monitor the standards of services provided and to measure the impact of the intervention of the pharmacist in a community setting. The validation process is divided into two parts namely the internal validation study where measurement of standards is undertaken from within the profession and the external validation study where measurement of standards is carried out by consumers and by non-pharmacist members of the health-care team. In order to develop internal validation tools, background studies were carried out to identify professional services for which measurement instruments had to be developed. The background studies consisted of a baseline study and of a field observation study. In the baseline study, data on the services provided from community pharmacies were collected from private community pharmacies (n=184) through a personal visit to all private community pharmacies in Malta (n=189). The field observation study was carried out in 10 community pharmacies selected using stratified random sampling. The investigator visited each pharmacy and in total 1800 minutes of pharmacist time were observed. Using the data obtained in the field observation study the Quantitative Community Pharmacy Model was developed from which the internal validation tools to be established were elicited. Five internal validation tools were developed namely The Setting of the Community Pharmacy, Dispensing a Prescription, Responding to Symptoms, Communicating with the Patient and Equipment and Professional Services available in a Community Pharmacy. Local systems and established international guidelines were used to identify indicators of good pharmacy practice which in turn were used to develop the tools. Face and content validity of the internal validation tools were assessed by setting up a group of explicit judges with mixed expertise. Inter-observer reliability of the five internal validation tools was assessed. The five internal validation tools were applied by the investigator and another rater in the community pharmacies which were randomly selected for the field observation study. Factor analysis was carried out using Biomedical Data Package software version 7.0. Face and content validity of the five internal validation tools were found to be strong. The correlation coefficient for the overall score obtained by the two raters for each tool was high (rs >0.70) indicating consistency of scoring of the tools by different raters. Internal consistency was high (Cronbach's alpha >0.80) for the five internal validation tools. For the external validation process, two external validation tools were developed, namely the Consumer Services Tool directed at consumers and the Health Professionals Tool directed at non-pharmacist members of the health-care team. Face and content validity of the external validation tools were assessed using the same expert judges involved with the review of the five internal validation tools. The test-retest method was adopted to assess the reliability of the two external validation tools. The Biomedical Data Package Software version 7.0 was used to carry out factor analysis. Face and content validity of the two external validation tools were found to be strong. The correlation coefficient for the overall score for test 1 and 2 for each tool was high (rs >0.95) indicating reliability of the two tools. Internal consistency was found to be high (Cronbach's alpha >0.95) for both external validation tools. A standardised protocol for the implementation of the process of validation of community pharmacy was prepared. A pilot test was carried out in 50 community pharmacies selected using stratified random sampling. Areas where these pharmacies need to upgrade the professional services provided were identified. The study revealed that consumers had a good perception of the community pharmacist and that they are satisfied with the services provided while non-pharmacist members of the health-care team were aware of the need to improve professional services provided by the community pharmacist. This research project led to the development and to the psychometric evaluation of validation tools which can be used to monitor standards of professional services provided by the community pharmacist. The validation tools are intended to serve as benchmark procedures in different countries so that international harmonisation of instruments used to measure the effectiveness of the pharmacist in a community setting is achieved. Description: PharmD

1998-01-01T00:00:00Z