Tesis sobre el tema "Pharmaceutical policy. Pharmacy"

Objective To describe common facilitators, challenges, and lessons learned in 5 schools and colleges of pharmacy in establishing community pharmacy research fellowships. Setting: Five schools and colleges of pharmacy in the United States. Practice description: Schools and colleges of pharmacy with existing community partnerships identified a need and ability to develop opportunities for pharmacists to engage in advanced research training. Practice innovation: Community pharmacy fellowships, each structured as 2 years long and in combination with graduate coursework, have been established at the University of Pittsburgh, Purdue University, East Tennessee State University, University of North Carolina at Chapel Hill, and The Ohio State University. Evaluation: Program directors from each of the 5 community pharmacy research fellowships identified common themes pertaining to program structure, outcomes, and lessons learned to assist others planning similar programs. Results: Common characteristics across the programs include length of training, prerequisites, graduate coursework, mentoring structure, and immersion into a pharmacist patient care practice. Common facilitators have been the existence of strong community pharmacy partnerships, creating a fellowship advisory team, and networking. A common challenge has been recruitment, with many programs experiencing at least one year without filling the fellowship position. All program graduates (n = 4) have been successful in securing pharmacy faculty positions. Conclusion: Five schools and colleges of pharmacy share similar experiences in implementing community pharmacy research fellowships. Early outcomes show promise for this training pathway in growing future pharmacist-scientists focused on community pharmacy practice.

Medical Academia Conflict of Interest Policy and Potential Impact on Research Funding by Michael K. Maahs MPA, Troy University, 1993 BA, Ripon College, 1990 Dissertation Submitted in Partial Fulfillment of the Requirements for the Degree of Doctor of Philosophy Public Policy and Administration Walden University July 2015 The partnership between medical academia and the pharmaceutical industry has been scrutinized for issues associated with research bias. As a result of this scrutiny, the Institute of Medicine (IOM) issued policy recommendations in 2009 directing academia to adopt comprehensive conflict of interest (COI) policies. During the same time, a slowdown of funded research into academia occurred, and it is not clear whether the IOM recommendations contributed to this problem. The purpose of this case study was to determine the extent to which compliance with the IOM policy resulted in a reduction in funded research. The Advocacy Coalition Framework (ACF) was the theoretical lens used for study. COI policy statements (n = 15) were analyzed from American Association of Medical Colleges member schools that engage in medical research. In addition, in-depth interviews were conducted with 4 medical academic researchers. Data were inductively coded and organized around key themes. Key findings indicated that medical academia is compliant with IOM recommendations and COI policies did not appear to have a direct effect on research placement by industry. Interestingly, a possible explanation for reductions in industry funding relate to inefficient institutional review board processes. Additionally, the ACF construct was validated via an observed complex and slowly evolving COI policy process. The positive social change implications of this study include recommendations to academia to continue to monitor and report on COI and explore efficiency improvements related to IRB oversight in order to support important pharmaceutical research that ultimately improves the health and wellbeing of people.

Objective: To compare community pharmacists' self-perceived communication confidence in prescription drug abuse and addiction (PDAA)-related scenarios to their self-confidence in other scenarios. Methods: An 18-item survey instrument adapted from the Self-Perceived Communication Competence instrument was administered to 2000 licensed Tennessee community pharmacists. Items elicited communication confidence across common community pharmacy scenarios. Analysis of communication self-confidence scores across context, receiver, audience, and demographic variables was conducted. Results: Mean self-confidence ratings ranged from 54.2 to 92.6 (0-100 scale). Self-perceived communication confidence varied across context, receiver, audience, personal and practice setting characteristics. Scenarios that involved PDAA communication with patients were scored significantly lower than non-PDAA patient scenarios (mean = 84.2 vs. 90.4, p Conclusion: Community pharmacists are less confident in their ability to communicate with patients about PDAA as compared to non-PDAA scenarios. Practice Implications: Engaging patients and prescribers in PDAA conversations is a critical component of preventing and treating PDAA. Research is warranted to further explore measures of situational communication self-confidence and interventions to optimize self-confidence beliefs across PDAA scenarios.

Elderly patients with chronic obstructive pulmonary disease may be at increased risk of exacerbation due to physical and cognitive deficits that make proper inhaled medication adherence more difficult despite consistent medication access. This retrospective study utilized administrative medical and pharmacy claims data to examine the likelihood of having a COPD exacerbation requiring acute medical care by means of an emergency room visit or hospitalization in elderly patients receiving maintenance COPD medications from mail order and retail pharmacies. It was hypothesized that mail order patients would be more likely to experience exacerbations despite differences in medication access when compared to retail patients. The primary outcome of interest was exacerbation frequency expressed as the incidence density rate, and the secondary outcome was the proportion of days covered (PDC). The incidence rate ratio for acute exacerbations was not significantly different for mail order and retail groups, indicating patients using mail-order pharmacies were not significantly more likely to experience an exacerbation requiring acute medical care. Despite insignificant differences in incidence rates, mail order patients had significantly higher adherence rates.

Consumers have begun to take a more proactive approach to their healthcare by accessing pharmaceutical companies Websites to obtain health and drug information, support groups, rebates, coupons, as well as free drug trials. In exchange for these benefits, companies require consumers to voluntarily disclose information. However, research has shown that consumers continue to be concerned about how their information is managed, used, and distributed by companies, especially if accessed via the Web. To date, there has been limited empirical research to examine the actual online practices of companies when it comes to privacy, especially those of pharmaceutical companies. Using Delphi expert panel process, the components of a benchmarking index were identified to examine the documented and actual online practices of 100 Website registrations with pharmaceutical companies. The evolution for the development of an index to measure the personal information privacy violations of pharmaceutical companies is presented. Second, empirical evidence is provided regarding the magnitude of voluntary adherence to the Fair Information Practices (FIPs) by pharmaceutical companies based upon the personal information privacy violations. The results revealed that companies with headquarters in Europe had fewer personal information privacy violations than those in Asia, UK, and the US. Moreover, the results indicate that fewer personal information privacy violations occur for chronic conditions than for non-chronic conditions, as well as fewer violations occur with Website registrations for updates than for discounts. Finally, both Europe and UK demonstrated more overall adherence to FIPs than the US and Asia. This suggests that self-regulation may not be sufficient, while more enforcement may be necessary to decrease personal information privacy violations.

This thesis aimed to elucidate the demographic characteristics associated with elevated or reduced rates of pneumococcal conjugate 13 (PCV13) vaccination. A retrospective cohort study was performed using the Truven Health MarketScan® Database. Three cohorts were created corresponding to populations for which the CDC recommends PCV13 vaccination. Cohort 1: children < 36 months of age. Cohort 2: adults 19-64 years of age with high infection risk. Cohort 3: adults > 65 years of age. Odds of having a PCV13 claim were calculated for each cohort. For Cohort 1, 78% out of a total of 353,214 subjects had a sufficient number of PCV13 doses to meet CDC recommendations. For Cohort 2, 3.7% out of a total of 673,157 subjects had a PCV13 claim. For Cohort 3, 18% of 1,262,531 subjects had a PCV13 claim. Odds of vaccination were generally lower in younger subjects, those with fewer outpatient claims, and those with residence in the Northeast and South regions. In Cohort 2, odds were reduced in subjects with generalized malignancy. Gender and urban residence were poor predictors of vaccination status. By understanding the demographic factors associated with lower rates of vaccination, clinicians may more effectively direct their efforts to increase pneumococcal vaccination coverage.

Background Maternal opioid use and neonatal abstinence syndrome (NAS) incidence have increased markedly in the US in recent years. Objectives (1) To assess prescribers’ and community pharmacists’ guideline-based NAS prevention behaviors; (2) to describe providers’ perceptions of contraceptive appropriateness in female patients of childbearing age. Method Cross-sectional study of 100 randomly selected primary care physicians, 100 prescribers authorized to engage in in-office treatment of opioid use disorders with buprenorphine, 100 pain management clinic directors, and 100 community pharmacists in Tennessee (N = 400 providers total) to evaluate self-reported engagement in 15 NAS prevention behaviors and perceived appropriateness of 8 contraceptive methods in opioid using women of childbearing age. Results An overall response rate of 17.5% was obtained. Pain clinic directors reported the most engagement in NAS prevention, engaging 80% or more of female patients of childbearing age prescribed an opioid in 11 prevention behaviors, followed by buprenorphine prescribers (8 behaviors), primary care physicians (5 behaviors), and community pharmacists (2 behaviors). Pain clinic directors, primary care physicians, and community pharmacists perceived oral contraceptive pills and patches to be as appropriate as long-acting, reversible forms of contraception (e.g., implants, injectable depots, intrauterine devices). Conclusion Provider engagement in behaviors that could prevent NAS is variable. Interventions should be implemented that equip providers to engage patients in conversations about long-acting, reversible contraception.

What is lobbying, properly understood, in the United States, and what strategies and tactics—including and especially those determined by contextual factors, as well as firm characteristics—are commonly employed by corporate lobbies as they operate in our American political environments? Considering this, what are the main strategies and tactics employed by the pharmaceutical lobby, with a particular focus on the Pharmaceutical Manufacturers and Researchers of America, or PhRMA? Finally, what roles did PhRMA play in the development and passage of the Obama administration’s Affordable Care Act, and what can this tell us about the lobbying strategies and tactics utilized by one of the most effective lobbies in modern times, as well as about how their strategies and tactics align, or not, with conventional conceptions of lobbying? Through effective use of key lobbying tactics such as direct lobbying and use of public awareness, PhRMA completed one of the more successful lobbying campaigns in recent history. When the White House came calling, they were first to the table, for they knew that with that seat came a position of leverage. From there, they were able to build both political and public support to complete a deal with the Obama administration that they positioned as necessary to keep the Affordable Care Act alive. This deal would ensure that the pharmaceutical industry would pay a flat rate of support for the act, and was therefore guaranteed protection from future government attempts to set or regulate the prices of their products and medicines. PhRMA played the long game, and they played it well.

The decision for adjuvant therapy in women with early stage breast cancer (ESBC) has historically been guided by the presence or absence of specific biological markers (hormone and HER2 receptors), age, and extent of nodal involvement. Oncotype DX® is a validated assay that quantifies protein expression that can predict the risk of cancer recurrence. This study evaluates if the use of Oncotype DX® impacts chemotherapy prescribing in ESBC. This retrospective, cohort study identified patients with ESBC from a large commercially insured population from January 2007 through June 2009. Patients were identified as having ESBC by utilizing procedure and diagnosis codes to indicate that a sentinel lymph node biopsy had been performed. Hormone receptor status was verified by patients receiving at least one month of hormonal therapy including: tamoxifen, anastrozole, letrozole, or exemestane. Exclusion criteria will include patients less than 18 years of age, procedure codes indicating axillary lymph node dissection, or charges for trastuzumab. The administration of Oncotype DX® was not found to significantly affect a physician’s decision to prescribe chemotherapy. However, there were significant regional differences in Oncotype DX® utilization by region. Future studies should be conducted at a population level to determine the effects of Oncotype DX®.

Background Renal cell carcinoma (RCC) is the most common type of kidney cancer. Patients diagnosed with metastatic RCC (mRCC) have shorter overall survival compared to those diagnosed at earlier stages. Several targeted therapies, which cost from $7,000 - $16,000 per month have been approved since 2005 to treat mRCC. In addition, there is a growing interest in the use of cytoreductive nephrectomy (CN) with targeted therapies among mRCC patients. However, little is known regarding the economic burden of RCC and role of CN and prescribing patterns of targeted therapies among older mRCC patients. Objectives 1) To assess the economic burden of RCC among older adults in the targeted therapy era 2) To compare the overall survival (OS) and total healthcare cost (THC) among older mRCC patients receiving CN and targeted therapy versus patients receiving targeted therapy alone 3) To describe prescribing patterns of targeted therapies and associated OS and THC among older mRCC patients. Methods This dissertation was conducted using the Surveillance Epidemiology and End Results (SEER) - Medicare linked data. For the first objective, the study included a prevalent cohort of RCC patients from 2013, diagnosed during 2005 - 2013 and continuously enrolled in Medicare. RCC patients were matched to non-cancer beneficiaries using propensity score matching. Generalized linear models estimated the incremental healthcare costs. Incremental total healthcare cost (THC) was multiplied by the estimated number of RCC patients on Medicare to calculate the total economic burden of RCC. For the second objective, we included patients diagnosed with mRCC between 2007-2014 and compared overall survival (OS), and THC between patients who received CN + targeted therapy and targeted therapy alone. A propensity score based inverse probability of treatment weighting (IPTW) method was used to balance the two treatment groups. A Cox proportional hazard model assessed the risk for death and a GLM compared healthcare costs between the groups. For the third objective, patients with mRCC were defined as patients who were diagnosed at stage-IV or at earlier stages but were currently using targeted therapies. Further, we restricted our sample to patients who initiated targeted therapy. We described the frequencies of the most common first and second line targeted therapies. We also described OS and THC per month for clear-cell and non-clear cell mRCC for each therapy and line of therapy. Results The first study included 10,392 each of RCC and control patients. The average THC associated with RCC was $7,419. The average THC was $4,584 for patients diagnosed at stage-I, $4,727 for stage-II, $9,331 for stage-III, and $31,637 for stage-IV. The annual economic burden of RCC on Medicare was estimated to be $1.5 billion. The second study included 471 mRCC patients that received CN + targeted therapy or targeted therapy alone. The median OS from the adjusted survival curves was significantly higher (p Conclusions The economic burden of RCC varied substantially between early stage and metastatic patients. Among mRCC patients, use of CN among targeted therapy users was associated with a higher median OS and similar monthly THC over a lifetime. Sunitinib and everolimus were the most common first and second line targeted therapies among mRCC patients. The descriptive analysis suggested that OS and THC were similar across types of targeted therapy sequences.

QBEST, a novel statistical method, can be applied to the problem of estimating the No Observed Adverse Effect Level (NOAEL or QNOAEL) of a New Molecular Entity (NME) in order to anticipate a safe starting dose for beginning clinical trials. The NOAEL from QBEST (called the QNOAEL) can be calculated using multiple disparate studies in the literature and/or from the lab. The QNOAEL is similar in some ways to the Benchmark Dose Method (BMD) used widely in toxicological research, but is superior to the BMD in some ways. The QNOAEL simulation generates an intuitive curve that is comparable to the dose-response curve. The NOAEL of ellagic acid (EA) is calculated for clinical trials as a component therapeutic agent (in BSN476) for treating Chikungunya infections. Results are used in a simulation based on nonparametric cluster analysis methods to calculate confidence levels on the difference between the Effect and the No Effect studies. In order to evaluate the statistical power of the algorithm, simulated data clusters with known parameters are fed into the algorithm in a separate study, testing the algorithm’s accuracy and precision “Around the Compass Rose” at known coordinates along the circumference of a multidimensional data cluster. The specific aims of the proposed study are to evaluate the accuracy and precision of the QBEST Simulation and QNOAEL compared to the Benchmark Dose Method, and to calculate the QNOAEL of EA for BSN476 Drug Development.

Projeto de Pós-Graduação/Dissertação apresentado à Universidade Fernando Pessoa como parte dos requisitos para obtenção do grau de Mestre em Ciências Farmacêuticas
O agravamento da situação económica que Portugal tem sofrido nos últimos anos tem levado os sucessivos governos a implementar medidas de contenção da despesa nos diferentes setores que compõem o Estado. O setor da saúde não é exceção, tendo-se verificado sucessivos cortes nos últimos anos. Ao nível da farmácia comunitária, a realidade tem-se alterado profundamente. As sucessivas alterações legislativas que têm sido aprovadas desde o ano de 2005, não só vieram aumentar a concorrência no setor, com medidas como a liberalização da propriedade, a possibilidade de fazer descontos nos medicamentos e a venda de MNSRM fora das farmácias, como também vieram diminuir a rentabilidade das farmácias com as reduções sucessivas dos preços dos medicamentos e das suas margens de comercialização, a aplicação de margens regressivas em vez de margens fixas e o aumento de stock por imposição legal, entre outras medidas. Tais alterações fizeram com que o setor das farmácias atravesse agora uma grave crise económica e financeira, havendo mesmo farmácias a fechar. Como consequência, tem havido também uma redução da assistência às populações. Para responder a estas dificuldades, as farmácias e os farmacêuticos devem unir-se em torno de objetivos comuns, defendendo uma nova forma de pensar a farmácia, em que o atendimento ao doente ganha uma maior importância face à venda do medicamento. The worsening of the economic situation that Portugal has suffered in the last years has lead the successive governments to implement measures to curb spending in the different sectors that compose the state. The health sector is no exception, and in recent years there have been successive cuts. In what community pharmacy is concerned, reality has profoundly changed. The successive legislative amendments that have been approved since 2005, not only have increased competition in the sector, with measures such as property liberalization, the possibility of making discounts on drug sales and the sale of non-prescription drugs outside pharmacy, as they also decreased the profitability of pharmacies with successive reductions in drug prices and their sales margins, the application of regressive margins instead of fixed margins and the stock increase by legal imposition, between other measures. Such changes caused a severe economic and financial crisis in the community pharmacy sector, with pharmacies having to shut. As a consequence, there has also been a reduction in assistance to populations. To address these difficulties, the pharmacies and pharmacists should unite around common goals, advocating a new way of thinking the pharmacy, where the patient’s care gains greater importance when compared to the drug’s sale.

The U.S. Food and Drug Administration (FDA) uses the FDA Adverse Event Reporting System (FAERS) to monitor adverse events resulting from pharmaceutical drug use. However, this system has limitations such as not allowing real-time data collection. To address these limitations, the FDA launched the Sentinel Initiative in 2008. This comparative case study was conducted to describe perceptions of investigating the efficacy of the Sentinel Initiative compared with the FAERS. The study was based on the theory of preemption as it emphasized the need for efficient means for providing unquestionable proof that consumers suffered adverse drug effects. The sample included interivews of 20 individuals, who worked closely with the FAERS program and were familiar with the Sentinel Initiative. In-depth key-informant interviews had been conducted to determine the perceptions of the participants regarding the challenges and benefits of the Sentinel Initiative compared with FAERS. To analyze data, content analysis was used. The study concluded that the FAERS and Sentinel Initiative provided a systematic database, which included health data, that could be used to improve public health. Due to the FAERS and Sentinel Initiative, adverse effects of drugs will be recognized and the safety of the patients and the public will be prioritized. The findings of this study have potential social impact for positive change at the societal level, organizational level, and individual level in terms of overall safety of the drugs. Sentinel initiative at its present state complements the existing FAERS and leverage its benefits by connecting at a grass roots level patients to an organization level as well as stakeholders to make an impact in providing safer drugs on the market.

The Pharmaceutical Services are an integral part of the health system and it has in the drug a essential ingredient in the actions in the promotion, protection and recovery of health. Increased access of population to the health system have required changes in the distribution and financing of drugs in order to increase coverage and minimize costs. The present study aimed to evaluate the relationship between the Brazilian governmental financing and assurance the population's access to Drugs, Essential of the Component of Primary Pharmaceutical Care in the city of Aracaju. This is an observational descriptive study of an exploratory nature, the case study type, evaluating the period between the years 2008 and 2012. Work begins rescuing briefly the history of Pharmaceutical Services in the Brazilian Health System and its funding mechanisms in the process of decentralization of health. Proceeds to the analysis of semi -structured interviews conducted by the Pharmaceutical Care`s Municipal Manager, Management Annual Reports of the municipality , reports prepared by Municipal Pharmaceutical Assistance Management and of the deposits made to the account of the Fund allocated to the Municipal Health Component Basic pharmaceutical services and discusses the results. After evaluating the results, it was found that, for the study period, there was sufficient resources to serve all municipal demand for medication of this component, however, it could be seen that there was discontinuity in the supply and consequently, access to these drugs. It is therefore concluded that there was no relationship between sufficiency and ensuring access to Drugs,Essential in the city of Aracaju during the survey period.
A Assistência Farmacêutica é parte integrante do sistema de saúde e tem no medicamento, o insumo essencial em ações voltadas à promoção, proteção e recuperação da saúde. A ampliação do acesso da população ao sistema de saúde exigiu mudanças na distribuição e no financiamento de medicamentos, de maneira a aumentar a cobertura e minimizar os custos. O presente estudo se propôs a avaliar a relação entre o financiamento tripartite da Assistência Farmacêutica Básica e a garantia ao acesso da população aos medicamentos do Componente Básico da Assistência Farmacêutica no município de Aracaju. Tratase de um estudo observacional descritivo, de cunho exploratório, do tipo Estudo de Caso, avaliando o período compreendido entre os anos de 2008 e 2012. Iniciase o trabalho com um breve resgate da história da Assistência Farmacêutica no Brasil, seus mecanismos de financiamento e o processo de descentralização da saúde. Procede-se à análise das entrevistas semi-estruturadas realizadas junto ao gestor Municipal de Assistência Farmacêutica, dos Relatórios Anuais de Gestão do município, dos relatórios elaborados pela coordenação Municipal de Assistência Farmacêutica e dos depósitos realizados na conta do Fundo Municipal de Saúde destinada ao Componente Básico da Assistência Farmacêutica e discutem-se os resultados encontrados. Após avaliação dos resultados, verificou-se que, para o período da pesquisa, existiu suficiência de recursos para atender toda a demanda municipal por medicamentos desse componente, entretanto, pôde-se perceber que, houve descontinuidade no abastecimento e, consequentemente, no acesso a esses medicamentos. Concluise assim, que não existiu relação entre suficiência financeira e garantia de acesso a medicamentos do Componente Básico da Assistência Farmacêutica no município de Aracaju durante o período da pesquisa.

For patients afflicted with symptoms of anxiety and insomnia, benzodiazepines are generally a safe and effective short-term pharmacological treatment option. Although considered safer than other sedative-hypnotic medications, substantial concern exists regarding the addictive nature and abuse potential of benzodiazepines along with potentially inappropriate prescribing and utilization in clinically vulnerable populations. These medication misadventures can have a significant impact on public health. Examples of medication misadventures as they pertain to benzodiazepines include the prescribing and use in clinically vulnerable populations for whom they are contraindicated or their efficacy has not been evaluated, the development of tolerance or addiction, abuse of the medication, and the manifestation of negative health outcomes including cognitive impairment, withdrawal symptoms upon discontinuation, or the reoccurrence of a preexisting substance use disorder. In order to better understand medication misadventures associated with benzodiazepines retrospective analyses using populations extracted from large health claims databases are employed. To understand how benzodiazepine use may lead to adverse events causing patient harm, the risk of exacerbations in benzodiazepine users diagnosed with chronic obstructive pulmonary disease was estimated. The inherent risk of benzodiazepine addiction and abuse was estimated in an HIV-infected population, a population with a high prevalence of substance use disorders. This risk was estimated by first determining whether HIV-infected individuals are more likely to have any benzodiazepine use compared to their uninfected counterparts, and secondly, by examining the association between HIV-infection and potentially problematic benzodiazepine use. Finally, in an effort to mitigate unexpected and undesirable consequences to public health associated with the prescription drug abuse epidemic in the US, states have implemented prescription drug monitoring programs (PDMPs) to track the prescribing and dispensing of controlled substance medications. The effect of these programs on benzodiazepine dispensing is evaluated on a state and national level. Findings will provide healthcare professionals a better understanding regarding the risk of medication misadventures involving benzodiazepines when evaluating their appropriateness in patients with anxiety, depression, and insomnia. Additionally, policymakers will understand the implications of PDMPs on the dispensing of benzodiazepines as they become a more widely used tool to combat prescription drug abuse and diversion.

Nursing homes are an essential yet understudied provider of cancer-related care for those with complex health needs. Nine percent of nursing home residents have a cancer diagnosis at admission, and it is estimated that one-third of them experience pain on a daily basis. Although pain management is an essential component of disease treatment, few studies have evaluated analgesic medication use among adults with cancer in this setting. Use of opioids, which are the mainstay of pain management in older adults because of their effectiveness in controlling moderate to severe pain, may be significantly related to coverage by the Medicare Part D prescription drug benefit. However, little is known about Medicare Part D’s effects on opioid use in this patient population. A limited body of evidence also suggests that despite known risks of overdose and respiratory depression in opioid-naïve patients treated with long-acting opioids, use of these agents may be common in nursing homes. This dissertation examined access to appropriate and effective pain-related health care services among US nursing home residents, with a special focus on those with cancer. Objectives of this dissertation were to: 1) estimate the prevalence, and identify resident-level correlates, of pain and receipt of analgesic medications; 2) use a quasi-experimental research design to examine the relationship between implementation of Medicare Part D and changes in the use of fentanyl patches and other opioids; and 3) to estimate the prevalence, and identify resident-level correlates, of naïve initiation of long-acting opioids. Data on residents’ health status from the Resident Assessment Instrument/Minimum Data Set (versions 2.0 and 3.0) were linked with prescription drug transaction data from a nationwide long-term care pharmacy (January 2005–June 2007) and the Centers for Medicare and Medicaid Services (January–December 2011). From 2006 to 2007, more than 65% of residents of nursing homes throughout the US with cancer experienced pain (28.3% on a daily basis), among whom 13.5% reported severe pain. More than 17% of these residents who experienced daily pain received no analgesics (95% confidence interval [CI]: 16.0–19.1%), and treatment was negatively associated among those with advanced age, cognitive impairment, feeding tubes, and restraints. These findings coincided with changing patterns in opioid use among residents with cancer, including relatively abrupt 10% and 21% decreases in use of fentanyl patches and other strong opioids, respectively, after the 2006 implementation of Medicare Part D. In the years since Medicare Part D was introduced, some treatment practices in nursing homes have not been concordant with clinical guidelines for pain management among older adults. Among a contemporary population of long-stay nursing home residents with and without cancer, 10.0% (95% CI: 9.4–10.6%) of those who began receiving a long-acting opioid after nursing home admission had not previously received opioid therapy. Odds of naïve initiation of these potent opioids were increased among residents with terminal prognosis, functional impairment, feeding tubes, and cancer. This dissertation provides new evidence on pharmaceutical management of pain and on Medicare Part D’s impact on opioid use in nursing home residents. Results from this dissertation shed light on nursing home residents’ access to pain-related health care services and provide initial directions for targeted efforts to improve the quality of pain treatment in nursing homes.

Nursing homes are an essential yet understudied provider of cancer-related care for those with complex health needs. Nine percent of nursing home residents have a cancer diagnosis at admission, and it is estimated that one-third of them experience pain on a daily basis. Although pain management is an essential component of disease treatment, few studies have evaluated analgesic medication use among adults with cancer in this setting. Use of opioids, which are the mainstay of pain management in older adults because of their effectiveness in controlling moderate to severe pain, may be significantly related to coverage by the Medicare Part D prescription drug benefit. However, little is known about Medicare Part D’s effects on opioid use in this patient population. A limited body of evidence also suggests that despite known risks of overdose and respiratory depression in opioid-naïve patients treated with long-acting opioids, use of these agents may be common in nursing homes. This dissertation examined access to appropriate and effective pain-related health care services among US nursing home residents, with a special focus on those with cancer. Objectives of this dissertation were to: 1) estimate the prevalence, and identify resident-level correlates, of pain and receipt of analgesic medications; 2) use a quasi-experimental research design to examine the relationship between implementation of Medicare Part D and changes in the use of fentanyl patches and other opioids; and 3) to estimate the prevalence, and identify resident-level correlates, of naïve initiation of long-acting opioids. Data on residents’ health status from the Resident Assessment Instrument/Minimum Data Set (versions 2.0 and 3.0) were linked with prescription drug transaction data from a nationwide long-term care pharmacy (January 2005–June 2007) and the Centers for Medicare and Medicaid Services (January–December 2011). From 2006 to 2007, more than 65% of residents of nursing homes throughout the US with cancer experienced pain (28.3% on a daily basis), among whom 13.5% reported severe pain. More than 17% of these residents who experienced daily pain received no analgesics (95% confidence interval [CI]: 16.0–19.1%), and treatment was negatively associated among those with advanced age, cognitive impairment, feeding tubes, and restraints. These findings coincided with changing patterns in opioid use among residents with cancer, including relatively abrupt 10% and 21% decreases in use of fentanyl patches and other strong opioids, respectively, after the 2006 implementation of Medicare Part D. In the years since Medicare Part D was introduced, some treatment practices in nursing homes have not been concordant with clinical guidelines for pain management among older adults. Among a contemporary population of long-stay nursing home residents with and without cancer, 10.0% (95% CI: 9.4–10.6%) of those who began receiving a long-acting opioid after nursing home admission had not previously received opioid therapy. Odds of naïve initiation of these potent opioids were increased among residents with terminal prognosis, functional impairment, feeding tubes, and cancer. This dissertation provides new evidence on pharmaceutical management of pain and on Medicare Part D’s impact on opioid use in nursing home residents. Results from this dissertation shed light on nursing home residents’ access to pain-related health care services and provide initial directions for targeted efforts to improve the quality of pain treatment in nursing homes.

Svarbūs socialinės ir farmacijos politikos uždaviniai yra aprūpinimas vaistais ir vaistų išlaidų kompensavimo sistemos vystymas. Šioje srityje susiduriama su problemomis, būdingomis visuomenėms, stokojančioms resursų, ekonominio ir politinio stabilumo. Visuomeninio sveikatos priežiūros finansavimo apimties problemos aktualios ir ekonomiškai pajėgiausių valstybių viešajai politikai. Senstant populiacijai, kyla sveikatos paslaugų poreikis, siekiama naujų efektyvesnių preparatų įdiegimo. Tai skatina vaistų išlaidų augimą šalyse. Valstybių vyriausybės bando reguliuoti farmacijos rinką. Jos turi subalansuoti besiskiriančius tikslus. Pirma, vyriausybės turi užtikrinti sveikatos politikos tikslus: saugoti visuomenės sveikatą; užtikrinti pacientų priėjimą prie saugių ir efektyvių vaistų; gerinti priežiūros kokybę; ir užtikrinti, kad išlaidos farmacijai netaps pernelyg didelės, kad pakenktų šiems vyriausybiniams tikslams. Taigi teisingumas ir efektyvumas (t.y. ribotų resursų geriausias panaudojimas norint padidinti visuomenės sveikatą) ir pacientų reikmių patenkinimas, yra svarbiausi tikslai. Vienas iš vyriausybės vaidmenų farmacijos politikoje yra pasirūpinti finansavimu ir sistema, kuri sudarytų sąlygas priežiūros kokybei. Nacionalinė vaistų politika – tai valstybės institucijų priemonės ir veiksmai siekiant užtikrinti galimybę įsigyti Lietuvoje kainos ir teritoriniu požiūriu prieinamų, tinkamos kokybės, veiksmingų bei saugių vaistų ir gauti tinkamos kokybės farmacines... [toliau žr. visą tekstą]
Important tasks of social and pharmacy politics are the supply of pharmaceuticals and developing system of reimbursement of costs on pharmaceuticals. There are problems with societies, which lack for resources, economical and political stability. Problems with financing health care are also important to economically strong countries. Because of population ageing, requirements of health care services grow and the object is implementation of new, more effective preparations. This also promotes growing of costs on pharmaceuticals. Governments try to regulate few markets as much as they do the pharmaceutical market. They have to balance contrasting objectives. First, governments must secure health policy objectives: protecting public health, guaranteeing patient access to safe and effective medicines, improving the quality of care and ensuring that pharmaceutical expenditure does not become excessive so as to undermine these and other government objectives. Equity and efficiency (i.e. making best use of limited resources to increase population health) and meeting patient need are, therefore, perhaps the prime objectives. One of the roles of government in pharmaceutical policy is to provide the funding and framework that allows that quality of care. National policy of pharmaceuticals involves means and acts of state institutions pursuing to ensure possibility to procure drugs, which are cost and territorially available, effective and secure, and also involves possibility to get... [to full text]

Since the first so-called “medical marijuana” legislation was passed in California in 1996, a total of twenty states and the District of Columbia have passed laws permitting limited use of cannabis. Despite the changes in state laws, cannabis remains illegal for any purpose under federal law. Changes in state laws have coincided with a renewed interest in the substance for the treatment of a variety of conditions. There has been a significant increase in published data over the past twenty years examining the efficacy of cannabis as an appetite stimulant, antiemetic agent, and analgesic adjuvant. The purpose of this meta-analysis was to synthesize published data on cannabis use as an analgesic agent. Five studies meeting inclusion criteria were located through searches of online databases, review of reference lists, author correspondence, and review of clinical trials databases. Meta-analysis was conducted using fixed-effects modeling. The overall effect of mean reduction of pain intensity was -4.895 (Z-score) with an associated p value of 0.003. The combined standardized mean difference (SMD) was -0.362 (CI -0.507 to -0.217), indicating on average a moderate significant reduction in pain intensity for patients with chronic pain. As the legal status of the substance evolves, additional research is needed to establish evidence-based clinical recommendations regarding the use of medicinal cannabis in pain management.

Cette thèse se propose d’étudier les déterminants des prix des médicaments innovants de l’oncologie, en s’interrogeant à la fois sur le rôle des caractéristiques propres à chaque produit, en particulier sa valeur thérapeutique ajoutée, et sur l’influence d’éléments structurels, notamment les modalités des politiques de fixation des prix appliqués par les Etats.Une revue de la littérature nous permet tout d’abord de spécifier les modalités de fixation des prix ainsi que les nouveaux instruments mis en place par les décideurs pour réguler leur montant. Nous montrons que la détermination des prix des traitements innovants passe par l’évaluation de la valeur ajoutée et donc la mise en place de politiques d’évaluation de type Health Technology Assessment (HTA). Toutefois, nous mettons en lumière que les politiques de prix se réfèrent à des doctrines différentes tant dans les démarches évaluatives que dans la fixation des prix. Dès lors, nous proposons un cadre théorique de détermination des prix qui permet de prendre en compte ces différences. En complément, la constitution d’une base de données incluant les caractéristiques des anticancéreux et leurs prix fixés dans huit pays de l’OCDE, nous permet d’entreprendre différentes analyses statistiques.A partir des études empiriques, nous examinons dans un premier temps la relation entre les prix et le caractère innovant des anticancéreux. Nous commençons pour cela par nous intéresser à l’accès au marché de ces produits dans les pays retenus avant d’examiner les disparités de prix entres les pays.Si l’on constate qu’une majorité des médicaments de notre échantillon étaient bien disponibles dans ces pays, il apparaît néanmoins des différences en matière réglementaire, notamment concernant l’octroi du statut de médicament orphelin ou encore en matière de délais d’enregistrement. Une étude comparative plus fine des évaluations faites par le NICE et la HAS confirme l’existence de divergences sur les décisions et/ou recommandations de prise en charge malgré une appréciation similaire de la valeur ajoutée. Enfin lorsqu’on procède à la comparaison des prix, on constate un écart de prix considérable selon les modalités de fixation des prix appliqués par les Etats.Ce dernier constat nous conduit ensuite à rechercher des éléments d’explication à partir d’une approche économétrique permettant de mesurer l’effet de la valeur ajoutée, définie par la survie incrémentale, sur le prix des anticancéreux. De façon complémentaire, nous montrons que cette influence se manifeste même lorsque l’estimation de cette valeur ajoutée reste incertaine au regard du niveau de preuve obtenu.De façon complémentaire, les analyses économétriques confirment que les écarts de prix entre pays reflètent les différences internationales sur les choix de politique de prix. En effet, nous montrons que les prix les plus élevés sont relevés dans les pays exerçant une politique de prix libres. A l’inverse, les prix les plus bas sont retrouvés dans les pays pratiquant une évaluation économique. Et l’on retrouve à un niveau intermédiaire les pays ayant recours à la négociation et au référencement international
This PhD thesis focused on the regulation and the determinants of innovative drugs prices in oncology. First, with a literature review we provided a comprehensive description examining the pricing mechanisms of innovative drugs in OECD countries. This approach shows us that most of the countries determine their prices according the assessment of the added value of the pharmaceutical product, and use HTA policies in their decisions making. Based on that conclusions and regarding the differences observed between the policies’ countries we assumed a framework to describe the pricing mechanism.In addition, we developed an original database which contains the anticancer drugs characteristics and their prices in 8 OECD countries. From empirical studies, we examined the relationship between the prices and the drugs characteristics. Before assessing prices disparities between the selected countries, we focused on the market approval of these medicines in each country. Nevertheless, even if most of the products were available in all studied countries, we observed differences between their regulations notably concerning the orphan status designation as well as for the time to market authorization.Thereafter, we achieved a comparative study to assess the discordance between the NICE and HAS. This analysis shows that despite a similar estimation of the added value, there is divergences between these HTA bodies in term of decisions making. Then, when we investigated the trends in prices across the selected countries, the level of pricing disparities observed, in most cases, seems to reflect the differences in pricing regulations.Finally, in order to highlight the determinants of these disparities between countries with respect to anticancer drug prices, we used the econometric approaches, we assessed both the effects on the prices of the added value (the incremental survival) and the pharmaceutical policy: It appears that the incremental survival impacts on the prices, independently of its uncertainties and its level of evidence provided in the clinical trials. In addition, the analysis confirms that the prices disparities reflect the pricing policy applied. Indeed, the countries using a free pricing policy have the highest-level prices, followed by the countries using the pricing negotiation and external reference pricing. Lastly, the countries using economic evaluation have the lowest prices

This research involved a rigorous implementation of the conceptual framework of Australia's National Strategy for Quality Use of Medicines through a planned sequence of studies across a large defined geographical region to test the hypothesis that: The National Strategy for Quality Use of Medicines can be used to design, implement and evaluate a research program to achieve sustained improvement in health care in a regional setting.

The dispensing Medical Practitioner has become topical since 13B4 . Dn this issue, much confusion and ignorance prevails, both amongst members of the medical and allied professions and in the public mind. This study was undertaken to demonstrate some aspects of dispensing of medicines in South Africa and to cansider the implications arising out of the application of legislation governing such dispensing of medicines by family practi tioners. The main objectives of this study were: CaD To identify and ascertain the opinions and policies of all those who are involved and concerned with the dispensing of medicines. Cb) To determine the implications of all the legislation governing the dispensing of medicines on: 1. patient care 2. the dispensing of medicines by doctors Cto their patients}. Information was gathered from a questionnaire sent to service/ consumer groups; from literature review of journals; publications and gazettes; and from legal consultations. The results of the study indicated that: C13 Professional Associations such as, Medical Association of South Africa, the Pharmaceutical Society as well as statutory bodies such as the South African Medical and Dental Council and the Pharmacy Council are concerned with issues such as 'trading in medicine ' and 'profiteering '. Inadequate patient care resulting from the physical, financial and economic hardships suffered by a majority of patients are issues which appear not to have been addressed by these bodies. CE) The fundamental issues of "what is in the best interest of the patient " appears to be ignored in legislation pertaining to dispensing. C33 Dispensing to patients became difficult due to the impractical stringent restrictions imposed by the legislation governing dispensing of medicines. C4D The dispensing of medicines by a doctor is less timB consuming, more convenient and cheaper for the patient as well as for the Sick Benefit Funds. The results were discussed with respect to their theoretical and practical implications and the conclusion reached was that the dispensing legislation presently designed for first world communities, became totally impractical when applied to third world communities, and that most doctors dispense medicines in response to the needs of the individual communities they service. Further research possibilities and recommendations were suggested in order to gain a greater understanding of the dispensing issue, which hopefully will assist to improve the quality of health care and also ensure the best possible advantage for the patient.
Thesis (MMed.)-University of Natal, Durban, 1986.