The Ethical Issues Of Pharmacogenetic Tests

The Ethical Issues Of Pharmacogenetic Tests

A466 VA L U E I N H E A LT H 1 9 ( 2 0 1 6 ) A 3 4 7 – A 7 6 6 and patient condition improved 38 (23.17%). The most PharmacoEconomic impact was th...

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A466

VA L U E I N H E A LT H 1 9 ( 2 0 1 6 ) A 3 4 7 – A 7 6 6

and patient condition improved 38 (23.17%). The most PharmacoEconomic impact was the patient length of hospital stay decreased 89 (54.27%), and reduction in the cost drug therapy monitoring 46 (28.05%). The estimated cost avoidance in the study period was (87,717.08 USD), and the total annual estimated cost avoidance (350,856.32 USD)  Conclusions: Therapeutic Drug Monitoring pharmacist had the significant impact on patient condition and outcome, decrease a length of hospitalization, and avoid unnecessary an additional cost. The TDM program should apply in all clinical pharmacy services and at all hospitals in Saudi Arabia PHP151 Adherance To Medication Errors Repoting System At Public Hospital, Riyadh, Saudi Arabia Alomi YA1, Al-Shubbar NA2 of Health, RIYADH, Saudi Arabia, 2King Salman Hospital, RIYADH, Saudi Arabia

1Ministry

Objectives: Medication safety program started at Riyadh region of Ministry of Health in 2013. The pharmacist document all drug related problems. The goal of this study is to explore the pharmacist’s adherence to medication errors reporting system at the public hospital in Riyadh, Saudi Arabia.  Methods: It is the retrospective analysis of a 12-month in the year of 2015; at 300-bed General Hospital through preventing and documentation of medication errors in adults and pediatrics. The hospital had medication safety officer with medication safety committee. The program Led by trained pharmacist and delivered Basic medication safety education to all health professional. The medication error report consisted of patient demographic information, qualification of committing mistakes, time of errors occurs, type of medication errors, reasons for medication errors, medications stages involved, errors outcome, and action was taken  Results: The total number of reports were 805. The pharmacist reported all reports (100%). The most information completed was causes of medication errors 775 (96.3%) and type of medication errors 770 (95.6%) followed by outcome of medication errors 764 (94.9%) and medication process stages involved 711 (88.3%). While the patient’s demographic information completed only (50%) in reports. The least completed item was the qualification of committing errors 3 (0.4%), and suggestion to prevent errors 2 (0.25%) followed by the time of mistakes and reporter information 0 (0%).  Conclusions: Despite the medication error reporting is consider new at the public hospital the number of reporting was high. The system needs more effort to Adhere completeness medication errors reporting system; and that by development of an electronic reporting system, program awareness, and positive documentation system feedback changes in pharmacy practice PHP152 Workload Analysis And Staffing Requirement Of Clinical Pharmacy Services At Ministry Of Health In Saudi Arabia Alomi YA Ministry of Health, RIYADH, Saudi Arabia

Objectives: Clinical Pharmacy services at King Saud Medical City (KSMC) were the first founded by Ministry of Health. The aim of this study was to explore workload analysis of clinical pharmacy services at MOH hospital in Saudi Arabia  Methods: Cross-sectional of a 6-month of providing clinical pharmacy services for adults at KSMC. Ten Clinical Pharmacist and expert trained pharmacist-provided clinical pharmacy services. It is including; drug information services, poisoning control services, therapeutic drug monitoring services, orthopedic services, oncology pharmacy services, pharmacoeconomic services, pain management services. All pharmacists should document the clinical pharmacy activities on a monthly basis; the clinical activities consisted of Central Clinical Pharmacy Activities domain, Patient-Specific Clinical Pharmacy Activities, Administration-Specific Clinical Pharmacy Activities domain, and some activities and time spent.  Results: The Total full-time employee (FTE) for clinical pharmacy services was (15.752 FTE). The Central Clinical Pharmacy Activities was (4.72 FTE) pharmacist, Patient-Specific Clinical Pharmacy Activities was (4.292 FTE) pharmacist, and the  Administration-Specific Clinical Pharmacy Activities was (6.68 FTE) pharmacist. The demand number of the full-time clinical pharmacist (5.75 FTE) pharmacist Of central clinical pharmacy activities, the highest number, was drug information services (1.43 FTE) pharmacist and in-services education (1.03 FTE) pharmacist. Of the patient specific clinical pharmacy activities; the highest number was medication monitoring (0.879 FTE) pharmacist and round medical participation (0.807 FTE) pharmacist. Of administration clinical pharmacy activities; the highest number was policies and procedures design (2.293 FTE) pharmacist and planning of clinical pharmacy services (1.56 FTE) pharmacsit.  Conclusions: Workload analysis of clinical pharmacy services part of TQM indicators of clinical pharmacy system. Clinical pharmacy services overloaded with a high demand of clinical pharmacist. Administration clinical pharmacy should revise with changing emphasis to patient-specific clinical pharmacy activities. PHP153 Dimensionality Of Value: Are The Us And Europe Moving Towards Similar Or Different Definitions Of Pharmaceutical Value? Rowbottom R1, Capuano C2, Bower D2, Suponcic S3 Life Sciences, London, UK, 2Navigant Life Sciences, Boston, MA, USA, 3Navigant Life Sciences, Lawrenceville, NJ, USA

archetypes.  Results: Emerging US value frameworks differ in dimensionality. However, a commonality across them is consideration of incremental improvement in efficacy, safety and/or tolerability vs. comparator. At its core this approach aligns closely with the comparative clinical effectiveness archetype central to many European HTA constructs. Select frameworks (especially ICER) layer on additional dimensions from other archetypes including health economic assessment. Interviewed European stakeholders acknowledge these similarities and are interested in better understanding differences in definition and dimensionality of pharmaceutical value as the US transitions to a value-based system and emerging frameworks build global awareness.  Conclusions: Like European HTA constructs, US value frameworks aim to define the dimensions and scales of value that should be considered by stakeholders in making access decisions. This analysis illustrates key similarities between the dimensions of value considered in emerging US frameworks and those implicit to European HTAs. It concludes that the markets are converging in their definition of value, although this is driven primarily by changes ongoing in the US and spillover effects in Europe are yet to be determined. PHP154 The Ethical Issues Of Pharmacogenetic Tests Colak M, Tunceli HD, Pak MD baskent university, Ankara, Turkey

Objectives: It is possible to verify a genetic disorder of an individual and also to determine if the individual carries the sick gene to future generation in risky pregnancies or not with pharmacogenetic tests and also these tests enable us to do genetic mapping. Pharmacogenetic studies can be considered as “personalized medicine”. At this point ethical issues come up.  In this study, the ethical issues of pharmacogenetic tests were evaluated according to medicine students.  Methods: It is a descriptive cross-sectional study. The universe of the study consists of 456 medicine students and the sample consists of 280 randomly selected medicine students. Firstly definitive information about pharmacogenetic tests were given and then 11 ethical dimensions of pharmacogenetic tests were asked by face to face questionnaire design. Data were analyzed with SPSS 21.0 program. Descriptive statistics were used in the analysis.  Results: 73,9% of the participants are concerned about unauthorized individuals may take the test results into their possession. 48,6% of the participants are worried about insurance companies may put pressure to their customers into taking pharmacogenetic tests. 70,4% of the participants are anxious about drawing biological map of nations having the threat of bioterrorism.  Conclusions: The possibility of unauthorized individuals taking patients medical records into their possessions, genetic information being commercialized, insurance companies putting pressure on customers to take pharmacogenetics tests and employers putting pressure on employees to take this tests, securing medication safety with pharmaceuticals industry and possibility of the society’s genetic map being a potential for a biological attack (bioterrorism) as ethical issues were determined in the study PHP155 Stakeholders Views On The Role Of Hta And Rsas In Pharmaceutical Policy In Greece Tsakalogiannis C, Karampli E, Athanasakis K, Kyriopoulos J National School of Public Health, Athens, Greece

Objectives: The scope of this study was to record various stakeholders’ beliefs regarding the use of health technology assessment (HTA) in pharmaceutical policy in Greece and to investigate issues regarding the introduction of Risk Sharing Agreements (RSAs) in the reimbursement procedure. Methods: Fifteen semistructured interviews were conducted. Interviewees were recruited from Social Security organizations (public payers), policy makers, academia, pharmaceutical companies and patient associations. Participants were selected using purposive sampling, main inclusion criteria being their profession and knowledge of HTA methods. Twenty three individuals were contacted, from which eighteen agreed to participate. Saturation point was reached after fifteen interviews. Data were analyzed using framework content analysis.  Results: According to stakeholders, there is an urging need for more extensive use of HTA methods. HTA is considered an appropriate tool for rationalizing pharmacy policy decisions. The establishment of an HTA organization is a demand of wide consensus, however opinions about its function and jurisdiction are diverse. Beyond concerns about technical and legal prerequisites, change in the current culture towards greater transparency were seen as prerequisites for the successful establishment of HTA. The latter refers also to the introduction of RSAs, which are considered a supplementary tool in reducing pharmaceutical expenditure. The extended use of e-prescription as a starting point for appropriate measurement of health outcomes and the experience of multinational companies and certain domestic organizations are marked as areas of opportunity. Stakeholders agreed that the introduction of HTA should be part of a pharmaceuticals’ pricing and reimbursement system reform, with the purpose to maximize health outcomes within closed budgets.  Conclusions: The implementation of HTA in Greece has been delayed and abstract; however, currently there is consensus on its necessity. Greek health authorities are required to take major steps towards that direction. Engagement of all stakeholders is considered crucial for its success.

1Navigant

Objectives: There is a proliferation and evolution of new frameworks for assessing therapeutic value in the United States. These frameworks are garnering significant attention with regard to the dimensionality along which value is assessed and the stakeholder viewpoints considered. This research analyzes the dimensionality of US value frameworks and seeks to understand the extent to which they align with or diverge from payer (HTA) archetypes in Europe. Methods: Secondary research was conducted to characterize dimensionality of US value frameworks. Their temporal evolution was considered based on revisions and public comments. European archetypes were defined based on HTA guidelines and existing literature. Primary research was conducted with Payer, HTA and Policy decision-makers across several countries to compare and contrast US value frameworks with European

PHP156 Recommendations In Clinical Guidelines, ‘No Benefit’ Ratings, And Opt-Out Decisions In Germany Since The Introduction Of The Amnog Law In 2011: How Do The Pieces Fit Together? Staab TR1, Dintsios C2, Schulenburg J3, Ruof J1 1Roche Pharma, Grenzach-Wyhlen, Germany, 2Bayer Vital GmbH, Leverkusen, Germany, 3Leibniz University, Hanover, Germany

Objectives: Based on the pharmaceutical law (‘AMNOG’) that was introduced in Germany in 2011, the Federal Joint Committee (G-BA) is charged with the determination of the additional benefit of new medicines versus the available standard. This decision constitutes the basis for price negotiations between the statutory health insurance (GKV-SV) and the pharmaceutical companies. At any time the