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Nice Collateral Effect: What Is The Influence Of Nice On Other Hta Bodies?
A486
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
Objectives: Most national regulatory authorities (NRAs) have established regulations and guidelines on post approval changes (PACs) for vaccines with the manufacturer usually submitting PACs to all the respective NRAs in the countries of license. The multiplicity of PACs evaluation processes adopted by different NRAs requires the generation and submission of similar evidence as part of distinguished applications, possibly leading to delays in patient access. The objective of this study is to estimate the socioeconomic impact of vaccines’ PAC requirements in Brazil and Mexico and compare them with the processes in EU and US. Methods: Secondary and primary data were collected and analysed. A literature review was conducted, followed by interviews with regulatory experts to understand the regulatory landscape and identify potential sources of cost to society. Two vaccines were used as case studies. A health economic model was built to analyse the implication of delayed PAC approvals. Different scenarios (including shortage of vaccine due to delayed approval) were considered to account for direct and indirect costs of PAC delays. Results: Across the four regulatory authorities in the study regions (ANVISA, COFEPRIS, EMA, FDA), PACs are broadly divided into three categories relating to major, moderate, or major changes. The case studies revealed that PAC delays do not have a significant socioeconomic impact (e.g. supply shortage), but predominantly solely on manufacturers’ (e.g. supply complexity). Consequently, a supplementary literature review on vaccine delays showed a number of direct and indirect health effects and a model estimated the socioeconomic impact of hypothetical PACs scenarios (shortage of vaccine, indication extension, delayed approval), revealing that a significant societal burden might be posed by delays. Conclusions: There are a number of regulatory redundancies in the evaluation of vaccines’ PACs. International harmonization of regulations and information sharing networks would support a more efficient supply of high quality vaccines. PHP264 Prevalence, Perception And Reasons For Self Medication Jan SU1, Gul R2, Mustafa G1, Ali SH2, Shah A2, Shah AK3 of Balocistan, Quetta, Pakistan, 2University of Balochistan, Quetta, Pakistan, 3Hashim Khan Medical Store, Quetta, Pakistan
1University
Objectives: Self medication is always a major concern of health care providers worldwide. The aim of this study was to find out the prevalence, perception and reasons for self medication Methods: A pre-tested questionnaire was made and used for this study for the collection of data. The data was collected from various pharmacies in the city during June to August, 2015. A total of 500 out of 850 participants were agreed and interviewed who came for the medications Results: The prevalence of self medication was found in all age groups but it was high in age group of 25-50 years of age, where as it was un-predictable in lower aged group and females as most the elders were purchasing the medications for them. The drug groups mainly contain analgesics and antipyretics 140 (28 %), antibiotics 150 (30 %), antacids and anti spasmodic 105 (21 %), anti diarrheal 53 (10.6 %), cough 14 (2.8 %), anti malarial 12 (2.4 %) and others 26 (5.2 %). Whereas, the sources for medications were the private pharmacy (OTC) 306 (61.2 %), leftover drugs (old prescriptions) 213 (42.6 %), family and friends 127 (25.4 %) and others 66 (13.2 %). Sources for information on self medication were, pharmacies 382 (76.4 %), previous prescriptions 213 (42.6 %), health officials 148 (29.6 %), relatives and friends 83 (16.6 %), media 51 (10.2 %) and others 37 (7.4 %). Reasons for using self medication were minor illness 332 (66.4 %), lake of money 314 (62.8 %), no medical services 208 (41.6 %), lake of time 125 (25 %), waiting time at medical facility 95 (19 %) and others (emergency etc) 73 (14.6 %) Conclusions: Self medication is very high in this region of the world which is a major concern and needs public education, regulations for pharmacies and to utilize the services/ role of pharmacists
PHP265 Pro Instruments Used In Studies Published Since 2005: Which Populations And Diseases Have Had The Most Tools Developed? Martin A Crystallise Ltd., London, UK
Objectives: To determine the number of unique patient- and clinician-reported outcome (PRO) tools that have been used in studies published since 2005 for different disease areas and populations. Methods: We developed a PRO instrument ontology from those tools cited within the abstracts of over 100,000 studies identified by a systematic search of PubMed on the humanistic and economic burden of disease, which were stored in an online database (www.heoro.com). The ontology items are semantically indexed by general topic, population, disease or body area, symptom or treatment. Abstracts are tagged to each relevant ontology item during an automated process using natural language processing and tokenising approaches, and indexing is then checked by experts. Results: A total of 4,272 instruments were identified from 22,254 relevant abstracts. Of these, most (2,648) were disease-specific, 309 related to non-disease-specific treatments, 246 to nondisease-specific symptoms, 243 were for use in children, 117 for caregivers or family members, 70 for the elderly and 13 for clinicians or researchers. Utility values were assessed by 38 instruments. Of the disease-specific instruments, mental disorders had the largest number of different tools (434), followed by musculoskeletal diseases (344 tools), neurological disorders (292), cancers (243), gastrointestinal diseases (231), respiratory diseases (204) and urogenital disorders (172). Treatmentrelated instruments generally assessed adverse events (100) or satisfaction or effectiveness (92 tools each). Symptom-related instruments most commonly assessed pain (122 tools), urinary incontinence (62), sleep disorders (61) or fatigue (49). Conclusions: A vast number of different PRO tools have been developed and used in research published over the past 10 years, with a new instrument reported on average for every 5 PRO study publications. The reasons for the diversity remain
unclear, but it makes it difficult to compare the impact of diseases on quality of life, or the efficacy and cost-effectiveness of interventions across studies. PHP266 Nice Collateral Effect: What Is The Influence Of Nice On Other Hta Bodies? Wijnands T1, Kreeftmeijer J1, Kooreman PJ1, Wagner P2, van Engen A1 Services, Hoofddorp, The Netherlands, 2Quintiles Advisory Services, NeuIsenburg, Germany 1Quintiles Advisory
Objectives: The National Institute for Health and Care Excellence (NICE) is known for its rigour in reviewing novel treatments and its cost-effectiveness driven methodologies for determining a treatment’s benefit to the healthcare system. Value for money is also a key concern for non-UK governments, however not all jurisdictions have the same health technology assessment (HTA) processes in place to evaluate novel treatments entering the market. With increased pharmaceutical spending and subsequent increase of importance of HTA to inform funding decisions, these non-UK governments potentially look elsewhere to assist in developing HTA methodologies and funding decisions. This study investigated NICE’s impact on HTA methodologies and decision-making in ex-UK health care systems. Methods: Review and comparison of guidelines from NICE and 13 HTA bodies in 12 countries across the world. Review and comparison of NICE recommendations and subsequent decisions from 13 agencies between January 1st 2013 and May 31st 2016 Results: Similar to NICE, cost-effectiveness and budget impact data are mandatory in 10 (77%) and 8 (62%) of the selected agencies. Amongst selected non-EU (CADTH, CONITEC, ICER, HIRA and PBAC) agencies, this is 80% and 100%, respectively. NICE provided guidance on 83 drugs and a total of 159 assessments - subsequent to NICE’s guidance on these drugs - by the other HTA bodies were identified (range 2 from HIRA to 36 from HAS). Of the recommendations given by the selected 13 HTA bodies, 60% echoed the NICE outcome and 40% provided a different recommendation. Amongst all recommendations from formal HTA bodies that have compulsory pharmacoeconomic requirements, 61% matched NICE’s decision; this varied from 25% of CADTH recommendations to 100% of HIRA recommendations. Conclusions: Our findings confirm that many agencies outside the UK adopt similar methodologies to NICE. However, no clear correlation was found between the decision-making by these agencies and NICE. PHP267 Adherence To Vancomycin Therapeutic Guidelines At Ministry Of Health Hospital In Saudi Arabia Alomi YA, Almudaiheem HY Ministry of Health, Riyadh, Saudi Arabia
Objectives: To explore the adherence of Vancomycin therapeutic monitoring guidelines in Saudi Arabia Methods: a prospective study of vancomycin guidelines adherence. It conducted over a 3-Month at King Saud Medical City (KSMC). The guidelines based on Central Diseases Control and American Society of HealthSystem Pharmacist. Any patient received vancomycin followed up by trained pharmacist. He followed the following elements including; FDA labeled indication, all details such as weight, height, bug culture sensitivity, any adjustments in dosage, trough levels and duration of administration recorded on a TDM form on a systematic basis. All data gathered were statistically evaluated using SPSS version 22. Results: Results the total number of patients 53, which 34 (64.15%) were male and 19 (35.85%) were female with a mean age of 36.21 ± 16.4 years. Of those; 18 (33.96%) patients from General Surgery wards and 35 (66.04%) patients from orthopedic wards. Twenty-nine (54.7%) non-adherence to indications guidelines while 24 (45.3%) adherence to an indication. All patients 53 (100%) were non-compliance of vancomycin duration of administration time. The levels of vancomycin were sub-therapeutic level in 23 (43.4%) patients, 9 (17%) patients above therapeutic levels, and 10 (18.9%) patients have not checked the drug levels. The sampling time 22 (41.5%) Patients were wrong, 16 (30.18%) patients were correct, and 10 (18.9%) patients not documented. Conclusions: There was indigent adherence to international guidelines of Vancomycin. Targeting compliance, the guidance leads to decrease multi-drug resistance, improve patient therapeutic outcome, prevent the drug-related problem and avoid the unnecessary additional cost. PHP268 Economic Impact Of Adverse Drug Reactions: A Pubmed Based Study Bhat B, D S, Udupa N Manipal University, Manipal, India
Objectives: To list and analyze cost incurred for the treatment of ADRs from the articles present in pubmed database. Methods: Pubmed database was searched with keywords “Cost incurred due to Adverse Drug Reactions”, “Preventable Adverse Drug Reactions” and “Economic impact of ADR”. Results: A total of 18, 19 and 141 articles were present in pubmed with the key words “Cost incurred due to Adverse Drug Reactions”, “Preventable Adverse Drug Reactions” and “Economic impact of ADR” respectively. Majority of the ADRs were for due to medications used for the treatment of cancer, followed by Disease Modifying Anti-Rheumatoid Drugs. On an average the cost of treatment for each ADR was found to be 2000 USD (in an US set up), 2000 Euro (in an European set up), and around 150 USD for an Indian set up. However, the cost incurred due to ADRs depends on various factors. It was observed from one of the study that out of all ADRs that occurred, 60 percent of the ADRs were preventable. Conclusions: It is evident from this study that ADRs cause unnecessary economic burden to the patients. By taking proper care, training the patient and physician can surely lessen the occurrence of avoidable or preventable ADRs thus may decrease the economic burden on patients. A study can be taken up to understand the economic burden due to ADRs caused by herbal medicines as there are hardly any studies conducted in this domain.
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
Objectives: Most national regulatory authorities (NRAs) have established regulations and guidelines on post approval changes (PACs) for vaccines with the manufacturer usually submitting PACs to all the respective NRAs in the countries of license. The multiplicity of PACs evaluation processes adopted by different NRAs requires the generation and submission of similar evidence as part of distinguished applications, possibly leading to delays in patient access. The objective of this study is to estimate the socioeconomic impact of vaccines’ PAC requirements in Brazil and Mexico and compare them with the processes in EU and US. Methods: Secondary and primary data were collected and analysed. A literature review was conducted, followed by interviews with regulatory experts to understand the regulatory landscape and identify potential sources of cost to society. Two vaccines were used as case studies. A health economic model was built to analyse the implication of delayed PAC approvals. Different scenarios (including shortage of vaccine due to delayed approval) were considered to account for direct and indirect costs of PAC delays. Results: Across the four regulatory authorities in the study regions (ANVISA, COFEPRIS, EMA, FDA), PACs are broadly divided into three categories relating to major, moderate, or major changes. The case studies revealed that PAC delays do not have a significant socioeconomic impact (e.g. supply shortage), but predominantly solely on manufacturers’ (e.g. supply complexity). Consequently, a supplementary literature review on vaccine delays showed a number of direct and indirect health effects and a model estimated the socioeconomic impact of hypothetical PACs scenarios (shortage of vaccine, indication extension, delayed approval), revealing that a significant societal burden might be posed by delays. Conclusions: There are a number of regulatory redundancies in the evaluation of vaccines’ PACs. International harmonization of regulations and information sharing networks would support a more efficient supply of high quality vaccines. PHP264 Prevalence, Perception And Reasons For Self Medication Jan SU1, Gul R2, Mustafa G1, Ali SH2, Shah A2, Shah AK3 of Balocistan, Quetta, Pakistan, 2University of Balochistan, Quetta, Pakistan, 3Hashim Khan Medical Store, Quetta, Pakistan
1University
Objectives: Self medication is always a major concern of health care providers worldwide. The aim of this study was to find out the prevalence, perception and reasons for self medication Methods: A pre-tested questionnaire was made and used for this study for the collection of data. The data was collected from various pharmacies in the city during June to August, 2015. A total of 500 out of 850 participants were agreed and interviewed who came for the medications Results: The prevalence of self medication was found in all age groups but it was high in age group of 25-50 years of age, where as it was un-predictable in lower aged group and females as most the elders were purchasing the medications for them. The drug groups mainly contain analgesics and antipyretics 140 (28 %), antibiotics 150 (30 %), antacids and anti spasmodic 105 (21 %), anti diarrheal 53 (10.6 %), cough 14 (2.8 %), anti malarial 12 (2.4 %) and others 26 (5.2 %). Whereas, the sources for medications were the private pharmacy (OTC) 306 (61.2 %), leftover drugs (old prescriptions) 213 (42.6 %), family and friends 127 (25.4 %) and others 66 (13.2 %). Sources for information on self medication were, pharmacies 382 (76.4 %), previous prescriptions 213 (42.6 %), health officials 148 (29.6 %), relatives and friends 83 (16.6 %), media 51 (10.2 %) and others 37 (7.4 %). Reasons for using self medication were minor illness 332 (66.4 %), lake of money 314 (62.8 %), no medical services 208 (41.6 %), lake of time 125 (25 %), waiting time at medical facility 95 (19 %) and others (emergency etc) 73 (14.6 %) Conclusions: Self medication is very high in this region of the world which is a major concern and needs public education, regulations for pharmacies and to utilize the services/ role of pharmacists
PHP265 Pro Instruments Used In Studies Published Since 2005: Which Populations And Diseases Have Had The Most Tools Developed? Martin A Crystallise Ltd., London, UK
Objectives: To determine the number of unique patient- and clinician-reported outcome (PRO) tools that have been used in studies published since 2005 for different disease areas and populations. Methods: We developed a PRO instrument ontology from those tools cited within the abstracts of over 100,000 studies identified by a systematic search of PubMed on the humanistic and economic burden of disease, which were stored in an online database (www.heoro.com). The ontology items are semantically indexed by general topic, population, disease or body area, symptom or treatment. Abstracts are tagged to each relevant ontology item during an automated process using natural language processing and tokenising approaches, and indexing is then checked by experts. Results: A total of 4,272 instruments were identified from 22,254 relevant abstracts. Of these, most (2,648) were disease-specific, 309 related to non-disease-specific treatments, 246 to nondisease-specific symptoms, 243 were for use in children, 117 for caregivers or family members, 70 for the elderly and 13 for clinicians or researchers. Utility values were assessed by 38 instruments. Of the disease-specific instruments, mental disorders had the largest number of different tools (434), followed by musculoskeletal diseases (344 tools), neurological disorders (292), cancers (243), gastrointestinal diseases (231), respiratory diseases (204) and urogenital disorders (172). Treatmentrelated instruments generally assessed adverse events (100) or satisfaction or effectiveness (92 tools each). Symptom-related instruments most commonly assessed pain (122 tools), urinary incontinence (62), sleep disorders (61) or fatigue (49). Conclusions: A vast number of different PRO tools have been developed and used in research published over the past 10 years, with a new instrument reported on average for every 5 PRO study publications. The reasons for the diversity remain
unclear, but it makes it difficult to compare the impact of diseases on quality of life, or the efficacy and cost-effectiveness of interventions across studies. PHP266 Nice Collateral Effect: What Is The Influence Of Nice On Other Hta Bodies? Wijnands T1, Kreeftmeijer J1, Kooreman PJ1, Wagner P2, van Engen A1 Services, Hoofddorp, The Netherlands, 2Quintiles Advisory Services, NeuIsenburg, Germany 1Quintiles Advisory
Objectives: The National Institute for Health and Care Excellence (NICE) is known for its rigour in reviewing novel treatments and its cost-effectiveness driven methodologies for determining a treatment’s benefit to the healthcare system. Value for money is also a key concern for non-UK governments, however not all jurisdictions have the same health technology assessment (HTA) processes in place to evaluate novel treatments entering the market. With increased pharmaceutical spending and subsequent increase of importance of HTA to inform funding decisions, these non-UK governments potentially look elsewhere to assist in developing HTA methodologies and funding decisions. This study investigated NICE’s impact on HTA methodologies and decision-making in ex-UK health care systems. Methods: Review and comparison of guidelines from NICE and 13 HTA bodies in 12 countries across the world. Review and comparison of NICE recommendations and subsequent decisions from 13 agencies between January 1st 2013 and May 31st 2016 Results: Similar to NICE, cost-effectiveness and budget impact data are mandatory in 10 (77%) and 8 (62%) of the selected agencies. Amongst selected non-EU (CADTH, CONITEC, ICER, HIRA and PBAC) agencies, this is 80% and 100%, respectively. NICE provided guidance on 83 drugs and a total of 159 assessments - subsequent to NICE’s guidance on these drugs - by the other HTA bodies were identified (range 2 from HIRA to 36 from HAS). Of the recommendations given by the selected 13 HTA bodies, 60% echoed the NICE outcome and 40% provided a different recommendation. Amongst all recommendations from formal HTA bodies that have compulsory pharmacoeconomic requirements, 61% matched NICE’s decision; this varied from 25% of CADTH recommendations to 100% of HIRA recommendations. Conclusions: Our findings confirm that many agencies outside the UK adopt similar methodologies to NICE. However, no clear correlation was found between the decision-making by these agencies and NICE. PHP267 Adherence To Vancomycin Therapeutic Guidelines At Ministry Of Health Hospital In Saudi Arabia Alomi YA, Almudaiheem HY Ministry of Health, Riyadh, Saudi Arabia
Objectives: To explore the adherence of Vancomycin therapeutic monitoring guidelines in Saudi Arabia Methods: a prospective study of vancomycin guidelines adherence. It conducted over a 3-Month at King Saud Medical City (KSMC). The guidelines based on Central Diseases Control and American Society of HealthSystem Pharmacist. Any patient received vancomycin followed up by trained pharmacist. He followed the following elements including; FDA labeled indication, all details such as weight, height, bug culture sensitivity, any adjustments in dosage, trough levels and duration of administration recorded on a TDM form on a systematic basis. All data gathered were statistically evaluated using SPSS version 22. Results: Results the total number of patients 53, which 34 (64.15%) were male and 19 (35.85%) were female with a mean age of 36.21 ± 16.4 years. Of those; 18 (33.96%) patients from General Surgery wards and 35 (66.04%) patients from orthopedic wards. Twenty-nine (54.7%) non-adherence to indications guidelines while 24 (45.3%) adherence to an indication. All patients 53 (100%) were non-compliance of vancomycin duration of administration time. The levels of vancomycin were sub-therapeutic level in 23 (43.4%) patients, 9 (17%) patients above therapeutic levels, and 10 (18.9%) patients have not checked the drug levels. The sampling time 22 (41.5%) Patients were wrong, 16 (30.18%) patients were correct, and 10 (18.9%) patients not documented. Conclusions: There was indigent adherence to international guidelines of Vancomycin. Targeting compliance, the guidance leads to decrease multi-drug resistance, improve patient therapeutic outcome, prevent the drug-related problem and avoid the unnecessary additional cost. PHP268 Economic Impact Of Adverse Drug Reactions: A Pubmed Based Study Bhat B, D S, Udupa N Manipal University, Manipal, India
Objectives: To list and analyze cost incurred for the treatment of ADRs from the articles present in pubmed database. Methods: Pubmed database was searched with keywords “Cost incurred due to Adverse Drug Reactions”, “Preventable Adverse Drug Reactions” and “Economic impact of ADR”. Results: A total of 18, 19 and 141 articles were present in pubmed with the key words “Cost incurred due to Adverse Drug Reactions”, “Preventable Adverse Drug Reactions” and “Economic impact of ADR” respectively. Majority of the ADRs were for due to medications used for the treatment of cancer, followed by Disease Modifying Anti-Rheumatoid Drugs. On an average the cost of treatment for each ADR was found to be 2000 USD (in an US set up), 2000 Euro (in an European set up), and around 150 USD for an Indian set up. However, the cost incurred due to ADRs depends on various factors. It was observed from one of the study that out of all ADRs that occurred, 60 percent of the ADRs were preventable. Conclusions: It is evident from this study that ADRs cause unnecessary economic burden to the patients. By taking proper care, training the patient and physician can surely lessen the occurrence of avoidable or preventable ADRs thus may decrease the economic burden on patients. A study can be taken up to understand the economic burden due to ADRs caused by herbal medicines as there are hardly any studies conducted in this domain.