ISPOR Forum STANDARD TREATMENT GUIDELINES (STG'S) AND THE EFFECT OF A LACK OF IMPLEMENTATION

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1 ISPOR Forum STANDARD TREATMENT GUIDELINES (STG'S) AND THE EFFECT OF A LACK OF IMPLEMENTATION Standard treatment guidelines (STGs) provide a tool to practice and prescribe medicines that are therapeutically effective and cost efficient. STG's are considered a necessity in many countries so that maximum number of patients can derive benefits from scarce resources. The lack of implementation of STG's across the region has led to big variations in levels and standards of care delivered to patients, leading to further misallocation of resources. Presented by the ISPOR Arabic and ISPOR Africa Networks Forum Moderator & Speakers Moderator: Mahmoud Elmahdawy, PharmD, President, ISPOR Egypt Chapter, Ministry of Health, Cairo, Egypt mahmoud77@yahoo.com Speakers: Barbara Castelnuovo, PhD, Infectious Diseases Institute, Makerere University College of Health Sciences, Kampala, Uganda Shelley McGee, M Health Econ, PRICELESS SA (Wits School of Public Health), Johannesburg, South Africa Ola Ghaleb Al Ahdab, PhD, PGD, RPh, President, ISPOR United Arab Emirates Chapter, Ministry of Health, Abu Dhabi, UAE Peter Agyei-Baffour, PhD, President, ISPOR Ghana Chapter, Kwame Nkrumah University of Science & Technology, Kumasi, Ghana Anthony Waka Udezi, PhD, University of Benin, Benin City, Nigeria 1

2 Background: Egyptian health care system Population: 85 million residing in 28 governorates private and governmental hospitals primary health care units. Fragmented health care system with multiple sources of financing and providers. Spending on pharmaceuticals is 34% (OOP* and government) of total health care spending in the country! Share of OOP spending of total health spending has increased from 51% to 72% in the past 2 decades. * Out-of-pocket Macro-dimensions of our Healthcare system 1994/ / / /09 THE per Capita (LE) Percent of GDP Spent on Health 3.7% 6.0% 4.8% 5.9% Public Health Expenditures Percent of THE 33.0% 30.0% 33.0% 24.8% MOHP Expenditures Percent of THE 22.0% 23.0% 24.0% 16.5% Out-of-Pocket Expenditures as Percent of THE 51.0% 62.0% 60.0% 71.8% Pharmaceuticals as Percent of THE 36.0% 37.0% 26.0% 34.2% Public Spending as Percent of GOE Expenditures MOHP Expenditures as Percent of GOE Expenditures 5.0% 5.0% 4.3% 4.0% 3.5% 2.8% Source: Egypt NHA1-4 WE NEED TO PUMP MORE MONEY INTO HEALTH CARE 2

3 Egypt s perspective Strong efforts underway, standard treatment guidelines are in place for majority of ailments. Lack of enforcement tools!! (audits,etc) Miscommunication amongst health care practitioners Variations do exists in levels of practice amongst different health care institutions Egypt s perspective, STG s Current efforts Clinical pharmacy implementation: strengthening communication between HCP, establishment of Drug Information Centers (DIC s) to provide additional resources for prescribers Supply chain project: aimed to align (procurement +distribution+ storage+ dispensing process), enforcement of STG will facilitate an efficient supply chain cycle Participating in the WHO (AMR/ABR surveys) 3

4 Egypt s perspective, STG s Periodical updating of the Egyptian Essential Drug List (EDL). Treatment protocols indicate whether products should be placed on the list. RX/OTC classification ( approval from ministry in July 2014), aimed at strengthening ties on prescribing and dispensing process Pilot project under way with new hepatitis C treatments (Egypt has one of the highest incidence and prevalence worldwide) Egypt s perspective, STG s Adopting Pharmacoeconomic principles is creating an awareness campaign amongst health care practitioners Aim is to better utilize and allocate our drug spending ( Governmental + Out of pocket expenditures) Outcomes Research! 4

5 Conclusion Areas of opportunity do exist to further assist with implementation and enforcement of STG s in Egypt. With our limited health care resources and financing, STG s can assist with better allocating our drug spending. PE/OR have a major role in decision making process for treatment protocols 10 5

6 STANDARD TREATMENT GUIDELINES (STG'S) AND THE EFFECT OF LACK OF IMPLEMENTATION Case study: HIV monitoring in Uganda B. Castelnuovo, PhD Infectious Diseases Institute, Makerere University College of Health Sciences ISPOR Uganda Chapter Standard Treatment Guidelines in Uganda Disease specific guidelines 6

7 Case study Monitoring antiretroviral treatment in HIV infected adults in Uganda HIV in Uganda HIV burden : 1.5 million people, estimated HIV prevalence: 7.3% Number of adults and children in HIV care: 883,736 Coverage of viral load monitoring: No data HIV AND AIDS UGANDA COUNTRY PROGRESS REPORT;

8 HIV monitoring by WHO guidelines Immunologic (CD4 count) Immunologic failure Virologic (viral load) If available Every 6 months Use only if VL is Along with VL not available 1) Fall of CD4+ count to/below pre-therapy 2) 50% fall from peak 3) Persistent CD4+ count<100 cells/ L Confirm ART failure Confirm ART failure Every 6 months Viral failure VL >10,000 copies/ml VL > 5000 copies/ml If available every 6 months > 1,000 HIV Ugandan guidelines VL: optional VL: recommended Revisions prompted by WHO guidelines updates 8

9 Immunologic (CD4 count) Immunologic failure Virologic (viral load) Monitoring in a Ugandan research setting If available Every 6 months Use only if VL is Along with VL not available 1) Fall of CD4+ count to/below pre-therapy 2) 50% fall from peak 3) Persistent CD4+ count<100 cells/ L Confirm ART failure Confirm ART failure Every 6 months Viral failure VL >10,000 copies/ml VL > 5000 copies/ml If available every 6 months > 1,000 copies/ml Infectious Diseases Institute HIV Research cohort Commenced in 2004, 6 months VL (cut off 1,000) and CD4 count Clinical practice HIV & CD4 count monitoring Barriers to adoption of guidelines Lack of manpower Inadequate training Lack of laboratory facilities No electricity or electricity interruptions Interruptions in the supply chain (e.g. reagents) Lack of financial resources Poor data for planning resource allocation 9

10 Operational Research supporting practice Change in policy Guidelines- immunologic monitoring Barriers in implementing guidelines Change in practice Clinical practice- implementation of guidelines Operational Research supporting practice Change in policy Guidelines- immunologic monitoring Supporting change in practice Operational research- validation and making operational point of care CD4 count testing Change in practice Clinical practice- implementation of guidelines 10

11 Studies from Cohort form a gold standard Time on ART SOC SOC+VL Exclusive VL Month 3 NA NA 21 Month Months NA Month NA Castelnuovo B, Parkes R, Kakaire T, Sempa J, Reynolds S, Lamorde M MONITORING ANTIRETROVIRAL THERAPY IN UGANDA: BUDGET IMPACT ANALYSIS OF TWO STRATEGIES FOR VIRAL LOAD MONITORING VERSUS IMMUNOLOGIC MONITORING Research anticipating guidelines Change in policy Guidelines- immunologic monitoring Change in practice Guidelines evaluation CD4 count monitoring Cohort studies Cost analysis Change in policy New guidelines 11

12 Standard Treatment Guidelines (STGs) and the Effect of a lack of implementation Shelley McGee, PRICELESS SA (Wits School of Public Health) For ISPOR South Africa Chapter STGs in South Africa South Africa first published Standard Treatment Guidelines and Essential Medicines Lists in levels: Primary Health Care Hospital Adults Hospital Paediatrics 2013 added a Tertiary/Quaternary level EML, but no accompanying STG Included in medical and pharmacy curricula including competency requirements for assessment of nurses Regular review and revision of STGs and EML 12

13 Percentage supplied (standard deviation) South African Health Care Prescribed Minimum Benefits Clinical Society and International Guidelines 16% 21%? Private sector 8.5 million people Private medical insurance $1,000 pc per annum 90 private insurers?? million people No insurance - use private providers Pay out of pocket STGs 63% Public sector 46 million people Tax funded $250 pc per annum 9 provinces Fragmented Clinical Guideline Application Compliance with the STGs and EML 2004 Study into antihypertensive use in sixteen hospitals STG at the time: 1. diuretics 2. Reserpine 3. Beta Blockers 4. ACEI 5. CCB Proportion of Antihypertensives Supplied to hospitals over a six month period Diuretics ACEI Methyldopa Reserpine Beta blockers CCB Pharmacological Agents Supplied over 6 months Source: Pillay, A; Hill, S. Impact of an essential drugs list and treatment guidelines on prescribing in South Africa.. Presentation at ICIUM Conference 2004 Suggested STGs were not being followed Other 13

14 Going beyond the STGs and EML 2011 Source: McGee, S. The Essential Medicines List as the Basis for National Health Insurance Benefits. Poster presentation to South African Public Health Association conference, 2012 Significant deviation outside of the EML and STGs STG and EML Application Provision of health care in the public sector is the responsibility of the provinces (9) Each province has a Pharmacy and Therapeutics Committee 2011 Western Cape had 180 molecules on its provincial list which were NOT on the EML Source: McGee, S. The Essential Medicines List as the Basis for National Health Insurance Benefits. Poster presentation to South African Public Health Association conference, 2012 Varied Accessibility depending on geographic situation 14

15 Compliance with the STGs Source: Khaole, O et al Compliance with National Tuberculosis Treatment Guidelines in Six Provinces in South Africa. Presentation to 4 th South African Tuberculosis Conference, June 2014 Even in critical disease areas STG compliance varies Differing Guidelines Prescribed Minimum Benefit Algorithms (2004) Clinical Society Guidelines (2011) reference JNC7 STGs PHC (2008) and Adult Hospital (2012) Clinical Disagreement, fragmentation & access issues 15

16 Department of Health Actions View on common processes within the proposed National Health Insurance (NHI) Process to rationalize and align national medicines tenders and purchasing with the EML and STGs Inclusion of private health insurers on the EML technical subcommittees Suggestion that the medical scheme use the STGs and EML as the basis for their formularies = requires regulatory reform Moves in the direction of the adoption of STGs for all Conclusion South Africa s STG and EML processes have been in place for a number of years STG and EML review now functioning well There is deviation from STGs on a number of levels Provinces entitled to make additions to the medicines they make available Provinces practise differently even in the face of guidelines Multiple sets of guidelines make prescribing, provision and reimbursement more difficult Moves towards harmonizing the processes 16

17 Thank you Shelley McGee Health Economist PRICELESS SA ISPOR 17th Annual European Congress, November 2014 Amsterdam, The Netherlands ISPOR Arabic & ISPOR Africa Networks STANDARD TREATMENT GUIDELINES (STG'S) AND THE EFFECT OF A LACK OF IMPLEMENTATION Dr. Ola Ghaleb Al Ahdab, PhD, PGD, RPh, BSc. Pharm. President, ISPOR United Arab Emirates Chapter Pharmaceutical Advisor, Drug Dept. MoH, UAE. Adjunct Assistant Professor, Colleges of Pharmacy, UAE Visiting Post Doctoral Research Fellow, School of Pharmacy, Queens University of Belfast, NI, United Kingdom Vice-President for Pharmacy Society, EMA ola.ghaleb@eim.ae 17

18 STANDARD TREATMENT GUIDELINES (STG'S) AND THE EFFECT OF A LACK OF IMPLEMENTATION Agenda STANDARD TREATMENT GUIDELINES-RELATEDV TERMS UNITED ARAB EMIRATES AN OVERVIEW HEALTH CARE SYSTEM & STG IN THE UAE SUMMARY Arabic& Africa Network Forum-ISPOR 17, Amsterdam, November Standard Treatment Guidelines (STG) Involve drug therapy and all other aspects of patient care such as laboratory tests, x-rays and surgery. Recommended series of actions concerning a specific disease or condition Evidence based medical treatment and prescribing guidelines Enhance consistency, improve quality of care and improve outcomes for patients while reducing costs. Arabic& Africa Network Forum-ISPOR 17, Amsterdam, November

19 Standard Treatment Guidelines (STG) Advantages Standardizing delivered care Evidence based approach Assure quality of care Promote patient safety and care Increased patient satisfaction Utilize health care resources efficiently Reduce unwanted variation in outcomes Clinical: reduce complications & admissions to ICU Economic: Reduce hospital stay,, cost of complications Arabic& Africa Network Forum-ISPOR 17, Amsterdam, November STG: Guiding Principles Evidence-based STG Transparent and unbiased decision making selection criteria and process Uniformity between drug formulary and STGs Uniformity between local and national health care programs Related training and education Indicators of process, impact, and outcome Arabic& Africa Network Forum-ISPOR 17, Amsterdam, November

20 STANDARD TREATMENT GUIDELINES/PROTOCOLS ( STG) Enhances other medication management practices designed to optimize patient care, including: Formulary Management Drug utilization review/ drug use evaluation programs Physician, pharmacist and other HCP education. Patient education and empowerment Outcomes research Arabic& Africa Network Forum-ISPOR 17, Amsterdam, November UAE: Facts and Figures Population: 8.2 population (2010) 1, 9.3 million (est 2014) 2 Age structure: years 81%, 0-14 years 18 %, 65 years 1% Total life expectancy at birth 77 years Total GDP $ bn 3 2nd in GCC 3rd in MENA region One of most organized & fastest growing health care markets in the GCC Has highest per capita drug expenditure in ME Has strong HC infrastructure UAE is a medical tourism hub in the GCC and the Middle East UAE has the most attractive Investment environment 4 1.UAE Statistics 2. World Bank Reports 3. MOE The Global Competitiveness Index Report 2014 Arabic& Africa Network Forum-ISPOR 17, Amsterdam, November

21 Health Care System in the UAE Industry is fuelled with latest technology Government operates the majority of hospitals in the UAE International service providers manage many facilities with higher standards The UAE s MOH has mandated all facilities to achieve JCI accreditation Private sector participation has increased over last few years Arabic& Africa Network Forum-ISPOR 17, Amsterdam, November Health Care System in the UAE Regulator Payer HC Providers Federal laws International obligations Ministry of Health Local health Authorities Governmental & Semi Gov. (MoH, HAAD/SEHA, DHA) + Private sector Free Medical Zones Health Insurance Governments Employers Individuals Non profit organization Health Insurance models becoming the dominant way of health funding. Arabic& Africa Network Forum-ISPOR 17, Amsterdam, November

22 STG in UAE National Standard Treatment Guidelines: MoH develop/ Update few STG such as: i.e. Antihypertensive, Tuberculosis, Diabetes ( Local Health Authorities STG: 1. Abu Dhabi Health Authority (HAAD): Clinical Care Pathways Stakeholders efforts: (HAAD, healthcare providers, insurers) Developing 68 evidence-based clinical care pathways Priority : cardiovascular disease, cancer control and prevention, and occupational health. 2. Dubai Health Authority (DHA) Guidelines ulation/regulationsandstandards/pages/healthcarefacilities.aspx Arabic& Africa Network Forum-ISPOR 17, Amsterdam, November Executive Summary UAE is one of the most organized and fastest growing health care markets in GCC Quality health care standards and reform are at the top priority list at the UAE GOV agenda Abu Dhabi Health Authority has the lead in the health reform and in implementing high standard health care system Joint efforts required to develop, implement and update national STG efficiently Pharmacoeconomics & HTA are future s decision making tools in STG, formulary inclusion and re-imbursement process Outcomes research and drug use studies are required to assess and evaluate the prescribing trend and compliance with standard treatment guidelines Arabic& Africa Network Forum-ISPOR 17, Amsterdam, November

23 ISPOR 17th Annual European Congress November 2014, Amsterdam, The Netherlands Dr. Ola Ghaleb Al Ahdab, PhD, PGD, RPh, BSc. Pharm. President, ISPOR United Arab Emirates Chapter Pharmaceutical Advisor, Drug Dept. MoH, UAE. Adjunct Assistant Professor, Colleges of Pharmacy, UAE Visiting Post Doctoral Research Fellow, School of Pharmacy, Queens University of Belfast, NI, United Kingdom Vice-President for Pharmacy Society, EMA ISPOR Arabic & ISPOR Africa Networks, Forum, Amsterdam, November Standard Treatment Guidelines and Effects of a Lack of Implementation By Anthony Waka Udezi, PhD Dept. of Clinical Pharmacy Faculty of Pharmacy University of Benin, Nigeria 23

24 Outline Introduction Objective of Nigeria s STGs The missing links Effects of non implementation Proposed solutions conclusion Introduction - Nigeria Population of 173.6MILLION GDP is $521.8billion with a growth rate of 5.4% Inflation rate is 8.5% Unemployment rate is 24% Less than 5% have health insurance Infant mortality is per 1000 live births Maternal mortality is 630 per live births 24

25 Introduction- STGs Overview STGs promotes evidence based systematic uniform management of patients with the same health and demographic characteristics in a cost effective manner Nigeria s STGs was produced in 2005 by the Federal Ministry of Health in consultation with healthcare practitioners and other stakeholders Technical assistance and funding was provided by the European Commission and the World Health Organization. Objectives of Nigeria s STGs Promote the rational use of drugs hence promote quality healthcare Reduce disease burden thus reduce healthcare bill Assist prescribers in their duties such that only drugs in the essential drug list are used in disease management and prevention STGs should be a major reference document for all healthcare workers in both public and private sectors 25

26 The missing links Lack of organized local evidence based treatment outcomes for medicines.therefore, does the STG contain medicines fit for use by patients in other Countries with characteristics that may differ from that of Nigeria? No training on how to use the guidelines Prescribers were not followed up for compliance and the document has not been reviewed since 2005 considering the dynamic nature of healthcare The missing link-2 Incomplete Nigeria s STG does not contain Glaucoma management Many healthcare practitioners in Nigeria have not seen and do not have a copy of the STG though may have heard of it s existence and free copies are actually available at the Federal Ministry of Health. The above seems to suggest lack of OWNERSHIP by the stakeholders despite wide consultations during the production process Document is difficult to use- appears to be a mere reference document for treatments rather than a road map to treatment selection based on objective and subjective patient data Unstable healthcare system characterized by strikes and interprofessional squabbles 26

27 Effects of Lack of implementation Treatment failures, prolonged pain and suffering of patients Increased healthcare cost due to high rate of relapse and emergency visits Excessive workload for healthcare workers due to relapse and emergency visits Over worked healthcare force increases medical and dispensing errors, poor motivation and lack positive feedback from patient management Increased disease burden retards economic growth of the nation. Proposed Solutions I strongly believe that Nigeria s health care problems are largely due to that of LACK OF ORGANIZATION rather than that of infrastructure and manpower. 27

28 Proposed Solutions Federal Level Policy consistency and the political will to implements programs should be entrenched Reorganization of medical records units nation wide Nationally coordinated synthesis of local evidence on drug use and treatment outcomes Review of current STG ; identification and resolution of ownership issues working against assimilation of STGs into normal practice Feedback mechanism between the Federal Ministry of Health and all government owned hospital with proper regulation and supervision of private clinics Proposed Solutions- At the point of care Training on how (and why) STGs should be used Inter professional collaboration between all stakeholders Academic detailing: hospital based units examines prescription patterns of prescribers and have discussions with them with a view of improving compliance and highlighting the cost and health implications of nonadherence to STGs. 28

29 Conclusion Lack of compliance with STGs makes monitoring and evaluation of healthcare to be difficult since it appears that there is no universally accepted standard of patient care in Nigeria. Thank you. ISPOR Forum STANDARD TREATMENT GUIDELINES (STG'S) AND THE EFFECT OF A LACK OF IMPLEMENTATION STANDARD TREATMENT GUIDELINES (STG'S) AND THE EFFECT OF A LACK OF IMPLEMENTATION: GHANA s Experience By Peter Agyei-Baffour, PhD Department of Community Health Kwame Nkrumah University of Sciences and Technology Kumasi, Ghana ISPOR 17 th Annual European Congress Amterdam RAI 8-12, November

30 Background information Area land sq. km Population density per sq. km 99 Literacy Rate (2010 census) 71.5% STATISTICS Total population (2012) 25,366,00 0 GDP 2013 estimate $/Billion Gross national income per capita (PPP international $, 2012) Life expectancy at birth m/f (years, 2012) Probability of dying under five (per live births, 2012) Probability of dying between 15 and 60 years m/f (per population, 2012) Total expenditure on health per capita (Intl $, 33 1,910 61/ / Summary of health statistics Total Health Facility 3219 Number of OPD Attendance Outpatient Attendance per capita Number of Hospital Beds Hospital bed utilization % occupancy Case fatality ratio for Malaria 19,747, , The Health Sector in Ghana, Facts and Figures 2010, Ghana Health Service HIV/AIDS (Adult Prev. 1.8 % 30

31 Organisation of HEALTH Background Standard treatment guideline A systematically developed statement designed to assist practitioners and patients in making decisions about appropriate health care for specific clinical circumstances STGS are important because: Treatment of diseases may have many alternative approaches and choice has to be made Many practitioners will not remember the best method of treatment all the time Applying the most effective treatment benefits both the patient and the health care system Formulary management will have only limited impact if the medicines are used incorrectly 31

32 ADVANTAGES OF STG Provide assistance to all health care providers, especially to those with lower skill levels Ensure patients are receiving optimal therapy Help providers to concentrate on making the correct diagnosis Provides a basis for evaluating quality of care Provide effective therapy in terms of quality Provide a system for controlling costs Provide inputs for forecasting and ordering CHALLENGES IN THE USE OF STG s The use of STGs could be dangerous if: inaccurate guidelines are used. Guidelines are based on existing practice rather than evidenced based It is expensive to develop STGs takes much time and effort 32

33 Rationale for implementation of STGs in Ghana Ghana has a comprehensive STGs which has undergone various reviews since 1983 Ghana currently has a sixth edition of STGs s and it is in the process of receiving another review Implementation of STG s to standardize treatment and contain cost importance of STG s in Ghana Provide cost containment measure for the growing National Health Insurance Scheme Reduce inappropriate prescription of medicines Minimize Irrational medication use Eradicates the provision of low quality health care Reduce health care cost for providers and patients Eradicates Misuse and misallocation of scarce resources Check inefficiencies, fraud, etc in the healthcare delivery system 33

34 EFFECTS OF LACK OF IMPLEMENTATION The reverse of slide nine holds. CONCLUSION ISPOR is a formidable group to provide sound pharmacoeconomics analysis of drug utilization, generate evidence for the selection of drugs into the STG and the adherence of STGs in provision of quality health care in Ghana and Africa 34

35 THANK YOU! Reference MoH, Republic of Ghana Treatment Guidelines, 6 th Edition 35