eﬀorts'made'by'the'university'of'costa'rica'to'...

Efforts'made'by'the'University'of'Costa'Rica'to'promote'Pharmacovigilance'

!'Victoria'Hall'Ramírez,'Pharm'D,'MS'in'Economics.'

Professor,!Pharmaceu.cal!Care!and!Clinical!Pharmacy!Department,!School!of!Pharmacy!Na.onal!Drug!Informa.on!Center,!Pharmaceu.cal!Research!ins.tute!

University!of!Costa!Rica!

Faculty'and'researchers'involved' '

• CIMED`s team • Pharmaceutical Care I and II

courses professors • Pharmacoepidemiology Topics

course professors • Students involved with projects

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• The author declare no conflict of interest (financial and non-financial).

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Conflict'of'interest '

•  Introduction • Objective • Results

- The Pharmacovigilance System in Costa Rica - School of Pharmacy - Experiences of teaching, social work and research - Colaboration with other stakeholders

• Challenges

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PresentaGon'overview '

• The School of Pharmacy of the University of Costa Rica, has been compromise since 1897 with the Costa Rica`s population health.

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Training!of!pharmaceu.cal!professionals! Provision!of!services!

Development!of!ac.vi.es!that!

directly!affect!the!public!health!of!the!

country!

IntroducGon '

•  Describe the efforts made the School of Pharmacy of the University of Costa Rica and the challenges the academia have in promoting Pharmacovigilance

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ObjecGve '

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Ministry!of!Health!

Na.onal!Health!Security!System!

(CCSS)!

Na.onal!Insurance!Ins.tute!(INS)! Private!sector!

Ins.tute!of!Aqueducts!and!Sewers!(AyA)!

Universi.es!

Other!ins.tu.ons:!IAFA,!INCIENSA!

Source:!Presentación!Atención!Primaria!en!Salud!y!Sistemas!Universales!Dr.!Álvaro!Salas,!2014.!

The'NaGonal'Health'System'in'Costa'Rica '

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•  Popula'on:*5*003*402*inhabitants •  7.6% older than 65 years

•  3 levels - Hospitals -  Clinics -  Basic primary care facilities

•  Private sector Source:!Presentación!Atención!Primaria!en!Salud!y!Sistemas!Universales!Dr.!Álvaro!Salas,!2014!and!INEC.!

The'NaGonal'Health'System'in'Costa'Rica '

• Ministry of Health • National Pharmacovigilance Centre • National Pharmacovigilance Committe • Good Pharmacovigilance Practices* • All the health care proffessional should report adverse

drug reactions (ADR) - Printed Form - Online platform – Noti Facedra

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The'Pharmacovigilance'System'in'Costa'Rica '

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•  Creation of new courses. •  Incorporation of diverse

didactic techniques, besides lectures and laboratory sessions,

such as role plays, community work, case analysis and

simulations.

•  Definition of conceptual, procedimental and attitudinal

contents in each area. •  17 elective courses - 6.07% of the

total credits of the curriculum

•  A new curriculum was developed through a process of reflection, research and selection of contents from interviews with employers, students and teachers, along with the analysis of dominant, decadent and emerging practices in many areas, and according to international realities

Source:!!Arias!Mora!F!et!al.!Case!report:!designing!a!new!curriculum!for!a!PharmD!Degree!Faculty!of!Pharmacy,!University!of!Costa!Rica,!2016.!FIP!Congress.!Seoul,!Korea.!2017!!

School'of'Pharmacy'–'New'curriculum '

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Pharmacovigilance'in'different'courses''

Pharmaceu.cal!Care!and!!Clinical!Pharmacy!

Department!

•  5!courses!•  III,!IV!and!V!year!

Industrial!Pharmacy!Department!

•  5!courses!•  III,!IV!y!V!year!

Pharmacology,!Toxicology!and!

Pharmacodependence!Department!•  4!courses!

•  I,!!IV!and!V!year!

• Mandatory courses in IV and V year •  50-60 students •  8 pharmacist •  2 Pharmacovigilance Lectures about

- Definitions and history - Drug Adverse Reactions and notification in Costa Rica - Medication Errors - Counterfeit medicines

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PharmaceuGcal'Care'I'and'II '

• Practice

• Visit to National Pharmacovigilance Center - Causality assesment workshop

• Practice in community pharmacy •  Identification and report of ADR of a patient in therapeutic

follow-up* - Pharmaceutical interventions to manage the ADR

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PharmaceuGcal'Care'I'and'II '

Pharmacoepidemiology'Topics '

• Elective course in V year • 10-15 students • 3 pharmacist • Pharmacovigilance

- International Pharmacovigilance Programe -  Lectures with proffesionals of industry, regulatory affairs,

hospitals and the National Pharmacovigilance Center. -  Interviews with professionals about pharmacoepidemiology

(pharmacovigilance and pharmacoeconomy)

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• Desing of a campaing to promote report


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Source:!!Hall!V,!Jiménez!LG,!Rocha!M.!Opinion!of!Costa!Rican!pharmacists!regarding!some!aspects!of!the!Spontaneous!Adverse!Drug!Reac.ons!repor.ng,!2017.!ISoP!Liverpool,!2017.!!!


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In!rela.on!to!PV'regulaGons'in!Costa!Rica,!63.16%'of!the!pharmacist!know!about!the!

existence!of!the!one!that!creates!the!Na.onal!Pharmacovigilance!System!

(NPVS)!!and!the!Na.onal!Pharmacovigilance!Center!(NPVC)!and!

52.63%'about!the!one!that!regulated!the!Good!Pharmacovigilance!Prac.ces.!



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Final'research'projects '• Thesis •  Interships • Graduation project • Different scenarios:

- Hospitals - Industry -  Academia -  Specialized centers

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An'experience'with'an'industry '

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Health Authorities

Academia

Industry

Source:!!Calderón!Díaz!T!et!al.!Fomento!de!la!farmacovigilancia,!como!un!servicio!profesional!farmacéu.co:!La!experiencia!del!trabajo!conjunto!entre!academia!e!industria!farmacéu.ca.!SIMPODADER!Internacional,!Granada,!Spain.!2016.!!


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• Bibliographic review • Key words: pharmacovigilance, adverse drug reaction, signal

detection, risk plan management • EBSCO, Access Pharmacy, Pubmed • Legislation in Central America and the Caribbean



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Source:!!Calderón!Díaz!T.!Elementos!Básicos!de!Farmacovigilancia.!1!edición.!2016!!


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• Definitions and history • Adverse Drug Reactions and the importance of the report • Periodic Safety Reports • Signal Detection • Risk Plan Management • Good Pharmacovigilance Practices • Legislation in the Region


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Source:!!Calderón!Díaz!T.!Elementos!Básicos!de!Farmacovigilancia.!1!edición.!2016!!

An'experience'with'an'industry'V'Learning'experience'

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•  Innovative work experience between different stakeholders • Publication for the Region • Promotes report based in the knowledge • Promotes the development and strengthening of legislation in

the region


An'experience'with'an'private'hospital '

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Source:!!Aguilar!Marín!Luis!Diego.!Diseño!de!un!servicio!de!SFT!basado!en!el!método!Dáder!para!su!aplicación!en!el!programa!de!AF!en!un!hospital!privado!en!Costa!Rica.!TFG.!2017!

An'experience'with'an'private'hospital '

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• Development of Standart Operating Procedure - Each phase of therapeutic-follow up with Dader Method - Report of and Adverse Drug Reaction: printed form and on line platform

• Training to pharmacist • Quality of services indicators

-Including number of ADR reports

Source:!!Aguilar!Marín!Luis!Diego.!Diseño!de!un!servicio!de!SFT!basado!en!el!método!Dáder!para!su!aplicación!en!el!programa!de!AF!en!un!hospital!privado!en!Costa!Rica.!TFG.!2017!

Job'posiGons'in'PV'of'our'graduates '

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Source:!!School!of!Pharmacy,!UCR.!Facebook!Profile!12th!November!2018!

2015: 5%

2016: 17%

'Pharmacovigilance'and'social'acGon'in'the'School'of'Pharmacy'

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• Medicine rational use in older adults and other vulnerable populations

• Actions with school and high school students

• Prevention of poisoning

Source:!Faculty!of!Pharmacy!web!page:!hhp://farmacia.ucr.ac.cr/node/81!!

PharmaceuGcal'Research'InsGtute'(INIFAR) '

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Source:!!www.inifar.ucr.ac.cr!!

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Source:!!Jeimy!Blanco.!Pharm!D.!Director!of!LAYAFA.!www.inifar.ucr.ac.cr!!

• Official Laboratory for Quality control of Medicines in Costa Rica

-Guarantee the quality and safety of the medicines registered and sold in the community pharmacies

• Participation in the interinstitucional Commission against counterfeit and ilegal health products – Ministry of Health

PharmaceuGcal'Analysis'and'Advisor'Laboratory'(LAYAFA)'

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PharmaceuGcal'Analysis'and'Advisor'Laboratory'(LAYAFA)'

Source:!Jeimy!Blanco.!Pharm!D.!Director!of!LAYAFA.!No.cias!Repretel.!December,!2017.!

NaGonal'Drug'InformaGon'Center'(CIMED) '

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Medica.on!Therapy!

Management!

Public!Health!

Drug!Informa.on!

NaGonal'Drug'InformaGon'Center'(CIMED)!!'• 11 pharmacist and 15 research assistants

•  Inquiries about ADR and toxicity: - 28.40% during 2012-2016

• ADR reports to National Pharmacovigilance Center: - 69 reports in 2017

• Online courses about pharmacovigilance - 2: PV basics and medication errors

• Workshops with pharmacist -2: internal and external

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Source:!CIMED!Annual!Reports.!

TherapeuGc'follow'up'to'paGents'with'chronic'diseases '

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• CIMED and Pharmaceutical Care II course • Combination of

- Social action - Research - Teaching

• Process - Interview - Identification of drug related problems - Pharmaceutical interventions

Adverse'Drug'ReacGons'idenGfied'2012V2017'n=299'paGents '

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59!ADR!iden.fied!in!the!1st!interview:!!

48!!female,!!11!!male!

56!!of!the!ADR!were!described!in!the!

literature!

No!ADR!requiered!hospitaliza.on!

Source:!Project!Final!Report,!2017.!!

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AVAlimentary'tract'and'metabolism'

20%'

BVBlood'and'blood'forming'organs'3%'

CVCardiovascular''System'26%'

DVDermatologicals'2%'

HVSystemic'hormonal'exc'sex'hormones'and'insulins'

8%' LVAnGneoplasGc'and'inmunomodulators'

5%'

MVMuscoloVskeletal'system''15%'

NVNervous'system'13%'

RVRespiratory'system'6%'

VVVarious''2%'

GRAPHIC'NO.'1'ATC'CLASSIFICATION'OF'SUSPICIOUS'DRUGS'INVOLVED'WITH'ADR'IN'PATIENTS'IN'THERAPEUTICO'FOLLOWVUP'SFT'2012V2017'

N=61'

Source:!Project!Final!Report,!2017.!!

Challenges'for'the'Academy '

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Strengthening partnerships with institutions specialized in patient safety

Publication of experiences that contribute to the generation of knowledge with country data

Measurement of the impact of the actions developed that allow decision-making

Challenges'for'the'Academy '

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Strengthening of the practice in the curriculum

Joint work between Schools that allows to strengthen the teaching of the PV

Take'home'messages'

• Everyone is involved in Pharmacovigilance, no matter the area of pharmacy.

•  It`s necessary to promote the interdisciplinary training at universities with activities at real settings.

• Pharmacovigilance must be an combined effort of different stakeholders.

• Each stakeholder has their own strength so they have to work together to maximize the benefits.

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Contacts'

• CIMED [email protected]

• LAYAFA [email protected]

•  INIFAR [email protected]

• School of Pharmacy [email protected]

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Thank'you'for'your'afenGon!'

•  Victoria Hall Ramírez •  [email protected]

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Efforts'made'by'the'University'of'Costa'Rica'to'promote'Pharmacovigilance'

!'Victoria'Hall'Ramírez,'Pharm'D,'MS'in'Economics.'

Professor,!Pharmaceu.cal!Care!and!Clinical!Pharmacy!Department,!School!of!Pharmacy!Na.onal!Drug!Informa.on!Center,!Pharmaceu.cal!Research!ins.tute!

University!of!Costa!Rica!

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