CUBANPHARMACOVIGILANCE

SYSTEM

Dra Giset Jiménez LópezDra Blanca Estela González DelgadoTéc Jenny Ávila PérezDr Julián Pérez PeñaPharmacoepidemiology Development SystemNational Drug Surveillance Coordinating Unit

The republic of CubaThe republic of Cuba is the largest island of the Antilles is the largest island of the Antilles and encompass 4 195 keys and islets.and encompass 4 195 keys and islets.

Cuba covers 110 922 kmCuba covers 110 922 km22 and is located at the and is located at the entrance of the gulfentrance of the gulf of Mexico in the Caribbean seaMexico in the Caribbean sea

CUBAN HEALTH RECORDS (2005)CUBAN HEALTH RECORDS (2005)

PopulationPopulation 11 25710511 257105Natality gross rateNatality gross rate 10,7 x 1000 hab.10,7 x 1000 hab.Institutional birth percentageInstitutional birth percentage 99,9 %99,9 %Mortality gross rateMortality gross rate 7,5 x 1000 hab.7,5 x 1000 hab.Infant mortality rateInfant mortality rate 6,2 x 1000 n.v.6,2 x 1000 n.v.Paediatric mortality ratePaediatric mortality rate 8,0 x 1000 n.v.8,0 x 1000 n.v.Maternal mortality rateMaternal mortality rate 52,2 x 100000 n.v.52,2 x 100000 n.v.

CUBACUBA DRUG PIPELINE

REGISTRATION

IMPORTING

PRODUCTION

DISTRIBUTION

PRESCRIPTION

DISPENSING

REGULATORY AUTHORITY

FARMACUBA Y MEDICUBA(Government enterprises)

National Pharmaceuticalmanufacturers (58)

ENCOMED (15 Wholesales)2050 retail pharmacies

Pharmacoepidemiology(prescription quality and drug safety)

PHARMACY NETWORK

Cuba Essential Drug List 828 pharmaceutical products

CUBAN HEALTH MINISTER

PDC

15 Provinces

PROTECTION HEALTH

BURO

169 Municipalities

Regulatory AuthorityMedical

Equipment

Nutrition and FoodInstitute

NCUPh

Cuban Pharmacovigilance System Organigram

Health MinistryPharmacoepidemiologyDevelopment Centre

(NCUPh)

WHO (1994)National Centres

Province HealthDirection

ProvincialPharmacoepidemiology

group

Health Professionals.

CUBAN PHARMACOVIGILANCECUBAN PHARMACOVIGILANCEMAIN CHARACTERISTICSMAIN CHARACTERISTICS

Pharmacovigilance National NetworkPharmacovigilance National Network

Spontaneous report systemSpontaneous report system

Expert group discussionExpert group discussion

Quality review of reportsQuality review of reports

Signal generationSignal generation

QUALITY + ANALYSIS

0

5000

10000

15000

20000

25000

30000

96 97 98 99

2000

2001

2002

2003

2004

2005

2006

No de RAM.

Spontaneous reporting in Cuba.1996 -2006

Years

DATA BASE ANALYSISDATA BASE ANALYSIS

Most frequentlyMost frequently--reported drugreported drug--adverse effect adverse effect

associations (change of frequency)associations (change of frequency)

Serious drugSerious drug--adverse effect associationsadverse effect associations

Rarely and Unknown drugRarely and Unknown drug--adverse effect associationsadverse effect associations

DrugDrug--adverse effect associations in risk groupsadverse effect associations in risk groups

Herbals drugHerbals drug--adverse effect associations.adverse effect associations.

Special organ system drugSpecial organ system drug--adverse effect associationsadverse effect associations

MAIN RESULTS LAST 5 YEARS

82 51582 515 ADR reportsADR reports

16 50016 500 reports / yearreports / year

Reporting ratioReporting ratio: : 1467 x 1 000 000 inhab/year1467 x 1 000 000 inhab/year

45.1%45.1% ADR “important” criteriaADR “important” criteria

Stable behaviour of : Health professionals Stable behaviour of : Health professionals (doctors(doctors), Age (), Age (young young

adultsadults), Sex (), Sex (femalefemale), Pharmacological group (), Pharmacological group (Antibiotics, Analgesic Antibiotics, Analgesic

no opioids and Antihypertensives drugsno opioids and Antihypertensives drugs), Organ system class (), Organ system class (skin, skin,

general, digestive systemgeneral, digestive system) and Causality () and Causality (probableprobable))

ADR ratio serious / mildADR ratio serious / mild : 51.4% / 48.3%: 51.4% / 48.3%

FEEDBACK

Courses and training Data base consult Butlletin PublicationsInvestigations Expert group meetingYearly reports Rapid alertsWorkshops Drug related problems

Web Sitehttp://www.cdf.sld.cu

NATIONAL IMPACT

To To ALERTALERT industry and national health industry and national health

systemsystem

Immediate Immediate

Quality of the dataQuality of the data

DRUG SAFETYINFORMATION

Top 20 countriesTop 20 countriesNo of reports /100 000 inhabitants. Vigibase 2005No of reports /100 000 inhabitants. Vigibase 2005

CUBA: place No 13 Source: Uppsala Reports 33 April 2006www.who-umc.org

LOOKING FOWARD...LOOKING FOWARD...

ADRs hospital admission statistics.ADRs hospital admission statistics.

ADRs cost data.ADRs cost data.

ADRs in clinical trials.ADRs in clinical trials.

CaseCase--control studiescontrol studies

Cohort studiesCohort studies

Data miningData mining

Centro para el Desarrollo de la Farmacoepidemiología

Calle 44 y 5ta. Ave. #. 502. Playa. CP 11300Ciudad Habana

Telef.: (537)2026447 Fax:(537) 2047227

email: giset@mcdf.sld.cuestela@mcdf.sld.cujenny@mcdf.sld.cujpp@mcdf.sld.cufrank@mcdf.sld.cu

http://www.cdf.sld.cu