Pharmacovigilance in Sultanate of Oman - Uppsala Monitoring Centre

Ahmed AlharbiMpharm, MSc

Situated in east of Arabian peninsula Member of the Gulf cooperation council (GCCcountries) Total population◦ 3274000 people as per 2009 sensus

• Launched in 1994• Initially only one pharmacist was dedicated• Oman became a member of the UMC in 1995• In 2003, Pharmacist attended the UMC PVcourse• In 2003, another pharmacist joined thecentre, PhD, pharmacology• In 2011, third pharmacist appointed to jointhe centre Mpharm, MSc, Clinical pharmacy

Receiving and processing spontaneous ADRreports Forwarding ADR reports to UMC periodically Publishing case reports as a feedback activityand another feedback to health careprofessional. Generating alerts on reported ADR Providing national drug information service

Conducting regular workshops to all healthcare professional about ADR reporting Participating as invitees to differentworkshops to give talks aboutpharmacovigilance Providing data to local researcher interestedand related in the field pharmacovigilanceand pharmacoepidemiology

YearNo. of reports2005 2762006 3322007 4732008 6532009 8322010 1066

No. of Spontenous Reports12001000No. of Reports800600400Series120002005 2006 2007 2008 2009 2010Years

Increase awareness Conducting workshops Giving Feedback of reported ADR Addition of the 2 nd staff

Shifted to documenting ADR reports inelectronic format and reporting to UMC using(WINADR) Introduced a new ADR form which includesquality and drug related problems. The formwas piloted in Muscat region which thenvalidated and approved to be used across thecountry Indentified under reporting obstacles bydistributing questionnaires duringworkshops. As a result more workshopsconducted with visual aids facilities.

MINISTRY OF HEALTHDIRECTORATE GENERAL OF PHARMACEUTICAL AFFAIRSAND DRUG CONTROLDEPARTMENT OF DRUG CONTROLName of patient:CONFIDENTIALSUSPECTED ADVERSE DRUG REACTION REPORTON DRUGS / BIOLOGICAL PRODUCTSDate of Birth/Age: Sex: Weight(kg):O.P.D. No:Suspected Drug (trade/brand name):Route:Date Started:Daily Dose:Nationality:Date Stopped:IndicationSuspected Reactions:--Date of onset:Outcome (e.g. fatal/recovered)Date Stopped:Other Drug(Please record all other drugs,including self-medicationtaken during the last 3 weeksand give brand names ifknown)RouteDailydoseDatestartedDatestoppedReason for druguse/indicationAdditional Notes:Reporting Doctor/Health Care provider (block letters)Name:Address:Tel. No.SignatureSpecialty:Date:SEND TO:DURG CONTROL DEPARTMENTDirectorate General of PharmaceuticalAffairs & Drug ControlMinistry of Health, PO Box 393Muscat, PC-113, Sultanate of OmanPhone: 24694744 Fax: 24602287

ONFIDENTIALSuspected Adverse Drug Reaction and other Drug-related Problems ReportA.. Report type (select more than one ifnecessary) Adverse reactions minor or serious to drugs, Increased frequency of given reactionbiologicals or herbals ADRs associated with interactions ADRs occurring from overdose Lack of efficacy (ineffectiveness) ADRs in Special fields of interest: Drug abuse,Pregnancy (teratogenicity), LactationADRs occurring from medication errors:Drug quality problems: wrong drug wrong dose/ route / rate counterfeit drugs If others describe in Part D suspected pharmaceutical defectsOther adverse drug reaction due to non compliance with chemical / physical / Pharmaceutical device Health productsmicrobiological properties or quality of Cosmeticsinformation ADRs associated with drug withdrawals handling difficulty if others describe in Part (D)How many samples affected in the batch_______, please providesample.Patient Informationent (name or initials) : _________________________________________ Weight(kg): ___________________ O.P.D. No: _____________________of Birth/Age:______________________Sex: M / F ( if pregnant in which month__________) Ethnic origin: _______________________Suspected Pharmaceutical ProductTrade Name, dosage form & strength Generic name Dose/Day Route Prescribed forDate started Date stopped Batch No. / Lot Expiry date Manufacturerer drugs taken during the last 3 months or self medication including herbal (Atach additional page if more than two)ade Name Generic Name Route Dose/Day Date started Date stopped Prescribed forSuspected Adverse Reactions / Drug Problem / Errorscribe the reaction / problem / error: _______________________ Outcome: Recovered / Recovering / Not recovered_____________________________________________________ (If treatment given) describe ______________________________________________________________________________________________ _____________________________________________________________________________________________________________________ Seriousness: Do you consider the reaction/s as serious? YES NO_____________________________________________________ If YES, please indicate why? Death (due to the reaction) Life threatening Persistent disability_____________________________________________________ Hospitalization – initial or prolonged Congenital abnormality_____________________________________________________ If other ___________________________________________________________________________ Additional information: e.g. if event reappeared after reintroduction of themedication, all medications taken during pregnancy for congenital abnormality_____________________________________________________ case, test results, known allergies, medical history _____________________________________________________________________________ _____________________________________________________________________________________________________________________ _________________________________________________________________te of onset: ________________or / Reaction appeared after …… _________________________________________________________________y/s of treatment Date reaction stopped: __________________ _________________________________________________________________Reporter informationme ___________________________ Designation: _________________ Do you need feed back on this report? YES (phone call or letter) / NOork address _______________________________________________Send to:one / Mobile No.______________________ Reporting date ___________ Directorate General of Pharmaceutical Affairs & Drug Control, NationalPharmacovigilance Center , Ministry of Health, PO Box 393, Muscat,mail: __________________________ & Signature: _________________Postal code 100Phone: 24692115 Fax: 24602287 e-mail: dg-padc@moh.gov.om

CONTAINS INFORMATION :Basic information onPOSTMARKETINGSURVIELANCE SYSTEA profile of PharmacovigilancecentreContains a (Drug InteractionIndex)

Underreporting despite the annual increment Reports only comes from governmentalhealth institutes Reports from Private health sector are veryminimal Understaffing

Expand the service of the Pharmacovigilanceservice to include drug information Continue in setting up workshops andtraining courses for detecting and reportingADR Introduce E-Reporting system

Involve the private health sector in trainingand/or any awareness activities toencourage detecting and spontaneousreporting of ADR Continue in promoting the ADR reportingby doing regular and frequent presentationof the activity being carried out Continue in feeding back the reporter