Presentation on theme: "Post Market Surveillance KNH/UON Pharmacy Symposium Optimizing Medicine use to Improve Patient Outcome Edward Abwao Pharmacy and Poisons Board 16th."— Presentation transcript:
1Post Market Surveillance KNH/UON Pharmacy Symposium Optimizing Medicine use to Improve Patient Outcome Edward Abwao Pharmacy and Poisons Board 16th May 2014
2Post Market Surveillance: Definition Post-market surveillance refers to all the processes that are carried out to continuously track/ monitor quality, safety and efficacy of medicines in the market (after registration).
3Why Post Market Surveillance? Medicines do not necessarily retain their quality, safety, efficacy after registration over their shelf life.Several factors from shipment, warehousing, distribution and eventual dispensing to patients such as handling and storage conditions can affect quality of the medicines.Some people can compromise on these factors and inherent quality of medicine by adopting unethical business practices.Varying climatic conditions in the country may affect quality of medicines.
4Post Market Surveillance: Importance PMS ensures that, even after registration, drugs continue to meet the required standards whilst in the market.
5Post Market Surveillance System It involves active and reactive PMS.Active PMS refers to:coordinated surveys, sampling and analysis, evaluation and assessment of regulatory requirements in relation to labeling, storage etcReactive PMS refers to:follow up on complaints from spontaneous reporting
6The regulatory actions taken included; Recall Quarantine During the life of a product in the market, quality issues may arise necessitating regulatory action to be taken.The regulatory actions are taken to ensure that the products meet quality, safety and efficacy as per requirements of the law.PPB takes action to ensure that public is not harmed by the continued use of products under investigation.The regulatory actions taken included;RecallQuarantineSuspension of marketing authorizationWithdrawalEdward Abwao
7In our Pharmacovigilance and Post-Market Surveillance activities We can all appreciate there is a place for Regulatory Actions to be undertakenThese need to be undertaken at the soonest in many cases to avoid greater potential harm that the poor quality medicine can inflict on its consumerHowever, actions need to be based on facts, ‘proof’ and/ or reports of potential to cause harmJayesh- Pharmacovigilance
8Jayesh- Pharmacovigilance Summary of findings…PMS of Anti-TB Medicines:1 product unregistered8% (10/120) failed: assay… all over 110% upper markPMS of Antiretroviral Medicines:27% (26/95) unregistered0.37% (1/274) failed analysis: uniformity of weight*PMS of Antimalarial Medicines:6% (36/536) samples unregistered16% (7/44) samples failed lab compendia analysisJayesh- Pharmacovigilance
9Common Regulatory Problems Unregistered products found in the marketPoor quality medicines found in the marketStorage of medicines in public health facilities wantingJayesh- Pharmacovigilance
10Common Regulatory Actions on PMS Step wise:Unregistered medicines identifiedPoor quality medicines identified (lab analysis, mini-lab tests)Letters to implicated manufacturers and distributor of the said products issued to quarantine and recall product(s)Product(s) withdrawn from the market“Pharmacovigilance E-shot” sent outJayesh- Pharmacovigilance
11Common Regulatory Actions on PMS (2) Implicated company pharmacists summoned to Practice / Enquiries and Disciplinary Committee of PPBInspection of cGMP enhancedClosure of pharmaceutical manufacturer / distributorContinued vigilance of medicines implicatedNewsletters published and disseminated widely with alert of the medicinesConsumer awarenessJayesh- Pharmacovigilance
13Examples of some of the recalls include A medicine or a particular batch may be removed from the market due to safety , quality or efficacy concerns.Recall can be voluntary or initiated by PPBPoor quality Paracetamol tabletsPoor quality BenzypenicillinScheriproct ointmentB-Immune sachetsDiuride 20mgTyphim Vi® (Typhoid vaccine) by Sanofi PasteurPolaramine expectorantEdward Abwao
15Examples of withdrawals This involves revocation or cancellation of the marketing authorization by PPB. This is mainly done due to safety concerns but can also b due to quality and efficacy issues.Nimesulide tabletsVioxx (Rofecoxib)- incrased risk of cardiovascular eventsChlorproguanil + Dapson (Lapdap)- anemia in G-6-PD deficient patientsThalidomideEdward Abwao
16Rescheduling Policy Change This can be done to move medicines from POM, OTCE.g SPs moving from POM to OTCChloroquin rescheduled from OTC to POMPolicy ChangeE.g putting patients on TDF instead of D4t due to the safety concernsEdward Abwao
17Jayesh- Pharmacovigilance Brand NameActive IngredientManufacturerBatch No.Reason for RecallUltracaine Heavy InjectionBupivacine HCl 5mg and Dextrose 80mg/mLJayson Pharmaceutical Ltd, BangladeshAll batchesComplaints on lack of efficacy; Products failed analysisMinyua Oral SuspensionMebendazole 200mg/5mLCosmos Ltd, Kenya100299Caking of suspensionAmoebazole SuspensionMetronidazoleSphinx Pharmaceuticals, Kenya0251MCrystallization of suspensionParacetamol TabletsParacetamol 500mgNingbo Shuangwei Pharmaceutical Co. Ltd081201, , ,Moulding and DiscolourationHePBQuin InjectionHepatitis B immunoglobulinSanquin, Netherlands08K20H506APackage insert not complying to PPB requirementsRihide-P Paediatric TabletsRifampicin 60mg/Isoniazid 30mgCosmos Ltd080648, ,Products failed quality analysisEthambutol/ Isoniazid TabletsEthambutol 400mg/Isoniazid 150mgSvizera Europe BVSL836, SL889Gentamicin InjectionGentamicin 20mg/mLDawa Ltd, KenyaNon-compliance to labeling requirementsAugpen Oral SuspensionAmoxicillin / Clavulanate potassium 156mg/5mLEmcure Pharmaceuticals Ltd, IndiaPFA 09008Change of colourJayesh- Pharmacovigilance
18Reason for mopping out of the market and destruction Brand NameManufacturerReason for mopping out of the market and destructionCo-Malasin TabletsDawa Ltd, Nairobi, KenyaUnregisteredArsun-AQ TabletsArex SuspensionGesto Pharmaceuticals LtdLum-artem Oral SuspensionCo-fantrin TabletsComet Healthcare LtdDaquinex Oral SolutionArtecure TabletsMepro Pharmaceuticals LtdComether TabletsPharma Link LaboratoriesPharmasidar TabletsShanghai PharmateqArtefantrine TabletsNBSW Pharma LtdQuinine TabletsUrnav B.V.Spectino 2g InjectionDawa Ltd, Kenya
20PPB has also developed and launched an online reporting system that allows both the healthcare worker and consumers of medicines to submit a report on any suspected poor quality medicine or suspected adverse drug reaction.Developed Pharmacovigilance e-shot (an electronic mailing system used to communicate to subscribers issues of concern)Also for clinical trials
25Specific Activities (2) Introduction of mini-lab screening for antimalarialsScale up to ARV and anti-TB medicines currently ongoingDevelopment of a Post Market Surveillance Strategy (PMS) for KenyaCollaboration with WHO, USAID and other partnersCollaboration with INTERPOL and ACA on SSFFCs
26Returns from our activities Poor quality medicinal products complaints received:“CakingNot-flowingMouldingLaminatingFloating particlesCrystalizationCorrosion of Al coversChange of colourPoor coatingChippingPoor packagingExpired medicinesLack of efficacySuspected counterfeitsUn-registered products...”
28Challenges Lack of enough funds Fewer members of staff Delays in getting laboratory analysis resultsPoliticsUnscrupulous businessmen/ professionalsUnder reporting – most cases are not reportedConsumer reporting for suspected ADRs and Poor Quality Medicines