Pharmacy and Poisons Board Pharmacy and Poisons Board, Kenya Post Market Surveillance KNH/UON Pharmacy Symposium Optimizing Medicine use to Improve Patient

Pharmacy and Poisons Board

Pharmacy and Poisons Board, Kenya

Post Market Surveillance

KNH/UON Pharmacy SymposiumOptimizing Medicine use to Improve Patient Outcome

Edward AbwaoPharmacy and Poisons Board

16th May 2014



Post 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).



Why 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.



Post Market Surveillance: Importance

• PMS ensures that, even after registration, drugs continue to meet the required standards whilst in the market.



Post 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 etc

• Reactive PMS refers to:

– follow up on complaints from spontaneous reporting



• 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;

1. Recall

2. Quarantine

3. Suspension of marketing authorization

4. Withdrawal

Edward Abwao



In our Pharmacovigilance and Post-Market Surveillance activities

• We can all appreciate there is a place for Regulatory

Actions to be undertaken

• These need to be undertaken at the soonest in many cases

to avoid greater potential harm that the poor quality

medicine can inflict on its consumer

• However, actions need to be based on facts, ‘proof’ and/ or

reports of potential to cause harm Jayesh- Pharmacovigilance



Summary of findings… • PMS of Anti-TB Medicines:

– 1 product unregistered– 8% (10/120) failed: assay… all over 110% upper mark

• PMS of Antiretroviral Medicines:- 27% (26/95) unregistered - 0.37% (1/274) failed analysis: uniformity of weight*

• PMS of Antimalarial Medicines:– 6% (36/536) samples unregistered– 16% (7/44) samples failed lab compendia analysis

Jayesh- Pharmacovigilance



Common Regulatory Problems

• Unregistered products found in the market

• Poor quality medicines found in the market

• Storage of medicines in public health facilities wanting




Common Regulatory Actions on PMS

Step wise:

• Unregistered medicines identified

• Poor 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 out




Common Regulatory Actions on PMS (2)

• Implicated company pharmacists summoned to

Practice / Enquiries and Disciplinary Committee of PPB

• Inspection of cGMP enhanced

• Closure of pharmaceutical manufacturer / distributor

• Continued vigilance of medicines implicated

• Newsletters published and disseminated widely with alert

of the medicines

• Consumer awareness




Brand Name Active Ingredient Manufacturer Batch No. Reason for Recall

Utracaine Heavy Injection

Bupivacaine Hcl 5mg & Dextrose 80mg/ml

J ayson Pharmaceutical Ltd, Bangladesh

All batches Complaints on lack of efficacy, products failed quality analysis

Minyua Oral Suspension

Mebendazole 100mg/5ml

Cosmos Ltd, Kenya

100299 Caking of suspension

Amoebazole Suspension

Metronidazole Sphinx Pharmaceuticals, Kenya

0251M Crystallization of suspension

Paracetamol Paracetamol 500mg Tablets

For Shangai Pharma Ind. Ltd, China by Ningbo Shuangwei Pharmaceutical Co. Ltd

081201,090106, 081254,081219

Moulding and Discolouration

HePBQuin Injection

Hepatitis B immunoglobulin

Sanquin, Netherlands 08K20H506A Package insert not complying to PPB requirements

Rihide—P Paediatric Tablets

Rifampicin 60mg/ Isoniazid 30mg

Cosmos Limited 080648, 080650, 080652

Products failed quality tests

Ethambutol/ Isoniazid Tablets

Ethambutol 400mg / Isoniazid 150mg

Svizera Europe BV SL836, SL889 Products failed quality tests

Gentamicin Injection

Gentamicin 20mg/ml Dawa ltd, Nairobi Kenya 0710304 Non-compliance to labeling requirements

Augpen Oral Suspension

Amoxicillin / Clavulanate potassium 156mg/

Emcure Pharmaceuticals ltd, India

PFA 09008 Change of colour

Benzyl Penicillin 1 MU

Benzyl penicillin 5ml 1 MU

Nestor Pharmaceuticals Ltd

All batches Corrosion on caps

Gestamol Tablets

Paracetamol BP 500mg

Gesto Pharmaceuticals Ltd

All batches Change of colour, growing mould



Examples 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 PPB

1. Poor quality Paracetamol tablets2. Poor quality Benzypenicillin3. Scheriproct ointment 4. B-Immune sachets5. Diuride 20mg6. Typhim Vi® (Typhoid vaccine) by Sanofi Pasteur7. Polaramine expectorant

Edward Abwao



Examples of quarantine

1. Darrow’s solution

2. Hartman’s solution

3. Dextrose 5%

4. Oxytocin injections

5. HES containing solutions

Edward Abwao



Examples 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.

1. Nimesulide tablets

2. Vioxx (Rofecoxib)- incrased risk of cardiovascular events

3. Chlorproguanil + Dapson (Lapdap)- anemia in G-6-PD deficient patients

4. Thalidomide

Edward Abwao



Rescheduling

• This can be done to move medicines from POM, OTC• E.g SPs moving from POM to OTC• Chloroquin rescheduled from OTC to POM

Policy Change• E.g putting patients on TDF instead of D4t due to the

safety concerns

Edward Abwao




Brand Name Active Ingredient Manufacturer Batch No. Reason for RecallUltracaine Heavy Injection

Bupivacine HCl 5mg and Dextrose 80mg/mL

Jayson Pharmaceutical Ltd, Bangladesh

All batches Complaints on lack of efficacy; Products failed analysis

Minyua Oral Suspension

Mebendazole 200mg/5mL

Cosmos Ltd, Kenya 100299 Caking of suspension

Amoebazole Suspension

Metronidazole Sphinx Pharmaceuticals, Kenya

0251M Crystallization of suspension

Paracetamol Tablets

Paracetamol 500mg Ningbo Shuangwei Pharmaceutical Co. Ltd

081201, 090106, 081254, 081219

Moulding and Discolouration

HePBQuin Injection

Hepatitis B immunoglobulin

Sanquin, Netherlands

08K20H506A Package insert not complying to PPB requirements

Rihide-P Paediatric Tablets

Rifampicin 60mg/ Isoniazid 30mg

Cosmos Ltd 080648, 080650, 080652

Products failed quality analysis

Ethambutol/ Isoniazid Tablets

Ethambutol 400mg/Isoniazid 150mg

Svizera Europe BV SL836, SL889 Products failed quality analysis

Gentamicin Injection

Gentamicin 20mg/mL

Dawa Ltd, Kenya 0710304 Non-compliance to labeling requirements

Augpen Oral Suspension

Amoxicillin / Clavulanate potassium 156mg/5mL

Emcure Pharmaceuticals Ltd, India

PFA 09008 Change of colour



Brand Name Manufacturer Reason for mopping out of the market and destruction

Co-Malasin Tablets Dawa Ltd, Nairobi, Kenya Unregistered

Arsun-AQ Tablets Dawa Ltd, Nairobi, Kenya Unregistered

Arex Suspension Gesto Pharmaceuticals Ltd Unregistered

Lum-artem Oral Suspension Gesto Pharmaceuticals Ltd Unregistered

Co-fantrin Tablets Comet Healthcare Ltd Unregistered

Daquinex Oral Solution Comet Healthcare Ltd Unregistered

Artecure Tablets Mepro Pharmaceuticals Ltd Unregistered

Comether Tablets Pharma Link Laboratories Unregistered

Pharmasidar Tablets Shanghai Pharmateq Unregistered

Artefantrine Tablets NBSW Pharma Ltd Unregistered

Quinine Tablets Urnav B.V. Unregistered

Spectino 2g Injection Dawa Ltd, Kenya Unregistered



Various PV sensitizations



• www.pv.pharmacyboardkenya.org• PPB 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• www.ctr.pharmacyboardkenya.org

http://www.pv.pharmacyboardkenya.org/

http://www.ctr.pharmacyboardkenya.org/





Launch of PVERS



AL CEM Launch



PV Training of UoN final year students



Specific Activities (2)

• Introduction of mini-lab screening for antimalarials– Scale up to ARV and anti-TB medicines currently ongoing

• Development of a Post Market Surveillance Strategy (PMS) for Kenya

• Collaboration with WHO, USAID and other partners

• Collaboration with INTERPOL and ACA on SSFFCs



Returns from our activities

– “Caking

– Not-flowing

– Moulding

– Laminating

– Floating particles

– Crystalization

– Corrosion of Al covers

– Change of colour

– Poor coating

– Chipping

– Poor packaging

– Expired medicines

– Lack of efficacy

– Suspected counterfeits

– Un-registered products...”

Poor quality medicinal products complaints received:



Ever seen this?



Challenges

1. Lack of enough funds

2. Fewer members of staff

3. Delays in getting laboratory analysis results

4. Politics

5. Unscrupulous businessmen/ professionals

6. Under reporting – most cases are not reported

7. Consumer reporting for suspected ADRs and Poor Quality Medicines



Thank you very much



Our contact …

Directorate of Medicines Information and PharmacovigilancePharmacy and Poisons Board

Lenana Road

P.O. Box: 27663-00506 Tel: +254-(020) 3562107

Nairobi KENYA 2716905/6

Fax: +254-(020) 2713431 / 2713409

e-mail: [email protected]

www.pharmacyboardkenya.org

mailto:[email protected]

http://www.pharmacyboardkenya.org/

Documents

Pharmacy and Poisons Board Pharmacy and Poisons Board, Kenya Post Market Surveillance KNH/UON Pharmacy Symposium Optimizing Medicine use to Improve Patient