Pharmacy and
Poisons Board, Kenya
Post Market Surveillance
KNH/UON Pharmacy Symposium
Optimizing Medicine use to Improve Patient Outcome
Edward Abwao
Pharmacy and Poisons Board
16th May 2014
Pharmacy and Poisons Board
Pharmacy and
Poisons Board, Kenya
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).
Pharmacy and Poisons Board
Pharmacy and
Poisons Board, Kenya
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.
Pharmacy and Poisons Board
Pharmacy and
Poisons Board, Kenya
Post Market Surveillance: Importance
• PMS ensures that, even after
registration, drugs continue to meet
the required standards whilst in the
market.
Pharmacy and Poisons Board
Pharmacy and
Poisons Board, Kenya
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
Pharmacy and Poisons Board
Pharmacy and
Poisons Board, Kenya
• 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
Pharmacy and Poisons Board
Pharmacy and
Poisons Board, Kenya
In our Pharmacovigilance and PostMarket 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
Pharmacy and Poisons Board
Pharmacy and
Poisons Board, Kenya
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
Pharmacy and Poisons Board
Pharmacy and
Poisons Board, Kenya
Common Regulatory Problems
• Unregistered products found in the market
• Poor quality medicines found in the market
• Storage of medicines in public health facilities wanting
Jayesh- Pharmacovigilance
Pharmacy and Poisons Board
Pharmacy and
Poisons Board, Kenya
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
Jayesh- Pharmacovigilance
Pharmacy and Poisons Board
Pharmacy and
Poisons Board, Kenya
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
Jayesh- Pharmacovigilance
Pharmacy and Poisons Board
Brand Name
Active Ingredient
Manufacturer
Utracaine Heavy Bupivacaine Hcl 5mg
Injection
&
Dextrose 80mg/ml
Batch No.
Reason
forand
Pharmacy
Recall
Poisons Board, Kenya
Jayson 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, Moulding and
081254,081219 Discolouration
HePBQuin
Injection
Hepatitis B
immunoglobulin
Sanquin, Netherlands
08K20H506A
Rihide—P
Paediatric
Tablets
Rifampicin 60mg/
Isoniazid 30mg
Cosmos Limited
080648,
Products failed
080650, 080652 quality tests
Ethambutol/
Ethambutol 400mg /
Isoniazid Tablets 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 Benzyl penicillin
1 MU
5ml 1 MU
Nestor Pharmaceuticals
Ltd
All batches
Corrosion on caps
Gestamol
Tablets
Gesto Pharmaceuticals
Ltd
All batches
Change of colour,
growing mould
Paracetamol BP
500mg
Pharmacy and Poisons Board
Package insert not
complying to PPB
requirements
Pharmacy and
Poisons Board, Kenya
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.
2.
3.
4.
5.
6.
7.
Poor quality Paracetamol tablets
Poor quality Benzypenicillin
Scheriproct ointment
B-Immune sachets
Diuride 20mg
Typhim Vi® (Typhoid vaccine) by Sanofi Pasteur
Polaramine expectorant
Edward Abwao
Pharmacy and Poisons Board
Examples of quarantine
1.
2.
3.
4.
5.
Darrow’s solution
Hartman’s solution
Dextrose 5%
Oxytocin injections
HES containing solutions
Edward Abwao
Pharmacy and Poisons Board
Pharmacy and
Poisons Board, Kenya
Examples of withdrawals
Pharmacy and
Poisons Board, Kenya
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
Pharmacy and Poisons Board
Pharmacy and
Poisons Board, Kenya
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
Pharmacy and Poisons Board
Brand Name
Ultracaine Heavy
Injection
Minyua Oral
Suspension
Amoebazole
Suspension
Active Ingredient
Bupivacine HCl 5mg
and Dextrose
80mg/mL
Mebendazole
200mg/5mL
Metronidazole
Paracetamol
Tablets
Paracetamol 500mg
HePBQuin
Injection
Hepatitis B
immunoglobulin
Rihide-P Paediatric Rifampicin 60mg/
Tablets
Isoniazid 30mg
Ethambutol/
Isoniazid Tablets
Gentamicin
Injection
Augpen Oral
Suspension
Pharmacy and
Poisons
Board, Kenya
Reason
for Recall
Complaints on lack of
efficacy; Products
failed analysis
Caking of suspension
Manufacturer
Jayson
Pharmaceutical
Ltd, Bangladesh
Cosmos Ltd, Kenya
Batch No.
All batches
Sphinx
Pharmaceuticals,
Kenya
Ningbo Shuangwei
Pharmaceutical Co.
Ltd
0251M
Crystallization of
suspension
081201,
090106,
081254,
081219
08K20H506A
Moulding and
Discolouration
Sanquin,
Netherlands
Cosmos Ltd
100299
080648,
080650,
080652
SL836, SL889
Ethambutol 400mg/ Svizera Europe BV
Isoniazid 150mg
Gentamicin
Dawa Ltd, Kenya
0710304
20mg/mL
Amoxicillin /
Emcure
PFA 09008
Clavulanate
Pharmaceuticals
potassium
Ltd, India
Jayesh- Pharmacovigilance
156mg/5mL
Pharmacy and Poisons Board
Package insert not
complying to PPB
requirements
Products failed
quality analysis
Products failed
quality analysis
Non-compliance to
labeling requirements
Change of colour
Pharmacy and
Poisons Board, Kenya
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
Pharmacy and Poisons Board
Pharmacy and
Poisons Board, Kenya
Various PV sensitizations
Pharmacy and Poisons Board
Pharmacy and
Poisons Board, Kenya
• 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
Pharmacy and Poisons Board
Pharmacy and
Poisons Board, Kenya
Pharmacy and Poisons Board
Pharmacy and
Poisons Board, Kenya
Launch of PVERS
Pharmacy and Poisons Board
Pharmacy and
Poisons Board, Kenya
AL CEM Launch
Pharmacy and Poisons Board
Pharmacy and
Poisons Board, Kenya
PV Training of UoN final year
students
Pharmacy and Poisons Board
Pharmacy and
Poisons Board, Kenya
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
Pharmacy and Poisons Board
Pharmacy and
Poisons Board, Kenya
Returns from our activities
Poor quality medicinal products complaints
received:
– “Caking
– Change of colour
– Not-flowing
– Poor coating
– Moulding
– Chipping
– Laminating
– Poor packaging
– Floating particles
– Expired medicines
– Crystalization
– Lack of efficacy
– Corrosion of Al covers
– Suspected counterfeits
– Un-registered products...”
Pharmacy and Poisons Board
Pharmacy and
Poisons Board, Kenya
Ever seen this?
Pharmacy and Poisons Board
Pharmacy and
Poisons Board, Kenya
Challenges
1.
2.
3.
4.
5.
6.
7.
Lack of enough funds
Fewer members of staff
Delays in getting laboratory analysis results
Politics
Unscrupulous businessmen/ professionals
Under reporting – most cases are not reported
Consumer reporting for suspected ADRs and
Poor Quality Medicines
Pharmacy and Poisons Board
Pharmacy and
Poisons Board, Kenya
Thank you very much
Pharmacy and Poisons Board
Pharmacy and
Poisons Board, Kenya
Our contact …
Directorate of Medicines Information and Pharmacovigilance
Pharmacy 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: pv@pharmacyboardkenya.org
www.pharmacyboardkenya.org
Pharmacy and Poisons Board