Pharmacy and Poisons Board Pharmacy and Poisons Board MOMS-Kenya Jayesh- Pharmacovigilance...

Pharmacy and Poisons Board

Pharmacy and Poisons Board MOMS-Kenya

Jayesh- Pharmacovigilance

Pharmacovigilance in Kenya

Dr. Jayesh M. PanditHead

Dept. of Pharmacovigilance


Ministry of Medical Services

2nd December 2009

5th Global Congress, INTERPOL

Cancun, Mexico




The Pharmacy and Poisons Board




Role of Pharmacy and Poisons Board

The PPB is the Drug Regulatory Authority of the Ministry of Health, Kenya.

It was established in 1957 under the Pharmacy and Poisons Act- Cap 244 of the Laws of Kenya, with the mandate:

“to make better provision for the practice and profession of pharmacy and the trade in pharmaceutical products.”







What is Pharmacovigilance?




Pharmacovigilance• Pharmacovigilance is the science of collecting, monitoring,

researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medicines, biological products, herbals and traditional medicines, with the view to: Identifying new information about hazards, and Preventing harm to patients.

From:• Greek pharmakon- drug• Latin vigilare- to keep awake or alert, to keep watch

• Safety……Efficacy



Post Market Surveillance

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

• Safety……Efficacy……Quality

All drugs are dangerous Some may also be useful

N. Moore, BMJ, 2005, 330;539-40



Widening scope of PharmacovigilanceThese include:

• Substandard and counterfeit medicines• Product development• Medication error reporting• Adverse interactions of medicines with chemicals,

other medicines, and food reports

• Assessment of drug-related mortality • Abuse and misuse of medicines reports • Efficacy monitoring • Off-label use of medicines• Case reports of acute and chronic poisoning






Thalidomide tragedy!

Phocomelia



Stevens Johnsons Syndrome and Toxic Epidermal Necrolysis



• Philippine survey- 8% fake

• Cambodia 1999, 60% of 133 drug vendors sold ineffective and much cheaper sulphadoxine-pyrimethamine as mefloquine tabs.

• 38% of tablets sold in 5 South East Asia countries as artesunate were fake.

• Fake packaging, fake holograms, harmful ingredients…


• Neomycin eye drops and meningococcal vaccine made of tap water

• Paracetamol syrup made of industrial solvent

• Ampicillin containing turmeric

• Contraceptive pills containing wheat flour

• Antimalarials, antibiotics and snake venom containing no active ingredients

Recent Global Cases of Counterfeit Medicines

Murder by fake drugs BMJ 2002; 324:800-801 P. Newton et al

It is high time that industry, drug regulatory authority, police, standards authority, customs, public et al

all come together against this crime!




Pharmacovigilance in Kenya

Guidelines for the National PV System in Kenya’ developed- ver 2.0

Tools developed: Suspected ADR Reporting Form Alert Card Form for Reporting Poor Quality Medicinal Products Definitions in PV

Training material developed: training curricula, guides and manuals

Start with a 45 min video on counterfeit medicines (BBC/WHO) Tutorial on identifying counterfeits Reporting of suspected cases



Guidelines for the National Pharmacovigilance System in Kenya



Pharmacovigilance tools




What to report?• Report all suspected adverse reactions to allopathic

(modern) medicines, traditional / alternative / herbal medicines, x-ray contrast media, medical devices and cosmetics.

• Report product quality problems, e.g. Suspected contamination, moulding, colour

change Poor packaging / poor labeling Therapeutic failures Suspected counterfeit medicine Receiving expired medicines




Prevention of drug-related morbidity

Prevention of drug-related mortality

Minimize in-patient and out-patient morbidity

Huge savings in healthcare costs

Better patient compliance


Greater understanding of drug-induced disorders

Early signals / warnings to potentially serious ADRs

Greater awareness of agents that commonly cause drug-induced disorders

Better patient care

Greater importance of Role of the Healthcare Worker

Benefits of Pharmacovigilance




Benefits of Post-Market Surveillance

Continuous quality assessment of pharma products in Kenya

Reduce, if not alleviate, sub-standard, illegal and counterfeit medicines

Understand the range, availability and use of various medicines in various diseases

Closer working relationship with other departments within the NRA, especially:

Medicines Regulation Dept, Inspectorate Dept, GMP Dept.

Greater importance of Role of a Healthcare Worker




PPB Post-Market Surveillance activities

Past: Surveys of medicines to evaluate:

Range and availability, Registration status with PPB and Quality analysis

- Antimalarials (baseline pre-ACT, QAMSA), cough and colds, ARV, Anti-TB (research thesis, country-wide)

Present: Pro-active and reactive surveillance Similar sounding / spelt medicines Drug interactions highlights

Now and Ahead: Routine PV and PMS of all pharmaceutical products PMS strategy (under development)



Activities with INTERPOL… Working closely with INTERPOL since 2008

Educate, train and partner with the police, KIPI, Pharmacy and Poisons Board

Better collaboration with inspectors, drug registration, public

IMPACT - Operation MAMBA II : joint efforts in Kenya, Uganda, Tanzania to combat counterfeits Aug 2009

Foster link with the Kenya Bureau of Standards (KEBS), Surveillance Department and jointly enforce the new Anti-Counterfeit Bill, 2008

Better networking with this Congress




Sensitize and train field staff across all provinces- for both MoMS and MoPHS

Collaboration with KMA, NC, professional societies, stakeholders to encourage reporting of suspected cases

Include course on PV at University, Schools and Training Institutions

Stakeholders meeting to combat counterfeiting


More steps ahead…



Challenges

• Legal backing- Cap 244 Pharmacy Law outdated 1957

• Personnel

• Dedicated confirmed financial support- routine

• Advocacy and awareness- within healthcare fraternity, media + cover

• Encouraging reporting- no punitive action on reports

• Strengthening Pharmaceutical & GMP inspectors and the link with

Pharmacovigilance




PharmacovigilanceCurriculum and Implementation Guide




If you are still wondering how Pharmacovigilance affects you?

“To undergo treatment you have to be very healthy, because, apart from your

sickness you have to withstand the

medicine”

Molière





THANK YOU

Asante sana…

“You need not be certain…

Just be suspicious”




Our contact …

Department of 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

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