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Dr. Jayesh M. Pandit Head Dept. of Pharmacovigilance Pharmacy and Poisons Board Ministry of Medical Services 2 nd December 2009 5 th Global Congress, INTERPOL Cancun, Mexico. Pharmacovigilance in Kenya. The Pharmacy and Poisons Board. Role of Pharmacy and Poisons Board.

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pharmacovigilance in kenya
Dr. Jayesh M. Pandit

Head

Dept. of Pharmacovigilance

Pharmacy and Poisons Board

Ministry of Medical Services

2nd December 2009

5th Global Congress, INTERPOL

Cancun, Mexico

Pharmacovigilance in Kenya

Jayesh- Pharmacovigilance

the pharmacy and poisons board
The Pharmacy and Poisons Board

Jayesh- Pharmacovigilance

role of 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.”

Jayesh- Pharmacovigilance

slide5

What is Pharmacovigilance?

Jayesh- 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

Latinvigilare- to keep awake or alert, to keep watch

Safety……Efficacy

Pharmacovigilance

Jayesh- Pharmacovigilance

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

Post Market Surveillance

All drugs are dangerousSomemayalsobeuseful

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

widening scope of pharmacovigilance
Widening scope of Pharmacovigilance

These 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
slide9

Globally, much attention is paid to the infringement of intellectual property rights, loss of monopoly, loss of millions of US$ with counterfeits...

And unfortunately, lesser attention is provided to the number of lives lost, number of severe drug reactions experienced and the morbidity associated with the murderous trade of counterfeiting!

Jayesh- Pharmacovigilance

slide12
Recent Global Cases of Counterfeit MedicinesMurder by fake drugs BMJ 2002; 324:800-801 P. Newton et al
  • 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

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

all come together against this crime!

Jayesh- Pharmacovigilance

pharmacovigilance in kenya13
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

Pharmacovigilance in Kenya

Jayesh- Pharmacovigilance

pharmacovigilance tools
Pharmacovigilance tools

Jayesh- Pharmacovigilance

what to report
What to report?
  • Report allsuspected 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

Jayesh- Pharmacovigilance

benefits of pharmacovigilance
Benefits of Pharmacovigilance
  • 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

Jayesh- Pharmacovigilance

benefits of post market surveillance
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

Jayesh- Pharmacovigilance

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)

PPB Post-Market Surveillance activities

Jayesh- Pharmacovigilance

activities with interpol
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

Jayesh- Pharmacovigilance

more steps ahead
More steps ahead…
  • 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

Jayesh- Pharmacovigilance

challenges
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

Jayesh- Pharmacovigilance

if you are still wondering how pharmacovigilance affects you
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

Jayesh- Pharmacovigilance

thank you asante sana
THANK YOUAsante sana…

“You need not be certain…

Just be suspicious”

Jayesh- Pharmacovigilance

our contact
Department of 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

Our contact …

Jayesh- Pharmacovigilance