WN-2 Fred Siyoi - WHO | World Health Organization · Pharmacy and Poisons Board MOMS – Kenya MISSION OF THE BOARD To improve the quality of life of Kenyans by ensuring provision

www.pharmacyboardkenya.org

Pharmacy and Poisons BoardMOMS – Kenya

QUALITY OF VENOMS

A Critical Step for the Manufacture of Anti-Snake Venoms

ICDRA – Singapore 30th Nov – 3rd Dec 2010 DR. SIYOI

DEPUTY REGISTRARPHARMACY AND POISONS BOARD - KENYA



BACKGROUND• The Pharmacy and Poisons Board was established as a

Regulatory Authority under the Pharmacy and Poisons Act, Chapter 244 of the Laws of Kenya and commenced operation on the 1st of May 1957.

• The Pharmacy and Poisons Board is a body corporate established under section 3 (6) amended of the Pharmacy and Poisons Act 1993. It is a semi autonomous body which can sue and be sued, acquire, hold and dispose property. It can also borrow and lend money.

• The Board regulates the Practice of Pharmacy and the Manufacture and Trade in drugs and poisons.

2



MISSION OF THE BOARD

To improve the quality of life of Kenyans by ensuring provision of good quality, safe and efficacious pharmaceutical products and services in Kenya

3



VISION OF THE BOARD

To be global leader in the control and regulation of drugs (food, chemicals) poisons and practice of pharmacy

4



Our Offices



Side view


Pharmacy and Poisons BoardMOMS – KenyaCategories of Snakes

(WHO snake antivenoms Website)WHO categorises snakes according to their medical importance into:1.Category 1: Highly venomous snakes that are common or widespread and cause numerous snakebites, resulting in high levels of morbidity, disability or mortality.2.Category 2: Highly venomous snakes capable of causing morbidity, disability or death, for which exact epidemiological or clinical data may be lacking; and/or are less frequently implicated (due to their activity cycles, behavior, habitat preferences or occurrence in areas remote to large human populations).



Distribution of Snakes

• There are 54 snakes identified by WHO being of some medical importance in Africa.

• Of those 54, WHO categorises 26 as Category 1 and 28 as Category 2.

• In Kenya, WHO has identified 20 with 7 being Category 1 and 13 being Category 2



Bio-Ken Snake Farm - Kenya• Bio-Ken is a research centre, which deals with

reptiles, especially snakes and snake-bite. Located less than 5 minutes drive from the hotels in Watamu, Malindi – Kenya Coast, it houses the largest collection of Snakes in East Africa and is open to the public.

• There are about 127 different snake species in Kenya. Of these only 18 have caused human fatalities and only another 6 could kill you. Another 10 could cause you a lot of pain and the remaining 93 or so, are non-venomous nor dangerous.



Effects

• Proteolytic venom dismantles the molecular structure of the area surrounding and including the bite.

• Hemotoxic venoms act on the heart and cardiovascular system.

• Neurotoxic venom acts on the nervous system and brain.

• Cytotoxic venom has a localized action at the site of the bite.



Selection of Venom CriteriaThe selection of the most appropriate snake venoms for the production of antivenoms needs to be carefully analyzed and should take into consideration:• the geographical region where the antivenom is going to be

used;• the medically most relevant snakes from the geographical

region where the antivenom is going to be used;• the variability of venom composition within the region of

distribution of a snake species;• the information on cross-neutralization of antivenoms against

the venoms of species not included in the mixture of venoms used to immunize animals for antivenom manufacture.



Recommendations ...11. When selecting snake antivenoms national health authorities

should first obtain and consider the information on the local species and their relative medical importance.

2. The design of the venom mixture used in immunization, and the decision to prepare monospecific or polyspecific antivenoms, depend on the epidemiological and clinical information on snakebites in that particular region, country or area.

3. Owing to the difficulty of identifying clinically the snake species responsible for envenoming, polyspecific antivenoms appropriate to the geographical region may be more practical and convenient to use than monospecific antivenoms.



Recommendations ...23. Manufacturers seeking marketing authorization for

antivenoms in a given country should provide experimental evidence from preclinical testing that the product exhibits a neutralization capacity against different local venoms..

4. Quality control of snake venoms is essential to provide assurance that the venoms are representative of the venomous snakes inhabiting the region for which the antivenoms are prepared



Challenges Kenya

• Lack of facilities in the country to test the quality aspects of various antivenoms

• Lack of capacity by the regulator to ascertain the efficacy claim and the toxicity profile of the various antivenoms

• Limited information on the species of snakes found in different parts of the country

• Lack of data on the adverse effects of various antivenoms within the local population


Pharmacy and Poisons BoardMOMS – KenyaOpportunities for collaboration

within NRAs• There are various ongoing initiatives within

East african countries aimed at sharing expertize in regulation of various medicines

• There is a successful pilot project on joint EAC/WHO evaluation of medicines, where dossiers are jointly evaluated and the decisions reached are binding to all the EAC countries.

• The same could be extended to antivenoms



Oppurtinities within Kenya

• Availability of snake farms(bio-ken,Nairobisnake park).-preparation of ref stds.

- preparation of the venoms.• Licensing system in place.• Pharmacovigilance system in place



• Capacity building within the various national medicines regulatory agencies specifically in the field of antivenoms

• Encouraging joint initiatives and close collaboration between various NRAs

• Setting up of infrastructure eg Quality control laboratories that can act as reference facilities to ascertain the quality aspects of the antivenoms within the region

Way forward to improve regulation of antivenoms within the region



Way forward conti…

• Increased post marketing surveillance of the registered antivenoms within various countries

• Setting up regional centers where local data on efficacy and adverse reactions of various antivenoms can be gathered

• To encourage public/private partnership in setting up manufacturing facilities within the region for antivenoms



CONCLUSION

• The quality of venoms as a starting material determines the quality of the antivenom to be produced.

• Whereas, the are challenges in the selection and production of quality venoms and antiveoms there exists opportunities for these challenges to addressed through cooperation and collaboration



Asante Sana

[email protected]

Documents

WN-2 Fred Siyoi - WHO | World Health Organization · Pharmacy and Poisons Board MOMS – Kenya MISSION OF THE BOARD To improve the quality of life of Kenyans by ensuring provision