drug registration and evaluation ppbnewsletter practice

ISSUE NO.2 APR-JUN 2014

PPB Newsletter+++++

Drug Registration and Evaluation

Practice and Surveillance

Business Support

Medicines Information & Pharmacovigilance

Pharmaceutical Manufacturing Services

Pharmacy Practice & Regulation of Training+

MINISTRY OF HEALTHPharmacy & Poisons Board

Ensuring Safety, Quality and Efficacy of Medicines & Practice of Pharmacy

Kenya nominated host for Regional Centre of Regulatory Excellence (RCOREs)

in Africa for Pharmacovigilance

PPB Newsletter Issue No. 2, 20142

Management Board

Dr. Francis Kimani OGWChairman

Dr. Kipkerich Koskei OGWRegistrar

Dr. Paul MwanikiMember

Dr. Joseph OwokoMember

Mr. Abdi O. JamaMember

Dr. Jennifer Orwa, OGWMember

Dr. Evans MwangangiMember

Dr. Sara AgakMember

PPB Newsletter Issue No. 2, 2014 3

MESSAGE FROM THE REGISTRAR

The Pharmacy and Poisons Board (PPB) is tasked with overseeing the quality, safety and efficacy of medicines in Kenya.

There is no doubt that medicine regulation has re-cently become more critical with the liberal-ization and globaliza-tion of trade in pharma-ceuticals. The growth of imported products has been rapid and is ex-pected to continue to increase.

However, globalization and the scaling up of med-icines including herbal products to the developing world are highlighting the urgent need for systems to assure product efficacy, safety, and quality.

The need to ensure that people in Kenya have ac-

cess to essential, high quality, safe medicines has just received a major boost with the introduction of guidelines that will be used for registration of herb-al or complementary/alternative medicines in the country. The registration is on-going and we have advised all dealer’s in herbal products and comple-mentary medicines to come forward and register their products with the Board.

The Board has a vigorous surveillance and post marketing surveillance of the market to ensure un-registered, substandard and counterfeit drugs are detected and eliminated. Our top priority is to en-sure the safety and quality of medical products in the market through rigorous standards.

Notable progress has been made since the estab-lishment of the National Pharmacovigilance Cen-tre. A system of reporting suspected poor quality medicines and suspected adverse drug reactions has also been established and this helps the board monitor the medicines in the country.

We call upon the members of the public to support the board by ensuring that they only buy their med-icines from PPB approved premises. In case of any suspicion, one can contact the board through tele-phone, come to the offices, email, or even through Facebook and twitter account.

Our goal is to establish strong linkages and re-lationships with mwa-nachi and all health service providers in the spirit of coordination and cooperation so as to improve the quality

of medical and herbal products in the market.

The Board will continue to provide the leadership that is required to ensure the entire mandate is im-plemented. The Board needs your support in these matters.

Better regulation of medicines initiative

Dr. Kipkerich Koskei

Our goal is to establish strong linkages and relationships with mwanachi and all health

service providers in the spirit of coordination and cooperation so as to improve the quality of

medical and herbal products in the market

4 PPB Newsletter Issue No. 2, 2014

MESSAGE FROM THE DEPUTY REGISTRAR

The constitution of Kenya, Vision 2030 and the health policy framework tasks the health sec-tor to come up with core strategies to ensure

that Kenyans enjoy the highest standards of health services.

The core function of Pharmacy and Poisons Board is to safeguard and protect the public health through ensuring that all pharmaceuticals that are sold and used in Kenya are safe, therapeutically effective and consistently meet acceptable standards of qual-ity. Quality of medicines is close to every Kenyan

Standards to improve access to quality medicines

citizen’s heart, because quality, safety and efficacy have a great bearing on the prognosis of an illness and recovery when we all fall ill.

As a social responsibility the PPB has taken adequate precaution and steps to safeguard public health. There is a very elaborate drug registration system established that ensures that only safe, quality and efficacious products are registered. These drugs are analyzed by laboratories to ensure that they comply with the label claims.

All the manufacturing sites are inspected to ensure that they comply with the required standards and imported products must get an import permit from PPB for them to get into the country. PPB has offi-cers in designated ports to ensure compliance and regulates all premises where medicines are sold including personnel to ensure they meet required standards.

All the technological advancements taking place within the Pharmacy and Poisons Board today are supposed to make it easier and more efficient for staff to monitor and assist our customers.

As you all know customer relationships are key to our business strategy. To support our regulatory activities and efforts, all stakeholders are urged to play a bigger role in sharing ideas and information that is useful for the common good.

Dr. Fred Siyoi

Quality of medicines is close to every Ken-yan citizen’s heart, because quality, safety and efficacy have a great bearing on the prognosis of an illness and recovery when

we all fall ill

Health is one of our great-est God given assets. ‘’The healthier we are, the more

stable our emotions. ’With in-creased access to new essential medicines, there is a greater need to monitor and promote safety and effectiveness of medicines.

There is no doubt that regula-tory authorities in nations require the necessary infrastructure and resources including laws, systems and structures, human resources and financial resources to execute their mandate.

In Kenya, the Pharmacy and

Poison Board under the Ministry of Health has been mandated to regulate pharmacy practice and trade in pharmaceutical products, in line with the Pharmacy and Poi-sons Act Cap 244 of the laws of Kenya which was enacted in 1957.

The Board, with its huge man-date strives to maintain high stan-dards of professionalism in its quest for high quality drugs and other medical devices to the Ken-yan people. Today, thanks to PPB measures a number of achieve-ments have been realized in the areas pharmacovigilance, ICT, Drug Registration, Inspectorate, pharmacy practice, GMP and ad-ministration.

The second edition of PPB newsletter highlights the strat-egies the board is undertaking to ensure the safety, efficacy and quality of medicines in the coun-try to instigate you to rise and make important steps in the jour-ney to good health.

It is our hope as an Editorial team that our readers will find this publication useful in understand-ing the organization’s objectives and values and share in its culture. Send your views and comments to [email protected]

The PPB Newsletter is a publication of The Department of Public Relations of The Pharmacy and Poisons Board. It is designed to act as a tool of communi-cation, documenting and diseminat-ing important news and information to the staff and stakeholders of The

Board.

Department of Public Relations,Pharmacy and Poisons Board,

Lenana RoadP.O. Box 27663-00506 Nairobi.

Tel: +254-020- 3562107/2716905/6Fax: +254-020- 2713431/2713409

Email: [email protected]: www.pharmacyboardkenya.org

Editorial Board

Editorial Advisor Dr Fred Siyoi

EditorJudy Sirima

Sub-Editors and ContributorsDr. Edward AbwaoSophie Waihenya

Sheila MuriithiGideon MurimiDorine Odongo

ISSUE NO.1 OCT-DEC 2013

PPB Newsletter +++++

Product Evaluation and Registration

Inspectorate, Surveillance and Enforcement

Business Support



Pharmacy Practice & Training


Inside this editionWord from the Registrar ........................................ 2

Word from Deputy Registrar ..................................... 3

Word from the Editors .............................................. 4

Directorates & their tasks ...................................... 5

Medicine Regulation Harmonisation .................... 7

Setting pace in Pharmacovigilance ....................... 10

PPB at Mombasa ASK show .................................... 11

The PPB Pictorial ....................................................... 12

Regional Heads Consultative Meeting ............ 14

Colleges Licensed to offer Pharmacy courses .... 14

+

MINISTRY OF HEALTHPharmacy & Poisons Board

Ppb Marks Milestone with the Launch of Stakeholder’s E-Portal To Promote Ease of Doing Business Pg. 8

1

5

Kenya nominated host for Regional Cen-tre of Regulatory Excellence (RCOREs) in Africa for Pharmacovigilance

Judy Sirima

Design and layoutCommwide Concepts

The broader PPB medicines safety agenda for the country

EDITOR’S NOTE


Kenya launches National Electronic Single Window System 7

6

9Kenya sets record as a leader in ADR ReportsStriving for Excellence; PPB Achievements

11Fostering partnership to stump out illegal premises

16Launch of Continuing Professional Devel-opment Guidelines on course

17Good service is good businessBuilding the exceptional workforce

19Ensuring public safety PPB trains fire marshals

19Herbal medicines in Kenya: Review of efficacy, safety and regulation

20Employee benefits: PPB medical insurance, office space and reward system underway

Content


ACHIEVEMENTS

The Pharmacy and Poisons Board has been chosen to host a Regional Centre of Regulatory Excellence (RCOREs) in Africa for Pharmacovigilance.

Kenya was selected by New Partnership for Africa’s Development (NEPAD) effective on 2nd May 2014 after beating five African countries National Regulatory Au-thorities and Universities including Ghana who had re-sponded to NEPAD call for applications to be considered as Regional Centres of Regulatory Excellence in Africa for Pharmacovigilance in October 2013. The application was open to all the National Drug Regulatory Authorities in Africa.

World Health Organization defines Pharmacovigi-lance (PV) as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.

This means Kenya is now a model where other African Countries are expected to come to learn Pharmacovig-ilance activities. The Pharmacy and Poisons Board was nominated by NEPAD, primarily for the regional centre’s ideal location and the quality of services it provides.

The criterion for selection was based on training capacity; regulatory capability; Partnerships & collabo-rations; Training programmes certified by national ed-ucation accreditation body and/or other accreditation systems; Governance & Management systems and Infra-structure.

NEPAD an African Union strategic framework for pan-African socio-economic development is a new in-

tervention, spearheaded by African leaders, to address critical challenges facing the continent: poverty, devel-opment and Africa’s marginalization internationally.

NEPAD provides unique opportunities for African countries to take full control of their development agen-da, to work more closely together, and to cooperate more effectively with international partners.

The Pharmacy and Poisons Board (PPB) is the Nation-al Medicines Regulatory Authority of the republic of Ken-ya. It was established in 1957 under the Pharmacy and Poisons Act, Chapter 244 of the Laws of Kenya. PPB has the mandate to regulate pharmaceutical services, ensure the quality, safety and efficacy of human and veterinary medicines, and evaluate medical devices.

PPB was chosen for its proven track record in deliver-ing innovative programmes. PPB launched the Pharma-covigilance in 2009 and established a National Pharma-covigilance Centre. The centre has eight members of staff who have undertaken both local and international train-ings on issues of pharmacovigilance including training at the WHO Uppsala Drug Monitoring Centre.

A training curriculum for training of healthcare work-ers across the country has been developed. In collabo-ration with Management Sciences for Health (MSH) and tertiary training institutions such as the University of Nairobi (UON) and the Kenya Medical Training College, several pharmacovigilance training sessions for under-graduate pharmacy students have been conducted to sensitize health workers on pharmacovigilance before

Kenya nominated host for Regional Centre of Regulatory Excellence (RCOREs) in Africa for Pharmacovigilance

Healthy consultation; PPB Registrar Dr. Koskei consult with his Deputy Dr. Siyoi at a press briefing during the customer care training workshop

System expected to enhance the ef-ficient exchange of information be-tween trade and government.

On 2nd May 2014, Rwandan President Paul Kagame launched

7PPB Newsletter Issue No. 2, 2014

they graduate.With support from partners PPB has prioritized train-

ing of health workers and other stakeholders such as representatives of the Pharma industry in Kenya on phar-macovigilance and medicine safety. In March 2014, over 10,000 individuals drawn from the public and private sectors in Kenya had undergone the training.

A Pharmacovigilance e-shot, an electronic mailing system used to communicate to subscribers issues of concern has been developed and an online reporting system that allows healthcare workers and consumers of medicines has been launched to submit reports on poor quality medicine or suspected Adverse Drug Reaction (ADR). www.pv.pharmacyboardkenya.org

Kenya is the 98th member of the WHO international drug monitoring program contributing to the database on the Adverse Drug Reactions (ADRs.) In Africa, Kenya is the fourth leading reporter and the leading in the East and Central African Region. It has reported more than 7,600 suspected Adverse Drug Reactions to the WHO da-tabase.

The Pharmacovigilance centre has a newsletter that it regularly shares with its clients to update them on the latest development on issues pharmacovigilance. The centre has also successfully carried out an active sur-veillance study on monitoring the safety of artemether lumefantrine and is currently data cleaning and analyz-ing.

Through the centre PPB has also carried out Post marketing studies of products like antimalarials, anti TBs, ARVs and most recently reproductive health products.

To carry out its mandate, the centre receives financial support from the PPB, development/implementing part-ners and pharmaceutical industry. PPB provides overall leadership for the implementation of the “one” national and integrated Kenya Pharmacovigilance System.

We are honoured to receive such recognition and look forward to working with our partners in contribut-ing to Kenya’s knowledge-generation capacity. This pres-tigious award now means we have the freedom to set our own research priorities and the opportunity to think strategically and focus on the long term.

As technological develop-ment is a constant process, like during the earlier years,

in 2014 too, a whole new breed of technologies is waiting to reshape

the ICT industry in Kenya. Of course, one of the most im-

portant changes that are taking place in the industry is the introduc-tion of the Electronic Single Window

Kenya launches National Electronic Single Window System

Kenya President Uhuru Kenyatta addresses delegates at the launch of National Electronic Single Window System

ACHIEVEMENTS

8

ACHIEVEMENTS


Kenya’s National Electronic Single Window System (KNESWS). The sys-tem is expected to boost regional trade by easing clearance processes of goods in the country. The tech-nology would make it possible for traders to submit information about their goods to multiple government agencies in various locations, mak-ing business faster and more effi-cient.

In the spirit of the integration of the EAC, the event was graced by four Presidents’ among them Uhuru Kenyatta of Kenya, Yoweri Museveni of Uganda and Salva Kiir Mayardit of South Sudan. Also present were the 2nd Vice-President of Burundi and the Tanzanian Prime Minister.

Five agencies were involved in the launch, KRA, KPA, KEPHIS, KEBS & PPB. 24 other agencies are expect-ed to join. The Board has already trained staff namely Gideon Murimi, Naomi Nkuiya, Allan Wambua, Shei-la Muriithi, James Thuo and Robert Omondi and has issued them with Certificates of ‘Super User’ status.

Case studies on Single window

implementation in ten countries namely Finland, Germany, Guatema-la, Hong Kong, Mauritius, Malaysia, Senegal, Singapore, Sweden, United States point to a common set of key factors for success. These include;

• Strong leadership, which came from private or public sector

• Cooperation and commit-ment of all stakeholders, pri-vate and public

• User friendly system which do not create complications for usual business

• Investment in the modern technologies

• Phased, flexible approach and

• Neutrality of the proposed technical solution

However, operations from these countries have reported difficulties in established business and state practices, establishing cooperation and commitment of various states authorizes involved in import and export procedures in particular in Finland and USA and modernizing

the technologies currently used by the state and private sector and small and medium sized enterprises in particular Sweden. These coun-tries provide concrete examples Kenya can learn from.

A single window is a practical application of trade facilitation con-cepts intended to reduce non-tariff trade barriers and deliver immediate benefit to all members of the trading community.

In most countries, companies engaged in international trade reg-ularly have to submit large volumes of information and document to governmental authorities to comply with import, export and transit re-lated regulatory requirements, this information and documents often has to be submitted through several different agencies, each with its own specific system (manual or automat-ic) and paper forms.

Establishing a single window fa-cility is one means of addressing this problem.

Launch of the National Electronic Single Window System by EAC Presidents in May 2014

9

ACHIEVEMENTS


Continuous monitoring of adverse drug reactions after medicines have been registered is important so as to pick the reactions that were not previous-

ly identified during clinical trials. Different patients react differently to medicines and similarly different races re-act differently to medicines. During clinical trials only a small number of patients are exposed to a medicine be-fore the approval after which almost the whole popula-tion can use the product.

Kenya is the 98th member of the WHO international drug monitoring program since 2010 when she joined the program and started to contribute to the Vigiflow database on ADRs from 23rd April 2010. In Africa, Ken-ya is among the top four countries in terms of Individual Case Safety Reports (ICSRs) to WHO global ICSR database while in the East and Central African Region it is the lead-ing reporter. It has reported more than 7,000 suspected adverse drug reactions (ADRs) to the WHO database.

The Pharmacy and Poisons Board launched Pharma-covigilance system in June 2009. To promote collection of the ADR reports from all over the country so as to monitor the quality of marketed products, the PPB con-ducted training of healthcare workers on pharmacovigi-lance and also supplied them with guidelines, reporting tools and job aids.

In order to improve further the reporting rates and promote sustainability, the PPB with support from MSH/

Kenya sets record as a leader in ADR Reports

HCSM developed and launched an online reporting sys-tem (PVERS) that allows both the healthcare workers and consumers of medicines to submit reports on any sus-pected poor quality medicinal products (sPQMP) or sus-pected adverse drug reaction (sADR).

The establishment of this electronic submission of sADR and sPQMP has resulted in increased reporting which helped PPB in recalling or withdrawing some poor quality medicines. Over 700 suspected ADR reports and 70 suspected PQMP reports were submitted via the online reporting system to the pharmacovigilance unit from April 2013 after the launch in December 2013.

By 31st March 2014, PPB received 7,643 ADR reports as defined by the figures below.

ANALYSIS 1.1 Trends in Reporting by Year

There was a general upward trend in the number of reports received from 2010 until 2012 followed by a peak and subsequent downward trend until 2013. An upward trend is anticipated in the coming months of 2014 fol-lowing the introduction of the PVERS in May 2013 as well as Training of Trainers (ToTs) on PV by NASCOP.

1.2. Cumulative Number of Reports by CadreThe overwhelming majority - almost ¾ - of ADR re-

Timely orientation of medical students on pharmacovigilance by the Department of Pharmacovigilance of the Pharmacy and Poisons Board

10

ACIHIEVEMENTS

Reporter institution County Total % of Reports Cumulative %1. Moi Teaching and Referral Hospital Uasin Gishu 939 12.3% 12.3%2. St. Camillus Mission Hospital Migori 582 7.6% 19.9%c3. Thika District Hospital Kiambu 389 5.1% 25.0%4. Kilifi District Hospital Kilifi 311 4.1% 29.1%5. Vihiga District Hospital Vihiga 282 3.7% 32.7%

ports was received from health professionals other than pharmacists and physicians.

1.3. ADR Reports by CountyNairobi, Uasin Gishu and Migori counties contribut-

ed the highest number of ADR reports with 13%, 12% and 10% of the total reports received respectively. Eight counties have never submitted a single ADR report over the four year period

1.4. ADR Reports by InstitutionA total of 286 facilities contributed to ADR reports

over the four year period. Moi Teaching and Referral Hos-pital in Uasin Gishu County, with 939 ADR reports, con-tributed the highest number of reports in the country. St. Camillus Mission hospital (582 reports), Thika District Hospital (389 reports) and Kilifi District Hospital (311 re-ports) were other health facilities with a high number of reports. Thirteen institutions accounted for over 50% of all the ADR reports (Table 1)

6. Coast Province General Hospital Mombasa 265 3.5% 36.2%7. Maragua District Hospital Murang’a 186 2.4% 38.6%8. Mater Hospital Nairobi 166 2.2% 40.8%9. Liver Pool Care & Treatment Nairobi 161 2.1% 42.9%10. Kenyatta National Hospital Nairobi 160 2.1% 45.0%11. Kiambu District Hospital Kiambu 149 1.9% 47.0%12. Kisii District Hospital Kisii 145 1.9% 48.9%13. Machakos General Hospital Machakos 135 1.8% 50.6%14. All other institutions (273) 3,773 49.4% 100%Total 7,643 100%

1.5. ADR Reports by Drug ClassThe overwhelming majority of ADR reports (5,618,

74%) were ARVs-related. No specific drug class was im-plicated for 21% of the ADR reports. Antibiotics, anti-TBs, anti-malarials and anti-hypertensives together account-ed for 5% of the ADR reports and 15 other drug classes accounted for the remaining ADR reports

1.6. Completeness of ADR ReportsCompleteness of ADR reports was generally high.

Only 4%, 2.7% and 0.5% of the reports did not have the gender, qualification of reporter, and type of reaction respectively indicated. However, a major gap noted was with regard to the age of the patient with 23% of the ADR reports missing this parameter.

RECOMMENDATIONSCompleteness of ADR reports was generally high.

Only 4%, 2.7% and 0.5% of the reports did not have the gender, qualification of reporter, and type of reaction respectively indicated. However, a major gap noted was

with regard to the age of the patient with 23% of the ADR reports missing this parameter.

The following recommendations are made based on the findings of the analysis:1. The County Health Management Teams (CHMTs) in

counties with low reporting rates should liaise with PPB to come up with strategies to improve ADR de-tection and reporting.

2. Health workers are encouraged to fill out the ADR forms as completely as possible to ensure that all ba-sic data is captured

3. Sensitization of the PVERS by PPB and partners should continue in order to boost ADR reporting rates.

4. ADR data should be routinely analyzed and used to inform policy and decision-making at national-, county-, sub-county and facility levels


Edward Abwao(PPB) , Victor Sumbi (MSH), Ndinda Kusu (MSH), Mary Njeri (PPB)

11

ACIHIEVEMENTS


Measures put in place to ensure that only safe medicines are on the shelves;

• An elaborate drug registration system has been established that ensures that only safe, quality and efficacious products are registered.

• Drugs are analyzed by laboratories to ensure compliance with the label claims.

• All the man-u f a c t u r i n g sites have to be inspected to ensure that they comply with the required standards.

• The registered medicines have to be retained each year in order to monitor them.

• Imported products must get an import permit from PPB for them to get into the country includ-ing donations. About 70% of the medicines used in the country are imported with the remaining amount being produced locally.

• Designated ports manned by PPB staff have been

set up through which one is allowed to either im-port or export medicines through.

• The board regulates the premises where these medicines are being sold and they must be un-der the control of PPB approved personnel.

• These premises are inspected before they are approved and must all get annual approval from the board. •The same applies to the personnel who man these facilities. They must pass their professional examina-tion and also must get annual approval to run their premises.

• The board carries out post marketing surveil-lance of the products in the country to ensure they are safe, efficacious and of good quality. This is done by randomly collecting samples from all over the country and taking them for analysis at the National Quality Control Laboratory that is WHO prequalified.

• A system of reporting suspected poor quality medicines and suspected adverse drug reactions has also been established and this helps the

STRIVING FOR EXCELLENCE PPB ACHIEVEMENTS

The board carries out post marketing surveillance of the products in the country to ensure they are safe, efficacious and of good quality. This is done by ran-domly collecting samples from all over the country

and taking them for analysis at the National Quality Control Laboratory that is WHO prequalified

Human medicines. PPB has established an elaborate drug registration system that ensures only safe, quality and efficacious medicines are registered.


board monitor the medicines in the country.

How can people know that drugs are safe?• The public should only buy medicines from PPB

approved health facilities. • They should ensure that

they are only served by qualified personnel in these premises.

• It is a requirement that the premises display the PPB issued licenses for both the premises and the personnel.

• PPB website has the list of all registered medi-cines in the country and by frequently checking the website; one will be able to ensure that they are getting quality products.

• In case of any suspicion, one can contact the board through telephone, come to the offices, email, or even facebook.

• Equally PPB has an online reporting system www.pv.pharmacyboardkenya.org where one can report any suspicious product for the board to take action.

Ways of enhancing public participation in monitoring and ensuring quality and safety of medicines in Kenya.

• The public should be vigilant about the medi-cines they are consuming

• They should report any suspicious quality and safety issues to the board

• This can even be done through PPB facebook ac-count and through the online reporting system.

• The public should also support the board by en-suring that they only buy their medicines from PPB approved premises.• While at the premises they should ensure that they are served by qualified per-

sonnel and also get a receipt with the name of the medicine indicated on it. This is important es-pecially when it comes to tracing the medicines incase of any problem.

DRUG REGISTRATION Arms

1. Human Medicine- Biological and vaccines 2. Veterinary Medicines3. Herbal/ complementary4. Medical devices5. Borderline

Achievements• Common Technical Document (CTD). This is the

human and veterinary registration• Retention from analog to digital. Annual reten-

tion from 2010. Keeping the product in the Ken-

ACIHIEVEMENTS

The public should be vigilant about the medicines they are

consuming

Ports of Entry (POE) and Drug Crime Investigation & En-forcement Unit (DCIE) have the following core mandate:

• Inspections of pharmaceutical premises (distri-bution outlets) to ensure they meet required standards.

• Investigation of drug related crimes and recom-mend for prosecution or disciplinary

• Inspections at ports of entry• Surveillance of the market to ensure unregis-

tered, substandard and counterfeit drugs are de-tected and eliminated.

• Coordinate recall and supervise disposal of Phar-maceutical waste.

To achieve the above objectives the Directorate has a team of 59 inspectors spread across various ports of entries, regions and districts. A high standard of profes-sionalism, integrity, budgetary support and confidence is essential to ensure achievement of above objectives.

Inspection of Distribution OutletsDuring the 3rd quarter a total of 1278 premises

including hospitals and clinics were inspected for com-pliance to Good Distribution Practices. Various actions were taken against those not complying including sei-zure of all the products therein and taking offenders to courts.

A total of 345 premises were arrested and charged in court with various offences that were in violation of Cap 244.

13PPB Newsletter Issue No. 2, 2014

The Kenya Pharmaceutical Association held its region-al stakeholders meeting in

Kisumu on 4th April 2014. The meeting which was attended by stakeholders from pharmaceuti-cal industry sought to strengthen partnership with Pharmacy and Poisons Board.

Regional head Beatrice Obinge moderated the meeting which was also attended by PPB Public Relation office. During the meeting core activities of Inspec-

Fostering partnership to stump out illegal premises

tors in the region in particular in-vestigation of drug related crime and surveillance of the market were discussed.

Ms. Obinge noted that de-spite challenges of delayed court cases and absenteeism by super-intendents in hostile areas such as Oyugis the region has made tremendous achievements in the area of elimination of illegal premises. Nyanza has 900 regis-tered chemists she noted.

ACIHIEVEMENTS

yan market. E- Retention was launched in 2013 October and it’s on going.

• Committee of internal evaluation – departmen-tal meetings to deliberate on written communi-cation from pharma companies.

• Notification – updated information from the pharmaceutical companies about registered products in the Kenyan market.

• Queries – communication from PPB to applicants of registered product, prior to registration and after

• Registration of products – issuing of a registra-tion certificate after a product has met registra-tion criteria.

ICT ACHIEVEMENTS• E-Portal System- The stakeholder’s e-portal will

enable pharmaceutical industry to access trade licensing and drug retention services from PPB online

• Spearheading the EAC harmonization in QMS & IMS. - The East African Community states have initiated a medicines regulation harmonization project (EAC MRH) to improve access to safe effi-cacious and good quality essential medicines in the partner state.

INSPECTORATE ACHIEVEMENTSPharmacy and Poisons Board’s Inspectorate Direc-

torate comprising of Good Distribution Practices (GDP),

14

PICTORIAL


Pharmacovigilance team trains a group of health workers

Super induction; PPB drivers display their dress code

Dr Mohammed, Director Inspectorate, Surveillance & Enforcement flanked by senior inspectors Mr Kingori, Head Nairobi Region and Mr Kiptoo, Head Ports of Entry addressing the press outside Kayole Police Station during the National Crackdown on Illegal Pharmacy Practice

PPB staff listens keenly to Fire Marshal training proceedings

PPB Deputy Registrar Dr. Siyoi addresses a press conference. Beside him is the Registrar Dr. Koskei and Dr. Inyangala, Director, Business Support.

PPB ICT strategist Mr. Gideon Murimi gives a presentation on samsung application during the acheivement press breifing

Dr. Edward Abwao from PPB gives a presentation during the launch of the PV reporting system

15

PICTORIAL


Dr. Francis K

imani, the D

irector M

edical Services, The Registrar D

r Kipkerich K

oskei to

gether with m

embers o

f EAC

after a meeting to

discuss the mid-term

review

of the East A

frican Co

mm

unity Medicines R

egulatory H

armo

nization (EA

C-M

RH

)

16

TRAINING


From June 2014 all pharmacists and pharmaceutical technologists will have a legal obligation to under-take and record Continuing Professional Develop-

ment activity (CPD) in order to maintain registration as a pharmacy professional in Kenya.

PPB plans to launch the high quality revised Continu-ing Professional Development guidelines designed to help pharmacists and pharmaceutical technologists up-hold the best pharmaceutical practices, improve treat-ment outcomes and enhance patient safety.

This is an opportunity for the industry to take charge of its learning and development and push the boundar-ies in achieving new standards.

Continuing Professional Development (CPD) is an in-ternationally accepted approach that facilitates profes-sionals to acquire the necessary knowledge, skills and ethical attitudes so as to remain current and competent

in their prac-tice as en-

Launch of Continuing Professional Development Guidelines on course

shrined in the sessional paper No. 4 of 2012 (Kenya Na-tional Pharmaceutical Policy).

The first edition of CPD guidelines was produced in 2006 in consultation with stakeholders. Subsequently, lessons learned during the implementation of CPD in the country have been valuable for the review and updating of the CPD guidelines in order to address the identified gaps. The reviewed guidelines will be launched and dis-seminated in June 2014.

The new CPD guidelines outline the requirements that must be met by pharmacists in order to meet the CPD standards. It will be a requirement that pharma-cy practitioners earn a predetermined number of CPD points for re-registration or re-licensure. CPD programs will be administered by PPB and other accredited CPD providers such as professional associations, NGOs, devel-opment partners, health training institutions or individ-uals.

The Board will keep a record of programs, activities and attendance for all the CPD activities of the accredit-ed CPD providers including those offered by the Board.

Practitioners will be required to accumulate a mini-mum total of 40 CPD points per year, of which 10 points must be obtained from activities organized by profes-sional associations. It will be illegal to accumulate more than 80% of CPD points from one activity category over the CPD calendar year.

The Board will recognize and reward high perform-ers annually. Non-compliance to CPD requirements may lead to imposition of sanctions by the Board including denial of practice license.

The Board is set to work with national professional bodies and other

stakeholders to establish na-tional standards that can underpin stronger systems. Efforts will be made to elim-inate and avoid conflict of interest in the accredita-tion of CPD providers and implementation of CPD courses as provided in the guidelines. Timelines for implementation of the guidelines will be com-municated to all stake-holders in due course by the Board.

• Be honest and transparent with your customers• Double check with your customers to ensure

complete satisfaction• Use positive language that is motivating and in

ways persuading • Be friendly and compassionate to create the right

atmosphere for coming to the best solution • Learn from mistakes• Maintain good body language even when talking

with your client on the phone• Learn to effectively communicate with clients.

Know when to listen, when to speak and how to speak

• Be calm and patient • Have computer skills for easier communication • Keep your promises • Be confident for easier convincing of your cus-

tomer• Be a leader – show you are capable of providing

new solutions for customers • Manage your time• Analyze problems as soon as you begin to speak

with a customer as a way to show professional-ism

• Negotiate and persuade – win-win results• Understand human psychology. Body language

and tone of voice when talking to customers • Know your organization. Become an expert –

learn everything from product and service you are selling or offering to your client

• Work under pressure - knowing how to solve problems, thinking ahead and maintaining your composure at all times will help you offer the best solutions to your customers.

17

TRAINING


Customer service excellence has always been and will always be one of the critical competitive ad-vantages for any business. On 8th and 9th May

2014, the Pharmacy and Poisons Board held a custom-er care training workshop to equip staff with customer care, public relations and communication skills aimed at increasing accessibility and customer satisfaction. Train-ing and development is an essential cornerstone in pro-moting customer philosophy.

The objective of the two day workshop which was opened by the Registrar of Pharmacy and Poisons Board Dr. K. Koskei was to improve the quality of service and communication between the board and its customers. During the opening Dr. Koskei noted that the training is crucial, in ensuring that the goals set out in the Pharmacy and Poisons Act are met.

The registrar noted that the board has an expanded mandate to regulate herbal or complementary/ alterna-tive medicines in the country. To fulfil its mandate the Board is conducting customer care training programmes for staff whose emphasis is competence based to ensure clients who come to the board receive quality services.

Customer service is perhaps the most vital part of conducting business as it reflects directly on the com-pany and how it is able to meet the needs of patrons. ‘’The Board would like to establish strong linkages and relationships with all health service providers in the spir-it of coordination and cooperation so as to improve the quality medical and herbal products in the market,’’ the Registrar noted.

Skills on excellent customer service • Be a great listener. This will show you care and

want to offer the right solution

Good service is good business

Addressing customer needs; PPB staff at a customer care training workshop

18

TRAINING


Training and development can be initiated for a vari-ety of reasons for an employee or group of employ-ee’s e.g. when a performance appraisal indicates

performance improvement is needed, to “benchmark” the status of improvement in a performance improve-ment effort or as part of an overall professional develop-ment program.

Out of these reasons the Directorate concerned with of Good Manufacturing Practice (GMP) has set standards for inspectors to undergo a minimum of ten hours GMP training annu-ally to keep track GMP in-spection.

Employee development gives the workforce a good chance to realize their potential and e v e n t u a l l y work at their highest level. Between January and May 2014, GMP has conducted three capacity building pro-grams;

• GIZ training at the Red Court Hotel from 31st

Building the exceptional workforce

March to 4th April 2014• GMP training for inspectors for EAC member

countries at Panafric Hotel from 10th - 21st Feb-ruary, 2014 and

• GMP training for PPB inspectors organized by United Nations Industrial Organization (UNIDO) at the Sentrin Lake Elementaita Lodge from 28th – 30th April, 2014

These successful trainings by GMP indicate the im-portance of employee training. Training is crucial for

o r g a n i z a -tional devel-opment and success be-cause it edu-cates work-ers about the effective use of technolo-gy, ensures competitive edge in the

market, creates opportunities for career development and personal growth, an important factor in retaining workers, helps employers comply with laws and regula-tions, and improves productivity and profitability.

Strenthening the Local Production of Essential Generic Medicines in Kenya UNIDO Training on WHO-GMP for Policy and Regualatory Organisations at Sentrim Lake Elementaita Lodge from 28th-30 April, 2014

You can work really hard, but if you are not training in the right way you are not going to improve and get to the level

that you want to - Micheal Chang

19

TRAINING


Ensuring public safety PPB trains fire marshals

Pharmacy and Poisons Board knows that maintaining safe-ty is the most important job

and has worked hard to ensure the premise is fully prepared for any emergency.

On 21st -22nd February 2014 the Board organized Fire Marshal training for staff. The training was conducted by Mr. Clive Lee from Duo-Tech Fire Services (DTFS) in col-laboration with Disaster Solutions Africa.

The objective of the training was to provide the staff with basic knowledge and skills on fire regula-tions and precautions. The training covered topics such as fire aware-ness, Fire marshal training, First Aid training, and Disaster preparedness and management.

Public safety was one of PPB priorities throughout the budget process, and the board worked to ensure that the budget made invest-ments to maintain PPB status as one of the safest building in Nairobi city.

All workplaces are required by

law to have a sufficient number of fire marshals to deal with fire emer-gencies faster and effectively. The training targeted those who are re-sponsible for overseeing fire safety, designated fire marshals and anyone who needs to know how to use a fire extinguisher.

During the training a practical drill session was held and trainees were shown how to act and use fire

extinguishers in case of fire at the office.

About Fire MarshalsFire Marshals typically enforce

fire codes, handle fire inspections and investigate the origins and caus-es of fires.

The main role of the Fire Marshal is to conduct all operations until a safe conclusion is reached or until the arrival of the Fire Brigade. Basi-cally, they are the person in charge and their role consists of liaising di-rectly with all the building Fire War-dens to ensure:

• Everyone in the building is accounted for;

• Investigating the cause of the incident;

• Ensuring the Emergency Services and Security are in-formed;

• Directing Fire Wardens to as-sist in the situation;

• Liaising with the Emergency Services on their arrival;

• Coordinating contingency planning if the situation war-rents it;

• Ensuring the building is safe before anyone is allowed to re-enter.

• Compiling a Fire Related In-cident Report.

To ensure Fire Marshal’s are com-petent in carrying out all their duties, it is important that they are properly trained.

Mr. Claine from Du-Tech Fire Service illustrates fire awareness tips to PPB staff. Below: Fire Marshal Evacuation kit.

20

REGULATION

Regulation of herbal medicines is a key means of ensuring safety, efficacy and quality of herbal me-dicinal products. Herbal products have gained in-

creasing popularity in the last decade, and are now used by approximately 85 percent of the African population. Herbal products are complex mixtures of organic chem-icals that may come from any raw or processed part of a plant, including leaves, stems, flowers, roots, and seeds. Unfortunately, there is limited sci-entific evidence to establish the safety and efficacy of most herbal products.

Despite the uncertainty about the safety, effectiveness, and cost-effectiveness of traditional medicine expanding their use, where reasonable evidence of their effectiveness and good evi-dence of their safety exists, might yield health, social, and economic benefits.

To promote the responsible commerce of herbal products, medical devices and dietary sup-plements, the Government via Legal Notice 192 of 2010 and Gazette no. 1879 of 21st March, 2014, conferred the powers of regulation to the Pharmacy and Poisons Board.

The Pharmacy and Poisons Board (PPB) is the Nation-al Medicines Regulatory Authority of the republic of Ken-ya. It was established in 1957 under the Pharmacy and Poisons Act, Chapter 244 of the Laws of Kenya. PPB has the mandate to regulate pharmaceutical services, ensure the quality, safety and efficacy of human and veterinary medicines, and evaluate medical devices.

To safeguard public health the Board has notified

Herbal medicines in Kenya: Review of efficacy, safety and regulation

firms/companies who manufacture locally, repackage, relabel, import/export or distribute these products to be sold or used in Kenya for the pending regulation.

Guidelines and application forms for registration are available at the Pharmacy and Poisons Board offices or can be downloaded at the board website www.pv.phar-macyboardkenya.org .

Before, herbs were defined as dietary supplements, and manufacturers could pro-duce, sell, and market without first demonstrating safety and ef-ficacy, as is required for pharma-ceutical drugs. Although herbs are often perceived as “natural” and therefore safe, many differ-ent side effects have been report-ed owing to active ingredients, contaminants, or interactions with drugs.

According to the Registrar Dr. Kipkerich Koskei the Board has taken this adequate precautions and steps to safeguard the public health. The registration is on-go-ing and the board has advised all

dealer’s in herbal products and complementary medi-cines to come forward and register their products.

Government and clearing agencies have been ad-vised to ensure all herbal or complementary/alternative products and complementary medicine coming from outside have import permits from the Pharmacy and Poi-sons Board.

‘’We are encouraging the media not to allow any ad-vertisements of any herbal or complementary/alterna-tive medicines unless they are approved by the Board,’’ the Registrar stressed.


PPB Registrar Dr. Koskei (Centre), Deputy Registrar Dr. Siyoi (left) and Dr. Toroitich during a press conference on regulation of herbal products.

21

STAFF WELFARE

To recruit and retain the very best employees in to-day’s marketplace, you must offer a competitive employee benefits package–especially one that

offers affordable health insurance.The good news is that PPB has secured a Medical In-

surance for the staff, Head of Administration, Ms Dorine Odongo has disclosed. There are a number of reasons why it makes good business sense for employers to of-fer insurance benefits to their employees and their fami-lies. The overriding reason being a healthy workforce is a more productive workforce. It’s plain and simple.

Ms Dorine also says plans are also underway to intro-duce a reward system for staff. It is worldly recognized

Employee benefits: PPB medical insurance, office space and reward system underway

Staff welfare – Healthy working lives

Any successful organization recognizes its staff as key to their success. As such most or-

ganizations invest in employee wel-fare. In 2013 staff of Pharmacy and Poisons Board formed a staff welfare association with an aim to assist members in times of need through financial contribution and morale support.

According to the Chairman of the welfare, Mr. James Kingori the objective of employee welfare is to improve life for a worker both in and outside of work. He anticipates the welfare will have many benefits as it grows. Some of the plans the

that a modern approach to compensation and employee benefit plans rewards and recognizes best employees. Therefore effective employee benefits strategies being implemented by the board raise productivity, increase employee retention, and have a positive impact on the bottom line.

Aside from these benefits and the job scope itself, one factor that significantly influences how employees feel about work is the environment. The Administrator reveals that PPB new office space is in the final stages and is expected to provide adequate work environment for better performance.

association has is to establish a PPB canteen and a Cooperative Sacco, the Chairman disclosed during the members meeting recently.

‘Staff welfare’ is an all-encom-passing term covering a wide range of facilities that are essential for the well-being of employees. During the meeting Kingori assured members that the welfare officials are negoti-ating with the Management to en-sure that the work environment is safe and offers basic amenities like fitness center break rooms or rec-reational facilities. Welfare benefits outside the workplace may include services like hospital bills, funeral ex-

penses among others. These programs increase em-

ployee satisfaction and ensure that workers are healthy and not distract-ed by personal issues that may affect their productivity. Additionally, em-ployee welfare programs promote goodwill in the community and en-hance the public image of the orga-nization.

The welfare officials include: Chairman James Kingori , Vice chair-man Mr. Peter Kwena, Secretary Gen-eral Joshua Plekwa, Treasure Coster Chebet, and Organizing Secretary Helen Odundo.


PPB staff at a customer care training workshop on 8th May 2014

22

PPB NEWS

There is nothing better than having a baby. Triza, as you welcome your new baby into your life, PPB staff hope that you find parenthood to be an amazing and rewarding experience. May you cherish every memory and succeed in everything that you set out to do, con-gratulations!

Congratulations for a New Born Baby


The management and staff of PPB would like to join the family, relatives and friends in mourning the passing of Dr. Lawrence Nzumbu’s dear mother.

Our thoughts are with you and your family during this difficult time. May the love of those around you help you through the days ahead. Please accept our utmost heartfelt sympathies

for the loss.

We pray the love of God enfolds to you during these difficult times and helps you to heal with the passage of time.

He is before all things, and in Him all things hold together. Col 1:17. May the Lord rest her soul in eternal peace

Condolences for Demise of Dr. Nzumbu’s Mother

23

PPB NEWS


Editorial Board

Dr Fred Siyoi Editorial Advisor

Judy Sirima Editor

Dr. Edward Abwao Contributor

Sophie Waihenya Sub-Editor

Sheila Muriithi Sub-Editor

Dr. Kipkerich Koskei OGW Registar

Dorine AdongoContributor

Gideon MurimiContributor

PPB NewsletterEnsuring Safety, Quality and Efficacy of Medicines & Practice of Pharmacy

ISSUE NO.1 OCT-DEC 2013

PPB Newsletter+++++

Product Evaluation and Registration

Inspectorate, Surveillance and Enforcement

Business Support



Pharmacy Practice & Tra

ining


Inside this edition

Word from the Registra

r ............

................

............ 2

Word from Deputy Registrar .....

................

................

3

Word from the Editors ...

................

................

........... 4

Directorates & their ta

sks ............

................

.......... 5

Medicine Regulation Harmonisation ..............

...... 7

Setting pace in Pharmacovigilance ...............

........ 10

PPB at Mombasa ASK show ...............

................

..... 11

The PPB Pictorial .............

................

................

.......... 12

Regional Heads Consultative Meeting ............

14

Colleges Licensed to offer Pharmacy courses .... 14

+

MINISTRY OF HEALTH

Pharmacy & Poisons Board

Ppb Marks Milestone

with the Launch of

Stakeholder’s E-Portal

To Promote Ease of

Doing Business

Pg. 8

1

For more information contact:Department of Public Relations, Pharmacy and Poisons Board

Lenana RoadP.O. Box 27663-00506 Nairobi.

Tel: +254-020- 3562107/2716905/6Fax: +254-020- 2713431/2713409

Email: [email protected]: www.pharmacyboardkenya.org

drug registration and evaluation ppbnewsletter practice

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