ISSUE NO.2 APR-JUN 2014 + Drug Registration and Evaluation + Practice and Surveillance PPB Newsletter + Business Support Ensuring Safety, Quality and Efficacy of Medicines & Practice of Pharmacy + Medicines Information & Pharmacovigilance + Pharmaceutical Manufacturing Services + Pharmacy Practice & Regulation of Training

MINISTRY OF HEALTH Pharmacy & Poisons Board

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

Dr. Francis Kimani OGW Chairman

Dr. Kipkerich Koskei OGW Dr. Jennifer Orwa, OGW Dr. Sara Agak Registrar Member Member

Mr. Abdi O. Jama Dr. Paul Mwaniki Dr. Joseph Owoko Member Member Member

Dr. Evans Mwangangi Member

2 PPB Newsletter Issue No. 2, 2014 MESSAGE FROM THE REGISTRAR

Better regulation of medicines initiative

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. Dr. Kipkerich Koskei We call upon the members of the public to support he Pharmacy and Poisons Board (PPB) is the board by ensuring that they only buy their med- tasked with overseeing the quality, safety and icines from PPB approved premises. In case of any Tefficacy of medicines in . suspicion, one can contact the board through tele- phone, come to the offices, email, or even through There is no doubt that medicine regulation has re- Facebook and twitter account. cently become more critical with the liberal- Our goal is to establish strong linkages and Our goal is to establish ization and globaliza- strong linkages and re- tion of trade in pharma- relationships with mwanachi and all health lationships with mwa- ceuticals. The growth of service providers in the spirit of coordination nachi and all health imported products has and cooperation so as to improve the quality of service providers in the been rapid and is ex- spirit of coordination pected to continue to medical and herbal products in the market and cooperation so as increase. to improve the quality of medical and herbal products in the market. However, globalization and the scaling up of med- icines including herbal products to the developing The Board will continue to provide the leadership world are highlighting the urgent need for systems that is required to ensure the entire mandate is im- to assure product efficacy, safety, and quality. plemented. The Board needs your support in these matters. The need to ensure that people in Kenya have ac-

PPB Newsletter Issue No. 2, 2014 3 MESSAGE FROM THE DEPUTY REGISTRAR

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 Dr. Fred Siyoi including personnel to ensure they meet required he constitution of Kenya, Vision 2030 and the standards. health policy framework tasks the health sec- Ttor to come up with core strategies to ensure All the technological advancements taking place that Kenyans enjoy the highest standards of health within the Pharmacy and Poisons Board today are services. supposed to make it easier and more efficient for staff to monitor and assist our customers. The core function of Pharmacy and Poisons Board is to safeguard and protect the public health through As you all know customer relationships are key to ensuring that all pharmaceuticals that are sold and our business strategy. To support our regulatory used in Kenya are safe, therapeutically effective and activities and efforts, all stakeholders are urged to consistently meet acceptable standards of qual- play a bigger role in sharing ideas and information ity. Quality of medicines is close to every Kenyan that is useful for the common good.

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

4 PPB Newsletter Issue No. 2, 2014 EDITOR’S NOTE

ISSUE NO.1 OCT-DEC 2013 + Product Evaluation and Registration + Inspectorate, Surveillance and Enforcement PPB Newsletter Business Support Ensuring Safety, Quality and Efficacy of Medicines & Practice of Pharmacy + + Medicines Information & Pharmacovigilance + Pharmaceutical Manufacturing Services + Pharmacy Practice & Training Ppb Marks Milestone The broader PPB medicines with the Launch of Stakeholder’s E-Portal To Promote Ease of Doing Business Pg. 8 safety agenda for the country

Inside this edition Word from the Registrar ...... 2 Poison Board under the Ministry Word from Deputy Registrar ...... 3 Word from the Editors ...... 4 Directorates & their tasks ...... 5 of Health has been mandated to Medicine Regulation Harmonisation ...... 7 Setting pace in Pharmacovigilance ...... 10 PPB at ASK show ...... 11 regulate pharmacy practice and The PPB Pictorial ...... 12 Regional Heads Consultative Meeting ...... 14 MINISTRY OF HEALTH Colleges Licensed to offer Pharmacy courses .... 14 Pharmacy & Poisons Board trade in pharmaceutical products, 1 in line with the Pharmacy and Poi- Editorial Board sons Act Cap 244 of the laws of Editorial Advisor Kenya which was enacted in 1957. Dr Fred Siyoi The Board, with its huge man- Editor date strives to maintain high stan- Judy Sirima dards of professionalism in its Sub-Editors and Contributors quest for high quality drugs and Dr. Edward Abwao other medical devices to the Ken- Sophie Waihenya yan people. Today, thanks to PPB Sheila Muriithi measures a number of achieve- Gideon Murimi ments have been realized in the Dorine Odongo areas pharmacovigilance, ICT, The PPB Newsletter is a publication of Judy Sirima Drug Registration, Inspectorate, The Department of Public Relations of pharmacy practice, GMP and ad- The Pharmacy and Poisons Board. It is ealth is one of our great- ministration. designed to act as a tool of communi- est God given assets. ‘’The The second edition of PPB cation, documenting and diseminat- newsletter highlights the strat- ing important news and information Hhealthier we are, the more to the staff and stakeholders of The stable our emotions. ’With in- egies the board is undertaking Board. creased access to new essential to ensure the safety, efficacy and medicines, there is a greater need quality of medicines in the coun- Department of Public Relations, to monitor and promote safety and try to instigate you to rise and Pharmacy and Poisons Board, effectiveness of medicines. make important steps in the jour- Lenana Road ney to good health. P.O. Box 27663-00506 . There is no doubt that regula- Tel: +254-020- 3562107/2716905/6 tory authorities in nations require It is our hope as an Editorial Fax: +254-020- 2713431/2713409 the necessary infrastructure and team that our readers will find this Email: [email protected] resources including laws, systems publication useful in understand- Web: www.pharmacyboardkenya.org and structures, human resources ing the organization’s objectives and financial resources to execute and values and share in its culture. Design and layout their mandate. Send your views and comments to Commwide Concepts In Kenya, the Pharmacy and [email protected]

Content Launch of Continuing Professional Devel- Kenya nominated host for Regional Cen- opment Guidelines on course 16 tre of Regulatory Excellence (RCOREs) in 6 Good service is good business Africa for Pharmacovigilance Building the exceptional workforce 17 Kenya launches National Electronic Single Ensuring public safety PPB trains fire Window System 7 marshals 19 Kenya sets record as a leader in ADR Reports Herbal medicines in Kenya: Review of Striving for Excellence; PPB Achievements 9 efficacy, safety and regulation 19 Fostering partnership to stump out illegal Employee benefits: PPB medical insurance, premises 11 office space and reward system underway 20

PPB Newsletter Issue No. 2, 2014 5 ACHIEVEMENTS

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

he Pharmacy and Poisons Board has been chosen tervention, spearheaded by African leaders, to address to host a Regional Centre of Regulatory Excellence critical challenges facing the continent: poverty, devel- T(RCOREs) in Africa for Pharmacovigilance. opment and Africa’s marginalization internationally. Kenya was selected by New Partnership for Africa’s NEPAD provides unique opportunities for African Development (NEPAD) effective on 2nd May 2014 after countries to take full control of their development agen- beating five African countries National Regulatory Au- da, to work more closely together, and to cooperate thorities and Universities including Ghana who had re- more effectively with international partners. sponded to NEPAD call for applications to be considered The Pharmacy and Poisons Board (PPB) is the Nation- as Regional Centres of Regulatory Excellence in Africa for al Medicines Regulatory Authority of the republic of Ken- Pharmacovigilance in October 2013. The application was ya. It was established in 1957 under the Pharmacy and open to all the National Drug Regulatory Authorities in Poisons Act, Chapter 244 of the Laws of Kenya. PPB has Africa. the mandate to regulate pharmaceutical services, ensure World Health Organization defines Pharmacovigi- the quality, safety and efficacy of human and veterinary lance (PV) as the science and activities relating to the medicines, and evaluate medical devices. detection, assessment, understanding and prevention of PPB was chosen for its proven track record in deliver- adverse effects or any other drug-related problem. ing innovative programmes. PPB launched the Pharma- This means Kenya is now a model where other African covigilance in 2009 and established a National Pharma- Countries are expected to come to learn Pharmacovig- covigilance Centre. The centre has eight members of staff ilance activities. The Pharmacy and Poisons Board was who have undertaken both local and international train- nominated by NEPAD, primarily for the regional centre’s ings on issues of pharmacovigilance including training at ideal location and the quality of services it provides. the WHO Uppsala Drug Monitoring Centre. The criterion for selection was based on training A training curriculum for training of healthcare work- capacity; regulatory capability; Partnerships & collabo- ers across the country has been developed. In collabo- rations; Training programmes certified by national ed- ration with Management Sciences for Health (MSH) and ucation accreditation body and/or other accreditation tertiary training institutions such as the University of systems; Governance & Management systems and Infra- Nairobi (UON) and the Kenya Medical Training College, structure. several pharmacovigilance training sessions for under- NEPAD an African Union strategic framework for graduate pharmacy students have been conducted to pan-African socio-economic development is a new in- sensitize health workers on pharmacovigilance before

6 PPB Newsletter Issue No. 2, 2014 ACHIEVEMENTS

they graduate. The Pharmacovigilance centre has a newsletter that With support from partners PPB has prioritized train- it regularly shares with its clients to update them on the ing of health workers and other stakeholders such as latest development on issues pharmacovigilance. The representatives of the Pharma industry in Kenya on phar- centre has also successfully carried out an active sur- macovigilance and medicine safety. In March 2014, over veillance study on monitoring the safety of artemether 10,000 individuals drawn from the public and private lumefantrine and is currently data cleaning and analyz- sectors in Kenya had undergone the training. ing. A Pharmacovigilance e-shot, an electronic mailing Through the centre PPB has also carried out Post system used to communicate to subscribers issues of marketing studies of products like antimalarials, anti TBs, concern has been developed and an online reporting ARVs and most recently reproductive health products. system that allows healthcare workers and consumers of To carry out its mandate, the centre receives financial medicines has been launched to submit reports on poor support from the PPB, development/implementing part- quality medicine or suspected Adverse Drug Reaction ners and pharmaceutical industry. PPB provides overall (ADR). www.pv.pharmacyboardkenya.org leadership for the implementation of the “one” national Kenya is the 98th member of the WHO international and integrated Kenya Pharmacovigilance System. drug monitoring program contributing to the database We are honoured to receive such recognition and on the Adverse Drug Reactions (ADRs.) In Africa, Kenya look forward to working with our partners in contribut- is the fourth leading reporter and the leading in the East ing to Kenya’s knowledge-generation capacity. This pres- and Central African Region. It has reported more than tigious award now means we have the freedom to set 7,600 suspected Adverse Drug Reactions to the WHO da- our own research priorities and the opportunity to think tabase. strategically and focus on the long term.

Kenya launches National Electronic Single Window System

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

s technological develop- the ICT industry in Kenya. System expected to enhance the ef- ment is a constant process, Of course, one of the most im- ficient exchange of information be- Alike during the earlier years, portant changes that are taking tween trade and government. in 2014 too, a whole new breed of place in the industry is the introduc- On 2nd May 2014, Rwandan technologies is waiting to reshape tion of the Electronic Single Window President Paul Kagame launched

PPB Newsletter Issue No. 2, 2014 7 ACHIEVEMENTS

Kenya’s National Electronic Single implementation in ten countries the technologies currently used Window System (KNESWS). The sys- namely Finland, Germany, Guatema- by the state and private sector and tem is expected to boost regional la, Hong Kong, Mauritius, Malaysia, small and medium sized enterprises trade by easing clearance processes Senegal, Singapore, Sweden, United in particular Sweden. These coun- of goods in the country. The tech- States point to a common set of key tries provide concrete examples nology would make it possible for factors for success. These include; Kenya can learn from. traders to submit information about • Strong leadership, which A single window is a practical their goods to multiple government came from private or public application of trade facilitation con- agencies in various locations, mak- sector cepts intended to reduce non-tariff ing business faster and more effi- • Cooperation and commit- trade barriers and deliver immediate cient. ment of all stakeholders, pri- benefit to all members of the trading In the spirit of the integration of vate and public community. the EAC, the event was graced by • User friendly system which In most countries, companies four Presidents’ among them Uhuru do not create complications engaged in international trade reg- Kenyatta of Kenya, Yoweri Museveni for usual business ularly have to submit large volumes of Uganda and Salva Kiir Mayardit of • Investment in the modern of information and document to South Sudan. Also present were the technologies governmental authorities to comply 2nd Vice-President of Burundi and • Phased, flexible approach with import, export and transit re- the Tanzanian Prime Minister. and lated regulatory requirements, this Five agencies were involved in • Neutrality of the proposed information and documents often the launch, KRA, KPA, KEPHIS, KEBS technical solution has to be submitted through several & PPB. 24 other agencies are expect- However, operations from these different agencies, each with its own ed to join. The Board has already countries have reported difficulties specific system (manual or automat- trained staff namely Gideon Murimi, in established business and state ic) and paper forms. Naomi Nkuiya, Allan Wambua, Shei- practices, establishing cooperation Establishing a single window fa- la Muriithi, James Thuo and Robert and commitment of various states cility is one means of addressing this Omondi and has issued them with authorizes involved in import and problem. Certificates of ‘Super User’ status. export procedures in particular in Case studies on Single window Finland and USA and modernizing

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

8 PPB Newsletter Issue No. 2, 2014 ACHIEVEMENTS

Kenya sets record as a leader in ADR Reports

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

ontinuous monitoring of adverse drug reactions HCSM developed and launched an online reporting sys- after medicines have been registered is important tem (PVERS) that allows both the healthcare workers and Cso as to pick the reactions that were not previous- consumers of medicines to submit reports on any sus- ly identified during clinical trials. Different patients react pected poor quality medicinal products (sPQMP) or sus- differently to medicines and similarly different races re- pected adverse drug reaction (sADR). act differently to medicines. During clinical trials only a The establishment of this electronic submission of small number of patients are exposed to a medicine be- sADR and sPQMP has resulted in increased reporting fore the approval after which almost the whole popula- which helped PPB in recalling or withdrawing some tion can use the product. poor quality medicines. Over 700 suspected ADR reports Kenya is the 98th member of the WHO international and 70 suspected PQMP reports were submitted via the drug monitoring program since 2010 when she joined online reporting system to the pharmacovigilance unit the program and started to contribute to the Vigiflow from April 2013 after the launch in December 2013. database on ADRs from 23rd April 2010. In Africa, Ken- By 31st March 2014, PPB received 7,643 ADR reports ya is among the top four countries in terms of Individual as defined by the figures below. Case Safety Reports (ICSRs) to WHO global ICSR database while in the East and Central African Region it is the lead- ANALYSIS ing reporter. It has reported more than 7,000 suspected adverse drug reactions (ADRs) to the WHO database. 1.1 Trends in Reporting by Year The Pharmacy and Poisons Board launched Pharma- There was a general upward trend in the number of covigilance system in June 2009. To promote collection reports received from 2010 until 2012 followed by a peak of the ADR reports from all over the country so as to and subsequent downward trend until 2013. An upward monitor the quality of marketed products, the PPB con- trend is anticipated in the coming months of 2014 fol- ducted training of healthcare workers on pharmacovigi- lowing the introduction of the PVERS in May 2013 as well lance and also supplied them with guidelines, reporting as Training of Trainers (ToTs) on PV by NASCOP. tools and job aids. In order to improve further the reporting rates and 1.2. Cumulative Number of Reports by Cadre promote sustainability, the PPB with support from MSH/ The overwhelming majority - almost ¾ - of ADR re-

PPB Newsletter Issue No. 2, 2014 9 ACIHIEVEMENTS

ports was received from health professionals other than 1.4. ADR Reports by Institution pharmacists and physicians. A total of 286 facilities contributed to ADR reports over the four year period. Moi Teaching and Referral Hos- 1.3. ADR Reports by County pital in , with 939 ADR reports, con- Nairobi, Uasin Gishu and Migori counties contribut- tributed the highest number of reports in the country. ed the highest number of ADR reports with 13%, 12% St. Camillus Mission hospital (582 reports), District and 10% of the total reports received respectively. Eight Hospital (389 reports) and District Hospital (311 re- counties have never submitted a single ADR report over ports) were other health facilities with a high number of the four year period reports. Thirteen institutions accounted for over 50% of all the ADR reports (Table 1)

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%c 3. Thika District Hospital 389 5.1% 25.0% 4. Kilifi District Hospital Kilifi 311 4.1% 29.1% 5. District Hospital Vihiga 282 3.7% 32.7% 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. 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 Class with regard to the age of the patient with 23% of the ADR The overwhelming majority of ADR reports (5,618, reports missing this parameter. 74%) were ARVs-related. No specific drug class was im- The following recommendations are made based on plicated for 21% of the ADR reports. Antibiotics, anti-TBs, the findings of the analysis: anti-malarials and anti-hypertensives together account- 1. The County Health Management Teams (CHMTs) in ed for 5% of the ADR reports and 15 other drug classes counties with low reporting rates should liaise with accounted for the remaining ADR reports PPB to come up with strategies to improve ADR de- tection and reporting. 2. Health workers are encouraged to fill out the ADR 1.6. Completeness of ADR Reports forms as completely as possible to ensure that all ba- Completeness of ADR reports was generally high. sic data is captured Only 4%, 2.7% and 0.5% of the reports did not have the 3. Sensitization of the PVERS by PPB and partners gender, qualification of reporter, and type of reaction should continue in order to boost ADR reporting respectively indicated. However, a major gap noted was rates. with regard to the age of the patient with 23% of the ADR 4. ADR data should be routinely analyzed and used reports missing this parameter. to inform policy and decision-making at national-, county-, sub-county and facility levels RECOMMENDATIONS Completeness 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 Edward Abwao(PPB) , Victor Sumbi (MSH), respectively indicated. However, a major gap noted was Ndinda Kusu (MSH), Mary Njeri (PPB)

10 PPB Newsletter Issue No. 2, 2014 ACIHIEVEMENTS STRIVING FOR EXCELLENCE PPB ACHIEVEMENTS

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

Measures put in place to ensure that only safe set up through which one is allowed to either im- port or export medicines through. medicines are on the shelves; • The board regulates the premises where these • An elaborate drug registration system has been medicines are being sold and they must be un- established that ensures that only safe, quality der the control of PPB approved personnel. and efficacious products are registered. • These premises are inspected before they are • Drugs are approved and must all analyzed by The board carries out post marketing surveillance of get annual approval laboratories from the board. to ensure the products in the country to ensure they are safe, • The same applies to compliance efficacious and of good quality. This is done by ran- the personnel who with the label domly collecting samples from all over the country man these facilities. claims. They must pass their • All the man- and taking them for analysis at the National Quality professional examina- ufacturing Control Laboratory that is WHO prequalified tion and also must get sites have to annual approval to run be inspected their premises. to ensure that they comply with the required • The board carries out post marketing surveil- standards. lance of the products in the country to ensure • The registered medicines have to be retained they are safe, efficacious and of good quality. This each year in order to monitor them. is done by randomly collecting samples from all • Imported products must get an import permit over the country and taking them for analysis at from PPB for them to get into the country includ- the National Quality Control Laboratory that is ing donations. About 70% of the medicines used WHO prequalified. in the country are imported with the remaining • A system of reporting suspected poor quality amount being produced locally. medicines and suspected adverse drug reactions • Designated ports manned by PPB staff have been has also been established and this helps the

PPB Newsletter Issue No. 2, 2014 11 ACIHIEVEMENTS

board monitor the medicines in the country. • They should report any suspicious quality and How can people know that drugs are safe? safety issues to the board • The public should only buy medicines from PPB • This can even be done through PPB facebook ac- approved health facilities. count and through the online reporting system. • They should ensure that • The public should they are only served by The public should be vigilant also support the board by en- qualified personnel in suring that they only buy their these premises. about the medicines they are medicines from PPB approved • It is a requirement that premises. the premises display the consuming • While at the premises PPB issued licenses for they should ensure that they both the premises and are served by qualified per- the personnel. sonnel and also get a receipt with the name of • PPB website has the list of all registered medi- the medicine indicated on it. This is important es- cines in the country and by frequently checking pecially when it comes to tracing the medicines the website; one will be able to ensure that they incase of any problem. are getting quality products. • In case of any suspicion, one can contact the DRUG REGISTRATION board through telephone, come to the offices, email, or even facebook. Arms • Equally PPB has an online reporting system 1. Human Medicine- Biological and vaccines www.pv.pharmacyboardkenya.org where one 2. Veterinary Medicines can report any suspicious product for the board 3. Herbal/ complementary 4. Medical devices to take action. 5. Borderline Ways of enhancing public participation in Achievements monitoring and ensuring quality and safety of • Common Technical Document (CTD). This is the medicines in Kenya. human and veterinary registration • The public should be vigilant about the medi- • Retention from analog to digital. Annual reten- cines they are consuming tion from 2010. Keeping the product in the Ken-

12 PPB Newsletter Issue No. 2, 2014 ACIHIEVEMENTS

yan market. E- Retention was launched in 2013 Ports of Entry (POE) and Drug Crime Investigation & En- October and it’s on going. forcement Unit (DCIE) have the following core mandate: • Committee of internal evaluation – departmen- • Inspections of pharmaceutical premises (distri- tal meetings to deliberate on written communi- bution outlets) to ensure they meet required cation from pharma companies. standards. • Notification – updated information from the • Investigation of drug related crimes and recom- pharmaceutical companies about registered mend for prosecution or disciplinary products in the Kenyan market. • Inspections at ports of entry • Queries – communication from PPB to applicants • Surveillance of the market to ensure unregis- of registered product, prior to registration and tered, substandard and counterfeit drugs are de- after tected and eliminated. • Registration of products – issuing of a registra- • Coordinate recall and supervise disposal of Phar- tion certificate after a product has met registra- maceutical waste. tion criteria. To achieve the above objectives the Directorate has a team of 59 inspectors spread across various ports of ICT ACHIEVEMENTS entries, regions and districts. A high standard of profes- • E-Portal System- The stakeholder’s e-portal will sionalism, integrity, budgetary support and confidence enable pharmaceutical industry to access trade is essential to ensure achievement of above objectives. licensing and drug retention services from PPB online Inspection of Distribution Outlets • Spearheading the EAC harmonization in QMS & During the 3rd quarter a total of 1278 premises IMS. - The East African Community states have including hospitals and clinics were inspected for com- initiated a medicines regulation harmonization pliance to Good Distribution Practices. Various actions project (EAC MRH) to improve access to safe effi- were taken against those not complying including sei- cacious and good quality essential medicines in zure of all the products therein and taking offenders to the partner state. courts. A total of 345 premises were arrested and charged in INSPECTORATE ACHIEVEMENTS court with various offences that were in violation of Cap Pharmacy and Poisons Board’s Inspectorate Direc- 244. torate comprising of Good Distribution Practices (GDP),

Fostering partnership to stump out illegal premises he Kenya Pharmaceutical tors in the region in particular in- Association held its region- vestigation of drug related crime Tal stakeholders meeting in and surveillance of the market on 4th April 2014. The were discussed. meeting which was attended by Ms. Obinge noted that de- stakeholders from pharmaceuti- spite challenges of delayed court cal industry sought to strengthen cases and absenteeism by super- partnership with Pharmacy and intendents in hostile areas such Poisons Board. as Oyugis the region has made Regional head Beatrice tremendous achievements in Obinge moderated the meeting the area of elimination of illegal which was also attended by PPB premises. Nyanza has 900 regis- Public Relation office. During the tered chemists she noted. meeting core activities of Inspec-

PPB Newsletter Issue No. 2, 2014 13 PICTORIAL

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

Pharmacovigilance team trains a group of health workers

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

PPB staff listens keenly to Fire Marshal training proceedings

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 Super induction; PPB drivers display their dress code Illegal Pharmacy Practice

14 PPB Newsletter Issue No. 2, 2014 PICTORIAL review of the East African Community Medicines Regulatory Harmonization (EAC-MRH) Dr. Francis The Registrar Kimani, the Director Medical Services, Dr Kipkerich Koskei together with members of EAC after a meeting to discuss the mid-term

PPB Newsletter Issue No. 2, 2014 15 TRAINING Launch of Continuing Professional Development Guidelines on course

rom June 2014 all pharmacists and pharmaceutical shrined in the sessional paper No. 4 of 2012 (Kenya Na- technologists will have a legal obligation to under- tional Pharmaceutical Policy). Ftake and record Continuing Professional Develop- The first edition of CPD guidelines was produced in ment activity (CPD) in order to maintain registration as a 2006 in consultation with stakeholders. Subsequently, pharmacy professional in Kenya. lessons learned during the implementation of CPD in the PPB plans to launch the high quality revised Continu- country have been valuable for the review and updating ing Professional Development guidelines designed to of the CPD guidelines in order to address the identified help pharmacists and pharmaceutical technologists up- gaps. The reviewed guidelines will be launched and dis- hold the best pharmaceutical practices, improve treat- seminated in June 2014. ment outcomes and enhance patient safety. The new CPD guidelines outline the requirements This is an opportunity for the industry to take charge that must be met by pharmacists in order to meet the of its learning and development and push the boundar- CPD standards. It will be a requirement that pharma- ies in achieving new standards. cy practitioners earn a predetermined number of CPD Continuing Professional Development (CPD) is an in- points for re-registration or re-licensure. CPD programs ternationally accepted approach that facilitates profes- will be administered by PPB and other accredited CPD sionals to acquire the necessary knowledge, skills and providers such as professional associations, NGOs, devel- ethical attitudes so as to remain current and competent opment partners, health training institutions or individ- in their prac- uals. tice as en- 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.

16 PPB Newsletter Issue No. 2, 2014 TRAINING Good service is good business

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

ustomer service excellence has always been and • Be honest and transparent with your customers will always be one of the critical competitive ad- • Double check with your customers to ensure Cvantages for any business. On 8th and 9th May complete satisfaction 2014, the Pharmacy and Poisons Board held a custom- • Use positive language that is motivating and in er care training workshop to equip staff with customer ways persuading care, public relations and communication skills aimed at • Be friendly and compassionate to create the right increasing accessibility and customer satisfaction. Train- atmosphere for coming to the best solution ing and development is an essential cornerstone in pro- • Learn from mistakes moting customer philosophy. • Maintain good body language even when talking The objective of the two day workshop which was with your client on the phone opened by the Registrar of Pharmacy and Poisons Board • Learn to effectively communicate with clients. Dr. K. Koskei was to improve the quality of service and Know when to listen, when to speak and how to communication between the board and its customers. speak During the opening Dr. Koskei noted that the training is • Be calm and patient crucial, in ensuring that the goals set out in the Pharmacy • Have computer skills for easier communication and Poisons Act are met. • Keep your promises The registrar noted that the board has an expanded • Be confident for easier convincing of your cus- mandate to regulate herbal or complementary/ alterna- tomer tive medicines in the country. To fulfil its mandate the • Be a leader – show you are capable of providing Board is conducting customer care training programmes new solutions for customers for staff whose emphasis is competence based to ensure • Manage your time clients who come to the board receive quality services. • Analyze problems as soon as you begin to speak Customer service is perhaps the most vital part of with a customer as a way to show professional- conducting business as it reflects directly on the com- ism pany and how it is able to meet the needs of patrons. • Negotiate and persuade – win-win results ‘’The Board would like to establish strong linkages and • Understand human psychology. Body language relationships with all health service providers in the spir- and tone of voice when talking to customers it of coordination and cooperation so as to improve the • Know your organization. Become an expert – quality medical and herbal products in the market,’’ the learn everything from product and service you Registrar noted. are selling or offering to your client • Work under pressure - knowing how to solve problems, thinking ahead and maintaining your Skills on excellent customer service composure at all times will help you offer the • Be a great listener. This will show you care and best solutions to your customers. want to offer the right solution

PPB Newsletter Issue No. 2, 2014 17 TRAINING Building the exceptional workforce

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

raining and development can be initiated for a vari- March to 4th April 2014 ety of reasons for an employee or group of employ- • GMP training for inspectors for EAC member Tee’s e.g. when a performance appraisal indicates countries at Panafric Hotel from 10th - 21st Feb- performance improvement is needed, to “benchmark” ruary, 2014 and the status of improvement in a performance improve- • GMP training for PPB inspectors organized by ment effort or as part of an overall professional develop- United Nations Industrial Organization (UNIDO) ment program. at the Sentrin Lake Elementaita Lodge from 28th Out of these reasons the Directorate concerned with – 30th April, 2014 of Good Manufacturing Practice (GMP) has set standards These successful trainings by GMP indicate the im- for inspectors to undergo a minimum of ten hours GMP portance of employee training. Training is crucial for training annu- organiza- ally to keep tional devel- track GMP in- opment and spection. You can work really hard, but if you success be- Employee cause it edu- development are not training in the right way you are cates work- gives the not going to improve and get to the level ers about the workforce a effective use good chance that you want to - Micheal Chang of technolo- to realize their gy, ensures potential and competitive eventually edge in the work at their highest level. Between January and May market, creates opportunities for career development 2014, GMP has conducted three capacity building pro- and personal growth, an important factor in retaining grams; workers, helps employers comply with laws and regula- • GIZ training at the Red Court Hotel from 31st tions, and improves productivity and profitability.

18 PPB Newsletter Issue No. 2, 2014 TRAINING

Ensuring public safety PPB trains fire marshals

extinguishers in case of fire at the office. About Fire Marshals Fire 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- Mr. Claine from Du-Tech Fire Service illustrates fire awareness tips to sist in the situation; PPB staff. Below: Fire Marshal Evacuation kit. • Liaising with the Emergency Services on their arrival; • Coordinating contingency harmacy and Poisons Board law to have a sufficient number of planning if the situation war- knows that maintaining safe- fire marshals to deal with fire emer- rents it; Pty is the most important job gencies faster and effectively. The • Ensuring the building is safe and has worked hard to ensure the training targeted those who are re- before anyone is allowed to premise is fully prepared for any sponsible for overseeing fire safety, re-enter. emergency. designated fire marshals and anyone • Compiling a Fire Related In- On 21st -22nd February 2014 who needs to know how to use a fire cident Report. the Board organized Fire Marshal extinguisher. To ensure Fire Marshal’s are com- training for staff. The training was During the training a practical petent in carrying out all their duties, conducted by Mr. Clive Lee from drill session was held and trainees it is important that they are properly Duo-Tech Fire Services (DTFS) in col- were shown how to act and use fire trained. 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

PPB Newsletter Issue No. 2, 2014 19 REGULATION Herbal medicines in Kenya: Review of efficacy, safety and regulation

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

egulation of herbal medicines is a key means of firms/companies who manufacture locally, repackage, ensuring safety, efficacy and quality of herbal me- relabel, import/export or distribute these products to be Rdicinal products. Herbal products have gained in- sold or used in Kenya for the pending regulation. creasing popularity in the last decade, and are now used Guidelines and application forms for registration are by approximately 85 percent of the African population. available at the Pharmacy and Poisons Board offices or Herbal products are complex mixtures of organic chem- can be downloaded at the board website www.pv.phar- icals that may come from any raw or processed part of a macyboardkenya.org . plant, including leaves, stems, flowers, roots, and seeds. Before, herbs were defined as dietary supplements, Unfortunately, there is limited sci- and manufacturers could pro- entific evidence to establish the duce, sell, and market without safety and efficacy of most herbal first demonstrating safety and ef- products. ficacy, as is required for pharma- Despite the uncertainty about ceutical drugs. Although herbs the safety, effectiveness, and are often perceived as “natural” cost-effectiveness of traditional and therefore safe, many differ- medicine expanding their use, ent side effects have been report- where reasonable evidence of ed owing to active ingredients, their effectiveness and good evi- contaminants, or interactions dence of their safety exists, might with drugs. yield health, social, and economic According to the Registrar Dr. benefits. Kipkerich Koskei the Board has To promote the responsible taken this adequate precautions commerce of herbal products, and steps to safeguard the public medical devices and dietary sup- health. The registration is on-go- plements, the Government via ing and the board has advised all Legal Notice 192 of 2010 and Gazette no. 1879 of 21st dealer’s in herbal products and complementary medi- March, 2014, conferred the powers of regulation to the cines to come forward and register their products. Pharmacy and Poisons Board. Government and clearing agencies have been ad- The Pharmacy and Poisons Board (PPB) is the Nation- vised to ensure all herbal or complementary/alternative al Medicines Regulatory Authority of the republic of Ken- products and complementary medicine coming from ya. It was established in 1957 under the Pharmacy and outside have import permits from the Pharmacy and Poi- Poisons Act, Chapter 244 of the Laws of Kenya. PPB has sons Board. the mandate to regulate pharmaceutical services, ensure ‘’We are encouraging the media not to allow any ad- the quality, safety and efficacy of human and veterinary vertisements of any herbal or complementary/alterna- medicines, and evaluate medical devices. tive medicines unless they are approved by the Board,’’ To safeguard public health the Board has notified the Registrar stressed.

20 PPB Newsletter Issue No. 2, 2014 STAFF WELFARE

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

o recruit and retain the very best employees in to- that a modern approach to compensation and employee day’s marketplace, you must offer a competitive benefit plans rewards and recognizes best employees. Temployee benefits package–especially one that Therefore effective employee benefits strategies being offers affordable health insurance. implemented by the board raise productivity, increase The good news is that PPB has secured a Medical In- employee retention, and have a positive impact on the surance for the staff, Head of Administration, Ms Dorine bottom line. Odongo has disclosed. There are a number of reasons Aside from these benefits and the job scope itself, why it makes good business sense for employers to of- one factor that significantly influences how employees fer insurance benefits to their employees and their fami- feel about work is the environment. The Administrator lies. The overriding reason being a healthy workforce is a reveals that PPB new office space is in the final stages more productive workforce. It’s plain and simple. and is expected to provide adequate work environment Ms Dorine also says plans are also underway to intro- for better performance. duce a reward system for staff. It is worldly recognized Staff welfare – Healthy working lives

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

ny successful organization association has is to establish a PPB penses among others. recognizes its staff as key to canteen and a Cooperative Sacco, These programs increase em- Atheir success. As such most or- the Chairman disclosed during the ployee satisfaction and ensure that ganizations invest in employee wel- members meeting recently. workers are healthy and not distract- fare. In 2013 staff of Pharmacy and ‘Staff welfare’ is an all-encom- ed by personal issues that may affect Poisons Board formed a staff welfare passing term covering a wide range their productivity. Additionally, em- association with an aim to assist of facilities that are essential for the ployee welfare programs promote members in times of need through well-being of employees. During the goodwill in the community and en- financial contribution and morale meeting Kingori assured members hance the public image of the orga- support. that the welfare officials are negoti- nization. According to the Chairman of ating with the Management to en- The welfare officials include: the welfare, Mr. James Kingori the sure that the work environment is Chairman James Kingori , Vice chair- objective of employee welfare is safe and offers basic amenities like man Mr. Peter Kwena, Secretary Gen- to improve life for a worker both in fitness center break rooms or rec- eral Joshua Plekwa, Treasure Coster and outside of work. He anticipates reational facilities. Welfare benefits Chebet, and Organizing Secretary the welfare will have many benefits outside the workplace may include Helen Odundo. as it grows. Some of the plans the services like hospital bills, funeral ex-

PPB Newsletter Issue No. 2, 2014 21 PPB NEWS

Congratulations for a New Born Baby

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!

Condolences for Demise of Dr. Nzumbu’s Mother

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

22 PPB Newsletter Issue No. 2, 2014 Editorial Board PPB NEWS

Dr. Kipkerich Koskei OGW Registar

Dr Fred Siyoi Editorial Advisor

Judy Sirima Sophie Waihenya Editor Sub-Editor

Sheila Muriithi Dr. Edward Abwao Sub-Editor Contributor

Gideon Murimi Dorine Adongo Contributor Contributor PPB Newsletter Issue No. 2, 2014 23 PPB Newsletter Ensuring Safety, Quality and Efficacy of Medicines & Practice of Pharmacy

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2 3 ...... 4 ...... 5 Registrar the Inside this editionRegistrar 7 from d s ...... Wor Deputy or ...... 10 from Edit ...... ALTH d d tasks ar or the 11 W om their Y OF HE d fr monisation ...... oisons Bo 1 or & Har MINISTR W tes 12 ora macy & P ect Dir Regulation macovigilance...... 14 Phar show ...... 14 Medicine ace in PharASK .... asa ses e Meeting Setting pMomb ...... cour at orial macy For morePPB informationConsultativPhar contact: PPB Pict ffer Department of Public Relations,The Heads t oPharmacy o and Poisons Board Regional Licensed LenanaColleges Road P.O. Box 27663-00506 Nairobi. Tel: +254-020- 3562107/2716905/6 Fax: +254-020- 2713431/2713409 Email: [email protected] Website: www.pharmacyboardkenya.org