Pharmacy and Poisons Board

Last updated

The Pharmacy and Poisons Board (PPB or the Board in short) is the Drug Regulatory Authority established under the Pharmacy and Poisons Act, Chapter 244 of the Laws of Kenya.

Contents

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

Mandate

The Pharmacy and Poisons Act, Cap 244 is an Act of Parliament to make better provision for the Control of the Profession of Pharmacy and trade in drugs and poisons.

The Pharmacy and Poisons Board is established as a body corporate, under the Pharmacy and Poisons Act, Cap 244 Laws of Kenya. The PPB is regulatory body within the Ministry of Medical Services. It is a body corporate under Section 3(6), and the de-linking process is on-going.

Membership of the Board

The board members consists of the following: (1) There is established a Board which shall consist of— (a) a chairperson who shall be appointed by the President and who shall— (i) be a registered pharmacist of good standing with a degree in pharmacy; and (ii) have at least ten years’ experience in the pharmaceutical sector; (b) the Director of pharmaceutical services; (c) the Principal Secretary in the ministry for the time being responsible for matters relating to finance or his or her representative; (d) two persons representing the pharmacy training institutions, of which one shall be a pharmacist and one shall be a pharmaceutical technologist; (e) three other persons appointed by the Cabinet Secretary, of whom— (i) one person shall be a pharmacist representing institutions of higher learning; (ii) one person shall be a pharmaceutical technologist representing mid-level colleges; and (iii) one person shall be an enrolled pharmaceutical technologist with expertise in community Health Laws (Amendment) 2019

Services

The Board offers the following services:

1. Product Evaluation and Registration. Certificates of Analysis are issued by three accredited laboratories namely the National Quality Control Laboratory, MEDS and the Drug Analysis and Research Unit,

2. Evaluation of Applications for Advertisements of Medicines and Medical Devices

3. Ensuring Good Manufacturing Practice (GMP)

4. Registration of Pharmacists

5. Enrolment of Pharmaceutical Technologists

6. Issuance of Annual Practice Licenses

7. Issuance of Annual Permits for Pharmaceutical Representatives

8. Approval of Institutions Offering Pharmacy Training Programmes

9. Approval of Pharmaceutical Imports and Exports

10. Registration of Pharmaceutical Premises/Outlets

11. Pharmacovigilance and Post-Market Surveillance

12. Documentation and Information Services on Medicines and Pharmacy Practice

13. Public relations services for the pharmaceutical sector

Functions of the Board

The functions of the Board as spelt out by law are as follows:

Registration of Pharmacists and Enrollment of Pharmaceutical Technologists

The process is done through administration of a professional examination to the persons with degree and diploma certificates from institutions recognised by Pharmacy and Poisons Board. There are two types of examinations for each group namely;

(i) Stage I and II for pharmacist (ii) Level I and II for Pharmaceutical Technologist

Stage I examinations – This is administered to persons with degree from universities outside Kenya. When one pass he/she proceeds for a one-year internship, supervised by Pharmacy and Poisons Board.

Stage II Examination- This is administered to persons from University of Nairobi after completing one-year internship supervised by PPB and Stage I group upon completion of one-year internship. The pharmacists that pass Stage II exams are entered into the pharmacists register.

Level I examination – This administered to persons with diploma obtained in colleges (i) outside Kenya and (ii) approved by Pharmacy and Poisons Board other than Kenya Medical Training College. Once one passes the exam, they proceed to a seven months practical attachment supervised by PPB.

Level II examination – This is administering to persons for KMTC and those that have finished the seven-month attachment. Upon passing this the name of pharmaceutical technologist is entered into the Roll of Pharmaceutical Technologist.

Annual Practice License

Registered pharmacists and enrolled pharmaceutical technologists are legally required to hold an annual practice licence when working. This is obtained from PPB an application using a prescribed form, and issued by Training and Assessment department.

Related Research Articles

<span class="mw-page-title-main">Pharmacist</span> Healthcare professional

A pharmacist, also known as a chemist or a druggist, is a healthcare professional who dispenses medications and who provides advice on their effective use, with the aim of preventing disease and promoting public health. Pharmacists often serve as primary care providers in the community, and may offer other services such as health screenings and immunizations.

<span class="mw-page-title-main">Pharmacy</span> Clinical health science

Pharmacy is the science and practice of discovering, producing, preparing, dispensing, reviewing and monitoring medications, aiming to ensure the safe, effective, and affordable use of medicines. It is a miscellaneous science as it links health sciences with pharmaceutical sciences and natural sciences. The professional practice is becoming more clinically oriented as most of the drugs are now manufactured by pharmaceutical industries. Based on the setting, pharmacy practice is either classified as community or institutional pharmacy. Providing direct patient care in the community of institutional pharmacies is considered clinical pharmacy.

A Doctor of Pharmacy is a professional doctorate in pharmacy. In some countries, it is a doctoral degree to practice the profession of pharmacy or to become a clinical pharmacist. In many countries, people with their Doctor of Pharmacy are allowed to practice independently and can prescribe drugs directly to patients. A PharmD program has significant experiential and/or clinical education components in introductory and advanced levels for the safe and effective use of drugs. Experiential education prepares graduates to be practice-ready, as they already have spent a significant amount of time training in areas of direct patient care and research.

<span class="mw-page-title-main">Regulation of therapeutic goods</span> Legal management of drugs and restricted substances

The regulation of therapeutic goods, defined as drugs and therapeutic devices, varies by jurisdiction. In some countries, such as the United States, they are regulated at the national level by a single agency. In other jurisdictions they are regulated at the state level, or at both state and national levels by various bodies, as in Australia.

<span class="mw-page-title-main">Pharmacy technician</span> Licensed health care provider well-versed in pharmacy

A pharmacy technician performs pharmacy-related functions. Training, certification, licensing, and actual practice of pharmacy technicians varies not only worldwide but in some countries regionally as well as by employer.

Pharmacotherapy is therapy using pharmaceutical drugs, as distinguished from therapy using surgery, radiation, movement, or other modes. Among physicians, sometimes the term medical therapy refers specifically to pharmacotherapy as opposed to surgical or other therapy; for example, in oncology, medical oncology is thus distinguished from surgical oncology. Pharmacists are experts in pharmacotherapy and are responsible for ensuring the safe, appropriate, and economical use of pharmaceutical drugs. The skills required to function as a pharmacist require knowledge, training and experience in biomedical, pharmaceutical and clinical sciences. Pharmacology is the science that aims to continually improve pharmacotherapy. The pharmaceutical industry and academia use basic science, applied science, and translational science to create new pharmaceutical drugs.

A Bachelor of Pharmacy is a graduate academic degree in the field of pharmacy. In many countries, this degree is a prerequisite for registration to practice as a pharmacist. Since both PharmB and PharmD are prerequisites to license in most western countries they're considered equivalent. In many western countries, the foreign graduates with BPharm, PharmB or BS Pharm practice similarly as PharmD graduates. It is analogous to MBBS vs. MD where MBBS is foreign equivalent of MD. It is training to understand the properties and impacts of medicines and developing the skills required to counsel patients about their use.

<span class="mw-page-title-main">Compounding</span> Preparation of a custom medication

In the field of pharmacy, compounding is preparation of a custom formulation of a medication to fit a unique need of a patient that cannot be met with commercially available products. This may be done for medical reasons, such as administration in a different format, to avoid a non-active ingredient the patient is allergic to, or to provide an exact dose that isn't commercially available. Medically necessary compounding is referred to as "traditional" compounding. It may also be done for medically optional reasons, such as preference of flavor or texture, or dietary restrictions.

The pharmaceutical industry in Bangladesh is one of the most developed technology sectors within the country. Manufacturers produce insulin, hormones, and cancer drugs. This sector provides 97% of the total medicinal requirement of the local market. The industry also exports medicines to global markets, including Europe. Pharmaceutical companies are expanding their business with the aim to expand the export market.

A veterinary pharmacist is a specially trained pharmacist who dispenses veterinary drugs and supplies or products and advice to owners of companion animals and livestock. In addition, they advise the regulatory bodies and are involved in the formulation of veterinary drugs. Veterinary pharmacy is a field of pharmacy practice, in which veterinary pharmacists may compound medications, fill prescriptions, and manage drug therapies for animals. Veterinary pharmacists are licensed pharmacists who specialize in the distribution of medications for animals.

Pharmacy in China involves the activities engaged in the preparation, standardization and dispensing of drugs, and its scope includes the cultivation of plants that are used as drugs, the synthesis of chemical compounds of medicinal value, and the analysis of medicinal agents. Pharmacists in China are responsible for the preparation of the dosage forms of drugs, such as tablets, capsules, and sterile solutions for injection. They compound physicians', dentists', and veterinarians' prescriptions for drugs. Pharmacological activities are also closely related to pharmacy in China.

The basic requirement for pharmacists to be considered for registration is often an undergraduate or postgraduate pharmacy degree from a recognized university. In many countries, this involves a four- or five-year course to attain a bachelor of pharmacy or master of pharmacy degree.

<span class="mw-page-title-main">Wildlife inspector</span>

A wildlife inspector is a person empowered by law to protect wildlife.

<span class="mw-page-title-main">Drug packaging</span> Packaging for pharmaceutical preparations

Pharmaceutical packaging is the packages and the packaging processes for pharmaceutical preparations. It involves all of the operations from production through drug distribution channels to the end consumer.

The certificate of pharmaceutical product is a certificate issued in the format recommended by the World Health Organization (WHO), which establishes the status of the pharmaceutical product and of the applicant for this certificate in the exporting country; it is often mentioned in conjunction with the electronic Common Technical Document (eCTD). A CPP is issued for a single product, because manufacturing arrangements and approved information for different pharmaceutical forms and strengths can vary. The CPP is mentioned in World Trade Organization documents, although the tightly regulated products are subject to bilateral trade agreements or regional trade agreements. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has instituted standards for this purpose but it is unclear how the ex-ICH countries operate their health regulators.

The General Pharmaceutical Council (GPhC) is the body responsible for the independent regulation of the pharmacy profession within England, Scotland and Wales, responsible for the regulation of pharmacists, pharmacy technicians and pharmacy premises. It was created, along with the Royal Pharmaceutical Society, in September 2010 when the previous body responsible for regulation, the Royal Pharmaceutical Society of Great Britain, was split so that representative and regulatory functions of the pharmacy profession could be separated.

Korean Oriental Pharmacists are a licensed healthcare professionals who take charge of various pharmaceutical affairs like the manufacturing, preparation, identification, storage, importation, sales of drugs and other pharmaceutical technologies in the Republic of Korea.

<span class="mw-page-title-main">Pharmaceutical Society of Ghana</span>

The Pharmaceutical Society of Ghana was founded on December 19, 1935 out of the former Gold Coast Pharmacists and Druggists Union and the Chemists Defense Association which had existed before 1929. The Society was founded by a group of pharmacists led by William Ayiah Hansen, Hansdrug College of Pharmacy, Hansdrug Hall, Accra. He did so with the support of Dr. D. Duff, then the Director of Medical Services. William Ayiah Hansen was then the Organizing Secretary and Registrar of the Society. Before 1935, the predominant Pharmacists groups in Ghana were two associations. Pharmacists affiliated themselves to these groups according to their bonding or non-bonding to government service. The private pharmacists groups were led by William Ayiah Hansen.

<span class="mw-page-title-main">Drug labelling</span>

Drug labelling is also referred to as prescription labelling, is a written, printed or graphic matter upon any drugs or any of its container, or accompanying such a drug. Drug labels seek to identify drug contents and to state specific instructions or warnings for administration, storage and disposal. Since 1800s, legislation has been advocated to stipulate the formats of drug labelling due to the demand for an equitable trading platform, the need of identification of toxins and the awareness of public health. Variations in healthcare system, drug incidents and commercial utilization may attribute to different regional or national drug label requirements. Despite the advancement in drug labelling, medication errors are partly associated with undesirable drug label formatting.

<span class="mw-page-title-main">Human Medicines Regulations 2012</span> United Kingdom legislation

The Human Medicines Regulations 2012 in the United Kingdom were created, under statutory authority of the European Communities Act 1972 and the Medicines Act 1968 in 2012. The body responsible for their upkeep is the Medicines and Healthcare products Regulatory Agency. The regulations partially repealed the Medicines Act 1968 in line with EU legislation.

References