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NTA Level 4 • Semester 2 • PST04208 Handling and Disposal of Unfit Medicines and Cosmetic Products Law and Ethics in Pharmacy Practice • Source Session/Topic 10 Full source-text version: all educational wording from the extracted learning source is retained; only presenter/tutor metadata and web-layout noise are removed, while formatting is improved for readability. Procedures for Handling and Disposal of Unfit Medicines and Cosmetic products Students Learning Tasks By the end of this session students are expected to be able to: Define the terms “ unfit medicines and cosmetic products” Describe the handling of unfit medicines and cosmetic products at facility level Describe the procedures for application to dispose off unfit medicines and cosmetic products prepare the format of the Register Book of unfit medicines/cosmetic products(Annex I) prepare Model of Application form for disposal of unfit products(Annex II) Definition of Unfit Medicines and Cosmetic products Unfit medicines and cosmetic products Medicines and Cosmetic products shall be considered as unfit when they are: expired improperly sealed damaged, unexpired and improperly stored improperly labelled counterfeit, substandard and adulterated prohibited unauthorized Prohibited drugs means any drug declared to be a prohibited drug in terms of the provisions of section 81 of this Act (TFDC Act). Counterfeit : a drug, medical device or herbal drug shall be deemed to be counterfeit if – it is manufactured under a name which belongs to another drug; or it is an imitation of, or is a substitute for, another drug, medical device or herbal drug resembles another drug or medical device likely to deceive or bears upon its label or container the name of another drug, medical device or herbal drug unless it is plainly and conspicuously marked so as to reveal its true character and its lack of identity with such other drug, medical device or herbal drug; or the label or container bears the name Of an individual or company purporting to be a manufacturer of the drug, medical device or herbal drug; which individual or company is fictitious or does not exist; or it has been substituted wholly or in Part by another drug substances; or it Purports to be it is a Product of manufacturer of whom it is not truly product. Expired: means a product should not be sold because of an expected decline in quality or effectiveness after a certain date. Substandard products are products that do not meet their quality standards and specifications. Handling of Unfit Medicines and Cosmetic products at Facility level Handling of Unfit Medicines and Cosmetic products at Facility level In order to manage properly unfit medicines and cosmetic products at a facility level, the following requirements shall be adhered to: Maintain a register book (Annex I) for unfit medicines and cosmetic products Keep them into different categories by dosage form such as:- Solids, semi-solids and powders: capsules, powders for injection, tablets, granules, creams, gels, suppositories etc. Liquids: Solutions, suspension, syrups, mixtures, lotions, aerosol, inhalers etc. Keep separately medicines which fall under controlled drugs, antineoplastics, antibiotics and any other hazardous medicines or cosmetic products. Keep in containers according to their dosage forms to facilitate verification exercise, sorting and selection of disposal method Demarcate an area for keeping containers of unfit medicines and cosmetic products which shall be labeled conspicuously with words “Expired medicines/ cosmetic products – Not for Sale” or “Unfit medicines/cosmetics – Not for sale” or “Dawa/Vipodozi hivi muda wake wa matumizi umekwisha – visiuzwe” au “Dawa/Vipodozi hivihavifai kwa matumizi – zisiuzwe” in red ink. Maintain safe custody of unfit pharmaceutical products in registered premises until they are disposed off to avoid pilferage. The decision of when to initiate disposal of unfit medicines and cosmetic products shall be made by regional, district or hospital pharmacist, owners, in-charge of facility, dispensers, and inspectors (including inspectors at ports of entry) to avoid accumulation of such products. Application for disposal of unfit medicines from Government institutions shall be accompanied by an approval from Accountant General declaring that the product have been written off and that are subject to disposal as required by law under Section 256 of the Public Finance Regulations,2001. Procedures for Application to dispose off Unfit Medicines and Cosmetic products Any person who intends to dispose off unfit medicines or cosmetic products shall adhere to the following procedures: Request in writing to the Director General of TFDA by using application for (Annex II) which is available at TFDA headquarter offices, TFDA zone offices, Regional and District Medical officer’s offices and TFDA website: www.tfda.ac.tz. A request shall be accompanied with a list of products to be disposed of and should state clearly trade name, generic name and strength (where applicable), dosage form, pack size, quantity, manufacturer, batch number and market value of product. Once the request has been received by TFDA, the Authority shall acknowledge and inform the applicant through a letter to contact Directorate of Medicines and Cosmetics to arrange or TFDA zone offices for verification of the product. In case of regions where there are no TFDA zone offices, applicant shall be informed to contact the Regional or District Medical officer’s offices for the same. TFDA-HQ or TFDA zone office/Regional/District Medical officer’s offices shall send inspectors to the premises to verify and authenticate the information submitted. Format of the Register Book of Unfit Medicines /Cosmetic products Important information in the Register book: Name of the product trade name generic name Strength of the product(where applicable) Dosage form: suspension, cream, ointment, tablet,…. Pack size Quantity Batch number Value(Tshs.) Annex I Format of Register Book S/N Name of a product Name of a product Strength where applicable Dosage form Pack size quantity Batch number Value (TZs) Trade name Generic name Strength where applicable Dosage form Pack size quantity Batch number Value (TZs) STEP 6: Model of Application form for Disposal of Unfit products (10 minutes) Important information in Application Form for Disposal Form number Postal address of TFDA Postal address of the applicant Specification of type of business of the applicant Type of products to be disposed

NTA Level 4 • Semester 2 • PST04208 Laws Relating to Storage and Distribution of Medicines and Medical Supplies Law and Ethics in Pharmacy Practice • Source Session/Topic 9 Full source-text version: all educational wording from the extracted learning source is retained; only presenter/tutor metadata and web-layout noise are removed, while formatting is improved for readability. Laws Relating to Storage and Distribution of Medicines and Medical supplies Students Learning Tasks By the end of this session students are expected to be able to: Define terms storage ,distribution, good storage practices Identify sections in the Pharmacy Act 2011 related to storage and distribution of medicines and medical supplies Describe sections in the Pharmacy Act 2011, related to storage and distribution of medicines and medical supplies Definition of Terms Storage and Distribution according to Pharmacy Act 2011 Definitions: Storage of medicines and medical supplies Storage means putting and safe keeping of medicines and medical supplies up to the point of use. Good Storage Practices (GSP) means part of quality assurance that ensures that the quality of pharmaceutical products is maintained by means of adequate control throughout the storage thereof. Distribution Distribution means a business of dealing in human medicines or medical devices in bulk or wholesale but does not include importers of human medicines, medical devices, food, cosmetics and veterinary medicines. Good distribution practices (GDP) Are practices that ensure that the quality of a pharmaceutical product is maintained by means of adequate control of the numerous activities which occur during the distribution process as well as providing a tool to secure the distribution system from counterfeits, unapproved, illegally imported, stolen, counterfeit, substandard, adulterated, and/or misbranded pharmaceutical products. Identification of Sections in the Pharmacy Act 2011,related to storage and distribution of medicines and medical supplies Section 34 Registration of premises Section 36 Application of permits Section 44 Conditions for body corporate to become authorized seller of medicines and pharmaceutical products Description of Sections in the Pharmacy Act 2011,related to storage and distribution of medicines and medical supplies Section 34 Registration of Premises A person shall not sell, dispense or supply medicinal products except in premises registered under this Act. An application for registration or renewal of registration of premises shall be made to the Council in the prescribed form, and shall be accompanied by such fee as the Council may prescribe. The Registrar or any person in his behalf shall- keep a register of all premises registered under this section; register premises if he is satisfied that the requirements to be complied with by the applicant as prescribed by the Council from time to time have been complied with; or have powers to approve the location and name of the proposed premises. The Council may, for good cause, refuse to register or cause to be removed from the register, any premises which is or has become unsuitable for purposes for which they were registered. A person who contravenes the provisions of subsection (1) commits an offence and upon conviction shall be liable to a fine not exceeding ten million shillings or imprisonment for a term not exceeding two years or to both. Section 36 Application for Permits A person shall not sell, dispense or supply medicinal products unless he has obtained a permit issued under this Act. An application for a permit shall be made to the Council in the prescribed form, and shall be accompanied by such fee as the Minister may prescribe. The Council shall not issue a permit to sell medicines and related medical supplies under this section unless the Council is satisfied that the premises in respect of which the application relates shall be stored, meets the prescribed standards; that the equipment are available for storing the medicines and related medical supplies; with the suitability of the equipment and facilities which are used for distributing the medicines and related medical supplies; and With the arrangements made or to be made for securing the safe keeping, and the maintenance of adequate records in respect of medicines and related medical supplies stored in or distributed from those premises. Section 44 Conditions for body corporate to become authorized seller of medicine and pharmaceutical products Anybody corporate carrying on business involving sale of drugs shall be an authorized seller of medicines within the meaning of this Act, if- with regard to the keeping, selling, dispensing and compounding of medicines the business is under the management of a superintendent who- is a Pharmacist; has signed and submitted to the Registrar a statement in writing on behalf of the body corporate stating his name and specifying whether or not he is a member of that body; and is not at that time acting in similar capacity for any other body; in each set of premises for the sell of medicines, the business is carried on either under the personal supervision of the superintendent or subject to his directions under the personal control of another Pharmacist; the name and certificate of registration of the superintendent or of some other Pharmacist having control of the business is conspicuously exhibited in the premises. Where- a body corporate which is an authorized seller of drugs has been convicted of an offence under this Act; or any member of the body corporate or any of its officer or any officer employed by it in carrying on the business, has been convicted of any criminal offence, or has been guilty of misconduct which, in the opinion of the Council, renders him or would, if he were a Pharmacist, render him unfit to be on the register, the Council may inquire into the matter and may, subject to this Act, direct that- the body corporate cease to be an authorized seller of medicines, and be disqualified for a period to be specified in the directions from being an authorized seller of medicines; or any or all of the premises of medicines and the body corporate be removed from the register of premises and be disqualified for such period as the Council

NTA Level 4 • Semester 2 • PST04208 Roles of Pharmaceutical Personnel in Health Care Delivery Law and Ethics in Pharmacy Practice • Source Session/Topic 8 Full source-text version: all educational wording from the extracted learning source is retained; only presenter/tutor metadata and web-layout noise are removed, while formatting is improved for readability. Roles of Pharmaceutical Personnel Students Learning Tasks By the end of this session students are expected to be able to: Mention roles of pharmaceutical dispensers Describe roles of pharmaceutical assistants Mention roles of pharmaceutical technicians Roles of Pharmaceutical Dispensers Assist the sale of pharmacy only and prescription only medicines under general sale Assist in compounding, manipulation or preparation of non sterile medicines or categorized substances according to a formula or standard operating procedures approved by a superintendent Assist the provision of information to individuals in order to promote health Assist in the distribution and control of stock of categorized medicines or categorized substances Roles of Pharmaceutical Assistants Pharmaceutical assistants enlisted may under supervision of a pharmacist, perform the following services or acts; Assist the sale of pharmacy only and prescription only medicines under general sale Assist in compounding, manipulation or preparation of non sterile medicines or categorized substances according to a formula or standard operating procedures approved by a superintendent Assist in manufacturing of sterile medicines or categorized substances according to formula and standard operating procedures approved by superintendent Assist in repackaging of medicines Assist in the distribution and control of stock of categorized medicine or categorized substances Assist the provision of information to individuals in order to promote health Undertake any other service or act as the council as the council may prescribe Roles of Pharmaceutical Technicians A pharmaceutical technician enrolled by the pharmacy council may, under the personal supervision of a pharmacist, perform the following activities Sale of pharmacy only and prescription only medicines under general sale Compounding, manipulation or preparation of non-sterile medicines or categorized substances according to a formula and standard operating procedures approved by a superintendent Assist in manufacturing of sterile or non sterile medicines or scheduled substances according to a formula and standard operating procedures approved by superintendent Repackaging of medicines in accordance with standard operating procedures approved by superintendent The distribution and control of stock of schedule medicines or categorized substances in the manner prescribed under any written law The ordering of medicine and scheduled substances upon review such medicine by an authorized practitioner in the manner prescribed under the Act or any other written law , or to purchase or obtain such medicine or categorized substance Interpretation and evaluation of prescription, selection, manipulation or compounding of medicine, labelling and supply of the medicine in an appropriate container Provision of instructions regarding the correct use of medicines supplied The provision of information to individuals in order to promote health Assist in data collection for research purposes Supervision of pharmaceutical Assistant Promotion of medical products and medical devices as per the Act Undertake any other Act or service as may be prescribed by the Council ← Previous TopicNext Topic →View all Law and Ethics in Pharmacy Practice topicsOpen Complete Full Notes PDF / OFFLINE NOTES Unataka kutumiwa notes hizi kupitia WhatsApp?Kwa notes zilizopangiliwa vizuri kwa kusoma offline au PDF, bonyeza kitufe hapa chini. Ujumbe wenye Level, Semester, Module na Topic utaandaliwa moja kwa moja.TUMIWA NOTES WHATSAPP WhatsApp: 255620339260

NTA Level 4 • Semester 2 • PST04208 Health Care Delivery and Referral System in Tanzania Law and Ethics in Pharmacy Practice • Source Session/Topic 7 Full source-text version: all educational wording from the extracted learning source is retained; only presenter/tutor metadata and web-layout noise are removed, while formatting is improved for readability. Health Care Delivery and Referral System in Tanzania Students Learning Tasks By the end of this session students are expected to be able to: Define health care system Mention goals of health care system Mention levels of health care delivery system in Tanzania Describe the referral system in health care delivery Definition of Health Care System Health care system is a system which consists of all organizations, people and actions whose primary intent is to promote, restore or maintain health Source WHO 2005 Goals of Health Care System The goals of health care system are; Promoting a goal of universal health care To ensure that all people obtain the health services they need without suffering financial hardship when paying for them. To ensure good health for the citizens, Levels of Health Care Delivery System The organization structure includes five levels as follows: National Level The central level, is the Ministry of Health and social Welfare Regional Level This level sometimes referred to as an extension of the MOH. It has the regional secretariat and one hospital in the region. District hospital level The district is the focal point for the implementation of the national health policy managed by the local authorities. Divisional Level This consist of a health centre which provides both curative and preventive Ward Level This is the lowest level (dispensary) of the formal health care delivery system. Referral System in Health Care Delivery Referral System Is an organizational structure for coordinating, linking, & transferring responsibility of care. May be done by: a generalist to a specialist a specialist to a specialist one hospital to another Government’s referral system assumes a pyramidal pattern of a referral system recommended by health planners that is from dispensary to Consultant Hospital (Better Health In Africa, 1993). The following are health facilities from low level to the highest level through which a referral system go through; Dispensary Services The dispensary caters for 6,000 to 10,000 people and supervises all the village health posts in its ward. This is the first level where patients are attended to. If the patient cannot be attended to at this level because of the complexity of the condition is then referred to the next level which is a health centre Health Centre Services A health Centre is expected to cater for 50,000 people which is approximately the population of one administrative division. This is the second level where patients are attended to. If the patient cannot be attended to at this level because of the complexity of the condition is then referred to the next level which is a health centre District Hospitals The district is a very important level in the provision of health services in the country each district is supposed to have a district hospital. For those districts which donate have Government normally negotiates with religious organizations to designate voluntary hospitals get subventions from the Government to contract terms. Patients are referred to here from Health centres and dispensaries present within the District Regional Hospitals Every region is supposed to have a hospital. Regional Hospital offer similar services like those agreed at district level, however regional hospitals have specialists in various fields and offer additional services which are not provided at district hospitals. Patients from districts are referred to these hospitals for further management Referral/Consultant Hospitals This is the highest level of hospital services in the country presently there are four referral hospitals namely, the Muhimbili National Hospital which cater the eastern zone; Kilimanjaro Christian Medical Centre (KCMC) which cater for the northern zone, Bugando Hospital which cater for the western zone; and Mbeya Hospital which serves the southern Highlands. ← Previous TopicNext Topic →View all Law and Ethics in Pharmacy Practice topicsOpen Complete Full Notes PDF / OFFLINE NOTES Unataka kutumiwa notes hizi kupitia WhatsApp?Kwa notes zilizopangiliwa vizuri kwa kusoma offline au PDF, bonyeza kitufe hapa chini. Ujumbe wenye Level, Semester, Module na Topic utaandaliwa moja kwa moja.TUMIWA NOTES WHATSAPP WhatsApp: 255620339260