PST Level 4 Semester 2

NTA Level 4 • Semester 2 • PST04208 Destruction of Unfit Medicines and Cosmetic Products Law and Ethics in Pharmacy Practice • Source Session/Topic 12 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. Destruction of Unfit medicines and Cosmetic Products Students Learning Tasks By the end of this session students are expected to be able to: Identify different Participants involved in the Destruction process Describe the procedures for Destruction of Unfit Medicines and Cosmetic products Describe the Model of Drug Disposal Form of Unfit Medicines and Cosmetic products Describe the Model of Certificate of Destruction of Unfit Medicines and Cosmetic products Identification of Different Participants involved in the Destruction Process Identification of Different Participants involved in the Destruction Process It is the responsibility of the Tanzania Food and Drug Authority to implement the guidelines in coordination with regional and local health authorities, as well as with the directors of health facilities that face the problems of drug disposal. A local task force or advisory committee should be established at an early stage to assess, analyze and address the problem of drug disposal, and to monitor activities. Furthermore, it is suggested that such a task force has a maximum of five members and that meetings are held as near to the site of the stockpile as possible. Members/supervisors are chosen from: the drug regulatory authority the ministry of health; the police authority institutional pharmacists; A qualified hazardous waste expert may be appointed by the authority to be responsible for pharmaceutical waste disposal. If this is done the person appointed should become a member of the task force. The individual can be an expert in environmental management, a registered water chemist, hydro-geologist or sanitary engineer. The choice of expert depends on the technical problems to be faced. Therefore the destruction exercise shall be supervised by Health Officer, Environmental Officer, Policeman and Drug Inspector, and the owner/witness/superintended (pharmacist in charge) of the business. Procedures for Destruction of Unfit Medicines and Cosmetic Products Destruction of unfit medicines and cosmetic products shall involve the following procedures: A Drug Inspector, Health Officer, Environmental Officer and Policeman shall supervise the transport of consignment from the owner’s premises to the disposal site for destruction exercise. The destruction exercise shall be supervised by Health Officer, Environmental Officer, Policeman and Drug Inspector. Unfit medicines and cosmetic products shall be transported in a closed motor vehicle to avoid pilferage. Supervisors shall wear protective gears such as overalls, gloves, masks, caps and boots during the exercise. Upon completion of the exercise, a Drug Disposal Form (Annex V) shall be duly filled in and signed by the supervisors and owner/owner’s representative. Drug Disposal Form shall be sent to TFDA headquarter offices. Once TFDA has received the form, a certificate of destruction of unfit medicines and cosmetic products (Annex VI) shall be prepared and sent to the consignee. Particular care shall be taken while handling anti cancer drugs, narcotic drugs and penicillins to avoid associated hazards. Description of Model of Drug Disposal Form of Unfit Medicines and Cosmetic products Important information in the Disposal Form Name and address of the owner of the products destroyed Location/site where destruction exercise was conducted Date of the destruction exercise Methods of destruction used Total weight (Kg) and value(Tshs) of the products destroyed Name and signature of owner/in charge/representative of the organization Names, title and signatures of Drug Inspector, other supervisor(s) and witness of the disposal exercise. The Model of the form: (Annex V) Model of Disposal Form Form No……… (Pursuant to Section 99 of the Tanzania Food, Drugs and Cosmetics Act, 2003) The Tanzania Food and Drugs Authority declares to have supervised the disposal of unfit product (as per attached list) belonging to M/S…………………………………………………………………………………………… of postal address…………………………………………………………………………… The destruction exercise was conducted at (location, site) ……………………………………………on this date ……………………………………… by the following method(s) (state clearly):- 1…………………………………………………… 2…………………………………………………… 3…………………………………………………… The total weight of the products destroyed is ……………………………………… Kg and value is ………………………………………. Tshs. Name and signature of owner/in charge/representative of the organization: …………………………………… …… ……………………………………. (Name) (Signature) Names, title and signatures of Drug Inspector(s), other supervisor(s) and Witness of the disposal exercise:- Name: Title/Position: Signature & Date: 1………………………… ……. …………………….… …………………… 2…………………………. …………………. …………. ..…..……………… 3………………………… …. ……………………. …… …………………… 4…………………………. . ……………………. ……… …………………… 5………………………… …. …………………………… ……………………. Description of model of certificate of Destruction of Unfit Medicines and Cosmetic Products Important Information in the Certificate of Destruction Reference number of the certificate Date Name and postal address of owner Methods of destruction Place/site of destruction Serial number of the attached disposal form Weight(Kg) and value(Tshs) of products disposed Name and signature of Director General Annex VI Model of Certificate of Destruction Ref. No……………………………..… Date: ……………………….. THE TANZANIA FOOD, DRUGS AND COSMETICS ACT, 2003 CERTIFICATE OF DESTRUCTION I, being the person in-charge with the administration of the law relating to the Control of Pharmaceutical Products to which the Tanzania Food, Drugs and Cosmetics Act, 2003 apply, hereby certify the destruction of expired Pharmaceutical products belonging to…………………………………………………. of (Postal Address) …………………………………………………………… which took place on………………………………………………………………………………………………. The said consignment was destroyed by…………………………………………………… at………………………………………………….. …..under the witness and supervision of Drug Inspector, Environmental Officer, Health Officer and Police as specified in the attached disposal form with S.No. ………………………………….. The weight of the whole lot disposed is ………………….. Kg and its value is ……………… Tshs. ……………………………. Name and Signature of Director General ← Previous TopicView 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 Sorting and Verification of Unfit Medicines and Cosmetic Products Law and Ethics in Pharmacy Practice • Source Session/Topic 11 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. Sorting and Verification Exercise of Unfit Medicines and Cosmetic Products Students Learning Tasks By the end of this session students are expected to be able to: Define the term sorting of unfit medicines and cosmetic products Describe the sorting categories with their recommended disposal methods Describe sorting process of unfit medicines and cosmetic products Describe verification exercise of unfit medicines and cosmetic products Describe the Model of the Verification form(Annex III) Definition of the Term Sorting of Unfit Medicines and Cosmetic Products Sorting of unfit medicines and cosmetic products Sorting of medicines and cosmetic products means to separate the medicines and cosmetic products into separate categories for which different disposal methods are required. The separation should be made into those that can be safely used and returned to the pharmaceutical supply system and those that require disposal by different methods. For example, controlled drugs (e.g. narcotics), antineoplastic drugs and antibiotics all require special methods of disposal. Substantial investment in human resources may be required for identifying and separating those products. Sorting Categories and their Recommended Disposal Methods Sorting categories and their recommended methods Some of the examples of category of products and their recommended disposal methods are highlighted on the table below: S/N Categories Disposal methods 1. Solids, semi-solids and Powders Landfill, incineration and waste Immobilization 2. Liquids Sewer, high temperature incineration and treated waste 3. Antineoplastics Treated waste and landfill, high temperature incineration and return to manufacturer 4. Controlled drugs Treated waste and landfill, high temperature incineration 5. Aerosols and inhalers Landfill without waste inertization 6. Disinfectants Sewer or fast-flowing watercourse 7. PVC plastics, glass (ampoules, bottles and vials) Landfill and re-cycling 8. Paper, cardboard Recycle, burn, landfill Sorting process of Unfit Medicines and Cosmetic Products During verification exercise, the drug inspector shall supervise sorting exercise of unfit medicines and cosmetics products before determination of disposal method. Sorting should be done in an open or in a well ventilated area/building as close as possible to the stock pile in an orderly manner. Staff involved in sorting exercise shall be provided with protective gears such as gloves, boots, overalls and dust masks and shall be briefed on the sorting exercise, health and safety risks associated with handling the materials. Sorted medicines and cosmetics shall be carefully packed into steel drums or cardboard boxes or jute bags and information to be indicated outside the container shall include; dosage form(s) and proposed mode of destruction. The materials should be kept in a dry secure and preferably separate room to avoid being confused with in–date medicines or cosmetics until disposal is carried out. Verification Exercise of Unfit Medicines and Cosmetic Products After verification exercise is completed, a verification form (Annex III) shall be filled and signed by both parties. Verification process shall involve the following stages: Identification of the product. Separate medicines which fall under controlled drugs, antineoplastics, antibiotics and any other hazardous medicinal or cosmetic products. Sort according to Destruction Method (Annex IV). After verification the applicant shall be informed by either TFDA-HQ or TFDA zone office, Regional or District Authorities through a letter on the proposed mode of destruction and shall be directed to arrange with the respective local authority e.g. Municipal/ District Medical Officer/ Pharmacist to determine disposal site, cost and date of destruction. The cost of destruction shall be borne by the owner of the product as stipulated under Section 99 of Tanzania Food, Drugs and Cosmetics Act of 2003. Description of Model of Verification Form Annex III Model of Verification Form Form No…………… TANZANIA FOOD AND DRUGS AUTHORITY P.O. BOX 77150, DAR ES SALAAM Email: info@tfda.or.tz Telephone: 255 22 2450512, 2450751 Direct Line: 255 22 2450979 Fax No: 255 22 2450793 Name of applicant………………………………………………………………………….. of (postal address)… … … … … … … …… … … … … … undertaking the business of(specify)………………………………………………………………………………………. Location of Business……………………………………………………………………………. Weight (in Kg)………………………………………………………………………………………. Value (in Tshs)…………………………………………………………………………………….. Does the actual product(s) tally with the list of product(s) submitted to TFDA? YES/NO Other observation (s)……………………………………………………………………………… ………………………………………………………………………………………………………….. Suggested mode of destruction………………………………………………………………… ………………………………………………………………………………………………………….. Name of Applicant……………………………………………………..Signature…………. Date of verification………………………………. 1. Name of Drug Inspector…………………………………………Signature…………….. 2. Name of Drug Inspector…………………………………………Signature……………… Handout 13.1: Sorting Categories and their Recommended Methods of disposal Sorting categories: The objective of sorting is to separate the medicines and cosmetic products into categories that require different disposal methods. The appropriate safe disposal method recommended will depend principally on the pharmaceutical dosage form of the drugs. Segregated temporary storage areas or receptacles must be provided for each sorted category. Practical advice on sorting Sorting involves an initial overall evaluation of the stockpile and subsequent division of pharmaceuticals into those suitable for use and those to be discarded. For those to be discarded a decision is made on the best method of disposal. To be efficient items should only be handled once. Pharmaceuticals suitable for use should remain in their packaging. The pharmaceuticals to be discarded should, when necessary, be separated from their packaging as late in the process as possible. The sorting process includes: identifying each item; making a decision on whether it is usable; if usable, leaving packaging intact; if not usable, making a judgement on the optimal method of disposal and sorting accordingly; leaving packages and boxes intact until reaching their location, prior to definitive disposal or Transport to an institution for use. Optimum conditions for sorting Sorting should be done in the open or in a well ventilated and, if necessary, heated covered structure designated by the local authority. Sorting should be done as close as possible to the stockpile in an orderly way, with all sorted material clearly labeled and separated at all times. Staff supplied with protective equipment (gloves, boots, overalls, dust masks, etc.), should

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