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Pharmaceutical Sciences Notes, PST Level 4 Semester 2, PST NTA Level 4, PST04209 Compounding of Pharmaceutical Preparations

Reduction and Enlargement of the Official – PST04209 Compounding of Pharmaceutical Preparations

NTA Level 4 • Semester 2 • PST04209 Reduction and Enlargement of the Official Compounding of Pharmaceutical Preparations • 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. Session 8: Reduction and Enlargement of the Official Formula to Obtain Required Formula for Compounding Total Session Time: 120 minutes + 1 hours of Assignment Prerequisites • None Learning Tasks By the end of this session students are expected to be able to: • Explain Reduction and Enlarging of Appropriate Formula for Compounding • Practice Reduction and Enlarging of Official Formula to Determine Amount of Each Ingredient Required for Compounding Resources Needed: • Flip charts, marker pens, and masking tape • Black/white board, chalk and whiteboard markers ,LCD projector and computer • Worksheet 8.1 take home assignment SESSION OVERVIEW Activity/ Step Time Content Method 1 05 minutes Presentation Introduction, Learning Tasks 30 minutes Reduction and Enlarging of Appropriate 2 Presentation Formula for Compounding 60 minutes Presentation Reduction and Enlarging of Official Formula to 3 Small group Determine Amount of Each Ingredient Required discussion for Compounding 4 10 minutes Presentation Key Points 5 05 minutes Presentation Evaluation 6 10 minutes Presentation Assignment CMT 04101 Dispensing NTA L 4 Semester 1 Facilitator Guide Session X: ———— -(Title)———————- 40 SESSION CONTENTS STEP 1: Presentation of Session Title and Learning Tasks (5 minutes) READ or ASK students to read the learning objectives and clarify ASK students if they have any questions before continuing. STEP 2: Reduction and Enlarging of Official Formula (30 minutes) • Reducing and enlarging formula are calculations performed when the required amounts of medicines (Prescribed/ordered) deviate from the official formula in a reference book. o Obtaining the amount of each ingredient required for compounding, the figures of the official formula are multiplied by a factor which is determined by the following proportion:- Total amount of the official = quantity of each ingredient in the official formula Total amount required x (x = quantity of each ingredient in the required amount i.e. x = total amount required × Quantity of each ingredient in the official formula . Total amount of official formula Thus the factor is determined by the ratio: Total amount required . Total amount of official formula Summary on obtaining the amount for each ingredient in the required amount (x): x = FACTOR × quantity of each ingredient in the official formula CMT 04101 Dispensing NTA L 4 Semester 1 Facilitator Guide Session X: ———— -(Title)———————- 41 STEP 3: Reduction and Enlarging of Official Formula (60 minutes) To Determine Amount of Each Ingredient Required for Compounding Activity: Small Group Discussion ( 60 minutes) DIVIDE students in small manageable groups ASK students to discuss in groups on the following questions • What is the amount of each ingredient required to make 40mls of Compound Sodium Chloride Mouth Wash BPC. 1973? • What is the amount of each ingredient required to make 20mls Aromatic Magnesium Carbonate mixture PCx. (Syn. Mistura Carminativa)? REFER Students to Tanzania Pharmaceutical Handbook (2011): Chapter 2, Formulary and list of alternatives for Pharmaceutical ingredients including water, for reference ALLOW students to discuss for 20 minutes ALLOW each groups to present for 5 minutes CLARIFY and SUMMARIZE by using the contents below • Official formula given for Compound Sodium Chloride Mouth Wash BPC. 1973 o Sodium chloride …………………………………….. 1.5g o Sodium bicarbonate …………………………………. 1.0g o Peppermint emulsion, concentrated …………………. 2.5 mL o Chloroform water double strength …………………… 50.0 mL o Water for preparation ………………………………. to 100.0mL Thus: Total amount of official formula = 100mL Total amount required = 40 mL Amount of each ingredient (x) =? FACTOR = Total amount required . Total amount of official formula FACTOR = 40 mL / 100mL FACTOR = 0.4 CMT 04101 Dispensing NTA L 4 Semester 1 Facilitator Guide Session X: ———— -(Title)———————- 42 Then, amount of each ingredient can be obtained as summarized in table below, Total amount of the official FACTOR total amount required Sodium chloride…………………….. 1.5g 0.6 g Sodium bicarbonate ………………… 1.0g 0.4 g Peppermint emulsion, concentrated…. 2.5 mL 0.4 1.0 mL Chloroform water double strength … 50.0 mL 20.0 mL Water for preparation ………….. to 100.0mL 40.0 mL Therefore amount required for each ingredient to make 40 mL of Compound Sodium Chloride Mouth Wash BPC. 1973 are: o Sodium chloride ……………………………………… 0.6 g o Sodium bicarbonate …………………………………. 0.4 g o Peppermint emulsion, concentrated …………………. 1.0 mL o Chloroform water double strength ………………….. 20.0 mL o Water for preparation …………………………….. to 40.0mL • Official formula given for Aromatic Magnesium Carbonate mixture PCx. (Syn. Mistura Carminativa) o Light magnesium carbonate ………………………..….. 3.0 g o Aromatic cardamom tincture ……………………..……. 3.0 mL o Sodium bicarbonate ……………..………………..……. 5.0 g o Chloroform water double strength …..………………… 50.0 mL o Water for preparation ………………….…………… to 100.0mL Thus: Total amount of official formula = 100mL Total amount required = 20 mL Amount of each ingredient (x) =? FACTOR = total amount required . Total amount of official formula FACTOR = 20 mL / 100mL FACTOR = 0.2 Then, amount of each ingredient can be obtained as summarized in table below, Total amount of the official FACTOR total amount required Light magnesium carbonate ……….. 3.0 g 0.6 g Aromatic cardamom tincture ………. 3.0 mL 0.6 g Sodium bicarbonate .………………. 5.0 g 0.2 1.0 mL Chloroform water double strength … 50.0 mL 10.0 mL Water for preparation …………. to 100.0mL 20.0 mL CMT 04101 Dispensing NTA L 4 Semester 1 Facilitator Guide Session X: ———— -(Title)———————- 43 Therefore amount required for each ingredient to make 20 mL of Aromatic Magnesium Carbonate mixture PCx, o Light magnesium carbonate …………………………….. 0.6 g o Aromatic cardamom tincture ………………………..…. 0.6 mL o Sodium bicarbonate ……………..…………………..…. 1.0 g o Chloroform water double strength …..………………… 10.0 mL o Water for preparation ………………….……………. to 20.0mL STEP 4: Key Points (10 minutes) • Reducing and enlarging formula are calculations performed when the required amounts of medicines

Pharmaceutical Sciences Notes, PST Level 4 Semester 2, PST NTA Level 4, PST04209 Compounding of Pharmaceutical Preparations

Listing of Ingredients, Equipment/ Instruments/ – PST04209 Compounding of Pharmaceutical Preparations

NTA Level 4 • Semester 2 • PST04209 Listing of Ingredients, Equipment/ Instruments/ Compounding of Pharmaceutical Preparations • 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. Session 7: Listing of Ingredients, Equipment/ Instruments/ Apparatus for Compounding as per Official Formula Total Session Time: 60 minutes + 1 hours of Tutorial Prerequisites • None Learning Tasks By the end of this session students are expected to be able to: • List Ingredients for Compounding According to Official Formula • List Equipment/Instrument/Apparatus for Compounding as per Official Formula Resources Needed: • Flip charts, marker pens, and masking tape • Black/white board, chalk and whiteboard markers • LCD projector and computer SESSION OVERVIEW Activity/ Step Time Content Method 1 05 minutes Presentation Introduction, Learning Tasks 20 minutes Ingredients for Compounding According to 2 Presentation Official Formula 25 minutes Presentation Small Equipment/Instrument/Apparatus for 3 group Discussion Compounding as per Official Formula 4 05 minutes Presentation Key Points 5 05 minutes Presentation Evaluation CMT 04101 Dispensing NTA L 4 Semester 1 Facilitator Guide Session X: ———— -(Title)———————- 35 SESSION CONTENTS STEP1: Presentation of Session Title and Learning Tasks (5 minutes) READ or ASK students to read the learning tasks and clarify ASK students if they have any questions before continuing STEP 2: Ingredients for Compounding According to Official Formula (20 Minutes) • After identifying a correct official formula that is suitable for compounding of the product, then list all ingredients present in official formula, • If some of ingredients are out of stock, prepare that ingredient in advance, or find an alternative one if the official formula provides such assumption • Check for compatibility of the alternative ingredient with other ingredients in the formula Some examples of preparations with their respective ingredients include: • IODINE PAINT, COMPOUND (Syn. Mandl‟s Paint) o Iodine o Potassium iodide o Water for preparations o Peppermint oil o Alcohol (90%) o Glycerol • AMMONIUM CHLORIDE MIXTURE o Ammonium chloride o Aromatic ammonia solution o Liquorices liquid extract o Water for preparations • ORAL REHYDRATION SALTS (ORS) o Glucose, anhydrous o Sodium chloride o Trisodium citrate dehydrate o Potassium chloride CMT 04101 Dispensing NTA L 4 Semester 1 Facilitator Guide Session X: ———— -(Title)———————- 36 STEP 3: Equipment/Instrument/Apparatus for Compounding as per Official Formula (25 Minutes) • It is very important to identify the apparatus, instrument, or equipment that will be needed for pharmaceutical compounding Activity: Small Group Discussion ( 20 minutes) DIVIDE students into small manageable groups ASK students to discuss on the following question • What apparatus/ equipments that are used in the compounding of the 500 mL of Normal saline? • What apparatus/ equipments that are used in the compounding of the 250 mL Dextrose solution 5%? ALLOW students to discuss for 10 minutes ALLOW few groups to present and the rest to add points not mentioned CLARIFY and SUMMARIZE by using the contents below • The following are apparatus/ instruments/ equipments used in compounding of the Normal saline; o Weighing balance o Beaker o Stirring rod o Measuring cylinder • The following are apparatus/ instruments/ equipments used in compounding of the Dextrose solution 5%; o Weighing balance o Beaker o Stirring rod o Measuring cylinder STEP 4: Key Points (5 minutes) • Each preparation has its own formula for compounding together with its ingredients • Apparatus/ instruments/ equipments used for compounding should be appropriate to the pharmaceutical preparations to be compounded CMT 04101 Dispensing NTA L 4 Semester 1 Facilitator Guide Session X: ———— -(Title)———————- 37 STEP 5: Evaluation (5 minutes) • What are the ingredients used in compounding of Ammonium chloride mixture? STEP 6: Tutorial (1 hours) • INFORM the students that “every student will practice in the laboratory in identification of ingredients and apparatus/ instrument/ equipments needed for compounding the following preparations: Benzaldehyde spirit TPH • Aluminium acetate solution TPH • Compound Sodium Chloride Mouth Wash TPH CMT 04101 Dispensing NTA L 4 Semester 1 Facilitator Guide Session X: ———— -(Title)———————- 38 References Pharmaceutical Society of Great Britain., & . Department of Pharmaceutical Sciences. (1994). The Pharmaceutical Codex, Principles and Practice of Pharmaceutics (W. Lund Ed. 12th ed.). London,: Pharmaceutical . Senya, S. S., Mwasha, C. Y. S., Muyinga, A. M., Amiri, R. I., & Mauga, E. A. S. K. (2011). Tanzania Pharmaceutical Handbook (2nd ed.). Dar es salaam: School of Pharmaceutical Sciences, Institute of Allied Health Sciences, Muhimbili University of Health and Allied Health Sciences. United States Pharmacopeial Convention. Committee of Revision. (2013). The United States pharmacopeia (pp. v.). Rockville, Md.: United States Pharmacopeial Convention, Inc. CMT 04101 Dispensing NTA L 4 Semester 1 Facilitator Guide Session X: ———— -(Title)———————- 39 ← Previous TopicNext Topic →View all Compounding of Pharmaceutical Preparations 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

Pharmaceutical Sciences Notes, PST Level 4 Semester 2, PST NTA Level 4, PST04209 Compounding of Pharmaceutical Preparations

Identification of Formula Needed in Pharmaceutical Compounding from the References – PST04209 Compounding of Pharmaceutical Preparations

NTA Level 4 • Semester 2 • PST04209 Identification of Formula Needed in Pharmaceutical Compounding from the References Compounding of Pharmaceutical Preparations • Source Session/Topic 6 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. Session 6: Identification of Formula Needed in Pharmaceutical Compounding from the References Total Session Time: 120 minutes + 4 hours of Practical Prerequisites • None Learning Tasks By the end of this session students are expected to be able to: • List References /Compendia Used in Compounding of Pharmaceutical Preparations • Identify Formula for Pharmaceutical Preparation Resources Needed: • Flip charts, marker pens, and masking tape • Black/white board ,chalk and whiteboard markers • LCD projector and computer SESSION OVERVIEW Activity/ Step Time Content Method 1 05 minutes Presentation Introduction, Learning Tasks 35 minutes Presentation References /Compendia Used in Compounding 2 of Pharmaceutical Preparations Buzzing 60 minutes Presentation Identification of Formula for Pharmaceutical 3 Preparation Demonstration 4 10 minutes Presentation Key Points 5 10 minutes Presentation Evaluation CMT 04101 Dispensing NTA L 4 Semester 1 Facilitator Guide Session X: ———— -(Title)———————- 30 SESSION CONTENTS STEP1: Presentation of Session Title and Learning Tasks (5 minutes) READ or ASK students to read the learning tasks and clarify ASK students if they have any questions before continuing STEP 2: References/ Compendia Used in Compounding of Pharmaceutical Preparations (35 Minutes) • A reference book is a book containing useful facts or specially organized information, as an encyclopedia, dictionary, or atlas. Or is a book intended to be consulted for information on specific matters rather than to read from beginning to the end. o These books have been written as a student guide to extemporaneous pharmaceutical compounding and dispensing. It has been designed to assist the student compounder in understanding the key dosage forms encountered within extemporaneous dispensing. Activity: Buzzing (5 minutes) ASK students to pair up and buzz on the following question for 2 minutes • What are the references/ Compendia used in compounding? ALLOW few pairs to respond and let other pairs to add on points not mentioned WRITE their response on the flip chart/board CLARIFY and SUMMARIZE by using the content below • The following are the reference books used in compounding: o Tanzania Pharmaceutical Handbook (TPH) o Pharmaceutical Codex (PCx) o British Pharmacopoeia (BP) o United State Pharmacopoeia (USP) o Martindale‟s Extra Pharmacopoeia o Remington: The Science and Practice of Pharmacy 21st Edition o The Tanganyika Formulary STEP 3: Identification of Formula for Pharmaceutical Preparation (60 Minutes) • After comprehended the request in the prescription, a compounder has to identify the correct formula from the reference book • The correct formulas from the reference book can be obtain through the following ways: CMT 04101 Dispensing NTA L 4 Semester 1 Facilitator Guide Session X: ———— -(Title)———————- 31 o Find the name of the pharmaceutical preparation to be compounded through table of contents of the reference book and go to formulation, e.g. solution. o The formulation in the content indicates the page where the respective formula is indicated. o Find the name of the pharmaceutical preparation to be compounded through the index of the reference book o The index indicates the number of page where the respective formula is indicated Below are official formulas obtained from the reference book (TPH) under the indicated table of content of the book • AQUEOUS IODINE SOLUTION PCx (Syn. Lugol‟s Solution) Iodine………………………………………………………….. 5.0 g Potassium iodide………………………………………………. 10.0 g Purified water freshly boiled and cooled ……………………… to 100mL • WEAK IODINE SOLUTION PCx. (Syn. Iodine Tincture) Iodine………………………………………………………. 2.5 g Potassium iodide…………………………………………… 2.5 g Purified water, freshly boiled and cooled………………….. 2.5 g Alcohol (90%)……………………………………………… to 100.0 mL Activity: Demonstration (50 minutes) DIVIDE students in small manageable groups. PREPARE formula from a reference book for demonstration POSITION students so that everyone can see and hear REVIEW steps of that skill with students using a reference book REFER students to the Tanzania Pharmaceutical Handbook (TPH) DEMONSTRATE the procedure of identifying a formula from a reference book ALLOW one student from each group to do a return demonstration and let others comment on it CLARIFY and SUMMARIZE the procedures to identify a Formula for Pharmaceutical Preparation INFORM the students that “every student will practice in the laboratory under supervision until is competent” CMT 04101 Dispensing NTA L 4 Semester 1 Facilitator Guide Session X: ———— -(Title)———————- 32 STEP 4: Key Points (10 minutes) • A reference book is a book containing useful facts or specially organized information, as an encyclopedia, dictionary. • After comprehended the request in the prescription, a compounder has to identify the correct formula from the reference book • The correct formulas from the reference book can be obtain through table of content and index of the respective book. STEP 5: Evaluation (10 minutes) • What is a reference book? • How the correct formula from the reference book can be identified? STEP 6: Practice (4) • INFORM the students that they have to practice in the laboratory in identification of formula needed in pharmaceutical compounding from the references book o BENZOIC ACID SOLUTION (TPH) o SALICYLIC ACID OINTMENT (TPH). o SALICYLIC ACID AND SULPHUR OINTMENT (TPH) o CHLOROFORM WATER, DOUBLE STRENGTH (TPH) CMT 04101 Dispensing NTA L 4 Semester 1 Facilitator Guide Session X: ———— -(Title)———————- 33 References Pharmaceutical Society of Great Britain., & . Department of Pharmaceutical Sciences. (1994). The Pharmaceutical Codex, Principles and Practice of Pharmaceutics (W. Lund Ed. 12th ed.). London,: Pharmaceutical . Senya, S. S., Mwasha, C. Y. S., Muyinga, A. M., Amiri, R. I., & Mauga, E. A. S. K. (2011). Tanzania Pharmaceutical Handbook (2nd ed.). Dar es salaam: School of Pharmaceutical Sciences, Institute of Allied Health Sciences, Muhimbili University of Health and Allied Health Sciences. United States Pharmacopeial Convention. Committee of Revision. (2013). The United States pharmacopeia (pp. v.). Rockville, Md.: United States Pharmacopeial Convention, Inc. CMT 04101 Dispensing NTA L 4 Semester 1 Facilitator Guide Session

Pharmaceutical Sciences Notes, PST Level 4 Semester 2, PST NTA Level 4, PST04209 Compounding of Pharmaceutical Preparations

Describe Cleaning, Preventive Maintenance and Storage of Apparatus, Containers and Closures – PST04209 Compounding of Pharmaceutical Preparations

NTA Level 4 • Semester 2 • PST04209 Describe Cleaning, Preventive Maintenance and Storage of Apparatus, Containers and Closures Compounding of Pharmaceutical Preparations • Source Session/Topic 5 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. Session 5: Describe Cleaning, Preventive Maintenance and Storage of Apparatus, Containers and Closures used in Compounding Total Session Time: 120 minutes + 6 hours of Practice Prerequisites • None Students Learning Tasks By the end of this session students are expected to be able to: • Explain Proper cleaning of Apparatus, Containers and Closures • Describe Preventive Maintenance of Apparatus, Containers and Closures • Describe Storage of Apparatus, Containers and Closures used in Compounding Resources Needed: • Flip charts, marker pens, and masking tape • Black/white board , chalk and whiteboard markers, • LCD projector and computer SESSION OVERVIEW Activity/ Step Time Content Method 1 05 minutes Presentation Introduction, Learning Tasks 25 minutes Presentation Proper Cleaning of Apparatus, Containers and 2 Closures Demonstration 35 minutes Presentation Preventive Maintenance of Apparatus, 3 Containers and Closures Demonstration 35 minutes Presentation Storage of Apparatus Used in Compounding, 4 Demonstration Containers and Closures 5 10 minutes Presentation Key Points 6 10 minutes Presentation Evaluation CMT 04101 Dispensing NTA L 4 Semester 1 Facilitator Guide Session X: ———— -(Title)———————- 23 SESSION CONTENTS STEP1: Presentation of Session Title and Learning Tasks (5 minutes) READ or ASK students to read the learning tasks and clarify ASK students if they have any questions before continuing STEP 2: Proper Cleaning of Apparatus, Containers and Closures (35 Minutes) • The following are common apparatus, containers and closures used in pharmaceutical compounding: o Beaker o Measuring cylinders o Pipette o Mortar and pestle o Thermometer o Stirring rod o Spatula (stainless steel or plastic) o Sucker / rubber tit o Evaporating dish o Fluted/ Plain amber containers and closures o Fluted/ Plain colorless container and closures o Ointment jars and closures o Dropper bottle • After use, apparatus, containers and closures should be cleaned, all items should be soaked in water to prevent deposits drying up, as this makes them more difficult to remove • Use clean and general purpose detergent water for reusable plastic, glass, or metal items. Most items only need to be soaked for about 30 minutes to remove debris before disinfection or sterilising. • Do not leave items, especially metal items, soaking for long periods of time, e.g. overnight, as this can damage them. • After cleaning, rinse with clean water and dry thoroughly CMT 04101 Dispensing NTA L 4 Semester 1 Facilitator Guide Session X: ———— -(Title)———————- 24 Activity: Demonstration (20 minutes) DIVIDE students in small manageable groups. PREPARE apparatus, containers and closures needed for demonstration POSITION students so that everyone can see and hear REVIEW steps of that skill with students using a Standard Operating Procedures (SOP) if any REFER students to the SOP of conducting cleaning of apparatus, containers and closures DEMONSTRATE the procedure of conducting cleaning of the apparatus, containers and closures ALLOW one student from each group to do a return demonstration and let others comment on it CLARIFY and SUMMARIZE by using the content below INFORM the students that “every student will practice in the laboratory under supervision until is competent” STEP 3: Preventive Maintenance of Apparatus, Containers and Closures (25 minutes) Preventive Maintenance • Preventive Maintenance is a regular service, recommended by manufacturers and carried out by trained technicians, to check apparatus performance and replace parts. Maintenance can double the life time of apparatus and reduce breakdowns. • The frequency of maintenance and repair depends on the type of apparatus and the manufacturer‟s instructions/ recommendation • Pharmaceutical personnel play an essential role in routine care and maintenance of apparatus, containers and closures, checking for damage and reporting any defects. Important care and maintenance tasks include: o Keeping all items clean and dry. o Pipette, test tubes, containers and measuring cylinders are stored while they are in upside down position. o Protecting items from dust and dirt after use by keeping them covered. o Switching off and unplugging items when they are not in use. o Storing items properly when they are not in use, e.g. thermometer in their case and other glass ware o Replacing lost, worn, cracked or broken parts, e.g. measuring cylinders, beakers, stirring rods, mortar and pestle. CMT 04101 Dispensing NTA L 4 Semester 1 Facilitator Guide Session X: ———— -(Title)———————- 25 • You can help to remind staff about these care and maintenance tasks by putting written instructions near the equipment. Activity: Demonstration (20 minutes) DIVIDE students in small manageable groups. PREPARE apparatus needed for demonstration POSITION students so that everyone can see and hear REVIEW steps of that skill with students using a Standard Operating Procedures (SOP) if any REFER students to the SOP of conducting preventive maintenance of apparatus, containers and closures DEMONSTRATE the procedure of conducting preventive maintenance of apparatus, containers and closures ALLOW one student from each group to do a return demonstration and let others comment on it CLARIFY and SUMMARIZE the procedures for cleaning INFORM the students that “every student will practice in the laboratory under supervision until is competent” STEP 4: Storage of Apparatus, Containers and Closures Used in Compounding (25 minutes) • Most of the apparatus, containers and closures will be kept in a store, from which they are issued when needed. • Apparatus, containers and closures should be stored according to the manufacturer‟s instructions. Proper storage conditions are important to protect apparatus, containers and closures from damage • The store should be: o Secure o Clean o Free from pests o Dry o Not too hot or cold o Well ventilated o Not exposed to direct sunlight CMT 04101 Dispensing NTA L 4 Semester 1 Facilitator Guide Session X: ———— -(Title)———————- 26 • To ensure security, keep the store locked. Make one person responsible for looking after the supplies, keeping the keys

Pharmaceutical Sciences Notes, PST Level 4 Semester 2, PST NTA Level 4, PST04209 Compounding of Pharmaceutical Preparations

Cleaning, Preventive Maintenance and Storage of Equipment and Instruments used in Compounding – PST04209 Compounding of Pharmaceutical Preparations

NTA Level 4 • Semester 2 • PST04209 Cleaning, Preventive Maintenance and Storage of Equipment and Instruments used in Compounding Compounding of Pharmaceutical Preparations • Source Session/Topic 4 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. Session 4: Cleaning, Preventive Maintenance and Storage of Equipment and Instruments used in Compounding Total Session Time: 120 minutes + 4 hours of Practice Prerequisites • None Learning Tasks By the end of this session students are expected to be able to: • Explain Proper Cleaning of Equipment and Instruments • Describe Preventive Maintenance of Equipment and Instruments • Describe Storage of Equipment and Instruments Used in Compounding Resources Needed: • Flip charts, marker pens, and masking tape • Black/white board , chalk and whiteboard markers, • LCD projector and computer SESSION OVERVIEW Activity/ Step Time Content Method 1 05 minutes Presentation Introduction, Learning Tasks 35 minutes Presentation Proper Cleaning of Equipment and Instruments 2 Demonstration 35 minutes Presentation Preventive Maintenance of Equipment and 3 Instruments Demonstration 35 minutes Presentation Storage of Equipment and Instruments Used in 4 Demonstration Compounding 5 05 minutes Presentation Key Points 6 05 minutes Presentation Evaluation CMT 04101 Dispensing NTA L 4 Semester 1 Facilitator Guide Session X: ———— -(Title)———————- 17 SESSION CONTENTS STEP1: Presentation of Session Title and Learning Tasks (5 minutes) READ or ASK students to read the learning tasks and clarify ASK students if they have any questions before continuing STEP 2: Proper Cleaning of Equipment (35 Minutes) • Cleaning is the process of removing visible material such as dirt, grease, so as to reduce the possibility of contamination. • Equipment need proper cleaning before and after use to prevent contamination to the prepared products and other instruments and apparatus used in compounding, every equipment has got it‟s cleaning procedures but generally the procedures depend on the type of equipment to be cleaned, there are equipment which require cleansing using chemicals (disinfectants, detergents) and the one which require dusting/wiping off • Personnel responsible for cleaning should: o Wash their hands with soap and water o Be aware of the risks of contamination o Wear thick, protective gloves o Be careful when handling sharps and sharp instruments o Follow manufacturer‟s instructions Activity: Demonstration (20 minutes) DIVIDE students in small manageable groups. PREPARE equipment needed for demonstration POSITION students so that everyone can see and hear REVIEW steps of that skill with students using a Standard Operating Procedures (SOP) REFER students to the SOP for cleaning of equipment or Instrument DEMONSTRATE the procedure of conducting cleaning of the equipment using SOP ALLOW one student from each group to do a return demonstration and let others comment on it CLARIFY and SUMMARIZE by using the manufacturer‟s instruction according to the equipment or instrument used. INFORM the students that “every student will practice in the laboratory under supervision until is competent” CMT 04101 Dispensing NTA L 4 Semester 1 Facilitator Guide Session X: ———— -(Title)———————- 18 STEP 3: Describe Preventive Maintenance of Equipment (35 minutes) • Preventive maintenance is a regular service, recommended by manufacturers and carried out by trained technicians, to check equipment performance and replace parts. • The frequency of preventive maintenance depends on the type of the equipment and the manufacturer‟s recommendation. • Regular servicing of the equipment can double the life time of the equipment and reduce breakdowns. o For example refrigerators and weighing scales can last for about 8 years if they are regularly serviced • Proper maintenance affects the performance and safety of the equipment. Poorly maintained equipment deteriorates more quickly and is more likely to break down. • Unreliable or inaccurate equipment is often worse than no equipment at all. A sterilizer, for example, will not sterilize its contents properly • NOTE: All maintenance and repairs should be carried out according to manufacturer‟s instruction Activity: Demonstration (20 minutes) DIVIDE students in small manageable groups. PREPARE equipment needed for demonstration POSITION students so that everyone can see and hear REVIEW steps of that skill with students using a Standard Operating Procedures (SOP) REFER students to the SOP of conducting preventive maintenance of equipment DEMONSTRATE the procedure of conducting preventive maintenance using SOP ALLOW one student from each group to do a return demonstration and let others comment on it CLARIFY and SUMMARIZE by using the content below INFORM the students that “every student will practice in the laboratory under supervision until is competent” CMT 04101 Dispensing NTA L 4 Semester 1 Facilitator Guide Session X: ———— -(Title)———————- 19 For example, Practical tips for steam sterilizer maintenance • Clean the inside of the sterilizer after use and check regularly for signs of wear and damage. • Regularly clean the nozzle that the weights rest on • Check for steam leakages around the lids and valve. If there is a problem, turn off the heat, open the pressure valve and wait for the sterilizer to cool • If steam is leaking out from under the sterilizer lid, check the position and quality of the rubber seal and adjust or replace it • If steam is leaking out from the safety valve, check the position of the valve and adjust or replace it • If you cannot solve the problem, use another sterilizer and inform your supervisor STEP 4: Describe Storage of Equipment used in Compounding (35 minutes) • Pharmaceutical personnel play an essential role in routine care and proper storage of equipment and instruments used for compounding. • Therefore proper storage is essential for keeping safe the equipment and instruments used in compounding Activity: Demonstration (20 minutes) DIVIDE students in small manageable groups. PREPARE equipment and materials needed for demonstration POSITION students so that everyone can see and hear REVIEW steps of that skill with students using a Standard Operating Procedures (SOP) REFER students to the SOP of conducting storage of equipment DEMONSTRATE the procedure of storage of equipment using SOP ALLOW one student from each

Pharmaceutical Sciences Notes, PST Level 4 Semester 2, PST NTA Level 4, PST04209 Compounding of Pharmaceutical Preparations

Identification and Correct use of Apparatus, – PST04209 Compounding of Pharmaceutical Preparations

NTA Level 4 • Semester 2 • PST04209 Identification and Correct use of Apparatus, Compounding of Pharmaceutical Preparations • Source Session/Topic 3 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. Session 3: Identification and Correct use of Apparatus, Instrument and Equipment in Compounding Total Session Time: 120 minutes +6 hours of Practice Prerequisites • None Learning Tasks By the end of this session students are expected to be able to: • Mention apparatus, instrument and equipment used in compounding • Demonstrate correct use of apparatus, instrument and equipment Resources Needed: • Flip charts, marker pens, and masking tape • Black/white board, chalk and whiteboard markers • LCD projector and computer SESSION OVERVIEW Activity/ Step Time Content Method 1 05 minutes Presentation Introduction, Learning Tasks 35 minutes Presentation Apparatus, Instruments and Equipments Used in 2 Compounding Buzzing 60 minutes Presentation Correct Use of Apparatus Instruments and 3 Equipments Demonstration 4 10 minutes Presentation Key Points 5 10 minutes Presentation Evaluation CMT 04101 Dispensing NTA L 4 Semester 1 Facilitator Guide Session X: ———— -(Title)———————- 11 SESSION CONTENTS STEP1: Presentation of Session Title and Learning Tasks (5 minutes) READ or ASK students to read the learning tasks and clarify ASK students if they have any questions before continuing STEP 2: Apparatus, Instruments and Equipment Used in Compounding (35 Minutes) Activity: Buzzing (5 minutes) ASK students to pair up and buzz on the following question for 2 minutes • What are the apparatus, instruments and equipment used for compounding? ALLOW few pairs to respond and let other pairs to add on points not mentioned WRITE their response on the flip chart/board CLARIFY and SUMMARIZE by using the content below • Apparatus used for compounding are the following: o Beaker (glass and plastic) o Measuring cylinders o Pipette o Mortar and pestle o Thermometer o Stirring rod o Spatula (stainless steel or plastic) o Sucker / rubber tit o Evaporating dish o Storage container (jar and bottles) o X – ray film o Cylindrical or conical measures o Conical flasks o Funnel (glass or plastic) o Filtration material ( filter paper, muslin, cotton gauze, gauze) o Sieve • Instruments used for compounding include; o Weighing balance o Water bath o Bunsen burner CMT 04101 Dispensing NTA L 4 Semester 1 Facilitator Guide Session X: ———— -(Title)———————- 12 o Stove • Equipment used for compounding include; o Reverse Osmosis machine o Autoclave machine o Tablet compression machine o Fluidized bed drier o Coating machine o HPLC machine o Dissolution STEP 3: Correct Use of Apparatus, Instruments and Equipment (60 minutes) • Pipette should be held in upright while forefinger is positioned at the top for good reading of meniscus • Reading of the meniscus should be taken at the bottom curvature • Viscous liquid should not be measured by using pipette, because it will not be poured easily, instead use measuring cylinders. • Weighing balance before use, should be tarred to zero or pointer should be at zero • Pieces of paper or x-rays film are covered on top for protection of the weighing balance. And also for an easy cleaning of the weighing balance • Stainless spatula should not be used when weighing metals (e.g. Iodine) because it will cause chemical reaction and stain on the spatula, instead used plastic spatula • Chemicals liquids are sucked by using sucker and not by using mouth CMT 04101 Dispensing NTA L 4 Semester 1 Facilitator Guide Session X: ———— -(Title)———————- 13 Activity: Demonstration (50 minutes) DIVIDE students in small manageable groups. PREPARE apparatus, instruments and equipments needed for demonstration POSITION students so that everyone can see and hear REVIEW steps of that skill with students using a Standard Operating Procedures (SOP) REFER students to the Tanzania Pharmaceutical Handbook for correct use of the equipment DEMONSTRATE the procedure of correct use of the apparatus, instrument and equipment ALLOW one student from each group to do a return demonstration and let others comment on it CLARIFY and SUMMARIZE by using the content below INFORM the students that “every student will practice in the laboratory under supervision until is competent” STEP 4: Key Points (10 minutes) • Apparatus, instruments and equipment used for compounding are the following: o Beaker o Measuring cylinders o Pipette o Mortar and pestle o Thermometer o Stirring rod o Spatula (stainless steel or plastic) o Sucker / rubber tit o Evaporating dish o Storage container o X – ray film o Weighing balance o Water bath o Bunsen burner o Stove o Reverse Osmosis o Autoclave machine o Tablet compression machine o Fluidized bed drier CMT 04101 Dispensing NTA L 4 Semester 1 Facilitator Guide Session X: ———— -(Title)———————- 14 o Coating machine o HPLC machine o Dissolution • To ensure quality pharmaceutical preparations, the apparatus, instruments and equipment for compounding must be used correctly STEP 5: Evaluation (10 minutes) What are the apparatus, instruments and equipment that are used in compounding? STEP 6: Practice (6 hours) • INFORM the students that “every student will practice in the laboratory under supervision until is competent” on identifying and demonstrate the correct use of the apparatus, instruments and equipments used in compounding CMT 04101 Dispensing NTA L 4 Semester 1 Facilitator Guide Session X: ———— -(Title)———————- 15 References Pharmaceutical Society of Great Britain., & Pharmaceutical Society of Great Britain. Department of Pharmaceutical Sciences. (1994). The Pharmaceutical Codex, Principles and Practice of Pharmaceutics (W. Lund Ed. 12th ed.). London,: Pharmaceutical P. Senya, S. S., Mwasha, C. Y. S., Muyinga, A. M., Amiri, R. I., & Mauga, E. A. S. K. (2011). Tanzania Pharmaceutical Handbook (2nd ed.). Dar es salaam: School of Pharmaceutical Sciences, Institute of Allied Health Sciences, Muhimbili University of Health and Allied Health Sciences. United States Pharmacopeial Convention. Committee of Revision. (2013). The United States pharmacopeia (pp. v.). Rockville, Md.: United States Pharmacopeial Convention, Inc. CMT 04101 Dispensing NTA L 4 Semester 1 Facilitator Guide

Pharmaceutical Sciences Notes, PST Level 4 Semester 2, PST NTA Level 4, PST04209 Compounding of Pharmaceutical Preparations

Describe Personnel and Premises Requirements – PST04209 Compounding of Pharmaceutical Preparations

NTA Level 4 • Semester 2 • PST04209 Describe Personnel and Premises Requirements Compounding of Pharmaceutical Preparations • Source Session/Topic 2 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. Session 2: Describe Personnel and Premises Requirements for Compounding Total Session Time: 60 minutes Learning Tasks By the end of this session students are expected to be able to: • Outline Personnel Requirements for Compounding • Outline Premise Requirements for Compounding Resources Needed: • Flip charts, marker pens, and masking tape • Black/white board , chalk and whiteboard markers, • LCD projector and computer SESSION OVERVIEW Activity/ Step Time Content Method 1 05 minutes Presentation Introduction, Learning Tasks 25 minutes Presentation Personnel Requirements for Compounding 2 Brainstorming 20 minutes Presentation Premise Requirements for Compounding 3 Buzzing 4 05 minutes Presentation Key Points 5 05 minutes Presentation Evaluation CMT 04101 Dispensing NTA L 4 Semester 1 Facilitator Guide Session X: ———— -(Title)———————- 7 SESSION CONTENTS STEP1: Presentation of Session Title and Learning Tasks (5 minutes) READ or ASK students to read the learning tasks and clarify ASK students if they have any questions before continuing STEP 2: Personnel Requirements for Compounding (25 minutes) Activity: Brainstorming (5 minutes) Ask students to brainstorm on the following question: • Who is responsible for compounding of pharmaceuticals? ALLOW few students to respond? WRITE their responses on the flip chart/ board CLARIFY and SUMMARISE by using the content below The following are personnel required for compounding: • Pharmacist • Pharmaceutical Technician • Pharmaceutical assistant • Pharmaceutical dispenser STEP 3: Premise Requirements for Compounding (20 minutes) Activity: Buzzing (5 minutes) ASK students to pair up and buzz on the following question for 2 minutes • Where pharmaceutical products should be compounded? ALLOW few pairs to respond and let other pairs to add on points not mentioned WRITE their response on the flip chart/board CLARIFY and SUMMARIZE by using the content below CMT 04101 Dispensing NTA L 4 Semester 1 Facilitator Guide Session X: ———— -(Title)———————- 8 • The following are areas for compounding: o Pharmaceutical laboratory o Pharmaceutical industry o Pharmaceutical training institution o Drug outlets i.e. Pharmacy etc STEP 4: Key Points (5 minutes) • Personnel required for compounding include: o Pharmacist o Pharmaceutical Technician o Pharmaceutical assistant o Pharmaceutical dispensers • Premises for compounding are: o Pharmaceutical laboratory o Pharmaceutical industry o Pharmaceutical training institution o Drug outlets i.e. Pharmacy. STEP 5: Evaluation (5 minutes) • Who is responsible for compounding of pharmaceuticals? • Where pharmaceutical products should be compounded? CMT 04101 Dispensing NTA L 4 Semester 1 Facilitator Guide Session X: ———— -(Title)———————- 9 References Senya, S. S., Mwasha, C. Y. S., Muyinga, A. M., Amiri, R. I., & Mauga, E. A. S. K. (2011). Tanzania Pharmaceutical Handbook (2nd ed.). Dar es salaam: School of Pharmaceutical Sciences, Institute of Allied Health Sciences, Muhimbili University of Health and Allied Health Sciences. MoHSW (2011), the Pharmacy Act 2011. Dar-es-Salaam: Government Printer MoHSW (2003), Tanzania Food, Drugs and Cosmetics Act. Dar-es-Salaam: Government printer. CMT 04101 Dispensing NTA L 4 Semester 1 Facilitator Guide Session X: ———— -(Title)———————- 10 ← Previous TopicNext Topic →View all Compounding of Pharmaceutical Preparations 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

Pharmaceutical Sciences Notes, PST Level 4 Semester 2, PST NTA Level 4, PST04209 Compounding of Pharmaceutical Preparations

Introduction to Pharmaceutical Compounding – PST04209 Compounding of Pharmaceutical Preparations

NTA Level 4 • Semester 2 • PST04209 Introduction to Pharmaceutical Compounding Compounding of Pharmaceutical Preparations • Source Session/Topic 1 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. Session 1: Introduction to Pharmaceutical Compounding Total Session Time: 60 minutes Prerequisites • None Learning Tasks By the end of this session students are expected to be able to: • Describe Historical Background of Compounding • Define Pharmaceutical Compounding • Explain Reasons for Compounding in Pharmacy practice Resources Needed: • Flip charts, marker pens, and masking tape • Black/white board, chalk and whiteboard markers • LCD projector and computer SESSION OVERVIEW Activity/ Step Time Content Method 1 05 minutes Presentation Introduction, Learning Tasks 15 minutes Presentation 2 Historical Background of Compounding Buzzing 10 minutes Presentation 3 Definition of Pharmaceutical Compounding Buzzing 20 minutes Presentation Reasons for Compounding in Pharmacy 4 Practice 5 05 minutes Presentation Key Points 6 05 minutes Presentation Evaluation CMT 04101 Dispensing NTA L 4 Semester 1 Facilitator Guide Session X: ———— -(Title)———————- 1 SESSION CONTENTS STEP 1: Presentation of Session Title and Learning Tasks (5 minutes) READ or ASK students to read the learning objectives and clarify ASK students if they have any questions before continuing. STEP 2: Historical Background of Compounding (15 minutes) Activity: Buzzing (5 minutes) ASK students to pair up and buzz on the following question for 2 minutes • What is the origin of Compounding? ALLOW few pairs to respond and let other pairs to add on points not mentioned WRITE their response on the flip chart/board CLARIFY and SUMMARIZE by using the content below • Compounding has its origins since the beginning of the profession of pharmacy itself. • The profession of pharmacy is as old as mankind, it has been a part of everyday life. • The oldest settlements support the contention that prehistoric peoples gathered plants for medicinal purposes. • By trial and error, the folk knowledge of the healing properties of certain natural substances grew • Compounded Medications were the standard means of providing prescription medications prior to medications being mass produced in high volume by large pharmaceutical manufacturers. . • In the last few decades, patient and physicians have realized that not all patients can tolerate commercial, “off the shelf” medications. And hence demand for professional compounding to meet the required dosage strengths, dosage forms. • Patients often experience better outcomes with customized compounded prescriptions that are formulated specifically for them. CMT 04101 Dispensing NTA L 4 Semester 1 Facilitator Guide Session X: ———— -(Title)———————- 2 STEP 3: Definition of Pharmaceutical Compounding (10 minutes) Activity: Brainstorming (10 minutes) Ask students to brainstorm on the following question: • What is pharmaceutical compounding? ALLOW few students to respond? WRITE their responses on the flip chart/ board CLARIFY and SUMMARISE by using the content below • Pharmaceutical compounding is the art and science of preparing a particular pharmaceutical product by combining appropriate ingredients using various tools to meet the unique need of a patient. Or • Compounding is defined as the art and science of creating personalized medications for patient. Or • The pharmaceutical compounding includes preparation, mixing, assembling, altering, packaging, and labeling of a drug, drug-delivery device, or device in accordance with a licensed practitioner‟s prescription, medication order, or initiative based on the practitioner/ patient/ pharmacist/compounder relationship in the course of professional practice. STEP 4: Reasons for Compounding in Pharmacy Practice (20 minutes) The following are reasons for compounding: • To adjust strength or dosage • To flavour a medication (i.e. to make it palatable for a child) • To reformulate the drug to exclude an unwanted , nonessential ingredient • To change the form of the medication for patients who, for example, have difficulty in swallowing or experience stomach upset when taking oral medication. • To ensure the patient is getting the right drug STEP 5: Key Points (5 minutes) • Compounding has its origins since the beginning of the profession of pharmacy itself. • The profession of pharmacy is as old as man kind CMT 04101 Dispensing NTA L 4 Semester 1 Facilitator Guide Session X: ———— -(Title)———————- 3 • Compounding is defined as the art and science of creating personalized medications for patient • The following are reasons for compounding; o To adjust strength or dosage o To flavour a medication (i.e. to make it palatable for a child) o To reformulate the drug to exclude an unwanted , nonessential ingredient o To change the form of the medication for patients who, for example, have difficulty in swallowing or experience stomach upset when taking oral medication. STEP 6: Evaluation (5 minutes) • What is the origin of compounding? • What is pharmaceutical compounding? • What are the reasons for compounding in pharmacy? CMT 04101 Dispensing NTA L 4 Semester 1 Facilitator Guide Session X: ———— -(Title)———————- 4 CMT 04101 Dispensing NTA L 4 Semester 1 Facilitator Guide Session X: ———— -(Title)———————- 5 References Senya, S. S., Mwasha, C. Y. S., Muyinga, A. M., Amiri, R. I., & Mauga, E. A. S. K. (2011). Tanzania Pharmaceutical Handbook (2nd ed.). Dar es salaam: School of Pharmaceutical Sciences, Institute of Allied Health Sciences, Muhimbili University of Health and Allied Health Sciences. A. J. Winfield, J. A. R., I. Smith. (2009). Pharmaceutical Practice (4th ed.) Britain, R. P. S. o. G. (1994). The Pharmaceutical Codex (12 ed.). London: London Pharmaceutical Press. CMT 04101 Dispensing NTA L 4 Semester 1 Facilitator Guide Session X: ———— -(Title)———————- 6 Next Topic →View all Compounding of Pharmaceutical Preparations 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

Pharmaceutical Sciences Notes, PST Level 4 Semester 2, PST NTA Level 4, PST04208 Law and Ethics in Pharmacy Practice

Destruction of Unfit Medicines and Cosmetic Products – PST04208 Law and Ethics in Pharmacy Practice

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

Pharmaceutical Sciences Notes, PST Level 4 Semester 2, PST NTA Level 4, PST04208 Law and Ethics in Pharmacy Practice

Sorting and Verification of Unfit Medicines and Cosmetic Products – PST04208 Law and Ethics in Pharmacy Practice

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

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