Hospital And Clinical Pharmacy New Syllabus Important Questions With Answers PDF

1 HOSPITAL AND CLINICAL PHARMACY ER-2020 CHAPTER WISE IMPORTANT QUESTION AND ANSWERS LALIT SHUKLA M.Pharm Patel College Of Pharmacy...

1 HOSPITAL AND CLINICAL PHARMACY ER-2020 CHAPTER WISE IMPORTANT QUESTION AND ANSWERS LALIT SHUKLA M.Pharm Patel College Of Pharmacy PATEL COLLEGE OF PHARMACY BY- LALIT SHUKLA  2 Chapter 1 5 Marks 1. Define Hospital Pharmacy &describe qualification, Responsibilities, and work load requirement for hospital pharmacy. Ans: Hospital pharmacy may be defined as a department of hospital where procurement, storage, compounding, dispensing, or distribution is under a control of legally qualified pharmacist. QUALIFICATION Chief pharmacist must be post-graduate (M. Pharmacy) in pharmacy or hospital pharmacy as a special subject & having an adequate practical experience. He should be the coordinator for the pharmacy and non -pharmacy staff working under him. He reports to the administrator and interact with other medical departments. Responsibilities 1. Specifications for purchase of all drugs, chemicals and pharmaceutical preparations used in treatment of patients. 2. Forecasting the demand of the department. 3. It decides to manufacture or Purchase medicine from the industry. 4. Selection of reliable supplier. 5. Purchasing of drug products from reliable suppliers and maintaining a record of the purchased drug. 6. Purchasing raw material for drug manufacturing and maintaining a record of purchased raw material. 7. Manufacturing of sterile and non-sterile preparation and maintaining manufactured records. 8. Quality control of the manufactured products and maintaining the record of quality control of the manufactured products. 9. Storage of drugs. Work Load The manpower trained in pharmacy varies with the size of the hospital, and the services it offers. The number of pharmacists required for a hospital is calculated on the basis of some workload norm like the number of prescriptions received and dispensed or the number of beds available in the hospital & its occupancy rate. AS a rule of thumb, it can be said that there must be minimum 3 pharmacists in a very small hospital. For a 100-bed hospital there can be 5 pharmacists, as the number of beds increases, the number of pharmacists also increases, but not proportionately. PATEL COLLEGE OF PHARMACY BY- LALIT SHUKLA  3 Pharmacist requirement Bed strength Number of pharmacists required Up to 50 beds 3 Up to 100 beds 5 Up to 200 beds 8 Up to 300 beds 10 Up to 500 beds 15 2. Explain Good Pharmacy Practice (GPP) & Hospital Pharmacy Standard (FIP Basel statement & AHSP). Ans: GOOD PHARMACY PRACTICE IN HOSPITAL (GPP) International pharmaceutical federation (FIP) developed standard for pharmacy services under the heading of "Good Pharmacy Practices in community and hospital pharmacy settings. The mission of good pharmacy practice is to provide medication and health care products and services to people and society to achieve good outcomes from treatment. ROLE OF PHARMACIST IN SATISFYING GOOD PHARMACY PRACTICE REQUIREMENT 1. He must establish and maintain relationship particularly with physician as a therapeutic collaborative partnership which involves mutual trust and confidence in all matters relating to pharmacotherapeutics. 2. All the colleague’s pharmacist must work together to improve pharmacy services. 3. In hospital, pharmacy manager should accept a share of responsibility for the selection, evaluation and improvement of quality of drugs used. 4. Pharmacist must update the information about therapeutics and medicines in use. 5. Pharmacist must ensure the integrity of supply chain and quality of medicines. 7. Pharmacist must prepare, store, secure distribute and dispose of medical products. 8. Pharmacist must support national policy that promotes improved health outcomes. HOSPITAL PHARMACY STANDARDS FIP BASEL STATEMENTS FIP Is the global federation of national associations of pharmacists and pharmaceutical scientists. It is active across all areas of pharmacy practice, pharmaceutical science and education, primarily through the work of member associations and dedicated volunteers. It initiates and implements numerous projects and programs to improve the responsible use of medicines. These statements cover following six main areas of hospital pharmacy (FIP Basel statement) 1. Procurement 2 Influences on prescribing 3. Preparation and delivery of medications 4.Medication administration 5. Monitoring medication 6. Human resources and training PATEL COLLEGE OF PHARMACY BY- LALIT SHUKLA  4 ASHP (AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS) American Society of Health-System Pharmacists have been formerly called as American Society of Hospital Pharmacist. It is a professional organization that represents pharmacists who serve as patient care providers in hospitals and other health care settings. It is a professional organization that demonstrates the description of minimum standards competencies of pharmacists in health care settings. NAQS (NATIONAL QUALITY ASSURANCE STANDARDS) National Quality Assurance Standards have been developed keeping in the specific requirements for public health facilities as well global best practices. NQAS are currently available for District Hospitals, CHCs, PHCS and Urban PHCS. Standards are primarily meant for providers to assess that own quality for improvement through pre-defined standards and to bring up their facilities for certification. 1 Marks 1. Define hospital. Hospital is defined as an institution that provides community health, where prevention, diagnosis, treatment, therapy, rehabilitation, training, and social services are provided 2. GPP stand for… (GOOD PHARMACY PRACTICE) … 3. Prescription is dispensed by …(PHARMACIST) 4. NABA stands for … (National Accreditation Board for Hospital and healthcare) 5. FIP stands for … (INTERNATIONAL PHARMACEUTICAL FEDERATION) 6. Define HOSPITAL PHARMACY Ans: may be defined as a department of hospital where procurement, storage, compounding, dispensing, or distribution is under a control of legally qualified pharmacist.. Chapter 2 3 marks 1. Write objective, composition & function of PTC. ANS: PTC is an organization respond to rational use of drugs by creating a mechanism is called as PTC (pharmacy therapeutic committee) which formulate policy regarding therapeutic use of drugs. Objective of PTC: a. Advisory: It formulates policies regarding selecting, procuring, prescribing, dispensing and administration of the drug in the hospital. b.Educational: It recommended and formulates programs to educate on current knowledge on matters related to drug and drug use. Composition of PTC: 1. The PTC should comprise of at least three physicians, a pharmacist, a nurse and administrator. 2. The administrator acts as Director. 3. The PTC appoints a member physician as its chairman and the pharmacist as its secretory. Functions of PTC: 1. To guide the medical staff and the hospital administration in all matters related to the use of drug. PATEL COLLEGE OF PHARMACY BY- LALIT SHUKLA  5 2. Lay down written policies and procedure for the appraisal, selection, procurement, storage, and distribution of drugs. 3. To form the hospitals, own formulary and periodically up-date it. 4. Prepare a list of drugs for emergency kit and first aid kit. 5. Prepare a list of drugs to kept in ward pharmacy, floor stock drug system. 6. Conduct quality audit and check GMP practiced at own and other manufacturing units. 7. To review adverse drug reaction (ADR) to the drug. 2. Write a note on Role of pharmacist in preventing Antimicrobial Resistance. Ans: Antimicrobial resistance is a natural process. It occurs when microorganisms evolve to be able to resist the drug that has been used to fight them. Hospital pharmacists have a key role in avoiding misuse of antibiotics to prevent antimicrobial resistance. Following are the role of pharmacist in AMR, 1. Infection prevention and control is an essential strategy to reduce infection and the subsequent increased use of antimicrobials. 2. Immunization is an important part of any infection control strategy. It helps reduce the misuse of antimicrobials. 3. Advice the hospitals about the selection and use of appropriate antibiotics, disinfectants and sterilant. 4. Arrange the review program for accessing and improving the quality of antimicrobial therapy. 5. Quantitative data on antimicrobial drug use should be routinely generated and used. 6. Offer an effective medication therapy management. 7. Counselling on consumption of medicines and also engage patients in their appropriate, efficacious, safe, and responsible use. 8. Consulting and collaborating with physicians to ensure optimal and responsible use of antibiotics. 3. Write a note on hospital formulary Ans: Hospital formulary can be defined as an important document of the hospital containing a collective list of drugs. This book is used extensively by the interne and fellow doctors. The hospital formulary is to be revised periodically and should reflect the current, aspects of the clinical judgements of the medical staff. The hospital formulary system is a powerful tool for improving the quality and controlling the cost of the drug therapy. The pharmacy therapeutic committee of the hospital is in charge of the preparation and its revision. Physicians own formula. tound to be useful, is incorporated into the hospital formulary. Objectives Significances of Hospital formulary system: 1. To provide information on which drug products have been approved for the use by PTC. 2. To furnish staff the basic therapeutic information about each approved drug products. 3. To deliver information on hospital policies and procedures pertaining to the use of drug. 4. To elicit special information of drug about drug dosing, rules and abbreviations used in a hospital. Limitations of Hospital Formulary System: 1. The system may prevent the physician's right to prescribe and obtain the brand of his choice. 2. The system in many instances permits the pharmacist to act as the sole judge of which brand of medicine is to be purchased and dispensed. 3. The system do not minimize the cost of medicine to the patient by passing discount or any scheme received at the time of purchase in bulk quantity by the hospital. PATEL COLLEGE OF PHARMACY BY- LALIT SHUKLA  6 4. Explain role of PTC in Drug safety Ans: Drug safety is one of the prime responsibilities of the hospital pharmacist. There is vast advancement of new categories of therapeutic drugs. The drug safety aspect being taken for granted by the hospital professionals in our nation. Pharmacy medication dispensing errors or accidents result in serious conditions or lead to the death of the patient. Therefore, PTC play a vital role for drug safety in a hospital. 1. The chief pharmacist should be registered pharmacist with minimum B.Pharm. qualification and other should be diploma holder. 2. Dispensing of medicine shall be done only by the registered pharmacist. 3. Adequate number of pharmacists 5. Explain role of PTC in ADR. Ans: Sometime the drug may produce unwanted or unexpected effects. this is called adverse drug reaction. It is a result of overdose, hypersensitivity, or allergic condition. The committee acts in two ways i.e., to treat such patients and to prevent such happenings in the future. a physician concerned will submit a report for this. A typical format of ADR is as follows: ADVERSE DRUG REACTION REPORT Report No.: ………………… Date: ……………… Name of the patient: …………………………. Age: …… Year Sex: ………………. Body weight: ….……kg Therapy Followed: a) Report disease / Indication: …………………. b) Drug that produced ADR: ……………………... c) Reaction details: …………………………………… d) Sources of drugs.  Batch No.: ……………….  Mfg. and Exp. Date: - ………………….  Manufacturer: …………………… Steps taken to treat ADR: ……………………. Name of attending physician: ……………………. Signature of the Physician: ……………………. 1 mark 1. What is PTC is an organization respond to rational use of drugs by creating a mechanism is called as PTC (pharmacy therapeutic committee) which formulate policy regarding therapeutic use of drugs. 2. What is infection control committee PATEL COLLEGE OF PHARMACY BY- LALIT SHUKLA  7 The infection control committee is an integral component of the patient safety programmes of the health care facility, and is responsible for establishing and maintaining infection prevention and control, its monitoring, surveillance, reporting, research and education. 3. Write the function of PTC a. To guide the medical staff and the hospital administration in all matters related to the use of drug. b. To form the hospitals, own formulary and periodically up-date it. c. Prepare a list of drugs for emergency kit and first aid kit. d. Prepare a list of drugs to kept in ward pharmacy, floor stock drug system. 4. Hospital formulary is a … (important document of the hospital containing a collective list of drugs). 5. Secretary of PTC is……(Pharmacist) Chapter 3 5 marks 1. Explain expiry drug removal and disposal method. Ans: Expired or unwanted medicines that should never be used and should always be considered as pharmaceutical waste. Most expired medicines become less effective and few might be poisonous, but the defective disposal of them poses serious hazard to the public health. Standard operating procedures for good disposal practice of expired medicines is created and available to the all from manufacturers to retailers and the regulating authorities. Following steps require to be taken when disposing of unwanted pharmaceuticals, 1. Sorting of pharmaceuticals 2. Disposal SORTING OF EXPIRED PHARMACEUTICALS The objective of sorting is to isolate the drugs into separate categories for which different removal techniques are used. The expired medicines are needed to be sorted out into various categories that require different disposal techniques, based on active ingredients, or based on dosage forms. However, the special attention is needed for disposal of the controlled drugs like narcotics and psychotropic substances; antineoplastics; antiseptics; disinfectants; anti-infective drugs etc DISPOSAL METHODS Disposal options of medicines may vary considerably situations, and the ideal solution may not be feasible. The following disposal methods are used: 1. Returning to the manufacturer: Wherever possible this should be the first choice because the manufacturer is likely to have good disposal strategy available at its. 2. Landfill: The waste substances are directly placed into a land discarding site without prior treatment. This is the oldest and most accepted method for solid waste disposal. Untreated waste must be rapidly covered with other municipal waste to prevent scavenging. Care should also be taken to avoid contamination of ground water. 3. Waste immobilization (encapsulation): Encapsulation includes immobilizing the drugs in a solid block inside a plastic or steel drum. They are entirely filled to 75% capacity with solid and semi-solid drugs, and the additional space is filled by a medium such as cement or cement & lime mixture, plastic foam or bituminous sand. Once the drums are filled to 75% capacity, the mixture of cement, lime and water in the proportions 15:15:5 is added and the drum fully flled. The sealed drums should be keep at the bottom of a landfill and covered with fresh municipal solid waste. 4, Waste immobilization (inertisation): Inertisation method includes the drugs are removed from the package like removing pills from blister. The medicines are then ground and a mixture of cement, lime and water added to form a homogenous paste. The paste is transported in the liquid form by truck to a landfill and emptied into the normal urban waste. 5 Sewer: Some liquid drugs like syrups, i.v. fluids can be flushed into sewer after dilution, Small amounts of liquid medicines like antiseptics can be disp0sed of very much diluted prior to flushing. PATEL COLLEGE OF PHARMACY BY- LALIT SHUKLA  8 6 Burning in open containers: Burning of medications in open containers at low temperature mav cause release of poisonous contamination to the environment. It is strongly recommended that very small quantities of waste drugs can be disposed by this method. 7 Incineration: Medium (800-1000°C) and high temperature above 1000°C incineration devices require a capital investment, operation, and maintenance budget. Large number of medications can be disposed of within a short period of time but incineration method is recommended only when unconditionally essential. In retail practice, when it is not possible to return the expired medicines to the supplier, they should be keep separately in cupboard or rack or any other assigned area with adequate marking "expired good - not for sale". The following procedure is recommended:  Cutting the package in such manner that the label is also cut. Tablets and capsules can be destroyed in a bucket of water.  Utilizing landfill methodology according to medical waste disposal method. Pouring the liquids into the sink and flush with adequate water.  Maintaining a record of all such disposal with full details of drugs destroyed. 2. Define inventory control. write objective and explain different techniques of inventory control. Ans: INVENTORY CONTROL Drug store management is based on principles of inventory control. Mismanagement of stores and non-applicability of modern methods has been identified as the main cause of material deficiency in most of the hospitals. DEFINITION It is the balance between not ordering too much and avoiding stockout situation of material. OBJECTIVES 1. To supply drugs in time 2. Efforts are made to procure drugs at minimum price without bargaining the quality. 3. To avoid stock out situation or shortage TECHNIQUES OF INVENTORY CONTROL  Inventory control techniques are the tool available for smooth running of the business enterprises.  The inventories should be maintained at a level lying between the excessive and the inadequate. This level is known as the optimum level" of inventories.  ABC Analysis (Always Better Control)  VED Analysis (Vital, Essential, Desirable)  EOQ (Economic order quantity)  Load time  Buffer stock  SOS Classification  XYZ Classification ECONOMIC ORDER QUANTITY: (EOQ) It is the quantity of Item to be purchased where inventory carrying cost and ordering cost are minimum. It is derived from expected usage Cost/work purchase cost etc. EOQ = Where, S = Ordering cost or fixed cost D= annual quantity demanded H= Holding cost or variable cost PATEL COLLEGE OF PHARMACY BY- LALIT SHUKLA  9 Significant position of Pharmacist working capital is tide up in inventory that's small reduction in inventory gives more benefits like, Significant increase in working capital, decrease in amount of money needed to purchase further quantity carrying cost includes specific items like insurance, taxes. interest, spoilage during handling, transport. REORDER QUANTITY LEVEL: Reorder quantity methods inventory management. Reorder quantity is the quantity of items to be ordered to continue production without any interruptions in the future. re-order quantity is the quantity at which additional stock purchase or manufacture for consumption. It maintains buffer stock otherwise there will be stock out situation. It has to consider time between placing order & receiving goods. For re- ordering attention must be given to unavoidable large consumption & expiry date of product. Inventory Turnover: Inventory turnover is a measure of the number of times inventory is sold or used in a time period such as a year. It is calculated to see if a business has an excessive inventory in comparison to its sales level. Inventory Turnover: calculating inventory turnover helps business make better pricing, manufacturing, marketing and purchasing decisions. Well managed inventory levels show that a company's sales are at the desired level and costs are controlled. The inventory turnover ratio is a measure of how well a company generates sales from its inventory. Inventory turnover indicates the rate at which a company sells and replaces its stock, of goods during a particular period. 3. What high risk medicines, emergency drugs and reserved antibiotics? Give example of each. Ans: HIGH RISK MEDICINE A high-alert medication is a drug that has a high risk of causing harm to patients when misused the list includes the following: Class/category of medications  anesthetic agents, general, inhaled and IV (e.g., propofol, ketamine)  chemotherapeutic agents, parenteral and oral  adrenergic agonists, IV (e.g., norepinephrine, epinephrine, phenylephrine) and antagonists (e.g., labetalol, propranolol, metoprolol)  antiarrhythmics, IV (e.g., lidocaine, amiodarone) Specific medications  epoprostenol (e.g., Flolan),  promethazine injection  potassium phosphates injection  IV subcutaneous insulin U-500,  magnesium sulfate injection EMERGENCY DRUGS Definition: Emergency drugs are the medications which may be essential to receive the immediate therapeutic requirements of patients and which are not available from any other approved source in necessary time to prevent risk or harm to patients. Emergency drugs are important to effectively manage patients in the intensive care unit (1CUs). The absence of emergency drugs may cause mortality and morbidity. Hence availability of Emergency drugs shall be important in a designated department. PATEL COLLEGE OF PHARMACY BY- LALIT SHUKLA  10 Aspirin Antibiotics (range depends on Glucagon Furosemide local circumstances) Ipratropium nebulization and inhaler Hydrocortisone Atropine with a spacer Lignocaine IV Insulin Medical oxygen Thiamine Naloxone Sodium bicarbonate 8.5% RESERVED ANTIBIOTICS These antibiotics are reserved for the treatment of confirmed or suspected infections due to multidrug resistant organisms. Reserve group of antibiotics should be used as "last resort" options. These antibiotics should be available, but their use should be in highly specific patients or when all antibiotic options have failed or are not suitable ceftazidime + avibactam omadacycline Oxazolindinones tigecycline meropenem + vaborbactam eravacycline aztreonam linezolid Cefaroline daptomycin colistin fifth generation cephalosporins polymyxins plazomicin ceftolozane + tazobactam 4. What is reorder quantity? Describe the procedure for procurement of material in hospital. Ans; REORDER QUANTITY LEVEL: Reorder quantity methods inventory management. Reorder quantity is the quantity of items to be ordered to continue production without any interruptions in the future. re-order quantity is the quantity at which additional stock purchase or manufacture for consumption. It maintains buffer stock otherwise there will be stock out situation. It has to consider time between placing order & receiving goods. For re- ordering attention must be given to unavoidable large consumption & expiry date of product. PROCEDURES OF DRUG PURCHASES – DRUG SELECTION, SHORT TERM, LONG TERM AND TENDER PROCESS. PATEL COLLEGE OF PHARMACY BY- LALIT SHUKLA  11 Pharmaceutical for hospital use may be purchased in one of the following ways. By direct purchase from the manufacturer or whole salers. By inviting tender from retail drug store. By a contract purchase arrangement with manufacturer.  Purchase Request Form  Quotation Invitation  Purchase Order Form  Return Of Goods 1. PURCHASE REQUEST FORM: The Pharmacist or a person authorized by him complete a purchase request form. This Form provides the purchase department with the data concerning description specifications, packing. price, quantity heeded and also information about the inventory balance and anticipated monthly use. 2. QUOTATION INVITATION: On receipt of request for purchase invites competitive rules (quotations) from different Suppliers. To prevent delay in supply an annual rate contract can also be in consultation with pharmacists and prepares a purchase order. The purchase order may take the form of any different type it may consist of two page or a many page or a many page snap out form. However, a multicopy snap out form is suitable as it provides copy for the supplier, accounts department, purchasing number file, department which sent the purchase requisition, two receiving reports and a copy which indicate the history of the purchase. 3.PURCHASE ORDER FORM: The purchase officer scrutinizes quotations received, checks the quality expected to be supplied. 4. RETURN OF GOODS: If for any reason, any portion of the articles received are to be returned to the supplier and returned goods memorandums must be prepared because it is by its means that the hospital can be assured of receiving credit for the goods. This form is of the snap out type and provides four copies first to account department, second to the purchasing officer, third to the store room, fourth to the pharmacy and the supplier. 3 marks 1. Write disposal methods of expired drugs. Ans: 1. Returning to the manufacturer: Wherever possible this should be the first choice because the manufacturer is likely to have good disposal strategy available at its. 2. Landfill: The waste substances are directly placed into a land discarding site without prior treatment. This is the oldest and most accepted method for solid waste disposal. Untreated waste must be rapidly covered with other municipal waste to prevent scavenging. Care should also be taken to avoid contamination of ground water. 3. Waste immobilization (encapsulation): Encapsulation includes immobilizing the drugs in a solid block inside a plastic or steel drum. They are entirely filled to 75% capacity with solid and semi-solid drugs, and the additional space is filled by a medium such as cement or cement & lime mixture, plastic foam or bituminous sand. Once the drums are filled to 75% capacity, the mixture of cement, lime and water in the proportions 15:15:5 is added and the drum fully flled. The sealed drums should be keep at the bottom of a landfill and covered with fresh municipal solid waste. 4, Waste immobilization (inertisation): Inertisation method includes the drugs are removed from the package like removing pills from blister. The medicines are then ground and a mixture of cement, lime and water added to form a homogenous paste. The paste is transported in the liquid form by truck to a landfill and emptied into the normal urban waste. 5 Sewer: Some liquid drugs like syrups, i.v. fluids can be flushed into sewer after dilution, Small amounts of liquid medicines like antiseptics can be disp0sed of very much diluted prior to flushing. 6 Burning in open containers: Burning of medications in open containers at low temperature mav cause release of poisonous contamination to the environment. It is strongly recommended that very small quantities of waste drugs can be disposed by this method. 7 Incineration: Medium (800-1000°C) and high temperature above 1000°C incineration devices require a capital investment, operation, and maintenance budget. Large number of medications can be disposed of within a short period of time but incineration method is recommended only when unconditionally essential. PATEL COLLEGE OF PHARMACY BY- LALIT SHUKLA  12 2. Write the role of pharmacist in maintaining cold chain. Ans: Role of pharmacist in maintaining cold chain: 1. Hospital pharmacy administrator is responsible for the safe and proper storage of all medications. 2. Pharmacy team is responsible for following policies and procedures to maintain the cold chain. 3. Standard operating procedures must be in designed within the pharmacy to assure that the cold chain is maintained throughout the time a product is received, stored, dispensed and administered to the patient. 4. All pharmacy and supporting staff involved in handling cold chain products must be trained on these guidelines and procedures. 5. Temperature-controlled medicines are extensively available and ensure that remain cold, safe, and effective throughout the entire supply chain. 6. When dispensing a medication informed and given guidelines on suitable storage requirements. 7. The performance of cold storage equipment is regularly check and if any fault report to technician. 8. Record is maintained for equipment maintenance, calibration, etc. 3. Explain FEFO, FIFO method in inventory management. Ans: FEFO (First Expiry First Out) and FIFO (First In First Out) method This technique is utilized for stock management. In order to avoid accumulation of expired and old stock items should be stores and issued in FEFO or FIFO basis. The stock control system records the expiry date and date of receipt. Stock must be stored so that earliest expiring or first delivered batches can be selected and issued. FEFO, is an inventory management technique that permits for products with the earliest expiration date to be distributed first. This is a simple highly effective inventory management technique that focuses on the handling and moving of date sensitive inventory. FIFO principle generally have an arrangement of showing and selling older stock prior to selling recently obtained stock. By rotating stock in this way, its more likely that there will be less inventory waste. Recently received stock at the back of the shelf or behind the existing stock. For items that come in later but will expire first, usually the FEFO system is used. Recently arrived inventory sometimes has an earlier expiry date than a previously received batch of same item. This adjustment is important with item that have short shelf life like vaccines. Importance of FEFO and FIFO: 1. Enable effective traceability procedures 2. Minimize risk for expired drug 3. Plan for systematic recall measures 4. Monitor the whole supply chain. 4. Define inventory control and write the objective of inventory control. Ans: Drug store management is based on principles of inventory control. Mismanagement of stores and non-applicability of modern methods has been identified as the main cause of material deficiency in most of the hospitals DEFINITION It is the balance between not ordering too much and avoiding stockout situation of material. OBJECTIVES 1. To supply drugs in time 2. Efforts are made to procure drugs at minimum price without bargaining the quality. 3. To avoid stock out situation or shortage 5. Define Tender. Explain tender process. Ans: Tender is the process whereby hospital invites bids for drugs that must be submitted within given time limit. Tenders are broadly advertised to offer opportunities to a different supplier, encourage competition and make available greater pool of offer to select forms. PATEL COLLEGE OF PHARMACY BY- LALIT SHUKLA  13 Tender process: 1. The tenders are invited from various suppliers. 2. The tenders are sent by suppliers in sealed envelope before the due date. 3. Tenders opened on due date and time in the presence of representatives of suppliers. 4. A comparative statement is prepared by Purchase officers from the received tenders. 5. The order is placed to supplier which has quoted lowest rate. However, factors like quality, 9ro period of supply, other expenses like freight, sale tax, packaging and forwarding charges are nor also to be considered. E-TENDER It is the process for sending and getting tenders by electronic means, instead of old paper-based technique. e-tendering process: 1. The tenders are invited from suppliers by electronic means (e-procurement system) 2. The bids are sent by suppliers through online e-procurement system before the due date. 3. Received e-Tenders downloaded by purchase officer. 4. E-tenders evaluated by purchase officer and the result of an award of contract is uploaded on e-procurement system. 6. Which documents required for purchase and inventory control. Ans: Description Document Index suppliers It is a list of approved suppliers arranged alphabetically with address, contact numbers and description of items order from them. Departmental requisition It is prepared by staff member of department, approved by head of department. sent to purchase officer and one copy retain by the department. Quotation request It is written offer to supply material at a given fixed price within a prescribed period and under specified condition. Purchase order The purchase order is in written form evidence of agreement between the buyer and supplier Goods received note or delivery It enables the supplier to prove their delivery and the client to prove their note reception. Purchase Record Form Record the transaction for each item purchased. Stock Issue Confirmation (CI) Document identifies that requested items were removed from inventory and released to the patient. Over the Counter (0C) Document record items are issued immediately upon request. Stock Return (SN) Document record items that are returned to inventory. Inventory Adjustment (IA) Correction of inventory or stock records to bring them into agreement with the findings of the actual physical inventory. Physical Inventory Purchase Document records adjustment in on hand quantities at a specified unit price. Input (IP) Stock Transfer Issue (TI) Initiates the transfer of items from one department to another. 1 mark 1. EOQ stands for …… ECONOMIC ORDER QUANTITY 2. Define inventory turnover Inventory turnover is a measure of the number of times inventory is sold or used in a time period such as a year. It is calculated to see if a business has an excessive inventory in comparison to its sales level. 3. Cold storage temperature is …… Cold Storage (2º-8º C) PATEL COLLEGE OF PHARMACY BY- LALIT SHUKLA  14 4. ILR stands for ---- ILR (Ice-lined refrigerators) 5. Define Quotation It is written offer by supplier to supply material at a specified fixed price within a given period and under specified condition. 6. Vitamins store in …… Cool Temperature (8º- 25°C) 7. Reserved antibiotics Ans: These antibiotics are reserved for the treatment of confirmed or suspected infections due to multidrug resistant organisms. Reserve group of antibiotics should be used as "last resort" options. These antibiotics should be available, but their use should be in highly specific patients or when all antibiotic options have failed or are not suitable example: ceftazidime + avibactam, omadacycline, meropenem + vaborbactam, linezolid, colistin Chapter 4 5 marks 1. Describe how the drugs are distributed to in patient ANS: DRUG DISTRIBUTION- INPATIENT SERVICES Inpatient: Inpatient is the patient those are admitted in the hospital for diagnosis, treatment. Drugs are distributed to in-patients in a typical hospital. Distribution of drug to inpatient: (1) Physician prescribe drug to inpatient (2) Nurse Prepare requisition of drug & send towards pharmacy department (3) Pharmacist distributes a drug to nursing unit as per requisition slip. (4) Nurse brings these drugs towards inpatient & administered to it. (5) Record keeping for Administered drug DIFFERENT DRUG DISTRIBUTION SYSTEM TO INPATIENT Different systems are used to distribute drugs to inpatient 1. Individual prescription medication for each patient 2. Floor stock system 3. Combination of (1) & (2) Method 4. Unit dose dispensing 1. INDIVIDUAL IN-PATIENT PRESCRIPTION ORDER METHOD In this method physician prescribes the drug for individual patients, who obtains the prescribed drug from any medical store or hospital dispensary by paying his own charges. This system is generally used by the small or private hospital due to reduced manpower requirement and desirability to provide individualized services. Advantages of individual medication system 1. Close control on stock of medicine is possible. 2. Medication error can easily find out. Disadvantages 1. This method cannot be practiced in big hospitals. 2. Possibility of delay in obtaining medication. 3. High cost may be passed on to the patients. 2. FLOOR STOCK SYSTEM PATEL COLLEGE OF PHARMACY BY- LALIT SHUKLA  15 Under this system drugs are given to the patients through the nursing station. Pharmacy supplies the drugs to the nursing station through the drug store. This system is used in very big hospitals. In this system drugs are classified as... a. Free floor stock drugs b. Charge floor stock drugs When nursing station has both the charge & free floor stock drugs then the system is known as complete floor stock system. Advantages 1. Ready availability of medicines. 2. No return of drugs to the pharmacy. 3. Reduction in drug order transcriptions for pharmacy. 4. Reduction in pharmacy personnel requirement. Disadvantages 1. No review of prescription order by pharmacist & therefore increased risk of medication errors. 2. Increased drug inventory. 3. Drug deterioration hazards. 4. Greater demand on nurse’s time. 5. Extra capital is required for making storage facilities at each nursing point. 6.As nurse dispenses the drugs it infringes the professional duty of pharmacist && may also have legal implications. FREE FLOOR STOCKS DRUGS (NON-CHARGE FLOOR STOCK DRUGS) It is an inventory of routinely required medicines as per the predetermined list & are given as a part of hospitalization. These are not separately charged to the patient account. Charge floor stock It is an inventory of expensive drugs for which patients are charged on the basis of dosages given, it is the responsibility of pharmacist working in co-operation with nursing station to make these drugs always available. Pharmacist should periodically inspect the drugs stored at nursing station. 3. COMBINATION OF INDIVIDUAL DRUG ORDER AND FL0OR STOCK SYSTEM Falling into this category are those hospitals which use the individual prescription order system as their primary means of dispensing and also utilize a limited floor stock. This combination system is most commonly used in hospital today and also modified to include the use of unit dose medication 4. UNIT DOSE DISPENSING Definition: These are the medications which are ordered, packaged, handled & charged in multiples of single dose units, containing a pre-determined amount of drug.  Here pharmacist makes each & every dose of medication ready for administration. Viz. Solid medicaments are prepacked, liquids are premeasured & parenteral are premeasured & filled in sterile syringes. Strip packed tablets are common example of unit dose medication.  Drug supplies are received in bulk quantity by the pharmacy & making unit doses out of bulk is an important function carried out in the hospital pharmacy. Such unit dosages are useful for in-patients & out-patients.  Unit dose dispensing is carried out in centralized way at the level of pharmacy or in decentralized way at the level of Satellite pharmacy on the floor.  Once a unit dose container is opened pharmacy will not accept it back. Centralized Unit Dose Dispensing (CUDD) Decentralized Unit Dose Dispensing (DUDD) Satellite Pharmacy In this type of dispensing, medicines are stored in  This system is generally used where the centrally located pharmacy from where it is hospital has several buildings or floors. distributed to the patients through medication  This system consists of small satellite carts or dumb waiters as per the physician's pharmacies located on each floor of the prescription hospital.  Medication carts are used for the delivery of drugs to nursing station. PATEL COLLEGE OF PHARMACY BY- LALIT SHUKLA  16 Advantages 1. No pilferage & wastage. 2. Operational automation is possible. 3. Accounting becomes easier 4. Patients are charged only for the dose of drug they receive. Disadvantages 1. Cost of medicine may increase. 2. Need more staff to prepared unit dosage. 3. Extra space and facilities are required 2. Define Out-patient and describe to Out-patient. ANS: DRUG DISTRIBUTION: OUTPATIENT SERVICES DEFINITION Outpatient/ Ambulatory Patient: These are the patients who receive general or emergency treatment which could be diagnostic, therapeutic, or preventive, without being admitted as an in- patient in the hospital. These are also known as Ambulatory Patients as these patients are able to walk i.e., they are not bedridden. TYPES OF Outpatients Following are the types of outpatients, 1. General outpatient 2. Referred 3. Emergency 4. Special Location of outpatient dispensing  There is no hard & fast rule about its location. Wherever located it should not cause any disturbance to inpatients & should be easily accessible to outpatients.  Whenever possible there should be a separate independent outpatient dispensary. If it is not possible then combined unit is used for dispensing to outpatients as well as inpatients. Here dispensing is done from separate windows.  The outpatient dispensary should have two separate prescription presenting windows one for men & another for women. Same windows dispense drugs.  If needed window points can be raised to avoid overcrowding, but this also increases the manpower requirement PATEL COLLEGE OF PHARMACY BY- LALIT SHUKLA  17 & cost of the service.  The medical store of hospital pharmacy provides stock of at least 8 days to the dispensary & emergency supplies at any time.  During dispensing total elimination of waiting time is not possible so outpatient dispensary should have well- furnished waiting room. Layout of outpatient department Adequate no. of window for receiving & filling up prescription. Waiting room should be well furnished. Sufficient reading material like newspaper, magazine etc. available for patient leisure. Educative posters also available in outpatient department.If more crowd in outpatient department, then department should provide more no. of windows & manpower. 3. Write a note on automated drug dispensing system and device. Ans: AUTOMATED DRUG DISPENSING SYSTEM automation in drug dispensing includes, PATEL COLLEGE OF PHARMACY BY- LALIT SHUKLA  18  Computer- assisted physician order entry  Robotic handling, packaging, and sorting of drugs in the pharmacy  Stand-alone nursing-unit based cabinets  The automated generation of customizable reports and forms AUTOMATED DRUG DISPENSING DEVICES AUTOMATED DISPENSING CABINET Automated dispensing cabinet is a computerized drug storage device or cabinet designed for hospitals. The ADM provides proper storage, inventory control and security for pharmaceuticals at the point of care. It can be used only by authorized users who are authenticated by password. It 1s placed in wards, ICU rather than in central pharmacy Advantages 1. The commonly needed pharmaceuticals are at the point of care. This will reduce the workload of nurses. 2. Controlled substances remain in secure lock box until needed and access is secured by multifactor authentication. 3. ADM can improve patient safety by providing drug allergy alerts, drug-drug interaction and advice on high-risk medication Fig.: Automated dispensing cabinet ROBOTIC DRUG DISPENSING The robot can store up to 35000 medicines and dispense around 12 prescriptions in less than a minute. So, the patient's waiting time is significantly reduced. The dispensing process will be paper free as the robot will store the prescription as PATEL COLLEGE OF PHARMACY BY- LALIT SHUKLA  19 soon as a doctor documents it electronically. This also allows the pharmacist to focus on giving the customers right instruction on taking the medication Fig.: Robotic drug dispensing 4. Discuss Floor stock drugs give its advantage and disadvantages. Ans: FLOOR STOCK SYSTEM Under this system drugs are given to the patients through the nursing station. Pharmacy supplies the drugs to the nursing station through the drug store. This system is used in very big hospitals. In this system drugs are classified as... a. Free floor stock drugs b. Charge floor stock drugs When nursing station has both the charge & free floor stock drugs then the system is known as complete floor stock system. Advantages 1. Ready availability of medicines. 2. No return of drugs to the pharmacy. Disadvantages 1. No review of prescription order by pharmacist & therefore increased risk of medication errors. 2. Increased drug inventory. 3. Drug deterioration hazards. 4. Greater demand on nurse’s time. FREE FLOOR STOCKS DRUGS (NON-CHARGE FLOOR STOCK DRUGS) It is an inventory of routinely required medicines as per the predetermined list & are given as a part of hospitalization. These are not separately charged to the patient account.  Drug basket method.  Mobile dispensing unit. Drug basket method:  In this method nurse of night duty checks the drug inventory in the medicine cabinet, utility room & refrigerator.  This check is done against the master check list given by the pharmacy.  Nurse ticks the quantity required for each drug on the requisition for supply.  Empty containers along with requisition are placed in basket & it is sent to the pharmacy.  In the morning just after opening the pharmacy, pharmacist fills up empty containers & keeps the in basket.  These are then sent to the nursing station.  Nurse administers drug to the inpatient & keeps the record of administered drug. PATEL COLLEGE OF PHARMACY BY- LALIT SHUKLA  20 Mobile dispensing unit:  In this method, a trolley with castor wheels is used to carry the drugs to the wards.  Here, nurse of night duty is relieved of checking the inventory & transporting the empty containers.  Pharmacist or his assistant checks the nursing station for drug inventory.  Pharmacist restocks the ward with necessary drugs & leaves requisitions carbon copy at the ward as a proof of delivery.  Original requisition is sent back to the pharmacy for replenishment of mobile dispensing unit. Fig. Mobile dispensing unit Charge floor stock It is an inventory of expensive drugs for which patients are charged on the basis of dosages given, it is the responsibility of pharmacist working in co-operation with nursing station to make these drugs always available. Pharmacist should periodically inspect the drugs stored at nursing station. Selection of charge floor stock drugs  List is prepared by PTC. List may differ from hospital to hospital.  Hospital pharmacy conforms to the norms laid down by PTC & makes available requisite drugs.  Selected list is constantly reviewed by the committee for necessary revisions.  Selection of drugs is need based & generally vital lifesaving drugs are included in this category.  Ex. Cardiovascular drugs, Antihypertensives, Diuretics, Antibiotics, Antihistaminic, etc. Dispensing of charge floor stock drug: Envelope Method:  In this method Envelopes are used to dispense drugs to wards & also used as charge ticket.  Pre-labeled envelopes containing name & strength of drug are filled with the specific drug.  While administering the drug to the patient, nurse puts details of patient’s name && room number on the envelope & keeps it in the out-basket.  Then same is sent to the pharmacy for pricing 3 marks 1. Define out-Patient what services are provided by pharmacist to outpatients and different type of out patients. Ans: Outpatient/ Ambulatory Patient: These are the patients who receive general or emergency treatment which could be diagnostic, therapeutic, or preventive, without being admitted as an in- patient in the hospital. PATEL COLLEGE OF PHARMACY BY- LALIT SHUKLA  21 These are also known as Ambulatory Patients as these patients are able to walk i.e., they are not bedridden. TYPES OF Outpatients 1. General Out-patient These are the patients, given treatment on outpatient basis for the conditions other than emergency condition & are not referred cases. 2. Referred Out-patient These are the patients referred directly to the OPD by their attending medical or dental practitioner for specific treatment other than an emergency treatment & who latter returns to their practitioner for further care. 3. Emergency Out-patient These are the patients, given emergency or accident care for the conditions which require immediate medical attention. 4. Special outpatient After completion of the general checkup, the patients are asked to go for clinical, pathological or radiological examinations for accurate diagnosis. 2. What is unit dose dispensing Ans: Definition: These are the medications which are ordered, packaged, handled & charged in multiples of single dose units, containing a pre-determined amount of drug.  Here pharmacist makes each & every dose of medication ready for administration. Viz. Solid medicaments are prepacked, liquids are premeasured & parenteral are premeasured & filled in sterile syringes. Strip packed tablets are common example of unit dose medication.  Drug supplies are received in bulk quantity by the pharmacy & making unit doses out of bulk is an important function carried out in the hospital pharmacy. Such unit dosages are useful for in-patients & out-patients.  Unit dose dispensing is carried out in centralized way at the level of pharmacy or in decentralized way at the level of Satellite pharmacy on the floor.  Once a unit dose container is opened pharmacy will not accept it back. Centralized Unit Dose Dispensing (CUDD) Decentralized Unit Dose Dispensing (DUDD) Satellite Pharmacy In this type of dispensing, medicines are stored in  This system is generally used where the centrally located pharmacy from where it is hospital has several buildings or floors. distributed to the patients through medication  This system consists of small satellite carts or dumb waiters as per the physician's pharmacies located on each floor of the prescription hospital.  Medication carts are used for the delivery of drugs to nursing station. Advantages 1. No pilferage & wastage. 2. Operational automation is possible. 3. Accounting becomes easier 4. Patients are charged only for the dose of drug they receive. 3. What is satellite pharmacy Ans; Satellite pharmacy concept is adopted in very big hospitals, which have multistoried separate buildings in single premises. Big hospitals everyday face more problems during distribution of drugs to all the wards. Hence big hospitals are running satellite pharmacies in the form of mini-pharmacies. Satellite pharmacies (Floor pharmacies) are the branches of pharmacy located on each floor of the hospital. PATEL COLLEGE OF PHARMACY BY- LALIT SHUKLA  22 Here the main pharmacy serves as a feeder serving to all the satellites. Main pharmacy procures, stores, manufactures & packages the drugs. These drugs are then dispensed in ready to use form through carts to satellites. Stock for 24 hours is maintained in satellite pharmacy. In satellite pharmacy following procedure is adopted for dispensing... 1. Pharmacist prepares Patient profile card, containing personal data & disease parameters of the patient. 2. Physicians prescription is sent to the pharmacy; Pharmacist reviews it & enters it on profile card. 3. Dosage schedule is then communicated to the nurse. 4. Junior pharmacist then dispenses the drugs in the bins & keeps them in carts for transportation. 5. Nurse administers the drug to the patient & makes entry in patients’ medical record. 6. The cart is then returned to the pharmacy, which is then re-checked by the pharmacist. Advantages 1. Efficiently drug can be distributed. 2. Time of drug dispensing could be reduced. 3. Errors in drug distribution could be stopped. Disadvantages 1. Overall hospital budget may affect. 2. Additional manpower is required 4. Write a note on location and layout of OPD. Ans; Location of outpatient dispensing  There is no hard & fast rule about its location. Wherever located it should not cause any disturbance to inpatients & should be easily accessible to outpatients.  Whenever possible there should be a separate independent outpatient dispensary. If it is not possible then combined unit is used for dispensing to outpatients as well as inpatients. Here dispensing is done from separate windows.  The outpatient dispensary should have two separate prescription presenting windows one for men & another for women. Same windows dispense drugs.  If needed window points can be raised to avoid overcrowding, but this also increases the manpower requirement & cost of the service.  The medical store of hospital pharmacy provides stock of at least 8 days to the dispensary & emergency supplies at any time.  During dispensing total elimination of waiting time is not possible so outpatient dispensary should have well- furnished waiting room.  Layout of outpatient department Adequate no. of window for receiving & filling up prescription. Waiting room should be well furnished. Sufficient reading material like newspaper, magazine etc. available for patient leisure. Educative posters also available in outpatient department. If more crowd in outpatient department, then department should provide more no. of windows & manpower. PATEL COLLEGE OF PHARMACY BY- LALIT SHUKLA  23 5. Explain storage of narcotics and psychotropic substance. Ans: Narcotics & psychotropic substances or preparations including certain medicines that are eighter have the potential to bad, dangerous, or harmful to human health are subjected to control under the Narcotics drugs and psychotropic substances act 1985. Schedule 1: The drugs under this schedule have high potential for abuse and have no accepted medical use in treatment (e.g., Marijuana, raw opium). Schedule 2: The drugs under this schedule have high potentials for abuse but accepted for medical use (e.g., Cocaine, morphine). PATEL COLLEGE OF PHARMACY BY- LALIT SHUKLA  24 Schedule 3: The drugs under these schedules have less as compare to above potentials for abuse, accepted for medical treatment and have less physical dependence and psychological dependence (e.g., benzodiazepine and painkiller, phenobarbitone, low strength codeine, steroids etc. STORAGE  These drugs should keep under lock and key. A separate register should be maintained to register them.  Narcotics & psychotropic substances must be stored in separate cupboard with double lock and key.  The key of the locks should be kept in hand of two different people. Other than narcotics drug no items are permitted to be stored in the narcotic drug cupboard.  Narcotics drugs & psychotropic substances must be procured & stored in such a manner so as to prevent their falling into the hands of unauthorized persons.  The storage area for the narcotics & psychotropic substances may be opened and accessed by specific pharmacist In-charge and specific nursing In- charge of respective department. 6. Explain the distribution of drugs to ICCU/ICU/Emergency ward. Ans: In hospital specialized units dedicated for the patients who have life threatening illness or injuries and need intensive care and constant observation, Following are the specialized units, ICU (Intensive Care Unit), is also known as an intensive therapy unit or intensive treatment unit or critical care unit, is a special department for critical patients who needs intensive treatment and continuous observation. ICCU (Intensive Coronary Care Unit), is also known as an intensive Cardiac Care unit, is a unit which focused on intensive treatment for heart issues such as coronary heart disease, cardiac dysrhythmia, heart attack, heart failure and other cardiac conditions. NICU A neonatal or newborn intensive care unit) also known as an intensive care nursery (ICN), is an intensive care unit (ICU) specializing in the care of ill or premature newborn infants. EMERGENCY WARD also known as an accident & emergency department, emergency room or casualty department, is a medical treatment facility specializing in emergency medicine, the acute care of patients who present without prior Appointment; either by their own means or by that of an ambulance. Chapter 5 3 marks 1. Write a note on TPN. Ans: total parenteral nutrition (TPN) is a method that bypasses the GIT gastrointestinal tract, because s absorptive capacity is reduced. Fluids are administered into a vein to deliver most of the nutrients the body needs. In short, when the GIT is non-functional, TPN is essential for patients to maintain adequate nutrition. TPN provides a mixture of fluid, electrolytes, carbohydrate, lipids(fats), amino acids (protein), vitamins, minerals. Definition: Total parenteral nutrition (TPN) is intravenous administration of nutrients in adequate quantities to achieve tissue synthesis & anabolism TYPES OF TPN  Central Parenteral Nutrition  Peripheral Parenteral Nutrition PATEL COLLEGE OF PHARMACY BY- LALIT SHUKLA  25 Central Parenteral Nutrition: It is also called total parenteral nutrition (TPN) that is delivered into a central vein. It includes lipids, vitamins. minerals, amino acids, dextrose & trace elements. Peripheral Parenteral Nutrition (PPN): PPN is delivered into peripheral vein. Total kcal is limited by concentration & ratio to the volume being administered. CONTENTS OF TPN TPN is mixture of separate components which contain Carbohydrates, Lipids (fat), Amino acids, Electrolytes, Trace elements, Vitamins and Fluids. TPN composition adjusted as per requirement of individual patient. Carbohydrates: Carbohydrates is the main source of energy. Dextrose and monohydrates of glucose used as primary source of carbohydrate in TPN. Carbohydrate source such as galactose, fructose & sorbitol should not be used as energy sources in TPN. Lipids (Fat): Linoleic acid is used as primary source of essential fatty acid in TPN. Linoleic acid is useful as precursors of prostaglandins & in the synthesis of other fatty acids which are essential for cell membrane integrity. Electrolytes: Sodium (Na) - 100 to 200 mEq, Potassium (K) - 80 to 120 mEq, Magnesium (mg) -8 to 16 mEq, Calcium (Ca) -5 to 10 mEq, Chloride (Cl) – 100 to 200 mEq. Vitamins: Vitamins are required for the metabolism of carbohydrates, proteins, fats. water soluble (Bl, B2, B3, B5, B6, B7, B9, B12 & C) & fat-soluble vitamins (A, D, E & K) used in TPN formulation 2. Explain IV admixture service and write causes and consequences of incompatibilities of IV admixture. Ans: IV ADMIXTURES These preparations consist of one or more sterile drug products added to IV fluids- generally dextrose or sodium solution or ringer solution alone or in combination. IV admixture are used for drugs intended for continuous infusion and for drugs that may cause irritation or toxicity when given via direct IV injection. definition: An 1V admixture is a preparation of a pharmaceutical mixture of two or more drugs added into IV fluids alone or in combination for medication purposes. Following objectives expected to achieve by the pharmacist for the implementation of an IV additive service: 1. Preparation of final product under aseptic condition. 2. Rational choice of additive and mixing techniques for avoiding drug interactions. 3. Appropriate labeling, dispensing and storage of final product. IV ADMIXTURE INCOMPATIBILITY Definition: It is the simultaneous dilution and/or administration of two or more drugs that interfere with the therapeutic efficacy of the medications and patient safety. The types of incompatibility related with intravenous administration are  Physical incompatibility  Chemical incompatibility CONSEQUENCES OF INCOMPATIBILITIES The unintentional presence of precipitation and toxic products can induce various negative impacts on the patient. 1. Damage from toxic products multi-organ failure, Severe liver dysfunction, Toxic shock, Local embolus, Myocarditis, Respiratory difficulties, Systemic allergic reactions, Local allergic reactions, Thrombosis, Thrombophlebitis, Phlebitis, Local redness 2. Particulate emboli from crystallization and separation A large quantity of particles in injections is considered a potentially life-threatening health hazard. Drug incompatibility reactions may not only produce particles in the infusion but also alter the drug into an inactive form and injurious effects on the patient prescribed drug regimen. 3 Tissue irritation due to major pH modifications 4 Therapeutic failures PATEL COLLEGE OF PHARMACY BY- LALIT SHUKLA  26 5 Adverse effects of drug incompatibilities extend time span and total cost of patient's hospitalization in hospital. 3. Define IV admixture and write step required in prepration of IV admixture. Ans: : IV ADMIXTURES These preparations consist of one or more sterile drug products added to IV fluids- generally dextrose or sodium solution or ringer solution alone or in combination. IV admixture are used for drugs intended for continuous infusion and for drugs that may cause irritation or toxicity when given via direct IV injection. definition: An 1V admixture is a preparation of a pharmaceutical mixture of two or more drugs added into IV fluids alone or in combination for medication purposes. Following objectives expected to achieve by the pharmacist for the implementation of an IV additive service: 1. Preparation of final product under aseptic condition. 2. Rational choice of additive and mixing techniques for avoiding drug interactions. 3. Appropriate labeling, dispensing and storage of final product. PREPARATION OF IV ADMIXTURE 1. Upon receipt of the physician original order sheet, a pressure sensitive label must be prepared. which provides the following information: Patient name, Patient location, Physician's name, Name of the drugs with quantities added, Date of compounding, Expiration date, Name of the pharmacist preparing the product 2. Prepare the admixture under the laminar flow hood using sterile needles and syringes or double ended transfer needles. Sometimes the Cornwall syringe is also useful in the preparation of IV admixture. 3. Once the transfer is made, metadisc of the container must be replaced with a new seal crimped. For safety purposes, A different colored seal should be utilized that it warns individuals regarding drugs that have been added. 4. Pharmacists must inspect the final product before dispensing the final admixture. The inspection should contain a review of the label, clarity of the solution, and the calculation involved in the preparation. 1 mark 1. TPN stand for …… total parenteral nutrition. 2. What is bulk compounding Ans: Compounded drugs can serve an important role for patients whose medical requirements cannot be fulfilled by an FDA-approved drug. Following are the reasons in which pharmacy decides compounding in hospital: 1. Drug shortage in hospital. 2. Adjustment of dose require in premature infants 3. Changes need in dosage form to make medication easier to ingest in children and elder patients. 4 Patient has an allergy and needs a medication to be made without certain dye. 3. Define IV admixture. Ans: An 1V admixture is a preparation of a pharmaceutical mixture of two or more drugs added into IV fluids alone or in combination for medication purposes Chapter 6 3 marks 1. What are Radiopharmaceuticals? Explain dispensing and disposal of them. Ans: Definition: Radiopharmaceuticals are medicinal formulations containing radioisotopes which are used in major clinical areas for diagnosis & /or treatment. Example Xenon133 (133Xe) gas, Sodium iodide 123 (Nal23|), Iodine131(131 I) sodium rose bengal. PATEL COLLEGE OF PHARMACY BY- LALIT SHUKLA  27 DISPENSING OF RADIOPHARMACEUTICALS  Dispensing should be safe, straight forward & reliable. An important point in Radiopharmaceutical dispensing has been the production of ready to use kits or cold kits which provide individual or multiple doses & can be reconstituted by the addition of the radionuclide at the time of intended use.  Chemical reagents are prepared in a sterile environment using pyrogen free raw materials & dispensed into single or multiple unit dose containers. The preparation of individual doses can be carried out rapidly & safely when required with minimum manipulation.  The cold kit preparation should be subjected to terminal sterilization preferably by autoclaving or if not by membrane filtration.  Radiopharmaceuticals are never dispensed directly to patients; they are provided to trained health care professionals at the hospital or clinics & then administered to the patients.  Recommended dosage level is calculated on the basis of patient history, age, weight, surface area & other factors.  Dispensing of prescription is done as per applicable pharmacy law & appropriate records are maintained. DISPOSAL OF RADIOPHARMACEUTICALS  Radioactive materials no more required must be disposed to avoid any hazard to environment.  Practice that produces large volume of waste must be avoided. Dilute & dispense for low level solid, liquid & gaseous waste.  Segregate waste according to half- lives, delay & decay for waste that contain short live nuclides. Before storing, label waste. Release waste into sewage system depending on water flow.  Longer T1/2 radionuclides should be incinerated or deeply burnt in soil in a separately marked area. 2. Define Radiopharmaceuticals. Discuss storage of them. Ans: Radiopharmaceuticals are medicinal formulations containing radioisotopes which are used in major clinical areas for diagnosis & /or treatment. Example Xenon133 (133Xe) gas, Sodium iodide 123 (Nal23|), Iodine131(131 I) sodium rose bengal. STORAGE OF RADIOPHARMACEUTICALS These should be kept in well closed containers & placed in an area assigned for the purpose. The storage condition should be such that the maximum radiation dose rate to which person may be exposed is reduced to an acceptable level. Necessary care should be taken to comply with national regulations for protection against ionizing radiations. Radiopharmaceutical preparations intended for parenteral use should be kept in a glass vial, ampoule or syringe that is sufficiently transparent to permit the visual inspection of the contents. Glass containers may get darkened under the effect of radiation. 3. What are diagnostic & therapeutic radiopharmaceuticals. Ans: Diagnostic radiopharmaceuticals (radDx) are used for diagnostic purposes. They serve as tracers that when introduced into the body, emit radiations which are subsequently detected & measured. 2. Therapeutic radiopharmaceuticals (radRx) are used as internal or external radiation sources Internal radiation source: can be administered to a patient for the purpose of delivering radiation to body tissues internally. PATEL COLLEGE OF PHARMACY BY- LALIT SHUKLA  28 e.g used in Hyperthyroidism treatment. 4. what are ideal characteristics for radiopharmaceuticals Ans: 1. It should have relatively short half-life. 2. It should emit gamma particles & not alpha particles or beta particles. 3. Radiopharmaceuticals must be able to localize on target site before being metabolized. 4. The energy of Radiopharmaceutical should range from 30 to 300 kilo electron volts (KeV) 5. It should excrete from body. 6. It should be easily available & should be inexpensive. Chapter 7 1 mark 1. Define Electronic Health Record. Ans: EHR systems are computer-based application used to convert all the information found in paper based medical records to a computer-based system. Examples: eClinical Works, Allscripts 2. Enlist application of computer in hospital pharmacy Ans: APPLICATION OF COMPUTER IN HOSPITAL PHARMACY PRACTICE 1. Maintenance of patient records 2. Maintenance of drug records 3. Purchase and Inventory control record 4. Therapeutic drug monitoring 5. Drug Information retrieval 6. Drug dispensing 7. Avoiding medication error 8. Record relating to drugs in hospital formulary 3. How does the computer help regarding medication monitoring? Ans; to maximize the therapeutics action of medicines, avoiding any toxic effects pharmacist has started taking assistance of some pharmacokinetic and non-pharmacokinetic parameters. Therapeutic drug monitoring is most important in geriatric, pediatric and drugs having high tendency for interaction., clinical pharmacist using computer to calculate drug dosage. 4. Enlist software used in hospital pharmacy. Ans:  Electronic Health Record (EHR) Software- eClinicalWorks, Allscripts, Nextgenclinic PATEL COLLEGE OF PHARMACY BY- LALIT SHUKLA  29  Medical billing software -Epic Care  Hospital management software -Availity  Medical equipment management software -Sortly  Medical research software- PubMed.gov Chapter 8 5 marks 1. What is clinical pharmacy? Give its scope and describe development of clinical pharmacy. Ans: It is a branch of pharmaceutical science which deals with various aspects of patient care, not only with dispensing of drugs, but advising the patient on rational selection and safe use of drugs. SCOPE OF CLINICAL PHARMACY The scope and responsibilities of the clinical pharmacist in a hospital include the following. i) Decision Making- To participate in drug use decision making process. He may compile and evaluate patient specific information and assist the physician in selecting the appropriate drug product, dosage form and formulation. ii) Drug selection- To select the drug product, source of supply based on comparative evaluation of their bioequivalence, bioavailability, blood levels achieved and hence the time, intensity and duration of drug action. He may also judge the quality of products and select manufacturers based on economic and cost considerations and other quality parameters. iii) Dose schedule- To determine the dose and dosage schedules based on individual pharmacokinetic considerations and patient's pathological state. He may assess the existing dosage schedule and recommend modifications. iv) Medication- To prepare medication for patient use and provide drug products ready for administration to various patient care units. V) Counseling- To counsel the patients to ensure that they understand the importance, benefits and risks of therapeutic plans implemented. He provides drug information and encourages compliance. vi) Monitoring- To monitor the patients for detecting adverse drug reactions, drug interactions, drug abuse and toxicities. DEVELOPMENT IN INDLA AND OTHER COUNTRIES  In India, Clinical pharmacy services were initiated in 1992, when 2 Indian hospital pharmacists, B. Suresh and B.G. Nagavi, of Ooty and Mysore, respectively, sought out clinical pharmacist Frank May in Australia.  That same year, may visited their schools of pharmacy in India. Clinical pharmacy education programs have been launched in India still much work will be required to improve and expand these programs to bring the benefits of clinical pharmacy practice to the huge area of the Indian society.  In 1997, the hospitals in Ooty and Mysore were the sites of clinical pharmacy practice programs developed in collaboration with a senior clinical pharmacist from RGH. Developing competencies through academic curricula and establishing practice centers in hospitals were the target approaches for the programs.  A new branch in postgraduate courses was introduced, and curricular changes were selected in undergraduate curriculum development.  The government sector model and the private sector model such two model centers for the practice of clinical pharmacy were developed. 2. Explain pharmaceutical care in detail. Ans: DEFINITION- Pharmaceutical care is the responsible provision of drug therapy for the purpose of achieving definite outcomes that improve a patient's quality of life. DRUG RELATED PROBLEMS PATEL COLLEGE OF PHARMACY BY- LALIT SHUKLA  30 Definition: Drug related problem is an event or circumstance involving drug therapy that actually or potentially interferes with desired health outcome. PROCEDURES TO PROVIDE PHARMACEUTICAL CARE Pharmaceutical care is a prospective patient-centered practice with a focus on identifying, resolving, and preventing drug therapy problems. This objective is achieved by a patient care process comprising following steps: 1. Assessment of Drug Therapy Need: The pharmacist develops mechanisms to assure the patient has access to pharmaceutical care at all times. A professional relationship must be established and maintained. Interaction between the pharmacist and the patient must occur to assure that a relationship based upon trust, caring, cooperation, open communication, and mutual decision making is established and maintained. 2. Data Collection: Patient-specific medical information must be collected, organized, recorded, and maintained. Pharmacists must collect patient's general health, past medical history, social history, medication history, history of present illness, diet and exercise history, and economic situation. Patient information must be maintained in a confidential manner. 3. Information Evaluation and Formulating Plan: Patient-specific medical information must be evaluated and drug therapy plan developed mutually with the patient. The plan may have various components which address each of the patient's conditions or diseases. In designing the plan, the pharmacist must carefully consider the psycho-social aspects of the disease as well as the potential relationship between the cost and/or complexity of therapy and patient adherence. The essential elements of the plan, including the patient's responsibilities, must be completely and carefully explained to the patient. The drug therapy plan must be documented in the patient's pharmacy record and communicated to the patient's other healthcare providers as necessary. 4. Implementing the Plan: The pharmacist assures that the patient has all supplies, knowledge, and information necessary to carry out the drug therapy plan. The pharmacist must also assure that the patient has a thorough understanding of the disease and the therapy/medications prescribed in the plan. 5. Monitoring the Plan: The pharmacist reviews, monitors, and modifies the therapeutic plan as appropriate and necessary, in concert with the patient and healthcare team. Patient progress is accurately documented in the pharmacy record and communicated to the patient and to the patient's other healthcare providers as appropriate. 6. The pharmacist shares information with other healthcare providers as the setting for care changes thus helping assure continuity of care as the patient moves between the institutional setting, the community setting, and the long-term care setting. 3. Describe medication therapy management. ANS: Definition: Medication therapy management (MTM) is a distinct service or group of services provided by health care providers, including pharmacists, to ensure the best therapeutic outcomes for patients. Objective: The ultimate goal of all pharmacists providing MTM is to make sure that the medication is correct to the patient health conditions to get the best possible outcomes from the treatment. Following Considerations for Implementation of MTM: 1. MTM service has been implemented in health centers, managed care health systems, patient centered medical homes, hospital pharmacies, community pharmacies, and primary care clinics. 2. MTM includes five core elements in functioning i. Medication therapy review ii. A personal medication records iii. A medication-related action plan iv. Intervention or referral PATEL COLLEGE OF PHARMACY BY- LALIT SHUKLA  31 v. Documentation and follow-up 3. Medication therapy management services (MTMS) have been shown to improve patient health outcomes through improved control of chronic disease and more careful attention to potential drug-drug interaction. 4. Implementation guidance has been developed by various organizations: Centers for Medicare & Medicaid Services, American Pharmacists Association's MTM Central, which includes an MTM resource library, implementation guidance, and information about the added value of MTM. 5. Several federal agencies are working on initiatives that focus on greater involvement of pharmacists in cardiovascular prevention and MTM. Role of pharmacist in MTM: Pharmacists review patient medication for safety, efficacy, and appropriateness Pharmacists review patient medication record and fill the record form to maintain the updates of health status and medication of the patient. 4. Describe home medication review. Ans: Home Medicines Review (HMR) is a patient-focused, careful and collaborative health care service provided in the community setting, to enhance quality use of medicines and patient understanding. Or it is a service designed to assist patients living at home to maximize the benefit of their medication regimen & prevent medication related problems. Objective: 1. To identify, prevent and resolve potential medication-related problems 2. To optimize pharmacotherapy and assist in achieving better health outcomes for patients at home. Need of HMR:  The patients find it uneasy and difficult to get medical care in conventional settings like nursing homes, hospitals.  They are not very much enthusiastic of meeting a doctor and getting evaluated.  The patient would prefer to receive the health care in a personalized approach with confidentiality where the others do not come to know regarding his/her illness.  This also avoided hospital ward charges as well as need for an attendant for patients. Classification of HMR: Medication review can be classified into four types: 1. Prescription review 2. Adherence support revie 3. Clinical review 4. Clinical review with prescribing 1. A prescription review aims to address the technical issues of a patient's prescription such as changed items or anomalies. 2. An adherence support review, with the patient present, addresses a patient's medication- taking behavior focusing on improving a patient's knowledge of medicines and adherence to them. 3. A clinical medication review, with access to clinical notes and the patient present, is more comprehensive and addresses the patient's use of medication in the context of their clinical condition. 4. In some countries an extension of type 3 exists and includes the authority for prescribing. Role of pharmacist in HMR: 1. The HMR consists of visits by a pharmacist and analyzes the patients from the point of lite style, drug and disease. 2. The pharmacist prepares a customized care plan and implements it to the patient by explaining and educating about the drug, disease, and lifestyle modifications. 3. He also prepares a medication therapy management plan as per the prescription. 4. The pharmacist with his skills tries to interpret the reasons for failed or mixed outcomes. 5. He can communicate with doctors and nurses regarding the diagnosis and treatment to discuss the patient care issues. 3 marks PATEL COLLEGE OF PHARMACY BY- LALIT SHUKLA  32 1. Describe adverse drug reaction monitoring. Ans: According to the WHO definition ADR is defined as: "A response to a drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function". Patient safety is an important issue for hospitals and pharmacies. Research from several countries has found that treatment related complications, or adverse events, affect 2.5-16.6% of patients admitted to hospitals. The most common adverse events are those attributable to medication use, or adverse drug events (ADEs). ADEs account for up to a fifth of all adverse events. ADRs are estimated to account for about 3 to 15% of all hospital admissions and lead to an increase in morbidity and mortality. Almost 16% of nursing home patients are hospitalized annually due to ADRs. Goals of Adverse Drug Reaction Monitoring 1.To minimize the risk of adverse drug reaction 2. To reduce consequences after adverse drug reaction Procedure Pharmacist is involved in following steps of monitoring of ADR: 1 Literature review 2. Patient history 3. Drug level studies 4. Therapeutic decision making Pharmacist with better knowledge of the pharmacological action, adverse reaction and the pathophysiology of diseases can make the therapy to be safer. Role of Pharmacist in the Management of ADR 1. Monitoring the patients who are at greater risk of developing ADR S 2. Monitoring the patients who are prescribed with drugs highly susceptible to cause ADR's 3. Assessing and documenting the patient's previous allergic status 4.Assessing the patient's drug therapy for its appropriateness 5. Assessing possible drug interactions in case of multiple therapies 6. Assessing health care professionals in detection and assessment of ADR'S 7. Encouraging/ stimulating healthcare professionals in reporting on ADR 8. Documentation of suspected reported reactions for future reference 9. Follow up of patients to assess the outcome of the reaction and management 10. Obtaining feedback about the reported reaction 2. Explain drug information and poison information. Ans: Definition: Drug information and poison information is an independent body in hospital which provides information on drugs, poisons & their health aspects. Goal 1. To uplift the profession of pharmacy by bringing better interaction between the pharmacist & the community. 2.To improve patient compliance with drugs dosage regimen & to improve therapeutic effect. 3. The drug and poison information by using suitable techniques & methods such as verbal, written, or audio-visual communication for educating & counseling the patient. 4. Drug and poison information can provide information regarding poisons, their toxicity & treatment round the clock. 5. The concept of Drug and poison information is an attempt to collect the information of drugs by abstracting information about them. Procedure  Pharmacists have fundamental responsibility and a function that is unique to their profession as providers of drug information.  The information may be either patient specific, as an integral part of pharmaceutical care. or relative to a group of patients, such as in the development of a therapeutic guideline. publishing an electronic newsletter, or updating a website. PATEL COLLEGE OF PHARMACY BY- LALIT SHUKLA  33  The pharmacist can serve as a resource for issues regarding selection and use of cost- effective mediation, medication policy decisions (drug benefits), medication information resources election, or practice-related issues.  Pharmacists involved in patient care areas (e.g., hospitals, clinics, long-term care, and home health care) now frequently answer drug information questions; participate in evaluating a patient's drug therapy, and conduct medication usage evaluation activities. Drug Information is the provision of verbal and/or written information or advice about drugs therapy and drug in response to a request from other healthcare providers, organizations, patients, committees, or members of the public.  Drug information service describes activities to optimize drug use undertaken by pharmacists in providing information.  Drug information service provides well referenced, critically evaluated, unbiased and up- to-date information on any aspect of drug use.  Pharmacist's involvements directly impact patient care, improve medication compliance, and decrease the likelihood of medication errors. 3. Describe treatment chart review. Ans: Definition: It is a fundamental responsibility of a pharmacist to ensure the appropriateness of medication orders. It serves as starting point for other clinical pharmacy activities (ADR, DI, TDM, and medication counseling). Organizing information according to medical problems (like disease) helps breaking a complex situation into its individual parts. Goals 1. To optimize the patients drug therapy. 2. To minimize or prevent drug related medication errors /problems. Procedure  The patient's medical record should be reviewed in relation with the medication administration record  Recent consultations, daily progress and treatment plans should be taken into account when determining the appropriateness of current medication orders and planning each patient's care.  All recent and current medication orders should be reviewed. Components of Medication Order Review include 1. Checking that medication order is written in accordance with local and legal requirements. 2. Ensuring that the medication order is unambiguous and comprehensible, that appropriate terminology is used and that drug name are not abbreviated. Annotate the chart to provide no clarification as required. 3. Detecting orders for medication to which the patient may be intolerant /hypersensitive. 4. Ensuring that medication order is appropriate with respect to: The patient's previous medication order. Patient's specific considerations e.g., pregnancy, disease state - Drug dosage schedule and dose, especially with respect to age, liver function, renal function. - Route, method of administration and dosage form. 4. Explain ward round participation. Ans: Definition: A ward round is a visit made by a medical practitioner, alone or with a team of health professionals and medical students, to hospital inpatients at their bedside to review and follow up the progress in their health.  At least one ward round is conducted every day to review the progress of each inpatient, more than one can happen.  In psychiatry, the "ward round" may be conducted away from the patient's bedside in a non-traditional fashion, where to review each case, the team meets elsewhere. Goals for clinical pharmacists on ward rounds Pharmacists should attend ward rounds and clinical meetings whenever possible as an important member of the healthcare team. By this way pharmacists can contribute prospectively to patient care through the provision of drug therapy. The goals of a clinical pharmacist participation in ward rounds are to:  Gain an increased understanding of patient's clinical progress and status, current therapeutic goals and planned investigations PATEL COLLEGE OF PHARMACY BY- LALIT SHUKLA  34  Provide relevant information on various aspects of the patient's drug therapy such as pharmacokinetics, pharmacology, drug availability, adverse reactions, drug interactions and cost.  Optimize therapeutic management by influencing drug therapy selection, implementation, follow-up and monitoring.  Investigate unusual drug doses or orders. 5. Define clinical pharmacy and what are the scope of clinical pharmacy. Ans: It is a branch of pharmaceutical science which deals with various aspects of patient care, not only with dispensing of drugs, but advising the patient on rational selection and safe use of drugs. SCOPE OF CLINICAL PHARMACY The scope and responsibilities of the clinical pharmacist in a hospital include the following. i) Decision Making- To participate in drug use decision making process. He may compile and evaluate patient specific information and assist the physician in selecting the appropriate drug product, dosage form and formulation. ii) Drug selection- To select the drug product, source of supply based on comparative evaluation of their bioequivalence, bioavailability, blood levels achieved and hence the time, intensity and duration of drug action. He may also judge the quality of products and select manufacturers based on economic and cost considerations and other quality parameters. iii) Dose schedule- To determine the dose and dosage schedules based on individual pharmacokinetic considerations and patient's pathological state. He may assess the existing dosage schedule and recommend modifications. iv) Medication- To prepare medication for patient use and provide drug products ready for administration to various patient care units. 6. Explain medication history in clinical pharmacy. Ans: Definition: pharmacist conducts patient's interview and records all the drugs that the patient has taken in his past any hypersensitivity to a specific drug, food habits, drug dependence, intoxication with chemicals, idiosyncratic reactions etc. it should always include OTC (Over the Counter) drugs also. Goal 1. To help the physician for better faster and more accurate selection of drug therapy for the patients. 2. To study patient's compliance Procedure  Initially get the name, address, age, etc. of the patient.  To collect the past history of the patient, see if the old medications are available with the patient or ask him about it try to find out if the patient knows why he was taking the medication & what were the side effect if any. So as to find out self-prescribing (self-medication) habits & OTC preference ask direct questions such as, -what do you take for headache, cold, constipation or fever?  Allergic responses of the patient can be known by direct and indirect questions, patient will explain the allergic response in his own language or terms.  Apart from this take an account of his habits like alcohol, tobacco, smoking any other  chemicals or drugs which he comes in contact.  Study their impacts on compliance by the patient ask him the questions like 7. Patient counselling. Ans: Patient counselling can be defined as providing medication information orally, in written or by showing pictograms to the patient or their relatives on the direction of use, precautions, storage and diet etc. Goals of patient counseling  To improve the patient compliance & thus can reduce consequences of non-compliance. Patient can understand the safe & appropriate use of medicines.  Improves the coping strategies to deal with medication side effects and drug interactions. Motivates the patient to take medicine for improvement of his/her health status.  The patient becomes an informed, efficient, and active participant in disease treatment and self-care management. PATEL COLLEGE OF PHARMACY BY- LALIT SHUKLA  35  It encourages the patient to establish a working relationship with a pharmacist & foundation for continual interaction and consultation.  Patient recognizes the importance of their well-being. 8. Home medication review. Ans: : Home Medicines Review (HMR) is a patient-focused, careful and collaborative health care service provided in the community setting, to enhance quality use of medicines and patient understanding. Or it is a service designed to assist patients living at home to maximize the benefit of their medication regimen & prevent medication related problems. Objective: 1. To identify, prevent and resolve potential medication-related problems 2. To optimize pharmacotherapy and assist in achieving better health outcomes for patients at home. Need of HMR:  The patients find it uneasy and difficult to get medical care in conventional settings like nursing homes, hospitals.  They are not very much enthusiastic of meetin