Purchasing

Purchasing

Rational use of medicine The rational use of drugs requires that patients receive medications appropriate to their clinical needs, in dose that meet their own individual requirements for an adequate period of time, and at the lowest cost to them and their community

• Purchasing: to obtain an item by paying money per its equivalent or to buy for a price. • Procurement involves the process of selecting vendors, establishing payment terms, strategic evaluation, selection, the negotiation of contracts and actual purchasing of goods.

Procurement procedure • It includes – Selection of drugs items – Authority or purchase – Storage – Stock control

• Selection of items: – It is an important and basic function that must be performed by a pharmacist – Pharmacist can make better decisions regarding products, quantities required, product specifications and source of supply – A purchasing department can perform purchasing functions but setting of quality standards and specification requires professional knowledge and judgment so must be performed by a pharmacist

• A formulary system should be present. Which gives the authority of setting the specification to pharmacist • There should be a criteria to evaluate acceptability of manufacturers and distributers of items. • A pharmacist should have the authority to reject an item or supplier when professional judgment dictates so • PTC recommends guidelines for selection of drugs • Economy, quality and efficacy must be considered in selection of items. • In selecting suppliers, pharmacist consider price, terms, shipping times, quality of service, returned goods policy and packaging.

Purchasing Drugs and allied items can be purchased by • Bidding from manufacturer or whole sellers – Pharmacist estimates drug usage for a given period – Reputable manufacturer or whole sellers are invited to quote their prices for selected items – Manufacturer or whole sellers submit their quotations – The drug purchase order is hence given to the company with lowest price, yet with standard quality

• Purchase from local retail pharmacy – Costly, only in emergency situations

• Contract Purchase – Also known as prime vendor system – Contract with a manufacturer, whole seller or a company – The institution and a single manufacturer enters into a contract for supply of drug products. – Orders are facilitated using computers and emails – Provides items for small percentage fee – Provides minimum inventory and an optimum inventory rate

• Private hospitals use any of the above mentioned procedures • Governmental hospitals – Routine purchase [Public procurement regulatory authority (PPRA)], Medicine coordination cell (MCC) – Purchase section in secretariat of health department – Purchase cell advertise for prequalification notice for pharmaceutical firms, those showing interest and having accomplished the pre requisites are selected as pre qualified firms – Advertisement for bid is given in papers – And the quotation of those prequalified firms are accepted that have lowest price and acceptable quality

Public Procurement Regulatory Authority

The Public Procurement Regulatory Authority is an autonomous body, with the responsibility of prescribing regulations and procedures for public procurements by Federal Government owned public sector organizations

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Objectives of Procurement

•Economy (Value for money) •Efficiency •Transparency •Accountability •Competitiveness •Fairness

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PROCUREMENT PROCESS INVITATION FOR BIDS ( BY ANY DEPARTMENT) THROUGH ADVERTISEMENT

• Name of the Procuring Agency/Department • Availability of Bidding Documents @ given address, Date & with non-refundable Fees • Bidding Process:  Single Stage (Two Envelop) 28 June 2020

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SCOPE OF BID:

“Any Department (Procuring Agency) invites Bid for Supply of Medicines & Surgical Items as Specified in the Schedule of Requirements along with Technical Specifications.”

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ELIGIBLE BIDDERS • BID is open to all:  All Manufacturers  Sole Agents of Foreign Principals/Importers “Valid Authorization/Distribution from Manufacturer”  NOTE; (Already Pre-qualified by the Department for the Fiscal Year 2018 & 2019) 28 June 2020

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CORRUPTION & FRAUD “Indulgence in corrupt & fraudulent practices is liable to result in the rejection of Bids, Cancellation of contracts & blacklisting of the Bidder for a stated & indefinite period of time”

COST OF BIDDING “The Bidder shall bear all costs associated with the preparation & submission of its Bid, the Procuring Agency shall in no case be responsible or liable for those costs in any case” 28 June 2020

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BIDDING FOR SELECTIVE ITEMS • •

A Bidder can choose selective items from the list A Bidder is also @ liberty to bid for all required items NOTE; Bidder’s can not bid for Partial Quantities of an item, means BID MUST BE FOR WHOLE QUANTITY AS REQUIRED”

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WHAT IS SINGLE STAGE (TWO ENVELOP PROCEDURE)???????? • The bid shall comprise a single package containing (02) separate envelops.  Technical Proposal (Envelop 1)  Financial Proposal (Envelop 2) Note: The Envelops shall be marked as “TECHNICAL PROPOSAL” & “FINANCIAL PROPOSAL” in Bold & legible letters.

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• Initially envelop marked as “TECHNICAL PROPOSAL” shall be opened. • The envelop marked as “FINANCIAL PROPOSAL” shall be retained in the custody of Procuring Agency without being opened. • The Procuring Agency shall evaluate the Technical Proposal without reference to the price of medicines and reject any proposal which do not conform to the specified requirements.

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• During the Technical Evaluation no amendments in the Technical Proposal shall be permitted. • After Technical Evaluation & Approval of Technical Proposal, Financial Proposal shall be opened Publicly at given Date, Time & Place . NOTE: “REPRESENATIVES OF THE BIDDERS MAY BE PRESENT AT THE TIME FINANCIAL PROPOSAL”

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OPENING

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SAMPLES OF QUOTED DRUGS: • The Bidder shall provide samples of quoted Medicines along with Technical Bid @ his own cost in a quantity prescribed by the Procuring Agency.

• These samples will be evaluated as per technical specification laid in bid documents and will be finally approved or rejected as the case may be. 28 June 2020

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The Bid found to be the lowest evaluated in the “Financial Proposal” shall be accepted, means lowest offered price after meeting all the legal requirements & Technical specifications as laid down in the Bid document.

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• • • • •

AWARD OF CONTRACT SUPPLY ORDERS DELIVERY OF STOCK BY BIDDER WARRANTY/INVOICE PHYSICAL INSPECTION & VERIFICATION OF STOCK • TEST/ANAYLSIS OF MEDICINES BY DTL • FEES • Payments to the Contractor 28 June 2020

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• Purchasing authority – Centralised purchase • Material purchase department or its purchasing agent is responsible for purchase • In such case pharmacist requests the items to be purchased with specifications. Selection of brands and vendors are on the discrete of purchasing agent • In another system, Pharmacist can be given the authority to reject any item below standard or not complying with the specification • Pharmacist may consult PTC about the specification for drugs

• Purchase by hospital pharmacist – All the selection and purchasing procedures are carried out by pharmacist. – In this case the material purchase department is responsible for the payment

Purchasing 2

Purchasing Procedure • Purchase Order Prepared By Pharmacist – Order contains Specification, packaging, quantity needed as well as information concerning the inventory balance and anticipated monthly use.

• Forwarded to administrator for approval • After approval forwarded to purchasing agent • Upon receipt, purchasing agent prepare official purchase order. Data from previous document is utilized in this case. • A copy of official purchase order is sent to vendor, another to accounts department, and one copy for record, three copies to pharmacy for matching with the items on receipt and record. • On receiving the items, pharmacist record it.

Receiving drugs • Drugs must preferably be delivered to main pharmacy or other receiving area • Special storage area for radiopharmaceuticals and controlled drugs • If the drug items are received in main store then must immediately be sent to pharmacy without opening it. • At delivery stock must be checked against the purchase order. Any difference must be recorded along with expiry, date, batch number, manufacturer. • All unprofessional involved in receiving drugs must be trained and supervised by pharmacist. • All drugs must be arranged in stock promptly upon receipt and controlled substances must be directly transferred to safe and secure area.

Drug Storage: • Storage is an important aspect of total drug control system • Following consideration should be undertaken • Stability compatible storage – Proper storage control in terms of temperature, light, humidity, sanitation and ventilation conditions.

• Secure storage; – Storage areas must be well secured. Accessibility only to authorised personnel

• Safe storage: – Consideration to poisons and inflammables

• Segregate storage: – Radiopharmaceuticals, controlled drugs, refrigerated drugs

Store Room Arrangement • After receiving, drugs are either stored in hospital pharmacy or hospital supply storage facility, • Advantages of storage in pharmacy is Reduction in labour and record keeping and responsibility is on professional (Pharmacist) or authorised person under his supervision • Pharmacist is given the freedom for storeroom arrangement. • For arrangement, He keeps in mind inventory control, adjustment of inventory based upon prescribing trends and easy and safe access to drugs. • No definite rule of arrangement of storeroom • Depends upon local and personnel comfort • May be stocked in alphabetical order, code number sequence, separating the dosage forms.

• Each shelf, drawer or bin is numbered or identified. This helps in identification, safe dispensing and reduces medication error. • Identification by shelf stripping • Identification by floor marking •

Stock Control • Adequate stock control is required where ever drugs are stored like main pharmacy, satellite pharmacies, nursing units, OTs, PCAs, ERs etc. • Expiration dates must be monitored periodically. • For Those products agreed to be held in stocks all the times, out of stock situations must be prevented. • Method should be adopted to dispose off outdated, deteriorated, recalled, or obsolete drugs. • Record keeping procedure must be strictly followed. 31

Inventory Control Inventory is a list of goods and materials available in stock by an organization for some future use

" Inventory control is the process of managing inventory in order to meet customer demand at the lowest possible cost and with a minimum of investment ".

• If Inventory level is High – – – – –

Blocking the finance Large Storage space Large handling and Administration Charges Obsolescence (no longer wanted but in working condition) Spoilage

• If inventory Level is Low – Frequent Stock outs – High Shortage Costs

• So Balance should be there Which can be achieved by inventory control • Management consultants all agree that money invested in drug inventories should have a turn over of 4-5 times a year. • The turnover less than four indicates overstocking and a turn over of more than five may indicate under stocking • Inventory Turnover: Number of times inventory is sold or used

Objective of the inventory control • Maintain availability of material whenever and whatever required in optimal quantity • Minimize ineffective stocks • Optimize the various costs associated with inventory While keeping in mind factors of 1. Seasonal variation 2. Monitoring for pilferage 3. Changing patterns in usage/prescribing.

Disadvantages of not fulfilling the objectives of inventory control

• Pharmacy may lose business. For example, in a retail pharmacy, if a customer is unable to obtain their medication, they may go somewhere else and the pharmacy may lose future purchases. • In a hospital pharmacy, in case of run out of item: 2 possible outcomes 1. Result in lost of life 2. you might be required to obtain it by a more expensive method (over-night delivery, etc.).

Contradictory demands of inventory control

•Keeping a wide variety of stock while also maintaining a large supply that moves quickly •Increasing inventory turnover without affecting service •Maintaining minimal stock without affecting service

Methods / tools for inventory management • ABC Concept (Always Better Control) – Depends upon annual consumption and not upon unit price

• VED Concept (Vital, Essential and Desirable) – Based on importance, criticality and shortage cost of items in terms of availability, function, specification and storage

• HML Concept (High, Medium Low) – Based on unit price. Doesn't depend on consumption

• SDE Concept (Scarce(insufficient for demand), Difficult, easy to obtain) – Based on purchasing terms with respect to availability

• GOLF (Governmental Ordinary, local and foreign) – Based on source of supply

• SOS (Seasonal, off Seasonal) – Based on seasonal requirements

INVENTORY MANAGEMENT COMPUTER SYSTEMS

1. Perpetual inventory systems • method of recording the quantity of medication continuously as prescriptions are filled. After each prescription is filled and dispensed to the patient, the amount of medication used for the prescription is removed from the inventory to ensure the quantity on hand in the computer is always current. Deliveries and returns are also recorded, often automatically, as they occur. Modern inventory control systems often rely upon barcodes and radio-frequency identification(RFID) tags to provide automatic identification of inventory objects..

• In a perpetual inventory system, many pharmacies use reorder points, or periodic automatic replacement (PAR) levels, to automatically order more medication when levels are low. These points can be set in the computer system for each medication, which allows the user to set a maximum amount of medication that the pharmacy would like to have at any point in time and a minimum level that should be maintained at all times.

2.Periodic Review: This process involves regular review of usage and reorder to a carrying point. 3.Visual review

Role of Purchasing Agent • Depends upon hospital size • In small hospital an administrator, his assistant or a store keeper may function as purchasing agent • In large hospital where a lot of purchasing is carried out, a full time purchasing agent/s is required. • In relation to the drugs, purchasing agent duties may be – – – – – –

Issues purchase order Maintain purchase record Follow ups on delay order Initiates competitive bidding procedures Obtain quotation from specific source May have the power of selecting the brand and vendor

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Discount in Purchasing • Three ways in which items can be purchased at a discount or savings • Volume Contract: – Institute estimates its annual consumption of the particular products and sign an agreement with the company to purchase this amount on a contracted price which is usually less than the price for normal purchase

• Bonus Deals: – Special discount on a product – Specific Quantity of items free of cost after purchasing certain limit • Discount: – Special discount is given to an institution on prompt paying.

A hospital Pharmacist should investigate the discount policy of the firm with which he deals

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Bulk and Sterile Manufacturing

• Bulk Compounding – Mainly those drugs which are not commercially available and modified formulations intended for clinical/ investigational use

• Sterile preparation – Sterile topical solutions, Small volume injectable, I/V admixtures, TPN and special parenterals for clinical/ investigational use

Benefits • Development of a close relationship between physicians and pharmacists • Promote economy for hospital • Operation of formulary system • Making drugs available that are not commercially available • Opportunity to develop new pharmaceutical formulation • Enhancing the prestige of pharmacist

Control Systems Decision of bulk and sterile preparation in hospital depends upon certain control systems. – Manufacturing Process Control – Quality Control – Budgetary Control

Manufacturing Process Control • Responsibility of pharmacist to make a product that meet the high pharmaceutical standards. • Good manufacturing practice should be followed • Identity, strength, purity and quality control • Sufficient packaging and labelling control. • Palatability and stability should be considered

Quality Control • • • •

Validation Quality Control of Raw material Quality control of Instruments used Quality Control of Area to ensure specified pharmaceutical environment • Quality Control of Finished Product (including label)

Budgetary Control • Also called economic consideration • Regulate economic aspects of manufacturing program • Feasibility of manufacturing depends upon budget. Includes – – – – –

Manufacturing requirements Material requirements Manufacturing capacity Manufacturing staff Operating costs

• Manufacturing Requirement – Includes quantitative estimation of manufacturing frequency and the number of particular drugs to be manufactured per annum – Can be estimated in terms of rate or production volume, batch quantity or manufacturing frequency. – Depends on consumption rate

• Material requirement – The estimated manufacturing requirements provides a basis for the prediction of material requirements – Includes raw material, containers, labels, ancillary materials, boxes.

• Manufacturing capacity – Availability of particular equipment and manufacturing capacity of each equipment must be considered – Most of the times selection of equipment is based upon economy and its multiple function performed by single instrument. – Selection of such equipment which is capable of multifunction also prevent space allocation problem

• Manufacturing Staff – It is an important consideration in bulk and sterile manufacturing. – Pharmacist as supervisor and supportive personnel – Number of personnel should be optimum – Too many personnel will increase the cost of manufacturing – Too less personnel-------------

• Operating Cost It includes – Direct cost • Cost being spent on purchase of materials • Labour cost

– Indirect cost • Maintenance of machinery • Maintenance of building • housekeeping

Sterile Preparations • It requires the same controlled environment as that of bulk Manufacturing except additional stringent environmental control is needed. • Besides various control discussed environmental control is also needed.

Intravenous Additive Program • Pharmacist is responsible for – Preparation of final product under aseptic condition – Judicious choice of additive and mixing techniques to avoid interaction – Appropriate labelling

• Such products are prepared in aseptic environment using laminar flow hood

Laminar Flow Hood

Preparation of I/V additive solution • • • • •

Physician prescription order Label preparation (information on labels) Affixed upside down to the container----Why? Preparation is carried in laminer flow hood Final inspection before handing over

TPN and Cytotoxic Drugs • Preparation of TPN is the integral part of sterile preparation • Stability and compatibility • Facility and environment • Personnel and training • Documentation • Manufacturing procedures • Collection of materials and preparation • Formulation • Inspection • Labelling and packaging • Storage

Sterile supply room Central sterile supply room Central sterile supply Department

Definition “as that service, with in the hospital, catering or the sterile supplies to all departments, both to specialized units as well as general wards and OPDs.” Professional supplies : tubings, urine collection sets, IV admixture sets, needles , blood begs, Diagnostic sets like L.P set (lumbar puncture), Sternal Puncture set etc -Treatment sets like Cut down sets, aspiration set etc. -Dressing materials -OT linen & instruments -Rubber Gloves, Catheters, Special departments: clinics, special labs, operating room, burn rooms,

AIM • Centralizing the activities of receipt, cleaning, assembly, sterilization, storage and distribution of sterilized materials from a central department where safe sterilization is done under controlled conditions with adequate managerial and technical supervision at an optimum cost. • To provide an efficient, economic, continuous and quality supply of sterilized material to various areas of the hospital to deliver quality and infection free patient care. • Contributes to reduction in hospital infection rate • To reduce the burden of work of the nursing personnel, there by enabling them to devote more of their time to patient care .

• To provide sterilized material. • Contributing to a reduction in the incidence of hospital infection. • To avoid duplication of costly equipment. • To maintain record of effectiveness of cleaning, disinfection and sterilization process.

Functions and Activities  Rinsing  Cleaning  Drying  Checking  Sterilization  Labelling  Storage  Issue and Distribution  Receipt

Advantages  Processing issue and control  Infection free atmosphere  Economic, efficient and uniform source  Maintains standard  Reduces burden on nursing staff  Prevents cross infection  Shortens Patient’s stay  Ensures safe environment  Inventory Maintenance  Quality Care

The CSSD can broadly be classified into two parts CSSD 1) Central UniT • Responsible for receiving dirty utilities cleaning, processing, sterilization storage and supply 2) Peripheral Unit • Mainly responsible for distribution to various areas of hospital • TSSU (theater Sterile Supply unit)

Requirements

Requirement Central unit • Location • Size • Physical facility • Staffing • equipment • Water and steam supply

LAYOUT DESIGNING PRINCIPAL • There no back tracking of sterile goods • One way movement from receiving counter to issue counter • Sterile area should be prior to sterile storage and issue • The receiving counter must be away from the issue counter • Separate receiving and issuing counter There should be six basic division in CSSD • Cleaning area • drying area • Packaging area • Sterilization area • Storage • Issue counter

STRUCTURAL DSIGNING

EQUIPMENT CLEANING AREA  High capacity pass through washer disinfector at 80°C to 90° C having various shapes and sizes.  Cold and hot water streams.  Detergent Solution.  Steam when available.  Hot air ovens for drying instruments.  Wall fixtures for drying. STEIREATATION AREA  Autoclaves using dry heat, moist heat.  Ethylene oxide sterilizers.  Testing material to check effectiveness of sterilization. STORAGE AND DISTRIBUTION  Cup boards, selves, tables, chairs, racks.  Trolleys, instrument trays, wire baskets and containers.

OTHER EQUIPMENT  Cleaning and decontamination devices  Hot air Oven for drying & heat sterilization  Glove processing unit for surgical gloves  Instrument sharper e.g.. Needle sharper  Testing apparatus for emergency sterilization  Others :- trolleys, work surface, telephones  Maintenance and repair of equipments  Material : chemicals for washing and cleaning  Steam Boiler

Organization and Management Administration  It is a one of the specialized sections of hospital and may or may not function under pharmacy.  So administration varies from hospital to hospital  When it is not a major department and comes under another department then its manager report to the head of that department and not to the administrator of hospital like manager of Pharmacy, OT supervisor, head of surgical department or nursing services administrator

Management control of supply room  It may function under  Pharmacist control: procurement, storage, distribution preparation of sterile solutions should be done by pharmacist so in some hospitals pharmacist is the incharge.  Nurse control: Nurse use majority of the sterilized items dispensed. Furthermore nurse has full understanding of the intended use so can logically be responsible for CSSR  Pharmacist, Nurse Dual Control: some consider functions of CSSR of dual nature  Nurse: Cleaning, packaging, and distribution of medical equipment  Pharmacist: manufacture, sterilization of sterile fluids  OT supervisor: in some hospital CSSR is not accorded a full department but is under OT supervisor. In this case no preparation of sterile fluids can be carried out.

Staffing  Personnel must be skillful and trained in the principles of sterilization, use of autoclave, identification of surgical

instruments,

disassembly,

cleaning

assembling equipment, decontamination.  Pharmacist incharge can arrange training sessions

and

Pharmacist as manager of sterile room  Pharmacist has a diversity of knowledge that enables him to perform various jobs.  Purchasing of supplies

 Receiving and storing of supplies  Dispensing and distribution  Charging, inventory and accountability  Manufacturing sterile fluids

CSSD • • • • • • • • • •

Transport to OT Used material Transport Cleaning Disinfection Inspection Tray assembly Packaging Sterilization Sterile storage

TPN

IV Admixture: • The preparation of parenteral admixture usually involves the addition of one or more drugs to large volume solutions such as intravenous and nutrients fluids.

Introduction: • Components of an IV program

• • • • •

Preparation area Policies and procedures Personnel Storage space Admixture systems

Cont’: Components of an IV program Preparation area • Ideally in separate room in the pharmacy “clean room” • Size vary

Cont”: Components of an IV program Polices and procedures • Guidelines for preparing parenteral products should be outlined in the pharmacy’s policy and procedure manual. • Detailed information regarding preparation, labeling, storage and expiration dating of parenteral products should be readily available in the pharmacy • These policy help to provide quality control for the parenteral products

Cont”: Components of an IV program Polices and procedures • Stability • stability is affected by place, environmental condition, diluent used to administer the product, other drugs that may be mixed with • Stability and sterility! Gives the expiration date

Cont”: Components of an IV program Polices and procedures  incompatibility Physical: visible change e.g. precipitation Chemical: may or not visible change, deterioration or inactivation of an active ingredient. Therapeutic: drug-drug or drug-disease interaction that lead to potentiating of drug effect, drug toxicity, deterioration.

Cont”: Components of an IV program Polices and procedures • Aseptic Technique Method of handling sterile products, a sterile parenteral dosage form is free from living microorganisms, particulate matter, and pyrogens.

Cont”: Components of an IV program Polices and procedures • Labeling and check systems Reviewed against the patient’s current medication profile.

Cont”: Components of an IV program Personnel Carefully trained Who will prepare? Pharmacist or technician Proper training in aseptic technique and sterile product information is necessary.

Cont”: Components of an IV program Storage space Will depend on the type of system one chooses to use.

Aseptic Dispensing

Total Parenteral Nutrition • A method of feeding patients by infusing a mixture of all necessary nutrients into the circulatory system thus by passing the GIT • It is also known as artificial nutrition or parenteral alimentation

• Categories of PN – If enteral feeding is completely stopped or ineffective then total PN is used – If the enteral feeding is not enough or sufficient then partial PN is used

• Indications of Parenteral Nutrition • General: if a well nourished adult is starved for 7-10 days, then partial PN is accepted, but when starvation exceed 10 days, then TPN is used • Short Term: Bowel injury, Major trauma, burns, malabsorption, malnutrition • Long term: TPN’s indicated for long terms due to crohn’s syndrome, Bowl resection

• Composition of TPN – Macro components • Carbohydrates • Lipids • Proteins

– Micro components • Vitamins • Electrolytes • Trace elements

TPN in Hospital Pharmacy • TPN is a part of total care of any patient • Therefore the preparation of TPN must be an integral part of hospital pharmacy manufacturing program irrespective of its size • Its method of preparation are simple so does not require any extensive budget or equipment • Prepared in controlled environment like…… • Pharmacist should have knowledge of preparation method, stability and compatibility, facilities, equipment and environment required for TPN preparation

• Stability and Compatibility • As TPN is a mixture of complex pharmaceutical systems (specially lipids), there is a chance of interaction or incompatibilities between the ingredients, leading to impaired therapeutic value or increase risk for its toxicity to the patients • pharmacist must have knowledge about the incompatibilities between ingredients, so can advise physicians accordingly, and the available literature must be consulted prior to the preparation • Facility and environment • As with other aseptic processes, environment can effect the quality of TPN, so the facilities must thus be designed, cleaned, maintained and monitored to the highest achievable standards. For this purpose laminar flow hoods are used.

• Personnel and Training – Personnel having suitable training should carry out aseptic preparation of TPN. – It covers aseptic techniques, and validation, and theoretical aspects like patient’s requirements and use of products

• Documentation – Complete documentation of the patient history, labels details, raw material records, environmental record, preparation records all according to GMP

• Manufacturing procedures/ guidelines – Should be prepared by production and QC staff. – All personnel should adhere to these guidelines.

• Preparation is initiated on receipt of the request for TPN. After checking the feasibility and stability of the requested combination, information can be then transferred to dispensing area

• Formulation and preparation – Firstly identification and collection of required materials and then assembling in aseptic condition – Checked against the request sheet and prepared accordingly in laminar air flow – Care should be taken when more than one TPN’s are under process.

• Inspection – The nutrition beg should be checked for leaks, splits, and particulates.

• Labelling Patient name ward Batch (dispensing number) Storage conditions

product constituents expiry date/time

• • • •

Storage Packaging Dispensing Charging of TPN (according to the cost of ingredients)

CYTOTOXIC

Cytotoxic agents • Substances used in the treatment and control of malignant and other diseases. • They are designed to destroy/killing rapidly growing cancer cells • Most of the injectable cytotoxic agents are powdered preparations that needs to be reconstituted before use. – Chemotherapy: the use of any chemical agent to treat or control a disease. Most often used to describe treatment of malignant and other diseases with cytotoxic agents – Antibiotics: obtained from life (naturally) and used against life (microorganisms) – Chemotherapeutics: obtained artificially and used against microorganism – Mutagenic: capable of causing damage to genes – Carcinogenic: Capable of causing cancer – Teratogenic: Capable of causing foetal damages either physiological or anatomical

• Symbol of cytotoxic materials

General considerations • All medical, nursing and pharmacy personnel must ensure that they are familiar with the proper guidelines involved in handling transport, preparation, administration or disposal of waste of any cytotoxic agent • All personnel involved in the handling, transport, preparation or disposal of cytotoxic agent should have access to health monitoring staff • The handling, preparation, storage or disposal of cytotoxic agents are consistently lined with adverse health risks and these adverse health risks may be reduced by implementation of suitable safety precautions

Role of Pharmacist • Pharmacist can provide a cytotoxic reconstitution service • Due to his background of pharmacy, he is the one in handling cytotoxic agents • Should be well trained in aseptic techniques. • Provide a safe and efficient service for dispensing of cytotoxic agents

• Safe handling • As these agents are non selective generally and destroy some healthy tissue as well, thus personnel handling the drugs may be at risk if sensible precautions are not taken. • Exposure for short time can cause irritation, dizziness, nausea and allergic reactions. • Exposure for prolong period of time may have risks of malignancies, leukaemia's, teratogenesis, and infertility. • Exposure can be minimised by following strict safety procedures.

• Preparation • All cytotoxic agents should be prepared by oncology pharmacy • Use separate laminar flow hood. Avoid horizontal LFH. • Proper ventilation of the area but windows and doors should be closed. • Working surface should be non porous and easily cleanable. • Equipment and cytotoxic drugs should be properly and separately stored. • Neutralizing solutions should also be close to hand. • Preparation and dispensing must be in accordance with the country rules and regulations • Proper dressing should be followed. • Use of solid non porous surface or use of large tray in laminar flow hood. • Preparations will be packaged as required for direct administration to the patient and shall not be further modified • All cytotoxic agents should be labelled with cytotoxic symbol

• Packaging • Packaged in sealed, leak proof containers, with outer bags, heat sealed where possible. The container should protect the agent from breakage in transport, • Transport of cytotoxic agents • Transported in sealed inflexible containers resistant to breakage. The containers should be labelled with the sign and should be returned to pharmacy after use • Storage • Clearly marked storage areas must be available for all cytotoxic agents. Safe storage areas must be designed to minimize the risk of breakage. Cytotoxic agents must not be stored in food storage and preparation areas

• Spills and Disposal • Detailed procedures for coping with spills and waste disposal must be distributed to all staff handling cytotoxic agents. • IV admixture sets, syringes, and other contaminated materials should be placed in high risk waste containers and labelled as hazard. • Control of Substances Hazardous to Health (COSHH)

Spillage • Chemical spillage is defined as the uncontrolled release of hazardous chemicals which may be solid, liquid or gas. • Worksite measure to reduce the potential for spills and plans for responding to chemical spillage is necessary regardless of the type or quantity of hazardous chemical. Preparations for chemical spillage include safety equipment for spills and emergency procedures.

Cytotoxic Spill Management Procedure The following step is recommended for dealing with cytotoxic spill using a spill kit. a. Notify surrounding personnel of the spill. b. Open the spill kit and display the warning signage while isolating the spill area. c. Prevent the spill from spreading. d. Put on the cytotoxic gown, booties, overshoes, gloves and masks with isolation gown. e. Obtain set of pre-mix cleaning detergent and start to prepare 5% decon 90 solution by pour all amounts liquid in a bottle A to the bottle B. shake gently and 5% decon 90 solutions ready to used. f. Scoop up any broken glass. Place broken glass and any other sharp items into the sharp bin.

g. Use gauge to clean up the actual spill using 5% decon 90 solution as necessary. Repeat several times. Dispose of all waste into first cytotoxic waste bag. h. Working from the area of least contamination to the greatest clean with decon 90 solutions to remove all spillage residues and rinse the area with distilled water and dry. Repeat at least twice. i. All contaminated equipment and gauze used in the cleaning procedure must be discarded into the first cytotoxic waste bag including unused cleaning solution. Remove shoes cover and outer layer latex gloves, isolation gown and discard into the first cytotoxic waste bag.

j. Seal the bag with the plastic ties. k. Place the first bag into the second waste bag. l. Remove the cytotoxic gown, masks and remaining gloves and discard into the second cytotoxic waste bag. Seal the second waste bag with the plastic tie. m. Wash hand thoroughly. n. Notify supervisor of the spill and complete an incident report form as soon as possible. o. Obtain a replacement spill kit immediately from pharmacy services.

NURSING HOMES

Kinds of Care Curative Care: • Focuses on a cure to an illness and the prolonging of life. Palliative Care: • Focuses on comfort and quality of life that may be provided with other treatments. Hospice Care: • Focuses on comfort and quality of life when a cure is not possible with specialize care and services.

When a patient’s disease process is no longer curable or reversible, aggressive curative treatment begins to be less appropriate and may be considered harmful. Hospice philosophy emphasizes palliative care, which can be as aggressive as curative care, with a focus on comfort, quality of life, and patient-/family-directed care that promotes the patient’s right to self-determination and decision-making. Curative care: Focuses on quantity of life and prolonging of life. •Curative care can actually cause more suffering when cure is no longer possible and treatments and procedures needlessly extend the period of suffering. •Quality of life is often elusive if a patient is subjected to treatments and interventions that he/she did not choose, such as respirators, intravenous infusion and tube feedings. •Within the hospice philosophy, patients are encouraged to complete advance directives. patients’ choices regarding resuscitation measures and curative treatments are respected and honored by hospice. Palliative care: Focuses on quality of life and death, and views death as a natural part of life. •Palliative care is a lessening and relief of physical, psychosocial and spiritual suffering so that the patient can accomplish his/her goals and life-closure tasks. •Closure tasks may include saying goodbye, letting go, finding meaning and value in life and death, and mending relationships. •Control and management of physical, emotional, psychosocial and spiritual pain and suffering and other end-of-life issues are paramount. •Determining specific things that bring quality of life to each patient Hospice care: The most intensive comfort care available that focuses on quality of life; generally intended for the final months of life when a patient with a terminal illness decides to forgo other treatments for that disease. •Questions?

Role of Pharmacist in Small Hospitals and Nursing Homes • NURSING HOME: – A residential facility for people with chronic illness or disability. – Also known as a convalescent home and long term care facility – includes adults who suffer from chronic (longlasting) or such illnesses as stroke or Alzheimer’s disease . – both medical and residential care is provided.

• Methods of handling drugs in hospitals without pharmacist: – Most extended care facilities and small hospitals do not employ full time pharmacist, many of them contract for such services. – Medical staff rely upon community pharmacist to dispense medication from local pharmacy and deliver the facility . – Pharmacy service in small hospital may be provided by department of pharmacy of a nearby large hospital

• Extended care facility and pharmacy department : – If extended care facility has pharmacy department a licensed pharmacist is employed to administrate pharmacy department. – If no pharmacy depart. Then obtaining required drugs & biologicals from community pharmacist

• If facility has only drug room where bulk drugs are stored consultant pharmacist is responsible for control of bulk drugs • Consultant pharmacist dispenses drug from drug room properly labelled and make them available for nursing personnel.

• Small-large hospital relationship: – Sharing of departments like • Pharmacy • Radiology • Pathology

– Services are provided by the pharmacist on call in large hospitals.

• Roles of pharmacist in ECF:: – Drug regimen review : • encompasses the clinical activities of consultant pharmacist • Drug regimen must be reviewed at least monthly by pharmacist • patients drug regimen should be free from unnecessary drugs. • Any irregularity found during review must be reported to physician and director of nursing. • Examples of irregularities include • Use of three or more analgesics at a same time • Use of iron therapy without red blood cells assessment • Concurrent use of two or more hypnotics

• Pharmacist should check the medication order. – appropriate medication order includes drug, dose, route of administration, frequency and reason of use.

• Medication error and ADRs: – The consultant pharmacist should report and document any drug irregularities, drug interaction and clinical recommendations promptly to the attending physician or nurse-in-charge and the nursing home administrator. – Drug interactions, including interactions between prescription drugs and over-the-counter drugs, drugs and disease, and interactions between drugs and nutrients. – Contraindications and precautions.

• Medication pass observation: – To observe the preparation and administration of medication – Compare medication label with medicine administration sheet – Ensure drug dose, time – 5 RIGHTS(resident, drug, dose, time and route) – Adequate hydration when administering drug

• The consultant pharmacist should ensure the automatic stop order in case where duration and number of dose is not specified. • The consultant pharmacist ensures that all known allergies are documented in plain view in the patient's medical record. • Periodic inspection of nursing station medication cabinet to ensure external & internal med. Are separately placed – No outdated med.

• proper record of narcotics being administered to the patient .

• Provision of information and training • Advice to the patient regarding use of OTC products • Patient counselling for patient care and boost/builtup confidence of patients • HOSPICE CARE

Home Care

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What is meant by home Care? • Home care is a form of health care service provided where a patient lives. • Patients can receive home care services whether they live in their own homes, with or without family members, or in an assisted living facility.

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Purpose of Home Care • To promote, maintain, or restore a patient's health and reduce the effects of disease or disability.

Definition • A health service provided in the patient's place of

residence for the purpose of promoting, maintaining, or restoring health or minimizing the effects of illness and disability. 122

Frequently used terms for Home Care • The most frequently used terms for Home Care includes ; 1. Domiciliary care, 2. Social care, 3. In-home care.

123

Who can provide Home care service? • Care may be provided by licensed healthcare professionals who provide medical treatment needs or by professional caregivers who provide daily assistance to ensure the activities

of daily living (ADL) are met.

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Home Health Care Vs Home Care in USA • “Home health care" is used to describe medical services performed at home by a healthcare professional, whereas "home care" describes non-medical, private duty care.

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Aim of Home Care • Home care aims to make it possible for people to remain at home rather than use residential, long-term, or institutionalbased nursing care. Home care providers deliver services in

the client's own home.

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Professional home health services include

• Medical or psychological assessment, • Wound care, • Medication teaching, • Pain management, • Disease education and management,

• Physical therapy, speech therapy, or occupational therapy.

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Home Care Services includes; • Daily tasks such as meal preparation, • Medication reminders, • Laundry, • Light housekeeping,

• Shopping, • Transportation and • Companionship. 128

When home care is critically essential? • Home care is often an integral component of the posthospitalization recovery process, especially during the initial weeks after discharge when the patient still requires some level

of regular physical assistance.

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Activities of daily living (ADL) includes; • Bathing • Dressing • Transferring • Using Toilet • Eating

• Walking etc. that reflect the patient capacity of self care.

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Instrumental activities of daily living (IADL) • Includes daily tasks such as light housework, • preparing meals, • taking medications, • shopping for groceries or clothes, • using the telephone, • and managing money, that enables the patient to live independently in the community. 131

Worldwide Home Care Programs • Medicaid (USA) 1993 onward • Medicare (USA) 2000 onward • India Home Health Care (IHHC) in Chennai, Bangalore, Hyderabad, Pune & Gujrat in 2009.

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Home Care Services in Pakistan • Mamoo in Pakistan since 2003 in Karachi, Lahore (Teemar Dar Pharmacy).

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Home Care Services in Pakistan • Jacob Javed Home Based Patient Care Services in Pakistan since 1997

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Nuclear Pharmacy

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• A specialty area is the one that requires a concentration of knowledge in a once specific area. • The development of nuclear pharmacy as a specialty area followed the development of nuclear medicine as a recognized specialty by the American Medical Association in the early 1970's. 136

• Nuclear Medicine A specialty of medicine and medical imaging that uses radiopharmaceuticals in the diagnosis and treatment of diseases.

137

• Nuclear Pharmacy A specialty area of pharmacy dedicated to the receiving, preparation, quality control, storage, compounding and dispensing radiopharmaceuticals. Also deals with the disposal of radioactive wastes and documentation Nuclear pharmacy is a service to improve and promote health through safe and effective use of radiopharmaceuticals for diagnosis, therapy and palliation. Some time it is called radio pharmacy

138

What are the applications of Radiopharmacy? 1.

Diagnostic

– The radiopharmaceutical accumulated in an organ of interest emit gamma radiation which are used for imaging of the organs with the help of an external imaging device called gamma camera. 2.

Treatment – They are radiolabeled molecules designed to deliver therapeutic doses of ionizing radiation to specific diseased sites.

3. 4.

Palliative Research 139

Operation of a Nuclear Pharmacy

1. 2. 3. 4. 5. 6. 7.

Receiving of radioactive materials Preparation of radiopharmaceuticals Quality control tests of radiopharmaceuticals Storage Dispensing Radioactive waste disposal Infectious waste disposal 140

Receiving radioactive materials • Delivered directly to nuclear medicine department or nuclear pharmacy (short halflives) • Packages should be monitored within 3 hr if delivered during normal hours • Packages should be monitored within 3 hr from the beginning of the next working day if delivered after working hours

Preparation of radiopharmaceuticals • Only trained people should be responsible for and participate in the preparation • Aseptic technique • Lead barrier shields (Adequate shielding must be used to protect laboratory personnel from ionizing radiation.) • Syringe shields • Leaded gloves, aprons, and eye glasses should be worn • Quantity • Radiopharmaceuticals should be identified with a label containing the information as to the total activity concentration

Radiation •

shielding

Alpha and beta radiations are readily shielded because of their limited range of penetration.

Radiation

Protection

Alpha particles

Piece of paper •Mono-energetic and have a range of a few centimeters in air

Beta radiation

•Aluminum •Glass •Transparent plastic materials

Gamma radiation

•Lead •Tungsten

Radiation Alpha Particles Piece od paper Mono-energetic and have a range of a few centimeters in air. Beta radiation Aluminum Glass Transparent plastic materials Gamma Radiation Lead Tungsten

Quality Control Tests of Radiopharmaceuticals • Before dispensing for humans • Colloidal and macro-aggregated preparation should be checked for particle size. • Workstations and their environment should regularly be monitored with respect to aseptic quality.

Quality control tests of radiopharmaceuticals • Visual Inspection of Product - Visual inspection of the compounded radiopharmaceutical shall be conducted to ensure the absence of foreign matter - Assessment of Radioactivity -The amount of radioactivity in each compounded radiopharmaceutical should be verified and documented prior to dispensing, using a proper standardized radionuclide (dose) calibrator.

Storage • Should be properly stored to prevent degradation by light or temperature • Must be stored in lead containers or behind lead shields

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Dispensing • Starts with a prescription • Prescription should contain 1. 2. 3. 4. 5.

Patients name Identification no. Age Date time Physician signature

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Radioactive waste disposal • Syringes, vials containing residual activities, needles, contaminated papers, liquid waste • According to guideline 1. Decay in storage 2. Release into a sewerage system 3. Transfer to an authorized recipient (disposable facility) 4. Others (incineration and atmospheric release of radioactive gases) 148

• • • •

•

For soluble radioactive materials in water Disposed quantity should not exceed the limits of the maximum permitted concentrations (MPCs) Flow rate of water Number of radionuclide

•

Radionuclides that have lives less than 120 days usually are disposed of by this method Radio active should be stored separately according the similar half lives

• •

For long-lived radionuclide They bury or incinerate at approved sites and facilities

King Saud University

149

Infectious waste disposal • Should be stored in puncture resistant, leak resistant bags or containers • Should be labeled with international biohazard symbol • Storage period

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• Biohazard Sign Ionizing radiation Radiation Danger High Level Source Non Ionizing radiation

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organisation • Speciality Part of hospital pharmacy – Performs under the direction of pharmacy director.

• Or • Section of nuclear medicine department – function under the head of NMD – Radio pharmacist will be the incharge of radiopharmaceuticals

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RADIO 2

Discriminatory features of radiopharmaceuticals

• •

• • • •

Difference from ordinary pharmaceuticals Presence of radioactivity Scarcity of pharmacologic effect – Do not produce pharmacologic effect due to very minute quantity Having short half life – Expiry would be monitored Route of administration Dose measurement in terms of radioactivity rather than mg or ml Practice regulation – Practice requires NOC from PAEC 154

• Diagnostic – Gamma rays – Gamma energy between 100 KeV and 200 KeV – Examples technetium-99m, iodine-123, indium-111, thalium-201 and gallium-67 • Therapeutic – Beta particles – Energy 0.5-1.0 MeV. – Half life is long for several days – Iodine-131, Phosphorus-32 • Palliative – Strontium-89 and Phosphorus-32

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Basic requirements for radio pharmacy • Licensure • Radioisotopes can only be used by duly licensed individuals in premises complying with the requirements of Atomic energy regulations • Medical isotope committee for evaluation of all proposals for research, diagnostic and therapeutic uses of isotopes 156

• Facilities • •

• • • •

– Space Adequate space matching with the scope and services required Nuclear pharmacy area shall be separated from the pharmacy and non radioactive drugs. Secure from unauthorised persons Radioactive storage, product decay area, compounding and dispensing, QC and office area Floor plans to be approved from PAEC – Equipment Minimum equipment required – Isolators or LFH – Fume hood for fume generating radiopharmaceuticals – Dose calibrator – Refrigerator (Lead Lined) – Class A prescription balance – Single or multiple channels gamma scintillation counter – Microscope – Radiochemical hood and filter system 157

• Nuclear Pharmacist • • •

•

Not a legal requirement in Pakistan Should have knowledge and training in Radiopharmacy – Elementary aspects of structure of matter – Mode of radioactive decay – Technology and QC – Application of radiopharmaceuticals – Distribution and inventory control – Research methodology – Safe handling – Production – Formulation and uses Instrumentation – Principle of radiation detection and detector – Dose calibrator – Gamma well counter – Fundamental concepts of mathematics and computer science – Compartmental analysis and mathematical models of physiological systems

158

Radioisotope Committee •

Established for supervision and control of hospital isotope program. – Medical Physicist – Radiologist – Haematologist – Surgeon – Representative from administration – Pharmacy – Nurse

• Responsibilities • •

• • •

Review and approval of the use of isotopes within the institution Prescribe special conditions like training of personnel, designation of limited area of use, disposal methods Receive reports from the radiation protection officer and review records Recommend remedial action when an individual fails to observe protection recommendations, rules and regulations Keep record of actions taken in approving the use of isotopes 159

Role of Pharmacist • Responsibilities include • Ordering, receiving and keeping the record of all radioactive materials and cold kits • Labelling and dispensing of kits • Implementation of cGRP. • Radiation monitoring in the area • Implementation of radiation protection and safety policy • Performing all QC tests on RPs • Support research and participate in research • Training to the technologists on pharmaceutical aspects of nuclear medicine, radiation and protection 160

• Refers to location, physical space, temperature and environmental control, equipment and their space allocation and furnishing of a particular service • The plant facilities and equipment in hospital pharmacy must comply with the rules and regulations of that country • Two types of planning is carried out • Master planning: dictates goals and objectives • Functional planning: sets forth the operational demands (architectural design, control environment, plumbing and finishing) and equipment planning • Pharmacist can guide architect regarding departmental objectives, functional and equipment planning, space needed and other requirements

Location • Location of hospital pharmacy should be so as it can conveniently provide services to many departments of the hospital. • Should be easily accessible to in and out patients • Should be located on first floor to provide services to all departments and nursing stations. May be changed in case of large hospital or when first floor is not enough. But basement is not desirable • Concept of sub-pharmacies • Satellite pharmacy in case when various clinical departments are not in close vicinity • Comes Under main pharmacy and staffed with a pharmacist. • Number depends upon diversity of clinical services and distance from main pharmacy

Floor Space • Allocation of space depends upon number of beds and work load. • Now a days due to varied services depends mainly on different functions like unit dose dispensing, compounding bulk and sterile, drug information centre, clinical pharmacy program • Space requirements depends upon – Degree and scope of services – Type of equipment used – Expected future expansion

• Separate Floor space is required for the following areas • Clean-up area – Demanded for compounding and manufacturing – May be shared with pharmacy sterile services – Desirable features are appropriately located pass through windows and floor area with floor drain

• Non sterile mixing and filling room – Mixing and filling of liquids separated from ointments – Beside mixing and stirring, weighing, measuring, homogenization, filtration and filling should also be carried out

• Pre-packaging area – For oral solid dosage forms

• Injection reconstitution area – Addition of water for injection for powder injectable. – Laminar Flow Hoods

• Labelling and inspection room – Located adjacent to filling areas separated by pass-through windows (eliminate premature use). – Sufficient storage space must be available for labels, printing machines forms etc

• Storage of drugs and Para pharmaceuticals • Quarantine Storage area – Where manufactured or filled products are stored until declared pass by the QC tests

•

Temperature Control and Storage Facilities • Storage requirements are important for stability of drugs • Storage Temperature • Refrigerator: 2oC- 8oC • Cold Place: not exceeding 8oC • Cool Place: 8oC-15oC • Room Temperature: 15oC-30oC • Excessive Heat: above 40oC. This temperature is forbidden for some drugs. • For large hospitals a large number of refrigerators may be required. • An innovative approach is construction of cold room

Environmental Control Facility • Ventilation • Air Conditioning of Pharmacy is desirable due to – Provides ventilation even when doors and windows are closed – Use of autoclave, ovens, and steam jacketed kettles cause a hot environment – Maintain the temperature for most of the drugs

Equipment planning • Equipment planning and purchase is responsibility of administrator, pharmacist, purchasing agent and architect. • Depends upon number, varieties and per day duration of services offered. • Parameters that dictate the equipment planning – Services option: in and out patient services, bulk and sterile preparation, pharmacy education, research program, DIC, PCC, night time pharmacy services. – Choices of Internal services: delivering the order, handling I/V admixtures and controlled drugs, maintain medical profile – Workload and Work Flow: in the department – Automation: degree of automation and where it is required – Work areas: for offices, personnel – Ways of communication: telephone, faxes, internet – Environmental control requirements

• Equipment Selection Criteria • Equipment should be selected on the basis: – – – –

Efficient provision of services Affordable operating cost Requiring minimal maintenance Offering maximum safe performance

• Equipment are categorised in to • Fixed Equipment – Requiring installation and attached to the building. – Cabinets, counters, sinks, elevators – Special attention should be given to counter tops

• Movable Equipment – Not intended to be permanently fixed to the building – Balances, carts, desks, analytical equipment, mixers, furniture.

Other utilities • • • • •

Electric lighting Transport system Plumbing Floors walls