Hospital Pharmacy Course Notes PDF

Hospital pharmacy course Dr. Abdullah Saadallah 24 ،‫ تموز‬12 dr. Abduulah Saadallah 1 What comes to mind when you think of a pharmacist? What does their job involve? 24 ،‫ تموز‬12 dr. Abduulah Saadallah 2  What is Hospital Pharmacy ? Hosp...

Hospital pharmacy course Dr. Abdullah Saadallah 24 ،‫ تموز‬12 dr. Abduulah Saadallah 1 What comes to mind when you think of a pharmacist? What does their job involve? 24 ،‫ تموز‬12 dr. Abduulah Saadallah 2  What is Hospital Pharmacy ? Hospital pharmacy: is the health care service, which comprises the art, practice, and profession of choosing, preparing, storing, compounding, and dispensing medicines and medical devices, advising patients, doctors, nurses and other healthcare professionals on their safe, effective and efficient use. 24 ،‫ تموز‬12 dr. Abduulah Saadallah 4  Hospital pharmacists: Defined as professionally, legally and qualified pharmacists who have Bachelor degree in Pharmacy ( or higher) and are trained well to provide pharmaceutical care services to patients in a healthcare facility. 24 ،‫ تموز‬12 dr. Abduulah Saadallah 5 Hospital pharmacy VS clinical pharmacy? 24 ،‫ تموز‬12 dr. Abduulah Saadallah 6 Factors contributed to the growth of hospital pharmacy  Pharmacological advances led to more powerful medications that required the pharmacist’s expertise for control, distribution, and monitoring of use. 24 ،‫ تموز‬12 dr. Abduulah Saadallah 7 Objectives of a hospital pharmacy 1. To do pharmaceutical services in a professional way. 2. To ensure the availability of the right medication at the right time, in the right dose and at the minimum possible cost. 3. To serve as counseling department to patients and health professionals. 24 ،‫ تموز‬12 dr. Abduulah Saadallah 8 4. To act as a data bank on drugs utilization and pharmacokinetic aspects. 5. To manufacture drugs which are not available from outside source. 6. To implement decisions of DTC 24 ،‫ تموز‬12 dr. Abduulah Saadallah 9 Risks of hospital pharmacy practice Tens or perhaps hundreds of patients get into or admitted into the hospital every day. There is a great chance of infections transfer from patients to healthcare workers including pharmacists. The pharmacist as well as other healthcare workers should take all necessary measures to protect themselves from communicable diseases 24 ،‫ تموز‬12 dr. Abduulah Saadallah 10  Hospital and Its Organization 24 ،‫ تموز‬12 dr. Abduulah Saadallah 11  Hospital: is an institution which pools together all the health professionals, the diagnostic and therapeutic facilities and the physical facilities into a coordinated system for delivering health care to the public. 24 ،‫ تموز‬12 dr. Abduulah Saadallah 12  The first hospital established in the United States was Pennsylvania Hospital in Philadelphia, which was chartered in 1751.  Beyond the three basic essentials of human existene, the hospial has become a nesessary instrument for providing a 4th basic element for survival, Health. 24 ،‫ تموز‬12 dr. Abduulah Saadallah 13 Classification of Hospitals Hospitals can be classified in different ways 1) Based on type of service a) General hospitals: provide general care to patients with any type of illness (medical, surgical, pediatric, psychiatric, maternity,.. ) b) Specialized Hospitals: restrict the care they provide to special conditions (Cancer, psychiatric, pediatric, or maternity) c) General Specialized hospitals: provide specialized care to many types of patients 24 ،‫ تموز‬12 dr. Abduulah Saadallah 14 2) Based on length of stay a) Short-term hospital: the average length of stay of the patient is less than 30 days. General hospitals are short-term hospitals b) Long-term hospital: the average length of stay of the patient is 30 days or longer. Specialized hospitals are long-term hospitals 24 ،‫ تموز‬12 dr. Abduulah Saadallah 15 3) Based on ownership a) Government hospitals b) Nongovernmental hospitals i. Non-profit (Missionary hospitals) ii. For profit 4) Based on bed capacity Type of hospital Number of beds Small hospital 500 24 ،‫ تموز‬12 dr. Abduulah Saadallah 16 Functions of Hospitals Traditionally, the hospital’s basic purpose for existence has been the treatment and care of sick and injured In conjunction with this basic function, hospitals has been concerned with other functions The four fundamental functions of hospitals are: Patient care Teaching/education Research Public health (preventive medicine) 24 ،‫ تموز‬12 dr. Abduulah Saadallah 17 Departments  Hospitals are typically organized into medical departments  The common clinical departments are: Medical nursing Surgical radiology ENT Dentistry Pediatrics Psychiatry Ophthalmology Physiotherapy... Pharmacy Obstetrics & Gynecology *Clinical departments can have sub-specialty units 24 ،‫ تموز‬12 dr. Abduulah Saadallah 18  Hospital staff Medical staff: responsible for providing all clinical services to patients Administrative staff/Supportive staff: support the medical staff by availing all necessary resource for clinical service 24 ،‫ تموز‬12 dr. Abduulah Saadallah 19  Hospital Pharmacy and Its Organization 24 ،‫ تموز‬12 dr. Abduulah Saadallah 20  Hospital pharmacy is that division of the hospital in which all hospital pharmaceutical services are delivered by qualified, competent professionals. Selection/quantification Procurement Storage Distribution Compounding/manufacturing 24 ،‫ تموز‬12 dr. Abduulah Saadallah 21  Promotion of rational prescribing Dispensing Provision of drug information Pharmaceutical care TDM Research Education/training Public health services 24 ،‫ تموز‬12 dr. Abduulah Saadallah 22  Historical background 1752 Pennsylvania hospital Professional recogonition 1940 ASHP 24 ،‫ تموز‬12 dr. Abduulah Saadallah 23  Functions of Hospital Pharmacy 1. Purchasing 2. Inventory Control 3. Drug Distribution 4. Manufacturing bulk and sterile 5. Ancillary Products 6. Clinical Pharmacy Services 7. Research and education 24 ،‫ تموز‬12 dr. Abduulah Saadallah 24 Functions of Hospital Pharmacist 24 ،‫ تموز‬12 dr. Abduulah Saadallah 25  Physical (premises) organization 24 ،‫ تموز‬12 dr. Abduulah Saadallah 26  Location and layout of hospital pharmacy  The pharmacy should be located in the ground floor, easily accessible to all departments.  Branch of the pharmacy may be established in or near the OP block.  OP pharmacy should have enough place for waiting pts and suitable seating arrangement shall be provided.  Preparation of stock mixtures and dispensing areas should be adjacent 24 ،‫ تموز‬12 dr. Abduulah Saadallah 27 Considerations in designing the pharmacy: 1) The pharmacy must be located, so that it is -accessible to the OP department -convenient for dispensing and 2) Traffic within the department must be economical and flexible. 3) Its size is determined by its organization and operational policies. 24 ،‫ تموز‬12 dr. Abduulah Saadallah 28 4) Provision for security of dangerous drugs and narcotic drugs must be ensured. 5) Provision for control of fire must be ensured, as many inflammable substances are stored there 6) The corridors must allow easy turning of wheeled vehicles. 24 ،‫ تموز‬12 dr. Abduulah Saadallah 29 ❖Location of the H. pharmacy : 1) Centric: to provide services to all wards equally. 2) Multiple pharmacies : More than one pharmacy in the hospital and each serves a ward or a group of wards in the hospital e.g. in-patient pharmacy, out- patient pharmacy, emergency pharmacy, operation pharmacy, etc. ❖Size (Area) of H. pharmacy The pharmacy must have adequate space, equipment, and supplies for the professional and administrative missions of the pharmacy. 24 ،‫ تموز‬12 dr. Abduulah Saadallah 30  The area of the pharmacy depends on number of beds (inpatients) 24 ،‫ تموز‬12 dr. Abduulah Saadallah 31 ❖Interior design: Essential separated sections in the H.PHARMACY ✓Administrative office ✓Bulk store ✓Locker of controlled drugs ✓Refrigerator area ✓Preparation area : Non-sterile area , Sterile area, Radiopharmacy, Cyto unit ✓Dispensing area : In-patients , Out-patients ✓Emergency medications area ✓Drug information center ✓After-hours (Shift) area ✓Sanitary toilet ✓Document archive 24 ،‫ تموز‬12 dr. Abduulah Saadallah 32 ❖Personnel organization in H. Pharmacy There are a number of staff working in the pharmacy and each has a specific occupation and missions. The three groups of staff include: 1) administrative staff, 2) professional staff and 3) support staff. 24 ،‫ تموز‬12 dr. Abduulah Saadallah 33 24 ،‫ تموز‬12 dr. Abduulah Saadallah 34 Drug and Therapeutics Committee and Formulary system 24 ،‫ تموز‬12 dr. Abduulah Saadallah 35 ❖Drug and therapeutics committee (DTC): Means a group of health professional that advice on matters related to drug management Represents the official organizational line of communication and liaison b/n the medical & pharmacy staffs. Assists in the formulation of broad professional policies relating to drugs in institutions, including their evaluation, selection, procurement, storage, distribution and safe use 36 Role & purposes of the committee (DTC) 1. Establishing of policies and protocols of medication use in the hospital including the Hospital formulary. 2. Selecting of medications in the hospital based on i. Disease prevalence ii. Efficacy iii. Safety iv. Economic (cost effectiveness) 3. Preparation and implementation of budget for medications purchase 24 ،‫ تموز‬12 dr. Abduulah Saadallah 37 4. Enforcing national standard protocols of treatment 5. Approve evaluation, selection, and therapeutic use of drugs in hospitals. 6. Establish and update the ― Hospital formulary‖ 7. Educational. The committee recommends or assists in the formulation of programs designed to meet the needs of the professional staff (physicians, nurses, pharmacists, and other health-care practitioners) for complete current knowledge on matters related to drugs and drug use 24 ،‫ تموز‬12 dr. Abduulah Saadallah 38  Organization of DTC DTC shall be established at regional, zonal/woreda and health institution levels. DTC established at hospital level shall have the following members: Medical director – Chair person Head of the pharmacy section – Secretary Head of the nursing section – member Heads of no less than 4 departments- member Head of administration & finance section – Ex-officio member 39  Members and operation of the committee 1. The usual number of members is between 7-15. The members include: Physicians : a senior one from each ward ; at least 3 senior physicians The chief hospital pharmacist A senior nurse The hospital manager A member of quality assurance department 2. The chairman of the committee is one of the physician 3. The chief pharmacists works as secretary. He/she prepare the agenda of meeting is prepared and keeps the all meeting records 4. The committee meet periodically at least 6 times a year 5. The decisions & recommendations of the committee are obligatory to healthcare professionals in the hospital 24 ،‫ تموز‬12 dr. Abduulah Saadallah 40  Formulary services Formulary system: Is a method by which the medical staff of an institution, working through the DTC, evaluates and selects from among the numerous available drugs those that are considered most useful in patient care. Is an important tool for assuring the quality of drug use and controlling its cost. 41  Encompasses drug selection, drug utilization review, and other tools to promote best practice in prescribing, dispensing, administration of drugs and monitoring of outcomes. 42  Benefits of an effective formulary system A) Approved and efficacious drugs that all practitioners will have available for use: Only the most effective and safe products Drugs that have been evaluated systematically Drugs that are chosen and approved to treat the diseases of the region or country Physicians develop greater experience with fewer drugs 43 B) Drug therapy at lower cost Ineffective, high-cost drugs will not be available Availability of most effective drugs leads to improved outcomes and lower cost Reduced inventory cost 44 C) Consistent supply of drugs Regulating the number of drugs will improve procurement and inventory management Essential drugs will be available from many sources at competitive price 45  Selection criteria must be explicit and include: Efficacy Safety Quality Cost Make sure that drugs are consistent with national and regional formularies and STG. 46  Formulary: Is a list of drugs with associated information about each drug that are considered by the professional staff in health setting to be the most useful for patient care. 47 The primary objectives of formulary: Information on the drugs approved for use Basic therapeutic information about each drug Information on organizational policies and procedures governing drugs and their use Special information about drugs 48  List of formulary drugs are placed -alphabetically and/or therapeutic category The drug information section includes: Generic name DF(s) and strength(s) Indications, contraindications, precautions, side effects Dosage schedule Drug interactions 49  Supplementary information for drugs includes: Price regulatory category Storage guidelines Patient counseling information Labeling information Brand names and synonyms Other relevant drug information 50 7/12/2024 A. Saadallah 51 7/12/2024 A. Saadallah 52 Maintaining a formulary: Evaluate new drug requests and deletions Systematic review of therapeutic groups/classes on regular basis 53  Steps to add or delete a new drug: Physician or Secretary pharmacist Written request of DTC Drug literature evaluation Transparent DTC Written report; decision making meeting formulary recommendations Information disseminated Request approved/rejected 54 Criteria for evaluating and selecting drugs for the formulary: Disease patterns Efficacy Safety Quality Cost Well known drugs Health system personnel, expertise and equipments available to manage the drug Financial resources available to buy the drug 55 Stack management and control ❖Purchasing process Direct Purchasing Drug Wholesaler and Prime Vendor Purchasing Borrowing Pharmaceuticals ❖Receiving process RECEIVING PHARMACEUTICALS STORING PHARMACEUTICALS 24 ،‫ تموز‬12 dr. Abduulah Saadallah 56  Direct purchasing from a manufacturer involves the execution of a purchase order from the pharmacy to the manufacturer of the drug. A purchase order is a document, executed by a purchaser and forwarded to a supplier that is considered a legal offer to buy products or services. It usually indicates descriptive information, such as the item description, package size, desired quantity, and listed price. 24 ،‫ تموز‬12 dr. Abduulah Saadallah 57 ❖The advantages of direct purchasing include: not having to pay handling fees to a third-party wholesaler, The ability to order on an infrequent basis (e.g., once a month), and a less demanding system for monitoring inventory. ❖Some disadvantages include the following: a large storage capacity is needed; a large amount of cash is invested in inventory; the pharmacy’s return/credit process becomes more complicated; and staff resources required in the pharmacy and accounts payable department to prepare, process, and pay purchase orders to more companies are increased. 24 ،‫ تموز‬12 dr. Abduulah Saadallah 58  The wholesaler (also known as distributor) usually operates a large-scale warehouse in various geographic regions. They exist to help bring pharmaceutical products closer to the market, better meeting its dynamic demands. This helps local pharmacies buy in smaller quantities and receive drugs in a more timely manner (i.e., often same day or multiple times per day), as opposed to ordering products directly from the manufacturer, in which case shipping and product delivery may take many days. 24 ،‫ تموز‬12 dr. Abduulah Saadallah 59  Drug Wholesaler and Prime Vendor Purchasing: Purchasing from a drug wholesaler permits the acquisition of drug products from different manufacturers through a single vendor. These wholesaler services result in the following advantages: More timely ordering and delivery Less time spent creating purchase order Fewer inventory carrying costs Less documentation, analytics and reporting capabilities Computer-generated lists of pharmaceuticals purchased 24 ،‫ تموز‬12 dr. Abduulah Saadallah 60  Borrowing Pharmaceuticals there are times when the pharmacy must borrow drugs from other pharmacies. Borrowing or lending drugs between pharmacies is usually restricted to emergency situations and limited to authorized staff. 24 ،‫ تموز‬12 dr. Abduulah Saadallah 61  Some pharmacies follow a policy that dictates the person who receives pharmaceuticals cannot be the person who orders them. This process is especially important for controlled substances because it effectively establishes a check in the system to minimize potential drug-diversion opportunities. The receiving process begins with the verification of the boxes containing pharmaceuticals delivered by the shipper. first verifies that the name and address on the boxes are correct and that the number of boxes matches the shipping manifest. Products with a cold storage requirement (i.e., refrigeration or freezing) should be processed first. 24 ،‫ تموز‬12 dr. Abduulah Saadallah 62 RECEIVING PHARMACEUTICALS Receiving personnel play a critical role in protecting the pharmacy from financial responsibility for the following: Products damaged in shipment Products not ordered Products not received 24 ،‫ تموز‬12 dr. Abduulah Saadallah 63 RECEIVING PHARMACEUTICALS Products with a cold storage requirement (i.e., refrigeration or freezing) should be processed first. The next step of the receiving process entails checking the newly delivered products against the receiving copy of the purchase order. The name, brand, dosage form, size of the package, concentration strength, and quantity of product must match the purchase order. Once the accuracy of the shipment is confirmed, the person receiving the shipment generally signs and dates the purchase order copy. 24 ،‫ تموز‬12 dr. Abduulah Saadallah 64 RECEIVING PHARMACEUTICALS At this point, the expiration date of products should be checked to ensure that they meet the department’s minimum expiration date requirement. Frequently, departments will require that products received have a minimum shelf life of 6 months remaining before they expire. Otherwise, the products may expire before use and have to be wasted 24 ،‫ تموز‬12 dr. Abduulah Saadallah 65 The Storing Process Depending on the size and type of the pharmacy operation, the product may be placed in a bulk, central storage area or into the active dispensing areas of the pharmacy. In any case, prior to placement of received items into stock, the expiration date of the product should be compared with those products currently in stock. Products already in stock that have expired should be removed and appropriately segregated. Products that will expire in the near future should be highlighted and placed in the front of the shelf or bin. This is a common practice known as stock rotation. 24 ،‫ تموز‬12 dr. Abduulah Saadallah 66  The newly acquired products will generally have longer shelf lives and should be placed behind packages that will expire before them. Stock rotation is an important inventory management principle that encourages the use of products before they expire and helps prevent the use of expired products and waste. It is safe to assume that the first-in, first-out method of inventory management is applied when it comes to pharmaceutical products. FIFO & FEFO system 24 ،‫ تموز‬12 dr. Abduulah Saadallah 67  All stock should be organized and stored at temperature and humidity levels recommended by manufacturers and defined by The United States Pharmacopeial Convention (USP). Periodic checks of refrigeration and other storage areas should be conducted to ensure they fall within recommended ranges. 24 ،‫ تموز‬12 dr. Abduulah Saadallah 68 Storage conditions: Storage conditions can be arranged in two classes: 1. Normal storage conditions 2. Special storage conditions a. Cold storage conditions b. Combustible /flammable c. Secured 7/12/2024 Abdullah Saadallah 69 Normal storage conditions It’s Storage in dry, well-ventilated premises at temperatures of 15–25°C or, depending on climatic conditions, up to 30 °C. Extraneous odors, other indications of contamination, and intense light must be excluded. Medicine products that must be stored under defined conditions require appropriate storage instructions. Unless otherwise specifically stated (e.g. continuous maintenance of cold storage) deviation may be tolerated only during short-term interruptions, for example, during local transportation. 7/12/2024 Abdullah Saadallah 70 The use of the following labeling instructions is recommended: On the label Means:- “Do not store over 30 °C” from +2 °C to +30°C “Do not store over 25 °C” from +2 °C to +25°C “Do not store over 15 °C” from +2 °C to +15°C “Do not store over 8 °C” from +2 °C to +8°C “Do not store below 8 °C” from +8 °C to +25°C 7/12/2024 Abdullah Saadallah 71  Unless special storage conditions are stated, it is vital that medicines be stored in a dry, adequately ventilated shady and cool store room. Free air circulation by opening windows, using fans or air conditioners can be considered to reduce the effects of humidity. 7/12/2024 Abdullah Saadallah 72  Some products are photosensitive and will be damaged if exposed to light. ❖To protect products from sunlight: Shade the windows or use curtains, if they allow the passage of direct sunlight Keep products in intact cartoon Do not store or pack products in sunlight Maintain trees on the premises around the facility to help provide shade 7/12/2024 Abdullah Saadallah 73 ❖ Special storage conditions: a. Cold storage conditions b. Combustible /Flammable c. Secured storage conditions 7/12/2024 Abdullah Saadallah 74 a. Cold storage conditions: Refrigerators that open on the top are more efficient than vertical ones Store products that are sensitive to freezing on the upper shelves. If there is enough space, place a few plastic bottles of water in the refrigerator!! Do not keep staff food in the refrigerator ✓Record the temperature daily! (regularly). 7/12/2024 Abdullah Saadallah 75 b. Combustible /Flammable: Combustibles such as alcohol, ether and other organic solvents must be stored in special or separate rooms. 7/12/2024 Abdullah Saadallah 76 c. Secured storage conditions: ✓Narcotic drugs, psychotropic substances, and their documents should be kept in securely locked rooms or cupboards. ✓The keys should be kept in a secure place ✓As possible only the chief of pharmacy should have access to them. 7/12/2024 Abdullah Saadallah 77 Defined Storage Temperatures and Humidity 24 ،‫ تموز‬12 dr. Abduulah Saadallah 78 PRODUCT HANDLING CONSIDERATIONS Three main issues of product similarity are the following: 1. Look-alike/sound-alike (LASA) products—Stocking products of similar color, shape, and size could result in error if someone fails to read the label carefully. All staff members should be alerted to look-alike or sound-alike products 24 ،‫ تموز‬12 dr. Abduulah Saadallah 79 24 ،‫ تموز‬12 dr. Abduulah Saadallah 80  2. Misleading labels—Sometimes the company name or logo is emphasized on the label instead of the drug name, concentration, or strength. 24 ،‫ تموز‬12 dr. Abduulah Saadallah 81  3. Product storage—Storing products that are similar in appearance adjacent to one another can result in error if someone fails to read the label 24 ،‫ تموز‬12 dr. Abduulah Saadallah 82  Homework PHARMACEUTICAL WASTE MANAGEMENT Drug recall 24 ،‫ تموز‬12 dr. Abduulah Saadallah 83 Drug distribution system in hospitals 84  Drug distribution: is a continuous process of receiving drugs from the supplier and moving them safely/securely to the many points in health care system at which the drugs will be dispensed to patients. 85 Drug distribution cycle Drug Port procurement clearing Consumption Receipt & reporting inspection Dispensing Inventory To patients control Delivery storage Requisition Of supplies 86 Requisition of supplies Pull-system: each level of the system determines what types and quantities of drugs are needed and places orders with the supply source. Push-system: supply sources at some level in the system determines what types and quantities of drugs will be delivered to lower levels. 1- Distributions to outpatients The OP services provide the main linkage of the hospital with the community. An outpatient is one who after consultation and Dx, receives treatment without being admitted 88  Medicines are give to the OPs on the prescriptions. There shall be benches provided for the patients to sit during waiting period. Posters on health education and community health programs may be displayed in this waiting area. 89 5.2 Distribution to inpatients Inpatients are admitted patients in hospital, stay there for treatment till they are discharged The pharmacist’s service to IPs will vary depending upon the departments. 90  In radiology department: Medicines required for Dx purposes. In operation theatre: Anesthetic liquid/inj., infusion solutions, surgical gauges &cotton, antiseptic solutions, and some injectable In wards: apart from medicines, catheter, cotton lint and bandages, etc are called medical supplies 91 Types of drug distribution system for inpatient There are 5 basic drug distribution systems exist 1.Bulk ward stock system ( also called complete floor stock system) 2.Individual prescription system 3.Combination of bulk stock & individual systems 4.Unit-dose system 5.Automated medication dispensing 24 ،‫ تموز‬12 dr. Abduulah Saadallah 92 24 ،‫ تموز‬12 dr. Abduulah Saadallah 93 24 ،‫ تموز‬12 dr. Abduulah Saadallah 94 24 ،‫ تموز‬12 dr. Abduulah Saadallah 95 24 ،‫ تموز‬12 dr. Abduulah Saadallah 96 Types of drug distribution: Floor or ward stock system: In this system, all but the most unusual drug items are stocked on the nursing stations. Drug products which require special control (e.g., antineoplastic agents) are often omitted from floor stock, and are sent to the nursing unit upon receipt of a prescription order for the individual patient. All containers used for floor stock must meet specific labeling requirements as addressed in these rules. 97 Unit dose dispensing system: In this system, medications are contained in single unit packages; they are dispensed in as ready-to-administer form as possible, for most medications. All doses will be labeled properly to include name, strength, expiration date, or lot number or control number, or both. 98 ❖Wards inspection ✓The H. pharmacist has the right to periodically inspect all wards outside the H. pharmacy in which the medications are stored e.g. emergency room, operation room, nurse station ( in case of bulk or individual distribution systems ✓The H. pharmacist should inspect storage condition, exp. dates and also controlled drugs. 24 ،‫ تموز‬12 dr. Abduulah Saadallah 99 ❖ After-Hours pharmacy ( When the pharmacy is closed) Shift system is the most common and the beast system employed in hospital to ensure that a pharmacist exist in the pharmacy throughout 24 hours/day In some countries , other systems mat exist: ▪ On-call pharmacist system ▪ Trained nurse system : the trained nurse has an access to a definite part of the pharmacy where a group of essential drugs are available In this system, the H. pharmacist in the next morning check with the trained nurse for all medications dispensed at night. 24 ،‫ تموز‬12 dr. Abduulah Saadallah 100  Dealing with Controlled drugs Controlled drugs (dangerous drugs) are drugs: ✓that cause addiction (physical dependence) ✓or abused i.e. used for harmful purposes other than they are produced for e.g. anabolic steroids , or may be used to commit crimes e.g. chloroform, ether ,etc. Types of Controlled drugs: 1. Narcotics ( cause addiction) (i) Illegal (prohibited) (ii) (ii) Therapeutic: 2. Abused (Non- Narcotics) ( don’t cause addiction); 24 ،‫ تموز‬12 dr. Abduulah Saadallah 101 Prescribing Controlled Substances Controlled Substance Schedules: Schedule I Schedule II Schedule III Schedule IV Schedule V Abdullah Saadallah 102 Schedule I Examples: (heroin, methylene dioxymethamphetamine, lysergic acid diethylamide, mescaline, and all salts and isomers thereof): 1. High potential for abuse. 2. No accepted medical use in the U.S. or lacks accepted safety for use in treatment in the U.S. ▪ May be used for research purposes by properly registered individuals. Abdullah Saadallah 103 Schedule II Examples: ( morphine, oxycodone, fentanyl, meperidine, dextroamphetamine, cocaine, amobarbital): 1. High potential for abuse. 2. Has a currently accepted medical use in the U.S. 3. Abuse of substance may lead to severe psychological or physical dependence. Abdullah Saadallah 104 Schedule III Examples: ( anabolic steroids, nalorphine, ketamine, certain schedule II substances in suppositories, mixtures, or limited amounts per dosage unit): 1. Abuse potential less than substances in schedule I or schedule II. 2. Has a currently accepted medical use in the U.S. 3. Abuse of substance may lead to moderate-to-low physical dependence or high psychological dependence. Abdullah Saadallah 105 Schedule IV Examples: ( alprazolam, phenobarbital, meprobamate, modafinil): 1. Abuse potential less than substances in schedule III. 2. Has a currently accepted medical use in the U.S. 3. Abuse of substance may lead to limited physical or psychological dependence relative to substances in schedule III. Abdullah Saadallah 106 Schedule V Examples: buprenorphine, products containing a low dose of an opioid plus a non-narcotic ingredient such as cough syrup with codeine and guaifenesin, antidiarrheal tablets with diphenoxylate and atropine): 1. Low potential for abuse relative to schedule IV. 2. Has a currently accepted medical use in the U.S. Abdullah Saadallah 107 3. Some schedule V products may be sold in limited amounts without a prescription at the discretion of the pharmacist; however, if a physician wishes a patient to receive one of these products, it is preferable to provide a prescription. Abdullah Saadallah 108  All controlled drugs containing prescriptions must be: written in ink, refills of schedule II drugs are not allowed. Prescriptions for controlled substances must, by law, include the patient’s full name and address and the practitioner’s full name, address, and DEA registration number. Abdullah Saadallah 109 The prescription must also include: ▪ the drug name, ▪ strength, ▪ quantity, ▪ directions for use, and ▪ the number of refills, if allowed (based on the category of the drug). Abdullah Saadallah 110  All orders for controlled substances be dated as of, and signed on, the day issued and prohibits filling or refilling orders for substances in schedules III and IV beyond more than 6 months after their date of issuance. All medical personnel should be familiar with the latest CDC recommendations for prescribing opioids for chronic pain. Abdullah Saadallah 111 Oral Orders Prescriptions for schedule III, IV, and V medications may be telephoned to a pharmacy by a physician in the same manner as a prescription for a noncontrolled substance, although it is in the physician’s best interest to keep his or her DEA number as private as possible. Abdullah Saadallah 112  Schedule II prescriptions may be telephoned to a pharmacy only in emergency situations, that is: Immediate administration is necessary. No appropriate alternative treatment is available. It is not reasonably possible for the physician to provide a written prescription prior to the dispensing. Abdullah Saadallah 113  For an emergency prescription, the quantity must be limited to the amount adequate to treat the patient during the emergency period, and the physician must have a written prescription delivered to the pharmacy for that emergency within 72 h. If mailed, the prescription must be postmarked within 72 h. The pharmacist must notify the DEA if this prescription is not received. Abdullah Saadallah 114 Refills No prescription order for a schedule II drug may be refilled under any circumstance (CFR Title 21 §1306). For schedule III and IV drugs, refills may be issued either orally or in writing, not to exceed five refills or 6 months after the issue date, whichever comes first. Beyond this time, a new prescription must be ordered. For schedule V drugs, there are no restrictions on the number of refills allowed, but if no refills are noted at the time of issuance, a new prescription must be made for additional drug to be dispensed. Abdullah Saadallah 115 Preventing Diversion Prescription blanks often are stolen and used to sustain abuse of controlled substances. To prevent this type of diversion, prescription pads should be protected in the same manner as one would protect a personal checkbook. A prescription blank should never be presigned for a staff member to fill in at a later time. Also, a minimum number of pads should be stocked, and they should be kept in a locked, secure location. If a pad or prescription is missing, it should be reported immediately to local authorities and pharmacies. Abdullah Saadallah 116 24 ،‫ تموز‬12 Dr. Abdullah Saadallah 117 In patient services Extemporaneous preparation 24 ،‫ تموز‬12 Dr. Abdullah Saadallah 118  Pharmacists are responsible for ensuring that drug use is safe and effective. Wherever practicable, licensed medicines are used and represent the ‘gold standard’ for quality, safety and efficacy. There are, however, circumstances in which there is no licensed medicine that fully meets the clinical needs of a particular patient or patients. In these circumstances it is sometimes necessary for the pharmacist to extemporaneously prepare a limited quantity of a custom-made medicine for a specific patient. 24 ،‫ تموز‬12 Dr. Abdullah Saadallah 119  Oral liquid medicines are commonly extemporaneously prepared because of a ✓relative lack of licensed formulations for groups such as the young or elderly who are unable to swallow tablets or capsules, or ✓for whom the required dose is less than a single tablet/ capsule. 24 ،‫ تموز‬12 dr. Abduulah Saadallah 120 What is Extemporaneous preparation? ❖Definition: Extemporaneous preparations are pharmaceutical preparations prepared by the pharmacist in the pharmacy. ❖ Aims The fundamental aim of extemporaneous preparation is to make preparations that are unavailable in the drug market yet needed for certain cases. These include: ❖1. Products that have been manufactured by a pharmaceutical company , but are unavailable in drug market at the time of request. ❖2. Products that have never been manufactured by a pharmaceutical company because of short shelf life or very small market size. 24 ،‫ تموز‬12 dr. Abduulah Saadallah 121 ❖Types of extemporaneous preparations: A. Non-sterile extemporaneous preparations Include most preparations EXCEPT : parenteral , irrigation and ophthalmic preparations. B. Sterile extemporaneous preparations Include parenteral , irrigation and ophthalmic preparations. 24 ،‫ تموز‬12 dr. Abduulah Saadallah 122 ❖A. Non-sterile extemporaneous preparations 1. Repacking & Course of therapy packing In some cases, the medication is purchased or supplied as bulk quantities e.g. a bottle of 1000 tablet, 5-Liter liquids. In such cases, it is necessary to divide those quantities into a separated packages 2. Compounded extemporaneous preparations (i) From raw materials : e.g. compendia (pharmacopeia) preparations Such as (calamine lotion, NaCl mouthwash, sulfur ointment, glycerin suppositories. etc. (ii) From available dosage forms. Dosage form conversion 24 ،‫ تموز‬12 dr. Abduulah Saadallah 123 B. Sterile extemporaneous preparations Include parenteral preparations, irrigation solutions and ophthalmic preparations. ✓Parenteral preparations include: Iv-admixtures * reconstitution of IV powders * mixing of 2 or more small IV (vials or ampoules) into one syringe * Mixing of IV drugs into drips (IV infusions) * Total parenteral nutrition (TPN) Non-Iv admixtures: reconstitution of IM/SC powders, mixing of 2 or more small IM/SC (vials or ampoules) into one syringe 24 ،‫ تموز‬12 dr. Abduulah Saadallah 124  Risks of Extemporaneous preparation Extemporaneous preparation remains one of the highest risk preparative activities carried out in the pharmacy, as: ✓the risks of unlicensed medicines are combined with inherent risks associated with the pharmaceutical compounding process. ✓In addition, extemporaneously prepared medicines are commonly given to some of the most vulnerable patients in hospitals and communities (e.g. neonates, children, elderly patients, stroke victims, patients with feeding tubes in situ). These vulnerable patients are often not capable of alerting corers or staff to any adverse drug events they may be experiencing. 24 ،‫ تموز‬12 Dr. Abdullah Saadallah 125  Risks of Extemporaneous preparation There have been a number of reports of errors associated with the use of extemporaneously prepared medicines, resulting in serious harm to patients. ❖‘peppermint water case’, where the use of the wrong strength of chloroform water led to the death of a child. ❖the death of a child from a superpotent imipramine liquid, and another of ❖a 5-year-old child who received a thousand-fold overdose of clonidine (e.g. confusion between strengths expressed per mL or per 5 mL). 24 ،‫ تموز‬12 Dr. Abdullah Saadallah 126  Risks of Extemporaneous preparation Even where a given formulation has been shown to achieve suitable physical, chemical and microbiological stability, the bioavailability and palatability of the preparation may be unproven. All these risks have been potentiated by declining expertise in pharmaceutics and formulation within the pharmacy profession. An update of the existing standards together with the standardization and rationalization of current products and formulae will help to improve product quality, decrease the overall risk to patient safety. 24 ،‫ تموز‬12 Dr. Abdullah Saadallah 127 24 ،‫ تموز‬12 Dr. Abdullah Saadallah 128 ❖Alternatives to extemporaneous preparation: 1. Therapeutic substitution 2. Practical options Use of soluble or dispersible tablets Cutting tablets Use of a preparation intended for a different route 24 ،‫ تموز‬12 Dr. Abdullah Saadallah 129 Therapeutic substitution The use of a licensed medicine from the same therapeutic classification should be considered and may provide a better clinical option than the use of an extemporaneously prepared medicine which has limited data to support its formulation and stability. However, the decision to switch to a different medicine should also take into account the condition of the patient and the relative toxicity of the drug. For example, if a patient is stabilized on a medicine with a narrow therapeutic index, it is more risky to switch to a different, but therapeutically equivalent drug, than use a medicine that has been extemporaneously prepared against a validated formulation. 24 ،‫ تموز‬12 Dr. Abdullah Saadallah 130 Therapeutic substitution The use of a less potent steroid rather than diluting a potent agent is an example where a therapeutic alternative may eliminate the need for an extemporaneous preparation. The use of an alternative route of administration, for example use of the rectal rather than the oral route, could also be considered if an appropriate formulation is available. 24 ،‫ تموز‬12 Dr. Abdullah Saadallah 131 Practical options 1- Use of soluble or dispersible tablets: Some tablets can be dispersed, even if this is not within the terms of their marketing authorization (licence). Most tablets will disperse in a small volume of water (10 mL) within a few minutes. This practice presents fewer health and safety risks than crushing tablets, which can expose the carer to potentially harmful dusts via inhalation. When dispersing tablets, the dose should be prepared and administered immediately, as stability cannot be guaranteed. It should be noted that slow or modified release preparations should not be used in this manner. Care should be taken, however, if part doses are required. 24 ،‫ تموز‬12 Dr. Abdullah Saadallah 132 Use of soluble or dispersible tablets: This is because water has no suspending properties, commonly resulting in aggregation and sedimentation of the drug, leading to poor dosage accuracy. For this reason, tablet dispersion may not be a practical option in pediatrics where the required doses are frequently fractions of the lowest available strength tablet. 24 ،‫ تموز‬12 Dr. Abdullah Saadallah 133 Practical options 2- Cutting tablets: The use of tablet cutters can sometimes provide an acceptable option, especially when tablets are effectively scored and designed to help in the administration of part doses. However, tablets cannot be cut with great accuracy of dose and research suggests that the variability may range from 50% to 150% of the desired dose even when using commercially available tablet cutters. 24 ،‫ تموز‬12 Dr. Abdullah Saadallah 134 Practical options: 3- Use of a preparation intended for a different route: for example the use of an injection solution orally, or an oral solution rectally. However, this practice has its own inherent risks When using an injection by the oral route, consideration should be given to ✓the possibility of rapid absorption and elevated peak levels, ✓the potential for rapid drug degradation due to exposure to gastric acid and problems with first-pass metabolism. ✓The pH of an injection should also be considered, as extremes of pH can adversely affect the gastric mucosa. ✓Some consideration should also be given to other excipients in the formulation such as propylene glycol and ethanol, which may be problematic if large volumes of the injection are required to provide the dose. 24 ،‫ تموز‬12 Dr. Abdullah Saadallah 135 Beyond use date BUD Manufactured pharmaceuticals have expiration dates after which they are no longer supposed to be used. Instead of an expiration date, compounded pharmaceuticals have a BUD, which is the date after which a CSP should no longer be stored or transported to a patient. A compounded substance’s BUD is derived from both its sterility and stability 24 ،‫ تموز‬12 dr. Abduulah Saadallah 136  Shelf-life Given the risks associated with extemporaneous formulation, it is recommended that the shelf-life of any extemporaneous product should not exceed 28 days if preserved or 7 days if unpreserved. For drugs with narrow therapeutic indices, this may be as little as 2 or 3 days 24 ،‫ تموز‬12 Dr. Abdullah Saadallah 137  Sources for extemporaneous preparations In addition to the British Pharmacopoeia, United States Pharmacopoeia and European Pharmacopoiea, the following textbooks are useful sources of information: Connors KA, Amidon GL, Stella ZJ (1986). Chemical Stability of Pharmaceuticals: A Handbook for Pharmacists, 2nd edn. New York: Wiley Interscience. ISBN 0 471 87955 X. Florey K, ed. (1972 1990). Analytical Profiles of Drug Substances, Vols 1 19. London: Academic Press. Lund W, ed. (1994). The Pharmaceutical Codex: Principles and Practice of Pharmaceutics, 12th edn. London: Pharmaceutical Press. ISBN 0 85369 290 4. Moffat AC, Osselton MD, Widdop B (2003). Clarke’s Analysis of Drugs and Poison, 3rd edn. London: Pharmaceutical Press. ISBN 978 0 85369 473 1. 24 ،‫ تموز‬12 Dr. Abdullah Saadallah 138  Nahata MC, Pai VB, Hipple TF (2004). Pediatric Drug Formulations, 5th edn. Cincinnati:Harvey Whitney Books Co. ISBN 0 929375 25 4. Sweetman SC, ed. (2009). Martindale: The Complete Drug Reference, 36th edn. London: Pharmaceutical Press. ISBN 978 0 85369 840 1. Trissel LA (2005). Handbook on Injectable Drugs, 13th edn. Bethesda, MD: American Society of Health System Pharmacists. ISBN 1 58528 107 7. Trissel LA, ed. (2000). Stability of Compounded Formulations, 2nd edn. Washington DC: American Pharmaceutical Association, 24 ،‫ تموز‬12 Dr. Abdullah Saadallah 139  Examples Levothyroxine sodium oral liquid Using a typical strength of 10 micrograms/mL as an example: * levothyroxine sodium 100 micrograms tablet (10) * preserved xanthan gum 0.4% (or similar) suspending agent to 100 mL. 24 ،‫ تموز‬12 Dr. Abdullah Saadallah 140 Levothyroxine sodium oral liquid Method: Tablets can be ground to a fine, uniform powder in a pestle and mortar. A small amount of xanthan gum suspending agent may be added to form a paste, before adding a further portion up to 75% of the final volume. Transfer to a measuring cylinder. The remaining suspending agent can be used to wash out the pestle and mortar of any remaining drug before making the suspension up to 100% volume. Transfer to an amber medicine bottle. Shelf-life 7 days refrigerated in amber glass. Shake the bottle. 24 ،‫ تموز‬12 Dr. Abdullah Saadallah 141  Home works Hydroxyurea Sildenafil Beta blockers Metformin Omeprazole Enalapril 24 ،‫ تموز‬12 Dr. Abdullah Saadallah 142 ❖Considerations for sterile products preparation: These preparations must be prepared in an isolated sterile area under aseptic conditions. Workers should wear sterile face-mask, gloves and lab. coat Before permitting the admixture to begin, the pharmacist must review incompatibility of mixed drugs and the calculations involved in the preparation 24 ،‫ تموز‬12 dr. Abduulah Saadallah 143 ❖Laminar airflow is defined as "Air flow in which the entire body of air within a confined area moves with uniform velocity along parallel flow lines." 24 ،‫ تموز‬12 dr. Abduulah Saadallah 144  HAZARDOUS STERILE COMPOUNDING Hazardous drugs (HDs) are categorized into three categories developed by NIOSH: Category 1—This category includes antineoplastic drugs known to be hazardous with repeated exposure. Most chemotherapies are antineoplastics. Category 2—This category is for nonantineoplastic drugs that are hazardous. Category 3—This category includes medications with adverse effects on reproduction. 24 ،‫ تموز‬12 dr. Abduulah Saadallah 145  Each HD category requires special handling procedures to minimize the potential for accidental exposure. USP General Chapter explains these special procedures, including safeguards for receiving, preparation, labeling, storage, and transport. For example, all Category 1 medications need to be stored in a negative pressure room. 24 ،‫ تموز‬12 dr. Abduulah Saadallah 146 Remember!! USP General Chapter ❖For HDs USP General Chapter ❖For sterile compoundings USP General Chapter ❖For nonsterile compounding 24 ،‫ تموز‬12 dr. Abduulah Saadallah 147  I.V admixtures Although some medications are injected directly into the vein, most medications are added to a compatible solution such as Dextrose 5% in Water (D5W) or 0.9% NaCl (Normal Saline), and infused intravenously. By using small or large volume of solutions, drugs can be administered slowly over a period of time and diluted enough to not cause any damage or harm to the patient Most intravenous solutions or IV Admixtures are prepared in the Pharmacy setting by Pharmacy Technicians/ pharmacists 24 ،‫ تموز‬12 dr. Abduulah Saadallah 148 I.V admixtures ❖Definition IV admixtures are Sterile extemporaneous preparations produced by Hospital pharmacist through mixing more than one IV drug product into a single entity (The single entity may be an infusion drip, Y-set junction, syringe) and the mixture is then administered by intravenous route. 24 ،‫ تموز‬12 dr. Abduulah Saadallah 149  Advantages of IV admixtures 1. Treatment of more than one disease/symptom simultaneously. 2. Less injecting number will ensure patient convenience. 3. Control of drug input into the body ( can be increased, decreased or stopped) Disadvantages of IV admixtures 1. Potential of drug IV incompatibility 2. Short stability time ( most IV admixtures if unused but stored properly (2-8 oC) , they should be discarded after 24 hours of mixing) 24 ،‫ تموز‬12 dr. Abduulah Saadallah 150 ❖Types of IV admixtures 1. Small-volume IV admixtures : often not more than 20 ml The IV drug products are mixed in a syringe 2. Large-volume IV admixtures : ≥ 100 ml ❖IV infusions The IV infusion is an aqueous sterile solution intended for iv administration. Many iv drugs can be mixed in an infusion drip 24 ،‫ تموز‬12 dr. Abduulah Saadallah 151 24 ،‫ تموز‬12 dr. Abduulah Saadallah 152 Administration of IV medications: ❖IV Push or IV bolus - injection of a small amount of drug by means of a needle or syringe ❖Infusion - administration of a large amount of fluid (LVP) over a prolonged period of time ❖Piggyback - IV piggyback administration via a secondary line with an established running IV solution or primary line. Used to deliver medications 24 ،‫ تموز‬12 Dr. Abdullah Saadallah 153 Administration of IV medications: ❖IV Push or IV bolus - injection of a small amount of drug by means of a needle or syringe ❖Infusion - administration of a large amount of fluid (LVP) over a prolonged period of time ❖Piggyback - IV piggyback administration via a secondary line with an established running IV solution or primary line. Used to deliver medications 24 ،‫ تموز‬12 Dr. Abdullah Saadallah 154  Forms of Parenteral medications: 1. ampules - sealed glass containers designed to hold a single dose of medication. 2. vials - plastic or glass containers that have a rubber stopper (diaphragm) on them which is covered with a metal lid. 24 ،‫ تموز‬12 Dr. Abdullah Saadallah 155 24 ،‫ تموز‬12 dr. Abduulah Saadallah 156 3. Cartridge - prefilled glass or plastic container which requires a special holder called a tubex to release the medication from the cartridge 24 ،‫ تموز‬12 Dr. Abdullah Saadallah 157 4. Prepackaged syringes - medication prepared for administration in a syringe with the needle attache 24 ،‫ تموز‬12 Dr. Abdullah Saadallah 158 Emergency kit inj 24 ،‫ تموز‬12 Dr. Abdullah Saadallah 159  Syringes: Syringes have three parts 1. the barrel - the outer portion that has the calibrations of the syringe on it 2. the plunger - the inner device that is pushed to eject the medication from the syringe 3. the tip - the end of the syringe that holds the needle 24 ،‫ تموز‬12 Dr. Abdullah Saadallah 160  Where is the tip? 24 ،‫ تموز‬12 Dr. Abdullah Saadallah 161  Medications: Powdered Drugs : Drugs that are unstable in liquid form for long periods of time are packaged in powdered form. must be diluted with a liquid (Reconstituted) 24 ،‫ تموز‬12 Dr. Abdullah Saadallah 162  Reconstitution: 1. Carefully read the directions for reconstitution on the vial or in the package insert 2. The diluents commonly used for reconstitution are sterile water for injection 3. After adding the diluent to the powdered medication the total reconstituted volume will be greater than the amount of diluent 24 ،‫ تموز‬12 Dr. Abdullah Saadallah 163  Information needed for Reconstitution: 1. type of diluent to use for reconstitution 2. the amount of diluent to add 3. the length of time the medication is good for once it is reconstituted 4. directions for storing the medication after mixing 5. the strength or concentration of the medication after its reconstituted 24 ،‫ تموز‬12 Dr. Abdullah Saadallah 164  Reading Parenteral Labels Drugs labeled in Percentage Strength: Example: Dextrose 5% Water 1000 ml 0.9% NaCl 500 ml 50% MgSO4 25 ml 24 ،‫ تموز‬12 Dr. Abdullah Saadallah 165  Solutions expressed in Ratio Strength oftentimes ordered by ml or cc example: Epinephrine 1:1000 Parenteral Medications measured in Units: Measured in units for parenteral administration example: heparin 100 units / ml 1000 units / ml Insulin 100 units / ml Penicillin 600,000 units / ml Vitamin D 200,000 IU Parenteral Medications in Millequivalents Millequivalents (mEq) : KCl 10mEq/ml 24 ،‫ تموز‬12 Dr. Abdullah Saadallah 166 Infusion rate calculation The order is for 1800ml of saline solution to be infused in 12 hrs. the drop factor is 8gtt/ml. what drip rate should be used? 20 drop/ min The order is for an infusion of 2L in 24 hrs. if the solution on hand has drop factor is 15gtt/ml. what drip rate should be used? 20.833drop/min 24 ،‫ تموز‬12 dr. Abduulah Saadallah 167  A patient was prescribed to receive an IV infusion of D5W 1000ml to infuse over 8 Hrs. the IV tubing used was deliver 15 drops/ml, what is the correct drip rate? 31.25 drop/mint. 24 ،‫ تموز‬12 dr. Abduulah Saadallah 168  Labelling of I.V admixture 24 ،‫ تموز‬12 Dr. Abdullah Saadallah 169 Problems with IV therapy To be considered: Sterility Clarity Stability Compatibility, pH, osmolarity. Contamination Risks: Infection Allergy Extravasation Pyrogen Air emboli 24 ،‫ تموز‬12 dr. Abduulah Saadallah 170 IV Incompatibility Incompatibilities: Some drugs are incompatible with other drugs, containers, or solutions. If an incompatibility exists, the drug may precipitate (form a solid), be inactivated, or adhere to the container. Incomparability: a phenomenon which occurs when one drug is mixed with others to produce, by physicochemical means, a new product unsuitable for administration to the patient due to some modifications. 24 ،‫ تموز‬12 dr. Abduulah Saadallah 171  Characteristics of incompatibility: ❖Color change ❖Hazy appearance ❖Precipitation 24 ،‫ تموز‬12 dr. Abduulah Saadallah 172  Not all incompatibilities are dangerous, some are just normal. Color change: Imipenem-cilastatin or dobutamine may show some color change bot NOT a sign of incompatibility Hazy appearance: When ceftazidime is reconstituted, carbon dioxide gas is released causing hazy appearance Precipitation: The precipitate that forms when paclitaxel is refrigerated dissolves again at room temperature. 24 ،‫ تموز‬12 dr. Abduulah Saadallah 173 Contributing Factors ❖Light Amphotericin B, cisplatin, and metronidazole must be protected from light. ❖Temperature Cefazolin is stable at room temperature for 24 hours but under refrigeration for 14 days ❖Dilution Up to 10 mEq of Calcium can be added to each liter of TPN Containing 20 mEq of PO4 ❖Concentration dependant Bactrim 5ml/75ml ml D5W stable for 2 hours, whereas 5 ml/125ml is stable for 6 hours ❖Buffer capacity, pH, and Time Amino acid composition and concentration in TPN 24 ،‫ تموز‬12 dr. Abduulah Saadallah 174  Types of Incompatibilities ✓Therapeutic Incompatibility ✓Physical Incompatibility ✓Chemical Incompatibility ✓Drug IV Container Incompatibilities 24 ،‫ تموز‬12 dr. Abduulah Saadallah 175 Therapeutic Incompatibility The result of pharmacological effects of several drugs in one patient ( drug interactions). Mechanisms Pharmacokinetics: absorption, distribution, metabolism, excretion (e.g. Ciprofloxacin and Maalox). Pharmacodynamic: antagonism/ synergism (e.g. Coumadin and Vitamin K) Heparin and antibiotics? 24 ،‫ تموز‬12 dr. Abduulah Saadallah 176 Physical Incompatibility The incompatibility that is more on solubility changes and container interactions Type Ways to prevent Insolubility ❖Do not administer a Sorption phenomena precipitate forming drugs ❖Avoid mixing drugs prepared Gas formation in certain diluents with Solution pH others ❖Prepare each drug in a separate syringe 24 ،‫ تموز‬12 dr. Abduulah Saadallah 177 Examples of PI 24 ،‫ تموز‬12 dr. Abduulah Saadallah 178 24 ،‫ تموز‬12 dr. Abduulah Saadallah 179 24 ،‫ تموز‬12 dr. Abduulah Saadallah 180 Chemical Incompatibility Results from the molecular changes or rearrangement and leads to chemical decomposition (nonvisible change) Type Ways to prevent Hydrolysis Store drugs in moisture proof containers or use desiccants Oxidation Store drugs in amber bottles Reduction keep away from reducing agents Photolysis Use light proof containers 24 ،‫ تموز‬12 dr. Abduulah Saadallah 181 24 ،‫ تموز‬12 dr. Abduulah Saadallah 182 Drug IV Container Incompatibilities Incompatibility that arise from the chemical reaction of the drug and the intravenous container Type Definition Adsorption The property of solid/liquid to attract and hold to its surface a gas, liquid, solute, or suspension (e.g. Propofol) 24 ،‫ تموز‬12 dr. Abduulah Saadallah 183 References regarding incompatibility ✓Trissel’s “Handbook on Injectable Drugs” ✓www.globalrph.com ✓Manufacturer label 24 ،‫ تموز‬12 dr. Abduulah Saadallah 184  Types of I.V solution There are two types of intravenous solutions: A. Crystalloid B. Colloids 24 ،‫ تموز‬12 Dr. Abdullah Saadallah 185 Crystalloid: - a non-colloid substance resembling a crystal. A substance which, in solution passes readily through cell membranes. Examples would include: Dextrose 5% Water (D5W) and Sodium Chloride 0.9% Injection (NS or Normal Saline). Dextrose would be a source of calories and water for hydration while Sodium Chloride would be a source of sodium chloride and water for hydration. Dextrose and Sodium Chloride are also found and used in combination. Oftentimes, electrolytes such as potassium chloride (KCl) are added. 24 ،‫ تموز‬12 Dr. Abdullah Saadallah 186 Colloids - Colloid solutions are large molecular weight substances composed of proteins, carbohydrates or gelatin. Colloids cause a shift of fluid from interstitial spaces into the intravascular space or circulation. Its main use is to provide plasma volume expansion. Intravenous administration of colloids increases intravascular volume and restores normal blood volume.. Examples would include: Albumin Human, Plasma Protein Fraction, Dextran 40, Dextran 70 and Hetastarch 24 ،‫ تموز‬12 Dr. Abdullah Saadallah 187  Crystalloids 24 ،‫ تموز‬12 Dr. Abdullah Saadallah 188 Commonly Administered Crystalloid IV Solutions 24 ،‫ تموز‬12 Dr. Abdullah Saadallah 189 24 ،‫ تموز‬12 Dr. Abdullah Saadallah 190 24 ،‫ تموز‬12 Dr. Abdullah Saadallah 191 24 ،‫ تموز‬12 Dr. Abdullah Saadallah 192 24 ،‫ تموز‬12 Dr. Abdullah Saadallah 193 24 ،‫ تموز‬12 Dr. Abdullah Saadallah 194 24 ،‫ تموز‬12 Dr. Abdullah Saadallah 195  IV fluids Hypotonic Isotonic Hypertonic fluid shift ( NO fluid shift) fluid shift EC→→IC IC →→EC 24 ،‫ تموز‬12 Dr. Abdullah Saadallah 196 24 ،‫ تموز‬12 Dr. Abdullah Saadallah 197 24 ،‫ تموز‬12 Dr. Abdullah Saadallah 198 24 ،‫ تموز‬12 Dr. Abdullah Saadallah 199 The calculated plasma osmolality The effective plasma osmolality 24 ،‫ تموز‬12 Dr. Abdullah Saadallah 200  When the individual solute has been identified, its contribution to the measured osmolality can be estimated by dividing its concentration (mg/dL) by one-tenth of its molecular weight. 24 ،‫ تموز‬12 Dr. Abdullah Saadallah 201  Isotonicity describes equal osmotic pressure on both sides of a semipermeable membrane, so there is no net movement of the solvent across the membrane. Normal saline solution (NS), 0.9% NaCl, is an isotonic solution, meaning that no net fluid is distributed into cells on administration.  Dextrose 5% in water (D5W) does distribute into cells (approximately two-thirds of the volume administered) and is therefore described as free water. 24 ،‫ تموز‬12 Dr. Abdullah Saadallah 204 24 ،‫ تموز‬12 dr. Abduulah Saadallah 205