Institutional Pharmacy Practice Chapter 9 1 Introduction Hospital pharmacy: Most common institutional setting and most challenging area to work Fewer job openings for technicians More highly skilled technicians required Multitasking and more complicated tasks Tasks include: Preparing intravenous (IV) medications and loading patient medication drawers Entering data into pharmacy computer system There are fewer hospitals than community pharmacies, so there are not as many hospital pharmacy technician positions available. Despite the best efforts of managed care, hospital utilization is rising as the population ages. Hospitals are very busy and often overcrowded. As the health care industry changes and improves, so will the vital roles required of pharmacy technicians as pharmacies strive to provide improved health care services. A medication order is a prescription written for administration in a hospital or institutional setting. 2 Types of Hospitals Size of hospital: Depends on number of patient beds available Small: 50 beds or fewer Large: 50 to 250 beds or more Other differences: Capabilities in diagnosis, surgery, and outpatient services Small hospitals usually do not have specialized diagnosis or major surgery capabilities, so their patients might be transferred or referred to larger hospitals for such services. The size of a hospital may be thought of as the number of beds available for patient use. There are nonprofit and for-profit hospitals. Other factors that differentiate hospitals from one another are their capabilities for diagnosis, surgery, and outpatient services. For hospitals that are not staffed by pharmacy personnel at all times, contingent policies and regulations are in place that allow specific nursing personnel to have limited access to an inpatient pharmacy to obtain needed medications. In other facilities, an oncall pharmacist may provide the necessary services in times of less-than-full operation. Still other pharmacies may have off-site pharmacies that will provide courier services to deliver needed orders. 3
Hospital Pharmacy Settings Differences: Layout of pharmacies Older hospitals: Central inpatient pharmacy Larger, newer hospitals: Central and satellite pharmacies Teaching hospitals: Pediatrics, burn units, intensive care units (ICUs), cancer units Satellite pharmacies: Specialty pharmacies that supply a clinic Discharge pharmacies: Fulfill the same duties as a community pharmacy Satellite pharmacies fill most of the daily medications for patients on their floors. They may be equipped with an IV hood for preparation of a parenteral product if necessary. They also are used to replace any missing medications in the automated systems or in the patient s cassette drawers. Once a discharge order has been sent, the pharmacy fills the order by the same process used in any community pharmacy. This includes determining the patient s address, phone number, and insurance coverage. More hospitals are incorporating satellite pharmacies to expedite order preparation and delivery. The pharmacist s role is to monitor regulatory compliance and to oversee all medications dispensed from the particular satellite to ensure optimal patient care. 4 Policies and Standard Operating Procedures Policies and Procedures (P&P) manual is found in all pharmacies Outlines facility s rules Rules apply to all employees Information concerns daily work activities, benefits, emergency situations, mandatory training Technicians should be familiar with the P&P manuals of their facilities. Information contained in the policies and procedures manual concerns daily work routines and responsibilities, benefits, protocols for emergency situations, and mandatory training. 5 Hospital Protocol Protocol: Defines the guidelines for a particular facility Determines which medications are formulary drugs (approved for use) and which are nonformulary drugs (not approved for use) Purpose: To choose best medicines for patients Why do hospitals need protocols and formularies? (These tools guide and inform prescribers and pharmacists about the types of medications available for dispensing and issues concerning drug coverage. Having a set list of recommended drugs can help control costs.) A drug education coordinator is a pharmacist who helps educate the health care providers about the changes in protocol concerning drug coverage; he or she also assists the hospital pharmacy in implementing these changes. 6
Formulary Versus Non-Formulary Medications If the recommended criteria are not met, the drug is considered non-formulary and is not included on the approved list. Formulary medications: Approved for use by a particular health care entity Non-formulary medications: Not approved for use by a particular health care entity Formularies are developed by a group of specialty physicians and pharmacists Drugs are evaluated based on cost, effectiveness/ safety, and patient demographics 7 Pharmacy and Nursing Staff Relationship Nurses are the pharmacy s primary customers; they should receive the highest level of support Nurses depend on the pharmacy for all medications Nurses often make inquiries to pharmacies, including: Patient medication status and drug interaction Dosing ranges and pharmacy calculations Where are the medications I ordered? (most common) Collaboration prevents medication errors Nurses generally account for more than 80% of the calls or electronic contacts with the inpatient pharmacy. Any pharmacy technician, when asked, Where are the medications I ordered? can answer simply by accessing the computer system to see whether the medication has been sent or by checking the orders that have not yet been entered. The technician can also check the automated dispensing system (ADS) to see whether the stock is empty; this can be done from the main pharmacy ADS machine. Teamwork opens channels of communication and improves patient care. 8 Regulatory Agencies The board of pharmacy may impose fines on or close pharmacies that are not in compliance with current laws. Hospitals all must meet federal and state guidelines Department of Public Health sets standards of safe operation State board of pharmacy inspects facilities and ensures that personnel are working within guidelines 9
Regulatory Agencies Agencies that govern operations: The Joint Commission (TJC): Accreditation and inspection Centers for Medicare and Medicaid Services (CMS)The CMS regulates and administers Medicare, Medicaid, CHIP, HIPAA, and several other health-related programs. Department of Health and Human Services (HHS) Department of Public Health (DPH) State Board of Pharmacy (BOP) TJC inspections are performed every 3 years. Hospitals prepare carefully for these inspections, and they work continually to ensure that they meet standards for accreditation. CMS inspects facilities and must give approval for hospitals to provide care and receive reimbursement for patients covered by Medicaid and Medicare. HHS is the primary agency that protects the health of the American people and provides essential human services. Each state s DPH inspects hospitals and hospital pharmacies to ensure that they are in compliance with DPH regulations. State BOPs regulate the pharmacists and pharmacy technicians that work in each hospital facility. TJC accreditation is required to accept Medicare and Medicaid payments. 10 Flow of Orders Orders can include dietary restrictions, laboratory tests, and medications, which a nurse periodically sends to the appropriate area to be filled. Prescriber visits patient in hospital and writes a medication order (equivalent to a prescription) Medication order is written on the prescriber s order sheet and placed in the patient s record (chart) Unit clerk checks chart and sends new orders to appropriate department 11 Patient information: Full name Date of birth Flow of Orders Medical record number Room number Diagnosis, weight Drug allergies The medical record number is the primary way patients are identified, but the other information is used for the necessary secondary verification. Why are room numbers not a reliable way to identify a patient? (Patients might move through three or four units in a single day, from preop, to the OR, to postop, and then to a floor. Therefore, room numbers should be used only to indicate where a prescription is to be delivered, not to whom the prescription belongs.) 12
Flow of Orders Orders arrive in the pharmacy around the clock, 365 days a year Various methods are used to send orders: Pneumatic tube system, computerized physician order entry, fax machine, staff member As orders are entered, labels are produced Name alert stickers are used when two patients with same last name are on same the floor Technician pulls labels off printer and fills order Labels are placed on small zippered baggies for delivery Fragile items, controlled substances, expensive medications, chemotherapy agents, and protein-driven medications should not be sent via a pneumatic tube system because of the risk of breakage or loss. Pneumatic simply means operated by air pressure. A pharmacist checks the medication against the label before it is sent to the patient s floor. 13 Different Types of Orders Stat (meaning at once ): Order must be delivered within minutes; takes precedence over all orders ASAP (meaning as soon as possible ): Not as urgent as stat, but filled before new orders Standing order: Written protocol to be used in specific situations Emergency situation: Order is filled immediately Some stat orders can be filled quickly using stock off the shelf, whereas others may require special preparation, such as the mixing of an IV preparation. For standing orders, if a procedure is to be performed, a preprinted order with the list of medications to be administered is on file for the prescriber to use. This saves the prescriber from having to write the same order each time the procedure is performed. A stat order must be immediately filled; ASAP means as soon as possible, PRN (Latin, pro re nata) means as needed, and SO is a standing order for a specific situation. A standing order is a written protocol for drugs to be administered or treatments to be provided in a specific situation. 14 Computerized Physician Order Entry (CPOE) CPOE can help reduce medication errors. Electronic systems that can quickly and clearly transfer patient orders and information to and from the pharmacy Provide electronic access to medical information and drug information data, limiting errors of transcription 15
Computerized Prescriber Order Entry Medical record numbers are used to identify the inpatient rather than an address and phone number. Medication orders can be clearly identified, and the computer systems check new medications against current medications for interactions or contraindications Health care providers can enter all lab results, dietary requirements, medications, and special notes into the computer 16 Bar Code Point of Entry (BPOE) Each unit of medication is bar coded and can be scanned with a handheld device Nurse is notified of any warnings or special notes Orders are sent in real time Nurse must verify order before administering the drug Information is linked to the pharmacy and electronic medication administration record (E-MAR) systems. Any discrepancy between the current orders and the medications sent for the patient is detected by the scanner, and the nurse is alerted to the specific problem. The nurse s ability to check on dosages at the patient s bedside helps ensure that the five rights of medication safety are followed; it also reduces the time required for charting and creates less paperwork, so the nurse can spend more time attending to the patient. 17 Computerized Adverse Drug Event Monitoring (CADM) Published error reporting is a way to prevent future errors. The CADM system allows more direct and timely communication between nurses, physicians, and patients. Computerized systems can detect and monitor adverse drug events Pharmacies must make sure all medications are bar coded for identification. The information in the computer must accurately reflect the way the dosage form is to be given 18
Institutional Pharmacy Technicians Usually half as many technicians and pharmacists are present on night and weekend shifts, but the patient load often is the same. Flexibility needed to work all shifts; technician must be multifunctional for all shifts IV room Chemotherapy, controlled substances, and patient medication Medication preparation and inventory Miscellaneous duties Specialty tasks: Clinical duties and anticoagulant therapy tasks, preparing nuclear medications 19 Technician s Role in the Investigational New Drug (IND) Process Investigational drug technicians Prehuman and human testing phases Clinical trials Investigational drugs go to the central pharmacy; these are separated from other drugs Often used in hospitals, but under strict regulations Every drug has a logbook An investigational drug is an agent not yet approved by the U.S. Food and Drug Administration (FDA) for use. Clinical trials must be performed after the drug is approved. Why might someone want to participate in a clinical trial? (The patient may have found that none of the currently available treatments have worked, or he or she may want to promote the future development of medications.) Give examples of the information that must be included in the logbook for an IND. (Drug name and strength, unit size, principal investigator, manufacturer s lot number, date dispensed, and pharmacist s initials) 20 Patient Cassette Drawers and Pyxis Patient cassettes are loaded with unit doses of medication that must be removed by the nurse per the order or patient profile. Loading patient cassette drawers from a pick station is a long-standing daily task of the hospital pharmacy technician Medications needed for the next day must be loaded in a cassette drawer Automated floor dispensing systems: Pyxis, SureMed 21
Patient Cassette Drawers Accuracy is greatly increased with automation; in hospitals, most medications are provided this way. Held in large push carts so they may be delivered to the floor each day Robot dispensing machine: Fills each patient s medication cassette with 99% accuracy as the cassette moves along a conveyer belt Speeds up delivery of medication and helps ensure accuracy 22 Automated Dispensing Systems Pyxis MedStation Uses fingerprint scanners for verification Touch screen for medication removal Drawer opens for removal, then closes and records the removal Many ADS similar to the Pyxis MedStation rely on passwords or identification swipe cards to control access. Other products offered by the Pyxis Products division of Cardinal Health include the Pyxis CII Safe system and the Pyxis Oral Solid Packager. 23 Unit Dose Medications/Liquids Liquids can be prepared in syringes to be given as a single dosing by the nurse. Important daily task of pharmacy technicians: Preparation of unit dose medications not available from the manufacturer or stocked by the pharmacy Pharmacist performs the final check Unit dose liquids TJC now requires hospitals to make all medications patient-dose specific Every liquid dose is prepared in a unit dose package and labeled 24
Controlled Substances Counting, dispensing, and tracking narcotics is a critical job Each hospital conducts an actual count of controlled substances by two nurses every shift All controlled substances are counted three times daily Periodic automatic replenishment (PAR) levels: Amounts of medications kept on floors at all times Controlled substances are kept in a locked room in the pharmacy at all times Why are narcotics so tightly controlled? (Narcotics are highly addictive and can lead to heart or respiratory failure; they are also frequently pilfered by staff members.) The technician assesses how many controlled substances are needed to keep each unit close to its PAR level. 25 Controlled Substances All controlled substances must be countersigned off the pharmacy inventory sheet by a pharmacist after they have been signed into a department. After confirmation of the daily narcotic count, the technician signs out each drug onto a dispensing sheet, which is used to deliver medications Controlled substances must be kept unidentifiable during delivery They are placed in stapled brown bags Technician should never let these out of sight 26 Controlled Substances Who besides an RN can sign controlled substances into a department? (A technician) Counting of narcotics is done by a nurse and technician Return of controlled substances to the pharmacy is validated in the pharmacy Registered nurses (RNs), not licensed practical nurses (LPNs), must sign for controlled substances Make sure all numbers are correct 27
Intravenous Preparations When would reconstitution be needed? (Reconstitution is necessary when a patient is allergic to one of the components of IV therapy.) Reconstitution is adding diluent to a powdered drug to make a final product. Printing of IV labels Keeping up with changes in patient status Reconstituting and preparing all IV medications in a horizontal flow hood Delivery of medications to nursing floors 28 Aseptic Technique All technicians periodically are tested on their knowledge of and ability to perform the proper procedures for aseptic technique. Method used to prevent contamination of an object by microorganisms Extremely important in the preparation of all IV medications, chemotherapy, and ophthalmics Samples are periodically tested for microbial contamination 29 Non-Hazardous IV Preparation Parenteral medications: Meant for quick action Some must be prepared with additives Prepared in a laminar flow hood, in a clean room outside the compounding area Nurses on the floor maintain a floor stock of pre-made, large volume bags that can be supplied by central supply or by the pharmacy. Clean rooms buffer the IV admixture room and allow preparation of IV labels and stock to be maintained in a clean yet separate area. Parenteral medications bypass the digestive system but are intended for systemic action; the term parenteral most commonly describes medications administered by injection, such as intravenously or intramuscularly. 30
USP <797> Regulations and Standards Sterile compounding came under federal regulation in 2004 with publication of the U.S. Pharmacopoeia guidelines known as USP Chapter <797>. Enforceable USP regulations for facilities that prepare sterile products, both non-hazardous and hazardous (such as chemotherapeutic drugs) Compounding must be done only in a clean room rated ISO Class 8 or better Glove box isolators can be added 31 IV Therapy and Chemotherapy Preparation A clean room limits the number and size of airborne particles that might come into contact with sterile preparations. Vent hoods provide even better air filtration for compounding in the clean room. Technician is responsible for preparation of IV therapies and chemotherapies Horizontal flow hood: Used to prepare IV medications Orientation of hands must not block flow of air Vertical flow hood: Used to prepare chemotherapeutic drugs Technician must wear gown and double gloves Hands must not move over the top of any vial, needle, or IV bag 32 Horizontal and Vertical Flow Hoods Courtesy NuAire, Plymouth, Minn. 33
Labeling Proper placement of labels ensures visibility of the solution and contents Technician must initial all medications Pharmacist checks each prepared medication before delivery to floors Use of light-protected bags for light sensitive drugs Refrigerated drugs Storage requirements Medication stabilities A pharmacist also must countersign (verify by initialing) all medications. A technician must know these drug requirements, which are not indicated on the labels. How would you reference this additional information? (One source is The Injectable Drug Handbook, which is used mainly in inpatient pharmacies.) BUD stands for beyond-use dating and is assigned to the compounded preparation. 34 Supplying Specialty Areas The pharmacy normally receives floor stock orders from the specialty areas on a daily basis. Expired medications can also be destroyed by an independent company. Floor stock: Supplies kept on hand in units Pharmacies supply special preprinted forms with descriptions of commonly used drugs for specialty areas Outdated medications must be checked monthly Outdated medications are returned to the pharmacy if expiration is within 3 months Manufacturer will credit Outside company is contracted to do drug inventory on expired medications 35 Floor Stock by Department The oncology unit is the main specialty area stocking chemotherapeutic drugs. OR, PACU, wards, clinics stocked with own type of medications ED, OR, ICU stock many drugs in injectable form, also oral and injectable controlled substances 36
Floor Stock by Department Pediatrics: Medications in lower doses and in suspension form Labor and delivery: Injectables meant for labor, contractions, and cesarean births Technician collects and fills all floor stock medications Crash cart and OR trays, boxes, or carts Central supply Trays with specialty medications are prepared ahead of time for the OR, EMS, and for crash carts. Once used, they are sent to the pharmacy for refill or replenish. Another area that stocks supplies for the hospital is central supply. Usually boxes of large volume IVs and mixtures are kept here, in addition to dressings, tubing, and instruments used by various departments. 37 Special Departments Stocked by the Pharmacy Anesthesia Respiratory Injection clinic Radiology Physicians or nurse anesthesiologists administer medications used before and throughout surgery. Therapists administer breathing treatments to hospitalized or clinic patients. Nurses administer adult and pediatric immunizations and perform allergy skin tests. Technicians administer dyes for imaging and may use a medication cart. 38 Future of Institutional Pharmacy Technicians Technicians play an integral role in the institutional pharmacy practice. With continuing education, they become more engaged in their work, which leads to better accountability and greater job satisfaction. American Society of Health-System Pharmacists (ASHP) recognizes trained technicians as the cornerstone to the future Graduating from an ASHP-accredited program ensures the basic level of knowledge needed to gain employment in an institutional setting Increased education to prepare for expanded roles Increased job satisfaction 39