The Hospital Formulary PDF

The Hospital Formulary PharmD Pharmacy Practice-IVA (Hospital Pharmacy) Dr. Syed Saad Hussain  Content Definition and Purpose Format and preparation Role of Pharmacist Benefits and issues  Backgrou...

The Hospital Formulary PharmD Pharmacy Practice-IVA (Hospital Pharmacy) Dr. Syed Saad Hussain  Content Definition and Purpose Format and preparation Role of Pharmacist Benefits and issues  Background  Concept came into being in 1964 through guiding principles of ASHP Multiplexity of medication Increase in the cost of medications No documented line of communication among healthcare teams  Definition “The hospital formulary is a list of pharmaceutical agents with its important information which reflects the current clinical views of the medical staff.” The hospital formulary system is a method whereby the medical staff of a hospital with the help of pharmacy and therapeutic committee selects and evaluate medical agents and their dosage form which are considered to be most useful in the patient care. The hospital formulary system provides the information for procuring, prescribing, dispensing and administering of drugs  Definition A formulary is a list of drugs approved for use in a given setting, such as within: – Hospitals and Health Systems – Employer Groups – Government agencies (Medicaid, VA system) Dictates prescription drug/class coverage and/or the level of coverage (i.e. patient copayment) The system is the basis of appropriate, economical drug therapy  Purpose The creation and continuous evaluation of a hospital’s formulary facilitates – Superior patient care, – Achieves therapeutic goals, – Improves patient safety – Curtails expenses  Objectives Information of drug products that are approved by P&TC Basic therapeutic information Information on hospital policies and procedures governing the use of drugs Special information – Hospital approved abbreviations – Sodium contents etc,  Development of the Formulary The formulary generally: Offers one or more therapeutic options per disease category Facilitates purchasing and prescribing Helps manage cost by reducing duplication Formularies are often used as a negotiating tool with drug manufacturers Drug manufacturers may offer discounts (i.e. rebates) for drugs that are placed on the formulary  Development of the Formulary Content and Organization The formulary generally has three parts: Part One: Information on therapeutic policies Part two: Drug product listings Part three: Special information  Development of the Formulary Content and Organization Part One: Information on therapeutic policies Regulations regarding prescribing, dispensing and administration of drugs – Automatic stop orders – Restricted antibiotic use – Information on the use of formulary – Stat orders, emergency kits – Out prescription policies – Arrangement of non formulary medications – Request of addition of new drugs to formulary  Development of the Formulary Content and Organization Part two: Drug product listings Heart of formulary Contains the list of approved medications/products from P&TC – Generic name – Common synonyms or trade name – Dosage form, strength – Formulation – Identification no (if any)  Development of the Formulary Content and Organization Part three: Special information Can be part of drug product Vary hospital to hospital Contains – Dosage range – Special caution – Controlled or uncontrolled medicine – Monitoring information – Conversion metrics scales or tables  Development of the Formulary Preparation – Prepared by Pharmacist in chief (Director) – Prime responsibility of P&TC (approval) – Selection is based on need of hospital – Type of format Loose leaf or bound – Open or closed formulary – Policies on prescribing – Procedure of dispensing medications  Development of the Formulary Selection of medicines 1. Proven efficacy and use in the healthcare setting 2. Drug should be recognized by national formulary 3. Manufacturer should be one with proven integrity and dependability as well capable of conducting research 4. No secret composition preparation is allowed to be included in formulary 5. Multiple medications with similar therapeutic efficacy should be incorporated 6. Products with multiple composition  Development of the Formulary Format and Appearance Physical appearance and structure influence its use Should be visually pleasing, easily readable and professional Can be made attractive by – Different color page used for different sections – Using edge index – Making pocket size – Standout letter formatting  Development of the Formulary Format and Appearance Minimum composition – Title page – Names and title of P&TC committee – Table of contents – Information on hospital policies and procedures on drug use – Products approved for use in health care facility  Development of the Formulary Additional Considerations Outcomes-Based Agreements/Contracts Pharmacogenomics and Biopharmaceuticals Biosimilars Lifestyle Drugs Higher Tiers/Multiple Tiers Co-Insurance Health Savings Accounts  Development of the Formulary Distribution Each patient care unit Each division of pharmacy Each member of medical staff HOD of each department should get a personal copy  Potential Demerits Deprive the physician of his right and privilege to prescribe and obtain the brand of his choice: Permits the pharmacist to act as the sole judge of which brands of drugs are to be purchased & dispensed. Can be basis of purchase of inferior medicine and supplies Does not transfer the cost benefit to the patients  Advantages Therapeutic Economic Educational  Therapeutic benefit Most efficient products are listed and available Rationale drug use is promoted Single line of therapeutics is followed through rules and regulations  Economic benefit Eliminates duplication Beneficial for volume purchases Reduces drug expenses  Educational benefit Has prescribing tips Administration education (in case of high alert medications) Additional information regarding pharmacodynamics and pharmacokinetics  Role of Pharmacist Major role in development of formulary Evaluating medications for inclusion in the formulary – Evidence-based evaluation – Pharmacoeconomic assessments – Formulary exceptions  Role of Pharmacist – Cost-Effectiveness Analysis. A method for assessing the gains in health relative to the costs of different health interventions. – Cost Utility Analysis. A comparison of the costs of different procedures with their outcomes measured in “utility based” units—that is, units that relate to a person’s level of well-being and are most often expressed as qu ality adjusted life year  Role of Pharmacist – Generic Substitution. The substitution of drug products that contain the same active ingredient or ingredients and are chemically identical in strength, concentration, dosage form, and route of administration to the drug product prescribed – Medication-Use Evaluation. A systematic and interdisciplinary performance improvement method with an overarching goal of optimizing patient outcomes via ongoing evaluation and improvement of medication utilization  Role of Pharmacist – Therapeutic Alternatives. Drug products with different chemical structures but of the same pharmacologic or therapeutic class and usually have similar therapeutic effects and adverse reaction profiles when administered to patients in therapeutically equivalent doses  Role of Pharmacist Formulary Changes A process to continually update the formulary must be established. Process should include a method for making additions and deletions to the formulary. This process typically involves the submission of a request for formulary addition or deletion from the pharmacy or medical staff. This request may be written or verbal. Requests generally require specific information. – Agent to be considered for addition or deletion. – Rationale for request. This should include the impact on the cost and quality of patient care. – Alternative agents currently on the formulary Thank you Dispensing to Ambulatory Patients PharmD Pharmacy Practice-IVA (Hospital Pharmacy) Dr. Syed Saad Hussain  Content Definition and Type of Ambulatory Care Pharmaceutical Services in Ambulatory Care Setting Minimum Standard for Ambulatory Care Pharmaceutical Service Residency Training in Ambulatory Care Process of Dispensing in Ambulatory Care  Definition  Ambulatory Patients refers to Patients not occupying beds at a hospital  Physician’s office  Clinics  Health centers  Can be classified into  Emergency  Referral or Tertiary Care  Primary Care  Definition Emergency Care Self explanatory Services provided after the sudden onset of a medical condition manifesting itself by acute symptoms of sufficient severity (including severe pain) that the absence of immediate medical attention could reasonably be expected to result in: a) Placing the patient’s health in serious jeopardy; b) Serious impairment to bodily functions; c) Serious dysfunction of any bodily organ or part  Definition Tertiary Care Tertiary care is specialized consultative health care, usually given to inpatients. Basic evaluation is done in primary care Include complex procedures and interventions May be long term care  Definition Primary Care Majority care Daily personal health needs Includes prevention health and initial care Basic health evaluation General discomfort Early complaints, symptoms & issues  Ambulatory Care Growth attributes Supplementation of in-patients teaching programs Demands of population growth and increase in access to healthcare services Community health program participation Focus on primary care  Ambulatory Care Pharmaceutical Services  ASHP statement –  Ambulatory care encompasses the provision of health care service and education to patients who seek medical attention but do not require admission  Patient oriented pharmaceutical services is deemed required  Directors are responsible to develop and maintain comprehensive pharmaceutical service  Ambulatory Care Pharmaceutical Services  Activities Include  Obtaining and Documenting patient medication histories  Monitoring safety and efficacy of drug therapy  Providing drug information  Assisting prescribers in proper selection and adjustment of drug therapies  Detecting and reporting adverse drug reactions, interactions and non – compliant behavior of patients  Ambulatory Care Pharmaceutical Services  Activities Include  Participation in drug utilization reviews, patient care audits and clinical drug investigations  Participation in Educational projects  Supervision in storage, preparation, dispensing and administration of medication in patient care area  Developing system of delivery of pharmacy services in institution and community  Developing and utilizing system for finances and reimbursement  Ambulatory Care Minimum Standards  Must be directed by a qualified pharmacist  Appropriateness of therapy should be verified by pharmacist  Prevention of duplication of drug therapies and contraindications  All medicines dispensed to patients are correctly and completely labelled and in accordance with all applicable regulations and standards of practice  Upon receipt, it is responsibility of pharmacist to ensure patient or caretaker’s understanding related to use of medicine  All drugs in ambulatory care service are properly controlled  Ambulatory Care Supplemental Standards  Residency program  Post graduate program of training  Provision of training in providing clinical pharmacy services to ambulatory care patients  Training site should include institutional ambulatory care settings, satellite clinics  Should have minimum standards of ASHP  Ambulatory Care Supplemental Standards  Specific requirements for ambulatory care service program  Medical Records – Accessible on real time  Drug Information Resources – Centralized medical literature  Well Defined Scope  Preceptors  Review of Quality  Area of Emphasis should be directed towards solving clinical problems  Program should also focus on drug literature analysis and associated communication skills  Program should incorporate research and rotation among departments  Ambulatory Care Location of Dispensing Are  No specific rule a  Best to establish separate out patient dispensing area if the scope of geography is separate  Specialized services  Disadvantage of separate staff  Can be merged with in patient dispensing area with similar window or separate window  Ambulatory Care Types of Prescription  Depends on location and kind of hospital  Private patients  Indigent patients (patients having no insurance – welfare patients)  Prescription needed to be identified  Employees  Discharged patients  Ambulatory Care Dispensing Routine  For Ambulatory care, it is similar in both discharge and community care  Patients take written prescription by the Physician, which is given to the pharmacist where it is dispensed.  The pharmacist guarantees that the patient gets the right medication.  The pharmacist gives instructions to the patient about dispensed medicine.  Labeling of medicine.  Maintenance of payments by Pharmacist.  Finally, payment by the patient.  Ambulatory Care Dispensing Routine  Ambulatory Care Labelling Requirement  Vary according to federal laws  Minimum standards follow presence of  Name, address, and telephone number of the pharmacy;  Date of dispensing; serial number of the prescription;  Patient’s full  Name; name, strength, and dosage form of the medication;  Directions to the patient for use of the medication; authorized refills  Name of the prescriber;  Precautionary information;;  Initials (or name) of the responsible pharmacist  Ambulatory Care Medication Orders  All medication orders shall be reviewed for legality and clinical appropriateness by a pharmacist before being dispensed  Medication orders (or prescriptions) shall contain at a minimum the following information  Patient name and address; medication name, dose, frequency, Route, and quantity or duration;  Prescriber name, address, and telephone number; and prescriber DEA number for controlled substances  Any discrepancies to be resolved and Information concerning changes should be appropriately communicated to the patient, caregiver, and other involved healthcare providers  Ambulatory Care Home Care Routine  Home care prescriptions are dispensed and refilled from the ambulatory pharmacy as a service to this patient population.  Assessment of drug therapy is done during each dispensing of a new or refilled prescription including  Allergies, adherence, duplicate therapy,  Untreated conditions and over/under-dosing, taking renal and hepatic function.  Drug-drug, drug-food, drug-disease interactions  Ambulatory Care Home Care Routine  Criteria is established by relevant authorities  Criteria for a patient to have a home medicines review are one or more of the following. (Examples)  Currently taking 5 or more medications or 12 doses or more in a day.  Significant changes made to medication regimen in the last 3 months.  Medications with a narrow therapeutic index or medications requiring monitoring.  Symptoms suggestive of an adverse reaction.  Sub-therapeutic response to treatment with medicines.  Suspected non-adherence to prescribed medications or inability to manage medication related therapeutic devices.  Having difficulty managing their own medicines.  Attending several different doctors, both general practitioners and specialists.  Ambulatory Care Vaccination Services  Also known as immunization  Now part of community services  Verification of vaccination order is responsibility of pharmacist  Why pharmacist  The epidemiology of and patient populations at risk for vaccine-preventable diseases  Public health goals for immunization (e.g., local, regional, state, and federal goals)  Vaccine safety (e.g., risk–benefit analysis)  Screening for contraindications and precautions of vaccination in each patient  Vaccine stability and transportation and storage requirements  Immunologic drug interactions  Ambulatory Care Dispensing to Emergency Patie nts  Prescription is handled in the same pattern  Concept of pre packaged medication bins  Life saving medication are kept in areas of ready access  24 hours supply is maintained and dispensed as pre labelled medication  Injectable and irrigation solutions  Cardiac emergency medicines  Ambulatory Care Summary  Type of Patient Care  Minimum standards and supplemental standards  Pharmaceutical service  Dispensing routine Thank you Dispensing during off hours PharmD Pharmacy Practice-IVA (Hospital Pharmacy) Dr. Syed Saad Hussain  Content Dispensing revision Off hours Dispensing methods during off hours  Drug dispensing review Drug dispensing is the preparation, packaging, labeling, record keeping, and distribution of a drug or medicine to a patient or an intermediary, who is responsible for administration of the drug. Otc drugs or medicine Prescription medicine Control drug substances.  Drug dispensing review Drug dispensing elements and activities Evaluate and validate prescription. Checks prescriptions are complete, legal and authentic. Obtains information needed to make prescriptions complete and correct. Verifies prescriptions received by fax, telephone or email Assess prescriptions Determines whether individual prescriptions should be dispensed or not Priorities prescriptions. Determines the stock availability of prescribed medicines.  Drug dispensing review Correct dispensing procedures Evaluate and Validate prescription. Review prescribed medicine. Check the drug safety. Fill prescription accurately. Package medicines to optimize safety. Calculate and inform total cost of the drugs. Maintain dispensing record. Hand over the dispensed drugs properly with Patient counseling regarding proper usage and storage. Note: Avoid dispensing without a prescription, incomplete , confuse and prescription from an unauthorized prescriber.  Drug dispensing review Dispensing Cycle 5. Issue medicine to patient with 1. Receive and validate clear instructions and advice prescription 2. Understand and 4. Make a final check interpret prescription 3. Prepare and label items for issue 6  Categories of dispensing errors Wrong dispensing of medicines could be categories as follows: Dispensing Error may cost a life (hypothetical case) For the wrong patient The wrong medicine A patient visits the pharmacy with a Maxalon - antiemetic prescription. Due to The wrong drug strength poor handwriting the dispenser could only The wrong quantity make out the first letter i.e. “M” and the last letter “n”. The wrong dosage form The dispenser is unable to interpret the Expired drugs name correctly and dispensed a medicine Incorrect drug strength that he knew of starting with the letter “M” and ending at “n”. The dispenser dispenses The wrong information on the label “Marevan” tablets – an antiplatelet/blood thinning tablet and the patient dies of Incorrectly compounded medicine. excessive bleeding.  Dispensing errors Potential errors can be reduced by 1. Readable handwriting or computer generated prescription. 2. Interpret prescription carefully or clear oral communications. 3. Writing complete drug orders. 4. Do not hesitate to contact prescriber for any clarification. 5. Use generic and brand names when possible. 6. Do not abbreviate drug names. 7. Specifying the route of administration.  Dispensing errors Potential errors can be reduced by 7. Use TALL MAN lettering in drug name. 8. Specifying the drug strength, e.g. 100mg. 9. Never abbreviate unit as "U": Spell out "unit“. 10. Never use a trailing zero: 1mg, not 1.0mg. 11. Never leave a decimal point "naked": Use 0.25mg or 250 microgram, not.25mg. 12. Specifying directions for when required medicines, include frequency, total daily dose and indication for use.  Dispensing errors STRATEGIES FOR MINIMIZING DISPENSING ERRORS 1. Confirm that the prescription is correct and complete It is important to call the prescriber to clarify any uncertainties or doubts regarding the prescription. 2. Beware of look-alike, sound-alike drugs (LASA) A new, unfamiliar drug may be read as an older, more familiar one. Some of these errors are fatal. 3. Be careful with zeros and abbreviations Misplaced zeros, decimal points, and faulty units are common causes of medication errors due to misinterpretation. 4. Organize the workplace properly Proper lighting, adequate counter space, and comfortable temperature and humidity can help facilitate a smooth flow from one task to the next, thus reducing the chances of dispensing errors.  Dispensing errors STRATEGIES FOR MINIMIZING DISPENSING ERRORS 5. Reduce distraction and multitasking when possible Avoid multitasking and distractions Improve the internal environment 6. Focus on reducing stress and heavy workloads Regular breaks Sharing responsibilities 7. Take the time to properly store the drugs and other items in shelves and refrigerator. Store lookalike drugs away from each other Lock-up drugs with a high potential of error  Dispensing errors STRATEGIES FOR MINIMIZING DISPENSING ERRORS 8. Thoroughly check the dispensed prescriptions (Triple Check System) Repeated checking and counterchecking is an important strategy to minimize dispensing errors. It is advisable to have the rechecking done by another person, typically a pharmacist. If this is not possible, delayed self-checking rather than continuous self-checking is an alternate strategy. 9. Always provide thorough patient counseling/ guidance Counselling should also include the instructions on how to take the medication and appropriate route of administration. Educating patients about safe and effective use of their medication promotes patient involvement in their health care, which will likely reduce medication errors  OFF HOUR DISPENSING It was always criticized that the pharmaceutical services should be for 168 hours per week (24 hours). In hospitals where there is no round the clock pharmaceutical service, or no enough pharmacists are available. The procurement and distribution of the drug and ancillary supplies could be according to the different processes.  OFF HOUR DISPENSING Use of Nursing Supervisors Most common method, the evening and or night nurse supervisor (s) enters a limited portion of the pharmacy and get the required medicines. It is although the most widely used but most criticized and illegal practice in some hospitals. Pharmacy has to be made in such a way that secures a portion of the pharmacy that has to be separated from the permitted area. Should be used with caution  OFF HOUR DISPENSING Emergency Boxes Some large teaching hospitals or tertiary care hospitals have given the concept of “emergency carts” and “resuscitation carts” having all the supplies present on the emergency bases with addition of the resuscitation items like suction catheter, surgical supplies and the administration of oxygen. The pharmacist has to maintain the emergency ward pharmacy and especially for the drugs which are deteriorated in units must be checked periodically. For this an inventory checklist card is placed in the emergency box , which gives the information about last check, maintains the inventory and provides information to the nurse about the replenishment of the inventory.  OFF HOUR DISPENSING Emergency Boxes Emergency box also known as “STAT BOX” is an integral part of even 24-hour pharmacy but in small hospitals. It also could be placed by expand the inventory of the necessary supplies required by each floor / ward in the hospital. The box should be placed in an accessible place known to all ward personnel. The nurse withdraw the medicine and medical items charge on the Pt. file for drugs used and send it to pharmacy for the record purpose.  OFF HOUR DISPENSING Night Drug- Supply Cabinets It is adjunct to charge floor stock medications on each floor. It could be a simple cabinet or a large installation that include a narcotic vault and refrigerated compartments. The night supply cabinets could be constructed along the wall of the pharmacy so that it could be accessed from inside the pharmacy ( for pharmacy staff ) and from the outside for nursing staff. The pharmacy must maintain the cabinets inventory periodically. The nurse must maintain a inventory card mentioning the quantity of the drug removed form the cabinet and to whom it is administered, the pharmacy checks the inventory for patient billing when used and missing items.  OFF HOUR DISPENSING Use of Physician More drawbacks hence this system is discouraged One of the factor is burden and shortage of physicians Unfamiliar surroundings for physician in pharmacy  OFF HOUR DISPENSING Pharmacist-On-Call Organizations contracts with the pharmacist to serve them round the clock if required by visiting the pharmacy on call. This may be supported by some bonus or extra payment plan or allowance. This may be on rotational plan so not to burden any individual. This may be utilized by more than one institute in a community.  OFF HOUR DISPENSING Purchased Service (Community Pharmacy acquired services) In hospitals where there is limited staff pharmacists or the pharmacists are on leaves the hospital may obtain the services of the community pharmacy for drug supply in the hospital called off site pharmacy service. In selecting a pharmacy in a community where more than one pharmacy is established, a bid should be invited by the pharmacies for pre-described pharmaceutical services to avoid any politics or favouritism  OFF HOUR DISPENSING Reasons for switching from off hour dispensing to full time service Provide continuity in following services – Drug information and monitoring – IV admixture – Unit dose programs – Prevention of medication errors – Provide medication to night staff which is least experienced Thank you Distribution of Controlled Substances PharmD Pharmacy Practice-IVA (Hospital Pharmacy) Dr. Syed Saad Hussain  Content Controlled substances Laws applicable to controlled substances Distribution and dispensing of controlled substances  Controlled Substances A drug or other substance that is tightly controlled by the government because it may be abused or cause addiction. The control applies to the way the substance is made, used, handled, stored, and distributed. Controlled substances include opioids, stimulants, depressants, hallucinogens, and anabolic steroids. Controlled substances with known medical use, are available only by prescription from a licensed medical professional  Controlled Substances Division of controlled drugs, DRAP in consultation with the ministry of narcotics control is responsible for regulation and allocation of quota of narcotic drugs, psychotropic substances and precursor chemicals A number of psychoactive/chemical entities having important therapeutic uses are regulated internationally through UN Conventions There are three categories of controlled substances, namely: – Narcotic Drugs Psychotropic Substances Precursor Chemicals  Regulation of Controlled Substances Laws: Controlled substances (used as medicines) are regulated under:- DRAP Act, 2012. Drugs Act, 1976. Control of Narcotic Substances (CNS) Act, 1997 and rules framed thereunder  Distribution of Controlled Substances Fundamentals In the secure management of controlled substances, the following fundamental principles apply to all facilities and departments: Controlled substances are securely stored and handled throughout the medication management system, from the point of ordering to the time of administration or destruction Accurate and complete records of all transactions involving a controlled substance are maintained in a timely manner All manual documentation is made in indelible ink. There is a clear chain of signatures showing transfer of responsibility at each transition point. Records can be easily audited. All staff members check for completeness and accuracy of the records  Distribution of Controlled Substances Fundamentals Quantities of controlled substances are kept to the minimum needed, according to the patient population and degree of urgency. Only authorized staff handle, prescribe, or have access to controlled substances. Controlled substances are stored in restricted areas, such as locked rooms, carts, or fridges. All keys are accounted for at all times. Systems are set up to ensure that each user is uniquely identified and every transaction can be traced to a user.  Distribution of Controlled Substances Inventory Management Key principles of successful inventory management include keeping stock secure at all times, Maintaining accountability and sign-offs by authorized staff at all transition points, and Checking for completeness of an order and integrity of the product at all transition points Consideration should be given to maintaining the lowest amount of inventory possible while ensuring reasonable and timely access  Distribution of Controlled Substances Inventory Management The following factors are to be considered when determining the drug needs of a healthcare facility or a patient care area: medical conditions being treated; local protocols, pathways, and care maps; drug formulary and formulary policies utilization and prescribing patterns; range of dosing (e.g., pediatric vs adult care; acute vs chronic pain management) availability and capacity of secure storage; travel time between receiving department, pharmacy, care units, and other sites;  Distribution of Controlled Substances Inventory Management Once inventory levels are established, drug-use patterns should be periodically reviewed to assess the following:: Minimum and maximum stock levels; Changes in utilization trends; Changes in clinical practice or patient mix; Changes in regulatory requirements (e.g., schedules); Issues such as medication safety incidents that may shed light on potential for misuse or diversion of controlled substances;  Distribution of Controlled Substances Procurement A licensed dealer (e.g., manufacturer or distributor) shall supply a hospital with a controlled substance Manual Procurement Process Manual ordering should be minimized. When a manual procurement process is used, the forms used to purchase controlled substances should be sequentially prenumbered and closely controlled using a log Under no circumstances should blank purchase orders or requisitions for controlled substances be pre-signed or left unsecured. Electronic Procurement Process Only restricted to individual authorized Should have unique access code to order controlled substances  Distribution of Controlled Substances Storage Controlled substances maintained in the pharmacy department shall be stored a manner that Ensures their physical security, Adheres to the recommended storage conditions for the drug, and Meets relevant standards (e.g., from accreditation or regulatory authorities) Access to controlled substances or the areas where they are stored should be further limited to designated pharmacy staff. The issue of access and the list of individuals who may enter these areas should be specifically addressed in the facility’s policies and procedures  Distribution of Controlled Substances Storage In Patient Care Areas Should use a double or triple lock procedure The medication room door and the locked cupboard should never have the same lock, so this two-key system is desirable from both security and medication control standpoints. Alternatively, controlled substances may be stored in locked drawers in medication carts used to deliver the drugs to patients but it should never be left unattended  Distribution of Controlled Substances Dispensing Each formulation and container type should have a separate record within the perpetual inventory. As the drug is manipulated, each “new” type of repackaged or compounded drug requires a new inventory record. For each medication movement, the pharmacy record should include the following information: date; time of issue; patient care area; drug name, strength, and dosage form; quantity delivered or returned; and names and signatures of pharmacy and patient care area staff involved.  Distribution of Controlled Substances Dispensing For each medication movement, the record in the patient care area should include the following information: ▪ date; ▪ time of receipt; ▪ “Issued by Pharmacy” or “Returned to Pharmacy” (to indicate the direction of movement); ▪ Drug name, strength, and dosage form; ▪ Quantity added or subtracted from inventory in the patient care area; ▪ New Balance” (total after the addition or subtraction has been completed); ▪ Names and signatures of pharmacy and patient care area staff involved. Distribution of Controlled Substances  Distribution of Controlled Substances Model set of hospital control procedures Responsibility for controlled drug substances in hospital Administrator is responsible for the proper safeguarding and handling of controlled substances in the hospital Pharmacist in chief is responsible for purchase, storage, accountability and proper dispensing of controlled substances Registers must be maintained for dispensing of controlled substances Ward stock for controlled substances Stock is replaced by duly signed sheet and provision of empty vials Each request for new supply is therefore accompanied by controlled drug administration form For any drug that is lost or wasted, the nurse incharge must prepare incident form  Distribution of Controlled Substances Model set of hospital control procedures Doctor ’s order for administration of controlled drug Duly signed by physician in non edible ink Prescription can only be written by licensed and authorized physician or registered resident  Distribution of Controlled Substances Model set of hospital control procedures PRN or SOS orders Should be discouraged and non- entertained Telephone or Verbal orders Only during necessity, nurse can write the order which should be signed by physician within 24 hours  Distribution of Controlled Substances Miscellaneous Regulations Ward supplies of controlled medicines should only be used for patients on ward Narcotic prescriptions are not refilled Prescription is retained for records Physician may not prescribe narcotics for personal use  Distribution of Controlled Substances Control of Narcotics by Nurses Narcotics are audited for count and use in every shift change Every shift has designated nurse for narcotics control Both the nursing staff from new and old shift sign the records If discrepancy found, it should be reported to pharmacy  Distribution of Controlled Substances Research Use Personnel involved in research are to be registered under DRAP rules If there are more than one locations, each location has to be registered separately Each personnel has to keep records of research and controlled substance used Receipt records Dispensing records Administration records Thank you Dispensing to Inpatients PharmD Pharmacy Practice-IVA (Hospital Pharmacy) Dr. Syed Saad Hussain  Content Systems of Inpatient dispensing Central and Satellite pharmacy Unit dose dispensing Self medication programs  Inpatient Dispensing Why inpatient dispensing  Reduce the nursing time consumption for frequent visits to pharmacy  Drug dispensing is a pharmacy act and consists of the pharmacist removing two or more doses from a bulk drug container and place them in another container for subsequent use.  Drug administration is a nursing act which consists of the removal or withdrawal of a single dose from the drug container and its administration to a patient on the order of a physician or dentist  Inpatient Dispensing ASHP guidelines  Before the initial dose of medication is administered the pharmacist should review the prescriber’s original order or a direct copy.  Drugs dispensed should be as ready for administration to the patient as the curre nt status of the pharmaceutical technology will permit, and must bear adequate identification including; name or names of drug, strength, or potency, route(s) of administration, expiration date, control number, and such other special instructions as may be indicated.  Facilities and equipment used to store drugs should be so designed that the drugs are accessible only to medical practitioner authorized to prescribe, to pharmacist authorized to dispense, or to nurses authorized to administer such drugs.  Inpatient Dispensing ASHP guidelines  Facilities and equipment used to store drugs should be designed to facilitate routine inspection of the drug prior to the time of administration.  When utilizes automated (mechanical/electronic) devices as pharmaceutical tools, it is mandatory that provision be made to provide suitable pharmaceutical services in the event of failure of the device  ASHSP pronounced that the pharmacist in charge shall be responsible for specifications both as to quality and source for purchase of all drugs, chemicals, antibiotics, biological and pharmaceutical preparations used in the treatment of patients.  Since the pharmacist has the responsibility for the compounding, dispensing and manufacture of the drugs used in the hospital, he should also have the authority to specify the drugs used to be purchased  Inpatient Dispensing ASHP guidelines  Mechanical or electronic drug storage and dispensing devices, as require or encourage the repackaging of drug dosage form from the manufacturer’s original container, should permit and facilitate the use of a new package, which will assure the stability of each drug and meet USP standards for the packaging and storing of the drugs, In addition to meeting all other standards of good pharmacy practice  Inpatient Dispensing Different systems of dispensing  There are four systems in general for dispensing drug for inpatients. They may be classified as follows; i. Individual prescription order system ii. Complete floor stock system iii. Combination of (i) and (ii), and iv. The unit dose system.  Inpatient Dispensing Individual Prescription Order System  This system is generally used by the small and/or private hospital because of the reduced manpower requirement and the desirability for individualized service. Inherent in this system is the possible delay in obtaining the required medication and the increase in cost to the patient.  At the same time there are very definite advantages: A. All medication orders are directly reviewed by the pharmacist B. Provides for the interaction of pharmacist, doctor, nurse and patient and C. Provides closer control of inventory.  Inpatient Dispensing Complete Floor Stock System  Regardless of the size of the hospital or specialty of care a supply of drugs is stored in the medicine cabinet of the nursing unit which is serviced by a unit dose system. And the drug stored in the nursing station depending upon the specialty of care is term as floor stock drugs. It should be in minimum quantity.  Drugs in the nursing station may be divided into: a) Charged floor stock drugs,  Envelope method / Charged plate b) Non-charged floor stock drugs.  Drug basket method  Mobile dispensing unit  Inpatient Dispensing Complete Floor Stock System  Advantages i. Ready availability of the required drugs; ii. Elimination of drug returns; iii. Reduction in the number of drug order transcriptions for the pharmacy iv. Reduction the number of pharmacy personnel required.  Inpatient Dispensing Complete Floor Stock System  Disadvantages i. Medication errors may increase because the review of medication orders is eliminated; ii. Increased drug inventory on the pavilions; iii.Greater opportunity for pilferage (to steal small items of little value, especially habitually); iv.Increased hazards associated with drug deterioration; v. Lack of proper storage facilities on the ward may require capital layout to provide them vi.Greater inroads (a gradual violation) are made upon the nurses’ time.  Inpatient Dispensing Complete Floor Stock System  Envelope method i. Prefilled envelopes – Predetermined quantity on nursing units  Post administration it is charged on patients  Like emergency carts  Inpatient Dispensing Complete Floor Stock System  Drug Basket Method i. Basket with medicine containers which is replenished on timely basis  Mobile Dispensing unit i. Utilizes specially constructed mobile unit consisting of shelves ii. Always under supervision of professional personnel iii.Routine checking of stocks  Inpatient Dispensing Combination of Individual Prescription Order and Complete Floor Stock systems  Falling into this category are those hospital which use the individual prescription or medication order system as their primary means of dispensing, but also utilize a limited floor stock. This combination system is probably the most commonly used in hospitals today and is modified the use of unit dose medications.  A list of non-charge and charged floor stock is prepared on the basis of following criteria:  The cost of preparation  The frequency of use  The quantity use  The hospital budget  Inpatient Dispensing Unit Dose Dispensing System  The unit dose system of medication distribution is a pharmacy-coordinated method of dispensing and controlling medications in health care institutions.  It is defined as- Those medications which are ordered, packaged, handled administered and charged in multiples of single dose units containing a predetermined amount of drug or supply sufficient for one regular dose, dose application or use.’  Types A. Centralized unit-dose dispensing (CUDD) B. De-centralized unit dose dispensing (DUDD) – Satellite Pharmacies  Inpatient Dispensing Unit Dose Dispensing System  The unit dose system may differ in form depending on the specific needs of the institution. However, the following distinctive elements are basic to all unit dose system:  Medications are contained in a single unit packages  They are dispensed in as ready-to-administer form as possible  For most medications not more than a 24 hours supply of doses is delivered to or available at the patient-care area at any time.  Safer for the patient  More efficient and economical for the institution,  More effective method of utilizing professional resources.  Inpatient Dispensing Unit Dose Dispensing System  Advantages of Unit Dose System  Patient receive improved pharmaceutical services 24 hours a day and are charged for only those doses which are administered to them.  All does of medication required at the nursing station are prepared by the pharmacy thus allowing the nurse more time for direct patient care  Allows the pharmacists to interpret or check a copy of the physician’s original order thus reduction the incidence of medication errors  Eliminates excessive duplication of orders and paper work at the nursing station and pharmacy.  Inpatient Dispensing Unit Dose Dispensing System  Advantages of Unit Dose System  A reduction in the size of drug inventories located in patient-care areas (eliminates bulky floor stock)  Greater adaptability to computerized and automated procedure regarding medication orders and delivery system.  The pharmacists can get out of the pharmacy and onto the wards where they can perform their intended function as drug consultants and help providing the team effort that is needed for better patient care.  Inpatient Dispensing Unit Dose Dispensing System  Advantages of Unit Dose System  Decrease in the total cost of medication related activities  Transfers intravenous preparation and drug reconstitution procedure to the pharmacy  Improved overall drug control and drug use monitoring  More accurate patient billing for drugs  The elimination or minimization of drug credits  Greater control by the pharmacist over pharmacy workload patterns and staff scheduling  Inpatient Dispensing Unit Dose Dispensing System  Centralised unit-dose dose dispensing (CUDD):  All in-patient drugs are dispensed in unit doses and all the drugs are stored in central area of the pharmacy and dispensed at the time the dose is due to be given to the patient on or minimization of drug credits  Drugs are transferred from the pharmacy to the indoor patient by medication cards.  Inpatient Dispensing Unit Dose Dispensing System  Decentralized unit dose dispensing: (DUDD): - Satellite Pharmacies  This operates through small satellite pharmacies located on each floor of the hospital  Advantages:  Disadvantages:  Easy for the administration staff.  High cost.  Accounting becomes easier in certain cases.  Consumes more time and doubtful.  Better stability of the products  Occupy more space for storing.  Ex-Eno-fruit salt in sachets.  Ledger posting and inventory control problem  Inpatient Dispensing Step-by-Step outline of Unit Dose Procedure 1. Upon admission to the hospital, the patient is entered into the system. Diagnosis, allergies and other pertinent data are entered on to the patient profile card. 2. Direct copies of medication orders are sent to the pharmacist 3. The medication order are entered on to the patient profile card 4. He pharmacist checks medication order for allergies, drug interaction, drug interactions, drug laboratory test effects and rationale of therapy 5. Dosage schedule is coordinated with the nursing station  Inpatient Dispensing Step-by-Step outline of Unit Dose Procedure 6. Pharmacy technician picks medication orders, placing drugs in bins of transfer cart per dosage schedule 7. Medication cart is filled for particular dosage schedule delivery. 8. Pharmacist checks cart prior to release 9. The nurse administers the medication and makes appropriate entry on the medication record 10. Upon return to pharmacy, the cart is rechecked 11. Throughout the entire sequence, the pharmacist is available for consultation by the d octors and nurses. In addition he/she is maintaining surveillance for discontinued ord ers.  Inpatient Dispensing Other concepts  Patient servers  Drawers in hallway for each wards  Advantage for access but expensive  Pill pick systems  https://www.youtube.com/watch?v=8WFIKfqJYvw  Robotic dispensing  https://www.youtube.com/watch?v=CmFIhAb1fDQ Thank you Safe Use of Medication in the hospital PharmD Pharmacy Practice-IVA (Hospital Pharmacy) Dr. Syed Saad Hussain  Content Medication error and its types Factors contributing to medication error and corrective measures Unit dose dispensing ASHP guidelines related to safe use of medications  Medication Error Why inpatient dispensing Medication errors are errors or mistakes in the medication use process (prescribing, dispensing, administering of drugs) that may result in negative outcomes. Difference between drug related problems and Medication Error DRPs are medication errors because problems in medication use can occur even when best medication practices are applied. For example, side effects are DRPs that occur through no one’s mistake—indeed, they are expected, unavoidable reactions of the appropriate use of many drugs (e.g., potential upset stomach associated with non steroidal anti-inflammatory drugs).  Medication Error Why inpatient Classification dispensing of Medication Errors  Prescribing errors occur when prescriptions have an incorrect drug selection, dose, dosage form, quantity, route, concentration, rate of administration, or instructions for use of a drug product. These include illegible prescriptions or medication orders that lead to errors that reach the patient.  Dispensing errors are mistakes made during the dispensing process where a patient receives the wrong drug, the correct drug for the wrong patient or wrong dose.  Administration errors occur when patients are administered something other than that prescribed for the patient—the wrong dose, omitted dose, additional dose, wrong administration time, incorrect handling of drugs during administration, or wrong infusion rate.  Medication Error Why inpatient Classification dispensing of Medication Errors  Monitoring errors result from the failure to review a prescribed regimen for appropriateness or the failure to use appropriate clinical or laboratory data for adequate assessment of patient response to prescribed therapy.  Transcription and/or interpretation errors are made during the transcribing or interpreting of prescriptions due to causes including misinterpretation of abbreviations, illegible handwritten prescriptions, misinterpretation of spoken prescriptions.  Omission Error The failure to administer an ordered dose to a patient before the next scheduled dose or failure to prescribe a drug product that is indicated for the patient. The failure to administer an ordered dose excludes patient’s ref usal and clinical decision or other valid reason not to administer.  Medication Error Why inpatient Classification dispensing of Medication Errors  Wrong Time Error Administration of medication outside a predefined time interval from its scheduled administration time (this interval should be established by each individual healthcare facility).  Unauthorized Drug Error Dispensing or administration to the patient of medication not authorized by a legitimate prescriber.  Dose Error Dispensing or administration to the patient of a dose that is greater than or less than the amount ordered by the prescriber or administration of multiple doses to the patient, i.e. one or more dosage units in addition to those that were ordered.  Dosage Form Error Dispensing or administration to the patient of a drug product in a different dosage form than that ordered by the prescriber.  Medication Error Why inpatient Classification dispensing of Medication Errors  Drug Preparation Error Drug product incorrectly formulated or manipulated before dispensing or administration.  Route of Administration Error Wrong route of administration of the correct drug.  Administration Technique Error Inappropriate procedure or improper technique in the administration of a drug other than wrong route.  Deteriorated Drug Error Dispensing or administration of a drug that has expired or for which the physical or chemical dosage-form integrity has been compromised  Monitoring Error Failure to review a prescribed regimen for appropriateness and detection of problems, or failure to use appropriate clinical or laboratory data for adequate assessment of patient response to prescribed therapy.  Factors contributing medication errors Why inpatient dispensing HOSPITAL ADMINISTRATION RELATED FACTORS:  Inadequate policies regarding safe use of medication  Inadequate policies governing reporting of incidents in institution  Inadequate policies concerning performance of task for supportive personnel PERSONNEL RELATED FACTORS:  Lack of hospital pharmacist  Lack of administration nurse  Overburdened personnel  Factors contributing medication errors Why inpatient dispensing TECHNIQUE RELATED FACTORS:  Use of non-professional personnel in areas requiring professional judgment  Inadequate labeling of drugs and allied items for nursing station. FACILITY RELATED FACTORS:  Inadequate storage and equipment facilities  Inadequate drug station on patient care areas.  Factors contributing medication errors Why inpatient dispensing TECHNIQUE RELATED FACTORS:  Use of non-professional personnel in areas requiring professional judgment  Inadequate labeling of drugs and allied items for nursing station. FACILITY RELATED FACTORS:  Inadequate storage and equipment facilities  Inadequate drug station on patient care areas.  Preventing medication errors Why inpatient dispensing The Institute of Medicine made a series of general recommendations relating to the prevention of medication errors.  Involve the patient in the medication use process. This includes formalizing the rights of patients, educating them, and consulting with them.  Consumer-oriented medication resources should be made available to support patient self-management of their medication use.  Health care providers should have access to patient information and decision - support tools and technologies to enable them to be more active in monitoring and intervening.  Medication labelling needs to be improved along with methods for communicating medication information to consumers.  Health care payers and oversight organizations should be more active in promoting good medication use practices.  Corrective measures Why inpatient ADMINISTRATION dispensing RELATED MEASURES The administration of a hospital is mainly responsible for formulating policies regarding all operations in an institution. An institution must have adequate and clear cut polices as for the drug use in the institute. A comprehensive policy on incident detection and subsequent reporting system for each drug accident in hospital is to be formulated. LACK OF PERSONNEL The medical care without a pharmacist may eventuate into serious medication errors. Some hospitals have not deployed pharmacist to carryout pharmaceutical services. A pharmacist can prove his work. For this it is advisable that on receipt of a prescription to place signature, it must be checked for its correctness and any potential drug-drug interactions  Corrective measures LACK OF PERSONNEL Can also be solved by:  Sharing of pharmacist by two or more small hospitals  Combining responsibilities such as procurement, administration  Purchase of pharmaceutical services from community pharmacy  Use of consultant pharmacist  Use of supportive personnel for the following activities Taking telephone orders for new prescription or for prescription refills. Weighing or measuring ingredients for compounding of prescriptions. Mixing of already weighed or measured ingredient. Calculation of percentages in prescription compounding. Affixing of prescription labels to medication containers.  Corrective measures INADEQUATE LABELLING OF DRUG ISSUED TO NURSING STATIONS Affixing labels is an institutional policy matter and for this appropriate guidelines must be provided. The containers which are dispensed to nursing stations should must properly labelled and should be look like commercial labels have information for strength, identification, route of administration, warnings and caution if any present Use of colour coding (white for poison, blue ink are oral preparations) Use of label position indicator Use of auxiliary labels  Corrective measures Why INADEQUATE inpatient DRUG STATIONSdispensing ON PATIENT CARE AREA  Due to lacking of facilities such as inadequate place, poor lights, less storage for necessary materials, storage for equipment and persons passing due to which interference occur and nurse may distract and medication errors occur and can also be solved by: Medication Cabinet This concept is implemented effectively in small hospitals where separate room for medication is not possible. So for solving the problem ready- made stainless steel cabinets are available commercially with working top counter, sink, medicine cup dispenser, shelves for medicine, rack for medicine cards narcotic lockable cabinet, for biological products refrigerator, syringe drawer, light, and a basket for waste. These cabinets easily installed at corner  Corrective measures Why INADEQUATE inpatient DRUG STATIONSdispensing ON PATIENT CARE AREA Provision of medication room This room is built for preparation and storage of medications. It is clear for observation from in and out, enclosed for quite, more than one person can work. pharmacists can advise about requirements for such facility. The requirements for medication room are Division of shelves for individual patients. Safe, lockable (Double lock), and secure safe used for narcotics. For storage of syringes etc drawer underneath work top counter. For preparation bulletin board at eye level. For hand washing a sink. A refrigerator above the counter is convenient for different medications. Thank you Safe Use of Medication in the Hospital PharmD Pharmacy Practice-IVA (Hospital Pharmacy) Dr. Syed Saad Hussain  Content ASHP guidelines relative to the safe use of medications in hospitals  Labelling and medication containers  Dispensing in-patient prescriptions  Dispensing out-patient prescriptions  Drug cabinets in nursing units  Medication orders & cards  Preparation & administration of medications  Recording of medications  Medication errors  ASHP Guidelines Whyand Labelling inpatient medicationdispensing containers (basic)  Labelling should be done by pharmacist or under supervision of pharmacist  Pharmacist should be consulted for making labelling guidelines  Medication label should be typed or machine printed  Use of pen or pencil or adhesive should be prohibited and labels should not be superimposed on other label  Label should bear identification of pharmacy  One order should be filled and labelled at a time  Accessory or caution labels should be used where necessary  Metric system should be preferred over apothecary system  Name of therapeutically active system should be present where there is mixture of ingredients  ASHP Guidelines Why inpatient Labelling dispensing and medication containers  Labels for medication should indicate the amount of drug dispensed  Perishable drugs should have date of expiry mentioned  Route of administration and dilution technique (if needed) should be mentioned  Proper storage containers should be used to maintain stability and integrity of medicines (light resistant, child lock cap, etc.)  Medications brought by patients should be properly checked, recorded and labelled as patient own medications  Floor stock medications should carry codes to identify source and lot number of medications  ASHP Guidelines Why inpatient dispensing In patient dispensing  Label should bear additional information than general labelling  Patient name, non-propriety name of medicine, Strength, date of issue and initials of dispensing pharmacist  Label should also identify batch and source of drug Out patient dispensing  Label should bear additional information than general labelling  Patient name, non-propriety name of medicine, Strength, date of issue and initials of dispensing pharmacist  Name of prescriber and address  Caution and direction labels  ASHP Guidelines Why Druginpatient Cabinets in dispensing Nursing Unit  Adequate space, lighting, ventilation and working space  Inner lockable narcotic cabinet  Adequate means of security  Particular arrangement in accordance with established plan for particular hospital (alphabetically, speciality  Only drugs, equipment for preparation and administration should be stored in medication cabinets  Controlled drugs should be inventoried, recorded and inspection  Reconstitution of antibiotics at nursing level should be kept minimum.  ASHP Guidelines Why inpatient Medication dispensing orders  Medication should be dispensed only on written order of physician, exceptions should be covered by written policy  Emergency verbal orders may be accepted via nurse, but physician should verify before administration and signed  Stat telephone orders may be accepted but recorded and signed by a physician as soon as physician is available  Medication order cancellation policy should be devised  Medication order should be legibly written and any discrepancy or confusion should be consulted with physician before dispensing  Medication order should include Name of medication, Dosage in metric system, Signature or id of physician (in case of electronic order), route and date of order.  ASHP Guidelines Medication cards Why inpatient dispensing  Medication card should contain all identification details of patient and the medication prescribed with start and stop date  Should be clearly written in ink or printed and verified by the nurse against physician order  Cards for “delayed” or “omitted” medications should not be with regular medication card file  On assuming charge of patient, nurse should reconcile the medications against physician orders  ASHP Guidelines Why inpatient Preparation dispensing of medication  Ascertain that dose is not administered  Selection medication from cart and check from medication card for correct medication, timing and route  Give full attention while preparing medication for administration  Read the label three times  Medication used for preparation but not administered must be discarded  Pharmaceutical calculations should be checked by other nurse or ideally by a pharmacist and apothecary system should be used  ASHP Guidelines WhyRecording inpatient dispensing of medications  All medicines prescribed, dispensed or administered should be recorded to patient medical records  There should be established procedure for recording of patient medical history including medications and diagnosis  ASHP Guidelines Why inpatient Medication dispensing Errors  Each hospital should have clear statement policy for all medication errors which should include Reporting and recording Review and report Corrective and preventive policies  Report should be shared with management within the defined time limit and corrective actions should be noted  ASHP Guidelines Why Druginpatient dispensing interaction surveillance  Each hospital should have drug interaction surveillance program run by a pharmacist that should have following actions Preparation of drug interaction reporting form Method to check drug – drug, drug – food , drug – lab reports interactions Recording of identified interactions and extent of effect  Medication safety Why inpatient dispensing Pharmacists role  Ongoing counselling and education: A structured framework for patient consultations can improve the way patients monitor their medications and prevent potential problems with medication safety or drug interactions.  Screen for any issues: Ask patients about existing health issues, such as high blood pressure or diabetes, that might worsen due to medication interaction.  Medication safety Why inpatient dispensing Pharmacists role  Discuss all medications: Schedule one on one time with patients to go over all their medications. This step can help prevent side effects or drug interactions resulting from prescriptions from multiple doctors.  Educate patients: Remind patients of the role and importance of each medication in their regimen.  Emphasize adherence: Stress the importance of adherence for better outcomes. Thank you