HOSPITAL PHARMACY MANAGEMENT, Lecture notes of Pharmacy

Download HOSPITAL PHARMACY MANAGEMENT and more Lecture notes Pharmacy in PDF only on Docsity! 1 HOSPITAL PHARMACY MANAGEMENT  a promising career option for pharmacists who enjoy the challenges presented by administrative work in an institution. Hospital pharmacy director oversee the operations of the pharmacy department and are responsible for the department’s professional and administrative components.  They ensure that quality pharmaceutical services are provided according to accreditation and professional standards. HOSPITAL PHARMACY DIRECTOR  Oversee the operations of the pharmacy department  Ensure that quality pharmaceutical services are provided according to accreditation and professional standards  A pharmacy director has a deeper knowledge of the department’s operations, the department’s strategic planning and has greater involvement in the department’s decision-making processes.  He or she has experience leading evidence- based clinical decision-making about drug use, controlling pharmaceutical expenses while maximizing patient benefit through the formulary system.  Has in-depth knowledge of the pharmaceutical supply chain, medication management systems, medication-use policy, and the technology used to deliver and support patient care and about how those issues affect the overall success of the pharmacy department. HOSPITAL PHARMACY MANAGERS  Guarantee the efficient and effective operation of the pharmacy.  The Administrative and Regulatory functions of the pharmacy director or chief pharmacists are summarized below ADMINISTRATIVE REGULATORY  Budget manageme nt  Integrate professional services  Maximize revenues  Implements effective drug  Procureme nt process  implements  comply with statutory, regulatory, and licensing requirements of the regulatory agencies  review and submit reports to regulatory agencies effective inventory system 2 HOSPITAL PHARMACY OPERATION REQUIREMENTS A hospital pharmacy is governed by statutory and regulatory requirements of the following: o Health Facility Services and Regulatory Bureau (HFSRB) – Department of Health o Food and Drug Administration (FDA) o Philippine Drug Enforcement Agency (PDEA)  The hospital pharmacist must ensure timely compliance to existing rules and regulations, in maintaining pharmacy operations, set forth by governing bodies. REQUIREMENTS IN SECURING LICENSE TO OPERATE  DOH Administrative Order No. 2018-0016 o “Revised Guidelines in the Implementation of the One-Stop-Shop (OSS) Licensing System”  FDA Circular 2014-25 o “Guidelines on the Implementation of New Rules and Regulations on the Licensing of Drugstore/Pharmacy/Botika and Similar Outlets, following Administrative Order No. 2014-0034, dated 13 October 2014”  Administrative Order No. 2020-0017 o “Revised Guidelines on the Unified Licensing Requirements and Procedures of the Food and Drug Administration Repealing Administrative Order No. 2016-0003”  Administrative Order No. 2014-0034 o “Rules and Regulations on the Licensing of Establishments Engaged in the Manufacture, Conduct of Clinical Trial, Distribution, Importation, Exportation, and Retailing of Drug Products, and Issuance of Other Related Authorizations.” And other pertinent existing rules and regulations. PHARMACY LOCATION, PRACTICES, AND PREMISES  The pharmacy should be located within a suitable area of the hospital  A work flow chart must be posted in a conspicuous area within the pharmacy  The pharmacy must ensure compliance to the following FDA and international regulatory standards and requirements, but not limited to: o Good Manufacturing Practice (GMP) o Good Distribution Practice (GDP) o Good Storage Practice (GSP) o Good Clinical Practice (GCP) HOSPITAL PHARMACY OPERATION: DRUG SELECTION AND PROCUREMENT ROLE OF PHARMACISTS IN THE SELECTION OF DRUG PRODUCTS 5  Monitor and conduct physical inventory to check correctness of balance of drug products on record against actual issuances especially on expensive pharmaceuticals  Implement policies that aim to reduce wastage by expiration and by unusual drug movement DRUG SELECTION  Selection of medication/drug products is extremely important function of a qualified and well-trained hospital pharmacist who is in charge in making decisions regarding quantities, specifications, its therapeutic classification and sources of supplies  Drug product selection is vital as it is the foundation of a progressive pharmaceutical policy. Drug products are strictly analyzed, evaluated and validated in accordance with the above-mentioned factors. It is an important step in drug supply management as to the following reasons: o Drug selection process ensures access to rational drug use o Essential, affordable, and cost- effective drug products are highly prioritized o Availability of safe, effective and quality drug products at all time is ensured o Promote systematic selection of drug products based on clinical practice guidelines  Aids the Pharmacy and Therapeutics Committee (PTC) in ensuring optimal medication management  Coordinates with other health care providers with regard to the selection of drug products to be included in the list  Ensures that all drug products listed in the PPMP are included in the latest Philippine National Formulary (PNF)  Usually designed as the secretary of the PTC, but may also act as Chair/Vice-Chair  Documents and reports to all concerned hospital committees adverse drug reactions, adverse events (e.g., medication errors) concerning prescribed medications  Provide pharmaceutical expertise in the evaluation of drugs for possible inclusion in the hospital formulary  Administrative Order No. 2019-0041 or the “Implementing Guidelines in Assuring the Efficacy, Quality, and Safety of Pharmaceutical Products in the Public Health Facilities” states that the Therapeutics Committee of the Specialty and Retained DOH Hospitals shall be the FACTORS ON RECOMMENDED TREATMENT AND SELECTED MEDICATIONS DRUG PRODUCT SELECTION PROCESS IN A HOSPITAL SETTING 6 designated DOH clearing house for drugs and medicines.  As stated on said issuance, the clearing house shall evaluate the medicine procurement request of end-users. It must follow the following criteria: a) Drugs to be procured must be included in the current edition of the Philippine National Formulary, b) The Approved Budget for the Contract (ABC) must be within the latest Drug Price Reference Index (DPRI), and c) The Purchase Request (PR) to be submitted by the end-user must include the required packaging and delivery site  It further states that the Certificate of Product Registration (CPR) must be valid for the entire period of the award. If the CPR is about to expire, the supplier must have submitted a copy of an application of renewal to the FDA at least 3 months before the expiry date (a copy of the expiring CPR, which is stamped with an “extension of validity,” shall be submitted as proof).  Drugs purchases represent a large part of the hospital budget. Thus, it didn't essential to optimize the allocation through proper drug selection the treatment recommended, and the drug selected depends on factors, such as: o pattern of prevalent diseases o Treatment facilities o the training and experience of available personnel o financial resources o genetic demographics; and o environmental factors  Drug product selection may differ in each hospital depending on their policy guidelines, but the following generally apply: 1. Each clinical department prepares list of job products based on their clinical practice guidelines 2. List of drug products are submitted to the pharmacy department for verification and consolidation 3. Drugs are verified if: a. listed in Philippine National Formulary b. FDA registered 4. The hospital pharmacist evaluates, reviews, and reconciles the consolidated list. ROLE OF THE CHIEF PHARMACIST IN DRUG PROCUREMENT 7 5. The pharmacist shall present the consolidated list during the committee meeting for further evaluation and review. DRUG PROCUREMENT  Drug costs make up an increasing percentage of health care expenses. Proper management of drug procurement is essential for addressing cost and promoting patient safety and quality care.  To ensure pharmacy procurement activities are operating appropriately, management should develop formal procurement procedures to be followed throughout the organization. These procedures should be reviewed regularly and updated as necessary to reflect changes in regulations and operations. They should be designed to promote safety and efficacy for drug purchases  According to World Health Organization (WHO), drug procurement is based on selected drugs and dosage forms and available financial resources. Procedures adopted in procuring includes: o Estimating quantity of each drug product required for a given. o Finding out the prices of the different drug dosage forms required o Allocating funds for each drug dosage form depending on: o priority nature of the drug and dosage form o Available finances  Selection of drug products together with the Pharmacy and Therapeutics Committee  Quantification of drug products. The chief pharmacist must be able to provide an accurate estimate of procurement volume according to the needs of the pharmacy to avoid running out of stock or overstocking. The most reliable way to quantify feature demands is to start with accurate consumption data of all available medicines in the pharmacy.  Determine the re-order level of each drug product in accordance with hospital’s drug utilization to ensure continuous availability of drugs.  Determine the budget needed for the procurement of all drugs products PROCUREMENT PROCESS  An effective drug procurement process helps ensure the availability of the right medicines in the right quantities at reasonable prices and standards of quality at the right time. It is a collaborative process between the Pharmacy and 1 0 b. Storage areas should be of sufficient space to orderly store (and properly identify) pharmaceutical products including those in quarantine, and released, rejected, returned, or recalled c. Storage should be designed or adapted to ensure good storage conditions. It should be clean and dry and maintained within acceptable temperature limits, suitably spaced, with pallets which are clean and in good state. those products with special storage conditions (e.g., temperature, relative humidity) Should be provided, checked, monitored, and recorded d. Storage areas should be clean, and free of accumulated waste and vermin. Written sanitation program, as well as program for pest control, should be available. Appropriate procedure for clean-up of any spillage must also be available. e. The “first expired/first out” (FEFO) principle should be followed f. Narcotic drugs should be stored in compliance with Dangerous Drug Board Regulation No. 1 s. 2014, Annex L g. Storage areas should provide adequate lighting to enable operations to be carried out accurately and safely 2. Storage Conditions a. Storage conditions for pharmaceutical products and materials should be in compliance with the labelling 3. Monitoring Storage Conditions a. Recorded temperature monitoring data should be available for review b. equipment used for monitoring should be calibrated at defined intervals STORAGE REQUIREMENTS 1. Documentation: Written instructions and records a. Written instructions and records should be available which document all activities in the storage areas b. Permanent information, written or electronic, should exist for each stored material or product indicating recommended storage conditions c. Records should be kept for each delivery. They should indicate description of goods, quality, quantity, supplier, batch number, date of receipt, expiry date, etc. 2. Labelling and containers a. All materials and pharmaceutical products should be stored in containers which do not adversely affect the quality of the products 1 1 b. All containers should be clearly labelled with at least the name of the product with the product’s name, expiry date, specified storage conditions, and reference to the pharmacopoeia, where applicable c. Unauthorized abbreviations, names or codes should not be used 3. Receipt of incoming materials and pharmaceutical products a. On receipt, each incoming delivery should be checked against the relevant purchase order and each container physically verified, e.g., by the label description, batch number, pharmaceutical product and quantity b. Each container should be carefully inspected for possible contamination, tampering and damage c. When required, samples should be taken only by appropriately trained and qualified personnel and in strict accordance with written sampling instructions. Containers from which samples have been taken should be labelled accordingly. d. Pharmaceutical products should remain in quarantine until an authorized release or rejection is obtained 4. Stock rotation and control a. Periodic stock reconciliation should be performed by comparing the actual and recorded stocks b. Significant stock discrepancies should be investigated as a check against inadvertent mix-ups and/or incorrect issue 5. Control of obsolete and outdated materials and pharmaceutical products a. all the stocks should be checked regularly for obsolete and outdated pharmaceutical products. All due precautions should be observed to prevent the issue of outdated products 6. Returned goods a. Returned goods, including recalled goods, should be handled in accordance with approved procedures and records should be maintained b. All returned goods should be placed in quarantine and returned to saleable stock only after this has been approved by a nominated, responsible person following a satisfactory quality re- evaluation c. Any stock reissued should be so identified and recorded in stock records 7. Dispatch and transport MAINTAINING PROPER CONDITION OF STOREROOM/WAREHOUSE FOR MEDICINES/DRUG PRODUCTS HOSPITAL PHARMACY OPERATION: INVENTORY MANAGEMENT 1 2 a. Pharmaceutical products should be transported in such a way that their integrity is not impaired and that storage conditions are maintained b. All activities must be documented, retained, and readily accessible 8. product recall  There should be a prompt and effective procedure for product recall from the market  Prior to accept and storage of drug product deliveries, pharmacy staff must: o Ensure that there is sufficient storage space o Ensure that the cold chain system is implemented on all biological products and vaccines o Prepare and clean the areas used for receiving and storing PHARMACY INVENTORY MANAGEMENT  A complex but critical process within the healthcare delivery system. Without adequate pharmacy inventory management practices, hospitals run the risk of not being able to provide patients with the most appropriate medication when it is most needed. Additionally, pharmacies' dispensing patterns and drug selection choices may have a direct effect on the affordability of care. Utilizing drugs that are non- contracted or not on the formulary may be more costly to the patient or may result in a lower than expected reimbursement.  In addition to patient safety and financial considerations, stringent regulatory requirements pertaining to drug traceability, inventory reporting and inventory management elevate the importance of maintaining effective control over drug inventories in today’s ever expanding healthcare compliance environment. GOALS OF INVENTORY MANAGEMENT 1. To ensure medications are available when patient needs them  The products that are regularly kept in stock are based on the needs of the pharmacy and its customers. While some rarely used, extremely expensive or may be ordered in as needed, efforts should be made to keep the medications used regularly in stock and available for use – not outdated or damaged. 2. To keep medication costs at a minimum  Many pharmacies have preferred wholesalers to order from or contract pricing with specific drug 1 5 and that slow-moving medications are not overstocked. Some medications have much faster turnovers than others, which can differ based on the season and specialty of the hospital.  Example: o During cold season, medicines for colds and flu would be expected to have a much higher turnover rates compared to summer season. o The pharmacy of a mother and child specialty hospital would be expected to have a much higher turnover rate of OB and pediatric medications. INVENTORY MANAGEMENT PROCESS 1. Goods are delivered 2. Good are reviewed, sorted, and stored 3. Inventory levels are monitored 4. Stock orders are placed 5. Stock orders are approved 6. Goods are taken from stock 7. Inventory levels are updated 8. Low stock levels trigger purchasing PROCEDURES IN CONDUCTING PHYSICAL INVENTORY OF DRUG PRODUCTS Inventory procedures may vary from one hospital to another depending on the size and internal control system of the hospital  Many organizations utilize pharmacy management systems as a means of ensuring appropriate accountability over drug products and ensuring the traceability of inventory from purchase through administration to the patient or disposal. Effective and transparent tracking systems that allow pharmacies to accurately record inventory components, such as medication expiration dates, lot numbers, and physical quantities.  The “real-time” tracking ability offered through these systems includes recommending items and quantities to be ordered based on PAR levels set by the pharmacy in the system, providing limits on excessive orders, and electronically placing orders after a manual authorization.  When setting the PAR levels for the automated ordering, it is important to set appropriate levels to maximize the ordering process and minimize excessive supplies.  An additional benefit of tracking systems is more effective management for adding, updating, and removing inventory as well as the ability to restrict certain functions to responsible personnel (e.g., dispensing certain types of drugs restricted to certain pharmacists). There Are also enhanced reporting capabilities that serve as a benefit, not only for inventory ordering and replenishment, but also for regulatory compliance tracking and monitoring. There tracking systems are often capable of flagging discrepancies, such as potential concerns, safety risks, and compliance risks, based on 1 6 predefined rule sets.  Proper medication management requires pharmacies to maintain complete and accurate records of drugs purchased, received, stored, distributed, dispensed, and disposed, in the event of drug recalls or adverse events.