ACTIVITY 56. DRUG-DISPENSING SYSTEMS IN HOSPITALSDrugs are one of the main tools of medical therapy and are a significant part of hospital budgets. Implementing safe, organized, and efficient drug-dispensing systems is essential for controlling costs and assuring that the medical prescription is safely followed as requested within the appropriate deadline. An appropriate dispensing system is an important ally for the prevention or reduction of medication errors by helping to minimize dispensing error opportunities in a pharmacy. At present there are various types of dispensing systems for medical prescriptions within a hospital.The first studies on the organization of such systems, specifically their relationship with medication errors, were published in the mid-sixties. These studies mostly performed in the United States of America were intensified during the 1970s and 1980s, aiming to provide safer dispensing systems. Investigation in this area in Brazil was started during the1990s and is still not numerically significant.Collective SystemThe collective system, also known as the traditional system, is the oldest and most obsolete. In this system, drug-related actions are centered on nursing professionals, and the pharmacy is merely a drug delivery agent. This system has many facilitating conditions for errors. It is characterized by the distribution of drugs per hospital unit/service based on a request by a nurse. It implies the establishment of inventory in these units under the nurse's supervision.16,17It is estimated that nurses spend about 25% of their time transcribing prescriptions, checking inventory, filling requests, and transporting and separating drugs in the various units. Institutional costs are high due to losses by theft, inadequate storage, and drug expiration.17,18The advantages of this system are that drugs are readily available at the units, there are fewer requests to the pharmacy, with a corresponding reduction in pharmacy expenses related to human resources and materials. These advantages become obstacles for improved pharmaceutical service to patients.17A negative consequence is a high rate of medication errors, the most common being giving twice the dosage, giving the wrong drug, inappropriate dose and administration routes, and giving non-prescribed drugs. A further disadvantage is inefficient stock control and increased expenses related to drugs.16,18,19According to the first pharmacy assessment in Brazil in 2002, 51.2% of hospital pharmacies use the collective drug-dispensing system.20Individualized SystemIn the individualized drug-dispensing system, the pharmacy and pharmacists participate more actively on drug-use issues; however, nursing participation and error rates are still high. In this system, drugs are dispensed per patient, usually for a 24-hour treatment period. The pharmacy dispenses drugs separately per patient, according to the medical prescription, to the hospital units.16,17In Brazil, 34.8% of hospitals use this drug-dispensing system for in-hospital patients.20This system may be described as indirect, where drug dispensing is based on a transcription of the medical prescription made by nurses, or direct, where dispensing is based on a copy of the medical prescription (made daily). The indirect system has a high rate of errors and theft, as failure and omission may take place during transcription and items not present in the original prescription may be added.In the direct system, the prescription may be forwarded to the pharmacy as follows17:a) the prescription is written over carbon paper to produce a copy of the original. Poor quality carbon paper or inadequate pens may result in prescription copies that are difficult to read;b) photocopy to reproduce the original prescription;c) fax from the hospital unit to the pharmacy. This method may generate illegible documents, opening the door for new sources of medication errors and allowing loss of information with time;d) the physician writes the prescription on computer terminals in the hospital unit and sends it electronically to the pharmacy. The main advantage is the elimination errors due to poor handwriting. However, other types of errors may appear, such as printing the prescription made the previous day or not saving changes, resulting in wrong prescriptions. Also the prescriptions of 2 or more patients may be accidentally exchanged;e) computerized prescription: using clinical management software interconnecting the various hospital units. The prescription and the dispensing report are made in the system that may be integrated with pharmacology and inventory control software. Professionals access system data directly with no need to send files. There are also safety systems that warn against toxic doses, allergic and cross-reactions, drug interactions, duplication of therapeutic classes, contraindications, and adverse effects. Automation using bar codes allows drugs to be checked when dispensing and administering the drug;f) radio system interconnecting computers and optic readers: the physician uses a small electronic pen-operated or touch-sensitive terminal, allowing immediate checking of patient data, rapid prescription (at the bedside), and fewer computers in hospital units.The individualized drug-dispensing system has advantages, such as the possibility of reviewing medical prescriptions, increased control over drug use, less inventory in hospital units, reduced theft and losses, and individual patient invoicing. The disadvantages are the high rates of dispensing and delivery errors that still exist, the time spent by nurses calculating and preparing drug doses, increased expense regarding human resources and materials, and high losses due to theft and inadequate drug delivery.16,17Usually, the pharmacy is present in hospital units. Pharmacy assistants replenish emergency stocks daily, collect prescriptions for the day, collect drugs returned from the previous day, and send drugs for the following 24 hours of treatment. On a monthly basis they also check drug validity in the inventory and unauthorized inventory. Pharmacists visit hospital units daily to supervise work done by their assistants. They also help nurses clarify doubts related to drug delivery and stability as well as storage and use of heat-sensitive and photo-sensitive drugs. Pharmacists also discuss prescription issues with physicians. In hospitals with adequate human resources allied to professional and institutional interests, pharmacists develop clinical activities with the professional health team to reduce medication errors.Mixed SystemThe mixed dispensing system combines the collective and the individualized systems and is also used in Brazilian hospitals. Hospital units are supported partially or completely by the individualized systems, and specific units (radiology, endoscopy, emergency, outpatient department, among others) are supported by the collective system.17The mixed system is used by 13.2% of Brazilian hospitals for dispensing drugs.20The main disadvantage of the mixed system is a trend towards the collective rather than the individualized system, favoring drug dispensing by hospital unit rather than per patient dispensing. It is easier to dispense drugs by hospital unit instead of separating and packaging items for each patient. Pharmacy staff should be made aware of the importance of their work and that collective dispensing is easier but not as safe.Unit dose systemDrug administration in hospitals may involve 20 to 30 steps from prescription to delivery and monitoring. During the past 50 years, little has changed in this process except for the development and implementation of the unit dose drug-dispensing system.21The high rate of medication errors in hospitals reported in many North-American studies towards the end of the 1950s, demonstrated the need to review traditional dispensing systems to improve safety in drug dispensing and delivery. In 1960, North-American hospital pharmacists belonging to a multidisciplinary group developed the unit dose system, aiming to reduce medication error rates, drug costs, losses and theft, and to improve the productivity of health professionals and the quality of health care. This system consists of ordered drug dispensing with doses ready for delivery according to the patient's medical prescription. Every drug, in all pharmaceutical forms, is dispensed ready-to-use with no need for prior transference, calculation, and handling by nurses. Only drugs used in emergencies are stored in hospital units, together with the necessary doses for the next 24 hours of treatment of patients.16,17The system has the following advantages: drug identification right up to the moment of delivery; lower medication error rates; less nursing time spent on drug handling, increased nurse availability for patient care; less inventory in units, with decreased losses; optimizing the return of unused drugs; better hospital infection control through the practice of aseptic techniques in the preparation of drug doses; increased adaptability for automation; increased precision in invoicing drug use per patient; increased assurance for physicians that the prescription will be administered; effective pharmacist participation in defining drug therapy; improved control over the pattern and time of drug delivery; less space used to keep drugs in hospital units; and improved patient assistance. The disadvantages are resistance by nurses to the system, the need for extra staff and pharmacy infrastructure, the need to acquire specific equipment, and a high initial financial investment.16,17Furthermore, pharmacists need to be trained to prepare parenteral drugs, knowledge not imparted by the majority of pharmacy colleges in Brazil.Implementation of this system in Brazil is a huge challenge. Only 0.4% of hospitals use it to dispense drugs.20The initial investment to acquire specific equipment for a sterile product-preparation center is high and not within the reach of small and mid-sized institutions, which represent more than 80% of Brazilian hospitals.17ACTIVITY 6 3. How to report ADRs?Local Case Report Forms (CRF) should be obtained from the National Drug Regulatory Authority. Some countries have included CRF in their National Formularies (British National Formulary, Formularies of South Africa, Zimbabwe etc.).There are different Case Report Forms in different countries. But all of them have at least four sections which should be completed:1. Patient information:- patient identifier- age at time of event or date of birth- gender- weight2. Adverse event or product problem:- description of event or problem- date of event- date of this report- relevant tests/laboratory data (if available)- other relevant patient information/history- outcomes attributed to adverse event3. Suspected medication (s):- name (INN and brand name)- dose, frequency & route used- therapy date- diagnosis for use- event abated after use stopped or dose reduced- batch number- expiration date- event reappeared after reintroduction of the treatment- concomitant medical products and therapy dates4. Reporter:- name, address and telephone number- speciality and occupationThe completed Case Report Form should be sent to the national or regional ADR centre or to the manufacturer of the suspected product.Addresses of National Drug Regulatory Authorities and other useful information can be found on the Website of the WHO Collaborating Centre for International Drug Monitoring (www.who-umc.org) or requested from this Centre by e-mail: info@who-umc.org; by Fax: +46 18 65 60 80 or by Tel.: +46 18 65 60 60.4. How Long Must a Health Care Provider Keep a Patient's Medical Records?Generally, a provider must retain a patient's medical records for seven years after the last treatment date, or three years from the patient's death.(Department of Public Health (DPH) Regs. 19a-14-42).ACTIVITY 71. Roles and ResponsibilitiesMany of the responding P&TCs terms of reference indicated roles and responsibilities that are much broader than those related to establishing and maintaining a drug formulary listing, including but not limited to the following: evaluating safe, effective, ethical, and fiscally responsible drug use acting in an advisory capacity on all drug, as well as nutritional product use developing clinical guidelines and decision support tools relating to appropriate drug use providing educational activities for all health care professionals involved in the medication use process (i.e., prescribing, distribution, administration) preparing drug budget impact analyses developing criteria for use, treatment guidelines, and standardized orders reviewing adverse drug reactions and formulating recurrence prevention strategies establishing drug-use evaluation programs and conducting medication audits to optimize drug use having direct linkages to the provincial Ministry of Health for sharing information of mutual interest, and coordinating drug-related planning and/or prioritizing establishing subcommittees to address specialty practice areas (e.g., pediatrics, oncology, anti-infectives) working with other provincial organizations that may fund specific drugs in order to expedite and coordinate formulary statusFunctions and Scope of PTC

A. To serve in an evaluative, educational, and advisory capacity tothe medicalstaff andorganiztional administration in all matters pertaining to the use of drugs.

B. To develop a formulary of drugs accepted for use in the organization and provide for its constant revision.

C. To establish programs and procedures that help ensure safe and effective drug therapy.

D. To establish programs and procedures that help ensure cost effective drug therapy.

E. To establish or plan suitable educational programs for the organization's professional staff on matters related to drug use.

F. To participate in quality assurance activities related to distribution, administration, and use of medications.

G. To monitor and evaluate ADRs in the health care setting and to make appropriate recommendations to prevent their occurrence

H. To initiate or direct (or both) drug use evaluation program and studies, review the results of such activities, and make appropriate recommendations to optimize drug use.

I. To advise thepharmacydepartment in the implementation of effective drug distribution and control procedures.

J. To disseminate information on its actions and approved recommendations to all organizational health care staff.

2. How often does the Committee review medications?The P&T Committee meets quarterly to review new drugs that have recently been approved by the FDA as well as drugs that have been FDA approved for new medical conditions. The committee should meet on a regular basis to discuss the rapidly changing drug products and medical literature. Frequency: Monthly meeting. Length: 60-90 minutes.Note: Minimum: 10 meetings/year.3. Responsibilities:1. Formulary system maintenance: Develop list of medications for use.Guidelines for optimal use of medications. Review list & guidelines on regular basis.2. Medication selection and review:Medication selection criteria should be set and should include medication efficacy, safety and cost.3. Medication Use Evaluation:E.g. overuse of antibiotics resistant infections and increased cost.Approve drugs to be kept under restriction.4. Medication Safety Evaluation:Adverse drug reaction reports.Medication error reports.Review drug intervention reports.5. Drug Therapy Guidelines:Evaluates optimal use of drugs e.g. dosage, frequency, patient selection, length of therapy and combination.Guidelines should be updated routinely.6. Policy & Procedure Development:Medication procurement, selection and distribution.Medication for specific settings e.g. ICU.Develop policies e.g. automatic stop order, drug recall. Responsibilities:7. Education:Newsletter is often employed to communicate the committee decisions.Newsletter includes the following:Clinical information on drugs added to formulary.Drug therapy guidelines developed.Medication safety information.ACTIVITY 82. "Formulary" DesignationOnly those drugs approved by the Pharmacy and Therapeutics Committee on the basis of safety, efficacy, and cost to be most advantageous in patient care shall be designated as formulary drugs. These drugs are listed in the formulary; only formulary drugs are routinely stocked and available from the pharmacy.Only those drugs that have been approved by the Food and Drug Administration (FDA) shall be considered for formulary addition. Therefore, investigational drugs do not meet criteria for formulary addition.Drugs are included in the formulary by their generic names, even though trade names may be in common use in the hospital. Physicians are strongly encouraged to prescribe drugs by their generic names.The Department of Pharmacy is responsible for selecting, from available generic equivalents, those drugs to be dispensed pursuant to a physician's order for a particular drug product. Generally, this choice is consistent with competitive bids awarded by the University Hospitals group purchasing organization (Novation)5. Selection of Guiding Principles for Admission or Deletion of Drugs

Criteria:1. Drugs must be of proven clinical value based upon experience.2. The drugs must be recognized by USP/NF or their supplement.3. The manufacturers of these drugs must be of proven integrity and dependability as well as having the regulation of initiating and supporting research activities of merits.4. No preparation of secret composition will be considered or admitted to the formulary.5. No product of multiple composition shall be admitted if the same therapeutic value can be obtained through the use of a single drug entity.6. A formulary can contain both name-brand and generic drugs. Patients pay co-pays on formulary drugs. If a drug is not on the list, the patient will pay much more, up to the full cost of the drug. Every health care plan has a different list of acceptable drugs and co-pay prices.Since it is impossible to stock every type of medicine for every disease, hospitals create formularies listing the drugs they keep in house. It is possible for a hospital to obtain non-formulary drugs by ordering them from a neighboring hospital or pharmacy.7. Formularies cover all the categories of medications that patients need. The list is constantly being revised and updated to make sure patients receive the appropriate medication. For example, before a medication is added to or deleted from the formulary, teams of pharmacists, physicians, and other healthcare professionals in the hospital evaluate the drug products to make sure that they are safe, work well, and are cost-effective.

The Philippine National Drug Formulary (PNDF) is an integral component of the Philippine Medicines Policy which aims to make quality essential drugs available, accessible, efficacious, safe and affordableThe PNDF (Volume I) is the Essential Medicines List (EDL)for the Philippines prepared by the National Formulary Committee (NFC) in consultation with experts and specialists from organized professional medical societies, medical academe and the pharmaceutical industry.List of essential medicines that are registered with Food and Drug Administration (FDA)ACTIVITY 9I. Setup and equipmentThe center is equipped with computer terminals, printed materials (current, periodicals, bound journal volumes, reference texts) and has access to Medline, the Internet and various other online drug and medical references.The center maintains subscriptions to nationally recognized journals and texts of Pharmacy and Medicine.Direct access to computerized on-line data searching, CD ROM databases and the World Wide Web are also available.(Table 1)

2. Providing DI to patients, caregivers, and health care professionals9 2. Creating a variety of educational resources for patients (e.g., tip sheets or pamphlets)10 and health care professionals (e.g., inservices) on topics such as optimal medication use, 11 general health, or select clinical questions12 3. Developing and educating health care professionals on safe and effective medication-13 use policies and/or processes14 4. Leading or participating in continuing education services for health care professional 15 staff16 5. Precepting and educating pharmacy students and residents17 6. Participating in quality improvement research projects

1. Providing information when there is not sufficient time for the health care professional to appropriately research the DI question, when there is a knowledge gap, or when the question requires more specialized DI resources 2. Establishing and maintaining a formulary based on scientific evidence of efficacy and safety, pharmacoeconomics, and institution-specific factors 3. Coordinating programs to support population-based medication practices (e.g., development of pharmacotherapeutic guidelines and medication use evaluation criteria) 4. Developing and participating in efforts to prevent medication misadventures, including 6 adverse drug event, ensuring institutional compliance to Risk Evaluation and Mitigation Strategies (REMS), and medication error reporting and analysis programs 5. Collecting and applying health economic and outcome analyses 6. Coordinating investigational drug services 7. Managing drug shortages including identifying alternative treatments, developing protocols for restrictive use, and managing formulary concerns9a8. Developing clinical decision support tools such as order sets, dosing protocols, and order-entry alerts 9. Maintaining DI and medication use policy related intranet resources 10. Precepting or providing advanced DI education and training to students and residents 11. Coordinating purchase and selection of pharmacy and institution-wide DI resources12. Participating in various fee-for-service projects

ACTIVITY 103. To achieve these objectives, the Catalog is divided into the six Outcomes for improvement identified by the Institute of Medicine in the report Crossing the Quality Chasm: A New Health System for the 21st Century: Safety avoiding injuries to patients from the care that is intended to help them Effectiveness providing services based on scientific knowledge to all who could benefit, and refraining from providing services to those not likely to benefit Patient-Centeredness providing care that is respectful of and responsive to individual patient preferences, needs, and values, and ensuring that patient values guide all clinical decisions Timeliness reducing waits and sometimes harmful delays for both those who receive and those who give care Efficiency avoiding waste, including waste of equipment, supplies, ideas and energy Equitableness providing care that does not vary in quality because of personal characteristics such as gender, ethnicity, geographic location, and socioeconomic status