133 THE PHARMA REVIEW NOVEMBER - DECEMBER 2013 Pharmaceutical Services In Hospitals Nirmal K. Gurbani 1 & Abhishek Dadhich 2 Introduction The pharmacy profession comprising the industry and practice sectors is undergoing a rapid change. While Indian Pharma industry has registered a spectacular progress ranking 3 rd in volume and 13th in value in the global pharmaceutical market, the visibility and recognition of pharmacists in health sector has still a long way to go. The pharmacist in healthcare sector has to evolve from a mere dispenser of medicines to a more crucial role in medicine management and as overall health care programmer. While community pharmacy is largely dominated by mere dispensing of medicines without paying any attention to patient information while dispensing, the hospital pharmacy offers an emerging opportunity for the pharmacists to demonstrate their capabilities in view of the proliferation of corporate hospitals along with private hospitals aspiring for accreditation from National Accreditation Board for Hospitals & Healthcare (NABH) or JSI and by many accreditation boards in other countries. Among many stipulated requirements for the accreditation, medication management through a functional Drug and Therapeutics Committee (DTC) which is also referred to as Pharmacy & Therapeutics Committee (PTC), can provide an effective structure and tool to bring together all the relevant people to work jointly for promoting more effcient and rational use of medicines. Besides, playing a pivotal under the functioning of DTCs, pharmacists can also provide relevant patient information related to medicines being dispensed in the hospitals as a service. This would defnitely lead to his recognition by the society as competent health professional. Pharmaceuticals/medicines have always remained and would continue to remain as core in the healthcare. It constitute second highest item of expenditure after the manpower in any given health facility/hospital. Medicines save lives and improve quality of life, but can be dangerous with adverse drug reactions (ADR) and medication errors which would be expensive. Medicines have often been misused and abused. Irrational use of medicines is prevalent at all levels of health care leading to wastage of scarce resources as well as reduced medication safety in patients. Emergence of antimicrobial resistance continues to pose a global problem in handling the management of infections. Common drug related problems encountered in most hospitals are: Selection of medicines is not evidence based Quantifcation of demand of medicines is not scientifc Supply is not regular Standard Treatment Guidelines (STGs) are not developed or used Over enthusiasm in using newer & expensive medicines Rampant use of combination product Over use of antimicrobials No system for monitoring use of medicines Majority of hospitals do not have system / committee to tackle these problems. Pharmaceutical management in hospitals can be one of the most cost effective measures for appropriate use of scarce health care resources. Medication safety in patients can be best ensured if rational and appropriate uses of medicines are practiced. The effcacy and therapeutic benefts of medicines is often not grasped during the treatment which happens due to problems with medicine selection and dosages, improper administration of medicines and lack of adherence by patients to prescribed treatment, medicinemedicine and medicinefood interactions, and adverse medicine events. To reduce these healthcare burdens, the following pharmaceutical services in hospitals can contribute towards health improvement and to help patients: Formulary management Quality assurance of medicines Medicines safety & Pharmacovigilence Preventing, identifying, and resolving medication errors Patient education and counseling Prescription audit Monitoring medicines use Supply Chain Management of Pharmaceuticals including stock management and inventory control 1 Professor, 2 Asstt. Professor Pharmaceutical Management, Institute of health Management Research, Jaipur. P R T HOSPITAL & CLINICAL PHARMACY 134 THE PHARMA REVIEW NOVEMBER - DECEMBER 2013 Antibiotic stewardship and infection control Drug & Therapeutics Committee Drug & Therapeutics Committee signifcantly improve drug use and reduce costs in hospitals. In many developed countries, a well functioning DTC has shown to be one of the most effective structures to address drug problems. Concept of DTC is well accepted in developed world. As early as 1935, frst DTC was founded in USA. During 1940s, DTCs were established in UK. In some developing countries (African countries), DTC concept has been adopted. In India there are a few DTCs at certain places but their functioning is yet to catch up with the requirements of the National Accreditation Board for Hospitals & Healthcare Providers (NABH). The DTC is an advisory group that recommends policies related to drug therapy to the medical board. Every hospital, especially a teaching hospital must have a Therapeutic Committee. The goals and objectives of the DTC are to ensure that patients are provided with best possible cost effective care, and this could be achieved by providing treatment with quality essential medicines as per evidence based standard treatment guidelines and adverse drug reaction monitoring. Structure and Organization The committee should have suffcient members to represent all stakeholders, viz.; clinical departments, administration and pharmacy. Members should have technical competence with no confict of interest and should have defned terms of reference. It should include clinicians from each major specialty, a clinical pharmacologist, a nurse (infection control section), pharmacist, microbiologist, fnance person. Dedicated and committed persons as Chairperson (preferably Medical Superintendent/ Chief of the hospital) and Member Secretary (preferably a clinical pharmacologist/pharmacist) are crucial to its success. The committee may perform major roles like: 1. Advisory Functions The DTC can advise to medical, administrative, and pharmacy departments on all issues, policies and guidelines concerning the selection, distribution and use of medicines and participate in other hospital committees and departments on all matters concerning drugs. 2. Development of Drug Policies The review and development of drug policies within a hospital is taken care by DTC, since the committee members have the expertise and training in drug therapy and supply. These policies are concern with: Criteria for inclusion of medicines on the formulary list (essential medicines list (EML) New, non-formulary, restricted, investigational drugs Generic substitution and therapeutic interchange Standard treatment guidelines (and other interventions) Meeting Drug representatives and reviewing promotional literature The drug policies are to be periodically reviewed because of changing costs and indications, new information on safety, and availability of new medicines. The documents review process includes reputable textbooks, published treatment guidelines and formularies, newsletters and primary drug literature. 3. Evaluation and Selection of Drugs For The Formulary DTC perform the evaluation and selection of the drug on the basis of the standard treatment guidelines or protocols that have been developed or adapted for use in the hospital. The consideration for inclusion of medicine in formulary list is carried out by DTC which is followed by evidence based documentation of the effcacy, safety, quality and cost-effectiveness of drugs. The evaluating and selecting drugs should be through a consistent decision making on evidence, local context and transparency- driven. 4. Developing Standard Treatment Guidelines To promote rational use of medicines in hospitals standard treatment guideline (STGs) or protocols are developed by DTC in a participatory way involving end-users. STG are develop in such a way that they are easy to read and up to date. STGs provide a benchmark of optimum treatment in the monitoring and audit of drug use. 5. Assessing Drug Use Problems DTC may identify the priority problems and make appropriate recommendations for drug use. Common drug use problems include: Drug procurement and availability Drug prescribing Administration / Use Adverse drug reactions reports Medication error reports Antimicrobial resistance surveillance reports Unsafe injections 6. Improving Drug Use DTC in hospital have a major responsibility to ensure that drug information is provided to health staff and patients by conducting educational interventions. Managerial interventions are also need P R T HOSPITAL & CLINICAL PHARMACY 135 THE PHARMA REVIEW NOVEMBER - DECEMBER 2013 to be ensured by the DTC through Drug use evaluation program and Clinical pharmacy programs, besides, structured order forms and automatic stop orders, etc. Regulatory interventions are also performed by the DTC during drug selection (essential & non-essential medicines list) and also regulating visits of drug representatives. 7. Managing Adverse Drug Reactions Adverse drug reactions (ADRs) are serious problems in terms of patient harm (morbidity and mortality) and avoidable economic costs. These adverse drug reactions may be due to the unknown effects of new or older drugs, unknown drug combinations and interactions, or poor drug quality. DTC can plan effective ADR monitoring, assessment and reporting under National Pharmacovigilence program, besides initiating preventive measures to minimize adverse drug reaction. Success of DTC Experience shows that it is easy to establish DTC, but diffcult to ensure its functioning. The success depends on strong support from senior hospital management and administration, careful selection of members who are willing and committed to take on responsibility, besides, having regular meetings of DTC (monthly or quarterly) with regular attendance by the members, dissemination of recommendation, document operating guidelines, policies and decisions of DTC to all concerned. Objective relationship with other hospital committees, especially Antimicrobial Subcommittee and Infection Control Committee can strengthen linkages within the system. Accreditation of hospitals, only if they have functional DTC can contribute further in the success of the DTCs. Pharmaceutical manufacturers can be very infuential on this committee and the committee must remain unbiased and transparent at all times to maintain credibility. There should be no relationship with a manufacturer or supplier other than the exchange of unbiased drug information. Well functioning DTCs have improved use of medicines leading to savings & improved patient care and DTCs are considered as agents and vehicles for improving rational use of medicines. Pharmaceuticals Purchasing And Stock Management In hospitals medical stores or material management departments manages all hospital purchasing which includes pharmaceuticals, medical supplies and equipment etc. A separate designated committee or the DTC manages the purchasing of pharmaceuticals which is reviewed and approved by all committee members. Medicines and health products have its own shelf life and therefore, maintaining of optimum stocks would be the key feature under the stock management. Expiration of products is fnancial loss and stock outs leads to local purchases which are expensive. Therefore, Standard Operating Procedures (SOPs) for drug procurement, proper quantifcation, inventory management and written manuals, including security measures approved by the hospital administration and the appropriate committees can ensure optimum availability of medicines and health products stocks with least stock-out and expiry situations. Inpatient Medication Services In Hospital Inpatient services in hospital settings includes dispensing, patient education and medication counseling, besides, regular stock registers updating for periodic medicines purchasing and inventory management are also important tasks which are performed under pharmaceutical services. Medication Distribution System In Hospital Medication distribution is a primary function of pharmaceutical services in hospital and depending on hospital structure; medication distribution is categorized into four types, namely: Bulk wards stock replenishment, Individual medication order system, Unit-dose system and Automated medication system. All these four system may be used in same facility depending on the strategy developed. Bulk Ward Stock In this system, the pharmacy unit works as a warehouse and dispenses bulk container on requisition. The main advantage of this system is shorter turnaround time between prescribing and administering the medication. This is appropriate and desirable system for life-threatening emergency situation where medication need to kept near patient care areas as a time saving measure. Ward stock maintain high volume, low-cost medicine if the patient safety risk is low. Individual Medication Order System The individual medication order system performs dispensing to outpatients. The pharmacist reviews the appropriatness of medication order and dispenses a course of therapy according to a written prescription for an individual patient with proper drug related patient information. A patient-specifc medication profle can be maintained and optimum control of inventory is possible. Unit-Dose Distribution System This system is more preferable from a patient care perspective which has lower possibility for medication error. Medications are dispensed in unit-dose packages (each dose is separately packaged) in separate bins or drawers for each patient. Commonly, a twenty-four-hour supply is provided. Initially this system needs P R T HOSPITAL & CLINICAL PHARMACY 136 THE PHARMA REVIEW NOVEMBER - DECEMBER 2013 large capital investment for establishing the repackaging machine and system. The cost per delivered dose is higher than with bulk packaging, but these increased expenses may be offset by reduced wastage and easier detection of leakage. Automated Medication Dispensing Technology based intervention is made in medication distribution in which medication errors are minimized and it helps in improving medication safety within the hospital. This system works on a computer interface between the hospital pharmacy computer terminals and the dispensing machines at the clinical ward. This system electronically controls and tracks the dispensing of unit doses for each patient based on individual medication profle. The dispensing machines allow medicines to be stored on the ward and to be more conveniently accessed by the clinical staff. Hospital Antimicrobial Stewardship Antimicrobials and injectable drugs are amongst the most expensive of all drugs; often consuming major portion of a hospitals drug budget. Emergence of Antimicrobial resistance (AMR) has become a global problem and therefore, in this context antibiotics stewardship is designed to optimize antimicrobial therapy administered to hospitalized patients, ensure cost effective therapy and improve patients' outcome while containing antimicrobial resistance. Various goals under antimicrobial stewardship programme are: Ensure appropriate use of antibiotics at suffcient dose and duration Eradicate the pathogen Prevent recurrence of infection Prevent resistance Antimicrobial subcommittee assists the DTC in dealing with the management of antimicrobials. The subcommittee develops policies concerning use of antimicrobials for approval by the DTC and medical staff and the policies should specifcally include sections on methods to limit and restrict use of antimicrobials in the hospitals. Periodic drug use evaluations are conducted by this subcommittee to ensure use of effective antimicrobials of adequate quality only when clinically indicated, in the correct dose and for the appropriate length of time. This subcommittee also assists in evaluating and selecting antimicrobials for the formulary and standard treatment guidelines. Infection Control In Hospital Hospital acquired infections (HAI) are most dangerous and often diffcult to handle. Therefore, prevention of nosocomial infections is the responsibility of all individuals and services providing health care. Everyone must work cooperatively to reduce the risk of infection for patients and staff in the hospital. An Infection Control Committee provides a forum to prevent the spread of infection within the hospital or facilities within its jurisdiction. This forum involves overseeing the hospitals infection control, prevention, and monitoring programmes. DTC in hospital creates a subcommittee that will specifcally deal with all issues relating to infection control. The infection control committee in hospital is more concerned with environmental issues such as food handling, laundry handling, cleaning procedures, visitation policies, proper biomedical waste disposal practices and direct patient care practices, including hand washing and immunizations. An infection control committee carry out active surveillance of infections and antimicrobial resistance, with data analysis and feedback (ideally monthly reports) to the appropriate departments, health-care staff, antimicrobial subcommittee and the DTC. It develop and recommend policies and procedures pertaining to infection control, besides also organizing infection control education and training programmes for all hospital staff. Conclusion In context to provide better and effective healthcare services in hospital premises, pharmaceutical services perform a vital role under multidisciplinary responsibility that includes selection and formulary management, prescribing by the physician, procurement, storage and medication distribution within hospital. The Drug and Therapeutics Committee (DTC) is responsible for developing policies and procedures to promote rational medicine use. Antimicrobial and Infection Control subcommittees in hospitals perform systematic approaches towards safe and effective use of antibiotics as well as also focus on strengthening biomedical waste management under infection control programme in hospitals to minimize the risk of hospital acquired infections. In compliance to quality accreditation of hospitals, pharmaceutical services are integral component under medication management to ensure patient safety. References 1. Holloway K., Green T, Drugs and Therapeutics Committees (A Practical Guide), by WHO and MSH, 2003, France. Website: www.who.int/medicinedocs. 2. Management Support System Part III, Hospital Pharmacy Management, Pg.45.1-45.15 Website: apps.who.int/medicinedocs/documents. 3. DTC and its Role in Ensuring Drug Quality, Website: http://www.sgnhc.org.np. 4. Bero L, Cho MK (1994) Instruments for assessing the quality of drug studies published in the medical literature, Journal of American Medical Association 272(2): 101104. 5. Ducel G., Hygie F., Fabry J., et. al., Hospital Acquired Infection (A Practical Guide) By WHO, 2002, 2nd edition, Website: www.who.int/csr/resources/ publications.