Operationalizing Medicine and Therapeutic Committees (MTCs) at selected hospitals in Uganda BACKGROUND Irrational drug use has been identified as a global problem and occurs in institutional and community settings. Several global initiatives have recommended strategies to curtail irrational drug use. Prominent among these was International Conference on Improving Use of Medicines (ICIUM 1997 and 2004) that recommended Drug and Therapeutics Committees (DTCs) as a method of improving drug use in institutional settings. Additionally, DTCs have been advanced as a key intervention by the World Health Organization (WHO) Global Strategy to contain antimicrobial resistance (Joshi M, 2004). In hospital settings, a drug and therapeutics committee (DTC) provides a forum to bring together all the relevant people to work jointly to improve health-care delivery. As such, a DTC may be regarded as a tool for promoting more efficient and rational use of medicines. In many developed countries, a well-functioning DTC has been shown to be one of the most effective structures in hospitals able to address drug use problems (WHO, 2004). However, many hospitals in resource-constrained settings lack DTCs and in others they do not function effectively ( EPN, MSH/SPS, Moshi). According to WHO, the DTC is the most appropriate body to develop drug policies within a hospital especially concerning selection of medicines for the hospital formulary. They also assess medicine use and identify drug use problems for example through carrying out ABC and VEN analyses (Holloway K, Green T, 2003). 1
A research at Nepal s KIST medical college showed that the MTC there has worked out a process for addition or deletion of drugs to the hospital medicine list. This in addition to other functions led to a conclusion that the MTC has been partly successful in improving medicines use in the teaching hospital (P. Ravi Shankar et al, 2009). A MTC can significantly improve drug use and reduce costs in hospitals and other health care facilities by providing advice on all aspects of drug management and by developing drug policies. It also helps by evaluating and selecting drugs for the hospital formulary and develops and implements standard treatment guidelines. Assessing drug use to identify problems and conducting interventions to improve drug use is another strategy of the MTC. It also helps to manage adverse drug reactions and possible medication errors [Jha N et al, 2009]. For safety reasons a MTC at Manipal teaching hospital in Nepal decided not to approve Nimesulide a drug used in inflammatory conditions due to reports of fatal hepatotoxicity (Palaian S, Mishra P, 2005). Despite efforts to initiate MTCs, in some instances the committees do not function or are dormant. This in addition to their absence in various settings has resulted in inefficient and inappropriate use of medicines (CRS, 2011). This incorrect use of medicines results in an increase in antimicrobial resistance and in the number of medicines that are no longer effective against infectious disease. Resistance prolongs illnesses and hospital stays, and can even cause death, leading to higher costs of disease management. Wastage of resources leads to reduced availability of other vital drugs and increased costs (WHO, 2010). There is also an increased risk of adverse drug reactions and medication errors that is costly to manage. There is an overall reduction in the quality of drug therapy, leading to increased morbidity and mortality (WHO, 2004). A well functioning MTC would save both the government and the population the burden 2
of irrational use of medicines. Therefore this study aims at operationalizing MTCs at selected hospitals in Uganda. INTRODUCTION Health systems in most African countries are faced with a huge disease burden and yet have very limited funds for expenditure on the needed drugs. In Uganda, the public health system spends about USD 8-10 per person per year on their healthcare needs. Ensuring the optimal use of these limited funds is one of the major challenges facing health managers. A number of studies in both developed and developing world have shown that drug use is a complex process. Errors that affect the effectiveness of the therapy may be attributable to failure of patient to adhere to the treatment or to the prescription and dispensing process (DCP). In Uganda Medicines and and Therapeutic Committees were set up in hospitals to advise on medicines management and use to achieve rational use of medicines. However, these committees have remained largely dormant. Lack of information flow on medicines availability from the pharmacy stores to prescribers and vice versa affects the prescribing habits and therefore impacts on quality of treatment. Also at management level reconcilitaion of available funds with priority medicine needs for example using the Vital-Essential-Necessary (VEN) method is not done. Recently, the Ministry of Health with support from USAID and other development partners has established the Uganda Medicines and Therapeutic Advisory Committee to oversee implementation of MTCs and other initiatives focused on improving the drug use process at national level. Following the above developments, MeTA Uganda proposed to re-invigorate Medicine and Therapeutic Committees in selected hospitals to spearhead rational medicine use strategies in those Ugandan hospitals. Objectives 3
To assess the state of pharmaceutical management and rational drug use in selected regional referral hospitals a modified rapid pharmaceutical management assessment tool To assess the utilization of parenteral antimicrobial agents at the selected hospitals To design and implement interventions which involve mentoring and participatory health worker orientation to improve functioning of medicine and therapeutic committees. 4
Methods and materials This was an implementation research study conducted in three regional referral hospitals in Uganda. It involved a baseline and evaluation assessment. It employed both quantitative and qualitative methods to investigate rational drug use with a focus on use of parenteral antimicrobial preparations. A baseline assessment was carried out, then interventions were developed collaboratively with the responsible hospital staff and implemented at the selected sites and lastly an end-line assessment has been planned to evaluate and document any difference in aspects of therapeutic management and rational drug use that are attributable to intervention. The report of the study will be shared with MeTA council and disseminated to inform policy. Study setting The project was implemented in judiciously selected regional referral hospitals. Generally, regional referral hospitals are designated to provide health services to the population in several districts ranging from 10 to 30 districts. The hospitals in this project also serve as teaching hospitals for respective Nursing schools, Clinical officers schools and medical schools. As teaching hospitals, they offer a range of specialized services such as ultra sound scan. Regional referrals in Uganda offer a wide range of services to the populace. These include curative and clinical services for communicable and non communicable diseases, preventive services including immunization, surveillance for special diseases such as AFP/poliomyelitis, leprosy, measles, neonatal tetanus, health education and promotion, maternal and childcare and rehabilitation services. The project targeted regional referral hospitals because of the level of care provided, the extent of medicines handled and the fact that health professionals at these hospitals are mandated to periodically conduct support supervision to other lower level hospitals and health facilities. Hence, we envisage that successful implementation of this endeavor to improve use of antimicrobials at these facilities will have ripple effects to lower level hospitals. Sampling and sample size Given the nature of the study that involved both quantitative and qualitative data collection, indepth interviews were be held with selected pharmacy staff, and administrators to understand the system factors and challenges that broadly affect rational drug use and antimicrobial use. 5
For the quantitative part, a specific questionnaire was administered to 10 prescribers and another questionnaire was administered to 50 nurses involved in handling, dispensing and administering the prescribed medicines to patients. Data Collection Methods In depth Interviews The study employed this method more extensively with the pharmacy staff and other hospital staff with roles on the Pharmacy and Therapeutics committee in their different cadres and posts. This method was considered appropriate for the nature of questions the project posed. Most of the questions required explanations and sometimes an in depth understanding. Observation This was used in the medicine stores to quickly understand the challenges of medicine storage and related inventory. The research team moved around the hospitals, interacting freely with different hospital workers. The research team will also observe facilities such as treatment rooms, wards, drug stores, equipment maintenance workshops and staff houses in the various hospitals visited. Document Review This study has benefited immensely from document reviews. The study team will particularly review medicine related inventory and morbidity and mortality reports. Focus Group Discussions The study team conducted modified focus group discussions (FGDs) with current or potential members of the pharmacy and therapeutic committees at the respective hospitals. One of the study members moderated those focus group discussions. The FGDs focused on underlying opinions, attitudes and reasons for the challenges in having PTCs promote rational medicine use at the hospital. Permission was sought to record the conversion and the transcripts were analyzed systematically. 6
4.0 RESULTS AND DISCUSSIONS 4.1 Pharmaceutical Management and Rational Drug Use We assessed the current involvement of the MTCs in pharmaceutical management and rational drug use at the hospital. This included the existence and functionality of the MTCs. As far as rational drug use is concerned, we assessed the utilization and factors influencing the utilization of parenteral antimicrobial agents. In cases where the MTC was not functioning, we determined how pharmacy department proceeded to conduct the following activities; Providing medicine related advise to medical staff, administration and pharmacy Development of drug policies Evaluating and selecting medicines for the formulary list Developing hospital specific treatment guidelines/protocols Assessing medicine use at the hospital to identify problems Conducting effective interventions to improve medicine use Managing adverse drug reactions Managing medication errors Information dissemination and transparency - Informing all staff members about drug use issues, policies and decisions 4.2 Status of Medicines and Therapeutics Committee All three regional referral hospitals have a proposed structure for a Medicines and Therapeutics Committee. The proposed members for Mbarara Regional Referral Hospitals are as follows; Anaesthetist Chair Pharmacist Secretary Administrator Senior Nursing Officer Representatives from Pediatrics, Internal Medicine and Obstetrics/Gynecology The proposed members of the MTC in Mbale include; 7
Obstetrician Chair Pharmacist/pharmacy technician Secretary Principal Nursing Officer Administrator Medical Superintendent Representatives from Internal Medicine, and Pediatrics In both hospitals, the MTC had not held a meeting in the previous one year. Some of the reasons for non functionality of the MTC included lack of clarity on how members are selected and appointed, what their terms of reference are and what the mode of operation of the MTC should be. Other reasons included lack of funds for operational costs of MTC functions such as stationery, refreshments, communication and member honorarium, and heavy work load caused by high patient load. The members proposed the following as recommendations to improve the performance of MTCs; Conduct training on rationale and functioning of MTCs in hospitals for proposed and potential members of the MTC. Such training should respect principles of adult learning and should be participatory with the aim of orienting members to integrate their roles on the MTC into their day to day clinical tasks. Hospital to mobilize and provide funds to meet operational costs such as communication, stationery and refreshments during MTC functioning. 4.3 Utilization of Parenteral Antimicrobial Agents As part of the investigation of rational medicine use of parenteral antimicrobial agents, we analyzed the consumption levels of parenteral antimicrobials agents to determine the most 8
utilized AMDs and to identify the hospital units where these AMDs are being used. This is usually a first step in drug use evaluation processes. Additionally, we conducted a survey among prescibers and nurses to understand practices and factors influencing use of parenteral antimicrobial agents. COMPARATIVE LEVEL OF CONSUMPTION FOR PARENTERAL ANTIMICROBIAL AGENTS Table 1. Comparative consumption of parenteral preparations in Mbale Hospital by ward/unit. S/No Parenteral Comparative level of consumption medicine 1st 2nd 3rd 4th 5th 6th 1 Ceftriaxone Inj Ward 8/9 Acute Ward 3 Casualty PNW Ward 6/7 2 Water for Casualty Ward 8/9 MAT 1 Labour PNW Acute Injection Suite 3 Benzyl Penicillin Casualty Ward 8/9 MAT 1 MTD Acute Ward 3 Inj 4 Normal Saline Casualty Labour Suite Ward 8/9 Ward 6/7 Acute MAT 1 5 Gentamycin Inj Ward Casualty MTD Ward 3 Acute MAT 1 8/9 6 Chloramphenical Inj Ward 8/9 Ward 3 Acute Ward 6/7 Casualty 7 Quinine Injection Casualty Acute Ward 8/9 Ward 3 MAT 1 PNW Ceftriaxone injection was the most consumed parenteral antimicrobial agent. Other AMDs in the top ten most utilized agents included Benzyl penicillin Inj, Gentamycin Inj, Chloramphenical Inj and Quinine Inj. The units were there was most utilization of the parenteral AMDs were Ward 9
8/9 and Casualty. Other units in the top six for all the AMDs were Acute, MAT 1, Ward 6/7, Labour Suite, PNW and ward 3. IMPLICATION Pharmacy department and MTC has to develop treatment protocols/guidelines for Ceftriaxone to ensure its safe and effective handling and administration. These guidelines should be prioritized for implementation on the following units; Ward 8/9 and Casualty. Other units that should be given priority include Acute, MAT 1, Ward 6/7, Labour Suite, PNW and ward 3. The appearance of Quinine Inj among the top ten most consumed parenterals is of concern given the recent implementation of New Malaria Treatment Guidelines for Severe Malaria by MoH. These guidelines recommend use of Artesunate inj instead of Quinine Inj in treatment of Severe malaria. Proposed intervention Training on Ceftriaxone Inj, focusing on indications, its administration and monitoring for side effects/adverse effects. This training will also include aspects of reconstitution, use of giving sets, aseptic technique, stability and incompatibilities of ceftriaxone. Training on the revised Malaria Treatment Guidelines with specific focus on treatment of Severe malaria 10
Table 2. Consumption of parenteral preparations in Gulu Hospital by ward/unit. S/N o Parenteral medicine 1 Ceftriaxone Inj 2 Water for Inj 3 Normal Saline 4 Dextrose 5% 5 Gentamycin Inj 6 Quinine Inj Casualt y Comparative level of consumption 1st 2nd 3rd 4th 5th 6th Medical Surgical Gyn/M Casualty Mat/Neo Acute ot Surgical OPD/Dent Pead TB Medical Casualty al Casualt Surgical Acute Medical Gyn/Mot Mat/Neo y Casualt Medical Gyn/M Acute Peadiatric OPD/Dent y o s al t Surgical Medical Gyn/M Mat/Neo Pediatrics OPD/Dent ot Medical Acute OPD/Dent al Peadiatric s al Mat/Neo Ceftriaxone Inj was the most consumed parenteral antimicrobial drug. Others included Gentamycin Inj, and Quinine Inj. The hospital units that had the highest consumption for these items included the Medical, Surgical wards and Casualty. Other units among the top six in terms of consumption of Ceftriaxone Inj, Gentamycin Inj and Quinine Inj included Gyn/Mot, Mat/Neo, Acute, OPD/Dental and Peadiatrics. IMPLICATION Pharmacy department and MTC have to develop treatment protocols/guidelines for Ceftriaxone to ensure its safe and effective handling and administration. These guidelines should be prioritized for implementation on the following units; Medical and Surgical wards and Casualty. Other units that should be given priority include Gyn/Mot, Mat/Neo, Acute, OPD/Dental and Peadiatrics. The appearance of Quinine Inj among the top ten most consumed parenterals is of concern given the recent implementation of New Malaria Treatment Guidelines for Severe Malaria by MoH. These guidelines recommend use of Artesunate inj instead of Quinine Inj in treatment of Severe malaria. Proposed Intervention 11
Training on Ceftriaxone Inj, focusing on indications, its administration and monitoring for side effects/adverse effects. This training will also include aspects of reconstitution, use of giving sets, aseptic technique, stability and incompatibilities of ceftriaxone. Training on the revised Malaria Treatment Guidelines with specific focus on treatment of Severe malaria 4.4 Prescribers and utilization of parenteral antimicrobial drugs 12
Table 3. Background Characteristics of Participant Prescribers at Mbale and Mbarara Regional Referral Hospitals Background Characteristics Professional Background Mbale (N=10) Frequency/Value Mbarara (N=15) General practitioner 2 6 Internist/internal medicine 1 2 Obstetrics and gynecology 1 1 Clinical officer 6 5 Pediatrician 0 1 Level of Education Master s 2 7 Degree 2 3 Diploma 6 5 Gender Male 6 11 Female 4 4 Marital Status Married 9 13 Not married 1 2 Average Age 39 38 Average years of work experience 12 11 Median Number of Patients Examined in a Day Median Number of Inpatients Handled per Day 50 40 30 18 13
Most of the participant prescribers were either general practitioners or clinical officers and majority were male and married in both Mbale and Mbarara hospitals. Their average age was about 38 years and they had work experience of about 11 years. The prescribers in Mbale hospital on average examined more patients per day than those of Mbarara hospital. Table 4. Practices around prescription of Antimicrobials in Mbale Hospital Item Always Occasionally No/Never Conduct Antimicrobial Sensitivity Tests before 0 5 5 prescription Patients demand for antibiotics 4 6 0 Prescribe only antimicrobial medicines available at your hospital 1 5 4 Only half of the prescribers occasionally conduct antimicrobial sensitivity tests and the other half does not conduct any. Additionally, patients demand for antimicrobial agents influences the prescriber to prescribe and lastly, some prescribers prescribe medicines that are not available at the hospital. Table 5. Practices around prescription of antimicrobials in Mbarara hospital Item Always Occasionally No/Never Conduct Antimicrobial Sensitivity Tests before 2 12 1 prescription Patients demand for antibiotics 3 7 5 Prescribe only antimicrobial medicines available at your hospital 2 4 9 At least two prescribers always conduct antimicrobial sensitivity tests while 10 prescribers prescribe antimicrobials because of the demand from patients. Most prescribers recommend medicines that are no available at the hospital. 14
Figure 1. Average number of times prescriber had recommended the following antimicrobials in week prior to survey Figure 2. Antimicrobial practices at the hospitals Item Mbale (n=10) Frequency Mbarara (n=15) 15
Always Occasionally No/Never Always Occasionally No/Never a) Generic drug 7 2 1 10 3 2 name b) Brand drug 3 5 2 2 12 1 name c) Dosage form 9 1 0 15 0 0 d) Route of 9 1 0 15 0 0 administration e) Dose/amount to 9 1 0 14 1 0 be administered f) If intravenous, I 5 4 1 8 7 0 state the rate of administration g) If the drug requires reconstitution, I state the liquid/solution to be used to dilute/reconstitut e 2 2 6 3 7 5 h) Duration of 8 2 0 15 0 0 treatment i) Any precautions during administration 2 4 4 3 11 1 Antimicrobials that cause a challenge to most clinicians when in use Prescribers in Mbale mentioned the following antimicrobial drugs as those that cause challenges during clinical practice and hence require closer attention from the Medicine and Therapeutics Committee. They are presented in the decreasing order of importance. 1. Benzylpenicillin 2. Ceftriaxone 3. Metronidazole 4. Ciprofloxacin 5. Procaine Penicillin Fortified 6. Chloramphenical 7. Ampicillin/Cloxacillin Prescribers in Mbarara mentioned the following antimicrobial drugs as those that cause challenges during clinical practice and hence require closer attention from the Medicine and Therapeutics Committee. They are presented in the decreasing order of importance. 16
1. Ceftriaxone 2. Ciprofloxacin 3. Clindamycin 4. Amphotericin B 5. Gentamycin 6. Co-trimoxazole 7. Ampicillin 8. Anti TB medicines Proposed and suggested interventions to improve the use antimicrobials at the hospitals When prescribers were asked to suggest some of the interventions that could be implemented to improve use of antimicrobial drugs, the following initiatives were recommended; 1. Establish or improve hospital laboratory capacity to conduct antimicrobial culture and sensitivity. This will include acquisition of equipment, consistent availability of appropriate consumables, chemicals and reagents, training of laboratory personnel on antimicrobial culture and sensitivity tests and re-orientation of the hospital values and culture towards such tests. Furthermore, some prescribers advocated for increase number of laboratory personnel and their sensitization on their role in promoting rational antimicrobial use 2. Training of prescriber/clinicians on antimicrobial drug use and administration including development and adaptation of evidence based treatment protocols for priority common illnesses. Provision of up-to-date treatment reference materials 3. Promote reliable supply of essential antimicrobial agents to prevent stock outs and subsequently non compliance by affected patients. 4. Development and implementation of the hospital antimicrobial formulary list to promote the essential medicines concept. This would be coupled by other strategies to restrict and regulate prescription and widespread use of certain antimicrobial drugs. 5. Address antimicrobial medicine administration issues such as pain during administration, challenges in accessing the IV route for some fat patients, six hourly intervals in administration that can be very burdensome to patient and attending nursing staff. Additionally, consider increasing availability of antimicrobial drugs that have a better administration profile but may have high initial costs. Challenges faced/met by prescribers/clinicians in using parenteral antimicrobials at the hospitals. 1. Unsafe storage practices especially after reconstitution 2. Unreliable supply and availability which leads to non compliance and no/limited treatment choices, cost, drugs are always out of stock and patients take them out of the hospital and areprone to poor injection giving methods, short-dated supplies from NMS, some important AMCs such as Vancomycin, Azithromycin and Doxycycline. 17
3. Medicines administration issues such as pain to patient, inability to ensure aseptic technique may lead to abscess, lack/shortage of proper administration devices (right size syringes e.g. for reconstituting ceftriaxone, giving sets), lack of knowledge and skills required to reconstitute and administer some of the antimicrobial medicines, inconvenient, inadequate number of staff versus workload. 4. Occurrence of adverse and side effects; No monitoring, reporting and management of SEs 5. Bacterial resistance with no mechanism to monitor/avoid affected antimicrobials leads to treatment failure which may be fatal. 6. Presence of unsafe and substandard antimicrobials. 7. Non existence of patient treatment monitoring protocols. 18