Clinical Pharmacokinetic Service Research Articles

A National Survey of Attitudes and Practices of Physicians Relating to Therapeutic Drug Monitoring and Clinical Pharmacokinetic Service: Strategies for Enhancing Patient's Care in Saudi Arabia.

PurposeThe aim of the study was to evaluate physicians’ perception of the concept of pharmacokinetics and therapeutic drug monitoring (PK/TDM) and their use in clinical practice.MethodsA novel, structured, self-administered questionnaire was designed, validated and distributed to physicians in 3 major cities in Saudi Arabia (Riyadh, Jeddah, Dammam) during a 4-month period. Data were collected on demographics, knowledge and practice of PK/TDM. Attitudes toward integrating these skills into daily clinical practice were also investigated.ResultsA total of 724 physicians completed the survey and included in the study. European and North American physicians were found to be more exposed to PK/TDM than other physicians. About 70% of the participants stated that they have applied PK/TDM in their practice, at least, once and most of these were consultants. Only 4.3% of respondents had never checked organ function prior to prescribing narrow therapeutic index drugs. Although the majority (78.4%) perceived PK/TDM as very important to their practice, only 35.3% have tried to calculate drug PK parameters for their patients when necessary.ConclusionThe result of this study showed that the knowledge of physicians about PK/TDM was inadequate. Moreover, the utilization of competent clinical pharmacists trained in PK/TDM was low. An interdisciplinary educational program between the physicians and pharmacist in PK/TDM will lead to a better health care outcome.

National Survey of Pharmacokinetic Services in Saudi Arabia: Perceptions and Barriers of Service Implementations

International Journal of Pharmacology and Clinical Sciences,2019,8,3,194-198.DOI:10.5530/ijpcs.2019.8.33Published:September 2019Type:Research ArticleAuthors:Yousef Ahmed Alomi, Ban Abdullah Aldosary, and Rasha Abdelsalam Elshenawy Author(s) affiliations:Yousef Ahmed Alomi*, The Former General Manager of General Administration of Pharmaceutical Care and Head, National Clinical pharmacy, and Pharmacy Practice and Pharmacy R & D Administration, MOH, Riyadh, Saudi Arabia. Ban Abdullah Aldosary, Pharmaceutical Care Department, Al-Amel Mental City, Ministry of Health, Riyadh, Saudi Arabia. Rasha Abdelsalam Elshenawy, BCS. Pharm. BCPS (AQ-ID), CPHQ, M.Sc., TQM (AUC), SIDP, CEO of FADIC, Ministry of Health, Makkah, Saudi Arabia. Abstract:Objectives: To explore the pharmacokinetic services at the Ministry of Health (MOH) hospitals in Saudi Arabia with an emphasis on perceptions and barriers of service implementation. Methods: This is a 2-month cross-sectional national survey of pharmacokinetic services with a focus on pharmacy management and resources at MOH hospitals in Saudi Arabia. The study consisted of two parts: the first part collected demographic information and the second part consisted of 43 questions divided into three domains. The questions were derived from the American Society of Health-System Pharmacists (ASHP) guidelines and from the literature. We used 5-point Likert response scale system with close-ended questions to obtain responses. An electronic questionnaire was distributed to the coordinators of the clinical pharmacy services or drug information centers at MOH hospitals and it analyzed the perceptions and barriers of pharmacokinetic service implementations section through the Survey Monkey system. Results: A total of 43 hospital pharmacies responded to the questionnaire, with the response rate of 86%. The majority of pharmacokinetic services were provided to the adult patients (37 (86.05%)) followed by the pediatric and geriatric patients (19 (44.19%) and 13 (30.23%), respectively) with most of the responding hospitals having less than 20 beds (23 (53.5%)). The categories with most of the barriers of pharmacokinetic service implementation were lack of knowledge (20 (64.52%)), lack of pharmacokinetic education (16 (51.61%)) and lack of an expert pharmacist in pharmacokinetic services (16 (51.61%)). Most of the responders agreed that clinical pharmacokinetic services were necessary for hospitals (23 (53.5%)). The responders agreed that the clinical pharmacist through pharmacokinetic services had a positive financial impact and cost avoidance on healthcare system (23 (53.5%)). Most of the responders stated that pharmacokinetic services improve the safety and efficacy of patient care (33 (89.2%)). Most of the responders agreed that the pharmacokinetic services improved patients’ clinical outcome (33 (89.2%)) and prevented drug-related problems (33 (89.2%)), whereas few of the pharmacokinetic services were provided only 10 (29.4%) over 24 hr per day. Conclusion: Despite the positive attitude of hospital management toward pharmacokinetic services, there was a lack of education and training regarding the same at MOH hospitals in Saudi Arabia. Revision of strategic planning of pharmacokinetic services with regard to their improvement and implementation are required at all MOH hospitals in Saudi Arabia. Keywords:Barriers Ministry of Health, Perceptions, Pharmacokinetics, Saudi ArabiaView:PDF (190.56 KB) PDFClick here to download the PDF file. Images Demographic information about hospital.

Appropriateness of Antiepileptic Drug-Level Monitoring at a Childrens’ Hospital in Mexico

Introduction In Mexico, plasma drug monitoring is being used to check toxicity, compliance, and dose titration in treatment with antipileptic drugs (AEDs), but without taking into account the principles of pharmacokinetics due to the absence of a clinical pharmacokinetic service with specialized

Development of clinical pharmacy services for intensive care units in Korea

ObjectiveTo be utilized for the development of pharmacists’ intervention service by determining factors which affect pharmacists’ prescription interventions.SettingPatients who were admitted to intensive care units (ICUs) in internal medicine departments in Korea.MethodsData including age, gender, clinical departments, length of hospital stay, status of organ dysfunction, intervention status, frequently intervened drugs, and health care providers’ questions were prospectively collected in ICUs in the department of internal medicine in a tertiary teaching hospital from January to December, 2012.Main outcome measurePrimary outcome was factors which affect pharmacists’ prescription interventions. Secondary outcomes included frequencies of the intervention, intervention acceptance rates, intervention issues, and frequently intervened drugs.ResultsA total of 1,213 prescription interventions were made for 445 patients (33.1%) of the 1,344 patients that were analyzed. Length of hospital stay was significantly longer for the group that needed pharmacists’ interventions (p < 0.001). Pharmacists’ intervention requirements were significantly higher in patients with kidney dysfunction (p < 0.001). The percentage of intervention accepted was 96.8%, and interventions that were common were as follows (in order): clinical pharmacokinetic service, dosage or dosing interval changes, dosing time changes or dose changes, and total parenteral nutrition consultation. The five medications with the highest intervened frequency were (in order) vancomycin, famotidine, ranitidine, meropenem, and theophylline.ConclusionThe need for pharmacists’ prescription interventions was highest among patients with longer length of stay and patients with kidney dysfunction. Based on these findings, prescription intervention activities could be initiated with severely ill patients. The results could be utilized in countries which are planning to develop pharmacists’ intervention service.

Putting pharmacogenomics into practice

Putting pharmacogenomics into practice

Development and implementation of a pharmacist-managed clinical pharmacogenetics service

The development and implementation of a pharmacist-managed clinical pharmacogenetics service are described. A pharmacist-managed clinical pharmacogenetics service was designed and implemented at an academic specialty hospital to provide clinical pharmacogenetic testing for gene products important to the pharmacodynamics of medications used in the hospital's patients. A series of accredited educational seminars were conducted for our pharmacists to establish competencies in providing pharmacogenetic consults for the genes to be tested by the clinical pharmacogenetics service. The service was modeled after and integrated with an already-established clinical pharmacokinetics service. A steering committee was formed to evaluate the use of available tests, new evidence for implementation of additional tests, and other service quality metrics. All clinical pharmacogenetic test results are first reported to one of the pharmacists, who reviews the result and provides a written consultation. The consultation includes an interpretation of the result and recommendations for any indicated changes to therapy. In 2009, 136 clinical pharmacogenetic tests were performed. The service has been met with positive clinician feedback. The successful implementation of this service highlights the leadership role that pharmacists can take in moving pharmacogenetics from research to patient care. The development of and experience with a pharmacist-managed clinical pharmacogenetics service are described. The program's success has depended on collaboration between the clinical laboratory and pharmacists, and pharmacists' pharmacogenetic recommendations have been well accepted by prescribers.

The future of therapeutic drug monitoring in clinical practice

Therapeutic drug monitoring (TDM) for psychotropic drugs offers the possibility to optimize psychiatric pharmacotherapy by tailoring the dosage of the administered drugs according to the characteristics of the individual patient. Thus, TDM may increase efficiency of therapy and reduce costs, and it makes a contribution to ensure patient safety. However, there is growing evidence that current use of TDM in routine psychiatric care is far from optimal so that its potential benefits can not fully come to fruition. Several studies have demonstrated a considerable amount of inappropriate TDM ordering, particularly blood sample taking too early after start of medication and change of dose, respectively, before steady state has been reached. Moreover, considerable discrepancies were apparent between the laboratory's recommendations and the actual clinical decision making on dose adjustments. In view of the potential benefits that TDM could have for medical and economic treatment outcome, there is the need for measures to improve its implementation in clinical routine. In addition to intensified physician education about the fundamental principles of drug pharmacokinetics, there are several possible strategies, which have turned out to be effective in other fields of medicine, including clinical pharmacokinetic services actively involved in the treatment process and use of computerized systems.

PID28: COMPARING DIFFERENCES IN CLINICAL EFFECTIVENESS, NEPHROTOXICITY, AND COST-EFFECTIVENESS OF AMINOGLYCOSIDE THERAPY BETWEEN ALTERNATIVE DOSING PROTOCOLS

OBJECTIVE: The objective of this study was to develop a pharmacoeconomic model which compared the difference in cost-effectiveness (CE) between a Multiple-daily-dosing (MDD) protocol of aminoglycosides (AG) managed by a Clinical Pharmacokinetic Dosing Service (CPS) and a protocol for Once-daily-dosing (ODD), from the perspective of a Managed Care Organization. METHOD: Event rates for both clinical effectiveness and aminoglycoside-associated-nephrotoxicity (ANN) for MDD were determined by a retrospective chart review of 262 randomly sampled patients who received gentamicin for the treatment of serious gram-negative bacterial infections between January 1, 1990 and March 30, 1998. The incidence of ANN was 3.1%. Event rates for ODD protocol for both clinical effectiveness and ANN were determined to be 82.2% and 5.8%, respectively based on an extensive review of the current literature. Time-in-motion studies were performed to determine personnel costs for all nursing and pharmacy activities. Decision analysis was used to determine the CE of the two protocols. RESULTS: The results were unexpected based on reports in the literature predicting substantial cost savings with the use of ODD programs. In the base case analysis the expected per patient cost value for MDD with CPS and ODD protocols was $241 and $237 respectively. However, MDD with CPS was determined to be more cost-effective than ODD due to slightly increased rate of clinical effectiveness and a decrease in the rate of ANN (average CE ratios = $281 versus $287, respectively). Both one-way and two-way sensitivity analyses were performed by varying the two key parameters of clinical effectiveness and ANN. The model was robust to alterations in these key parameters. CONCLUSION: This CE analysis questions the benefit of implementing an ODD program when compared to a more traditional MDD protocol managed by a CPS for aminoglycoside dosing.

Frequency of Nephrotoxicity with Vancomycin and Aminoglycoside Antibiotic Therapy

Three hundred and thirty four patients receiving aminoglycosides and/or vancomycin therapy for at least 72 hours were retrospectively reviewed for the development of nephrotoxicity. The patients' vancomycin and aminoglycoside serum concentrations were monitored by our clinical pharmacokinetics service. The average age, weight, and serum creatinine of the patients were 67.8 years, 71.3 kg, and 1.03 mg/dL, respectively. Nephrotoxicity occurred in 30 patients, but only 8 of these cases of renal toxicity (2.4%) were attributed to the use of vancomycin and/or aminoglycosides. The remaining 22 patients had other factors known to contribute to renal failure. Nephrotoxicity with aminoglycosides was more frequent than with vancomycin (2.8% versus 1.1%, respectively). Alarmingly, the frequency of renal toxicity increased by about four-fold when vancomycin was administered concomitantly with an aminoglycoside. Although further analysis is needed, preexisting renal impairment seems to be the major contributing factor for nephrotoxicity in our study.

Therapeutic drug monitoring beyond 2000.

Therapeutic drug monitoring beyond 2000.

A regional pharmacokinetic consultation service.

Clinical pharmacokinetics represents a way to ensure that a patient is receiving an optimal dose of a given drug for a specific indication. Pharmacokinetic consultation services have been implemented in many teaching hospitals and tertiary care facilities in the past. This project evaluated the feasibility of expanding the process to several community hospitals with one coordinator. Twenty-seven hospitals, members of the Ottawa Valley Regional Drug Information Service, were approached. Fifty-two pharmacists from 21 sites agreed to participate. Four modules were taught: basic principles, theophylline, aminoglycosides, and digoxin. Regular follow-up meetings were arranged so pharmacists from different hospitals could share their administrative and patient-specific problems and solutions. After two years, 16 departments have implemented a clinical pharmacokinetic service and monitor 82% of targeted drug levels. The pharmacists trained in clinical pharmacokinetics through the project recommended changes in the regimen in 45% of all their consultations. Eight-one percent of these were accepted and implemented by physicians. These results indicate that pharmacists from small community hospitals can be trained by one individual to provide clinical pharmacokinetic services with minimal supervision. It also shows that these hospitals have a need for such services.

Use of Therapeutic Drug Monitoring in Pharmacoeconomics

The use of therapeutic drug monitoring (TDM) for drugs with a narrow therapeutic range has contributed substantially to the literature. The pharmacoeconomics of this service for hospitalized patients has demonstrated significant hospital savings. Appropriate use of this pharmacy-based service has demonstrated savings, reduction in total length of hospitalization, and cost avoidance with aminoglycoside-induced nephrotoxicity. Use of a Clinical Pharmacokinetic Service (CPS) for inpatient theophylline therapy and outpatient anticonvulsant therapy documents the pharmacoeconomic benefits provided by this service to both in- and outpatients. This report will discuss current literature with regard to pharmacoeconomics and cost-benefit analysis of TDM.

Methods of minimising the cost of aminoglycoside therapy to hospitals.

Aminoglycoside agents are used for a wide variety of systemic infections and can profoundly affect hospital expenditures depending upon the amounts used, acquisition costs, and costs incurred during therapy. Significant cost advantages can be gained through selection and proper use of the appropriate aminoglycoside. Institutions can improve the selections by using inservice training and other educational methods, drug-use audits, and therapeutic substitution. Institutions may also restrict or delete certain aminoglycosides from the drug formularies to help minimise costs. Therapeutic drug monitoring can reduce the incidence of aminoglycoside adverse effects. However, some methods of monitoring, such as certain clinical pharmacokinetic services, can be time consuming and require additional manpower. These measures can be shown to be cost effective if they can decrease the length of therapy, minimise toxicity, decrease the length of hospitalisation, or affect mortality. Experimental data and preliminary clinical evidence suggest that once-daily regimens of aminoglycoside agents have some possible advantages over the standard regimens. If this regimen can be widely used, cost savings secondary to decreased use of aminoglycosides can be realised in the future. Potent, broad spectrum beta-lactam monotherapy has threatened to replace conventional combination therapies that include aminoglycosides in some infectious processes and a few studies have found certain single-drug therapies to be cost effective.

Risk of nephrotoxicity with combination vancomycin-aminoglycoside antibiotic therapy.

One hundred five patients receiving concurrent aminoglycoside and vancomycin therapy of at least 5 days' duration were retrospectively reviewed for development of nephrotoxicity. All had their vancomycin and aminoglycoside serum concentrations controlled by a clinical pharmacokinetics service. Nephrotoxicity occurred in 28 (27%) of the patients. Twenty-two of the 28 had other factors that are known to contribute to renal failure (amphotericin B therapy, sepsis, liver disease, obstructive uropathy, pancreatitis, anesthesia). The remaining six developed nephrotoxicity without other known contributing factors. Logistic regression analysis revealed associations between nephrotoxicity and age, sex, aminoglycoside trough and vancomycin peak and trough serum concentrations, length of aminoglycoside and vancomycin therapy, concurrent amphotericin B therapy, liver disease, neutropenia, and peritonitis (p less than 0.05). In addition to factors previously reported, this study found that neutropenia and peritonitis are associated with an increased risk of nephrotoxicity. Patients with one or more risk factors warrant close monitoring of renal function as well as vancomycin and aminoglycoside serum concentrations.

Does Accepting Pharmacokinetic Recommendations Impact Hospitalization? A Cost-Benefit Analysis

In a prospective, randomized study, 110 adults receiving aminoglycosides were randomized to follow-up by a clinical pharmacokinetic service (CPS). Of the 110 patients, 35 accepted pharmacokinetic recommendations less than 100% of the time. The two groups were similar in age, sex, height, APACHE II score, and initial creatinine clearance. A cost-to-charge ratio was used to derive direct costs of hospitalization and calculate cost-benefit. Patients whose physicians accepted pharmacokinetic recommendations 100% of the time had shorter hospitalizations (322.67 +/- 270.28 h; CPS less than 100%, 699.54 +/- 806.35; p = 0.001) and febrile periods (50.05 +/- 79.38 h; CPS less than 100%, 120.00 +/- 153.23; p = 0.002). Acceptance of CPS recommendations led to adequate peak levels. Acceptance of CPS recommendations led to lower direct costs ($7,102.56 +/- 9,898.19; CPS less than 100%, $19,629.94 +/- 28,051.89; p less than 0.001). Calculated direct cost of the service was $85/patient.

Impact of a Clinical Pharmacokinetic Service on Patients Treated with Aminoglycosides

In a prospective, randomized study, 75 adults receiving aminoglycosides were followed by a clinical pharmacokinetic service and 70 followed as controls. The two groups were similar in age, gender, height, and APACHE II score. A cost-to-charge ratio was used to derive direct costs of hospitalization and calculate cost-benefit. Excluded from this comparison were patients with incomplete acceptance of pharmacokinetic service recommendations and patients followed by other clinical pharmacists. Pharmacokinetic service patients had shorter hospitalizations (322.67 +/- 270.28 h; controls 442.89 +/- 536.81, p = 0.087) and febrile periods (50.05 +/- 79.38 h; controls 92.23 +/- 122.50, p less than 0.05). More pharmacokinetic service patients had adequate peak levels. Pharmacokinetic service direct costs were lower ($7,102.56 +/- 9,898.19; controls $13,758.64 +/- 22,874.31, p less than 0.05). Calculated direct cost of the service was $85.00/patient. Annual savings for 500 patients is $2,220,540.00.

Therapeutic Drug Monitoring Services at Kyushu University Hospital in Japan

Quantitative evaluation of the therapeutic drug monitoring services (TDMS) provided in Kyushu University Hospital from August 1981 to April 1989 was performed. Since 1982, the annual number of assay requests was about 4300-4400, but the annual number of clinical pharmacokinetic consultation services (CPCS) showed a tendency to increase. Antiepileptics were the drugs for which CPCS were most often performed (26.3 percent of the population given drugs for which TDMS was available); digoxin, lithium, and theophylline followed. Preparation of one consultation required 1.5-2.5 hours. Our TDMS team consists of eight members. In 1988, the average time per week spent for CPCS and TDMS was 8.2 and 11.3 hours per member, respectively. Thus, the number of pharmacists performing CPCS and TDMS was 1.2 and 1.7 full-time equivalents, respectively.

Demystifying Kinetics: Establishment of an Aminoglycoside Clinical Pharmacokinetic Service

Demystifying Kinetics: Establishment of an Aminoglycoside Clinical Pharmacokinetic Service

Development and implementation of clinical pharmacokinetic services

The basic issues involved in the development and implementation of pharmacokinetic dosing services are presented. A quality pharmacokinetic dosing service is activated by pharmacists immediately upon receipt of a consultation request or medication order. The patient's status is assessed, and recommendations are made for initial dosage, timing of blood sampling, and laboratory tests. Serum drug concentration data are interpreted and a maintenance dosage recommended. The patient is then monitored. The personnel selected for a dosing service need not have advanced pharmacy degrees but must be highly trainable. Their training should address basic pharmacokinetic concepts, the pharmacokinetics of specific drugs, and details on running the service and should be reinforced by extensive on-the-job training. As with other services, staffing should be tailored to workload. Continuous oral and written communication among the dosing service pharmacists and between the pharmacists and the medical and nursing staffs is essential to the smooth and expeditious operation of the service, as are complete and well-written policies and procedures. A quality dosing service cannot exist without commitment from hospital administration and the director of pharmacy and responsiveness of the nursing department and laboratory to the service's exacting requirements. Ongoing research is necessary to evaluate the pharmacokinetic models and software packages used and to find ways of conserving time. High-quality pharmacokinetic dosing services enhance patient care and the image of hospital pharmacy.

ASHP statement on the pharmacist's role in clinical pharmacokinetic services

ASHP statement on the pharmacist's role in clinical pharmacokinetic services