Study on pharmaceutical care model for drug-related problems in elderly patients based on comprehensive medication management review / 中国药房

OBJECTIVE To explore the pharmaceutical care model for elderly patients with drug-related problems （DRPs） based on the comprehensive medication management review （CMMR）， and to observe the effect of pharmaceutical care under the model. METHODS The pharmaceutical care new model for elderly patients was established by concerning CMMR guidelines in Australia. In other words， clinical pharmacists receive medical care through referral by health practitioners and active consultation by patients or their caregivers. Visits were made by a combination of face-to-face and telephone interviews. Follow-up was carried out in the form of outpatient follow-up， telephone follow-up， appointment， and home guidance to know about the treatment of DRPs by healthcare practitioners or patients.Under this model， the occurrence status and classification of DRPs in elderly patients were studied through cross-sectional investigation. The effect of pharmaceutical care was evaluated from the aspects of hospitalization rate， adverse drug reaction （ADR） incidence，medication compliance， the number of medications， blood lipid level， etc.， through self-before-after comparison. RESULTS In this study， a patient-centered， evaluation-intervention-reevaluation closed-loop pharmaceutical care model was formed. Among 317 study subjects， the average number of DRPs was 1.03 （0-7） cases. Compared before and after the intervention， the number of drug types increased from 2.00（0.00，3.00） to 2.00（1.00，3.00）， but the level of low-density lipoprotein cholesterin in patients decreased from 3.48 （2.58， 4.29） mmol/L to 3.11 （2.29，3.81） mmol/L （P＜0.05）. There was no statistical significance in hospitalization rate， ADR incidence within or medication compliance. CONCLUSIONS CMMR-based pharmaceutical care model can effectively identify and manage the patients’ DRPs and reduce the level of blood lipid.

Conformity evaluation of afinion 2 analyzer maintainability: Compliance practicality for Philippine National Standard PNS ISO 15189:2013 Accreditation

Objectives@#The implementation of Philippine National Standard PNS ISO 15189:2013 to support the medical laboratory to produce competent results is a recognised challenge. It is apparent that the approach of ensuring the equipment availability can be specifically optimised. No known research has focused on exploring on the conduct of conformity evaluation of Afinion 2 Analyzer maintainability for the PNS ISO 15189:2013 accredited medical laboratory. The aim of the current study was to develop a practical tool for the medical laboratory to support the internal audit process by determining the compliance status of Afinion 2 Analyzer maintainability. @*Methods@#The relevant conformance requirements in Clauses 4 (Management requirements) and 5 (Technical requirements) of PNS ISO 15189:2013, manufacturer requirements and specific requirements for accreditation from 70/101 (69%) accreditation bodies in 80/249 (32%) countries were identified as specific audit criteria for Afinion 2 Analyzer conformity evaluation checklists for the maintenance and reference equipment.

Impact of medication reviews on potentially inappropriate medications and associated costs among older women in aged care.

BACKGROUND: The Residential Medication Management Review (RMMR) service is a large investment by the Australian government and involves considerable time commitment. OBJECTIVES: This study determined the impact of RMMRs on the use of potentially inappropriate medications (PIMs), benzodiazepines and antidepressants, described patterns of PIM use, and examined costs. METHODS: The study included 5576 participants from the Australian Longitudinal Study on Women's Health from 2005 to 2017. Three generalised estimating equation (GEE) models were specified to separately analyse the impact of RMMRs on the use of PIMs, benzodiazepines and antidepressants. Descriptive statistics were used to present, at each year, the proportions of participants with PIMs, patterns of PIMs and costs of PIMs. RESULTS: There was no evidence for an association between the use of RMMRs and the use of PIMs (OR = 0.99; 95% CI = 0.88, 1.11), benzodiazepines (OR = 1.02; 95% CI = 0.95, 1.08) or antidepressants (OR = 0.99; 95% CI = 0.90, 1.10) in the following year. There were few differences in the use of particular classes of PIMs, nor any differences in the median benefits paid by government or out-of-pocket costs, between participants who did and did not receive RMMRs. There was a slight increase in median OOP costs and a decrease in government benefits over time. CONCLUSIONS: There was a lack of long-term changes on use of PIMs, however, its appropriate use must be considered during RMMRs. Healthcare professionals have an obligation to optimise the service to reduce medication costs whilst improving health outcomes among individuals residing in RACF.

Statistical Investigation of High Culture Contamination Rates in Mycobacteriology Laboratory.

Background: Culture of Mycobacterium tuberculosis remains the gold standard in mycobacteriology laboratories, constrained by the very high risk of contamination; therefore, contamination rate is an important key performance indicator (KPI) for laboratory monitoring and evaluation processes. Aim: This study aimed to investigate the factors that contribute to elevated contamination rates in the Sudan National Tuberculosis Reference Laboratory. Method: A laboratory-based retrospective study was applied; a TB culture register-book was carefully reviewed and data from 2 January 2019 to 31 December 2019 were entered, cleaned, and analyzed using IBM SPSS 20. A multivariate logistic regression model was performed to examine two dependent variables, the massive contamination, and the single tube contamination against predictors of reason for cultivation, type of specimen, experiment team, and the quarter of cultivation. Results: It has been found that in 2019 contamination rates were frequently higher; the highest rates were recorded in January and November, 28.2 and 25.2%, respectively. August is an exception with an accepted contamination rate of 4.6%. Of 1,149 specimens requested for culture, 945 (82.2%) samples were eligible to be included in multivariate logistic regression analysis. The team conducting the experiment was significantly associated with a high single tube contamination p value 0.007; adjusted odds ratio AOR 3.570 (1.415-9.005). The correlation between the single tube contamination and the massive contamination is significant; p value 0.01. Conclusion: The study concludes that high culture contamination is the greatest risk to the quality of laboratory service and can end in either the loss of specimens or delay in the decisions of initiating patient treatment. In addition, the low quality or incompleteness of data increases the uncertainty and undermines the measurement of key performance indicators.

Points to Consider When Using KPIs/Metrics.

Pharmaceutical quality systems according to ICH Q10 require the identification of processes that need to be measured. Designing and maintaining a metrics system in a way that serves its purpose well requires careful consideration of various aspects in order to meet expectations. The purpose of using key performance indicators/metrics can be defined by main aspects that include: 1) supporting the achievement of objectives by making them measurable, 2) reaching comparability and/or standardization of performance for organizational units, and 3) achieving objectiveness in assessing performance. The first two aspects are closely linked to management responsibilities. Therefore, management needs to be strongly involved with the activities of setting up and maintaining a metrics system. This article provides an overview of the points to be considered when setting up and managing a quality-related metrics system.

Industry One-Voice-of-Quality Solutions Management Review of Post-Approval Changes Guide.

Post-approval changes (PACs) are inevitable and necessary throughout the life of a drug product. Because many PACs require prior approval by individual regulatory agencies each having their own reporting requirements and approval timelines, this results in companies having to manage several versions of a manufacturing process at the same time. The global regulatory complexity increases risk of drug shortages. Chief quality officers and heads of quality from more than 20 global pharmaceutical companies have come together to speak with One-Voice-of-Quality (1VQ) and develop solutions to this problem by developing a science and risk-based approach to manage more PACs in the pharmaceutical quality system (PQS) rather than submitting these as prior approval supplements. Pharmaceutical companies already conduct management review (MR) according to the International Conference on Harmonization (ICH) Q10. This One-Voice-Of-Quality paper is a practical guide on how companies can expand the MR to also evaluate and demonstrate the effectiveness of their PQS in specifically managing PACs to achieve regulatory flexibility as stated in ICH Q10, Annex 1. Examples of PQS key performance indicators (KPIs) that may be used to assess, plan, implement, and monitor PACs are described. The intent is to provide assurance through MR that PACs can be managed effectively in the PQS, thereby resulting in a reduced need for regulatory prior approval of certain low risk changes that enhance product availability, reduce the risk of drug shortages, and/or facilitate timely innovation and continual improvement in the pharmaceutical industry. This document is endorsed by 1VQ chief quality officers and heads of quality.

Assessing the impact of medication management review service for females diagnosed with depression and anxiety: A randomized control trial.

Rationale, aims, and objectives Depression and anxiety are common mental illnesses suffered by females worldwide. Females face treatment-related problems (TRPs), including lack of adherence to their treatment. The Medication Management Review service (MMR) can be effective in identifying and resolving the TRPs. This study sought to assess the impact of the MMR service on identifying and resolving TRPs, improving adherence, depression, and anxiety scores in females diagnosed with depression and anxiety in Jordan. Design and settings Participants were recruited into this single-blind parallel randomized controlled trial and randomized into active and control groups. A clinical pharmacist identified TRPs for all participants. Adherence, depression, and anxiety scores were assessed. Active group patients received the MMR service: pharmacist-delivered counseling and a letter with recommended changes in the patient's treatment plan were sent to the patient's psychiatrist to be applied. Control group participants did not receive the intervention. Follow-up assessments were completed for all patients at 3 months from baseline. Main outcome measures were TRPs, adherence, depression, and anxiety scores. RESULTS: Study participants (n = 73; mean age = 41.8 [SD = 16.27]) had 177 TRPs identified, with 2.42(SD = 1.06) TRPs per patient. At baseline, only 54.8% of the participants reported to be adherent to their treatment, and no significant differences were found between the groups. At follow-up, a significant decline in the number of TRPs was found for the active versus control group (active: 0.58[SD = 0.64], control: 1.78[SD = 1.13], P < .001). A significantly higher proportion of adherent patients was identified in the active (88.9%) versus control group (51.4%), P < .001. Significant improvements in the depression (P < .001) and anxiety (P = .003) scores were detected for the active versus control group. CONCLUSION: The MMR service led to a significant decrease in the number of TRPs, improved adherence, depression, and anxiety scores for females diagnosed with depression and anxiety.

Conformity evaluation of afinion 2 analyzer maintainability: Compliance practicality for Philippine National Standard PNS ISO 15189:2013 accreditation

Objectives@#The implementation of Philippine National Standard PNS ISO 15189:2013 to support the medical laboratory to produce competent results is a recognised challenge. It is apparent that the approach of ensuring the equipment availability can be specifically optimised. No known research has focused on exploring on the conduct of conformity evaluation of Afinion 2 Analyzer maintainability for the PNS ISO 15189:2013 accredited medical laboratory. The aim of the current study was to develop a practical tool for the medical laboratory to support the internal audit process by determining the compliance status of Afinion 2 Analyzer maintainability.

Identifying treatment related problems and associated factors among hospitalized post-stroke patients through medication management review: A multi-center study.

BACKGROUND: Stroke is a major cause of disability and one of the leading causes of death among the elderly. Treatment related problems can lead to undesirable consequences. The Medication Management Review (MMR) service is aimed at identifying, resolving and preventing TRPs, subsiding the undesirable outcomes associated with TRPs. OBJECTIVES: To explore the types, frequencies and severity of TRPs amongst post-stroke patients recruited through hospitals via conducting the MMR service by clinical pharmacists in Jordan. Associations between patient factors and the identified TRPs were explored. METHODS: This cross-sectional descriptive study was conducted over three months in 2017 in different geographical areas throughout Jordan. Randomly recruited patients were interviewed at the hospitals to collect their demographic data and clinical characteristics. Types/frequencies/severity of TRPs for each stroke patient were identified by a clinical pharmacist. Associations between the identified TRPs and patient's factors were explored through multiple regression analysis.Key findings:Out of 198 stroke patients (mean age: 56.6 ±â€¯14.2) who completed the study, 110 (55.6%) were males. Many of the patients (82 (41.6%)) were smokers and 61 (69.2%) had hypertension and/or diabetes. The mean number of TRPs per patient was 2.5 ±â€¯1.1. The most common TRP categories involved efficacy issues (198 (40.6%)), inappropriate drug adherence (136 (27.9%)) and inappropriate patient knowledge (114 (23.4%)). More than 70.0% (342/487) of the identified TRPs were of major severity. Higher number of TRPs was found to be associated with being a male, having a lower educational level, being a current smoker, having a higher number of drugs and a poorer quality of life. CONCLUSION: Lack of drug efficacy, inappropriate drug adherence and patient knowledge were the major TRPs identified via delivering the MMR service to post-stroke patients. The identified TRPs highlights the importance of the MMR service, and supports planning future strategies aimed at decreasing the incidence of strokes.

Pharmacists in humanitarian crisis settings: Assessing the impact of pharmacist-delivered home medication management review service to Syrian refugees in Jordan.

BACKGROUND: Refugees all over the world are facing several health-related problems. Chronic diseases among Syrian refugees in Jordan are high. The Home Medication Management Review (HMMR) service could be ideal to optimize refugees' health management. OBJECTIVES: To assess the impact of the HMMR service on the type and frequency of Treatment Related Problems (TRPs) among Syrian refugees living in Jordan. METHODS: This prospective randomized single blinded intervention-control study was conducted in three main cities in Jordan, between May and October 2016. Syrian refugees with chronic conditions were recruited and randomized into intervention and control groups. The HMMR service was conducted for all patients to identify TRPs at baseline. Data were collected via two home visits for all study participants. Clinical pharmacist's recommendations were written in a letter format to the physicians managing the patients in the intervention group only. Physicians' approved recommendations were conveyed to the patients via the pharmacist. Interventions at the patient level were delivered by the pharmacist directly. Patients were reassessed for their TRPs and satisfaction 3 months after baseline. RESULTS: Syrian refugees (n = 106) were recruited with no significant differences between the intervention (n = 53) and control groups (n = 53). A total of 1141 TRPs were identified for both groups at baseline, with a mean number of 10.8 ±â€¯4.2 TRPs per patient. At follow-up, there was a significant decrease in the number of TRPs among the intervention group (P < 0.001, paired sample t-test) but not among the control group (P = 0.116). Physicians' approval rate of the pharmacist's recommendations was high (82.9%), and more than 70.0% of refugees in the intervention group reported high satisfaction with the HMMR service. CONCLUSION: Identified TRPs are high amongst Syrian refugees living in Jordan. The HMMR service significantly reduced the number of TRPs, and was highly accepted by the physicians. Refugees reported high satisfaction with this service.

Adoption of the Nova Scotia (Canada) Community Pharmacy Medication Management Program, 1-Year Post-Initiation.

BACKGROUND: Pharmacists conduct medication reviews to optimize drug therapy. Each jurisdiction implements and funds these programs differently. OBJECTIVE: To describe the uptake of the first year of a community pharmacy medication review program reimbursed by the publically insured seniors' drug benefit program in Nova Scotia, Canada. METHODS: This retrospective analysis included 294 pharmacies and 105,000 beneficiaries enrolled in the Nova Scotia Seniors' Pharmacare Program. Prescription and service claims data from this program were analyzed to determine type and number of beneficiaries receiving a medication review, number and predictors of pharmacies completing reviews, and number of prescribed medications 6-months before and 6-months after the review. RESULTS: 428 medication reviews were conducted and billed by 33% of Nova Scotia pharmacies (1-50 reviews per pharmacy per year). The mean number and range of medications before the review were 10.8 (4-28) and following the review 10.4 (0-24), with an average decrease of 0.4 medications (95% CI 0.1-0.6), p=.0043). Patients receiving a review had a mean age of 75.2 years; 64.9% were female. Most pharmacies conducted reviews when patients reached their annual copayment (93%). CONCLUSIONS: Approximately 33% of pharmacies billed at least one medication review in the first year of the program. In spite of a $150 reimbursement per community pharmacy medication review, only 428 reviews were conducted over a 13-month period for a population of over 100,000 seniors. Results suggest financial reimbursement alone is not sufficient to implement a medication management program; health systems need to determine patient, pharmacist, pharmacy and health system level strategies to implement medication reviews more broadly.

Value of a Community-Based Medication Management Review Service in Jordan: A Prospective Randomized Controlled Study.

STUDY OBJECTIVE: To assess the impact of a medication management review (MMR) service on treatment-related problems (TRPs) and certain clinical outcomes in outpatients. DESIGN: Prospective randomized controlled study. SETTING: Two community pharmacies in Amman, Jordan. PATIENTS: A total of 160 people who visited the two community pharmacies between September 2009 and June 2010. INTERVENTION: Patients were randomized into two groups: intervention (82 patients) and control (78 patients) groups. The clinical pharmacist conducted a baseline assessment MMR for patients in both groups to determine the prevalence and type of TRPs; however, recommendations regarding the identified TRPs were only submitted to the physicians of patients in the intervention group. MEASUREMENTS AND MAIN RESULTS: All patients were followed for an average of 3.39 months after their baseline visit to the pharmacy. The impact of the MMR service for the intervention group was assessed by evaluating the outcomes of the recommendations submitted by the clinical pharmacist to resolve the identified TRPs, physicians' acceptance of the recommended interventions, and the effect of the intervention on certain clinical outcomes: blood glucose levels, blood pressure, and triglyceride levels. Follow-up assessment of the control group included evaluating the outcomes of the identified TRPs (identified and corrected by physicians without any input from the clinical pharmacist) and comparing glucose level, blood pressure, and triglyceride-level results with baseline values. No significant differences in mean number of medical conditions (3.7 vs 3.42, p=0.134), mean number of medications (4.51 vs 4.96, p=0.135), or mean number of TRPs per patient (5.55 vs 5.17, p=0.42) were observed at baseline in the intervention group versus the control group. Follow-up results revealed a high acceptance rate of recommendations by the physicians (94%). Regarding outcomes of TRPs, almost 70% of the identified TRPs in the intervention group were resolved or improved compared with 2% in the control group (p<0.001). Significant differences were found between the intervention group versus control group with regard to mean ± SD glucose levels (99.08 ± 9.66 vs 115.48 ± 17.34, p<0.001), blood pressure (110.36/81.55 ± 9.45/3.91 vs 125.0/88.73 ± 10.34/4.12, p<0.001), and triglyceride levels (148.53 ± 15.98 vs 170.74 ± 6.26, p=0.001). CONCLUSION: The MMR service resulted in a significantly lower number of TRPs and significantly improved clinical outcomes, and it was highly accepted by the physicians.

Medical laboratory quality systems - a management review.

PURPOSE: The purpose of this paper is to highlight changes in ISO 15189:2012 and ISO 15189:2007 concerning management review requirements and to present a management review checklist, which includes all the revised ISO 15189's requirements. DESIGN/METHODOLOGY/APPROACH: The recent revised and updated ISO 15189:2012 standard recommends a management review using a process approach and includes some additional topics. FINDINGS: The management review is a key element in many quality management systems, including medical laboratory management systems in accordance with ISO 15189. The process approach enables laboratory top managers and personnel to achieve all the quality management system's important inputs and outputs. ORIGINALITY/VALUE: As laboratory staff often encounter difficulties fully exploiting the management review process, this checklist helps laboratory staff carry out an effective management review covering all the quality management system's important aspects.

[Essential guidelines for Quality Management System]. / Recommandations pour la mise en œuvre d'un système de management de la qualité.

The guidelines describe the essential parts of the quality management system to fulfil the requirements of the standard EN ISO 15 189. It includes mainly the organisation, the definition of responsibilities, training of personnel, the document control, the quality control, identification and control of nonconformities, corrective actions, preventive actions and evaluation, as audits and the management review.

[Recommendations for the evaluation and follow-up of the continuous quality improvement]. / Recommandations pour l'évaluation et le suivi de la démarche qualité.

Continual improvement of the quality in a medical laboratory is based on the implementation of tools for systematically evaluate the quality management system and its ability to meet the objectives defined. Monitoring through audit and management review, addressing complaints and nonconformities and performing client satisfaction survey are the key for the continual improvement.

Importance of Risk Management in Physiotherapy (review) / 中国康复理论与实践

@#Physiotherapy involves wide range elements. Many factors, such as the complications of the patients, may complicate the treatment. It is important for the physiotherapists to control the potential risk factors as much as to improve their efficacy.

Pain Management in Patients with Patellofemoral Pain Syndrome (review) / 中国康复理论与实践

@#The maltracking of patella due to patellar malalignment and overuse are suggested to contribute the painful state in patients with patellofemoral pain syndrome.More and more attention was paid on the management of pain.This paper reviewed the most widely used assessment tool.The pain management strategies were summarized,and the efficacy of the different interventions was also discussed.