Weeks Greg, George Johnson, Maclure Katie, Stewart Derek
Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Parkville, VIC, Australia, 3052.
Cochrane Database Syst Rev. 2016 Nov 22;11(11):CD011227. doi: 10.1002/14651858.CD011227.pub2.
A range of health workforce strategies are needed to address health service demands in low-, middle- and high-income countries. Non-medical prescribing involves nurses, pharmacists, allied health professionals, and physician assistants substituting for doctors in a prescribing role, and this is one approach to improve access to medicines.
To assess clinical, patient-reported, and resource use outcomes of non-medical prescribing for managing acute and chronic health conditions in primary and secondary care settings compared with medical prescribing (usual care).
We searched databases including CENTRAL, MEDLINE, Embase, and five other databases on 19 July 2016. We also searched the grey literature and handsearched bibliographies of relevant papers and publications.
Randomised controlled trials (RCTs), cluster-RCTs, controlled before-and-after (CBA) studies (with at least two intervention and two control sites) and interrupted time series analysis (with at least three observations before and after the intervention) comparing: 1. non-medical prescribing versus medical prescribing in acute care; 2. non-medical prescribing versus medical prescribing in chronic care; 3. non-medical prescribing versus medical prescribing in secondary care; 4 non-medical prescribing versus medical prescribing in primary care; 5. comparisons between different non-medical prescriber groups; and 6. non-medical healthcare providers with formal prescribing training versus those without formal prescribing training.
We used standard methodological procedures expected by Cochrane. Two review authors independently reviewed studies for inclusion, extracted data, and assessed study quality with discrepancies resolved by discussion. Two review authors independently assessed risk of bias for the included studies according to EPOC criteria. We undertook meta-analyses using the fixed-effect model where studies were examining the same treatment effect and to account for small sample sizes. We compared outcomes to a random-effects model where clinical or statistical heterogeneity existed.
We included 46 studies (37,337 participants); non-medical prescribing was undertaken by nurses in 26 studies and pharmacists in 20 studies. In 45 studies non-medical prescribing as a component of care was compared with usual care medical prescribing. A further study compared nurse prescribing supported by guidelines with usual nurse prescribing care. No studies were found with non-medical prescribing being undertaken by other health professionals. The education requirement for non-medical prescribing varied with country and location.A meta-analysis of surrogate markers of chronic disease (systolic blood pressure, glycated haemoglobin, and low-density lipoprotein) showed positive intervention group effects. There was a moderate-certainty of evidence for studies of blood pressure at 12 months (mean difference (MD) -5.31 mmHg, 95% confidence interval (CI) -6.46 to -4.16; 12 studies, 4229 participants) and low-density lipoprotein (MD -0.21, 95% CI -0.29 to -0.14; 7 studies, 1469 participants); we downgraded the certainty of evidence from high due to considerations of serious inconsistency (considerable heterogeneity), multifaceted interventions, and variable prescribing autonomy. A high-certainty of evidence existed for comparative studies of glycated haemoglobin management at 12 months (MD -0.62, 95% CI -0.85 to -0.38; 6 studies, 775 participants). While there appeared little difference in medication adherence across studies, a meta-analysis of continuous outcome data from four studies showed an effect favouring patient adherence in the non-medical prescribing group (MD 0.15, 95% CI 0.00 to 0.30; 4 studies, 700 participants). We downgraded the certainty of evidence for adherence to moderate due to the serious risk of performance bias. While little difference was seen in patient-related adverse events between treatment groups, we downgraded the certainty of evidence to low due to indirectness, as the range of adverse events may not be related to the intervention and selective reporting failed to adequately report adverse events in many studies.Patients were generally satisfied with non-medical prescriber care (14 studies, 7514 participants). We downgraded the certainty of evidence from high to moderate due to indirectness, in that satisfaction with the prescribing component of care was only addressed in one study, and there was variability of satisfaction measures with little use of validated tools. A meta-analysis of health-related quality of life scores (SF-12 and SF-36) found a difference favouring usual care for the physical component score (MD 1.17, 95% CI 0.16 to 2.17), but not the mental component score (MD 0.58, 95% CI -0.40 to 1.55). However, the quality of life measurement may more appropriately reflect composite care rather than the prescribing component of care, and for this reason we downgraded the certainty of evidence to moderate due to indirectness of the measure of effect. A wide variety of resource use measures were reported across studies with little difference between groups for hospitalisations, emergency department visits, and outpatient visits. In the majority of studies reporting medication use, non-medical prescribers prescribed more drugs, intensified drug doses, and used a greater variety of drugs compared to usual care medical prescribers.The risk of bias across studies was generally low for selection bias (random sequence generation), detection bias (blinding of outcome assessment), attrition bias (incomplete outcome data), and reporting bias (selective reporting). There was an unclear risk of selection bias (allocation concealment) and for other biases. A high risk of performance bias (blinding of participants and personnel) existed.
AUTHORS' CONCLUSIONS: The findings suggest that non-medical prescribers, practising with varying but high levels of prescribing autonomy, in a range of settings, were as effective as usual care medical prescribers. Non-medical prescribers can deliver comparable outcomes for systolic blood pressure, glycated haemoglobin, low-density lipoprotein, medication adherence, patient satisfaction, and health-related quality of life. It was difficult to determine the impact of non-medical prescribing compared to medical prescribing for adverse events and resource use outcomes due to the inconsistency and variability in reporting across studies. Future efforts should be directed towards more rigorous studies that can clearly identify the clinical, patient-reported, resource use, and economic outcomes of non-medical prescribing, in both high-income and low-income countries.
为满足低收入、中等收入和高收入国家的医疗服务需求,需要一系列卫生人力战略。非医疗处方是指护士、药剂师、专职医疗人员和医师助理替代医生履行处方职责,这是改善药品可及性的一种方法。
评估在初级和二级医疗环境中,与医疗处方(常规护理)相比,非医疗处方用于管理急性和慢性健康状况的临床、患者报告及资源使用结果。
我们于2016年7月19日检索了包括Cochrane系统评价数据库、医学期刊数据库、荷兰医学文摘数据库以及其他五个数据库在内的数据库。我们还检索了灰色文献,并手工检索了相关论文和出版物的参考文献。
随机对照试验(RCT)、整群随机对照试验、前后对照研究(至少有两个干预组和两个对照组)以及中断时间序列分析(干预前后至少有三次观察),比较:1. 急性护理中非医疗处方与医疗处方;2. 慢性护理中非医疗处方与医疗处方;3. 二级医疗中非医疗处方与医疗处方;4. 初级医疗中非医疗处方与医疗处方;5. 不同非医疗处方者群体之间的比较;6. 接受正规处方培训的非医疗保健提供者与未接受正规处方培训的提供者。
我们采用了Cochrane期望的标准方法程序。两位综述作者独立审查纳入研究,提取数据,并评估研究质量,如有分歧通过讨论解决。两位综述作者根据EPOC标准独立评估纳入研究的偏倚风险。当研究考察相同治疗效果且样本量较小时,我们采用固定效应模型进行荟萃分析。当存在临床或统计异质性时,我们将结果与随机效应模型进行比较。
我们纳入了46项研究(373,37名参与者);26项研究由护士进行非医疗处方,20项研究由药剂师进行非医疗处方。在45项研究中,将作为护理组成部分的非医疗处方与常规护理医疗处方进行了比较。另一项研究将指南支持的护士处方与常规护士处方护理进行了比较。未发现其他卫生专业人员进行非医疗处方的研究。非医疗处方的教育要求因国家和地区而异。对慢性病替代指标(收缩压、糖化血红蛋白和低密度脂蛋白)的荟萃分析显示干预组有积极效果。对于12个月时血压研究(平均差(MD)-5.31 mmHg,95%置信区间(CI)-6.46至-4.16;12项研究,4229名参与者)和低密度脂蛋白(MD -0.21,95%CI -0.29至-0.14;7项研究,1469名参与者),证据具有中等确定性;由于存在严重不一致性(相当大的异质性)、多方面干预和可变的处方自主权,我们将证据确定性从高等级降为中等。对于12个月时糖化血红蛋白管理的比较研究,证据具有高确定性(MD -0.62,95%CI -0.85至-0.38;6项研究,775名参与者)。虽然各研究中药物依从性似乎差异不大,但对四项研究的连续结果数据进行的荟萃分析显示,非医疗处方组在患者依从性方面有优势(MD 0.15,95%CI 0.00至0.30;4项研究,7名参与者)。由于存在严重的执行偏倚风险,我们将依从性证据的确定性降为中等。虽然治疗组之间与患者相关的不良事件差异不大,但由于证据的间接性,我们将证据确定性降为低等级,因为不良事件范围可能与干预无关,且许多研究中选择性报告未能充分报告不良事件。患者总体上对非医疗处方者的护理感到满意(14项研究,7514名参与者)。由于间接性,我们将证据确定性从高等级降为中等,因为只有一项研究涉及对护理处方部分的满意度,且满意度测量存在变异性,很少使用经过验证的工具。对健康相关生活质量评分(SF-12和SF-36)的荟萃分析发现,在身体成分评分方面常规护理更有优势(MD 1.17,95%CI 0.16至2.17),但在心理成分评分方面无差异(MD 0.58,95%CI -0.40至1.55)。然而,生活质量测量可能更恰当地反映综合护理而非护理的处方部分,因此由于效应测量的间接性,我们将证据确定性降为中等。各研究报告了多种资源使用指标,住院、急诊就诊和门诊就诊组间差异不大。在大多数报告药物使用的研究中,与常规护理医疗处方者相比非医疗处方者开具的药物更多、增加了药物剂量且使用的药物种类更多。
研究的偏倚风险在选择偏倚(随机序列生成)、检测偏倚(结果评估的盲法)、失访偏倚(不完整的结果数据)和报告偏倚(选择性报告)方面总体较低。选择偏倚(分配隐藏)和其他偏倚的风险尚不清楚。存在较高的执行偏倚风险(参与者和人员的盲法)。
研究结果表明,在一系列环境中,具有不同但较高处方自主权的非医疗处方者与常规护理医疗处方者一样有效。非医疗处方者在收缩压、糖化血红蛋白、低密度脂蛋白、药物依从性、患者满意度和健康相关生活质量方面可以取得可比的结果。由于各研究报告的不一致性和变异性,难以确定与医疗处方相比非医疗处方对不良事件和资源使用结果的影响。未来应致力于开展更严谨的研究,以便在高收入和低收入国家都能明确识别非医疗处方的临床、患者报告、资源使用和经济结果。