Buurma Henk, de Smet Peter A, van den Hoff Olga P, Sysling Henrieke, Storimans Michiel, Egberts Antoine C
SIR Institute for Pharmacy Practice Research, Leiden, The Netherlands.
Pharm World Sci. 2003 Dec;25(6):280-7. doi: 10.1023/b:phar.0000006521.41736.db.
To examine the frequency, nature and determinants of pharmacy compounded medicines in Dutch community pharmacies.
A prospective nested case-control study comparing prescriptions for pharmacy compounded medicines (cases) with non-pharmacy compounded medicines (controls) was carried out in 79 Dutch community pharmacies. 991 Prescriptions for compounded medicines (cases), dispensed by the pharmacy on a predetermined day in a specific period (29 March until 11 April 2001), and 993 prescriptions for non-compounded medicines (controls) randomly selected on the same day, were studied. The nature and frequency of compounded medicines as well as patient, drug and prescriber related determinants were assessed. In addition, some organisational characteristics, like compounding site and use of protocols, were investigated. Also, the value of compounded medicines in terms of the availability of an industrially compounded equivalent and patient specific reasons, as perceived by the participating pharmacists, was evaluated.
The overall frequency of prescriptions for pharmacy compounded medicines in relation to the total number of prescriptions was 3.4%. This means 12.5 compounded medicines per pharmacy per day on average, but there was a large variation between pharmacies. Excluding the products purchased from specialised compounding companies (28.4%) and the small part of medicines coming from other pharmacies (5.2%), we found an overall frequency of 2.3% of actual compounding in the pharmacy itself. On average, approximately one employee was needed for compounding activities with a large variation between pharmacies. More than 13% of the pharmacists stated that they delivered more than 25% of their compounded medicines to other pharmacies. In 2 pharmacies (2.6%) no actual compounding took place. For 58% of the products manufactured in the pharmacy itself or coming from other pharmacies a (semi-) standardised protocol was used. Compared to non-compounded medicines we found a huge share of dermatological dosage forms among compounded medicines (62.1% versus 5.3%). Oral solutions and ear-nose-throat (ENT) products were also found relatively often. While no ATC class was very pronounced in the control group, the group of dermatologicals was prominently present in the case group (57%) followed by CNS agents (8.4%). The dermatologist was a very strong determinant of compounded medicines compared to GPs (ORadj 12.2 [6.3-23.6]). Patients of 12 years or younger received a significantly higher rate of compounded medicines than persons older than 12 years of age (ORadj 3.4 [2.5-4.8]). Compounding occurred almost twice as often when a medicine was prescribed for the first time compared to a repeat prescription (ORadj 1.8 [1.5-2.2]). In about 63% of the cases the pharmacist judged that an industrially produced medicine could not substitute for the compounded medicine. In about 33% of the compounded products they indicated a patient specific reason. In about 10% this reason concerned a strictly defined pharmaceutical care issue.
Based upon our research, all Dutch community pharmacies compound more than 13,000 medicines per day (2.3% of all prescriptions). They consist mainly of dermatological preparations. Younger children (< 12 yr) receive a significantly higher rate of compounded medicines than other people. At least 1.2 compounded prescriptions per pharmacy per day have a specific pharmaceutical care reason according to the pharmacists.
研究荷兰社区药房中配制药品的频率、性质及决定因素。
在79家荷兰社区药房开展一项前瞻性巢式病例对照研究,比较配制药品处方(病例组)与非配制药品处方(对照组)。研究了2001年3月29日至4月11日特定时间段内药房在预定日期配发的991份配制药品处方(病例组),以及同日随机抽取的993份非配制药品处方(对照组)。评估了配制药品的性质和频率以及与患者、药物和开处方者相关的决定因素。此外,还调查了一些组织特征,如配制地点和方案的使用情况。同时,评估了参与研究的药剂师所认为的配制药品在工业生产等效品可用性及患者特定原因方面的价值。
配制药品处方相对于处方总数的总体频率为3.4%。这意味着每家药房每天平均有12.5种配制药品,但各药房之间存在很大差异。排除从专业配制公司购买的产品(28.4%)和来自其他药房的一小部分药品(5.2%)后,我们发现药房自身实际配制的总体频率为2.3%。平均而言,配制活动大约需要一名员工,但各药房之间差异很大。超过13%的药剂师表示他们将超过25%的配制药品送到了其他药房。在2家药房(2.6%)没有进行实际配制。对于药房自身生产或来自其他药房的产品,58%使用了(半)标准化方案。与非配制药品相比,我们发现配制药品中皮肤科剂型占比巨大(62.1%对5.3%)。口服溶液和耳鼻喉科产品也相对常见。虽然在对照组中没有哪个解剖治疗学及化学分类系统(ATC)类别非常突出,但皮肤科类别在病例组中显著存在(57%),其次是中枢神经系统药物(8.4%)。与全科医生相比,皮肤科医生是配制药品的一个非常重要的决定因素(校正比值比12.2 [6.3 - 23.6])。12岁及以下的患者接受配制药品的比例明显高于12岁以上的人群(校正比值比3.4 [2.5 - 4.8])。与重复处方相比,首次开具药品时配制的发生频率几乎高出一倍(校正比值比1.8 [1.5 - 2.2])。在约63%的病例中,药剂师判断工业生产的药品不能替代配制药品。在约33%的配制产品中,他们指出了患者特定原因。在约10%的情况下,该原因涉及严格定义的药学服务问题。
基于我们的研究,所有荷兰社区药房每天配制超过13000种药品(占所有处方的2.3%)。它们主要由皮肤科制剂组成。年龄较小的儿童(<12岁)接受配制药品的比例明显高于其他人。根据药剂师的说法,每家药房每天至少有1.2份配制处方有特定的药学服务原因。