PP-006 Extemporaneously compounded oral medicines in Spanish hospital pharmacies

Abstract

Background Pharmaceutical compounding, the preparation of customised medicines in order to meet the specific needs of patients, is an invaluable therapeutic alternative that allows patients the benefit of a bespoke treatment. Although an age-old practice, little is known regarding current compounding practices in Spain. Purpose To understand the current compounding practices in Spain, as follows: Identification of the concept of compounded medicines, legal requirements, professional organisations and information sources on compounding. Identification and characterisation of the oral compounded medicines most frequently dispensed in the hospital pharmacy setting. Materials and methods A self-completion questionnaire was developed and distributed to a selected sample of 40 hospitals across the country, including general hospitals, university hospitals and paediatric-specialist hospitals. These hospitals were identified as the ones in which the largest quantities of compounded medicines were likely to be dispensed in Spain. Results A response rate of 78% was obtained and a total of 281 different active substances (including 9 Narrow Therapeutic Index (NTI) drugs) was reported by the participant hospital pharmacies. The top 3 therapeutic groups were cardiovascular drugs, nutritional agents and antibacterials. Oral solid dosage forms were reported by 93% of participant hospitals and included (in decreasing order) capsules, oral powders and powders for oral liquids, in a total of 1,052,518 individual units. Oral liquid dosage forms were reported by 90% of participant hospitals and included (in decreasing order) solutions, suspensions, syrups, tinctures, oral drops and elixirs (multidose) and oral syringes (unidose), in a total sum of 60,117 multidose and 59,142 unidose containers. The top 5 active substances dispensed as oral liquids were: omeprazole, methadone HCl, colistin sulfate, amphotericin B and ranitidine. Conclusions Pharmaceutical compounding is a common practice in hospital pharmacies across Spain. There are several professional organisations and information sources on compounding and there is a detailed legal framework that regulates this practice. A wide variety of compounded medicines was dispensed in the hospital setting. Oral liquid dosage forms were more frequently dispensed than oral solids. No conflict of interest.

Evaluation of the Percutaneous Absorption of Ketamine HCl, Gabapentin, Clonidine HCl, and Baclofen, in Compounded Transdermal Pain Formulations, Using the Franz Finite Dose Model

“…Compounded drugs can be formulated to include special combinations of drugs at particular concentrations that may not be commercially available [16].…”

Why do we need hospital pharmacy preparation?

“…The extent of pharmaceutical compounding in the hospital setting varies from hospital to hospital, in accordance with the hospital specialties and number of beds; the doctor's prescribing habits; and the characteristics of the hospital pharmacy 2. For instance, hospitals engaged in clinical trials are likely to require additional compounded medicines for these particular studies 4 7…”

Analysis of the Physical Characteristics of an Anhydrous Vehicle for Compounded Pediatric Oral Liquids

“…Hospitals often require age-appropriate dosage forms with safe excipients formulated with one or more active pharmaceutical ingredients (APIs) at various strengths [7][8][9][10]. Amongst the most used dosage forms for pediatric patients are oral liquids, particularly suspensions [11][12][13][14][15][16]. Another important consideration for oral liquid medications is their potential suitability for feeding tube administration [17,18].…”