The Extent of Extemporaneous Preparation and Regulatory Framework of Extemporaneous Compounding in Latvia

Abstract

Background and objectives: Extemporaneous preparations are pharmaceutical preparations individually prepared for a specific patient or patient group, but also high-risk products accompanied by doubts regarding their safety and quality. Legislation regulating the compounding of extemporaneous preparations is not harmonized among European countries. This problem is partially resolved by Resolution CM/Res(2016)1 on quality and safety assurance requirements for medicinal products prepared in pharmacies for the special needs of patients. In order to understand the relevance of extemporaneous compounding in Latvia and the fulfillment of the abovementioned resolution’s requirements, it is essential to get information about the volume and breakdown of sales of extemporaneous medicinal products in community pharmacies. The purpose of this survey is to identify the sales volume of extemporaneous preparations in community pharmacies in Latvia in 2017 by analyzing unpublished data of the State Agency of Medicines (SAM), as well as comparing Latvian laws with the requirements of the resolution. Materials and Methods: A separate Microsoft Excel spreadsheet was prepared for each statistical region in order to summarize the unpublished information of SAM on the turnover of extemporaneous preparations in 2017 in all Latvian statistical regions. In order to compare the regulatory framework in Latvia with the resolution, the Latvian Pharmaceutical Law and the Cabinet of Ministers Regulations regulating prescription, compounding and control of extemporaneous preparations in community pharmacies were analyzed. Results: Only 280 of 384 pharmacies submitted a report of sales of extemporaneous preparations for 2017 to the SAM. These pharmacies represented all Latvian statistical regions. Extemporaneous preparations were mostly sold in Riga (78.93%). The Latvian regulation does not include all paragraphs of the resolution. Most of the paragraphs of the resolution are described in Latvian regulatory enactments only partially. Conclusions: The total number of compounding pharmacies evidence that the service is needed. Latvian example highlights a necessity for European Union countries to compare their national legislation with the requirements of the resolution’s last version and, if necessary, implement relevant amendments.

The Advent of a New Era in Digital Healthcare: A Role for 3D Printing Technologies in Drug Manufacturing?

“…Possible solutions to these issues would be the definition of certain brackets within which formulations could be prepared after testing dosage forms with the highest and lowest drug concentration [ 53 ]. Even if 3D-printed dosage forms are considered extemporaneous preparations, regulations vary between countries [ 71 ]. In specific situations, such as in the USA, current legislation specifies that such formulations can be manufactured by traditional compounding pharmacies, or “503A” pharmacies, only if specifically prescribed by a physician for a certain patient, largely avoiding the more burdensome regulations required for drug manufacturers under the Federal Food, Drug, and Cosmetic Act (FDCA).…”

Evaluation of the type and frequency of extemporaneous formulations dispensed in hospital and community pharmacies

“…More recently, the extent of compounding in Latvia was reported by Kiseļova through analysis of sales volumes in 2017, with 280 of 384 pharmacies submitting a report of sales, mostly in the capital. 27 In other work, during a period between 2011 and 2014, three out of ten prescriptions issued by German dermatologists were extemporaneous formulations. 9 Few studies explore the extent of extemporaneous compounding outside of Europe.…”

Prevalence, Scope and Quality of Extemporaneous Medications in Selected Healthcare Facilities and Implications for Pharmacy Practice

“…In some developed countries, data on compounded products and practices have been collated 10 - 12 . This information has led to the establishment and implementation of policies aimed at improving the quality and safety of compounded products.…”

“…In the US for example the FDA enacted an ACT to regulate compounding of medications 14 , 15 . Similarly, regulatory guidelines exist in other jurisdictions such as Europe (even though not harmonized across the European countries) 12 , 16 . Data on compounded medications in Ghana are currently inadequate or unavailable.…”