W1 – Is compounding (always) the answer to drug shortages?

Link to EAHP Statements

• Section 1 – Introductory Statements and Governance: Statement – 1.3
• Section 2 – Selection, Procurement and Distribution: Statement – 2.5
• Section 3 – Production and Compounding: Statements – 3.1, 3.2, 3.3, 3.4

ACPE UAN: 0475-0000-23-014-L07-P – An application-based activity  

Abstract

Since years drug shortages are the new reality in the pharmaceutical sector and will not disappear from the scene again. They may have their origin in increased demand, falling prices, lack of raw materials, logistical problems, administrative formalities, closed borders or even a pandemic. And they always cost hospital pharmacies hands full of money and personnel to manage. But even with extra staffing, it is not always possible to buy or to import a valid alternative to guarantee the continuity of therapy and pharmaceutical care.

Sometimes a registered drug is available on the market but at such a high price the healthcare payer cannot afford it, resulting in a practical shortage.

Fortunately, hospital pharmacists were trained in the art of compounding and can offer a way out of long term shortages of critical products. But is everything possible or are there limits to this solution?

In this workshop we will present different cases to discuss all possible hurdles and learn from best practices. Availability of raw materials, technical feasibility, operator safety, quality control, economic aspects, scalability and different legal requirements per country have impact on the equation.

Learning objectives

After the session, the participant should be able to: 

• To identify the possibilities and limitations of compounding as a solution to shortages
• To assess individual cases for feasibility
• To express the differences in European countries regarding hurdles and possibilities

Educational need addressed

Shortages are a new reality which hospitals have to deal with. Hospital pharmacists must be aware of the possibilities and limitations of compounding in order to resolve these shortages.

Keywords: Drug manufacturing, pharmaceutical care, USP chapter 795, USP chapter 797, shortages, compounding