7 considerations before you add compounding to your business
August 15, 2020
At a time when pharmacies are trying to differentiate themselves, particularly away from a discount model, compounding seems to be an easy add on into the pharmacy. From a state-of-the-art custom-built facility to a small space in the rear of the dispensary here are seven areas of consideration:
1. Is there a market for compounding in your area? It seems rather obvious, start with making sure you have prescribers in the immediate area. Research what their specialties are and the types of products they prescribe. This will provide insights into the type of compounding activities you will be undertaking e.g. whether you are setting up for simple or complex compounding which may need the provision for hazardous materials or sterile preparation. This has a flow on effect into the type of equipment you will need, the space requirements and type of staff you need to employ and their level of training.
2. Training/Accreditation Again, depending on whether you are undertaking simple or complex compounding, you may need additional training. There is a PSA National Competency Standards Framework which provides guidance on this. Both the PCCA and Medisca provide comprehensive courses which include technical training as well as training in operational matters, administrative and financial management.
3. Regulations There are a number of guidelines and reference materials covering the requirements (see reference list below). Whilst the current regulations in Australia are minimal, the USA is further advanced in this area, and it is likely that we will be moving to adopt may of their standards, understanding these will ensure that when you build your facilities you are ready for what may come e.g. the addition of a gowning room.
Of particular–note is the requirement to be compliant with the TGA in relation to Extemporaneous dispensing in community pharmacies in addition to complying with Safe Work Australia guidelines, particularly around protective clothing and a powder containment cabinet with HEPA filtered exhaust air. Similar to other parts of your business, there is a requirement to keep excellent records, of particular note, ingredients, batch numbers and expiry dates.
4. Insurances Make sure you speak with your insurer or broker and let them know you are adding compounding to include the appropriate professional indemnity cover. 5. Premises/Facilities Some pharmacies place compounding facilities in back of house, whilst others build compounding into the retail area, creating a sense of theatre in the pharmacy, clearly differentiating it.
The guidance is that compounding activities must take place within a pharmacy premise which is suitably designed and equipped, away from routine dispensing and high traffic areas. The area needs to be:
at least 9 sqm
separated by floor to ceiling walls with at least one door for entry and exit
have impervious flooring
has a dedicated stainless-steel or other impervious material sink
a bench of at least 2m long and minimum widths vary by state
easy to clean surfaces made from impervious materials
an area which can be used to isolate raw materials and finished products
adequately lit and ventilated
can maintain an ambient temperature of 25°C
6. Equipment and Devices
The products you make and compliance to regulations will guide you to what is needed. As a minimum you are likely to need a compounding hood, unguator, electronic balances, hot plate, appropriate storage, spill kit, mortar and pestle.
7. Make sure you build a profitable business model Investigate this well. There is no point adding compounding to your business if it is going to cost you more money than adding another professional service to your business. We suggest working with your accountant or financial advisor to understand your input costs, volumes and profitability. Treat it like any other category in your business and look at it as a return on space calculation.