New guidelines allow complex compounding

Simple compounding has long been a part of pharmacists’ scope of practice, but new guidelines have opened up the potential for complex compounding.

For some patients, compounding is their only medication option. At Soul Pattinson Chemist in Geelong, pharmacist and owner Stella Tsorotes MPS knows what it can do and how it can help.

‘I’ve got people who’ve said to me, “You’ve changed my life”,’ she says.

From making paediatric medicines for desperate parents to thyroid extract for an accountant unable to take thyroxine, compounding services like Ms Tsorotes’s help patients with nowhere else to turn.

Compounding has always been part of pharmacists’ scope of practice, but in recent years, federal and state guidelines have been introduced to an area of practice that had previously seen little regulation. The aim? Providing quality assurance in an area that can really improve patient care.

Compounding began in earnest in Australia with simple creams and then hormone replacement therapy.

‘Bio-identical hormone replacement was becoming very popular in the US,’ says Marina Holt MPS, Education and Training Manager at Professional Compounding Chemists Australia (PCCA Australia).

Customers wanted products that weren’t available in Australia at the time.

‘I had customers trying to get progesterone pessaries for IVF and they couldn’t get them anywhere, and I just saw their distress,’ says Ms Tsorotes.

Today, the compounding market is still largely patient driven, but it has grown beyond hormones.

‘Hormone replacement therapy [HRT] is still one very big area,’ says Ms Holt. ‘But there’s now dermatology, veterinarian compounding, pain medicine, and nutritional compounding, including for metabolic disorders.’

Compounding medicines that are not otherwise available continues to be a way for pharmacies to help customers with no other options. ‘It’s not to make it cheaper,’ says Ms Holt. ‘It’s not to make a larger batch at half the price. That’s not the point. The point is to help patients where their needs are not being met by commercially available, registered products.’

While Ms Tsorotes started out 15 years ago compounding progesterone pessaries for IVF, today her compounding business is largely paediatrics, other IVF medicine and dermatology. ‘Most of the paediatricians in the area send us their work. Right now we’re out of stock of Vallergan Forte – you can’t get it. It’s four times the dose of normal Vallergan, so we got some trimeprazine in and we’re making it,’ Ms Tsorotes says.

At Blackburn North Pharmacy in Melbourne’s eastern suburbs, pharmacist and owner Chris Zoanetti MPS launched a compounding service four years ago and has found the market to be similar.

‘A combination of dermatological and paediatric are my two focus areas, and I have an interest in hormone replacement and thyroid,’ he says.

While the mega-chemists of large discount chains are putting pressure on smaller pharmacies, Mr Zoanetti says there was an unmet need in his local area, and he decided compounding was a service that could expand his business. ‘I saw more of an influx of compounding scripts and I thought, “Well, I’m referring them to other pharmacies, there’s no reason why I can’t do them myself”,’ he says. ‘I did a bit of a scan of the area and looked for the closest pharmacies that were compounding and realised we were in a bit of a black hole – there was no-one around.’

Ms Tsorotes also believes there is an unmet demand and the chance for compounders to differentiate themselves: she regularly sends compounded medicines to customers in Queensland.

‘I’m sure there are compounding services up in Queensland, but if you find an area of compounding you really enjoy doing, you become known for being the best in that area,’ she says.

Neither PSA or PCCA keep statistics on the number of pharmacies regularly compounding, as they don’t have any different registration requirements. ‘We don’t really know; we think probably 500–600 pharmacies,’ Ms Holt says. Though compounding currently only represents 1–2% of the total number of scripts, many compounders agree it can be pro table as it isn’t covered under the PBS.

Jason Truong MPS is pharmacist manager at Compounding on Oxford, a compounding-only pharmacy in Perth, and he sees considerable potential in the sector. ‘It is definitely an additional income for the pharmacy and it can play a significant part if you know where to go. It is a lot more pro table than selling commercial products,’ he says.

As interest in genetic testing increases and costs fall, and with more customers than ever having specific allergies and restrictions, the interest in tailored, personalised medicine can only grow.

‘As our patient community has more access to individualised testing, it makes sense that they will come to expect that the compounding pharmacist will meet their individual needs,’ Ms Holt says.

Way to go

Compounding has always existed, but guidelines covering the practice only recently came into effect. While all therapeutic goods must be assessed by the Therapeutic Goods Administration (TGA) and listed on the Australian Register of Therapeutic Goods (ARTG), compounded products are exempt so long as they are prepared for an individual for a specific therapeutic need.

‘Before 2015, there were no Pharmacy Board guidelines for compounding until the Board released its Guidelines on Compounding of Medicines that year,’ says Ms Holt. A revised guidance titled Compounding of Sterile Injectable Medicines has since been incorporated into these guidelines, coming into effect in February 2018. PSA were the first to provide guidance on compounding in the Australian Pharmaceutical Formulary and the PSA Professional Practice Standards.

‘The guidelines definitely improved the standard for compounding, but they’re not yet enforced consistently. Some states, such as Victoria and NSW, enforce the guidelines, but there are still a lot of pharmacies not aware of the new guidelines,’ says Mr Truong.

Ms Holt agrees, and says that while Victoria, NSW and South Australia had stepped up their vigilance, Western Australia and Queensland – which still lack a state pharmacy regulator – lag behind.

‘Most people are aware of the guidelines  but they think something doesn’t apply to them or they don’t have a copy of the APF24, a standard text,’ says Ms Holt.

Ms Tsorotes has seen the transition from minimal regulation to the current guidelines, and acknowledges that while they have made practising compounding more difficult, the guidelines are necessary to ensure a certain standard of quality.

Mr Zoanetti has only known the guidelines, and says that while they mean considerable paperwork, they’re vital for safety and customer confidence. ‘It stops people doing the wrong thing, doing it in an incorrect manner in their sink or without a proper containment hood. It’s making it a safe environment for the pharmacist, the employee and the patient,’ he says.

Both Ms Tsorotes and Mr Zoanetti say that while compounding has added to their businesses’ bottom line, it is the improvement in patient care that is the biggest pay-off, both for the health of the business and personally.

‘It’s the personalisation, and the satisfaction and relief on people’s faces when you’ve made a difference,’ says Mr Zoanetti. ‘We’re a big customer service-based pharmacy. On the community side of things, we’re very patient focused, and the compounding just added another level to that.’

It’s an area of the business that allows them to differentiate themselves from discount chains and stand out from the competition. ‘You have to love doing it, for starters, and get that thrill of really helping a customer, and if you’re good enough to those customers then hopefully they’ll bring in more,’ Ms Tsorotes says.

Up and running

Ms Tsorotes, Mr Zoanetti and Mr Truong all agree that standard operating procedures (SOP) and quality control software are vital for any modern service. Compounding software allows a pharmacist to scan in chemicals, enter formulas, and create a traceable document of the process.

Standard operating procedures ensure that everyone in the pharmacy is following the same process, including documentation and reporting. ‘It’s the ability to capture adverse events, and recall a product if required. Was the correct temperature reached, were labs cleaned, how often, when were staff last trained?’ Ms Holt says.

Ms Tsorotes sees quality control software and SOPs as mandatory. ‘It’s lovely to say mistakes never happen, but when something goes wrong, you need that software,’ she says. ‘If you’re not prepared to pay for it, you shouldn’t be compounding.’

For those looking to take the next step and launch into compounding, training and adequate facilities are a must under the guidelines. But Mr Zoanetti recommends some market research before starting.

‘Research your demographic, your area, and see who else is doing it. I would think about your marketing strategy. You can’t just set it up and hope that everyone just walks in through your door,’ he says