Cover Story: Compounding Solutions

This article first appeared in Unlisted & Unlimited, The Edge Malaysia Weekly, on February 13, 2017 - February 19, 2017.

We realised that if we did it right, it would be something that could really help doctors and patients, especially with the education on bioidentical hormones. We could really get this going in the market for preventive medicine. > Yang

-A +A

When Stephanie Yang started Accent Wellness, compounding pharmacies were an unfamiliar concept in the country. Today, with more and more Malaysians aware of the services these pharmacies provide, she is ready to take her business to the next level.

When Stephanie Yang, CEO of Accent Wellness Compounding Pharmacy, was awarded the Young Entrepreneur of the Year by the Australian High Commissioner in 2014, part of her protested silently. “I stood there thinking, I am so not an entrepreneur! I am more about helping people, feeling good about helping people, and I have an attachment to what I do and am hands-on in everything,” she recalls.

To her, entrepreneurs are people who start a business, make a lot of money and move on seamlessly to the next big thing without much attachment to the enterprise itself. She, on the other hand, is passionate about what she does — compounding medications, supplements and hormones for people and animals. And for the past five years, she has been working hard to promote the concept of a compounding pharmacy in Malaysia.

In the old days, compounding was a normal part of any pharmacy, chemist or apothecary (as they used to be called), says Yang. Today, some doctors and clinics do some minor compounding as well.

“It is just that it is not very mainstream and it is not something everyone knows about, unless they are in countries such as the US. Even in Australia, most people do not really know what compounding is,” she says.

Yang was an exception because of her background in psychology. While in Australia, she worked with, among others, autistic children. “We would often refer them to a compounding pharmacy because they needed medication and supplements but were not able to take what was available commercially. That was how I first learnt about compounding pharmacies. But I never thought I would start one,” she says.

So, how did it come about? “My dad’s friend in the US, who knows Dr Neal Rouzier (the renowned hormone replacement specialist), came up with the idea of opening a compounding pharmacy in Asia,” says Yang.

Her father, Steven, is an investor in the company. His friend, Samuel Kupper, has a PhD in Chinese history and philosophy. The two of them were interested in preventive medicine, or fortifying the body so that it remains healthy.

Dr Rouzier is known for his revolutionary work in bioidentical hormone replacement therapy (HRT). While he was working in the trauma ward of a hospital years ago, he befriended nurses who were experiencing fatigue because of their 12-hour shifts and poor health, which was a result of hormonal imbalance due to conditions such as premenstrual syndrome, perimenopause and menopause.

When one of the nurses found that she felt better after taking natural thyroid hormones, she shared the hormones with her colleagues, who also felt better after taking them. They went to Dr Rouzier and asked him to prescribe the hormones. But, like any other conventional doctor, he refused.

However, he started studying the effects of natural hormones on women. He went through reams of peer-reviewed research, which supported his own findings on the subject. Soon, he became one of the leading advocates of bioidentical HRT in the US.

Dr Rouzier’s practice spread through word of mouth. His philosophy was that getting older does not have to be painful and debilitating.

Some of his patients, who lived in this part of the world, would fly to the US to be treated by him. That was why he was open to working with a partner to start something in this region, even before he started working with Accent Wellness.

Yang was still in Australia when her father asked her to return home to run the pharmacy. “Before I came back, I did some research to find out if anyone was doing compounding in Malaysia, what the market response was like, how the doctors and patients reacted to it and what sort of competitors we would have,” she says.

After 1½ years, Yang decided to go for it. “We realised that if we did it right, it would be something that could really help doctors and patients, especially with the education on bioidentical hormones. We could really get this going in the market for preventive medicine,” she says.

Kupper introduced her to Dr Rouzier. “He pretty much helped me to develop ties with Neal and this new world of preventive medicine,” says Yang.

She started a little compounding pharmacy at Plaza See Hoy Chan in Kuala Lumpur’s Jalan Tun Razak about five years ago. “At the time, it was just one pharmacist and I,” she says.

It was a capital-intensive business. They had to spend almost RM500,000 on equipment and raw materials, not to mention the cost of flying Dr Rouzier in to teach the local doctors.

“We only use quality raw materials from PCCA (Professional Compounding Chemists of Australia), which also drive up our costs. PCCA supplies the finest high-quality raw materials, especially when it comes to hormones,” says Yang.

“Neal usually asks the doctors to get their compounded hormones from us because we are the only PCCA pharmacy in Malaysia. And since compounding is a new thing in this country, I had to send all of our employees overseas for training.”

Pretty soon, the company was in the red. It was at this point that it sought investment from a venture capital (VC) firm, Astra Partners Sdn Bhd. “We were frank with Jap [Astra Partners chief operating officer Norazharuddin Abu Talib] about the state of our finances at the time. But I think what helped was that he also went on the treatment and felt really good as result. That was when he believed that this was something that could help people,” she says.

Once the VC firm came on board, Accent Wellness was really able to utilise its resources and educate the doctors. Although the company now provides other services (including treatments for hair loss and compounding medication for veterinarians), bioidentical HRT is still its core business.

“That is because we have Neal to back us up. He gives lectures on the use of bioidentical hormones and, obviously, ageing, menopause and andropause, which are inevitable processes — a part of life,” says Yang.

Accent Wellness works with those who have taken Dr Rouzier’s course. The doctors prescribe the hormones and the pharmacy compounds and dispenses them in specified quantities.

Yang sees growing interest in this area as the population continues to age, but it will take a lot of education, she says. “The first thing that comes to people’s minds when they think of HRT is that it is bad. There is always a negative connection with hormones because of what has been shared in the media about cancer and the negative side effects women face when they take hormones. But these articles do not really differentiate between synthetic and bioidentical hormones.”

What are bioidentical hormones? “Basically, they are hormones derived from soy and yam in a lab. The molecular structure of soy and yam is somewhat similar to the hormones our body produces. Synthetic hormones are not,” says Yang.

“And since everybody is different, with bioidentical HRT, we are able to customise the hormones for patients so that the treatment works for them.”

When Accent Wellness opened its doors, the market was not very accepting of what it had to offer. “People did not believe in the benefits of bioidentical HRT and they did not believe in what we had to offer as a compounding pharmacy,” she says.

Most patients were used to the conventional way of doing things. They did not see why they should have their medication or hormones compounded when they could get them off the shelf at regular pharmacies. For some, their doctors told them that there was no benefit to taking bioidentical hormones and that they should stick to birth control pills and synthetic hormones.

“We faced a lot of negative feedback from the market. It was very challenging, very hard for us to change their mindset,” says Yang.

Even getting people to come and listen to Dr Rouzier proved difficult. “They took a lot of convincing. It was pretty much trying to persuade the doctors to not dismiss what Neal had to say until they attended his talk. We also gave out booklets to doctors and patients to introduce them to bioidentical HRT.”

For Dr Rouzier’s first talk in Malaysia, Accent Wellness managed to get only 14 doctors to sign up — a cardiologist, obstetricians and gynaecologists, general practitioners and some specialists in anti-ageing treatments. It was a slow start, but the doctors who attended the course recommended it to their friends and gradually, the numbers grew.

“We kept trying. We used to cold-call the doctors, go out and meet them … doctors who were not really into this, but were not against it either,” says Yang.

“We had to find people who were open to learning what it was all about and through them, get connections with others in the medical industry for us to raise awareness in a more effective way. Now, we have 30 to 40 doctors per course and we are able to conduct it twice as often — up to four times a year.”

So far, Dr Rouzier has trained 300 to 400 doctors in this region. The awareness talks are not only held in Malaysia but also Indonesia and China.

As Dr Rouzier already had patients in Indonesia and China, but none in this country, why did they decide to start a compounding pharmacy in Malaysia? “We felt it would be easier to start one here. In terms of operating costs and obtaining raw materials, it is much easier because we understand our Ministry of Health’s processes and customs clearance,” says Yang.

Not that it was all plain sailing because compounding pharmacies were still a grey area here. “We thought a special licence would be required to operate a compounding pharmacy, but all we needed was a basic pharmacist’s licence,” she says.

Because nobody here seemed to know much about compounding pharmacies, Yang built hers based on standard operating procedures and guidelines in the US. “We pretty much did what we would need to do in the US if our lab was to be accredited there,” she says.

In this way, she helped educate the health ministry’s enforcement officers who came for a visit. “We told them a compounding pharmacy should be like such and such. These are the things you need to look out for when you inspect one. And they said, ‘Oh that is interesting. We will take note of that. Thank you.’”

Yang says the ministry only came out with guidelines for compounding pharmacies late last year. Although grateful that there are now proper guidelines, she does not know what to make of some of them.

“Some of them just do not make sense. They tell me that a compounding pharmacy should only be a complementary service to a retail pharmacy and that we need to have a retail front. I said that is impossible. Why do you make it compulsory? I do not want to have the hassle of stocking up ready-made items,” says Yang.

“My argument is that, being based here (it is now located at Subang Jaya Medical Centre’s mediplex), I do not want to compete with the hospital’s pharmacies. And they said, ‘Okay, that is fine.’”

Then, there was an argument about signboards. “They said that my signboard could not say Accent Wellness Compounding Pharmacy. Apparently, I cannot use the words ‘compounding pharmacy’ because I should not be running one. I should be running a retail pharmacy with a compounding service. I said that does not make sense,” she says.

“That is why some of my signage does not have the words ‘compounding pharmacy’ — they told me to take it down. To this day, I still do not understand why.”

Despite all this, Yang feels that it is better to have guidelines than none at all. “It is good to have rules, otherwise anyone will be able to start a compounding pharmacy and do whatever they like,” she says.

Yang is brimming with ideas for the future. One of them is to set up compounding pharmacies in China. “There are many entry points in China. It all depends on where the operating costs and barriers to entry are lower,” she says.

Currently, there are no plans to do something similar in Indonesia because the process is a bit more expensive and complicated there.

Now that its bioidentical HRT courses are getting more popular and the Accent Wellness brand more well known, Yang wants to turn her attention to other areas of interest. “Bioidentical HRT is catching on. We have managed to alter the mindsets of quite a number of doctors. If this snowballs, we will not have to put in as much effort as we did at the beginning,” she says.

The areas that she wants to look at include pain management with compounded medication and palliative care. “We will be going back to square one — look for a credible speaker and educate doctors on what pain management is with compounded medication. We will also be educating patients — for instance, oncology patients — on what kind of options they have if the commercially available medications are not working for them.”

Yang is passionate about palliative care. She is always eager to share the story of her grandmother and how she was mistreated by a leading hospital that cared more about milking the elderly woman’s relatives for as much as they could by giving her the wrong dosage of medication as well as keeping her in the intensive care unit for longer than was necessary to hike up the charges.

All of this probably sent her grandmother to her grave earlier than it should have and Yang still burns whenever she describes the incident. It has also focused her attention on the importance of proper end-of-life care.

“Palliative care is something I am passionate about and I would love to educate patients on it. Our population is ageing and we do not want to see our loved ones in pain and suffering towards the end. There are ways to manage this better and I would love the opportunity to educate the public about this,” she says enthusiastically.

At present, if a patient is in pain he is given an intravenous solution for whatever pain medication or mood enhancers his doctors have prescribed. “The thing is, these medications only work for a certain period of time and maybe they do not get to the root of the problem,” Yang points out.

“With palliative care, it is more a multifaceted approach to understanding what the problem really is and why the medication is not working. Perhaps the problem was the route of delivery.”

Yang comes up with a rather gruesome example. “Say a patient has cancer of the vulva. She would be in so much pain and a lot of medication cannot be applied directly because the pain is in that area itself. You need something that can be applied on-site that will not cause any side effects. With compounding, we can come up with different ideas, strategies and solutions,” she says.

In this particular example, she says they could come up with a spray so that the application does not cause further pain. “If you use pain cream, you will have to rub it on the area and that will hurt. But if we come up with a spray that contains ketamine and some antibiotics to prevent infection, it will decrease the risk of the wound or fissures getting worse.”

This kind of solution, however, is only available to someone with access to a compounding pharmacy as it involves a combination and manipulation of off-the-shelf medication.

Yang, whose child was barely a month old at the time of the interview, is raring to go. She sees so much potential for compounding pharmacies in the region and there is still a long way to go.

Save by subscribing to us for your print and/or digital copy.

P/S: The Edge is also available on Apple's AppStore and Androids' Google Play.