The complicated reasons behind drug shortages

The complicated reasons behind drug shortages

Released Friday, 21st March 2025
Good episode? Give it some love!
The complicated reasons behind drug shortages

The complicated reasons behind drug shortages

The complicated reasons behind drug shortages

The complicated reasons behind drug shortages

Friday, 21st March 2025
Good episode? Give it some love!
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Episode Transcript

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0:00

ABC Listen, podcasts, radio,

0:02

news, music and more.

0:04

I know you like to talk about

0:07

your ailments. Is that clear?

0:09

No, no, no, come on. You like

0:11

asking about them or do you

0:13

just raise them? It's hard to

0:16

know. Well, let's say, that goes

0:18

through to the keeper. So what

0:20

do you want to ask me

0:22

about this week? Priya. Do you

0:24

have any. osteoarthritis

0:26

going on, hips, knees. Funny you

0:29

should say that. The answer is

0:31

yes I imagine. Yeah yeah it's my

0:33

knee. Tell me more how long how does

0:35

it affect you? I was cycling to

0:37

school at the age of 14 in

0:39

Scotland in the snow fell off the

0:42

bike and damaged my knee and the

0:44

knee kept on jumping out the knee

0:46

cap and eventually I had it operated

0:49

on at the age of 18. The

0:51

surgeon said, it's a great operation for

0:53

stopping the knee cap jumping out, but

0:56

you'll have osteoarthritis by the time you're

0:58

60. Yeah. And I had it by

1:00

the time I was 40. Oh, Norman, so you get

1:02

knee pain. Well, interestingly, everybody around me

1:05

has been saying, you gotta have

1:07

a knee replacement. Got to have

1:09

a knee replacement. Do you? Do

1:11

you need a knee replacement? That's

1:13

the million dollar question. Well, I don't

1:15

think I do. And I've managed to

1:17

hold it at bay by... doing stuff

1:19

to my knee and to my leg.

1:21

I've discovered all sorts of interesting things

1:23

about rehabilitation of the knee. And there

1:25

you go. That's exactly what we're covering

1:27

on the health report today. That's your

1:29

story. And actually, even despite the pain,

1:31

you want to keep moving. That's the

1:34

kind of interesting paradox. It is. We'll have

1:36

much more on that today on the health support.

1:38

I'm Norman Swan on Gaddigoland. And I'm

1:40

Pre Alexander on Wur and Jerry Land.

1:44

Also on this show, a study that

1:46

shows that screening students from mental health

1:48

issues almost in its own right improves

1:50

the mental health without using extra services.

1:53

Even that can be quite protective for them

1:55

as they walk around the school knowing that

1:57

we're caring for them. And more evidence that

1:59

clients... changes hurting our health,

2:01

high temperatures are driving up

2:03

the risk of cardiovascular disease. To

2:06

the news now, so there are some

2:08

medication shortages and they appear to be

2:10

getting worse. Yeah, it just keeps on

2:12

going, doesn't it? I mean, you'd see

2:14

a lot of it in practice where...

2:16

HRT patches and what we call MTT

2:18

patches, drugs for ADHD, I mean just

2:20

the list keeps on going on and

2:22

on and on. It is really tricky

2:24

to navigate. Often we don't hear

2:26

about these things until the patient

2:29

comes and says I couldn't get

2:31

this. The pharmacist said there's a

2:33

shortage. It's very hard to keep

2:35

up and at the moment the

2:38

menopause hormone therapy space there are

2:40

lots of shortages of the transdermal

2:42

estrogen patches and ADHD so at

2:44

the moment we're experiencing methylphenidate shortages

2:47

it really impacts best practice you

2:49

can't do what the patient might need.

2:51

And so just before you panic if

2:53

you are on ADHD medication it's not

2:55

all methylphenidate which is a bit of

2:57

slower release it's called concerta. I thought

2:59

we might just chat a little bit

3:02

about it so that we kind of

3:04

understand a bit more aware of these

3:06

shortages, but it's more of a 400

3:08

I think listed in Australia at the

3:10

moment in the TGA website. And we're

3:12

better off in the United States by

3:14

the way. They have more shortages and

3:16

they are lasting longer. What's really interesting

3:19

about this is when you delve into it,

3:21

60% of the time, they've no idea

3:23

why the shortages occurred. Really? Yeah,

3:25

really no idea. The manufacturer will

3:27

say we've got manufacturing issues. Yes.

3:29

But it's quite hard to get

3:32

to the bottom of it. And

3:34

I thought what we might do

3:36

to illustrate the complexity of this

3:38

is use menoposs hormone treatment patches

3:40

as a case study so we

3:42

can just understand. the intricacy of

3:45

this. So let's start at the

3:47

front end. So at the front

3:49

end here, and this is often

3:51

the case by the way, with

3:53

IV fluids, with ADHD drugs as

3:56

well, is that demand changes. And

3:58

we've talked about hormone. replacement therapy

4:00

or MCT quite a bit recently

4:02

on the show. Prescription rates around

4:04

the world have probably doubled in

4:06

the last few years. So there's

4:08

an enormous number of new prescriptions

4:10

been written which weren't written before

4:12

for all sorts of reasons. Doctors

4:14

are a bit more relaxed about

4:16

prescribing and women are realizing that

4:19

they can have their menopause symptoms

4:21

or the pain and menopause symptoms

4:23

helped. As a result worldwide there's

4:25

more demand, perhaps doubling of demand

4:27

in a very short space of

4:29

time for MCT. And you've got

4:31

high demand in a manufacturing process

4:33

that is incredibly complicated and very

4:35

hard to just switch on and

4:37

off or dial up or down.

4:39

And it starts, believe it or

4:41

not, with soybean farmers in China.

4:43

Oh, I was not expecting that.

4:45

Eastern based patches or even double

4:47

patches. The patches are either go

4:49

Eastern alone or Eastern with pedestrian.

4:51

The Eastogen is Easter dial. So

4:53

it's a very effective form of

4:55

synthetic estrogen. And it comes from

4:57

plants, mostly from soybeans. It can

4:59

come from sweet potato. So it

5:01

starts with soybean farmers and most

5:03

of the supply comes from China.

5:05

They have a process which produces

5:07

cooking oil from soybeans. But there's

5:09

also another oil that's produced in

5:12

that process, which is rich in

5:14

plant-based estrogens. Okay, and that's what

5:16

you need for the patches. Well,

5:18

not yet. They then put that

5:20

through a chemical process, turn it

5:22

into a white powder, it then

5:24

goes overseas to manufacturers. who then

5:26

process that in reactors to Easterdile.

5:28

So you can have a farming

5:30

issue which affects soybeans. You could

5:32

have bad weather on soybean farms,

5:34

which means that their production goes

5:36

down. You could have pollution problems

5:38

on Chinese farms. You could have

5:40

problems with transportation. You can have

5:42

international trade wars. I mean, during

5:44

the first Trump administration, there were

5:46

major issues about soybeans, for example,

5:48

between the United States and China.

5:50

So there's so many ways. that

5:52

the chain can be impacted. And

5:54

all I see on the TGA

5:56

website when I look for information

5:58

before I prescribe the estrogen transdermal

6:00

patch is whether or not it's

6:02

there. And it just says supply

6:05

issue or manufacturing issue. But there's

6:07

nothing about soybeans. No. And the

6:09

point here is, analysts have said

6:11

this more than once, is that

6:13

the supply chain. for a medication

6:15

like an HRT patch is as

6:17

complicated as an iPhone. Point being,

6:19

you go to the pharmacy with

6:21

a script from Dr Alexander and

6:23

the pharmacist says, so I can't

6:25

fill it out. It could be

6:27

a problem on a farm in

6:29

China. Yeah, isn't that amazing? I

6:31

never realized it was that complex.

6:33

It does impact clinical practice significantly.

6:35

I think there are probably a

6:37

lot of people listening going, I

6:39

have had this happen, I've had

6:41

to change the dose of the

6:43

medication or the type of medication,

6:45

often what's best practice is really

6:47

hard to implement as the clinician

6:49

because it's just not available. And

6:51

for something like menopause symptoms or

6:53

peri menopause symptoms, people are often

6:55

struggling with hot flushes and impaired

6:57

sleep quality and mood. and you

7:00

think well I can't actually prescribe

7:02

the medication that you need. Now

7:04

the good news here is that

7:06

some other formulations have come onto

7:08

the PBS from the first of

7:10

March so hopefully that helps to

7:12

alleviate some of the pressure. But

7:14

I had never realized it was

7:16

that complex. No, and just to

7:18

finish off on this, it's not

7:20

just soybean farmers. With other drugs

7:22

or medications, it's also demand. So

7:24

for example, you go of a

7:26

natural disaster, which increases demand for

7:28

IV fluids. You can have a

7:30

tornado going through North Carolina damaging

7:32

a Pfizer factory, which is what

7:34

happened in 2003. You can have

7:36

floods affecting factories. So there are

7:38

multiple reasons why you end up

7:40

with a problem. at your local

7:42

pharmacy and then there's the business

7:44

side which is less true of

7:46

Australia than it is for the

7:48

United States where for some medications

7:50

despite the fact that America is

7:53

a very expensive place for medications.

7:55

They drive very low profit margins

7:57

on generics and some generics manufacturers

7:59

simply get out of the business.

8:01

Because that's the other problem with

8:03

hormone replacement patches is that one

8:05

manufacturer just got out of the

8:07

business with a drug called Klimara.

8:09

And so you had fewer drugs

8:11

on the market. Complicated stuff. Very

8:13

complicated. I'll just add that there

8:15

was an understanding the impact of

8:17

medicine shortages in Australia report that

8:19

came out late last year. A

8:21

big criticism was the lack of

8:23

communication with health care providers on

8:25

the ground. It would be lovely

8:27

to know what's potentially not in

8:29

supply, how we manage it, and

8:31

a bit of a guide as

8:33

to potential replacements. To avoid confusion.

8:35

Yeah, communication is not necessarily the

8:37

TGA's strongest suit, we might say.

8:39

But the PBS has also been

8:41

in the news this week or

8:43

two. It has from two angles

8:46

here. Firstly... The federal government's just

8:48

come out and said we're going

8:50

to slash the price of most

8:52

PBS medication so you won't be

8:54

paying $31.60. it will go down

8:56

to 25 which is going to

8:58

be a huge win for lots

9:00

of people. Just to be clear

9:02

it's not the price, it's what

9:04

you pay in terms of your

9:06

contribution to the subsidy, the price

9:08

is another matter which is another

9:10

key issue, the price is negotiated

9:12

with the manufacturer. And I guess

9:14

that's an important point that the

9:16

PBS is really there to subsidise

9:18

the cost of medication so that

9:20

you the patient pay less in

9:22

the government subsidises the cost for

9:24

you. But it's come under fire

9:26

from the United States which is

9:28

surprising to me that they would

9:30

be talking about the PBS but

9:32

apparently we're kind of the forefront

9:34

leaders here. Well it's not new

9:36

so when we were negotiating the

9:38

free trade agreement the pharmaceutical industry

9:41

in the United States had a

9:43

major goal at the PBS and

9:45

said this is a non-tariff trade

9:47

barrier even then and we're complaining

9:49

about it and they complain about

9:51

it for all sorts of reasons

9:53

but what they what really irks

9:55

them is that we negotiate very

9:57

low prices by international standards. and

9:59

this is the Pharmaceutical Benefits Advisory

10:01

Committee, largely responsible for this, is

10:03

that they go through new medications,

10:05

looks at their true value to

10:07

the community, to taxpayers and to

10:09

patients, and works out what a

10:11

fair cost would be. The manufacturer

10:13

comes back and says, well, you

10:15

know. get stuffed our international price

10:17

for this is why you're only

10:19

going to pay us X and

10:21

they have a commercial negotiation. They

10:23

haggle they haggle it. That's right

10:25

they haggle and they come to

10:27

an answer and as a result

10:29

we get very good prices discounts

10:31

on new medications into Australia. What

10:34

the what international pharmacy, American pharmacy,

10:36

well first of all that delays

10:38

our entry into the Australian market

10:40

and the price. And what you're

10:42

going to remember here is that

10:44

they have a good time of

10:46

it in the United States, where

10:48

parts of the health industry are

10:50

barred by law from negotiating pricing

10:52

with the pharmaceutical industry. So the

10:54

pharmaceutical industry, not entirely, but to

10:56

a significant extent can charge what

10:58

they like for the pharmaceuticals, which

11:00

is why America has the most

11:02

expensive drugs in the world, pretty

11:04

much. So they don't like the

11:06

haggling here. So the criticism is...

11:08

They've essentially said that the peaback

11:10

makes it really difficult for them

11:12

to introduce medications. They haggle about

11:14

pricing. And get the price that

11:16

they want. But I think the

11:18

real reason that's underneath this is

11:20

that we were amongst the first

11:22

to do this effectively and systematically,

11:24

and other countries in the world

11:27

have copied our system. So my

11:29

understanding is that if there's a

11:31

belief in the pharmaceutical industry in

11:33

the United States, is that if

11:35

they could knock us off... That

11:37

would be the start of knocking

11:39

off other subsidized systems and if

11:41

they could get that undermined here

11:43

and they had a good go

11:45

at it during the free trade

11:47

agreement discussions. They would love to

11:49

get rid of it because then

11:51

we'd be the chink in the

11:53

armour. Watch this space I guess

11:55

with fingers. ties is

11:57

that fair? fair? Yeah, but

11:59

the larger story with all

12:01

story with all

12:03

this and the

12:05

Trump trade trade

12:07

policies, such as they are,

12:09

are is that they are

12:12

trying to invagle themselves

12:14

into local social and economic

12:16

So they're talking about VAT value-added tax

12:18

GST, goods and services tax,

12:21

as non -tariff barriers, barriers. as if

12:23

you don't pay sales tax

12:25

when you go to New York

12:27

New York mean, I mean, there are you

12:30

go in the United States, the United

12:32

States. There are and somehow and somehow VAT

12:34

are different. are you know, there

12:36

are problems here of getting

12:38

involved in sovereign policies. sovereign And as

12:40

you say, as this space. space.

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