HDA Media And Political Bulletin – 6 April 2016

Compact machine produces drugs “on demand”

5 April 2016, The Pharmaceutical Journal, Kirsty Oswald


Researchers have developed a machine that can synthesise multiple drugs from start to finish. The system could give more flexibility to batch manufacturing, helping to prevent drug shortages and respond quicker to disease outbreaks. It could also be used to synthesize pharmaceuticals needed only for a small number of patients.


We’re running out of prescription drugs, and it’s not for the reason you think

4 April 2016, Business Insider, Lydia Ramsey


Drug shortages are a global problem due to be discussed at the WHO World Health Assembly in May. Hans Hogerzeil, former director for essential medicines at WHO, states that one of the causes is low pricing. When multiple companies manufacture generic drugs, prices begin to slip until making it is no longer profitable, causing product discontinuation. Very few manufacturers will be left producing it, leading to shortages if they run into problems.


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Compact machine produces drugs “on demand”

5 April 2016, The Pharmaceutical Journal, Kirsty Oswald


Researchers have developed a machine the size of a refrigerator that can synthesise multiple drugs from start to finish.


In a paper published in Science[1] on 1 April 2016, the team from the Massachusetts Institute of Technology (MIT) in Cambridge, Massachusetts, shows how the technology can be used to synthesise a number of “medic’s toolkit” drugs. The researchers say the system could be used to create active ingredients on demand, helping to prevent drug shortages and respond quicker to disease outbreaks.


“Current batch manufacturing has little flexibility to respond to surges in demand and is susceptible to severe disruption if one of the plants has to shut down,” says Klavs Jensen, whose laboratory at MIT carried out the work.


“In addition to providing an alternative for such a situation, the technology can be used to synthesize pharmaceuticals needed for only a small number of patients,” he adds.


The machine measures 1.0m wide x 0.7m long x 1.8m deep and synthesises active pharmaceutical ingredients from starting materials and reagents using an automated process of continuous flow chemistry. Described by the researchers as “plug and play”, it consists of integrated modules that can perform individual synthesis, purification and formulation, and can be reconfigured to produce different drugs. This contrasts with current drug production methods where different stages of the process are often performed at different sites, sometimes taking as long as 12 months from start to finish.


“Key to the continuous system is the development of chemical reactions that can take place as the reactants flow through relatively small tubes as opposed to the large vats in which most pharmaceutical reactions now take place,” explains Jensen. “Traditional batch processing is often limited by the difficulty of cooling these vats, but the flow system allows reactions that produce a great deal of heat to be run safely.”


The researchers report that they were able to synthesise four pharmaceuticals: diphenhydramine hydrochloride, lidocaine hydrochloride, diazepam and fluoxetine hydrochloride. These met US standards for purity and, when optimised, the machine could produce the equivalent of hundreds or thousands of doses per day.


As well as providing alternative forms of drug manufacture, it is hoped that the technology could find use in humanitarian and battlefield situations. The team at MIT receive funding from the US Department of Defense which has an ongoing project aiming to produce a number of drugs on demand using compact devices on the battlefield. In developing countries, the technology could increase accessibility to drugs by allowing them to be manufactured closer to the point of need.


A team involving some of the same researchers previously developed a much larger prototype that was able to perform continuous manufacturing of drugs in tablet form. The new and much more compact model is only able to synthesise liquid forms of drugs for topical or oral use. But the team says that developments, such as in 3D printing, should help them develop the technology to produce tablet, capsule or injectable forms.


“We are now working on the second phase of the project, which includes making the system about 40% smaller and producing drugs whose chemical syntheses are more complex,” says Jensen.


Alastair Florence, director of the EPSRC Centre for Innovative Manufacturing in Continuous Manufacturing and Crystallisation at the University of Strathclyde in Glasgow, says the paper shows the technological progress being made worldwide to revolutionise drug manufacture.


“Continuous processing offers flexible, configurable and sustainable processing with excellent consistency, reduced material and energy needs and environmental impact,” he says.


“The potential to bring more products to market cost effectively, in a greater number of dosage forms, clearly offers significant benefits to industry and patients, ensuring access to medicines and avoiding stock-outs.”


We’re running out of prescription drugs, and it’s not for the reason you think

4 April 2016, Business Insider, Lydia Ramsey


We’re facing a major problem with prescription drugs.


Around the world, there are constantly shortages of one drug or another. The American Society of Health-System Pharmacists (ASHP) lists 157 compounds that are currently facing shortages in the US alone. The list includes everything from antibiotics to vaccines to cancer medications.


And it could be for a counterintuitive reason: Prices are too low for some medications.


It might seem almost routine that the price of some generic drugs skyrocket, selling overnight for almost 14 times what they cost the day before.  But even though this happens — and occasionally draws public attention — the opposite is happening at a far larger scale: Dozens of generic drugs are being discontinued because prices are too low.


This can happen when the makers of a generic version of a branded drug, like the antibiotic clindamycin, decide to come out with their own, far cheaper version of the drug, and one or two other manufacturers hop on the generic bandwagon. Once those companies are producing enough generic drugs to satisfy demand, that price will keep slipping until making the drug is no longer a profitable exercise. At that point, manufacturers start to discontinue production, which leads to shortages if the ones left making the drugs run into any problems.


“Medicines can be too cheap,” Hans Hogerzeil, a professor of global health at Groningen University in the Netherlands and a former director for essential medicines at the WHO told Reuters. “For a viable market model you need at least three and preferably five different manufacturers.”


Having more manufacturers creates a safety net, so if any one of them runs into problems that require them to shut down, another can just amp up production. If prices are too low and manufacturers decide to drop out, then that safety net doesn’t work. But that doesn’t mean that setting a minimum price to keep manufacturers in the game is the right solution to drug shortage problems.


“It’s a ‘three bears’ situation,” Erin Fox, the director of the Drug Information Service at University of Utah Health Care, told Business Insider. Drug prices are too high, drug prices are too low, nothing seems to be “just right.”


Fox said that she expects prices to actually go up on their own as they move toward a situation where there’s more transparency about how the drug is manufactured. Until there’s more transparency around the quality of how the drug’s being processed, she said, “[The higher price is] a bitter pill to swallow.” It’s justifiable to pay for a product when you’re know you’re getting a higher quality in where and how it’s made but, without transparency, there isn’t as much of a case for a sudden rise in price.


The World Health Organization plans to discuss drug shortages — for the first time — at its World Health Assembly in May.


“I hope it will help dispel the myth that drug shortages are only happening in the US,” Fox said.

HDA Media And Political Bulletin – 6 April 2016

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