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Pharmaceuticals

U.S. Supreme Court leans toward allowing challenge to Texas abortion law

Source: Reuters

WASHINGTON, Nov 1 (Reuters) – Two months after letting a near-total ban on abortion in Texas take effect, conservative U.S. Supreme Court justices on Monday signaled they are reconsidering their positions and could let abortion providers pursue a bid to invalidate the law.

The court on Sept. 1 declined to halt the law in a 5-4 decision with all but one of its six conservative justices in the majority. During three hours of oral arguments on Monday, at least two of the justices who had allowed the law to be enforced – Brett Kavanaugh and Amy Coney Barrett – appeared to lean toward permitting abortion providers to proceed with their legal challenge.

The court’s conservatives seemed more skeptical about whether to let Democratic President Joe Biden’s administration pursue its own challenge. The Justice Department sued Texas in September seeking to block the Republican-backed law.

The administration and abortion providers have said the law violates a woman’s constitutional right to terminate a pregnancy recognized in the court’s landmark 1973 Roe v. Wade ruling and is impermissibly designed to evade federal judicial review.

The law imposes the nation’s toughest abortion restrictions, banning it after about six weeks of pregnancy – a time when many women do not realize they are pregnant – with no exceptions for pregnancies resulting from incest or rape. It is one of a wave of Republican-backed state abortion laws in recent years. Abortion opponents hope the court’s 6-3 conservative majority will pare back abortion rights or even overturn Roe v. Wade.

Some justices signaled that existing Supreme Court precedent could accommodate the lawsuit by the abortion providers despite the law’s novel design that makes it difficult for federal courts to block it. The law lets private citizens rather than state officials enforce it through lawsuits against providers and others who assist a woman in obtaining an abortion.

Depending on what approach the justices take, they could block the law entirely or pave the way for a lower court judge to do so. If the justices keep federal courts out of the process by virtue of the law’s design, it could be replicated in various other states seeking to curtail abortion access.

U.S. abortion rights are hanging in the balance as the justices review the Texas law before hearing arguments on Dec. 1 over the legality of a Mississippi measure, blocked by lower courts, prohibiting the procedure after 15 weeks of pregnancy.

Barrett asked clinic lawyer Marc Hearron about whether under the law’s structure the constitutional claims on the right to abortion could ever be “fully aired.” Under the law, abortion providers can bring up that constitutional issue as a defense only after they have been sued.

Kavanaugh expressed interest in an outcome raised by liberal Justice Elena Kagan in which state court clerks would be barred from allowing lawsuits brought by private individuals seeking to enforce the law to proceed while litigation over the legality of the measure unfolds.

Kavanaugh wondered if states could pass similar laws infringing on other constitutional rights including gun rights. A state, for example, could allow for $1 million in damages against anyone who sells an AR-15 rifle, he said. Kavanaugh also wondered about closing a loophole “exploited” by the Texas measure in the court’s precedents concerning when state officials can be barred from enforcing unconstitutional laws.

His tone was more skeptical toward the Biden administration lawsuit, telling U.S. Solicitor General Elizabeth Prelogar that challenge was “different and irregular and unusual.”

Kagan said the law was written by “some geniuses” to evade the broad legal principle that “states are not to nullify federal constitutional rights.” Kagan warned of the consequences of states passing laws that infringe upon rights, including same-sex marriage and religious liberty.

The Texas measure enables private citizens to sue anyone who performs or assists a woman in getting an abortion after cardiac activity is detected in the embryo. That feature made it more difficult to directly sue the state. Individual citizens can be awarded a minimum of $10,000 for bringing successful lawsuits under the law. Biden’s administration has called it a “bounty.”

Conservative justices Clarence Thomas and Samuel Alito asked whether anyone would have standing to sue under the law without having a direct injury. Texas Solicitor General Judd Stone, defending the law, said personal “outrage” toward abortion would be enough to justify a lawsuit.

The law has deterred abortion providers facing innumerable potentially costly lawsuits in Texas – the second most-populous U.S. state behind only California, with about 29 million people.

The court agreed to take up the matter on Oct. 22, bypassing lower courts considering the challenges.

Reporting by Andrew Chung and Lawrence Hurley in Washington; Additional reporting by Jan Wolfe; Editing by Will Dunham

Our Standards: The Thomson Reuters Trust Principles.

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Pharmaceuticals

Taking next-generation motion from concept to reality

~ How free motion can address challenges in the pharmaceutical industry ~

If companies were to take home one lesson from the COVID-19 pandemic, it should be that flexibility is key. This statement is no less true for the pharmaceutical industry, which has been pushing for flexibility for years. With a pandemic almost behind us and the challenges of a rapidly ageing population, flexible manufacturing is needed now more than ever. In this article , Adnan Khan, manager of pharma industries at Beckhoff UK, discusses the challenges of pharmaceutical production lines and how next-generation motion can help. 

While there are many tips for creating a more flexible manufacturing process, from plug-and-play robotics to single-use manufacturing, few tips focus on motion control in production lines. Motion control has the power to make production lines more flexible and efficient, but few motion control systems provide the freedom and range to maximise their benefits. 

From concept to reality

In interviews conducted by Donna Ritson, president of DDR communications and Paula Feldman, senior director of Business Intelligence, 75 per cent of pharmaceutical manufacturers said they were increasing their level of automation going forward. So for those wanting to invest in optimising their production lines, where should they spend their money? 

Over the years, technology has advanced, allowing the pharmaceutical industry to advance with it. However, despite the introduction of sophisticated technology, challenges still occur in the production of pharmaceutical products, such as flexibility and efficiency. The XPlanar, a first-of-its-kind planar motor system, can help address these challenges.

The XPlanar system comprises the mover, tile and control software. The magnetically driven mover is wireless, with six degrees of jerk-free movement, allowing for the technology to effortlessly levitate over the tiles, which can be moved and placed as a facility needs. With each singular mover having a bare load of up to 4.2 kg, a maximum speed of 2 m/s and an easily wipeable surface, the XPlanar is bringing the reality of next-generation motion to the pharmaceutical industry.

Flexible and efficient 

Flexibility has always been an issue in the pharmaceutical industry, as traditional plant layouts make it hard to switch over or adjust equipment to produce different products. Due to a large number of sensitive chemical processes in pharmaceutical manufacturing, moving equipment around requires equipment recalibrations and strategic positioning. However, with new methods such as modular manufacturing, allowing for multiple different drug productions in one facility, these challenges are slowly being addressed. 

Modular manufacturing refers to a type of manufacturing where there is no fixed equipment, meaning facilities can be broken down and rearranged as needed. As modular manufacturing is embraced, new techniques will be needed to achieve a modular facility. The XPlanar system elevates this manufacturing method to a more efficient, flexible and long-lasting one. Like with many of the equipment used for modular manufacturing, the XPlanar system can be laid out freely in a multitude of arrangements to suit the pharmaceutical facilities’ requirements. 

The XPlanar system provides the pharmaceutical industry with the production flexibility needed to not only create a modular manufacturing facility but a more efficient manufacturing facility. The XPlanar system allows manufacturers to create a flexible production line with movements of 360 degrees, allowing for easy and efficient product inspection, alignment or processing. 

The easy adaptability of the movers and tiles ensures the technology can last in an ever-evolving technological landscape. Using this free-moving system the pharmaceutical industry can see the benefits of next-generation motion becoming reality.

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Lifestyle

Keeping pets protected during heatwaves this summer

We’ve been lucky to have been hit with some great weather this summer, however, some days have been exceptionally hot and causing us discomfort to the point where we don’t want to leave the house! Our pets can also struggle in this heat and if not looked after correctly, can lead to life threatening issues for them. 

Dr. Sarah Machell, Medical Director for Vetster, has shared her top five top tips to ensure that our pets can enjoy the summer days as much as we can.

Vetster, is a digital platform that connects licensed vets with pet owners virtually, with 24/7 online appointments, launches in the UK this summer.

1.  Provide adequate rest, shade, and ventilation

Coping with high temperatures and humidity is tough enough on its own, but it’s even more difficult for pets who are exercising in direct sunlight and don’t have adequate ventilation. Limit outdoor activities to early mornings and late evenings when it’s cooler. When walking your pet, choose shady routes off the pavement.  Ensure outdoor pets have shady, ventilated places to escape the heat.  Keep in mind that pets also rely on evaporation for cooling, regardless of if they sweat like horses or pant like dogs, and high humidity decreases the effect of evaporation. This means your pet needs you to keep an eye on the heat index for them as well as for you.  Be sure your pets have easy access to a steady supply of clean water. Pets are naturally wired to stay hydrated as long as they are healthy and avoid heavy exercise in the heat, so there’s no need to try to encourage your pet to drink more.  Just make sure the water supply is in easy reach and doesn’t run dry. 

 2. Be wary of paws on the hot pavement! 

When the weather gets extremely hot, so does the pavement—asphalt, in particular. If you’re taking your dog out for a walk, try to remember that they don’t have shoes to protect against the heat. Even though paw pads are extremely tough, hot surfaces can burn them. Consider using padded booties for their paws to create a barrier between paw pads and the hot concrete.  Better yet, try to steer clear of the streets and walk on the cool grass instead. If there’s an opportunity to wade through some clean water or catch the spray from a sprinkler, that’s even better. Remember that pavement retains heat and you still need to be aware of the risks when you go for walks in the evening.

3. Look out for signs of heatstroke 

Heatstroke is a very serious condition and one to look out for in your pets. As a pet parent, it’s important to be aware of your pet’s fitness level and avoid overexertion when the weather’s too hot or humid. Less athletic dogs, dogs with underlying illnesses, and brachycephalic breeds are at higher risk for developing heatstroke, so keep an extra close eye on them. Heatstroke is life-threatening, but it can be avoided if you take action to cool your pet when they show early signs of heat stress. If your dog doesn’t want to keep walking, lies down in the shade, or digs up cool dirt to lie in, those are clues they’re getting too hot.  Excessive panting that doesn’t improve after a short rest is another indicator. Get out of the heat and offer water to keep the threat of heatstroke from escalating.  Splash down hot ears, paws, and bellies with water to achieve more rapid cooling.

4 Never leave your pet unattended in a hot vehicle 

Heatstroke can happen in the blink of an eye—it cannot be stressed enough that you should never, ever leave your pet unattended in a vehicle. This is true even if you leave the windows down for fresh air or if you think you’ll only be gone for a few minutes. Studies show that even if the outdoor temperature is 72℉ (22°C), a car can rise up to 117℉ (47°C) in only an hour. Imagine how quickly a car can become dangerously hot when outdoor temperatures are a balmy 86℉ (30°C). Even if you’re leaving your car unattended for a minute or think that leaving a window open will help – the life-or-death gamble you’re taking isn’t worth it.

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Pharmaceuticals

Why dosage matters in menopause treatment

By Rizvan Faruk Batha MPharm, PGDip GPP, IPresc, MRPharmS, Superintendent Pharmacist of Specialist Pharmacy.

Bioidentical Hormone Restoration Therapy (BHRT) is an alternative option to traditional synthetic HRT, using bioidentical hormones to treat hormonal conditions in both men and women. BHRT is compounded medicine and put simply, means that the individualised ingredients are mixed together under the direction of a qualified prescriber’s prescription to meet the tailored needs of a patient.

For women going through menopause, compounding treatments are often prescribed later down the line, when a woman has been unable to settle on the appropriate dose of HRT with a General Practitioner, often experiencing severe side effects from either too much or too little HRT. In short, compounded menopause medication offers another route for those patients where the licensed preparation is not appropriate or hasn’t worked.

Patient-led care plays an important role in compounded menopause medicine because the patient is involved throughout the process; during the consultation with the prescribing practitioner, and with the pharmacist developing the customised dosage.

One of the biggest challenges faced by compounding pharmacies is the drugs being classified as unlicensed. For drugs to be licensed, it involves research and clinical trials to assess the efficacy, quality, and safety of the medicines, and because of this process, more often than not it is the recommended route to prescribe licensed medicines. That being said, prescribing unlicensed compounded menopause medicines may be necessary, especially when it comes to the patient’s specific need and interests and where licensed medicines have been unable to satisfactorily meet the needs of the patient or are unsuitable for them.

Utilising compounded menopause medicine as a method to enhance patient care could be beneficial for the many patients that need specific dosing or formulation requirements, but sadly more often than not we see delays to patient needs and treatment, as the rise of mass manufactured licensed medicines have grown in popularity. Compounding menopause medicine could offer huge potential for many, but prescribing practices have moved towards evidence-based medicines because of the responsibility imposed on prescribers for prescribing compounded therapies. Clinicians need to understand that even licensed products are not safe or effective for all patients particularly if the product is being used in a population that were not part of the original clinical trials for the drug.

It is important to know that compounding pharmacies and pharmacists in the UK are also regulated and licensed by the General Pharmaceutical Council (GPhC). The GPhC set standards for pharmacists and pharmacies to meet to remain on their register with the aim to protect the public and give them assurance that they will receive safe and effective care when using pharmacy services.

So even though compounded medicines are ‘unlicensed’, there is a lot of due diligence exercised by the pharmacists to ensure the products meet the safe and effective care criteria. This is generally demonstrated through the purchase of medical grade active and inactive pharmaceutical ingredients (with certificates of analysis and safety data sheets), trained staff, following and updating SOPs, audits, traceability of ingredients and products during recalls, as well as continuous learning and error reporting being supported in the pharmacy.

Ultimately, how compounded menopause medicine is viewed will depend on the knowledge and experience of the patients and professionals involved. Although the medicine is unlicensed it is important to understand that experienced clinicians and pharmacists involved in the process of making the decisions are regulated, and patients are consistently monitored during their response to the medicine. If compounded menopause medicine was integrated in the healthcare system, it could change and improve the quality of life of many patients suffering with debilitating menopause symptoms, and we hope as a pharmacy that in the future we will see a shift in how compounded medicine is viewed.

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