The United States, Puerto Rico, and many islands in the Carribean have recently faced an immense amount of destruction thanks to mother nature. Several hurricanes and tropical storms have devastated many areas, causing destruction to communities, widespread power-outages, and quite possibly, drug shortages.
How could this cause a shortage?
Around 10% of drugs prescribed in the United States are manufactured in Puerto Rico. Pharmaceutical companies like Eli Lilly, Pfizer, and Baxter are just a few of the many manufacturers that have facilities located in Puerto Rico.
In response to these natural disasters, the FDA Commissioner, Scott Gottlieb, M.D., issued a statement regarding the potential for drug shortages. According to the FDA Commissioner, the pharmaceutical industry is responsible for nearly 90,000 jobs and for 72.4% of Puerto Rico’s 2016 exports totaling $14.5 billion.
You can read more of this statement here.
What drugs have been affected?
The types of medications and medical products produced in Puerto Rico include HIV and cancer drugs, immunosuppressants used by organ transplant patients, diabetes devices, and even hospital IV bags.
What is being done to address the shortages?
In order to address current and future problems, the FDA has been working with pharmaceutical companies to create a task force to prioritize efforts and address the potential for medical product shortages.
According to the American Society of Health-System Pharmacists (ASHP) the FDA is tracking 40 critical medications — 12 that are not produced outside of Puerto Rico — that are at risk of being in short supply because of hurricane-related manufacturing delays.
While there are no shortages yet, a small number may appear in the next couple of weeks. Stay tuned, we will keep you updated!
Asthma can feel different for everyone affected by it. For some people, allergies and various environmental allergens play a major role in the severity of their asthma. For others, triggers like perfume or exercise can lead to breathing problems.
If you have asthma, your doctor will most likely prescribe you a controller inhaler as well as a rescue inhaler. Controller or maintenance inhalers like Symbicort, Advair, and Flovent are used regularly to decrease the inflammation and swelling in the lungs associated with asthma. Rescue inhalers, on the other hand, are used to open your airways immediately when you’re having an asthma attack. These include Proair, Proventil, and Ventolin.
Using your maintenance inhaler regularly can help lessen the frequency and severity of asthma attacks—but many people aren’t using their maintenance inhalers correctly.
To help keep more people on track, a company called Adherium has recently received FDA clearance for their SmartTouch sensor. The sensor will only be used with AstraZeneca’s Symbicort inhaler for now.
What is SmartTouch?
SmartTouch is a device installed onto a an inhaler that will monitor and encourage adherence (taking your prescription as intended) as part of a self-management plan.
What is it meant to do?
According to the press release from Adherium, it’s common for patients with respiratory conditions, like asthma, to take only 30 – 50% of their prescribed medications! And believe it or not, they aren’t alone. The World Health Organization (WHO) notes that on average, 50% of folks suffering from chronic illnesses do not take their medications as prescribed. What’s the downside? It can be outright dangerous, with consequences including (obviously) your condition getting worse, but also increased costs, and even death.
How does SmartTouch work?
The SmartTouch device records the date and time the inhaler is used and automatically sends the info to an app on your phone or tablet.
It stores the history of your usage patterns, which also lets your doctor review the information and help make evidence-based decisions on how to best to meet your needs.
How is the device used?
SmartTouch is placed over the Symbicort inhaler—it’s designed to make installation and removal easy for everyone.
The SmartTouch design includes three buttons that help you easily access the audio-visual reminders, battery monitoring, and bluetooth pairing features.
How will SmartTouch help me?
According to Adherium, the SmartTouch can improve adherence by up to 59% in adults and 180% in children. That increased adherence was also associated with a 60% decrease in severe respiratory episodes in adults.
Is there already anything like SmartTouch out there already?
There are a couple of similar devices made by other companies, including CareTRx (previously known as GeckoCap, and recently purchased by TEVA pharmaceuticals) and Propeller Health (partnered with Boehringer Ingelheim).
Adherium also makes two otherdevices for inhalers (SmartTurbo and SmartTouch AV), but neither have been approved by the FDA for use in the US yet.
These price increases, among others, have shed necessary light on price hiking and transparency, and have caused many states to take this matter into their own hands. At the moment, 23 states are stepping up their efforts on drug pricing by proposing bills that take on the rising cost of drug pricing.
What is drug pricing transparency?
First off, it’s great for your pocketbook. Drug pricing transparency would require pharmaceutical companies and middlemen (like pharmacy benefit managers) to be less secretive about the actual costs of their medications.
Who would benefit?
Essentially everyone, minus those with a hidden agenda. Providing drug pricing will ensure affordable and accessible prescription drugs for consumers.
What’s going on in California?
Exciting things! Governor Jerry Brown just signed the SB-17 drug transparency bill. This bill requires that pharmaceutical companies give the state of California 60 days notice anytime they plan to raise the price of a drug by 16% or more over 2 years. The companies would also have to explain why the increases are necessary. In addition, health insurers would have to report what percentage of premium increases are caused by drug spending.
California also has another bill, AB-265, which would prohibit drug companies from offering coupons and other discounts to brand-name drugs that have an alternative cheaper generic available. This bill has yet to get to the governor but has passed in the Senate.
Vermont passed a bill in 2016 that requires pharmaceutical companies to provide justification for drug price hikes.
Each year the Green Mountain Care Board in collaboration with the Department of Vermont Health Access identifies drugs that have experienced price hikes by 50% or more over the past five years, or by 15% more over the past 12 months. For drugs that have experienced increases, the state can fine the pharmaceutical companies.
What about Nevada?
In June, Nevada passed a bill that focuses solely on the cost of diabetes medications. However, it is currently facing lawsuits from pharmaceutical lobbying groups, as they claim that it is unconstitutional and possibly violates patient rights. More to come on this!
What’s going on with the bill in Ohio?
The Ohio Drug Price Act is an initiative that aims to cut pricing. Or does it?
This act would mandate that the state agencies pay no more for prescription drugs than the U.S Department of Veterans Affairs, which typically gets a 24% discount on the price of drugs from pharmaceutical companies.
However, this bill does not apply to those with private health insurance; therefore, if passed Ohioans insured through their employers could actually see drug prices go up in order for the drug companies to regain the money lost from selling to certain buyers at a lower rate. A similar bill in California flopped just last year!
It seems like more bills are being proposed every day. Stay tuned, we will keep you in the loop.
Nasal polyps are common in people with allergies and asthma. Treatment has included nasal sprays and oral medications, and now we have a new one to add to the list, Xhance (fluticasone propionate).
What is Xhance indicated for?
Xhance is a corticosteroid indicated for the treatment of nasal polyps in patients 18 years of age or older. It will be available as a nasal spray in the strength of 93 mcg.
The recommended dose of Xhance is one or two sprays per nostril twice daily. The Xhance delivery system is called the Optinose delivery system. It works to help deliver Xhance deep into the nasal cavity. Be sure to read the instructions before using the delivery system.
Who is at risk for nasal polyps?
Any condition that causes chronic inflammation in the nasal passages or sinus area may increase your risk of developing nasal polyps. The following conditions can put you at a higher risk for nasal polyps: asthma, aspirin sensitivity, allergic fungal sinusitis, cystic fibrosis and Churg-Strauss syndrome.
What are the common side effects associated with Xhance?
Common side effects include nosebleeds, nasal septal ulceration, nasopharyngitis, nasal mucosal erythema, nasal mucosal ulcerations, nasal congestion, acute sinusitis, nasal septal erythema, headache, and pharyngitis. Be sure to speak with your doctor if you experience any of these symptoms for a prolonged period of time.
- The strength of Xhance is 93 mcg per spray whereas the strength of Flonase is 50 mcg per spray.
- Xhance is indicated for the treatment of nasal polyps whereas Flonase is indicated for the management of allergy symptoms.
- Xhance requires a prescription whereas Flonase can now be purchased over-the-counter without a doctor’s prescription.
- Flonase is available in a generic version, as fluticasone propionate, whereas Xhance is only available as a brand name medication.
On September 21st, the FDA issued a drug safety communication for Ocaliva (obeticholic acid), a medication used to treat primary biliary cholangitis (PBC).
The FDA warns that using Ocaliva can cause serious liver injury and even death when improperly dosed. The FDA has reviewed the 19 cases of death potentially caused by Ocaliva, and determined that in several cases patients with moderate to severe liver disease were receiving too high of a dose. This can result in an increased risk of serious liver injury or death.
What is Ocaliva indicated for?
Ocaliva is indicated in adults for the treatment of primary biliary cholangitis (PBC) with or without ursodeoxycholic acid.
Primary biliary cholangitis (PBC) is a rare liver disease in which your body begins to attack itself and destroy the bile ducts in the liver, leading to liver damage or eventual cirrhosis.
What are the signs and symptoms of associated with liver function?
If you or someone you know is taking Ocaliva, be sure to seek medical attention for the following signs and symptoms:
- New or worsening tiredness
- Weight loss
- Stomach pain
- Decreased appetite
- Nausea and vomiting
- change in behavior or confusion
- Anxiety or unease
- Stomach swelling
- Yellowing of the eyes or skin
- Bloody stool
What is being done to warn people about these serious side effects?
The FDA is reminding healthcare providers to determine patients’ baseline liver function before starting a patient on Ocaliva.
What does the FDA recommend prescribers do?
The FDA recommends the following:
- Patients with moderate to severe liver impairment should be started on the approved dosing schedule of 5 mg once weekly, rather than the 5 mg daily dose.
- Healthcare professionals should monitor patients frequently for disease progression, and reduce the dosing frequency for patients who progress to moderate or severe liver impairment.
- All patients treated with Ocaliva should be monitored frequently for liver injury (e.g. worsened liver blood tests and adverse liver-related reactions).
- If liver injury is suspected, discontinue Ocaliva.
- After the patient has stabilized, weigh the benefits against the risks when deciding whether to re-initiate treatment. Educate patients about the symptoms of potential liver injury.