Concerta, Methylphenidate ER formulations, Shortages and Formularies

The popular ADHD medicine, Concerta, has been subject of a lot of debate in the past couple of years, and that is continuing into 2015.

This is from a Canadian blogger, but I love the picture showing the difference inside.

Problem #1: Generics vs Concerta

It started when companies started making generic formulations that had a different delivery system.  (If you haven't heard of the issue, you need to read this before reading further for it to make any sense.)

The FDA said that the non-OROS formulations are not acceptable substitutions in November 2014.

Even the same active ingredient in a different delivery system could cause a problem with a child who is doing well on one type of delivery system who gets a different type the following month. The drug releases into the body at a different rate, so the drug is distributed differently throughout the day. This can be insignificant for some people, but can cause significant issues in others. I have heard that some children's medicine wears off much earlier (before the end of the school day) and much faster (leading to emotional and behavioral problems) with different delivery systems.

It is important that whatever delivery system a child does well on continues to be used. They are not interchangeable. Talk with your pharmacist every time you fill the prescription to be sure it is the same manufacturer, or in the case of Concerta, one of the manufacturers that makes the name brand or authorized generic.

Problem #2: Shortages

Since pharmacists can no longer use two of the three brands of generics to fill Concerta prescriptions, there is now a nationwide shortage of Concerta and the one generic that uses the OROS technology. The shortages are expected to last through the second quarter of 2015.

Problem #3: Formularies

To top it off, many insurance companies dropped Concerta and the authorized generic from their 2015 formularies. This means that if you buy the OROS methylphenidate medicine, it is not covered at all by insurance. You must pay cash and it does not count toward your deductible. This makes it out of reach for many most families. I am happy to see that some companies are adding it back to their formularies already -- I suspect there have been a lot of complaints. If it is not on your formulary and it is the medicine that works best for your family member, start complaining.

You will most likely need to try another medicine - or several other medicines - to make a good argument. If a formulary medicine also works, simply use it instead. Save yourself the trouble of going through the hoops to get the OROS methylphenidate. It is only if there is not a well tolerated and effective other option that you should fight for the OROS methylphenidate.

How do you fight the fight? Talk to your HR representative who deals with the insurance company. Call your insurance company directly. Send them e-mails and snail mail. Ask your physician to write a letter on your behalf. State why your family member needs the OROS technology. Give examples of how it works better than the other extended release methylphenidates and why the amphetamine class of medication failed. People were able to get the FDA to look into the issue and they agreed that there are significant differences, so insurance companies cannot pretend that it is an equal substitution.

Finding the right medicine

Due to the formulary changes and the shortage of OROS methylphenidate, I have heard that pharmacists are telling patients that they cannot fill a prescription because it cannot say "Concerta" and that they doctor must re-write the prescription as "methylphenidate ER" for them to be able to fill it. This means that they will fill it with the non-authorized generic formulation. If your child has done well on a non-OROS medicine in the past, great! If not, you must find out if it is a formulary issue or if the pharmacy is out of stock of one of the brands, since the remedy is different for different issues.

You will need to check on your formulary, usually available on your insurance company website, for the amount in milligrams that is allowable. It might be that another generic formulation of methylphenidate, not one for Concerta, is on formulary. Concerta comes in very odd sizes (18mg, 27mg, 36 mg, 54mg) and most others come in multiples of 5s or 10s. So if your formulary has only methylphenidates in multiples of 5s or 10s, you know that your child will not be getting the OROS formulation. It is more tricky if the odd sizes are available on the formulary, because unless the prescription says "Concerta", the pharmacist can pick which one to use.  All the pills with the OROS technology say "ALZA" on the pill. Look at the pills before finalizing the purchase and keep your child's medicine the same from month to month unless there are problems on it.

If a prescription is written "methylphenidate ER __ mg" instead of "Concerta __ mg" a pharmacist can fill with any of the long acting methylphenidate medicines that are the same strength, regardless of it is is OROS technology or another form of long acting medicine. The problem is that the same strength of the same active ingredient does not become usable at the same rate due to the delivery system of the pill, so try to keep your child on the same brand if he does well on it. If he doesn't do well on it, it might be better to simply try a different brand with a different delivery system, if allowable by your insurance and available at the pharmacy.

Since the prescription can no longer say "Concerta" if you want to try the other formulation, it might take a few trips between the doctor's office and the pharmacy to find a prescription to match the medicine available at the pharmacy that is covered on your formulary. Each might require a prior authorization before being able to finalize the purchase, so anticipate a few days to weeks before you will be able to take home the medicine.

It will be difficult to deal with drug shortages once the formulary issue is resolved. If your insurance allows 90 day prescriptions, this might be a good option once the dose is optimized. (This is not a good option for the first few months of a new medicine because dose changes might be needed.) Be sure to fill a new prescription as soon as possible to give time for the pharmacy to order in the drug if needed and to have any required prior authorizations completed by your doctor.

Take a deep breath. Slowly exhale. This will all pass in time, but it will be a rocky road for a bit.

Going to a new place for convenience

My family likes to go to Primary Restaurant for great food. We know the food is high quality and the chef takes special care to make everything just right with healthy ingredients. The staff gives great service, always making sure we have what we need. Because there's always room for improvement, they encourage quality development and the restaurant staff works to make things right to the best of their ability if a problem is identified.

Image source: Wikipedia

But one night we decided to go to Convenience Cooks. We were hungry and Convenience Cooks was on the way home. Were we starving to death? No. We had food at home we could have eaten, but Convenience Cooks was, well... convenient. Their menu was limited compared to what we are used to, but we were able to order something that was decent. While we were waiting, I decided to call Primary Restaurant to see if it was a good choice or if we should leave and go to their restaurant. They said since I made the choice and was already waiting, I should just stay at Convenience Cooks. The food wasn't the quality we were used to, but we ate it. I had second thoughts at the end of the meal, so I called the Primary Restaurant to see what they thought. The staff who is usually so helpful wasn't of any use helping me decide if what we ate was good for us or not. Since none of us felt satisfied and left still hungry, I feel like Primary Restaurant should deliver food to our home, but they refused. They said we should go to Primary Restaurant to eat if we want their food. Why? I already paid Convenience Cooks and had most of a meal there. Weeks later I get a bill from Convenience Cooks and am surprised about the cost of convenience, so I call Primary Restaurant to see if it's usual for Convenience Cooks to bill added fees.

In another scenario, you really want a good BBQ. Primary Restaurant specializes in All-American food, but don't offer slow-cooked BBQ, so they refer customers to BBQ-R-Us. But BBQ-R-Us is busy and requires reservations. Since you are used to same day seating at Primary Restaurant, you ask if they can get you preferential seating at BBQ-R-Us. After several phone calls back and forth with staff at each location, you realize you can be put on a waiting list, but no one was able to change your initial reservation. When that time finally comes, you enjoy the ribs, but leave with questions. Instead of asking the BBQ specialists, you call Primary Restaurant to ask if you should have gotten the burnt ends or the ribs. Even later you call Primary Restaurant to complain about the bill you got from BBQ-R-Us. You were surprised that the creamy corn was extra and they charged a seating fee.

Most people can see just how crazy it is for a restaurant to "fix" the problems with quality, cost, or service at another restaurant, yet many (MANY) people want their primary care physician to do just that after trips to convenience urgent cares or after we refer to a specialist. The scenarios above are based on real phone calls about medical care.

Convenience Cooks = Urgent Cares

I'm sure I'm not alone when I get frustrated at the number of calls asking me to give an opinion of treatment received elsewhere, or to fix a problem that wasn't fixed at an urgent care. I am glad that patient families feel so comfortable with my office that you will call to ask for help, but if I am not a part of the evaluation, I can't help.

Many problems seen at urgent cares can wait. I know it's easier to get your child in tonight so they can maybe go to daycare/school tomorrow, but many of these things are viral and just take time. Even if it's strep throat and they start an antibiotic at 8pm, they can't go to school in the morning. If you would have called my office before going to the urgent care (or looked on our website for advice), chances are the issue could have waited until office hours by using some at home treatments to make it through the night. The cost savings of staying out of an emergency room or urgent care can be substantial with many insurance plans. And my office would be available to help answer any questions that arise from that visit. (Note: sometimes when the symptoms change we still need to see a child again, but we are more likely to be able to help over the phone if we were the ones who saw the child than if they were seen anywhere else.)

If your child was having an issue that did need to be seen ASAP after our office hours, we would have referred you to an urgent care that has quality pediatric providers we trust and sends us a written report of what happened. Even with that, sometimes we need to see a patient on follow up to ascertain if a treatment plan is working or if it needs to be changed.

If you call us because your child is having an allergic reaction to a medicine someone else prescribed, we will tell you to call the place that prescribed the medicine. We cannot manage what someone else prescribed. Often we hear that "they're not open yet" or "they don't do phone calls, they want us to come back." Sorry. We will want to see your child before we treat him for this issue.

BBQ-R-Us = Subspecialist Referrals

As for specialist referrals, I know it's hard for people to wait for appointments, but I really can't get people in any quicker than a schedule allows. If it is a real emergent or urgent need, I can talk to the doctor to see options, such as admitting to the hospital so they can be consulted, or having someone go to the ER, where they might stop by to see the patient. But usually it isn't really that urgent from a medical standpoint, and waiting for the appointment is just what happens in the specialist world. I'm not saying that's a good thing, it's simply reality. Please don't beg me to call them to get you in sooner. I cannot invent time and I can't alter their schedule. Despite what the scheduler tells you, if the primary care doctor calls the specialist, the specialist rarely can get the appointment changed. I've done this frustrating scenario many times-- often when I really want the child seen sooner than scheduled. Unfortunately, it usually doesn't significantly alter the appointment time.

After your appointment I cannot tell you if the treatment plan they propose is the best for your child. Once I refer, it is usually because it is out of my knowledge base and needs specialist care. I can learn along with patients, but I rely on the specialist to know the latest and greatest in their field and they can give better advice than I can. I also don't like to "step on toes" if I refer. If they are driving the bus, they need to drive. Back seat drivers can cause problems on the road.

Expect higher fees any time you use a hospital based facility, whether it's for an office visit, a lab, or a procedure. They not only have charges for the physician's time, but they have facility fees to cover the costs of running the hospital. Of course the primary care physician cannot affect the charges incurred at any other clinic or hospital. We recommend researching costs prior to care, but we know that this is very difficult unless you know exactly what will be done at every visit. We cannot tell you what another physician will do... I can't even predict what I will do at a visit if you call me ahead of time. If your child has a fever and cough, I might send you home with at home treatment instructions without any expensive tests if the exam supports that. I might order labs or a CXR, prescribe a medicine, or admit your child to the hospital for treatment if the findings support that. It is hard to anticipate costs, and that is a problem with our healthcare system. I know that, but it is not in my control to fix that. We try to help by keeping a list of all our most common charges in the parent book in each exam room, but that doesn't help plan before the visit. I understand how that's frustrating, but I can only help with what is in my control. I cannot control how our billing and insurance system works and another office's charges are in no way under my control.

Dry Skin Tips

With the cold temperatures we've already seen this season, our skin is really taking a hit. Dry skin is often called eczema or atopic dermatitis. Whatever you call it, it's itchy and annoying!

It is really important to keep skin well hydrated or it tends to snowball. The dry skin is broken skin, which allows water to escape, which further dries it, which leads to more evaporation.... Broken skin is more likely to become secondarily infected, which leads to more problems....

Itching dry skin also contributes to its worsening by further damaging the skin and allowing more water to evaporate, so try to keep fingers from scratching! (I know this is easier said than done.)

Eczema is not simply dry skin. It can cause significant distress to infants and children. It can impair sleep. It can distract from learning at school. Children with eczema have higher rates of anxiety and depression.

Eczema doesn't simply go away with good treatment: it can come and go even with the best treatment. It can therefore be a serious problem for families.

Your goal with dry skin is to hydrate it as much as possible to repair the skin barrier. We don't always think about skin as an organ (like the heart and liver), but it is. Its functions are to help keep us at a normal temperature, to keep stuff (such as bones, blood, and nerves) inside our bodies, and it helps to keep some things (such as germs) out of our bodies. When skin is excessively dry, there is inflammation and cracking. This keeps the skin from doing its job. We must try to get it back to normal so it can help keep the rest of our body healthy.

Eczema can be from many factors.

• There is a genetic component, so if a parent or sibling has eczema, it is common for other family members to have it. 
• It is often worsened by environment, both cold dry air and excessive heat. 
• Clothing can irritate some skin, depending on the fabric and the detergent left in the fibers. 
• Any scented lotions or soaps can also irritate skin. (Don't be fooled that "baby" soaps and lotions are better for baby. I usually say to avoid any of the baby products because they are often scented. They make them to sell them, not to be better for baby's skin!)
• Allergies can exacerbate eczema.
• Saliva is very harsh on the skin. Drooling can cause problems around the mouth, chin, and chest. Thumb or finger suckers often have red, thick scaly areas on the preferred finger from the drying effects of saliva.

New eczema guidelines recently released downplay the need to alter foods to treat the skin. There are some kids who have true food allergies that manifest as atopic dermatitis (dry skin), but the large majority of kids do not. Restricting their diet can lead to nutritional deficiencies without any benefit. Talk to you doctor (and be sure they have read the newest on the topic) if you think a food might be exacerbating your child's dry skin.

My best tips for treating dry skin:

• Avoid exposures to soaps because they further damage skin. Non-soap cleansers that are fragrance free are much more mild on the skin.
• Soaking in bath water or in the shower can help hydrate the skin. After bathing the skin should be only briefly dried (remove large water droplets, but allow the skin to still be moist with water) and moisturizers (with or without steroids) must be applied immediately afterwards to prevent water from evaporating out of skin.
• Moisturizers should be hypoallergenic, fragrance free, and dye free. A good place to review if a product is good is on the National Eczema Association website. I really like the moisturizers with ceramide. This has been shown to help heal the skin barrier without steroids. Use moisturizers at least twice per day, more often as needed on the really dry spots.
• After the moisturizer soaks into the skin, cover extremely dry spots with petrolatum jelly. 
• Steroids can be used for flares. Steroids are available in 7 different strength categories. The stronger the steroid, the less often it should be used. Over the counter hydrocortisone is a very mild steroid and can be used twice a day with mild flares. Stronger (prescription) steroids should be discussed with your doctor if the eczema is more severe, but they can be safe and effective when used appropriately.
• Bleach baths have been shown to help in moderate to severe eczema. Add 2 ounces of bleach to the bath water and soak the body (not the face) for 20 minutes a few times a week.
• Oral antihistamines, such as zyrtec, allegra, or claritin (or any of their generics) can help control the itch. I recommend the long acting antihistamines over the short acting ones, especially overnight, to avoid gaps in dosing leading to the itch/scratch cycle. Avoid topical antihistamines due to variable absorption from disrupted skin.
• Add water to the air during the dry months. If your air conditioner is running you shouldn't need (or want) to add humidity. If your heat is on, you might have an attached humidifier, which is great. You can also buy a room humidifier or vaporizer to add water to the air. When there's more water in the air, the skin will have less evaporation.
• Use wet water cloths on dry patches. This can help get a child through an itchy time with a cool compress. It also helps hydrate the skin. Since it might remove the moisturizer, re-apply moisturizer when the wet cloth is removed. Some kids benefit from wet wraps (see link). This is time intensive, but very effective, so worth trying for more severe eczema patches. 
• If your child just can't stop itching, be sure nails are clipped to help avoid scratching. Sleeping with socks or mittens helps the inadvertent scratching during sleep. Many kids remove these, so sewing an old pair of socks onto the arms of long sleeve PJs can help. (Don't forget to put moisturizer on first!)
• If your child drools or sucks a finger, wipe the saliva off regularly and protect the skin with petrolatum jelly.

At times prescription medicines are needed. These can include steroids, immune modulators, and antibiotics. If your doctor recommends them, don't be afraid to use them. Many parents under utilize medical treatments out of fear of side effects. Yes, there are risks to all medicines, but there are also risks to having eczema untreated. Discuss fears with your doctor to come up with a good plan that you both agree with. Don't just not use the prescriptions.

Get control of your child's eczema. If you can't seem to do it alone, schedule an appointment with your pediatrician to see what else can be done.

For more information, see the American Academy of Pediatrics clinical report on eczema management and the American Academy of Dermatology's Guidelines.