The classification for medications that contain hydrocodone (like Vicodin) is changing from schedule III to schedule II in an effort to help combat prescription drug abuse.
When does this change take effect?
The change will take effect approximately 45 days from the date of publication of the DEA ruling. You can find more information and the final ruling from the Department of Justice Drug Enforcement Agency (DEA) here.
What is a schedule II substance?
According to the Drug Enforcement Agency (DEA), schedule II substances are drugs that have a high potential for abuse which may lead to severe psychological or physical dependence.
Check out more information on the various drug schedules here.
What are some examples of other schedule II narcotics?
What are some examples of medications containing hydrocodone that this change will affect?
These medications contain hydrocodone and will be affected by this new ruling:
Will this change effect how doctors write prescriptions for these medications?
Yes. The new schedule may affect current as well as future prescriptions.
The first change will be refills. Because these hydrocodone-containing medications will now be schedule II, they will no longer be able to be refilled. Currently these medications are allowed to have 5 refills (or 6 fills total).
The second change that may affect you is pharmacy support. When you run out of refills on one of your maintenance prescriptions, as a courtesy, your pharmacist will call your doctor to try and obtain a new prescription for you. Unfortunately, because these hydrocodone-containing medications are going from a schedule III to a schedule II classification, your pharmacist is no longer permitted to call your doctor for refills of this medication.
The third change will be prescription access. Your doctor will no longer be allowed to call or fax prescriptions for hydrocodone-containing medications to your pharmacy. Now, you, the patient, must take a brand new prescription into the pharmacy yourself each time you fill.
During pregnancy, women try to consider not only their own well-being, but the welfare of their developing child. It is crucial to take into account what you are putting into your body during your pregnancy—and after, for those who decide to breast feed. Medications are no exception.
In 2015, FDA published a final rule setting standards for how information about the risks using medications during pregnancy and breast-feeding is presented in the labeling of all prescription drug products.
What were the old classifications of risk, and what do they mean?
The lettered categories for the risk associated with using a medication while pregnant were designated by the U.S. Department of Health and Human Services. Here’s a break down of the categories, what they mean, and examples of medications in each category:
- Category A. Adequate and well-controlled studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters). Example: prenatal vitamins
- Category B. Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women. Example: Tylenol (acetaminophen), Claritin (loratadine)
- Category C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. Example: Sudafed (pseudoephedrine)
- Category D. There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. Example: tetracycline, aspirin
- Category X. Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits. Example: Coumadin (warfarin), Accutane (isotretinoin)
Why did the change taking place?
The new labeling for pregnancy and lactation is meant to help healthcare providers make informed decisions about the benefits and risks of the medications they prescribe.
It will also make it easier to educate yourself and make responsible decisions for yourself and your children.
What is the new labeling like?
The old letter categories have been be replaced by three detailed sections describing the potential risks:
- Females and Males of Reproductive Potential
Both the pregnancy and lactation sections will be broken down even further into:
- Risk summary
- Clinical considerations
When will the new standards start being used?
The new standards went into effect on June 30, 2015.
Will this change how over-the-counter (OTC) medications are labeled?
No. OTC medications are not affected by the FDA ruling.
Want to find out more?
For more information on the Pregnancy and Lactation Labeling Final Rule from the FDA click here.
It’s now one of the 10 most prescribed drugs in the United States. Lyrica (pregabalin) is a medication that is chemically and structurally similar to Neurontin (gabapentin) and is used for a wide variety of things: seizure disorder, pain and anxiety. So what is this Lyrica you hear so much about?
Pain. Real tooth-achy nerve pain. Lyrica is approved for the treatment of neuropathic pain. Nerve pain is burning, sharp, stabbing and numbing pain. Lyrica is helpful for folks with diabetic neuropathy (pain in your feet from diabetes), postherpetic neuralgia (your shingles sores have gone away but the pain persists), and pain after spinal cord injury. With neuropathic pain, start Lyrica 50 mg three times a day and you can increase to 300 mg a day. There is no benefit to going any higher and the side effects are worse.
Fibromyalgia. Lyrica is FDA approved for use in fibromyalgia but here is what you need to know. For fibro first start with an exercise, stretching and strengthening program before going to medications. No medications work great for fibromyalgia so start with good sleep hygiene, and treating other issues that may contribute to symptoms, including mood or sleep disorders. Then, if you can’t tolerate amitriptyline or have sleep disturbance with your fibro, Lyrica 75 mg twice a day, increasing to 150 mg twice a day may help. Know that any higher than that doesn’t work any better and just has more side effects.
Downsides. Higher doses of Lyrica mean more side effects. The most common side effects with Lyrica are dizziness (8 – 45%) and drowsiness (4 – 35.7%). Again, these side effects are worse at higher doses.
Money. Lyrica is a brand name drug with no generic option so it may be expensive for you. It comes only as a capsule so you can’t split it in half but know that the 75 mg, 150 mg, and 300 mg capsules are roughly the same price.
For many Americans with health insurance, more than 40 popular brand-name drugs may no longer be covered starting in January 2015. Express Scripts and Caremark, companies that handle pharmacy benefits for more than 200 million Americans, are removing over 40 drugs from their formularies at the end of 2014. This is in addition to the more than 50 drugs removed last year.
What are Express Scripts and Caremark?
Express Scripts and Caremark are companies that administer prescription drug benefits for many health insurance companies and Tricare. While you may have health insurance from Anthem, Aetna or another insurer, your pharmacy benefits are usually handled by these companies or their competitors. They set a national preferred formulary, and also work with employers and health plans to develop more individualized formularies (though it is your benefit provider—your health plan—that ultimately decides which formulary to offer).
What does this change mean for you?
The drugs listed below are, for the most part, brand names for which there may be a less expensive brand or generic alternative available. If your benefits are provided by Express Scripts or Caremark, you will pay the full cash price at the pharmacy for these brands in 2015. (You can see estimated cash prices on GoodRx by clicking on a pharmacy name after you look up a drug.)
If your coverage is changing, talk to your doctor to see if a covered alternative might work for you. If you can’t switch, you may be able to use GoodRx or find patient assistance programs to help cover the cost.
Which drugs are affected?
Under Express Scripts, several arthritis, pain, and testosterone replacement drugs will no longer be covered, along with others for diabetes, acne, and migraine. Some of the most notable drugs that will no longer be covered include: Vimovo and Duexis for arthritis pain; pain med Zohydro ER; diabetes injectable Tanzeum; Axert and Frova for migraine; and several viscosupplement injections for osteoarthritis like Hyalgan and Euflexxa.
Caremark has also made significant changes over the past couple of years, and is adding more exclusions in 2015. There is very little overlap with Express Scripts on the newly excluded drugs, so if you are choosing a new plan based on coverage of a particular medication, you may want to consider reviewing the formularies before deciding.
See the excluded medications below. For a full list of excluded drugs and covered alternatives, see the Express Scripts list here and the Caremark list here. If you’re not sure which company provides your pharmacy benefit, contact your insurance company.
2015 Excluded Drugs
Accu-Chek test strips and kits (Caremark)
All non-OneTouch strips and kits (Caremark)
Adderall XR (Caremark)
Aerospan HFA (Caremark)
Apexicon E (Caremark)
Aranesp (Express Scripts)
Axert (Express Scripts)
Benzaclin gel pump (Express Scripts)
Cetraxal (Express Scripts)
Epogen (Express Scripts)
Fentora (Express Scripts)
Frova (Express Scripts)
Gel-One (Express Scripts)
Hyalgan (Express Scripts)
Incivek (Express Scripts)
Pancreaze (Express Scripts)
Pertyze (Express Scripts)
Proventil HFA (Caremark)
Stendra (Express Scripts)
Subsys (Express Scripts)
Supartz (Express Scripts)
Tanzeum (Express Scripts)
testosterone gel (both)
Ultresa (Express Scripts)
Veltin (Express Scripts)
Zohydro ER (Express Scripts)
An important note about Medicare and individual plans:
These changes DO NOT apply to Medicare plans; if your Medicare benefit is managed by Express Scripts, you should check your coverage with your pharmacist or online through the Medicare.gov portal.
Some individual private insurance plans managed by Express Scripts or Caremark may have different formulary coverage, meaning different drugs may be covered or excluded. Please check with your plan if you have any questions or concerns.
EDIT 9/2/14: For greater accuracy, the final sentence in the second paragraph above has been updated. The previous text read: “They also set the formulary for everyone under their prescription drug benefit.”
Effective Friday, August 15, 2014, Namenda (memantine) 5 mg and 10 mg tablets have been discontinued. According to the manufacturer, Forest Laboratories, the discontinuation is not for safety reasons, but because the company is going to be focusing on their once-daily Namenda XR (memantine) capsules.
Will Namenda oral solution still be available?
Yes. Forest Laboratories will continue to make Namenda 2 mg/ml oral solution along with the XR capsules.
How do I switch from the tablets to the XR capsules?
- If you are currently taking the Namenda 5 mg tablet twice daily your dosage would change to the Namenda XR 14 mg capsule once-daily.
- If you are currently taking the Namenda 10 mg tablet twice daily your dosage would change to the Namenda XR 28 mg capsule once-daily.
Are there any advantages to using the Namenda XR capsules?
Yes. First, Namenda XR capsules are taken once-daily. Once-daily dosing usually means that you are more likely to use the medication.
The second advantage is that the Namenda XR capsules can be opened and sprinkled on applesauce for ease of administration. If you have difficulty swallowing pills these XR capsules would be beneficial.