In the summer of 2016, local and national media highlighted the problems with the current lack of drug pricing transparency with Mylan’s EpiPen® auto-injector prices rising hundreds of dollars. Epinephrine is the generic drug name for the brand EpiPen® and would deliver the same life-saving drug needed in case of a severe allergic reaction.
As a result of this controversy, Representative Derek Merrin joined over 240 pharmacy students, faculty members, and pharmacist volunteers to announce the introduction of new legislation under House Bill 101, which aims to improve access to epinephrine auto-injectors.
First off, HB 101 would allow pharmacists to substitute generic epinephrine auto-injectors for prescriptions written for brand EpiPen® as long as the patient agreed to this substitution. This change would prevent the current hurdles of having to contact the doctor to replace the prescription to the generic alternative since they are not considered substitutable under current law.
The second part of HB 101 would allow pharmacists to dispense epinephrine auto-injectors to those 18 years and older under a physician-approved protocol without requiring a prescription. This protocol process outlines the specific requirements that must be met for pharmacists to be able to dispense epinephrine auto-injectors without a prescription. This type of protocol process is currently available for naloxone for the reversal of opioid overdose. It is also available for all CDC-recommended vaccines so that pharmacists are equipped to fill gaps in care within the community.
With HB 101, hopefully more patients will have access to this vital medication in cases of severe allergic reactions while also facilitating better competition within the epinephrine auto-injector marketplace.
In President Trump’s first speech to Congress, he criticized the Food and Drug Administration for having a “slow and burdensome” approval process. He gave an example of how this slow approval process had prevented a young woman with a rare genetic disease from receiving optimal treatment. He stated that he would “slash the restraints, not just at the FDA, but across the government.”
To provide some background on the drug approval process, there are multiple steps in place to ensure drugs meet necessary safety and efficacy measures. The timeline for approval starts with pre-clinical trials to determine appropriate dosing and toxicity before testing in humans. Appropriate applications and approvals of study designs/protocols are needed before initiating clinical trials in humans, which are performed to confirm proper safety and efficacy with increasing numbers of human subjects with each phase. This entire process could potentially take several years, with some instances taking up to 15 years.
Over recent years, the FDA actually showed improved and faster approvals. According to FDA figures, the median review time for approvals was 10.1 months in 2016. This is a marked improvement from 27 months in 1993. The agency even has expedited the approval process for drugs that are meeting an unmet medical need or show exceptional promise. President Trump seems to be misguided on his belief about the slowness of the approvals, as many current agency officials state that they are actually getting criticized for pushing prescription products through too quickly.
One view that seems to capture the true issue today is from Vinay Prasad, an oncologist and assistant professor of medicine at the Oregon Health and Sciences University. He states, “Republicans are obsessed with the idea that the FDA is a barrier to wonderful drugs reaching the market, but that isn’t true; the barrier is that making wonderful drugs is scientifically difficult.”
For example, some cancer drugs that have faster approvals may only improve survival by a few months while costing the patient thousands of dollars. Also, some products that are just as expensive may not even improve survival, but just add to improved quality of life. The patient may be suffering from a terminal illness, but the benefits of some of these drugs may not outweigh the costs.
This topic highlights current unrealistic expectations that a drug is the answer to everything and that we have unlimited resources to pay for these drugs. This complex issue seems to require an alternative approach in place of loosening FDA regulations.
To find out more, keep up to date with the FDA on Facebook HERE.
There’s an elephant in the room. This elephant is killing humans and eliciting fear on a massive scale. The only way to get rid of this elephant is to talk about it.
The “elephant” I’m referring to is the opioid and heroin abuse problem. This abuse situation is plaguing every part of America, especially here in Ohio.
I’ll give you a fact: heroin kills at least twenty-three Ohioans every week. That number translates to one out of every five Ohio residents knowing someone who is struggling with heroin.
We have a huge problem on our hands.
It would help to understand how this problem happened with a bit of a heroin history lesson. It’s fair to say that heroin has always been an issue, but it has grown over the past decade. Heroin is derived from the opium that is extracted from the poppy plant (papiver somniferum). Heroin was first manufactured in 1898 by Bayer for treatment of tuberculosis and morphine addiction. It was discovered that using heroin to fix addiction problems created a new problem that hasn’t stopped for over one hundred years.
The reason heroin was thought to be used for morphine addiction is that heroin is chemically similar to other opiates used for pain. That means heroin has the same overall action as opioids, but a different intensity of the action, also called potency. Heroin is about 4-5 times more potent than morphine, which is why people use it to get high. The feeling of the high from heroin creates a euphoric state that eliminates sensations, such as pain. The more heroin you consume, the stronger the high and the less pain you feel.
The concerning issue of using too much heroin comes from the other effects heroin can have on the body. Remember how I said heroin reduces sensations? Another sensation your body loses is the “sense” to breathe when you are low on oxygen. This is where overdose causes death.
We’ve seen an increase in overdoses over the past few years. In 2015, there were just under 14,000 deaths from heroin overdose. That’s twice as many deaths compared to cocaine. This is a growing problem and hasn’t shown any signs of slowing down. This is where you can step in. Law makers have been combatting the issue along with first responders and officers trying to keep people safe. But waiting for a paramedic or other first responder to arrive on the scene takes time–and in overdose situations, we don’t have the liberty of letting time slip by.
There are two things you, with little or no background in medicine, can do right now to save a life.
- Recognize the signs and symptoms of an overdose: I hope you never have to come across someone who has overdosed on heroin. But if you do, I want you to act appropriately to save someone’s life. The first step is knowing if someone could have overdosed. Since opioids and heroin are related, they share the same signs and symptoms of an overdose. You can follow the rules below if you suspect someone has overdosed on heroin or any opioid.
- Use the antidote, naloxone: There is a medication that can correct an overdose to heroin. That medication is called naloxone (brand name Narcan). Naloxone is an opioid antagoinist, meaning it tries to kick heroin off of the receptors in the brain where it binds and reverse the overdose. While this is great, it is a short lived action. The heroin can come back in and re-bind to the receptors and cause symptoms of the overdose again. The purpose of naloxone is to buy time for the paramedics to reach the scene and take over. Any time spared can save a life.
I stated you should use the antidote, because naloxone can be purchased without a prescription from a pharmacy. This was recently allowed by new laws in the hopes that lives could be saved. An entire list of every pharmacy that sells naloxone can be found at this link.
Likewise, to find information about overdoses and how to use naloxone, please refer to Project DAWN (Deaths Avoided With Naloxone) for various resources.
We live in a time that is plagued with bad news. Whether it is politics, foreign affairs, or events close to home, life recently hasn’t been fun. Let’s do our part to bring good news–“another life saved from heroin.”
- Reichle C, Smith G, Gravenstein J, Macris S, Beecher H. COMPARATIVE ANALGESIC POTENCY OF HEROIN AND MORPHINE IN POSTOPERATIVE PATIENTS. Jpetaspetjournalsorg. 2017. Available at: http://jpet.aspetjournals.org/content/136/1/43.short. Accessed February 26, 2017.
- Watch Truth About Drugs Documentary Video & Learn About Substance Addiction. Get The Facts About Painkillers, Marijuana, Cocaine, Meth & Other Illegal Drugs. Foundation for a Drug-Free World. 2017. Available at: http://www.drugfreeworld.org/drugfacts/heroin.html. Accessed February 26, 2017.
- Overdose Death Rates. Drugabusegov. 2017. Available at: https://www.drugabuse.gov/related-topics/trends-statistics/overdose-death-rates. Accessed February 26
It is that time of year again. Time to enjoy a fish meal each Friday during Lent. Once again Saint Joseph’s Catholic Church and the local Knights of Columbus will be holding their Friday Fish Fries every Friday through April 7. The Fish Fries will be held at the Parish Activity Center (the PAC), 670 West Main Street (behind the firehouse) from 5:30-8 pm.
Meals are $8 for adults, $7 for seniors, $6 for children 12 and under. Besides either two pieces of fried or baked fish (please request the baked fish if you would like it), the adult meal also includes soda or coffee, and two sides–cole slaw, fries, or macaroni and cheese. The child meal includes one piece of fish, two sides, and a beverage. Additionally, you can purchase homemade desserts for a donation that benefits the St. Martin de Porres Society.
Carry out service of the meals is also available.
The St. Joe’s Fish Fry was voted “The Best Fish Fry 2017” by the Catholic Times Fish Fry Guy! Scroll down to pages 17/23 to read the review, which also mentions Lovejoy’s Market! You can also read the review at the bottom of this posting.
So please come out this Friday, March 3, and support the Knights of Columbus. Join them each Friday (March 10, 17, 24, 31 and April 7) throughout Lent (excluding Good Friday on April 14) for a delicious meal and lots of enjoyable socializing with neighbors, friends, and family.
For a complete Lenten Fish Fry Guide that lists churches throughout Ohio hosting fish fries, go HERE.
Meet Our March Student Pharmacist, Deanna Clause, From The Ohio State University’s College of Pharmacy.
This month, we are joined in the pharmacy and lab by Deanna Clause, a fourth year pharmacy student from The Ohio State University’s College of Pharmacy. Deanna will graduate in May and will then take the test to become a registered pharmacist. Deanna will be with us throughout March, so please stop by and meet her while she is here. Show her the Plain City hospitality!
Here is what Deanna has to say about herself:
I am a fourth-year pharmacy student from The Ohio State University College of Pharmacy. Most of my pharmacy experience has been within community pharmacy, but I have gained varied experiences with rotations at the Cleveland Clinic, free clinics around the Columbus area, and within other hospital systems. I look forward to completing one of my last rotations at Plain City Druggist before I graduate in May.
Whenever I have any free time away from rotations and work, I enjoy spending time with family and friends or visiting my fiancé in Cleveland. I love to spend time outside within the Cleveland Metro Parks or try new restaurants in the Cleveland area.
I also enjoy traveling whenever possible. One of my favorite travel destinations is an annual family trip. My family and I travel to Anna Maria Island, Florida every year to meet with family from all around the country.
I am in the process of applying for a residency that has an ambulatory care focus this upcoming year to transition into my first year as a pharmacist. This is an expanding area in pharmacy with growing opportunities for pharmacists to fill gaps in care. I am hoping to expand upon interests in teaching, geriatrics, and oncology upon completion of a residency and am excited about my future career in pharmacy.