My COVID-19 journey- Then and Now

It’s been a strange and unnerving year since the coronavirus stormed into our lives.

On March 1, 2020 I started to self-isolate because I have an autoimmune disorder called Sarcoidosis. Since I am immunocompromised, I always panic when an infectious disease makes its rounds.

COVID-19 was a new virus and not much was known about it a year ago.

The entire month of March I came in contact with three people: the pharmacy tech when I picked up my Sarcoidosis medication from CVS on March 18, a friend who delivered groceries to my home, and my husband.

I started developing symptoms around March 21. I was coughing a lot, had a fever, tightness in my chest, body-wide pain, and horrible headaches. I tried to get tested a few days later but I was turned away because I had not traveled outside the country. I was told to continue quarantining at home and just wait it out.

While I was in my own battle with the virus, two of my cousins also had COVID19.

Cousin Sharon died March 27, 2020.

Cousin Barry died March 31, 2020.

I feel a sense of survivors guilt that I survived and they didn’t. I miss them beyond words.

At the beginning of April 2020, I lost my sense of smell and taste, and my fever got worse so I went to the emergency room and was tested there.The results took a week.

April 6, 2020

April 8, 2020

April 9, 2020. Test came back positive

April 11,2020. My husband took care of me. He never developed symptoms.

April 11,2020. Interviewed by WCNC

April 12, 2020. Easter

April 13, 2020. My story went viral all over the world.

April 13, 2020. Thank you message for all the support I received.

April 17,2020. Second thank you message.

April 27, 2020. Quarantine over. Re-tested at Novant. It came back negative.

April 28, 2020. First time outside after recovering from COVID-19.

What I learned while all of this happened is that COVID-19 is not like the flu. It’s worse. Not only that, some people don’t fully recover and become what is called long-haulers.

It has been a year since my journey began with COVID-19. My pulse ox still dips to dangerous levels, I need oxygen on my bad days, and I still have intense headaches and rib pain.

May 22, 2020. Pulse ox was 81.

May 27, 2020. Pulse ox was 77.

Spent my 50th birthday in quarantine.

July 19, 2020. On oxygen due to post-COVID pulmonary fibrosis (scarring in the lungs).

February 8, 2021. One of my bad days.

Since I got COVID-19 a year ago, there have been over three million cases. Five hundred forty nine thousand people have died. It breaks my heart.

 

FDA Dermal Fillers Hearing: Consumer Representative Perspective

Disclaimer: Views in this post are my own and does not represent the views of the FDA.

On March 23, 2021, the Food and Drug Administration held an advisory panel hearing to discuss dermal fillers- Docket No. FDA-2020-N-0008

The purpose of the advisory panel hearing are:

(1) risks associated with intravascular injection of dermal fillers.

(2) patient preference and informed decision making. FDA is convening this meeting to seek expert opinion on the clinical evaluation and regulation of dermal filler products.

The hearing was somewhat complicated because dermal fillers are considered Class 3 medical devices. Class 3 means that it is “life saving” or “life sustaining” and if a patient develops adverse events, they cannot sue the manufacturer.

According to FDA there has been a marked increase in adverse events relating to dermal fillers, particularly vision impairment, blindness, and stroke. The theory is that any filler injected into any part of the face can embolize and migrate to the blood vessels and thought to result in partial or complete interruption of blood flow to the central retinal artery. There could also be inadvertent penetration of the arteries in the face by the needle or cannula. It is for this reason that I recommended to FDA to use image guided injection. I also brought up post monitoring to follow up with the patient to make sure nothing migrated or ended up where it wasn’t supposed to.
Hyaluronidase is used to melt filler that causes adverse reactions but the hyaluronidase is causing even more problems. Hyaluronidase is a medication and the filler and delivery system is considered a device so adverse reactions would be reported to two different post surveillance systems. I advised FDA to streamline those two systems so all information from both will be in the same place. We aren’t using accurate numbers if reports are in two different databases.
There was talk of issuing medical device cards to patients that has the name of the filler, the means of delivering it with the patient’s name, contact info, manufacturer contact information and a list of possible risks. Often patients are not told what they are being injected with so I think it might be helpful to have that.
Also risks should be conveyed both verbally and written with a checklist that the physician and patient both sign off on as having been discussed and read so there is informed consent. The language should be clear and specific so there is no confusion. The majority of patients harmed by dermal fillers report that they were never given clear possibilities of risk.
One thing I must speak out about is that the panel chairman Dr. Frank Lewis ignored me when I raised my hand. I had to message him to tell him it is unacceptable to ignore the consumer representative but allow the physicians on the panel to talk as long as they wanted. This also happened when I was the consumer representative for the breast implant hearing 2 years ago. I pulled him aside during break and told him it’s disrespectful and unacceptable to silence a consumer representative. To his credit, after pulling him aside both times, he did call on me when I wanted to talk. It shouldn’t have to be this way though. All panel members should have an equal seat at the table.
The slides we were given for the hearing can be found here. It is now on public record so I can share these now.

To listen to the hearing in its entirety, click here.

 

 

 

National Adverse Drug Event Awareness: 12 questions to ask your doctor and why you should be asking them

March 24 is National Adverse Drug Event Awareness Day. I wish I didn’t have to know that, but since 2006, I’ve been disabled from adverse reactions from Levaquin- a fluoroquinolone antibiotic. Over 30 tendon ruptures, nerve damage, bone and muscle pain, brain fog, neurodegeneration, autonomic and central nervous system damage. I could go on but we’d be here all day.

I have a unique perspective on adverse drug reactions.

I’m a harmed patient. I also work for the U.S. Department of Health and Human Services. I’m an SGE (Special Government Employee) at the U.S. Food and Drug Administration and I collaborate with the Centers for Disease Control and Prevention. I’m also a team leader and patient safety expert at the American Society of Pharmacovigilance STRIPE Initiative. In addition, I’m a contributor at Drugwatch, Medshadow Foundation, and Health Web Magazine.

The combined experience allows me to help others so that they can make informed decisions about their health. Trust me, what you don’t know can hurt you, and sometimes the treatment is worse than the illness.

“But Rachel, all drugs have side effects”. I get that one a lot. Side effects are things like dry mouth or constipation. Adverse drug events are completely different in that it flips your world upside down and sideways. We’re talking about life-changing, often permanent, health problems that stem from a medication.

In the next few weeks I am going to be writing more content around Adverse Drug Event Awareness Day and this is my jumping off point. Every patient has the right to information regarding their health and well-being in order to make informed decisions. Finding the balance between lack of transparency and wading through vast amounts of information often comes down to asking the right questions.

Had I known that Levaquin was not appropriate for my particular health issue, and had I asked questions, I’d have been able to give informed consent.

The following are 12 questions to ask your doctor when the subject of new medication is introduced. It comes from years of personal experience as well as professional experience being a patient safety advocate. I will also explain why asking these questions are important. Having as much information as possible allows you to paint a complete picture about what you feel is best for you and to determine the risk-benefit ratio.

Questions to Ask If Your Doctor Brings Up a New Medication

  1. Do you mind if I record this conversation with my phone so I can have it to refer to when I do my research?
  • Why is this important?: Recording a conversation means that you won’t have to rely on your memory to recall information during your visit. It also increases the likelihood that there will be more transparency about the risk vs benefit ratio of a new medication.

2. For what condition is this medication prescribed?

  • Why is this important?: Drugs often have more than one use. Understanding why a drug is being prescribed increases your knowledge of the medication and the condition for which is it prescribed.

3. Is it being prescribed off-label? If so, is there another medication specific to my condition?

  • Why is this important?: Prescription drugs are often prescribed for uses other than what the FDA has approved. This is legal, and in fact common. The FDA regulates the approval of a drug, not how it is prescribed. At least one in five outpatient prescriptions are prescribed off label and doctors are not necessarily required to inform a patient that a medication is being prescribed off label. Off label use is not necessarily a bad thing but it is important that a patient is fully aware of what they are taking and for what condition.

4. What are the risks associated with this medication and do the benefits outweigh those risks?

  • Why is this important?: Adverse reactions (ADRs) or adverse events (ADEs) can have a major impact on the health and well-being of patients. It’s something that I found out the hard way. I was never informed of the adverse reactions associated with Levaquin, many of which are permanent. Sometimes, unfortunately, the treatment can be worse than the illness for which it is prescribed. FDA approved does not always mean that a product is safe. Having a complete picture of the risk vs. benefit helps patients make an informed decision about their care and appropriate use of the medication.

5. Is this a new medication? If so, is there an older, more tried-and-true medication available?

  • Why is this important?: Newer doesn’t always mean better. There is no regulation requiring new medications to be better than older medications before they are approved by the FDA. The FDA approves approximately 20-25 new and unique medications annually. Of those, only four or five represent major advances for conditions with no decent treatment choices. The remaining new medications offer only marginal improvements or are combinations of what is already on the market, which are called “me too” drugs.

6. Is this medication necessary to my well being or are there alternative treatments I can try first?

  • Why is this important?: There may be other medications to consider for your condition. Some medications may be more effective but carry greater risks. There is also cost to consider. In some cases, medication may not be needed at all and other treatments may be available.

7. Will this medication interact with my other medications and/or other health conditions?

  • Why is this important?: Drug interactions may make your medication less effective, cause unexpected side effects, or increase the action of another drug. Medications can react with other medications, food, or beverage.

8. What are the Black Box warnings for this medication and where can I report adverse events?

  • Why is this important?: Black Box warnings are the strictest warning put in the labeling of prescription drugs by the FDA when there is reasonable evidence of association of a serious hazard with the drug, which can be life-threatening. Asking about Black Box warnings can help to protect your health and life. If you do experience an adverse reaction, it is important to report it to the FDA’s MedWatch, which can be found here.

9. What happens if I do not take this medication?

  • Why is this important?: You know what is best for you. You may decide that a medication has too many side effects, costs too much money, or you may think you might get better with alternative treatment. Asking what happens if you do not take a certain medication allows you to make an informed decision about what is best for you.

10. What is the cost of this medication and will insurance cover it?

  • Why is this important?: Many patients may face high out of pocket costs for prescription drugs each month, especially for those with chronic or multiple conditions. Even insured patients feel the burden. When the cost is too high, a patient may stop taking the medication, and this could be detrimental to the patient. Understanding the cost of prescription medications and whether it is covered by insurance can help prevent complications from stopping a medication cold.

11. Do you have any written information about this medication?

  • Why is this important?: Patients need accurate information to help them use their medications safely and effectively. Having written information to refer to helps patients fully understand everything they need to know.

12. Have you ever received any gifts or financial benefits from the company that makes this medicine?

  • Why is this important?: Doctors are not required to disclose payments they receive from pharmaceutical companies to prescribe their drugs. Patients want to know that the medication being prescribed is because it is in their best interest, not because doctors receive money to do so. Understanding these ties is important. Many brand name drugs are expensive and carry dangerous adverse reactions. As a patient and consumer, you have the right to know whether your doctor has close pharmaceutical ties. You can find out here.