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William Garst: The FDA MedWatch Reporting Program

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Did you know that you can participate in healthcare in a meaningful way? You can do this by becoming familiar with the MedWatch Program. MedWatch was founded in 1993 to collect 

William Garst Column HeadShot Webdata regarding healthcare adverse events. This is a program run by the U.S. Food and Drug Administration (FDA), in which consumers can report any adverse reactions directly to the FDA. An adverse event is any undesirable experience associated with a medical product.

The types of products include:

  • Prescription and over-the-counter medicines
  • Biologics such as blood components, blood/plasma derivatives, and gene therapies.
  • Medical devices such as hearing aids breast pumps and pacemakers.
  • Combination products such as pre-filled drug syringe, metered-dose inhalers, and nasal spray.
  • Special nutritional products such as dietary supplements, medical foods, and infant formulas.
  • Cosmetics such as moisturizers, makeup, shampoos, hair dyes, and tattoos.
  • Food such as beverages and ingredients added to foods.

Other products the FDA regulates such as tobacco, vaccines, and animal/livestock medicine and feed use different reporting pathways and it is recommended that reports concerning these products be sent directly to the appropriate FDA submittal portal.

Voluntary reporting by healthcare professionals, consumers, and patients are conducted on a single, one-page reporting form (Form FDA 3500). Reporting can be conducted online, by phone, or by submitting the MedWatch 3500 form through the mail or fax. Reporting helps in what is called Post-Marketing Surveillance, sometimes called Phase IV Studies.

There are several clinical trial phases that must be passed before a drug or device is eligible to be placed in the market. First, there is preclinical research to determine if a drug has merit for further study.

The next phase is Phase 0 trials in which a small amount of the drug is given to a few people to determine how the body reacts to the drug and how the body metabolizes the drug.

The drug then enters Phase I trials in which the dosage resulting with the fewest side effects is determined usually in 20 to 100 healthy volunteers or people with the disease/condition.

Next, there are Phase II trials where the drug is further tested for safety in a larger amount of people, up to several hundred people.

The last step before being allowed on the market are Phase III trials. In these trials, the new drug is usually compared to the current standard of care drug and is tested in more people, possibly 300 to 3,000 may participate. These trials are usually randomized so any bias is minimized that may affect any subjective outcomes.

The last phase is the above-mentioned Phase IV trials.

This is important because some serious, but rare adverse events cannot be detected until the medication has been used by many thousands of people in varying circumstances. In addition, some adverse events that may have been noticed in clinical trials were underestimated, and information about patients experiences with the medication is most valuable.

An example of how MedWatch helped remove a dangerous drug from the market involved the drug cerivastatin (Baycol, by Bayer Co.). This drug was approved to lower cholesterol and prevent cardiovascular disease. After being on the market for a few years it was reported that the drug had a higher than normal incidence of rhabdomyolysis, which is a breakdown of muscle and accumulation of protein in the kidneys. This can lead to kidney failure and serious injury. This class of drugs (statins) is known to cause muscle aches and pains, but the incidence of rhabdomyolysis was greater than expected as observed in the previous clinical trials for this drug.

The bottom line is to report any adverse reaction to your physician and pharmacist. Ask them to send in a MedWatch report, or you can do it yourself.

More information can be found about the MedWatch Program at www.fda.gov or ask your pharmacist or physician.

Ref: (https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program)

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William Garst is a consultant pharmacist who resides in Alachua, Florida. He received his B.S. in Pharmacy from Auburn University in 1975. He earned a master’s degree in Pharmacy from UF in 2001. In 2007 he received his Doctor of Pharmacy from the University of Colorado. He is a member of many national professional associations as well as the local Alachua County Association of Pharmacists, and he serves on the Alachua County Health Care Advisory Board. He works part time at the UF Health Psychiatric Hospital. He retired from the VA in 2016.  Dr. Garst enjoys golf, reading (especially history), and family. He writes a blog called The Pharmacy Newsletter (https://thepharmacynewsletter.com/). He can be contacted at communitypharmacynewsletter@gmail.com

#     #     #

Email editor@

alachuatoday.com

Did you know that you can participate in healthcare in a meaningful way? You can do this by becoming familiar with the MedWatch Program. MedWatch was founded in 1993 to collect 

William Garst Column HeadShot Webdata regarding healthcare adverse events. This is a program run by the U.S. Food and Drug Administration (FDA), in which consumers can report any adverse reactions directly to the FDA. An adverse event is any undesirable experience associated with a medical product.

The types of products include:

  • Prescription and over-the-counter medicines
  • Biologics such as blood components, blood/plasma derivatives, and gene therapies.
  • Medical devices such as hearing aids breast pumps and pacemakers.
  • Combination products such as pre-filled drug syringe, metered-dose inhalers, and nasal spray.
  • Special nutritional products such as dietary supplements, medical foods, and infant formulas.
  • Cosmetics such as moisturizers, makeup, shampoos, hair dyes, and tattoos.
  • Food such as beverages and ingredients added to foods.

Other products the FDA regulates such as tobacco, vaccines, and animal/livestock medicine and feed use different reporting pathways and it is recommended that reports concerning these products be sent directly to the appropriate FDA submittal portal.

Voluntary reporting by healthcare professionals, consumers, and patients are conducted on a single, one-page reporting form (Form FDA 3500). Reporting can be conducted online, by phone, or by submitting the MedWatch 3500 form through the mail or fax. Reporting helps in what is called Post-Marketing Surveillance, sometimes called Phase IV Studies.

There are several clinical trial phases that must be passed before a drug or device is eligible to be placed in the market. First, there is preclinical research to determine if a drug has merit for further study.

The next phase is Phase 0 trials in which a small amount of the drug is given to a few people to determine how the body reacts to the drug and how the body metabolizes the drug.

The drug then enters Phase I trials in which the dosage resulting with the fewest side effects is determined usually in 20 to 100 healthy volunteers or people with the disease/condition.

Next, there are Phase II trials where the drug is further tested for safety in a larger amount of people, up to several hundred people.

The last step before being allowed on the market are Phase III trials. In these trials, the new drug is usually compared to the current standard of care drug and is tested in more people, possibly 300 to 3,000 may participate. These trials are usually randomized so any bias is minimized that may affect any subjective outcomes.

The last phase is the above-mentioned Phase IV trials.

This is important because some serious, but rare adverse events cannot be detected until the medication has been used by many thousands of people in varying circumstances. In addition, some adverse events that may have been noticed in clinical trials were underestimated, and information about patients experiences with the medication is most valuable.

An example of how MedWatch helped remove a dangerous drug from the market involved the drug cerivastatin (Baycol, by Bayer Co.). This drug was approved to lower cholesterol and prevent cardiovascular disease. After being on the market for a few years it was reported that the drug had a higher than normal incidence of rhabdomyolysis, which is a breakdown of muscle and accumulation of protein in the kidneys. This can lead to kidney failure and serious injury. This class of drugs (statins) is known to cause muscle aches and pains, but the incidence of rhabdomyolysis was greater than expected as observed in the previous clinical trials for this drug.

The bottom line is to report any adverse reaction to your physician and pharmacist. Ask them to send in a MedWatch report, or you can do it yourself.

More information can be found about the MedWatch Program at www.fda.gov or ask your pharmacist or physician.

Ref: (https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program)

*     *     *

William Garst is a consultant pharmacist who resides in Alachua, Florida. He received his B.S. in Pharmacy from Auburn University in 1975. He earned a master’s degree in Pharmacy from UF in 2001. In 2007 he received his Doctor of Pharmacy from the University of Colorado. He is a member of many national professional associations as well as the local Alachua County Association of Pharmacists, and he serves on the Alachua County Health Care Advisory Board. He works part time at the UF Health Psychiatric Hospital. He retired from the VA in 2016.  Dr. Garst enjoys golf, reading (especially history), and family. He writes a blog called The Pharmacy Newsletter (https://thepharmacynewsletter.com/). He can be contacted at This email address is being protected from spambots. You need JavaScript enabled to view it.

#     #     #

Email editor@

alachuatoday.com