Drug and Medical device product failures and the stability of the pharmaceutical supply Chain PPT/PDF

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Drug and Medical device product
failures and the stability of the
pharmaceutical supply Chain

Department of Drug Regulatory Affairs

College Of Pharmacy

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Journal of the American Pharmacists Association


▪ Objective

• Our objective was to review recent drug and
medical device recalls, categorize recall types
based on the free text descriptions posted
within the recall announcements, and
conduct exploratory analyses for researchers
interested in pharmaceutical supply chain

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• In the United States, over 45% of Americans take at least 1

prescription medication. To ensure product safety, the U.S.

Food and Drug Administration (FDA) requires manufacturers

to use Current Good Manufacturing Practices for the production
of both drugs and medical devices. However, even with this

regulation in place there were over 70 recalls issued per

year between 2017 and 2019.

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▪ Without proper identification of supply chain shortcomings, appropriate recalls
may be delayed, jeopardizing the health of many Americans. The supply chain
process varies largely between product types (drug and device) and even within a
product group.

▪ Today, foreign outsourcing of a company’s manufacturing process is more popular
than ever, but this effort to cut costs comes at a price. As the complexity of the
supply chain increases, proper regulation and maintenance of high quality becomes
more challenging.

▪ The nuances of globalization of the pharmaceutical supply chain
have become more important with the spread of coronavirus
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– For our analysis we grouped them all as drug recalls. For each medical device

and drug recall we extracted the company name, product description, product
type, and recall reason description from FDA’s Recall List.


– A company was considered as a consensus top 20 pharmaceutical company if it
had a market capitalization and revenue (2018 fiscal year) that waswithin the
top 20 among all the pharmaceutical companies.

– We first created a dichotomous recall type variable reflecting “Labeling Error”
and “Product Quality Issue” to differentiate between recalls where the product
was manufactured properly but mislabeled and recalls where the product was
adulterated or packaged incorrectly.

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– We created different subcategories to further qualitatively
describe the recall types. For drug recalls, subcategories for
product quality included general quality issue, sterility,
potency, unapproved substance, and packaging.

– A general quality issue was a unique recall that did not fall
under any of the other product quality subcategories.

– In addition, we determined where in the supply chain
(manufacturing-level or distribution-level) the drug or device
recall occurred by analyzing data available on FDA’s website.

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– There were 195 (85.2%) drugs and 34 (14.8%) medical devices recalled by FDA in
the United States from January 2017 to September 2019. These recalls mostly

occurred within smaller companies, but 28 (12.2%) drug recalls were issued against
a consensus top 20 pharmaceutical company

– Of the 195 drug recalls, 166 (85.1) were categorized as a quality issue whereas all
but 2 (32 [94.1%]) of the medical device recalls fell under this category (Table 1). This

meant that most of the recalls for both drugs and devices were because of product
quality issues

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In this pilot study, we reviewed and categorized FDA drug
and device recalls using free text publicly available within

each specific recall
(1) to determine whether this type of categorization was

feasible, and
(2) to assess our initial hypotheses that recall types would

vary between drugs and devices.
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Most recalls for both pharmaceutical drugs and medical
devices from 2017 to 2019 were issued owing to quality issues,

specifically sterility issues during the drug supply chain.. By determining product
failures in the

supply chain, FDA can focus resources on specific areas which
will save both time and costs.

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1. National Center for Health Statistics. Prescription drug use in the past 30 days, by sex, race, and
hispanic origin, and age: United States, selected years 1988e1994 through 2013e2016. Available at:
https://www.cdc.gov/ nchs/data/hus/2018/038.pdf. Accessed January 20, 2020.

2. Harel Z, Harel S, Wald R, Mamdani M, Bell CM. The frequency and characteristics of dietary
supplement recalls in the United States. JAMA Intern Med. 2013;173(10):926e928.

3. U.S. Food and Drug Administration. Recalls, market withdrawals, & safety alerts. Available at:
https://www.fda.gov/safety/recalls-market-withdr awals-safety-alerts. Accessed August 31, 2019.

4. Zuckerman DM, Brown P, Nissen SE. Medical device recalls and the FDA approval process. Arch
Intern Med. 2011;171(11):1006e1011.

5. Langer ES. Biopharmaceutical industry outsourcing trends: China and India continuing full-court
press.PharmOutsourcing. 2012;13(5). Available at:https:// www.pharmoutsourcing.com/Featured-
court-Press/. Accessed August 31, 2019.

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6. Alexander GC., Qato D.M. Ensuring access to medications in the US during the COVID-
19 pandemic [e-pub ahead of print]. JAMA. https://doi. org/10.1001/jama.2020.6016.
Accessed August 31, 2019.

7. American Pharmacists Association. APhA house of delegates. Available at:
https://www.pharmacist.com/apha-house-delegates?is_sso_called¼1. Accessed April 13,

8. Bloomberg. Companies and quotes. Available at: https://www.bloomberg. com.
Accessed December 18, 2019.

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