Question: What are the FDA priorities for compounding for 2019?

Answer:
The following section is from the statement from FDA Commissioner Scott Gottlieb, M.D. and Deputy Commissioner Anna Abram on the new 2019 efforts to improve the quality of compounded drugs ( released on April 3, 2019). You are encouraged to go to the FDA website below and read the statement in its entirety. Additional sections will be covered each week.

Statement from FDA Commissioner Scott Gottlieb, M.D. and Deputy Commissioner Anna Abram on new 2019 efforts to improve the quality of compounded drugs

Statement (Opening)

Maintaining Quality Manufacturing and Compliance
“In 2019, we’ll utilize appropriated funds provided in FDA’s 2019 budget to lay the groundwork for the “Center of Excellence on Compounding for Outsourcing Facilities,� including trainings on current good manufacturing practice requirements for outsourcing facilities. The goal will be to bolster the quality of compounded drugs produced by outsourcing facilities. We’ll provide more updates and opportunities for public participation in this effort.

Also, we’ll continue our effort to help compounders to identify insanitary conditions in compounding facilities so they can implement appropriate corrective actions. We’ve highlighted some of the poor conditions that our investigators have found at some facilities. To help prevent these practices, we’ll work to finalize our guidance to promote activities that help compounders ensure their drugs are not prepared, packed, or held under insanitary conditions.

While some compounders work hard to meet quality standards including avoiding insanitary conditions, we recognize that there are still compounders that are not in compliance. To address these risks, a key component of our 2019 work will be continuing to perform our risk-based inspection and pursue other enforcement efforts to identify compounders who produce drugs under substandard conditions or use inappropriate practices that could lead to serious harm. In 2018, the FDA sent warning letters to 23 facilities for adulterated product violations. These include insanitary conditions. We also worked with compounders on 50 recalls of products from the marketplace that raised safety concerns. Since 2018, FDA has entered into four consent decrees of permanent injunction to address the risk of patient harm from exposure to unsafe compounded drugs.

In 2019, we’ll build on these and similar efforts, advance other new policies to strengthen our regulatory oversight and continue to help improve the quality of compounded drugs.�

Regulating Compounding from Bulk Drug Substances

Finalizing our Memorandum of Understanding with the States

Compounding by Hospital and Health Systems

Additional Compounding priorities

Note: We will continue to provide the text for each of the sections over the next few weeks; meanwhile, the complete statement can be obtained at:

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm635182.htm

Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition

News

Harm Reported from Sudden Discontinuation of Opioid Pain Medicines
The FDA has received reports of serious harm in patients who are physically dependent on opioid pain medicines suddenly having these medicines discontinued or the dose rapidly decreased. These include serious withdrawal symptoms, uncontrolled pain, psychological distress, and suicide. Patients may attempt to treat their pain or withdrawal symptoms with illicit opioids, such as heroin, and other substances. Healthcare professionals should not abruptly discontinue opioids in a patient who is physically dependent. When tapering the dose of opioid analgesic, consider a variety of factors, including the dose of the drug, the duration of treatment, the type of pain being treated, and the physical and psychological attributes of the patient. No standard opioid tapering schedule exists that is suitable for all patients. Create a patient-specific plan to gradually taper the dose of the opioid and ensure ongoing monitoring and support.
https://www.fda.gov/Drugs/DrugSafety/ucm635038.htm

Expanding Access to Genetics/Genomics/Pharmacogenomics Competency Education
As pharmacogenomics (PGx) use in pharmacy increases, education of healthcare providers and health profession students must be made broadly available to improve accessibility of such services to patients. Pharmacists must further their education to include pharmacogenomics; currently, however, few opportunities exist to gain this type of education, and, therefore, these services are not yet broadly available to the public. The specific goal of this study was to evaluate pharmacists’ and pharmacy students’ self-assessed perceptions of competence related to genetics, genomics, and pharmacogenomics as presented via an online “pharmacogenomics certification program� (PGx program). The study showed that dissemination of genetics/genomics/pharmacogenomics competency statements education can be accomplished via online delivery.
https://journals.sagepub.com/doi/full/10.1177/2382120519834325

More Antibiotic Rx from Pediatric Telemedicine Visit
According to new a report published April 8 in Pediatrics, telemedicine visits resulted in 52% of antibiotic prescriptions for children with acute respiratory infections; less frequent prescribing was observed in urgent care and in-person visits with a physician, at 42% and 31%, respectively. Compared with antibiotic prescribing at primary care and urgent care visits, antibiotic prescribing at telemedicine visits were also less likely to be consistent with clinical guidelines.
https://www.pharmacist.com/article/pediatric-telemedicine-visits-yielded-more-antibiotic-prescriptions-study-finds"

List of the Top 15 Pharma Companies by 2018 Revenue.

1. Johnson & Johnson
2. Roche
3. Pfizer
4. Novartis
5. Merck & Co.
6. GlaxoSmithKline
7. Sanofi
8. AbbVie
9. Bayer
10. Eli Lilly
11. Amgen
12. Bristol-Myers Squibb
13. Gilead Sciences
14. AstraZeneca
15. Teva Pharmaceutical Industries

Did You Know ...

…that Audrey Hepburn (Golden Days of Hollywood Actress) said the following?

“Make-up can only make you look pretty on the outside,
But it doesn’t help if you're ugly on the inside…unless you eat the make-up!�

Tip of the Week

One often wonders what our society would be like if we spent as much time fixing up our insides as we do on fixing up our outsides!

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Looking Back

Listen birds,
These signs cost money,
You can rest awhile,
But don’t get Funny!
     Burma-Shave