|
There are two areas that have been discussed at some length in recent years regarding the standardization of compounded dosage forms, both nonsterile and sterile; these include:
- Compounded oral liquids for pediatric patients, and
- Parenteral medications, including intravenous admixtures, etc.
Despite discussions, meetings, recommendations, and some limited success in some institutions, this is still a topic that is being addressed. We will discuss standardization of compounded oral liquids for pediatric patients this week and parenteral medications next week.
Compounded Oral Liquids for Pediatric Patients
Approximately 60% of the medications used in pediatric patients are not available in a suitable dosage form (i.e., they are available as oral solid tablets/capsules). Therefore, they are routinely compounded into oral liquids thousands of times daily in hospitals, community pharmacies, chain pharmacies, etc. However, errors do sometimes occur and include:
- Errors in calculation
- Errors in manipulation
- Errors when patients are transferred between healthcare facilities and between the healthcare facility and home (using a local pharmacy)
- Others
A number of reasons have been presented as to why the errors occur and include:
- Lack of knowledge of the drug
- Lack of information about the patient
- Transcription errors
- Inadequate identity checking (drug, patient)
- Inadequate interaction with other healthcare personnel
- Inadequate dose checking
- Preparation/compounding errors
- Availability of multiple concentrations (e.g., Baclofen 1 mg/mL, 5 mg/mL, 10 mg/mL)
- Violation of laws, regulations, and practice standards
- Lack of "double checking" calculations and compounding procedures
- Being too rushed and a heavy workload
Next week, we will continue looking at Standardization of Some Compounded Dosage Forms.
On the Compounders Network List (CNL), you may share your thoughts on standardized concentrations of compounded drug preparations.
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
CBS Opioid Coverage Did Not Defame Pharmacist
Coverage on "CBS Evening News" about the opioid crisis didn't defame a pharmacist, a West Virginia federal judge ruled, finding that the segments' statements about painkiller prescriptions were mostly true. The ruling was from U.S. District Judge Joseph R. Goodwin who granted summary judgment to CBS and discarded a $15 million complaint filed last year by pharmacist Samuel R. Ballengee. In his complaint, Ballengee accused CBS of "maliciously making him the de facto face of the painkiller epidemic in West Virginia," but Judge Goodwin found no defamatory...
https://www.law360.com/health/articles/1075608/cbs-opioid-segments-didn-t-defame-pharmacist-judge-rules
The FDA Bans Active Pharmaceutical Ingredients from Another Chinese Manufacturer
The FDA has banned products from Yicheng Goto Pharmaceuticals, a Chinese manufacturer of active pharmaceutical ingredients (APIs) and suggested it hire a consultant to direct upgrades after an inspection found serious problems in its manufacturing processes, some of which had been uncovered in two earlier inspections. The company was not properly testing for API stability and could not even show that it was reliably manufacturing products that met their predetermined quality attributes. Also, the FDA had issues with how the company was cleaning its equipment between production runs to prevent cross contamination.
https://www.fiercepharma.com/manufacturing/fda-bans-products-from-another-chinese-api-maker
Pfizer Responds to the FDA, EMA, and Canada after Reinspections of a Plant that Makes Injected Painkillers
Pfizer states it has made significant strides in upgrading the sterile injectables plant but acknowledges more must be done after reinspections by the FDA and other regulators. The plant has been at the heart of shortages at U.S. hospitals of injectable analgesics. Pfizer states that "Although we have demonstrated improvement in many areas, we are still on a journey to drive further improvement and meet our commitments to both our regulators and our patients."
https://www.fiercepharma.com/manufacturing/pfizer-responds-to-fda-ema-and-canada-after-reinspections-troubled-hospira-plant
|
|
Tip of the Week
It's interesting to think about what would have happened if Disneyland was a tax-funded government project. As Walt Disney said, "I could never convince the financiers that Disneyland was feasible, because dreams offer too little collateral." He also said, "We did it [Disneyland], in the knowledge that most of the people I talked to thought it would be a financial disaster—closed and forgotten within the first year."
We should all be thankful for entrepreneurship and the opportunity to dream and do things individually and not depend on the government! There is already enough government involved in slowing up progress!
|
