Meet The Professor

Quarterly Drug Price Inflation Monitor – Brand Prices Continue to Rise in 4Q with Y/Y Inflation ~10%

Dr. Craig Stern — Wed, 26 Dec 2012 20:20:25 +0000

Our analysis suggests that 4Q12 branded drug prices increased 10.2% y/y. Recall that historically the bulk of the y/y increase is typically experienced in 1Q and 3Q. Prices rose roughly 140 bps sequentially in 4Q12 compared to 3Q12. As we have maintained in the past, we believe branded manufacturers will continue to increase prices in the U.S. (positively impacting the drug distributors), as branded manufacturers look for ways to offset volume declines due to an accelerating patent expiration schedule and mandatory price declines in Europe. Throughout 2012, y/y price inflation trended in the 9.5% range and we would highlight that any decrease from that level could be a modest headwind. We will continue to closely monitor the trend in branded price inflation over the coming months and quarters to assess the ongoing sustainability of the elevated brand price inflation trend.

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Recall notice – West-Ward

Dr. Craig Stern — Mon, 17 Dec 2012 20:15:28 +0000

Recall notice – West-Ward

West-Ward has initiated a recall of Ethambutol Tablets, USP, 400 mg. The decision to recall the Ethambutol Tablets, USP, 400 mg is based on a recent observation by the FDA involving discoloration of the tablet cores that may be present in tablets.

Please immediately check inventory, quarantine, and discontinue distribution of the affected product and contact your wholesaler for directions.

Description	Lot #	Exp Date	UPC
ETHAMBUTOL TABLETS, USP, 400 MG	68977A 7/2015, 68977B 7/2015, 68977C 7/2013, 68978A 7/2013, 68978B 7/2015,68978C 7/2015, 68979A 7/2015		61748-014-06 (60′s), 61748-014-09(90′s), 61748-014-01 (100′s), 61748-014-10 (1000′s) and 61748-014-11 (Blister Pack –10′s)

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Pro Pharma Announces a Cost-Effective Solution to Formulary Problems

Dr. Craig Stern — Mon, 17 Dec 2012 20:11:57 +0000

We (Pro Pharma) have announced a cost-effective solution to your challenges in formulary design. No more looking up obscure or proprietary drug codes, no more reliance on third party agents for whom your organization’s interest may be secondary, no more guessing about patient access, costs, or benefits.

To read more about this, click on this link

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Fungal Meningitis Outbreak

Dr. Craig Stern — Fri, 16 Nov 2012 23:26:43 +0000

[UPDATE 11-01-2012] Laboratory results from samples of two additional recalled NECC products – preservative free betamethasone and cardioplegia solution – have tested positive for bacterial contamination. FDA and CDC laboratories have identified bacteria present in three separate lots (batches) of NECC-supplied preservative-free betamethasone, with each lot producing different culture results, and in a single lot of NECC cardioplegia solution. These results and the finding of fungal contamination of methylprednisolone acetate reinforce the FDA’s concern about the lack of sterility in products produced at NECC’s compounding facility and serve to underscore that hospitals, clinics, and health care providers should not use any NECC-supplied products.

You can obtain information about the outbreak by calling the FDA’s Division of Drug Information line at 855-543-DRUG (3784) or send an email to druginfo@fda.hhs.gov.

Read the MedWatch safety alert, including a link to the FDA Update,

FDA MedWatch – Laboratory Results from Samples of Additional NECC Products Tested Positive For Bacterial Contamination

Dr. Craig Stern — Thu, 01 Nov 2012 23:23:40 +0000

You can obtain information about the outbreak by calling the FDA’s Division of Drug Information line at 855-543-DRUG (3784) or send an email to druginfo@fda.hhs.gov.

Read the MedWatch safety alert, including a link to the FDA Update, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm323946.htm

Drug Information Update – Update on NECC Products: Samples of betamethasone and cardioplegia solution test positive for bacterial contamination

Dr. Craig Stern — Thu, 01 Nov 2012 22:24:31 +0000

The U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) are reporting laboratory results from samples of two additional recalled NECC products – preservative free betamethasone and cardioplegia solution. Previously, the fungus Exserohilum rostratum was identified in NECC-supplied, preservative-free methylprednisolone acetate (MPA).

The FDA and CDC laboratories have identified bacteria present in three separate lots (batches) of NECC-supplied preservative-free betamethasone, with each lot producing different culture results, and in a single lot of NECC cardioplegia solution.

The clinical significance of these results is not known. Both Bacillus idriensis and Bacillus circulans have been rarely reported as a cause of human disease. CDC continues to investigate reports of potential infections in patients receiving other NECC products. As of Nov. 1, CDC has not received reports of laboratory-confirmed cases of infection due to Bacillus or closely related organisms linked to betamethasone or cardioplegia solution from NECC.

Fungal cultures for betamethasone and cardioplegia solution are pending and the presence of additional microbial organisms and/or fungus in these products cannot be ruled out at this time.

For more information, including lot numbers and microbial identification, please visit: NECC Update

Pro Pharma Supports National Breast Cancer Awareness with Clinical Management Screening Analyses™

Dr. Craig Stern — Mon, 29 Oct 2012 19:20:53 +0000

Breast Cancer has touched many of our hearts at Pro Pharma both professionally and personally. In the spirit of Breast Cancer Awareness Month this October 2012, Pro Pharma announces its Clinical Management options that objectively address quality, choice, utilization and cost with measurable, verifiable and trendable results.

To read more about this, click on this link

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Pro Pharma Pharmaceutical Consultants Announces GER Validation Analysis

Dr. Craig Stern — Mon, 15 Oct 2012 19:17:47 +0000

We (Pro Pharma) have announced a GER Validation Analyses™ when doing this analysis, the Generic Effective Rate (GER) calculations verify that contract and performance/financial guarantee are being met with regard to the overall pricing of brand and generic claims. In many cases clients do not have the capacity to verify assertions of the Vendors. This allows Health Plans to manage their Vendors. GER Validation Analyses™ will be available to Health Plans Nationwide; which includes Weighted Average Wholesale Price (WAWP) review and evaluation or Generic Effective Rate (GER) calculations verify that contract guarantees are being met with regard to the overall pricing of brand and generic claims.

To read more about this, click on this link

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Pro Pharma Announces JCode Calculator™ Second Quarter 2012 Pricing Update

Dr. Craig Stern — Wed, 12 Sep 2012 16:00:31 +0000

Pro Pharma Pharmaceutical Consultants, Inc., announced that it has introduced NEW and IMPROVED Enhancements to the JCode Calculator™ Second Quarter 2012 Update via their secured web access for claims and billing professionals

To read more about this Click Here

Hospira Hydromorphone Hydrochloride Injection 2 MG/ML, 1 mL fill in 2.5 mL Carpuject: Recall- May Contain More Than the Intended Fill Volume

Dr. Craig Stern — Thu, 16 Aug 2012 15:11:50 +0000

Hospira and FDA notified healthcare professional of a nationwide voluntary recall of one lot of Hydromorphone Injection, USP, 2 mg/mL, (C-II), 1 mL fill in 2.5 mL Carpuject, NDC 0409-1312-30, due to a reported complaint of a single Carpuject containing more than the 1 mL labeled fill volume. The FDA has recommended anyone with an existing inventory should stop use and distribution, quarantine the product immediately, and call stericycle at 1-866-873-0312 to arrange for the return of the product. For medical inquiries, please contact Hospira Medical Communications at 1-800-615-0187. This phone number is available 24 hours a day, seven days a week.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm (if needed)
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 (if needed)