Kubic TT.* Law Enforcement and Industry: Key Partners for Safe Medicines. J Biolaw Bus. 2010;13(1&2):38-41.

Counterfeit and diverted medicines are a key public health concern. Developing as well as developed countries are experiencing increases in patient safety risks due to these illicit drug forms. Public-private coordination between industry stakeholders and law enforcement can address the developments and trends in the counterfeit and diverted drug arena. In this piece, one such…

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Liang BA.* International Drug Production and Supply: Challenges for Biopreparedness. J Biolaw Bus. 2010;12(3): 31- 34.

Biopreparedness uniquely relies upon drugs. However, the globalization of drug manufacturing and supply has created challenges to ensuring open and available access to these products. The heparin case illustrates the challenges of offshore and onshore efforts to secure the drugs necessary to address naturally-occuring and human-sourced biological agents. Economic incentives, international diplomacy, and alternative sourcing…

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Liang BA.* Supporting Pharmaceutical Diversion and Counterfeiting Prosecutions: A Role for Medical Professionals. J Biolaw Bus. 2010;13(1&2): 55-57.

Law enforcement efforts to prosecute pharmaceutical diversion and counterfeiting have begun to emerge as an important deterrent. By enlisting health care providers, the team of law and medical professionals can ensure that the full extent of harms is known to the court, and conviction results in appropriate penalties for this particularly atrocious crime.

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Winegar A, Shepherd MD*, Lawson KA, Richards K. Comparison of claim percent gross margin earned by Texas community independent pharmacies for dual-eligible beneficiaries claims before and after Medicare Part D. J Am Pharm Assoc. 2009 Sept/Oct; 49(5):617-2

Abstract. OBJECTIVES: To describe dual eligibles’ claims before and after Medicare Part D and to evaluate the effect that Medicare Part D has had on the claim percent gross margin (CPGM) earned by Texas community independent pharmacies.

DESIGN: Nonexperimental time series study.

SETTING: Texas, October 2005 through September 2006.

PARTICIPANTS: 313 community independent pharmacies.

INTERVENTION: Review of more than 150,000 Medicaid and 300,000 Medicare Part D claims acquired from a drug claims processor.

MAIN OUTCOME MEASURES: CPGM per prescription claim before and after the implementation of Medicare Part D, controlling for generic/brand drug status.

RESULTS: The mean CPGM for prescriptions dispensed before Part D (Medicaid claims) was 26.7%. The mean CPGM for claims dispensed after Part D (Medicare claims) was 17.0% (using ingredient costs in 2006 dollars) or 20.4% (using ingredient costs adjusted to 2005 dollars), a reduction of 36.3% and 23.6%, respectively. Under both Medicaid and Part D, pharmacies earned higher margins for generic drugs (39.9% and 29.5%, respectively) than for brand-name drugs (8.7% and 8.3%, respectively).

CONCLUSION: These results support community pharmacy assertions of lower reimbursements from Part D payers compared with Medicaid payers. Based on these results, pharmacies can respond to this evolving environment by carefully reviewing their Part D plans’ impact on CPGM and taking available steps to increase the proportion of generic drugs dispensed to Medicare beneficiaries.

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Liang BA.* Pigs, Drugs, and Terrorists. Patient Safe Qual Healthcare. 2008 Nov 1:10-12

Abstract. Making drugs is messy. Take heparin.You raise pigs and then slaughter them. You isolate the pig intestines and cook them. Then you scrape the intestinal insides, dry them, and get them to a factory to undergo more processing (Harris, 2008). Making drugs is also expensive. Outsourcing this messy activity to countries such as China…

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Panjabi SS, Panjabi RS, Shepherd MD*, Lawson KA, Johnsrud M, Barner J. Extended-release, once-daily morphine (Avinza) for the treatment of chronic nonmalignant pain: effect on pain, depressive symptoms, and cognition. Pain Medicine. 2008 Aug; 9(8):985-93.

Abstract. OBJECTIVE: To evaluate the impact of an extended-release, once-daily morphine sulfate formulation on depressive symptoms and neurocognition in patients with chronic nonmalignant pain.

DESIGN: Prospective, open-label, one-group trial with a pretest-posttest design.

SETTING: Outpatient pain management clinic.

PATIENTS AND INTERVENTION: Chronic nonmalignant pain patients inadequately controlled with short-acting opioid analgesics and eligible for treatment with once-daily morphine sulfate were initiated on a dose at or near the morphine-equivalent dose of the short-acting regimen.

OUTCOMES: The following assessments were made at baseline and 4 weeks after initiating intervention: pain intensity, pain unpleasantness, pain suffering, pain behaviors, Beck Depression Inventory, and cognitive function.

RESULTS: Eighty-four patients provided usable data. Pain intensity, unpleasantness, and suffering scores were significantly reduced at follow-up (P = 0.001). The mean Beck Depression Inventory scores were significantly lower at follow-up (P = 0.001). Significant improvements were seen in scores at follow-up on the three validated neurocognitive tests: the digit span test, the digit symbol substitution test, and the paced auditory serial addition test (P = 0.001).

CONCLUSIONS: Achieving adequate pain control with once-daily morphine was associated with a reduction in pain and improvements in depressive symptoms and cognitive functioning in the short term.

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Liang BA.* Safety Issues in Regulating Follow-On Biologic Drugs. J BIolaw Bus. 2007;10(4):44-49.

Biologic drugs are expensive, and hence policymakers are considering accelerating copies, or "follow on" biologic products to market using abbreviated pathways. However, important concerns relating to biologic products may have implications for follow on product regulation. The information gaps regarding biologic science, clinical issues associated with product excipients and active ingredient, and supply chain issues…

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Kubic TT.* Beer Cooler Biologics! J Biolaw Bus. 2007;10(4):28-32.

Every day, law enforcement officers throughout the United States are engaged in court authorized searches of persons, vehicles, homes and businesses. On occasion, during these searches, officers are surprised at what they uncover. For in some of the most unlikely places, their searches have disclosed the most advanced medicines – biologics, pharmaceuticals products critical to…

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Liang BA.* A Dose of Reality: Promoting Access to Pharmaceuticals. Wake Forest Intell Prop LJ. 2007 Dec 1;8:301-386

Abstract. The U.S. uses and benefits substantially from prescription drugs. Pharmaceuticals save lives, relieve suffering, and promote the quality of life for those with access to them. However, access means both availability of the authentic drug and access at prices patients can afford. Unfortunately, current public policy does not effectively address either component. The result…

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