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Drug Store News recently had an opportunity to sit down with Alissa Hsu Lynch, VP sales strategy, operations and global capabilities at Johnson & Johnson Consumer to discuss how J&J is optimizing its health-and-wellness position in retail. Hsu Lynch leads the strategic development of key retail initiatives across J&J's $6 billion portfolio of consumer brands…

• How is J&J delivering value within the health-and-wellness space to its retailer customers?
• What core consumer segments do you see as key to your health-and-wellness strategy?
• How is the Affordable Care Act affecting your growth plans?
• How is technology changing the way you engage with patients and consumers?
• How are you aligning your company’s assets to match the go-to market strategy of large integrated retail healthcare providers?
• What key insight do you want your retail partners to know about the future of health care?

Before…Theranos suspended use of its finger-prick blood draws in September because of Food and Drug Administration concerns, the company tangled with Arizona lab regulators over testing instruments and lab practices…Theranos, which operates retail locations inside 40 Walgreens stores across metro Phoenix, did not always meet lab regulations before taking corrective steps, according to inspection reports…After an April 2 survey of the company's Scottsdale lab, Arizona Department of Health Services inspectors noted four "deficiencies" at the lab...The state inspectors conducted the survey on behalf of the federal Centers for Medicare and Medicaid Services, which regulates laboratory testing…The four issues concerned proficiency testing, validation of instruments used to analyze blood samples, humidity levels outside of acceptable ranges for some lab instruments and how blood-sample collections were dated…In September, state lab inspectors said that Theranos did not meet proficiency testing standards for certain substances, including toxicology and four other regulated substances.

CBI’s Specialty Therapies Forum, the conference that brings together healthcare and pharmaceutical thought leaders to share best practices for managing specialty therapies…an opportunity to discuss not only strategies for managing the cost of specialty therapies, but also to provide the latest information and case studies dedicated to ensuring access and quality care in specialty benefit management. New to the agenda this year is a workshop dedicated to Specialty Pipeline Management.

Dialogue led by key thought leaders:

Avella Specialty Pharmacy | Blue Cross Blue Shield of Massachusetts | Blue Cross and Blue Shield of Minnesota | Blue Cross and Blue Shield of North Carolina | Denver Health Medical Plan | Fairview Specialty Pharmacy | Florida Blue | Gorman Health Group | Horizon Blue Cross Blue Shield New Jersey | Independent Health | NSHOA Cancer Centers in NY | Rutgers RWJ Medical School | Walgreens | Walmart | Widener University

European Medicines Agency has published a good practice guide on medication errors to improve the reporting, evaluation and prevention of medication errors by regulatory authorities and pharmaceutical industry throughout the EU…The…guide on medication errors published today complements the guideline on good pharmacovigilance practices…It consists of two parts:

• details how suspected adverse reactions that are caused by medication errors should be recorded, coded, reported and assessed. The goal is to improve reporting and to learn from medication errors for the benefit of public health.
• clarifies key principles of risk management planning in relation to medication errors. It describes the main sources and types of medication errors and proposes options to minimise the risk of medication errors throughout the lifespan of a medicine.

Express Scripts, the nation’s largest pharmacy benefits manager, will cover a new compounded version that costs just $1 a tablet. Moreover, two leading physicians’ groups quickly endorsed the move…The decision comes amid ongoing controversy over Daraprim, which Turing bought last summer from another company and then boosted the price from $13.55 a pill to $750, a 5,000 percent increase. The price hike triggered a new round of scrutiny of pharmaceutical costs and transformed Shkreli…into a poster boy for greed and outsized drug pricing…Turing took steps to thwart lower-cost generic competition by using a so-called closed distribution system. The drug maker is unwilling to sell Daraprim to other companies and, without sufficient supplies, a generic drug maker is unlikely to have enough medicine to run clinical tests needed for FDA approval…This explains why the compounded version is being embraced.

Lahey Hospital and Medical Center has agreed to pay $850,000 in a settlement with HHS' Office for Civil Rights to resolve alleged privacy and security violations stemming from the theft of a laptop computer with unencrypted patient records…health system also entered into a corrective action plan to address other privacy and security issues raised during the breach investigation. Lahey “impermissibly disclosed” electronic medical records of 599 individuals “for a purpose not permitted by the privacy rule” under the Health Insurance Portability and Accountability Act…Lahey had failed to meet a number of other HIPAA requirements, including not conducting “an accurate and thorough” security risk analysis, failing to assign “a unique username for identifying and tracking user identity” on the stolen computer and failing to “implement a mechanism to record and examine activity” on the computer.

…ex-CFO (James Canedo ) of the now-defunct Pacific Hospital in Long Beach, Calif., was among those who recently reached a plea agreement with prosecutors for his involvement in a fraud scheme that generated $580 million in false billings…The 15-year-long fraud scheme involved…submitting bills to workers' compensation insurers and the U.S. Department of Labor for spinal surgeries. The surgeries were performed on patients who had been referred by dozens of physicians, chiropractors and others who were paid illegal kickbacks…More than $580 million in bills were fraudulently submitted by Pacific Hospital during the last eight years of the scheme alone. [California Pharmacy Management and its successor, Industrial Pharmacy Management, were also important players in the scheme. Both companies set up and managed what were essentially mini-pharmacies within doctors’ offices.]

Healthcare IT security: you have a bad reputation. When it gets down to healthcare there’s always a little chuckle about how bad they are…This year was among the worst in cybersecurity across the healthcare sector…On average, companies that got breached did not know it for 270 days and some had even been breached for seven years without knowing it…that two-thirds of those entities did not even discover the breach internally; it was pointed out to them, either by someone outside the organization or by the federal government...As bad as breaches are, however, there are other worse threats emerging that hospital CIOs, CISOs and IT departments should understand and prepare for.

1. Ransomware
2. DDoS (Distributed Denial of Services)
3. Wiper attacks
4. Intellectual property theft
5. Straight theft of money
6. Data manipulation
7. Data destruction

Mobile medical applications increasingly are being used by patients and consumers. Now healthcare providers are evaluating whether and how to work with their patients in tapping these apps. But they're proceeding cautiously because of the dearth of clinical evidence for many consumer apps, and because some developers may be misleading consumers by overstating their products' capabilities…I think we will be seeing an increase in scrutiny and enforcement by the FDA and the FTC…medical devices treading in the areas of diagnosis and treatment, for those I think we'll see increased enforcement...healthcare providers, a major factor driving that adoption is the shift to value-based payment, which creates a powerful incentive to keep patients healthier and reduce costs by avoiding unnecessary hospitalizations and emergency department use…As with the introduction of any new clinical-care process, there are safety issues…We're going from a situation where we had no data to one where we probably have more data than we need…mobile apps can offer clinical benefits, particularly when used in a structured healthcare program…Healthcare lawyers caution that providers run a variety of legal risks in using mobile apps with patients. “If the patient brings in a bunch of stuff, if you rely on it and it's wrong, it's a problem”…“But if you ignore it and it's right, it's a problem. You're damned if you do and damned if you don't.”

Bryan Ziegler, PharmD, executive director of Kennedy Pharmacy Innovation Center, provides some resources for community pharmacists to use when implementing new collaborative services with primary care providers.