Category:

Poor medication adherence can lead to reduced treatment benefits, even death in some cases. Implants are being used by some medical professionals to increase the likelihood of patients “following the doctor’s orders.” Specifically, some clinicians are using these devices in individuals with an addiction to opioids...Even though buprenorphine can be used to treat opioid addiction, its efficacy is limited by the potential lack of adherence to daily, sublingual doses. To...increase...compliance among patients undergoing buprenorphine treatment...the FDA approved the first buprenorphine implant for the treatment of opioid dependence...Called Probuphine, the treatment provides a low-level dose of buprenorphine for six months...This treatment option may also be considered an effective relapse prevention tool. Icahn School of Medicine at Mount Sinai researchers found...

With the vast majority of drugs and drug ingredients being manufactured outside the U.S., the FDA has had to step up its international oversight and often ban products from plants that don’t meet its standards. But the FDA also has found itself increasingly having to walk a tightrope between drug safety and drug availability...Because of the nature of the business, with companies in China or India often being a primary source of essential drugs, the FDA sometimes must exempt products and allow imports from plants that it believes have a poor record. Since 2013 the FDA has allowed 8 plants whose products are otherwise banned from the U.S. to go ahead and import some drugs or ingredients to avoid shortages, according to FDA Import Alert records.

...federal prosecutors unsealed an indictment against three Miami-area residents, charging the suspects with conspiracy, obstruction, money laundering and healthcare fraud estimated at $1 billion...This is the largest single criminal healthcare fraud case ever brought against individuals by the Department of Justice...Philip Esformes...operated a network of more than 30 skilled nursing and assisted living facilities in South Florida...He is charged with Medicaid and Medicare fraud for providing "medically unnecessary" services to perhaps thousands of beneficiaries who did not qualify for federal reimbursement...In order to hide the kickbacks...(they)...were often paid in cash, or were disguised as payments to charitable donations, payments for services and sham lease payments...

What are the practice opportunities for pharmacists in your country? Are there too many pharmacists? Or are numbers insufficient to meet medicines-related health needs? Due to insufficient government policies, education and insurance programmes, there is a gravely uneven distribution of supply and demand for pharmaceutical expertise around the world...This issue of the International Pharmacy Journal (vol 34:2) marks a milestone year for human resources for health, including the publication of the new WHO global strategy. It offers a selection of articles to help you become conversant with the main factors at play (politics, private and public policies, economics, data collection and use, education and training, available skills and defined roles, working environment and motivation, technology and migration) and to help you to act where needed.

Pharmacist-led clinic enabling practice change in Canada

Your chance to say how the future of pharmacy workforce will look

Free movement of pharmacists in Europe: Impacts, issues, developments

Pharmacy students filling gaps in health care

Pharmacy in Ethiopia: Building professional capacity

WHA medicines shortages resolution accords with FIP recommendations

Ministers hear how pharmacists support victims of violence

Special interest group on pharmacy practice research formed

New report gives overview of pharmacy services around the world

Goals for global pharmacy workforce development to be established

NHS England plans to get more pharmacists into GP practices

Online pharmacies in Germany targeted by hackers

Sale of non-medical marijuana in Uruguayan pharmacies begins

Technicians to do final check in New Zealand

Last September, U.S. regulators faced a dilemma: whether to allow importation of drug ingredients from a Chinese factory (Zhejiang Hisun Pharmaceutical Co.) with a history of poor quality controls, or face shortages of treatments for American cancer patients...Food and Drug Administration inspectors had uncovered what the agency later called “broad data manipulation” at the factory, located in Taizhou....Information about the potency and purity of some product batches had been deleted, making it difficult to investigate a significant increase in customer complaints...The agency issued an indefinite ban on the factory...one of China’s leading exporters of pharmaceuticals products. Yet to avoid possible shortages of drugs, the FDA allowed the plant continue exporting about 15 ingredients for use in finished drugs in the U.S., including nine key cancer medicine components. Hisun says that it takes quality seriously and has complied with requirements.

Justin Gallagher, associate publisher of The American Journal of Managed Care. Welcome to This Week in Managed Care, From the Managed Markets News Network.

Five years after the Supreme Court blocked most personal-injury lawsuits against makers of generic drugs, a rule designed to strengthen patient protections have (has) stalled, leaving what consumer groups warn is a safety gap for millions of users...More than 88% of the prescriptions dispensed in the United States are for generic drugs...these drugs also have what some advocates describe as a hidden risk...Only makers of brand-name drugs have a legal duty to update their warning labels if they learn of new risks or side effects, the high court ruled in a 5-4 decision five years ago. By contrast, justices said that FDA rules forbid generic makers from acting on their own to update their warning labels...The...majority reasoned that because generics must be the same as the approved brand-name drugs, their makers are not to free to add new warnings. At the same time, they ruled that generic makers may not be sued by injured patients who contend they and their doctors were not warned of a drug’s serious new risks...In response to public petitions, the FDA proposed to change its rule so generic makers would have the freedom and a legal duty to update their warnings to patients and doctors. But the proposal ran into fierce opposition from industry leaders who said it would be costly and possibly confusing. If several generic versions of a drug were being sold, doctors and pharmacists could be confused if their warning labels differed, they said.

Roche won another reprieve in its fight against Accutane safety claims. The...drugmaker persuaded a New Jersey appeals court to overturn an $18 million jury verdict in favor of two Accutane (isotretinoin) plaintiffs...Appellate Division ruled...that the trial court judge "seriously erred" in allowing some revelations in court while restricting others. The judge’s mistakes were weighty enough to warrant a new trial...It’s the latest in a series of victories on appeal for Roche...The lawsuits are among 3,000 assigned to multicounty litigation in New Jersey. The plaintiffs allege that Roche’s acne drug, pulled from the market in 2009, triggered their inflammatory bowel disease...Accutane once was a blockbuster med for Roche and a staple therapy for acne sufferers. Roche pulled Accutane for "business reasons"...long after the drug went off patent and generics hit the market. The company already was facing hundreds of liability lawsuits at the time

...AstraZeneca is growing impatient with the U.K. government for not making available the new lung cancer med Tagrisso (osimertinib)...Already available through health programs in France, Germany, Sweden and several other European countries, Tagrisso this week bested chemo in a Phase III trial in advanced EGFR mutation-positive non-small-cell lung cancer. It’s already EU- and FDA-approved, but has so far failed to gain support from NICE (National Institute for Health and Care Excellence), which said on a preliminary basis last month that the drug shouldn’t be included in England’s National Health Service...Anson (AstraZeneca’s U.K. head Lisa Anson) renewed a call for the government to reform NICE, growing the chorus of displeasure among AZ’s pharma peers who have seen effective new drugs turned down on price concerns...

The U.S. Food and Drug Administration has become something of a bogeyman for India’s stock market...An inspection blitz on Indian drug factories that supply to the U.S. helped push the broader index of Indian health-care stocks down by as much as 20 percent earlier this year from its all-time high in 2015 after some top firms received warning letters for failing to meet the regulator’s standards...But even as the FDA has increased scrutiny of India, it’s been approving generic drug applications from the country’s firms at a record pace...Everything sounds negative around Indian pharma, but practically it’s just a few companies...India’s growing importance in the U.S. supply of generic medicines -- India Ratings & Research estimates it accounted for 31 percent of all new drug approvals last year -- prompted the FDA to increase its workforce in the country to 19 from 12 in recent years...