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Demystifying the Current Drug Shortage Problem in Emergency Medical Services
In a recent meeting held in Washington, DC, the Emergency Medical Services (EMS) industry and other key industry players were invited to learn more about why the current drug shortage situation exists. This meeting was addressed by a panel of experts from the FDA, Health and Human Services (HHS), drug manufacturers, drug suppliers, and a variety of EMS providers and industry trade associations and sponsored by the HHS and the Assistant Secretary for Preparedness and Response (ASPR).
It became evident that the problem being experienced by the EMS industry and others is due to a variety of unmanaged but tightly integrated series of manufacturing, regulatory, supply chain, and end-user processes and practices that have come together in a perfect storm. According to industry insiders, there is no simple solution.
EMS agencies must use their innate skill sets of "overcoming and adapting" in order to bridge drug shortfalls. One of the solutions shared at the meeting included working with local or regional compounding pharmacies to create the drugs needed. While this is a valid option for many drugs, there are some downsides, including that the average price reported by many EMS agencies that utilize compounding is 8 to 10 times more than they currently pay for drugs. Also of concern is the limited shelf life, which on average is 6 months versus a year or more for drugs manufactured the traditional way. Federal officials were quick to point out that agencies should only use accredited compounding pharmacies to ensure quality.
http://highperformanceems.com/2012/05/21/demystifying-the-current-drug-shortage-problem-in-ems/
Banning Sales Rep May be A Doubled-Edged Sword
As more physicians restrict and even eliminate face time with sales reps, a new study suggests the practice has a quantifiable downside. After approval of Januvia, for instance, physicians who had little interaction with reps took longer to write prescriptions than physicians whose access to reps was not as restricted. Also, physicians who rarely, if ever, saw reps were slowest to change their prescribing habits after negative news emerged about Avandia and Vytorin.
http://www.pharmalot.com/2012/05/sales-rep-bans-are-a-doubled-edged-sword/
International Drugmakers Work to Keep Medicines Flowing into Greece
Executives at leading drug companies, especially those with European headquarters, are under pressure to avert a health catastrophe that could occur if Greek imports are halted by a massive devaluation of newly issued drachma. "There's a moral obligation to continue to supply," said Simon Friend, global pharmaceutical leader at PricewaterhouseCoopers. "Greece is not a big market, so most drug companies can absorb it�the reputational damage would, I think, more than outweigh the economic cost."
The goal is to have a scheme ready for implementation to bridge the gap by supplying critical medicines for a few months. Meanwhile, many patients are already struggling to get the prescription medicines they need.
http://www.reuters.com/article/2012/05/18/us-greece-drugs-idUSBRE84H0IK20120518c
Fake and Substandard Malaria Drugs Increase
Fake and substandard malaria drugs are a growing threat to efforts to control the disease. About a third of the drug samples obtained and tested from both southeast Asia and African continents failed; some were clearly criminal counterfeits, some were expired drugs that had been repackaged and some were poorly made with too little active ingredient. It has been suggested that much more testing be done in China and India, where most drugs intended for poor countries are made. It also endorsed greater use of documentation, field testing, and shipment tracking. A published editorial also said that drugmakers and the World Health Organization need to stop fighting over what constitutes a "counterfeit" drug so that bad drugs can be seized while legitimate generics are not.
http://www.nytimes.com/2012/05/22/health/policy/fake-and-substandard-drugs-grow-as-threat-to-fight-malaria.html?_r=1
Osteoporosis Drug Link to Uncommon Breaks Confirmed
According to a new study, bisphosphonate therapy appears to be associated with an increased risk of atypical fractures of the femur, and may be driven by the duration of treatment. Of 477 patients hospitalized at one center, 39 had atypical fractures and 438 had common fractures. Among those with atypical fractures, 82.1% had been taking bisphosphonates compared with just 6.4% of those with common fractures. The study was by Raphael P.H. Meier, MD, from University Hospitals of Geneva, and colleagues and reported online in the Archives of Internal Medicine.
Current reports on bisphosphonate use and atypical fractures are conflicting. A recent meta-analysis of randomized trials found no association, but a registry-based study suggested that the risk of atypical fracture was more than doubled when bisphosphonates were taken for longer than 5 years (JAMA 2011; 305: 783-789).
In 2010, the FDA confirmed that bisphosphonate drugs for osteoporosis carried a small but meaningful risk of femoral fractures and ordered an update to product labels.
http://www.medpagetoday.com/Endocrinology/Osteoporosis/32806
Check Prefilled Syringes for Overfilling
The FDA has issued an advisory warning for healthcare providers to visually inspect Hospira Carpuject prefilled cartridges for overfill. Involved are about 46 million units from 280 lots. The advisory covers 15 types of medications supplied in the form of a Carpuject prefilled syringe, including meperidine, diazepam, fentanyl, heparin, hydromorphone, ketorolac, labetalol, lorazepam, metoprolol, midazolam, morphine, naloxone, ondansetron, and sodium chloride. A complete list of products and lot numbers is available on the FDA's Website.
The FDA recommends to "follow the instructions provided with the medication and visually inspect and confirm that the Carpuject pre-filled cartridge contains the labeled fill volume before dispensing and again before administering to patients." Also, "Because pharmacists and other healthcare providers can visually identify the presence of an overfilled Carpuject pre-filled cartridge, FDA is recommending that these steps be taken at this time rather than a product recall, because a recall of the affected products listed above would result in an immediate shortage."
http://www.medscape.com/viewarticle/764431
Generic Drugmakers' Complaints Over Brand-name Access Prompt Investigations
To get a generic drug approved by the FDA, a company has to test a sample of the brand-name version and show that the generic version is essentially identical and as effective. However, some companies say they are unable to create cheaper generic versions of drugs because their rivals are exploiting a legal loophole. The government has placed restrictions on distributing some drugs that are dangerous or prone to abuse. Critics say manufacturers of those brand-name drugs are using the restrictions to stop generic drugmakers from getting samples to test. It all boils down to "No samples, no generics." Some critics warn that the practice is bound to become more entrenched and widespread.
http://www.washingtonpost.com/business/economy/generic-drug-makers-complaints-over-distribution-law-provoke-investigations/2012/05/22/gIQAhExKiU_story.html
European Union Opens Probe of Parallel Drug Trade
The EU is investigating what is called parallel trade, in which wholesalers buy medicines at state-regulated prices in countries such as Spain or Greece and sell them in markets such as the United Kingdom, where drugs are more expensive. Large price differentials for the same drugs across the EU have spurred an arbitrage trade for medicines. One German drug trader, has annual sales of about $522 million from buying pharmaceutical products in one European country and selling them in another at a higher price.
http://www.sfgate.com/cgi-bin/article.cgi?f=/c/a/2012/05/22/BU5T1OLPFC.DTL
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