Pharmacy Industry News: Pfizer pullout means some patients are missing out on drugs
Pfizer pullout means some patients are missing out on drugs
PATIENTS are missing out on urgent medicines because Australia’s biggest drug supplier has opted out of an industry-wide distribution system.
Patients suffering heart disease, mental illness and other conditions requiring immediate medication are in some cases waiting days for their drugs because of Pfizer’s less regular deliveries, pharmacists say.
Under the industry-wide system many pharmacies get up to two free deliveries a day of drug brands other than Pfizer. A Pfizer spokeswoman said the company provided five free deliveries a month, with critical products delivered free on the same business day ”wherever possible”.
Toorak pharmacist John Button said the delivery service was ”a lot slower” under the new system. NSW pharmacist Anthony Ai Nguyen said one of his patients ended up back in hospital, unable to get the prescribed Pfizer treatment to combat a worsening infection.
The Pharmacy Guild has a confidential agreement with Pfizer to monitor deliveries and improvements where necessary. A report commissioned by rival wholesalers argues that Pfizer’s move to become sole distributor of its products imperils the current distribution system, which is backed by $180 million in federal subsidies.
Pfizer is understood to has taken over distribution of its products to lock in long-term deals with pharmacies before several of its most lucrative drugs go off patent next year.
Growing Prescription Drug Shortages Alarm Falls Pharmacists
Last year, the number of newly reported prescription drug shortages in the United States hit a record total of 211.
Already during the first quarter of 2011, there have been 196 reported shortages and if the trend continues, the number of drug shortages will double those seen in 2010.
That was the alarming message presented at Community Memorial Hospital recently during a President’s Advisory Council meeting. Terry Audley, the hospital’s Pharmacy Clinical Supervisor and Mark Meranda, the hospital’s Outpatient Pharmacist, painted a disturbing picture of the situation for area business leaders who attended.
The list of drugs becoming harder to get include certain antibiotics, cancer, heart and high blood pressure medications such as Dyazide and Maxide. The latest high profile drug to be added to the list is the generic form of Adderall XR, used to treat attention-deficit hyperactivity disorder (ADHD) in children and adults.
“We order medications that we generally use day to day in the hospital that are unable to be supplied to us through our wholesalers because manufacturers are not supplying them to the wholesalers,” Audley said. “So we can’t get the drugs. There have been documented cases where people have died because they could not get the antibiotic they needed to treat a particular infection. There have been delays in treatment for cancer where some patients get an alternate cancer treatment protocol that may not be as effective because you can’t get the most effective drugs.”
Why the shortages?
There are multiple reasons in play. In some cases, a product is recalled because there are issues with sterility, contamination or poor manufacturing practices. In other cases, a drug is in short supply and there is a surge to find an alternative drug which then creates a shortage with the alternate medication. Sometimes pharmaceutical companies consolidate so, instead of having two companies that produce the product, now there’s only one. That cuts the supply in half.
Another big contributing factor is the global nature of the pharmaceutical industry.
“The pharmaceutical industry is more global now so a lot of raw materials may come from other parts of the world,” Audley explained. “Things can disrupt the supply chain like a hurricane, a tsunami, or an earthquake, so you can’t get the raw materials or even the final product into the United States to prepare the meds that we need. Sometimes pharmaceutical companies aren’t making enough money on a product so they just choose to stop making it.”
The line of communication, or lack thereof, between the drug makers and the pharmacists also creates problems.
“I think communication with providers is essential and that’s something we don’t have right now,” Meranda said. “If we could get communication like a drug company saying, ‘This is not a profitable drug for us. We’re trying to streamline our production and get rid of those products where we don’t see much market share’ – well, let us know a year or six months in advance so we can start to plan, so we can move patients over to another manufacturer or find another alternative for the patient.”
The prescription drug shortages are also causing a stir on Capitol Hill. On June 27, a bipartisan group of federal lawmakers urged the U.S. Department of Health and Human Services (HHS) to hold a public hearing on the matter. They are also urging passage of a U.S. Senate bill called the Preserving Access to Life-Saving Medicines Act which will increase the Food and Drug Administration’s authority to address the problem.
“The biggest issue that we see is that there is absolutely no authority in the FDA over these drug shortages,” Audley said. “There is no requirement that the drug companies alert the FDA of an impending shortage or that they’re going to stop preparing a drug. They may be the only company that makes it and they can just stop making it without any advanced warning to anyone. Really, it’s kind of a free-for-all.”
In the meantime, what can consumers do to enhance their chances of getting the medications they need?
“Be your own advocate, talk to your legislators who can give FDA more authority to require that companies that are sole providers of a drug are not be able to just decide to stop making it because it’s not profitable enough,” Audley said.
Consumers are also urged to stay in contact with their pharmacists.
“Your pharmacist should be talking to patients when you pick up your prescription and giving some form of consultation,” said Meranda. “Don’t wait until the last minute for your medications to run out before you call in your refill because it takes time to come up with alternatives.”
Pharmacist tells how to identify fake drugs shop
Caution: During your next visit to a pharmacy, ensure the premises’ licence is visible and that you get a receipt showing the name of the drug purchased.
Dr Jayesh Pandit, the head of the pharmacovigilance department at the Kenya Pharmacy and Poisons Board, on Wednesday asked Kenyans to take part in the fight against counterfeit drugs by buying from licensed pharmacies.
Pharmacovigilance is the department charged with creating awareness on medicine safety.
“Medicines should only be bought from licensed pharmacists, who wear badges branded by the Pharmacy and Poisons Board,” Dr Pandit said.
He was speaking on the sidelines of a two-day conference that began on Wednesday, and which seeks to discuss the risks that counterfeit medicines pose and develop action plans to address the problem.
The World Health Organisation defines counterfeit medicine as “medicine which is deliberately and fraudulently mislabelled with respect to identity and/or source”.
“Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging,” the global body warns.
China, India, Colombia, South America and Egypt are some of the sources of most of the world’s counterfeit goods.
In March, the Kenyan Association of Pharmaceutical Industry estimated that counterfeit pharmaceutical products accounted for approximately Sh9 billion in sales annually.
The conference that continues on Thursday at Nairobi’s Panafric Hotel has participants from Burundi, Rwanda, Madagascar, Kenya, Tanzania and Uganda.
Supreme Court sides with pharmaceutical industry in two decisions
Justices rule that generic drug makers cannot be sued by injured patients in most cases and that drug manufacturers have a 1st Amendment right to buy private prescription records to use for marketing purposes.
June 24, 2011|By David G. Savage, Los Angeles Times
The Supreme Court gave the pharmaceutical industry a pair of victories, shielding the makers of generic drugs from most lawsuits by injured patients and declaring that drug makers have a free-speech right to buy private prescription records to boost their sales pitches to doctors.
In both decisions Thursday, the court’s conservative bloc formed the majority, and most of its liberals dissented.
About 75% of the prescriptions written in this country are for lower-cost generic versions of brand-name drugs. Federal law requires the makers of brand-name drugs to label their products with FDA-approved warning information and to update the warnings when reports of new problems arise.