World news wrapup: 14 March 2019


Patients suffer vision loss after receiving allegedly adulterated eye injections; Boots pharmacists vote for union representation; pharmacist facing charges after unsecured methadone stolen

Dallas, Texas: A federal court has ordered a company to stop producing compounded drug products intended to be sterile until the company complies with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other requirements. According to the complaint, despite previous warnings from the FDA, Guardian Pharmacy Services continued to violate the law, putting patients at risk.

The FDA had inspected Guardian Pharmacy Services in 2016 and sent a warning letter for insanitary conditions and other violations of the Act; in 2017 it received adverse event reports concerning at least 43 patients who were administered eye injections of a drug compounded by Guardian containing triamcinolone and moxifloxacin during cataract surgery.

These patients reportedly experienced various symptoms, including vision impairment, poor night vision, loss of color perception and significant reductions in best-corrected visual acuity and visual fields.

The FDA’s investigation into Guardian’s compounded triamcinolone-moxifloxacin product revealed a high percentage of an excipient, poloxamer 407, and the presence of potential process degradation products. The FDA conducted a follow-up inspection in April 2018 and issued a risk alert to inform patients about these products in July 2018.

Now, the government alleges in its complaint that Guardian manufactured and distributed purportedly sterile drug products that were adulterated because the drugs were made under insanitary conditions and in violation of current good manufacturing practice requirements under the FD&C Act. Drugs prepared, packed or held under insanitary conditions may have been contaminated with filth or rendered otherwise harmful to patients.

According to the complaint, Guardian also manufactured and distributed drugs that were misbranded because their labels did not include adequate directions for patient use, which describe how to use a drug safely and effectively for its intended purposes.

Some of Guardian’s drugs were also misbranded because their labels were false or misleading.

Andrew Sommerman, legal counsel for some of the injured patients, expressed concern to BuzzFeed that the pharmacy could continue to operate, albeit with conditions imposed.

Guardian Pharmacy Services in Dallas is not affiliated with Guardian Pharmacy of Dallas-Fort Worth in Arlington, a member of the national long-term care Guardian Pharmacy Services headquartered in Atlanta.

 

Waikato, New Zealand: A pharmacist who allegedly left methadone – which was later stolen – out on a pharmacy counter is now facing a professional misconduct charge, reports Stuff.

The pharmacist allegedly failed to store the methadone in line with legislation; failed to complete incident reports for two errors; failed to notice incorrect instructions on a medication product label; incorrectly prepared a script and took money from the till at various times, according to the charges.

In April 2013, about 400mL of methadone was stolen from the pharmacy, according to one witness.

She told a hearing that when a person broke into the pharmacy and took the methadone – which was normally prepared in the evening and locked in a safe overnight – they avoided alarm sensors and the alarm did not activate.

When she told the pharmacist in question that the medicine had been stolen, he responded with, “Will I get de-registered?” she told the hearing.

Another witness told the hearing that the pharmacist had a “relaxed” attitude to his job and this occasionally resulted in lax attention to paperwork and other work activity.

Another witness said she would hear the till being opened when the pharmacist in question was the only person in the store; she also said she saw him take IOUs from the till and that the cash book consistently failed to balance.

The pharmacist told her not to worry about the cash book balancing, she told the hearing.

 

UK: A huge majority of Boots pharmacists have voted in favour of their pay and conditions being negotiated by the Pharmacists’ Defence Association, the UK’s union for employee pharmacists.

Only 266 votes (7.6%) voted against union negotiation, with 3,229 (92.4%) in favour, a result which the PDA says shows how out of touch Boots senior management is from its pharmacists.

The vote surpasses the threshold of all eligible voters needed to support union negotiation: the threshold is 40% of all eligible voters, and the union position attracted the vote of 47.5% of eligible voters.

“We mustn’t forget that every single day over the last eight years the company have had the ability to voluntarily recognise the PDAU, but every single day they decided to keep fighting their own employees,” PDA assistant general secretary Mark Pitt said in response to the ballot results. “As a result of this behaviour Boots will now be forced to recognise their employees’ choice of union.

“Despite the clear message from pharmacists in the 2018 ballot, where 87% voted in favour of removing the BPA to allow PDAU recognition, the company continued to use everything it could to stop pharmacists securing an independent voice at work until now.”

The PDA says it now hopes Boots will work with it positively to improve conditions for Boots pharmacists, pre-registration pharmacists, patients and the company.

John Murphy, General Secretary of the PDA Union has written to Boots head Seb James inviting him to work with the union on a constructive relationship with pharmacists.

“We know that there are significant challenges for community pharmacy and any response to these should be developed in conjunction with pharmacists, not done to them,” he wrote. “We want to work with the company to ensure it continues to be a long-term success for the benefit of all.”

 

Tacoma, Washington: Walmart wrongly terminated the employment of a pharmacist who was unable to administer injections due to her disability, a court has found.

Lori Jacobs was terminated from the Port Angeles and Sequim Walmart stores in 2017, following an announcement in 2016 that all pharmacists would have to give injections.

“Having lived with both cerebral palsy and multiple sclerosis for almost my entire life, I know how hard it is for disabled employees to break through the stereotypes put in place by employers,” Ms Jacobs told Washington’s News Tribune.

“I am grateful to the jury for recognizing the importance of the Americans with Disabilities Act, and hopefully my determination will help others avoid what I went through.”

The jurors in US District Court determined that Walmart should pay Ms Jacobs a sum of around US$1 million (AUD$1,418,090).

Walmart issued a statement saying that the provision of immunisations was an “essential job function” for Walmart pharmacists, and that the company was now looking at its options, including an appeal.

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