Hurricane Devastation Impacts Health Care Supply Chains

The destruction caused by Hurricane Maria in Puerto Rico last month has created major disruptions for the island’s pharmaceutical product and medical device manufacturing facilities. Days of interruption and damage to manufacturing plants are affecting international supply chains for products such as cancer and HIV treatments, immunosuppressants for patients with organ transplants, and small-volume bags of saline, which are necessary for patients who need intravenous solutions.

Puerto Rico is the fifth-largest territory in the world for pharma manufacturing and produces about half of the world’s top-selling patented drugs, according to a 2016 report from Pharma Boardroom. Short-term economic losses are being estimated, while concerns persist about the storm’s long-term effect on employees’ abilities to travel to work, the safety and efficiency of the machinery used and the ability to keep the facilities running on generators. In a statement issued by the Food and Drug Administration (FDA) on Oct. 6, Commissioner Scott Gottlieb detailed plans to help Puerto Rico recover its medical product and manufacturing base, which he said “are a key component of the island’s economic vigor.”

“[..]even the facilities that sustained relatively minor damage are running on generator power. They could be without commercial power for months…Moreover, most of the facilities that we know of, that have resumed production, maintain only partial operations. New shortages could result from these disruptions and shortages that existed before the storms could potentially be extended.”

Citing data from the Bureau of Economic Analysis, Gottlieb said that pharmaceutical products manufactured in Puerto Rico “make up nearly 10% of all drugs consumed by Americans. And that doesn’t even account for medical devices.” He noted that the FDA is keeping a close watch on about 40 critical pharmaceutical and biological drug products which, in the event of a shortage, “could have substantial impact on the public health.”

He added, “In urgent cases, when critical products are at issue, we’ve intervened over the last two weeks to help firms secure fuel to maintain production lines, get clearance to move logistical support into the island or finished goods to their recipients.”

The Washington Post reported that more than four dozen FDA-approved drugmaking facilities are in Puerto Rico, including ones owned by Pfizer Inc., Merck, Eli Lilly, Johnson & Johnson, Bristol-Myers Squibb and Amgen. Baxter International Inc., which the Post cited as being the “dominant player” in the IV market, issued a statement acknowledging the impact of the storm on its operations:

Our sites sustained minimal damage, and we’ve initiated limited production activities in all of our facilities. In addition, we are examining all opportunities to leverage Baxter’s global manufacturing network as we continue efforts to restore operations in Puerto Rico.

As it relates to product supply, in advance of the hurricanes, we implemented our hurricane preparedness plan to help mitigate potential impact. We have also been delivering products to customers in Puerto Rico to help address patient need on the island. And we are continuing to proactively communicate with our customers the actions we are taking to minimize potential disruptions, including closely managing product inventory.

Not all facilities have suffered damage, however. Amgen announced on its site that back-up generators are powering its Puerto Rican site and that, “No product nor in-process inventory has been lost, and … the inventory maintained by the Company and its global distribution network is sufficient to meet patient demand.”

Lawsuits Question Arkema Emergency Preparedness Plan

Last week officials in Harris County, Texas were granted permission to file a lawsuit against international chemical company, Arkema, Inc., in attempt to recover the costs of responding to the crisis at the company’s plant in Crosby during Hurricane Harvey in August into September. The County has asked a court to review the plant’s environmental practices and disaster preparedness plan and to determine how, if at all, it was updated to reflect the projections of 50-plus inches of rain in the days leading up to Harvey’s landfall.

The New York Times reported that in its risk management plan to the federal government, Arkema indicated that floods and hurricanes, as well as power failure and loss of cooling, were threats to its Crosby chemical plant. In its filing with the government, however, Arkema did not provide contingency plans to address those concerns, the Times said.

As previously reported, several feet of floodwaters caused a power outage which subsequently prevented Arkema plant staff from ensuring that nearly 500,000 tons of organic peroxides were kept cooled and stable. The chemicals eventually overheated and caused a series of explosions which started in late August into the first week of September. This led to a mandatory 1.5-mile evacuation of the area, affecting about 300 homes and many nearby businesses.

Local media reported that Harris County Attorney Vince Ryan is expected to file the lawsuit this week. “The company’s lack of preparedness caused a crisis on top of this horrific storm,” Ryan said in a statement. “Dozens of first responders were required by this emergency caused by Arkema when their services were desperately needed elsewhere.”

According to the County’s statement:

Investigations conducted by the Harris County Pollution Control Services and the Harris County Fire Marshal’s Office uncovered serious violations of the Texas Clean Air Act. Ryan will seek to recover the County’s costs for responding to the week-long incident.

This is the second suit to arise from the Arkema plant’s explosions. On Sept. 7, seven first responders filed a negligence lawsuit against Arkema, alleging they were not warned of the smoke and fumes and their effects prior to arriving. The responders claim they became ill shortly after they began working on the scene following the Aug. 31 explosion; many left vomiting, gasping for air and unable to breathe during and after rescue efforts.

The Texas Tribune reported that the lawsuit was updated in late September, swelling to include six additional first responders and a number of area homeowners. They claim to have suffered “upper respiratory infections, bronchitis, pneumonia, itchy, burning eyes, tight, burning throats and the like—illnesses and injuries that did not exist prior to the explosions and fires at the Arkema facility and illnesses resulting from and exacerbated by the explosions and fire at the Arkema facility.” Plaintiffs are seeking more than $1 million in damages, according to the suit.

The third lawsuit was filed Oct. 2 by nearby residents who claim their properties were contaminated with toxins. The federal suit details how residents are now suffering from medical problems ranging from scaling and rashes to respiratory problems.

“Based on testing results received to date, Arkema has not detected chemicals in off-site ash, soil, surface or drinking water samples that exceeded Residential Protective Concentration Levels established by TCEQ for soil and groundwater,” company spokesperson Janet Smith said in an email to Houston Public Media.

Harris County’s full statement can be found here.

Jones Act Waiver Granted for Puerto Rico

A request to temporarily waive the Jones Act for Puerto Rico that was denied on Monday has been approved. President Donald Trump waived shipping restrictions on Thursday to help speed up fuel and supply deliveries to Puerto Rico, devastated by Hurricane Maria, the White House said.
Maria wiped out power on the island and destroyed infrastructure and cell towers, leading to massive shortages. Even though a waiver had been granted to Texas and Florida after Hurricanes Harvey and Irma, the Department of Homeland Security initially said there was no need to waive the restriction for Puerto Rico, as it would not address the issue of the island’s damaged ports.

The Jones Act, or the Merchant Marine Act of 1920, was initiated almost 100 years ago to keep foreign-flagged vessels from shipping fuel and goods between U.S. ports. The last previous waiver was in December 2012 to allow petroleum products to be delivered for relief assistance after Hurricane Sandy.

Sen. John McCain, R-Ariz., disagreed with the initial decision to deny suspension of the act for Puerto Rico. He wrote to the Department of Homeland Security urging it to allow a waiver and ultimately “a full repeal of this archaic and burdensome act.” Without the waiver, McCain said residents of Puerto Rico would end up paying at least twice as much for food, drinking water and other supplies.

Supporters of the Jones Act, including ship builders, have maintained that it supports American jobs, including jobs in Puerto Rico and keeps shipping routes reliable, according to Reuters. They also contend that the issue in Puerto Rico is distributing shipments across the island once they are delivered.

The temporary waiver was not a surprise, as Puerto Rico Gov. Ricardo Rossello said on Wednesday that he expected the federal government to suspend the Jones Act. He said he had been speaking with members of Congress from both parties who supported an emergency waiver.

Hurricane Debris Removal Costs Climbing

It’s difficult to find a photo of Houston, Miami, or any city hit by Hurricanes Harvey and Irma that doesn’t contain mountains of debris. As cleanup continues, more trash is piling up everywhere. Cities and towns are faced with a number of issues including costs, expediency, manpower and just what to do with all that trash.

Reuters reported that cleanup after Hurricane Katrina in 2005 took about a year. Hugh Kaufman, a retired EPA solid waste and emergency response analyst said the overall bill for Katrina was $2 billion, the largest to date. That cleanup spanned several states and the demolition of the more than 23,000 homes in the New Orleans area alone. He believes the combined cleanup tab for Harvey and Irma will top Katrina‘s.

In Houston, city officials estimate that about 8 million cubic yards of debris will need to be hauled away, enough to fill up the Texans’ NRG Stadium twice. There are about 100,000 piles of trash in the city, with collection farther along in some neighborhoods than in others, according to the New York Times. Moving these mountains of garbage has been left to county and local officials, who hire debris removal companies to help. FEMA reimburses local governments for 90% of their cost. About $136 million in federal funds were released to pay for initial cleanup around Houston, Reuters said.

In Brevard County, Florida, it is estimated there will be 600,000 cubic yards of trash hauled away—compared to 800,000 cubic yards after Hurricane Matthew—which they anticipate will take about a month, Florida Today reported. Because there is no set schedule for pickup, a number of residents decided not to wait, instead hauling their debris to landfills, causing traffic tie-ups.

Where will all this trash go? In Texas, contracted waste haulers and municipal crews are moving trash to dozens of landfills.

Judith Enck, a former regional administrator for the Environmental Protection Agency who dealt with the aftermath of Hurricane Sandy told the New York Times that figuring out what to do with debris is one of the most challenging aspects of any storm. Because decisions are generally made at the local level, she said, “every community has to kind of reinvent the wheel.”

Setting aside appliances like refrigerators for recycling, chipping downed trees for mulch instead of burning them, prevents pollution and extends the life of landfills, Enck said, adding that leaking landfills present a hazard that can pollute groundwater.

A number of municipalities are asking residents and businesses that put their trash out for pickup to separate trees and other plant material from debris such as shingles, fences and roofing materials.

Florida Today offered these guidelines for preparing storm debris for pickup:

  • Debris should be placed on the curbside, but not in the road or on a sidewalk.
  • Debris should be sorted into separate piles—such as piles for vegetation, for wooden construction debris and for metal construction debris—to help speed up the pickup process.
  • Vegetation and other debris should be cut into sections no longer than 4 feet.
  • Do not use bags for yard waste, as it makes it impossible to recycle or mulch.
  • Do not put yard waste on top of storm drains, as it could block receding waters from Hurricane Irma flooding.
  • Neatly stack construction and demolition debris (drywall, roof shingles, siding, carpet, fencing and docks).
  • Never place debris next to utility poles or transformers, under power lines, on top of water meters, by fire hydrants, near vehicles, next to mailboxes or fences.
  • Do not place debris on other people’s property.