Compounding Gold Standards and Compliance and Standards

Slides and Notes prepared by Alexander Pytlarz, PharmD, Keystone Consulting Rx on 12/1/2012, can be found here

State closes deadly drug shipment misbranding case

Published 2:00 p.m., Tuesday, November 27, 2012

AUSTIN, Texas (AP) — The Texas attorney general's office has resolved its case against a Dallas-based mail-order compounding pharmacy over a shipment of a misbranded drug ingredient blamed for three Pacific Northwest deaths.

An attorney general's office statement Tuesday says pharmacist Gary Osborn and his companies, Apothecure Inc. and SpectraPharm Inc., will pay $200,000 to the state, including $100,000 in civil penalties. They also agree to compound drugs to order and in a legal manner.

Osborn and ApotheCure received probation and $100,000 fines after pleading guilty to two misdemeanor criminal violations of the federal Food, Drug and Cosmetic Act.

The cases center on a February 2007 shipment of a gout drug containing some vials with dosages more than seven times stronger than shown on the label. Autopsies showed three Oregon patients suffered fatal overdoses.

Read more: http://www.sfgate.com/news/texas/article/State-closes-deadly-drug-shipment-misbranding-case-4071164.php#ixzz2DTGehD3Y

Could There Be Another Meningitis Outbreak?

Nov 26, 2012 Uncategorized, Updates

The recent fungal meningitis outbreak devastated the country’s confidence in the system of checks and balances that keep its healthcare system safe and effective. Caused by an improperly-sterilized batch of custom-made intravenous steroids, the outbreak has so far killed over 30 people and has afflicted nearly 500 others. It has also led to rounds of recrimination and soul-searching as the country’s healthcare watchdogs race to prevent another tragedy from occurring again. Unfortunately, there are indications that it may only be a matter of time before tainted vaccines, drugs or other supposedly-safe vehicles cause a similar outbreak.
It appears that the recent outbreak was caused by the collective failure of Massachusetts state health regulators and the FDA to recognize and halt a pattern of fraudulent and misleading activity at the company that manufactured the steroid cocktail responsible for the meningitis outbreak. Known as New England Compounding Center, the company may have been engaging in unsafe practices for a decade or more before the outbreak occurred. While both the FDA and the Massachusetts Pharmacy Board seemed to have been aware of systematic health violations at NECC’s main facility in Framingham, Massachusetts, neither took meaningful steps to correct the problem.
This seemingly unconscionable lack of oversight and accountability occurred partially by design. NECC was founded as as a compounding facility that existed to produce custom mixtures of prescription drugs on demand. The company was licensed as such and never cleared by any health regulators to operate as a direct-to-retail manufacturer of original drugs. The state and federal laws that govern the operation of compounding facilities are considerably more lax than those that govern the operation of pharmaceutical companies and drug manufacturers.
Unfortunately, it appears that NECC was operating as a de facto drug manufacturer. The company maintained agreements with doctors, hospitals and retailers in nearly every state and would regularly produce generic knockoffs of existing drugs and vaccines. It would also regularly produce made-to-order steroid mixtures like the batch that caused the outbreak.
Although the enormous scale on which this particular company distributed its products may have been unusual, many other compounding facilities continue to blur the line between custom compounding and wholesale manufacturing and distribution. In fact, a recent investigative report by NBC News found that over 7,000 compounding facilities regularly make mixtures of steroids and other drugs. About 3,000 adhere to sterile processing protocols designed to minimize the risk of the sort of cross-contamination that caused the NECC outbreak.
The FDA and the various state health regulators are now racing to come up with a framework for recognizing and punishing lapses in the production and sterilization processes used by these outfits. Since NECC was cited several times during the run-up to the outbreak without ever being ordered to halt its operations, it’s clear that regulators must put in place a stricter regime that immediately identifies and isolates problematic procedures. The task at hand is an urgent one: Every year, dozens of compounding facilities are cited by local health authorities for lapses resembling those that occurred at NECC.
It’s unclear whether regulators can update the safety protocols designed to prevent tainted drugs from reaching the market in time to prevent another outbreak. Bacteria, fungi and viruses suspended in improperly-sterilized compounds can continue to grow and avoid detection for long periods of time. It may ultimately fall to the FDA and other agencies to combine more sensitive testing procedures with more aggressive inspection schedules. Even so, this fungal meningitis debacle serves as a sobering reminder that medicine is an imperfect science.

Jesse Anderson has worked in the medical field, and knows how dangerous fungus and bacteria contamination can be for patients. If you believe that you have been infected by meningitis, seek help from a certified personal injury lawyer specializing in meningitis.

Dept. of Health cites Bayview Pharmacy for state law violation

November 26, 2012

By

MARIA SHANAHAN

mshanahan@ricentral.com

The Rhode Island Department of Health recently ordered the South Kingstown business to temporarily stop compounding certain medications.

SOUTH KINGSTOWN – The Rhode Island Department of Health recently found that Bayview Pharmacy on Tower Hill Road has been compounding medications in violation of state law and ordered it to stop doing so immediately.
When Bayview Pharmacy was unable to produce an environmental test result from its sterile room at a follow-up inspection Nov. 13, the Department of Health ordered Bayview to temporarily cease production of sterile medications until an outside company retests the sterile room and the Department of Health reviews the results.
Bayview Pharmacy produces both sterile medications, such as injectables or eye drops, and non-sterile medications, like capsules, and according to Ryan Dyer, owner and pharmacist at Bayview.
“That only accounts for about 1 or 2 percent of our business,” Dyer said of the production of sterile products. “The other 98 percent is non-sterile capsules, suspensions or suppositories.”
Compounding is defined by the Rhode Island Rules and Regulations Pertaining to Pharmacists as, “the act of combining two or more ingredients as a result of a practitioner’s prescription or medication order occurring in the course of professional practice based upon the individual needs of a patient and the relationship between the practitioner, patient and pharmacist. Compounding does not mean the routine preparation, mixing or assembly of drug products that are essentially copies of a commercially available product.”
On Tuesday, Bayview had an outside company in to re-test the sterility of the room in which they produce sterile medication. According to Dyer, the testing was completed Wednesday and Bayview will be recertified to produce sterile injectables by the end of the week.
The Department of Health did not order Bayview to cease production of non-sterile medication or to discontinue business. During the inspection, Bayview continued to produce non-sterile products without interruption.
Dyer admitted the missing environmental test results were an “oversight” but said that all of Bayview’s injectables are sent off site for sterility testing and said “every product that we’ve produced has always been sterilized to proper means we’ve had no reports in six years that our products are not sterile.”
None of Bayview’s medications, sterile or non-sterile, are being recalled.
The Department of Health also found that Bayview used expired powders on at least two occasions to compound a non-sterile topical preparation, and ordered the pharmacy to discontinue doing so.
Bayview also reportedly sent sterile injectables to practitioners in Indiana and other states, which is in violation of Rhode Island state law, according to the Department of Health findings. The department has ordered the pharmacy to cease doing so.
On Sept. 7, Department of Health inspectors observed bedding, food and water dishes for pets in the pharmacy, which have since been removed.
Ryan Dyer said he believes the Department of Health is acting out of early concern based on a recent meningitis outbreak. Nearly 500 people fell ill, including three in Rhode Island, after receiving steroid shots made by a compounding pharmacy in Massachusetts.
“We’ve provide to the [Rhode Island Board of Pharmacy] everything they’ve requested, we haven’t had to make any modifications to our facility,” Dyer said. “They’re doing this out industry concern and maybe to set an example.”
Dyer said Bayview does not produce spinal injectables, like those responsible for the meningitis outbreaks.
Despite the Department of Health’s findings, Dyer insists that Bayview Pharmacy has a reputation of cleanliness.
“We have the most state of the art compounding lab in Rhode Island, if not in New England,” he said. “We have had a company come in every six months for the past six years and they have certified that the sterile room is sterile; that’s 12 inspections and there was never an incident.”

Source

Southern Rhode Island Newspapers

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• The Narragansett Times 

Previous fungal meningitis outbreak a decade ago resulted in no oversight changes

By David Brown

First, David Brannon couldn’t believe it. Then he couldn’t stand hearing about it.
Hundreds of people were ill with fungal meningitis they had contracted after getting pain-killing injections made by a compounding pharmacy in Massachusetts. Dozens were dead, and the numbers were still rising.
“It’s quite painful to follow, actually,” said the 60-year-old North Carolina lawyer, recalling a similar outbreak that killed his mother, Mary Virginia Scyster, in 2002. “It took my mother 66 days to die.”
Scyster was a victim in an outbreak eerily similar to the one now unfolding. In both, a steroid called methylprednisolone acetate became contaminated with black fungus during production by compounding pharmacies making large quantities of the drug.

In 2002, at least seven people got sick and two died after being injected with a drug made by a South Carolina pharmacy. In thecurrent outbreak, 419 people have become ill and 30 have died.

Despite the much higher numbers, nothing much has changed. Mass production of high-risk medicines by local drug stores continues — not only in South Carolina but in most other states as well.
“There appear to be no lessons learned from our outbreak in terms of oversight and regulation of these pharmacies,” said Jeffrey Engel, a 58-year-old physician who as North Carolina’s state epidemiologist investigated the 2002 incident. All the cases occurred in North Carolina.
His view is shared by the infectious diseases expert who diagnosed Scyster’s rare infection.
“It’s déjà vu for sure,” said Srilatha Edupuganti, 44, who was at the University of North Carolina in Chapel Hill and is now at Emory University in Atlanta. “It’s painful that it’s happening again.”
In the earlier incident, health authorities recalled the drug made by Urgent Care Pharmacy of Spartanburg, S.C. South Carolina’s Board of Pharmacy found the pharmacy unsanitary and its sterilization practices inadequate. It suspended the pharmacist’s license for four years and fined him $10,000. Ultimately, the drug store closed and lawsuits were filed.
In the current outbreak, officials recalled tainted lots produced by New England Compounding Center of Framingham, Mass.
“I’m struck that this happened again,” said Engel, who now heads the Council of State and Territorial Epidemiologists in Atlanta. “There should be a cease and desist until safety can be guaranteed. Where is the next one happening?”
Traditional compounding involves a pharmacist making a drug only after getting a prescription with an individual patient’s name on it. Urgent Care Pharmacy and New England Compounding Center were involved in a different type of compounding, which involved the small-batch mass production of drugs — including the riskiest ones, “sterile injectables — by gowned technicians working in clean rooms with special ventilation.
This type of drug-making in pharmacies continues because 42 states permit some form of what’s known as “compounding for office use.” That allows pharmacists to prepare many doses of a drug without patient-specific prescriptions and to provide them to doctors’ offices and clinics based on those places’ regular need.
Compounding pharmacies are regulated by state boards of pharmacy and aren’t held to the same workplace standards and sterility requirements of pharmaceutical plants. Instead, most follow less strict standards — USP 797 — set by an organization called the United States Pharmacopeia. While the Food and Drug Administration can shut down any drug-making activity, in practice it gets involved with compounding pharmacies only if there are complaints of contamination or mislabeling — or after a disaster is underway.
The past outbreak
Mary Virginia Scyster and her husband, David, retired to Pinehurst, N.C., not only for the great golf courses but also because of the town’s reputation for excellent medical care.
In the spring of 2002, Scyster, who was 77, twisted her back while playing golf. The pain persisted and she went to a doctor, who injected the area with an anti-inflammatory steroid. When the drug’s effect wore off, she returned and got a second injection.
“Within two weeks, she was in bed with a headache that wouldn’t quit,” recalled her son, David Brannon. “She resisted going to the hospital, and finally my father just put her in the car and took her. She never came home again.”
Unbeknownst to her, between the first and second shots, the pain clinic at Moore Regional Hospital in Pinehurst had turned to a new source for methylprednisolone when its usual supplier, the drug company Pharmacia, temporarily stopped making it. Between May 6 and June 5, the pain clinic bought 557 vials of methylprednisolone from Urgent Care Pharmacy.
About 140 miles to the east, in Jacksonville, Johnston Pain Clinic also turned to Urgent Care, buying 525 vials of methylprednisolone over five months.
“I couldn’t get what I wanted from anybody else,” recalled anesthesiologist Scott Johnston, now 53. It was there that Vivian Conrad, a 71-year-old retired dispatcher for the sheriff’s department with arthritis, got an injection in her back on June 3.
For both women, weeks or months passed before their infections were fully diagnosed.
When Scyster didn’t improve after two weeks of therapy for bacterial meningitis, a second spinal tap was done. It showed microscopic fungus. She was immediately transferred to Duke University Medical Center, where a world authority on fungal meningitis worked. There, Exophiala dermatitidis, a species that sometimes darkens the tile of bathrooms, was identified.
“By the time she got to the hospital she was never out of pain,” recalled Brannon, her son. “She had a lot of visual hallucinations. It was very frightening for her. Sometimes she would realize what was going on and sometimes she wasn’t with us.”
She died on Aug. 25, 2002.
It gets worse
In the meantime, Vivian Conrad, who lived with her husband in the Atlantic Coast community of Emerald Isle, N.C., was baffling physicians.
“One particular weekend, I remember she was having bad headaches and had had them all week long,” recalled Conrad’s daughter, Chiquita Prestwood, a 63-year-old bookkeeper in Lenoir, N.C. “I asked where they were and she told me toward her neck. I said, ‘Mom, that sounds like meningitis. Why don’t you call your doctor?’ ”
When the weekend was over she did and was admitted to a hospital in Morehead City on July 8.
Her symptoms, however, resembled those of a stroke, and after eight days she was discharged home. Two weeks later, she was readmitted. She got no better. On Aug. 20, she was transferred to a hospital in Greenville, N.C. Fungal meningitis was diagnosed after that.
“They said her spinal fluid, which should be clear, was almost pure pus,” her daughter said.
What happened next is unclear. Either with a tip from a Greenville physician or by the observation of an infectious diseases physician at Duke, the cases of Scyster, now dead, and Conrad, still alive, were put together. Engel, the state epidemiologist, was notified and started to investigate.
On Sept. 27, the South Carolina Board of Pharmacy ordered Urgent Care to close. The pharmacy recalled the methylprednisolone, but it refused to recall other products, which had been shipped to 11 states. On Nov. 15, the FDA issued a nationwide alert against using them.

In early December, the Centers for Disease Control and Prevention described in its newsletter, Morbidity and Mortality Weekly Report, four cases of meningitis and one case of joint infection in North Carolina caused by Exophiala fungus.

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