November 26, 2012
The Rhode Island Department of Health recently ordered the
South Kingstown business to temporarily stop compounding certain medications.
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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