‘Blatant disregard for public safety’


Compounding pharmacist

A pharmacist who made and sold preparations from human placenta has had his licence cancelled for at least six years

Isidoro “Rudy” Sanchez was the manager of the now-closed Marigold Compounding and Natural Pharmacy in Courtney, British Columbia, Canada when he dispensed placenta capsules to patients.

According to the province’s regulator, the College of Pharmacists of British Columbia, Mr Sanchez showed a “blatant disregard for public safety and meeting pharmacy practice standards” while working at the pharmacy.

The College has released the results of its investigation into Mr Sanchez’ conduct, in which it found that he engaged in unprofessional conduct and failed to comply with the Health Professions Act, its regulations and bylaws and the Pharmacy Operations and Drug Scheduling Act and its bylaws.

In September 2014, the College’s Inquiry Committee had ordered the closure of the Marigold Compounding and Natural Pharmacy in Courtenay and a suspension on Mr Sanchez’ registration.

This followed an investigation where “serious concerns” were raised about both the pharmacy itself and the pharmacy practice conducted there.

“Human placenta intended for encapsulation was accepted, handled, and prepared with little evident regard for safety protocols necessary when handling human tissue,” says the College.

“This service was being offered despite the lack of a proper facility or the regulatory approval to provide it.”

According to one inspector who visited the premises in September 2014, Mr Sanchez’s PharmaNet records show that 88 prescriptions for placenta capsules were dispensed to patients.

Mr Sanchez was listed as the prescriber for “approximately 64 of the 88 prescriptions”.

A midwife and doctor were listed as the prescriber for some of the remainder of the scripts, but these two practitioners told the College that they had never prescribed human placenta capsules for the named patients.

Human placenta is not a recognised substance under Canada’s Food and Drugs Act.

In September 2014, two inspectors found two bottles of placenta capsules in a refrigerator in the pharmacy’s compounding room.

“There was no patient-specific information on the labels,” the Discipline Committee Panel noted. “This raises concerns about patient health safety.

“Compounding in a pharmacy practice is generally patient specific. In the case of human placenta this is very important. If placentas from different woman (sic) are pooled or if a placenta is used by an individual other than the mother, it raises the risk of transmission of infectious diseases.”

The pharmacy’s website had a section called “placental encapsulation” which outlined several “benefits” of the process, including that contained gonadotropin could prevent hair loss following birth, as well as preventing mood swings and post-partum depression.

Encapsulated placenta was also promoted as containing Oxytocin “for pain and bonding” and restoration of the thyroid stimulating hormone.

“Although it is unclear if the transformation of the human placenta of the mother into capsule form for her own use is the manufacture or sale of a placenta, it is clear that the representations contained on the website meet the definition of a drug for the purposes of the FDA.

“Further, the two bottles of placenta capsules found in the fridge with Marigold compounding labels without any specific patient identification information suggest that some of the human placenta capsules were being sold to women other than the original mother donor.”

The College listed further examples of unsafe practices, including “unsterile and generally unclean” facilities which were used to manufacture a variety of prescription and OTC health products without authority to do so.

“In addition, compounding safety standards appeared to not have been followed when delivering that service,” it says.

It said that patients were counselled on alternative drug therapies and products “well outside” the scope of pharmacy practice, and without notification to the original prescriber.

Documentation was completed and submitted incorrectly to a number of relevant parties.

The pharmacy’s licence was suspended in 2014 and it remains closed.

Now, the Discipline Committee Panel ordered that Mr Sanchez’s registration be immediately cancelled, and that he pay CAD$115,000 (AUD$122,505) in costs.

Mr Sanchez will be eligible to apply for reinstatement of registration six years following the order, and after having paid costs in full.

If Sanchez’s registration is reinstated, he will not be eligible to apply for a pharmacy license or act as a pharmacy manager or director for a period of five years following reinstatement.

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