From guesswork to standards: The history of medicine quality. In the early s, when people needed medicine, they went to their local apothecary, where the druggist would mix together a medical preparation derived from hand-collected plants and minerals. It might have seemed a bit like watching a barista at a coffee shop mixing ingredients in our favorite morning beverage. But the potential consequences of inconsistent or poor-quality medicinal ingredients, or a mistake by the person behind the counter could be far more serious than a less-than-delicious cup of coffee.
Two hundred years ago, the types and quantities of the drug ingredients varied widely. Patients were sometimes given too little or too much. There were often multiple names for the same medicine. And medicines with the same name didn't always share the same properties.
Often "miracle cures" were peddled during traveling side shows. Medical professionals did their best, but, in some instances, the treatment could be more dangerous than the ailment. In the years following the American Revolution, as poverty increased and America's water and air became more polluted, people grew sicker. Mainstream medicine became increasingly ineffective. Americans began to seek out nonconventional medicine and people who embraced these methods, such as midwives, folk healers, and Native American shamans.
Tensions grew between trained doctors and the American public looking for more effective cures 1. This growing distrust of traditional medicine was one factor that drove one of the most groundbreaking periods for medical inventions in the 19 th century, along with the development of modern medicine in general. Rising from this tension, Lyman Spalding, a physician and professor from New York, became alarmed when he observed inconsistent and poor-quality medicines threatening the health of his patients.
He, with the help of Samuel Mitchill, an American physician, naturalist and politician from New York, convinced other physicians to meet in January at the United States Capitol to form the United States Pharmacopeia. They put in place standards for the quality of medicines that would protect the public's health.
Reflecting the spirit of the young nation, the group would not be part of the government, but instead would remain an independent organization that relied on the latest science to build trust in medicines.
The group would meet to continuously revise the science-based standards, which were made publicly available—an early example of using "crowd sourcing" to create an "open source" product for public benefit.
They created a well-defined and clearly described roster of the best understood medicinal substances and preparations of the day that could be used by physicians, midwives and other medical professionals across the newly established United States of America to prepare medicines consistently and to establish independence from Britain. This first edition of the U. Pharmacopeia was written in both English and Latin, making it broadly accessible, and was printed at a low cost to make it easily affordable.
USP evolved from a resource into an authority, as the federal government began asserting itself as an overseer of drug quality. The U. Pharmacopeia was first officially recognized with the Drug Importation Act of , enacted to stop the importation of poor-quality medicines by drug makers in Europe, who stamped the products "good enough for America.
The role of government regulation of medicines continued to grow in the early 20 th century. Sadly, this often occurred in response to a tragedy resulting from the use of poor-quality medicines.
Beginning in the late 19 th century, an injection of antitoxin saved the lives of countless diphtheria patients, most of them children. But in , the treatment turned deadly when 13 children were injected with diphtheria antitoxin contaminated with tetanus. One physician who had administered the diphtheria antitoxin lamented, "There I found that the little girl was suffering from tetanus lockjaw.
I could do nothing for her. The poison was injected so thoroughly into her system that she was beyond medical aid. Physicians and patients trusted the antitoxin, but its purity hadn't been verified.
Consistent quality. Greater access. January 1 was more than just the start of a new year for USP in It was the implementation date of two new standards designed to safeguard the global drug supply from potentially toxic impurities — mercury, cadmium, arsenic, and lead, for example. USP was founded nearly years ago by eleven doctors who wanted to ensure that the nation had access to quality medicines.
They put together the first pharmacopeia, a book of recipes for making tinctures, extracts, and other medicines. USP Leadership. Will Whitaker. FACT: USP is a volunteer organization Our Council of Experts and Expert Committee volunteer members come from academia, health care, governmental agencies, the veterinary sciences, the pharmaceutical, herbal medicines, and dietary supplements industries, and retail pharmacies.
Learn More about pharmacopeias Visit the following to gain more pharmacopeial insights: Pharma-Co-What? Access the database. USP creates and continuously revises USP—NF standards through a unique public—private collaborative process, which involves pharmaceutical scientists in industry, academia, and government as well as other interested parties from anywhere in the world. Related Resources and Products.
Compendial Tools. Reference Standard Catalog.
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