Historical Evolution and Provider Awareness of Inactive Ingredients in Oral Medications.

PURPOSE: A multitude of different versions of the same medication with different inactive ingredients are currently available. It has not been quantified how this has evolved historically. Furthermore, it is unknown whether healthcare professionals consider the inactive ingredient portion when prescribing medications to patients. METHODS: We used data mining to track the number of available formulations for the same medication over time and correlate the number of available versions in 2019 to the number of manufacturers, the years since first approval, and the number of prescriptions. A focused survey among healthcare professionals was conducted to query their consideration of the inactive ingredient portion of a medication when writing prescriptions. RESULTS: The number of available versions of a single medication have dramatically increased in the last 40 years. The number of available, different versions of medications are largely determined by the number of manufacturers producing this medication. Healthcare providers commonly do not consider the inactive ingredient portion when prescribing a medication. CONCLUSIONS: A multitude of available versions of the same medications provides a potentially under-recognized opportunity to prescribe the most suitable formulation to a patient as a step towards personalized medicine and mitigate potential adverse events from inactive ingredients.

Reflections on the Formulary System from 1997 to the Present.

DISCLOSURES: No funding was received for the writing of this reflection. Avey is a member of the AMCP Foundation and has recently retired from MedImpact Health Systems, where he served as Vice President of Specialty Clinical Solutions.

The British Pharmacological Society's WDM Paton Memorial Lecture 2019: How doctors were informed about pharmaceutical products through advertising in the British Medical Journal from 1955/6 to 1985/6.

We have reviewed pharmaceutical advertisements in every available issue of the British Medical Journal (BMJ) in 12-month periods during 1955/6, 1965/6, 1975/6, and 1985/6. We have determined the amount of advertising, the therapeutic areas covered, and whether adverts reflected the large number of New Chemical Entities (NCEs) launched during that time. For each product we recorded the therapeutic indications, the marketing company, and the number of adverts appearing. The total number of products advertised fell from 340 in 1955/6 to 260 in 1965/6, 70 in 1975/6, and 16 in 1985/6. Advertisement numbers and companies advertising also fell. Antimicrobial drugs and cardiovascular drugs were the top products advertised over the 30 years, with respiratory, analgesic, and gastrointestinal drugs also in the top five. The number of different drugs advertised by individual companies fell from around eight per company in 1955/6 to one or two in 1985/6. There was good concordance between the most advertised therapeutic areas and NCEs entering the market. From the 1950s to the 1980s prescribers were extensively informed about pharmacological advances in therapeutics through BMJ advertisements. Many novel drugs that were advertised proved to be of lasting value. The Medicines Act 1968 introduced product licensing, regulations requiring demonstration of quality, efficacy, and safety, and restrictions on advertising. Subsequently many companies reduced their advertising or stopped altogether. Since advertising influences prescribing, and since antimicrobial drugs were the most commonly advertised products during 1955-86, we speculate that advertising, resulting in excess use, may have, at least partly, driven bacterial drug resistance.

Documenting Medications: Patients' Demand, Physicians' Virtuosity, and Genre-Mixing of Prescription-Cases (Fang'an) in Seventeenth-Century China.

Xianxingzhai guang biji ('Expanded Notes from the Studio of Early Enlightenment') is a Chinese medical case collection based primarily on the interaction between the physician Miao Xiyong and his patients. Professional interest alone, however, cannot explain the unique combination of cases with detailed prescriptions. Rather, elite patients played a crucial role in collecting and publishing these cases, driven in part by the need to prepare their own medications at home. Physicians then reciprocated by sharing their prescriptions for patronage, thereby fashioning a more flexible style of medical virtuosity. Finally, both patients and physicians grappled with the unbounded possibilities and dangers presented by novel illnesses and cures. This episode anticipates the consolidation of recipe-cases (fang'an) as a stable didactic genre by the eighteenth century.

Peter Bourne's drug policy and the perils of a public health ethic, 1976-1978.

As President Jimmy Carter's advisor for health issues, Peter Bourne promoted a rational and comprehensive drug strategy that combined new supply-side efforts to prevent drug use with previously established demand-side addiction treatment programs. Using a public health ethic that allowed the impact of substances on overall population health to guide drug control, Bourne advocated for marijuana decriminalization as well as increased regulations for barbiturates. A hostile political climate, a series of rumors, and pressure from both drug legalizers and prohibitionists caused Bourne to resign in disgrace in 1978. We argue that Bourne's critics used his own public health framework to challenge him, describe the health critiques that contributed to Bourne's resignation, and present the story of his departure as a cautionary tale for today's drug policy reformers.

The regulation of nicotine in the United Kingdom: how nicotine gum came to be a medicine, but not a drug.

This article explores the utility of actor-network theory (ANT) as a tool for socio-legal research. ANT is deployed in a study of the evolution of divided regulatory responsibility for tobacco and medicinal nicotine (MN) products in the United Kingdom, with a particular focus on how the latter came to be regulated as a medicine. We examine the regulatory decisions taken in the United Kingdom in respect of the first MN product: a nicotine-containing gum developed in Sweden, which became available in the United Kingdom in 1980 as a prescription-only medicine under the Medicines Act 1968. We propose that utilizing ANT to explore the development of nicotine gum and the regulatory decisions taken about it places these decisions into the wider context of ideas about tobacco control and addiction, and helps us to understand better how different material actors acted in different networks, leading to very different systems of regulation.

Blockbusters and controlled substances: Miltown, Quaalude, and consumer demand for drugs in postwar America.

In 1955 Carter Products launched its new tranquilizer Miltown with a huge marketing blitz; Miltown soon became one of America's earliest "blockbuster" celebrity drugs. In 1981, federal agents shut down a network of "stress clinics" and arrested the owners, medical staff, and other personnel for illegally trafficking in the sedative Quaalude; Quaalude soon became a "Schedule I Controlled Substance." Both of these stories are familiar, indeed archetypal, moments from America's postwar medical system. As the Miltown example reminds us, this fundamentally commercial system was built on the creation and courting of consumer demand for medical products and services, particularly drugs. As the Quaalude example shows, however, this system also incorporated tools for reining in excessive consumer demand. Together the two episodes affirm an enduring irony of the American medical system: the need for regulatory campaigns to tame lively markets for drugs that had become popular, in part, because of advertising campaigns. This article uses the Miltown and Quaalude sagas to explore the issue of consumer demand for prescription medicines, arguing that efforts to stoke or quash that demand have shaped (and linked) America's medical system and its drug control regimes.

Direct-to-consumer prescription drug advertising: history, regulation, and issues.

Direct-to-consumer advertising has changed the way prescription drugs are marketed in the United States. This article traces the history of direct-to-consumer advertising of prescription and over-the-counter medications and describes how drug advertising is regulated and by whom. It also discusses the controversies that surround direct-to-consumer marketing of prescription drugs.

"The physician's hand": trends in the evolution of the apothecary and his art across Europe (1500-1700).

This article surveys the place of the apothecary in the Italian and wider European social and professional context of the sixteenth and seventeenth centuries. In contrast to localized studies, a comparison across Europe can serve to measure the general pace and lines of development. The type of goods the apothecary sold will be analyzed, as well as the professional evolution of the apothecary and the competition offered by rival groups. Here, the apothecary shall be placed somewhere between merchants and medics, but his relationship with the civic authorities and the traditional guild structure shall also be elucidated. We shall see how changing circumstances, economic shifts and new therapeutic technologies affected the apothecary and his place in the world. For the Italian apothecary, trends only pointed to his eclipse, as northern European pharmaceutical texts, manufacture of medicinal goods and precepts of "the new science" came to the fore.

[Controversial expertise. The "Scientific Advisory Committee for Drug Safety" and its role in drug regulation in the Federal Republic of Germany, 1968-1976]. / Umstrittene Expertise. Der Beirat "Arzneimittelsicherheit" in der bundesdeutschen Arzneimittelregulierung 1968-1976.

The article focuses on the "Scientific Advisory Committee for Drug Safety" of the Federal Ministry of Health. Highlighting the role this committee played in West Germany's policy on medicinal drugs, it shows how drug regulation during this period shifted from expert committees to a larger public consisting of media, pressure groups of alternative medicine and politicians.

Keeping modern in medicine: pharmaceutical promotion and physician education in postwar America.

Recent critiques of the role of pharmaceutical promotion in medical practice invoke a nostalgic version of 1950s and 1960s medicine as representing an uncomplicated relationship between an innovative pharmaceutical industry and an idealistic and sovereign medical profession-a relationship that was later corrupted by regulatory or business practice changes in the 1980s or 1990s. However, the escalation of innovation and promotion in the pharmaceutical industry at mid-century had already provoked a broader crisis of overflow in medical education in which physicians came to use both commercial and professional sources in an attempt to "keep modern" by incorporating emerging therapeutics into their practices. This phenomenon was simultaneously a crisis for the medical profession- playing a key role in attempts to inculcate a "rational therapeutics"-and a marketing opportunity for the pharmaceutical industry, and produced the structural foundations for contemporary debates regarding the role of pharmaceutical promotion in medical practice. Tracing the issue from the advent of the wonder drugs through today's concerns regarding formal CME, we document how and why the pharmaceutical industry was allowed (and even encouraged) to develop and maintain the central role it now plays within postgraduate medical education and prescribing practice.