Journal of Pharmacy and Pharmacology 8 (2020) 228-239 D doi: 10.17265/2328-2150/2020.08.002 DAVID PUBLISHING Mediaeval Quality Assurance of Medicines within the Territory of the State of Burgundy Nanno Bolt Society of the History of Pharmacy in Belgium, the Netherlands and Luxembourg, Thury 21340, France Abstract: The State of Burgundy from Charles the Bold included in 1477 the Low Countries (comprising large parts of present-day Belgium, the Netherlands, Luxembourg and parts of northern France) as well as the counties of Nevers and Burgundy and the duchy of Burgundy. The quality of mediaeval medicines within the territory of the Burgundian State was assured by four themes in the municipal and governmental pharmaceutical regulations: inspection of the pharmacy, surveillance of medicines preparation, quality prescriptions and the professional education. Uniform prescriptions were a key factor in the QA (quality assurance) of medicines. Based on ordinances and on heritage inventories in nineteen Burgundian towns it became evident that between 1310 and 1540 the Antidotarium Nicolai was usually prescribed or present as a formulary and that from 1568 on, the presence of the Dispensatorium Cordis predominated. Key words: Middle ages, history of pharmacy, State of Burgundy, mediaeval QA of medicines. 1. Introduction 1300-1600. In an earlier study [1] nine common themes were distinguished and four of them have been Most studies on the history of mediaeval selected for further analysis in this study. pharmacists are country-based. But the State of Burgundy included in 1477 (large parts of) Belgium, 2.2 Analysis of the Regulations the Netherlands, Luxembourg and France (Fig. 1). The towns where the selected themes on late During the reign of Philip the Good (1419-1467) a mediaeval QA of medicines were found are in a further administrative cohesion for the territory was chronologic order represented and their relative developed with the convocation of the States-General importance has been established as well as their in 1464 in Bruges. After the Act of Abjuration in 1581 evolution in time and the surveillance of their the last link between the Low Countries and Burgundy application. expired. This study is on the various aspects of QA (quality assurance) of medicines in the territory of the 2.3 Inventory and Analysis of Quality Related Prescription Manuscripts and Books State of Burgundy up to 1600. 2. Methods The obligation to prepare medicines according to general accepted prescriptions was an important issue to 2.1 Identification of Late Mediaeval Regulations on warrant the mediaeval medicine quality. An inventory of QA in the course of time prescribed and in reality found Based on publications in the Netherlands, Belgium manuscripts and books have been made and analyzed and France, regulations for apothecaries, practicing in with respect to QA of medicines. thirty-five towns within the territory of the 3. Results and Discussion Burgundian State, have been identified over the period 3.1 Governmental Pharmaceutical Regulations Corresponding author: Nanno Bolt, PhD, research field: middle age history of pharmacists. Between 1200 and 1600 several medical-pharmaceutical Mediaeval Quality Assurance of Medicines within the Territory of the State of Burgundy 229 Fig. 1 The territory of the House of Valois-Burgundy in 1477. 230 Mediaeval Quality Assurance of Medicines within the Territory of the State of Burgundy inspection of the pharmacy by two government jurymen and preparation of medicines under the supervision of a physician; taking an oath to certify that the apothecary will deliver products prepared in a capable and reliable way; limitation of the number of pharmacies; fixation of the prices of various medicinal remedies. The French king Charles VIII promulgated in 1484 the following ordinance [3]: apothecaries own the monopoly for selling medicinal remedies; the pharmacy will be visited 2 or 3 times a year and inspected on the quality of the remedies and the exactness of the weights; the widow of a master apothecary (“femmes de Fig. 2 Portrait of Frederick II in the manuscript DeArte Venandi cum Avibus (About the art of hunting with Birds). maistres veufves”) may continue the pharmacy, provided she employs a sworn master servant; regulations have been promulgated by kings and the master apothecary should have been emperors touching the Burgundian State and often based examined, delivered a masterpiece and should have on earlier town proclamations. In Paris for example an served his seven years apprenticeship in a qualified extended regulation was already known in the year pharmacy; 1322, while the French king Charles VIII proclaimed the son of an apothecary could be exempted from not until 1484 a governmental regulation based on the the apprenticeship obligation and could enjoy Paris one. The governmental “Placcaert” from simplified requirements for the masterpiece Emperor Charles V, addressed to the Low Countries, preparation. was almost a copy of the medical-pharmaceutical Emperor Charles V issued in 1540 in Brussels a regulation from Ghent in 1456. Perhaps the medical-pharmaceutical decree [4] with the following “Constitutiones” from emperor-king Fredrick II, being subjects: unique, form an exception to this rule. inspection of the pharmacy each four months by Frederick II (1194-1250) (Fig. 2) was king of Sicily, 2 physicians and 2 sworn master apothecaries; Italy and Germany and from 1220 on Holy Roman control of the weights; Emperor. Between 1231 and 1243 he edited the education details for the master apothecary; “Constitutiones Regni Siciliae”, a coherent compilation preparation of compounded medicines only of laws and competences. His 1241 “Edict of Salerno” according to prescription of a qualified physician; [2], an appendix of the Constitutiones was the first obligation to make use of qualified prescription modern governmental law for the regulation of the books. apothecary profession with as most important issues: 3.2 The Municipal Proclamations separation of the occupations of physician and apothecary to prevent conflicts of interest; Apothecaries, physicians and municipalities Mediaeval Quality Assurance of Medicines within the Territory of the State of Burgundy 231 recognized the necessity for regulations in of Dijon in 1451, of Ghent in 1456, of Maastricht in pharmaceutical education and in keeping a pharmacy. 1490 [8] and in the 16th century, 23 of such monopoly In the small towns of the Low Countries—where clauses have been identified. usually just one apothecary was established—regulations (3) Price Regulation were formulated in the appointment agreement between In the smaller towns usually just one pharmacist is the town magistrate and the (town-) pharmacist. In the established. Because of the limited number of bigger towns, usually the municipality took the potential clients, it concerns often a town-pharmacist, initiative to draw up pharmaceutical regulations like in (partly) paid by the magistrate and with additional Anvers (1499), Beaune (1576) and Chalon, but in privileges or a monopolized position. Therefore, price Dijon (1490) and Autun the apothecaries themselves limits are promulgated already early in time, such as took the initiative in formulating the regulations [5]. in 1355 in Kampen, in 1451 in Zwolle where the The “Keure” of Ypres—dating from the period prices are fixed by the town-physician, in 1478 in 1292-1310—is the first (extended) regulation known Harderwijk [8] “so men die buten in anderen apteken in the State of Burgundy (and in Western Europe). It copen mach” (not more expensive than in other is assumed that Jan Yperman, during his surgeon pharmacies), in 1487 in Zutphen “dattet gemeyne study in Paris, came across the preparations of the volck niet onredelick beschat worde” (reasonable Paris regulation, promulgated in 1322 and he introduced prices for the inhabitants) and in Bergen op Zoom, the principles already around 1300 in Ypres, a relatively where each year the prices were evaluated by a big town with 30,000 inhabitants at that time [6]. physician [8]. Even in larger towns with a real 3.2.1 Common Themes in the Pharmaceutical competition we come across price limiting Regulations promulgations like in Ypres (1300), in Amsterdam In an earlier study 35 pharmaceutical (1519) with reduced prices for poor people and in town-regulations within the territory of the Leuven where the faculty of the university assesses Burgundian State have been identified over the period the value of the medicines. 1300-1600 and the following nine common themes (4) Position of the Widows and Sons could be distinguished [1]: For 6 towns, clauses are found concerning the (1) Weights and Measures position of the widow of a master apothecary. In The necessity to verify weights and measures is general, she is allowed to continue the pharmacy. In already early in the middle ages recognized and it Dijon, the statutes of 1490 specify that she should concerns not only the apothecaries but every merchant employ a capable servant and that her son enjoys using balances and measures. In Delft for instance, reduced demands for obtaining the mastership. In Lille each merchant was obliged—from 1480 on—to let she has in 1586 the choice to employ a master servant examine and adjust his weights by two merchants and or to enter into partnership with another apothecary a tinman [7]. In Gouda (1490) the weights should be [9]. gauged free of charge by the bailiff and his servants (5) Transfer of Poisons [4]. The