By A. Daryl. Marietta College. 2018.

The investigators reasoned that if even American college stu- dents 400 mg renagel with visa, who are savvy users of technology renagel 400mg free shipping, and undergraduate students of health science buy generic renagel 400 mg line, who are well educated about health renagel 400 mg generic, could be deceived by internet pharmacies buy renagel 800 mg on line, then how much greater the risk to the average con- sumer (Ivanitskaya et al. They found that participants were quickly deceived by professional-looking websites and unsuspicious of very low list prices. Sixty percent of respondents attributed the low prices to fewer regulatory restrictions; 16 percent thought people should be advised to buy drugs on the internet to save money (Ivanitskaya et al. Beyond promoting the verifed pharmacies, it is unclear what novel actions could better control internet drug sales. To complicate the problem, even unlicensed internet pharmacies have advocates who believe the stores empower them to avoid artifcially infated medicine prices (Wasik, 2012). They may maintain that individual impor- tation from foreign pharmacies improves the competiveness of the drug market (Shepherd, 2007b). Taking advantage of these countries’ price con- trols could, they reason, drive down prices in the United States (Shepherd, 2007b). However, internet importation is, at best, an exploitation of other countries’ price controls (Shepherd, 2007a). Encouraging internet importation is also a shortsighted solution to American problems with drug pricing. As the director of the University of Texas Center for Pharmacoeconomic Studies explained, “Our high drug prices are our problem. Trustworthy, accredited online drug stores do not sell medicine more cheaply than any other registered pharmacy would. In the United States, reducing the draw of unlicensed drug stores requires either regulating the internet, a fool’s errand, or completely renegotiating national drug price controls, which is outside the scope of this report (deKieffer, 2006). In either case, regulatory accreditation can help consumers by identifying the good-faith sellers. In developing countries, the most useful drug-seller accreditation programs are those that work with the private sector to improve retail, especially in rural areas and slums. Training and task shifting could also improve the quality of patient counseling and drug dispensing in low- and middle-income countries. Consumer confdence in drug safety could be improved by strengthen- ing the ability of every intermediary on the supply chain to track drugs’ movement from the manufacturer to the patient. Understanding a drug’s history and path is important, especially as it moves through the unpre- dictable wholesale market. Implementing changes to the American sys- tem would build momentum for stronger medicines regulation around the world. Brands, costs and registration status of antimalarial drugs in the Kenyan retail sector. Subsidizing vocational training for disadvantaged youth in developing countries: Evidence from a randomized trial. The role of pharmacists in developing countries: The current scenario in Pakistan. The changing roles of pharmacists in community pharmacies: Perception of reality in India. Medicine registration and medicine quality: A preliminary analysis of key cities in emerging markets. Can developing countries achieve adequate improvements in child health outcomes without engaging the private sector? Sub- standard medicines in resource-poor settings: A problem that can no longer be ignored. Implementation of falsifed medcines directive: Meeting with patients and conusmer organizations, 30 November 2011. Current development: “And the ones that mother gives you don’t do anything at all” combating counterfeit pharmaceuticals: The American and British per- spectives. Fake antimalarials in Southeast Asia are a major impediment to malaria control: Multinational cross-sectional survey on the prevalence of fake antimalarials. Re: Determination of system attributes for the tracking and tracing of presrip- tion drugs; [docket no. Role of pre-wholesalers in generic pharmaceutical manufacturers’ demand chain management strategy.

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For the purpose of this regula- that the required levels of the vitamins tion discount renagel 800mg without prescription, whole egg solids are the edible and minerals are maintained through- contents of eggs calculated on a mois- out the expected shelf life of the food ture-free basis and exclusive of any under customary conditions of dis- nonegg solids which may be present in tribution and storage generic renagel 800mg fast delivery. The quantitative standardized and other commercial egg content of the following vitamins shall products cheap renagel 400mg with mastercard. I (4–1–10 Edition) Reference form bread buy renagel 400 mg on line, the name of the food may be Vitamin Molec- "enriched milk bread" order 800mg renagel with visa, "enriched milk Name Empirical formula ular rolls", or "enriched milk buns", as ap- weight plicable. As egg but no greater than the amount ac- used in this section, the term "en- tually present. For purposes of this riched flour" includes enriched regulation, whole egg solids are the ed- bromated flour. When the food complies with the re- (b) The name of the food is "milk quirements for milk and/or other dairy bread", "milk rolls", "milk buns", as products content in §136. No flour, bromated ciation of Official Analytical Chem- flour, or phosphated flour is used. Unless such addition conceals damage or inferiority or makes the Subpart B—Requirements for Spe- flour appear to be better or of greater value than it is, one or any combina- cific Standardized Cereal tion of two or more of the following op- Flours and Related Products tional bleaching ingredients may be §137. Harmless oxide mixed with not more than six preparations of a-amylase obtained parts by weight of one or any mixture from Aspergillus oryzae, alone or in a of two or more of the following: potas- safe and suitable carrier, may be used. Final Action," under the heading When the optional ingredient a-amy- "Total Solids Moisture, Indirect Meth- lase obtained from Aspergillus oryzae" od," which is incorporated by ref- is used, it may alternatively be de- erence. The availability of this incor- clared in the list of ingredients as poration by reference is given in para- "Fungal alpha-amylase," "Fungal a- graph (a) of this section. Wherever the name of the Standard Series)" prescribed in para- food appears on the label so conspicu- graph (a) of this section. Attach bot- ously as to be easily seen under cus- tom pan to sieve in Ro-Tap sifter (or an tomary conditions of purchase, the equivalent sifter). Place half of a rub- word "Bleached" shall immediately ber ball or other sieving aid in the and conspicuously precede or follow sieve. Pour 100 grams of the sample in such name, without intervening writ- the sieve and turn on the sifter with ten, printed, or graphic matter; except knocker. The availability of this incor- sium bromate is added in a quantity poration by reference is given in para- not exceeding 50 parts to each million graph (a) of this section. Ash is cal- parts of the finished bromated flour, culated to a moisture-free basis by sub- and is added only to flours whose bak- tracting the percent of moisture in the ing qualities are improved by such ad- flour from 100, dividing the remainder dition. Niacin equivalents as nition and standard of identity, and is derived from tryptophan content shall subject to the requirements for label not be used in determining total niacin statement of ingredients, prescribed content. The quantitative procedure or other milling procedure, content of the following vitamins shall whereby controlled techniques are used be calculated in terms of the following to obtain a food too fine to meet the chemically identifiable reference granulation specification prescribed in forms: §137. Reference form (2) An agglomerating procedure, whereby flour that originally meets Vitamin Molec- Name Empirical formula ular the granulation specification pre- weight scribed in §137. The following proce- made for the added monocalcium phos- dure is substituted for the procedure phate. When it is tested by apparatus to stand 1–2 minutes to in- the method prescribed in paragraph (c) sure that the temperature and pressure of this section not less than 0. Close the stopcock, reacting substance is added in suffi- lower the leveling bulb somewhat to re- cient quantity to neutralize the sodium duce the pressure within the apparatus, bicarbonate. The combined weight of and slowly run into the decomposition such acid-reacting substance and so- flask from burette F 45 cc. Rotate and then vigor- self-rising flour is bleached, the op- ously agitate the decomposition flask tional bleaching ingredient used there- for three minutes to mix the contents in (see §137. Each of the in- the pressure in the measuring tube by gredients used in the food, shall be de- means of the leveling bulb and read the clared on the label as required by the volume of gas from the zero point on applicable sections of parts 101 and 130 the tube. I (4–1–10 Edition) number of mL of gas evolved by the nical purposes to give self-rising char- factor given in section 52. However, if ration by reference is given in para- such calcium is insufficient to meet graph (c) of this section), for the tem- the 960-milligram level, no claim may perature and pressure observed. Divide be made on the label for calcium as a the corrected reading by 100 to obtain nutrient. The quantitative salt, and a sufficient quantity of so- content of the following vitamins shall dium bicarbonate U.

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Initially discount renagel 400mg without prescription, however renagel 800 mg on line, the war years did not make it easy to establish a functioning laboratory in Dunedin renagel 800mg mastercard. There was hardly any equipment and much had to be improvised order renagel 400 mg mastercard, supplies were unreliable purchase renagel 800mg, and there was not much space for Smirk and his staff. During the war, Smirk turned to typical war-time research, such as the study of nitrogen mustards and the search for a pharmaceutical treatment 27 F. Fastier, ‘Biography: Sir Horace Smirk: Professor Emeritus’, New Zealand Medical Journal, 67 (1968), 258-265, p. Porter (eds), Companion Encyclopedia of the History of Medicine, London & New York: Routledge, 1993, pp. This search received a boost when in 1949 he spent a sabbatical at the Postgraduate Medical School at Hammersmith Hospital in London, where McMichael was director and professor of medicine. The therapeutic enthusiasts argued that such etiological questions did not matter, as long as lowering the blood pressure appeared to be benefcial. Furthermore, Smirk designed a detailed treatment regime, including quick and simple fxes for the most obvious shortcomings and side effects of ganglion blocker therapy, enabling it to become routine. An important problem of the methonium compounds was their low solubility in water and the resulting low (and unreliable) rate with which the drugs were absorbed into the bloodstream when taken by mouth. Smirk overcame this by devising a regime of subcutaneous injection, a management solution very similar to the administration of insulin to diabetics. Patients had to be ‘titrated’, the right dose found for each individual patient, and this dose adjusted as patient bodies got used to the drug. As the Hull physician Edmond Murphy observed (who, incidentally, characerised Smirk’s attitude towards hexamethonium as ‘enthusiastic’), ‘Smirk and Alstad [one of Smirk’s co-workers in Dunedin] claimed that with adequate parenteral doses – each patient being a law unto himself – a lowered tension can be maintained indefnitely’. Austin Doyle, who joined Smirk’s department in 1952, remembers: Having been working in a traditional way in a British hospital, I was amazed at the confdent and routine way that these diffcult drugs were being used. Blood pressures were then recorded in both postures at 30-minute intervals throughout the day. Patients would attend daily until the correct dose had been attained and would then be allowed to leave, having been supplied with tuberculin syringes, needles, and multidose containers of the drug, which they had been trained to use. Murphy, ‘Treatment of Hypertension with Hexamethonium Bromide’, Lancet, 258 (1951), 899- 901. The multidose containers had been prepared at the university’s pharmacology department by dissolving bulk supplies provided by May and Baker. Some years later, such multidose vials were available pre-packed, directly from the drug producers. Drugs and discipline Hexamethonium, it seems, disciplined doctors, patients, carers, and technicians alike. With intelligent girls who are keen to learn we have experienced no diffculty whatsoever in obtaining from them accurate pressure readings and comments on corresponding symptoms, if any. The ‘standing test’ took advantage of one of the most common side effects of hexamethonium, postural hypotension, a sudden lowering of the blood pressure when patients stood up, which led to dizziness. Smirk blamed the bad results that other clinical researchers reported with the methonium drugs, as Green wrote in a letter to Paton, on ‘“faulty technique”, namely lack of proper ancillary 34 Smirk, ‘Organisation of a Hypertensive Clinic’, p. Greene, ‘Therapeutic Infdelities: “Noncompliance” Enters the Medical Literature, 1955–1975’, Social History of Medicine, 17 (2004), 327-343. The psychology of the patients also needed tending to: ‘It is well to remember that nervous tension, worry, quarrels, excitement and adverse emotion lead to elevation of the blood pressure’, Smirk wrote. Patients would sit together in groups of four while undergoing their lengthy tests, exchanging experiences, and there was ‘something of the atmosphere of a club about the clinic’. If, however, as Smirk says, it is possible to keep patients with malignant hypertension alive and reasonably comfortable for periods at least of several years, then that does represent an important advance in therapy. A Lancet editorial in 1953 supports Green’s conclusions regarding the potential of the drugs, stating that ‘Early reports leave no doubt that the methonium compounds are the most powerful hypotensive agents yet developed. The ganglion blockers, along with the routines designed by Smirk and his colleagues, had come to form a relatively standardized package that circulated easily and that paved the way for new, more specifc antihypertensive drugs. Commercial exploitation followed, however, with several drug companies developing their own, patent-protected ganglion blockers on the back of the success with the methonium compounds. The new ganglion blockers were not necessarily better antihypertensives than hexamethonium, but they were more easily absorbed by the gut 39 Green to Paton, 25. Smirk, ‘Hypotensive Actions of Hexamethonium Bromide and some of its Homologues: Their Use in High Blood-Pressure’, Lancet, 260 (1952), 1002-1005.

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The role of professional control and surveillance remained all the more important as this weak administrative regulation was hardly balanced by strong industrial regulation discount 400mg renagel with mastercard. Schering buy renagel 800mg free shipping, sex hormones safe 800 mg renagel, and the rise of industrial regulation in Germany Schering’s contribution to the industrialization and molecularization of sex hormones has been discussed elsewhere purchase renagel 800mg free shipping. Three levels of practices need to be distinguished buy renagel 800 mg cheap, which expanded in the 1930s in parallel to the scaling up of production and with the shift from preparations based on the manipulation of pregnant-mare urine to pure biochemical entities, synthesized by using cholesterol as raw material. These three types of regulatory activities are rooted in the aims gradually associated with the industrial development of the German drug market mentioned above when discussing Madaus’s operations: to standardize, to ensure quality control, and to control prescription practices. First, higher productivity and reduced costs were associated with the quest for well-defned protocols and homogeneous preparations. When weighing investments against benefts, Schering always considered the partial synthesis of steroid hormones out of cholesterol as the best solution. The most obvious new feature for science historians is the in-house research laboratory. At Schering, its development out of testing facilities resulted in a combination of chemical and physiological investigations that reinforced the importance of processes, the specifc steps of which mimicked cellular biochemical reactions; these processes could be seen as industrial translations of biological transformations and as transferring the properties of natural substances to the products of the factory while conferring an aura of naturalness to industrial production. Another, less expected way of stabilizing and legitimizing production receipts, however, proved far more important: the management of patent applications to be evaluated by experts of the Reich patent offce. As recounted elsewhere, the interwar period is a critical moment in the history of drug intellectual property as this was when large companies established the set of scientifc, administrative, and legal practices that gradually made drug patents acceptable, leading to signifcant changes in the policies and jurisprudence of patent offces. Patents, biological drugs and industry in early 20th-century Germany”, History and Technology, 2008, 24 : 107-133. Protocols that were deemed too obvious, to overlap existing patents, or impossible to protect thus died at an early stage of development, while long-established routine procedures could suddenly lose their legitimacy as an effect of newly appropriated chemical knowledge. A good example of the consequences of this legal regulation of property on the standards of production is the “turn” toward a cholesterol-based partial synthesis of the three sex hormones (estrogens, progesterone, and testosterone) that Schering sold and was implemented during the war. A second approach typical of Schering’s industrial regulation linked questions of drug quality and safety of clinical uses with the control of highly variable biological raw materials. Defning consensual biological assays for hormone preparations was seen as a very important step in the company, since animal rather than human testing was considered indispensable to evaluate the potency of hormone charges in the production setting, the composition of which was complex, variable, and badly known. Until the late 1930s, direct measurement of one or a few carefully recorded physiological effects remained the only way to assess the presence of an active substance within these charges and to quantify it. In other words, the industrial standardization of hormone preparations was a problem of Wertbestimmung (valuation). As had been the case in the production of sera after 1895, biological assays played a critical role in measuring the potency of every single batch of the processed material. The characterization of each batch with a reference number of “male” or “female” biological units was the frst and mandatory step in the defnition of the pharmacological dosages to be employed by doctors. As a consequence, clinicians’ prescription practices relied on the same sort of bioassays as those of engineers. Legally defned professional responsibility of the pharmacist as drug manufacturer – biological or not – made the pharmacist liable if the composition of the products did not correspond to claims and if use under normal dosage and circumstances led to injuries. Standardized preparations were thought to be better and more reliable drugs, echoing the doctors’ quest for a more scientifc medicine. More precisely, Wertbestimmung as practiced in the testing laboratory did not aim only at the measurement of biological and – putative – clinical effects. Quantifying the concentration of active substance in a given batch was central to the surveillance and control of production. Testing was implemented at the end of the production process, and at the beginning as well, as routine control of the raw materials. As from the late 1920s, preparation of the female hormone started with the treatment 49 Wimmer, op. Schering collected large quantities of urine, frst from pregnant women and later from pregnant mares. The content of the incoming cans was regularly tested in Junkmann’s laboratory to verify that it was worth processing. When production shifted to the use of horses, this was also a way of controlling the work done by the farmers benefting from a supply contract. Another industrial function of the biological assay was to compare the effects of changes in the preparation process (modifying the nature of solvents, changing concentrations, or varying temperature and pressure), which were indispensable to transform new procedures envisioned by in-house scientists and engineers into full-fedged manufacturing practices. Biological assays of batches produced under different conditions thus became part of the industrial search for increased productivity.

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