By L. Esiel. Texas A&M University, Texarkana. 2018.

Later investigations buy 5mg aygestin with visa, including a Pulitzer Prize–winning New York Times series order 5 mg aygestin otc, implicated falsifed ingre- dients from China in an international poisoning crisis (Bogdanich, 2007; Rentz et al. Newspaper reports and other gray literature sources also contain a wealth of information about drug quality problems. Monitoring this litera- ture is a valuable way to follow what drugs are compromised and where. Pharmacopeia’s Media Reports on Medicine Quality Focusing on Copyright © National Academy of Sciences. The reports presented in the compendium suggest that a range of drugs are com- promised in low- and middle-income countries. An overview of case studies and gray literature is helpful to understand- ing falsifed and substandard drugs. Gray literature compendiums and peer- reviewed case studies indicate where and in what product lines drug quality problems occur. Such reports raise awareness of the problem and can trigger scientifc investigation and convenience sampling. Gray literature reports do not often give details of quality testing of compromised samples, but they generally describe products so grossly and obviously compromised that confrmatory lab testing would be unnecessary. Convenience Samples A convenience sample is a no-probability sample chosen for its acces- sibility to researchers, not from an a priori sampling frame. Research on drug quality often uses convenience samples of pharmacies or dispensaries. Convenience studies are logistically simpler than probability-based stud- ies and can be less expensive (Newton et al. Although useful for identifying problems, results of these studies cannot accurately estimate the population prevalence of poor-quality drugs. This section presents the results of some key convenience studies and review papers. Antimicrobial Drugs Antimicrobial drugs treat bacterial, viral, fungal, and parasitic diseases. There are considerable data to suggest that antimicrobial drug quality, par- ticularly the quality of antibiotics and antimalarials, is a problem in low- and middle-income countries. In 2007 Kelesidis and colleagues conducted a comprehensive literature review on antimicrobial drug quality, reviewing Copyright © National Academy of Sciences. They found that a lack of methodological detail prevented pooling or interpreting aggregate results (Kelesidis et al. As Table 3-6 indicates, they found reason for con- cern with antibiotic quality in low- and middle-income countries, though reports of poor-quality antibiotics surface all over the world, including the United States and Europe (Kelesidis et al. A year later, a study of 111 amoxicillin samples collected in four Arab countries found that 56 percent failed U. It is diff- cult, however, to draw frm conclusions about substandard drug production from these studies. Antibiotics degrade quickly in warm climates; it is hard to distinguish substandard manufacture from poor storage and handling. When researchers test only authorized products, they bias their sample against the unregistered products used by the poorest (Seear et al. Some convenience samples have compared the quality of approved and un- approved products. Between 2008 and 2012, Bate and colleagues collected samples of 2,652 anti-infective drugs from around the world: 11 African cities, 3 Indian cities, Bangkok, Beijing, Istanbul, Moscow, and São Paulo. The report mentions that the failure rates were higher among samples from Africa than among samples from middle- income nations (Bate et al. Acute malaria episodes come on quickly and often; antimalarials are bought on short notice from the most 3 Including, but not limited to, amoxicillin, ampicillin, chloroquine, rifampicin, and co-trimoxazole. For these reasons, they are often the target of criminals and unscrupulous manufacturers. Investigators found unregistered medicines least often at the central distribution level (see Figure 3-4). A recent review paper includes some higher estimates of poor-quality antimalarial drugs (Nayyar et al. The review included 28 published and unpublished studies, mostly (n = 22) from convenience samples, but also 7 that included some type of randomized design (Nayyar et al. Of the 497 samples that failed chemical testing, 34 percent had no active ingredient; 4 percent had low active ingredient. In a subset of 919 samples with intact packaging and a verifed, genuine packaging sample for comparison, 46 percent failed packaging analysis (Nayyar et al.

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Clinically important drug interactions • Drugs that increase effects/toxicity of etoposide: calcium chan- nel blockers purchase 5mg aygestin with visa. Discontinue drug administration if platelets <50 purchase aygestin 5 mg without prescription,000/mm3 or neutrophil count <500/mm3. Editorial comments • Use latex gloves and safety glasses when handling cytotoxic drugs. Adjustment of dosage • Kidney disease: Creatinine clearance 40–59 mL/min: dose q12h; creatinine clearance 20–30 mL/min: dose q24h; creati- nine clearance <20 mL/min: dose q48h. Advice to patient • Inform patient how to recognize early symptoms of herpes zoster infection, eg, itching, pain. Cimetidine (another H2 blocker) is considered compatible by American Academy of Pediatrics. Advice to patient • Change position slowly, in particular from recumbent to upright, to minimize orthostatic hypotension. Sit at the edge of the bed for several minutes before standing, and lie down if feeling faint or dizzy. Clinically important drug interactions • Drugs that increase effects/toxicity of calcium blockers: cime- tidine, β blockers, cyclosporine. Impaired renal function prolongs duration of action and increases tendency for toxi- city. Clinically important drug interactions: Other antihypertensive agents increase effects/toxicity of fenoldapam. Editorial comments: Fenoldapam has advantages over nitroprus- side because of its beneficial effects on renal function, particularly in patients with renal impairment. Increase in urine output will be maintained in patients on fenoldapam who are recovering from surgery (cardiac or noncardiac). Mechanism of action: Inhibits cyclooxygenase, resulting in inhi- bition of synthesis of prostaglandins and other inflammatory mediators. Mechanism of action: Binds to opiate receptors and blocks ascend- ing pain pathways. Adjustment of dosage • Kidney disease: Creatinine clearance 10–50 mL/min: give 75% of normal dose; creatinine clearance <10 mL/min: give 50% of normal dose. Contraindications: Hypersensitivity to narcotics of the same chem- ical class, management of acute or postoperative pain, use in outpatient surgeries. Warnings/precautions • Use with caution in patients with the following conditions: head injury with increased intracranial pressure, serious alco- holism, prostatic hypertrophy, chronic pulmonary disease, severe liver or kidney disease, postoperative patients with pul- monary disease, disorders of biliary tract. If nausea and vomiting per- sist, it may be necessary to administer an antiemetic, eg, droperidol or prochlorperazine. This drug can cause severe hypotension in a patient who is volume depleted or if given along with a phe- nothiazine or general anesthetic. Editorial comments • Transdermal fentanyl has become an important therapy for severe chronic pain. When such combination therapy is contem- plated, the dose of one or the other drugs should be reduced by 50% or more. Mechanism of action: Iron in ferrous sulfate replaces ferrous iron in formation of hemoglobin which is reduced in anemia. Eggs, coffee, tea, milk inhibit iron absorption and should be avoided when taking ferrous sulfate. Adverse reactions • Common: constipation, black stools, epigastric pain (15%), heartburn. Clinically important drug interactions • Drugs that increase effects/toxicity of ferrous sulfate: ascorbic acid (vitamin C). Advice to patient • Avoid driving and other activities requiring mental alertness or that are potentially dangerous until response to drug is known. Parameters to monitor: Efficacy of treatment: improvement of symptoms of rhinitis including sneezing, rhinorrhea, itchy/ watery eyes. Interactions with erythromicin, cimetidine, and ketoconazole do not appear to be clinically sig- nificant. Mechanism of action: Inhibits steroid 5α-reductase, thereby blocking the conversion of testosterone to 5α-hydroxytestos- terone. Contraindications: Hypersensitivity to finasteride, women of childbearing age, children. Warnings/precautions: Women who may become pregnant should not come in contact with crushed tablet. Advice to patient: Use two forms of birth control including hor- monal and barrier methods. Parameters to monitor • Efficacy of action: decreased size of enlarged prostate, decreased hesitancy, improvement in size and force of urinary stream, decreased dribbling.

When product tem- ations and at intervals of sufficient fre- perature in the holding tube drops quency to ensure that these values are below the temperature specified in the as specified in the scheduled process: scheduled process buy cheap aygestin 5 mg, product flow should Temperature-indicating device in hold- be diverted away from the filler or ing tube outlet; temperature recorder aseptic surge tank by means of a flow- in holding tube outlet; temperature re- diversion system cheap aygestin 5 mg with amex. If for any reason corder-controller at final heater outlet; product subjected to a temperature differential pressure recorder-con- drop below the scheduled process is troller, if a product-to-product regen- filled into containers, the product shall erator is used; product flow rate as es- be segregated from product that re- tablished by the metering pump or as ceived the scheduled process. The proc- determined by filling and closing rates essing deviation shall be handled in ac- and, if an aseptic surge tank is used, cordance with §113. The product sterile air pressure or other protection holding tube and any further system means; and proper performance of seam portions affected shall be returned to a seals or other similar devices. The condition of commercial sterility be- measurements and recordings should fore product flow is resumed to the be made at intervals not to exceed 1 filler or to the aseptic surge tank. When a regenerator is used, closing operation—(i) Equipment—(a) Re- the product may lose sterility when- cording device. I (4–1–10 Edition) filling and closing system shall be in- media flow rates, temperatures, the strumented to demonstrate that the re- container and closure rates (if applica- quired sterilization is being accom- ble) through the sterilizing system, and plished continuously. Automatic re- the sterilization conditions if a batch cording devices shall be used to record, system is used for container steriliza- when applicable, the sterilization tion. The measurements and recordings media flow rates, temperature, con- should be made at intervals not to ex- centration, or other factors. Incubation tests ilization, the sterilization conditions should be conducted on a representa- shall be recorded. A method(s) from each code; records of the test re- shall be used either to give the reten- sults should be maintained. Critical factors applicable, in the sterilizing environ- specified in the scheduled process shall ment specified in the scheduled proc- be measured and recorded on the proc- ess, or to control the sterilization cycle essing record at intervals of sufficient at the rate specified in the scheduled frequency to ensure that the factors process. A means of preventing unau- are within the limits specified in the thorized speed changes must be pro- scheduled process. A lock, or a notice from manage- and recordings should be done at inter- ment posted at or near the speed ad- vals not to exceed 15 minutes. The container conveyor mitted to make adjustments, is a satis- speed shall be specified in the sched- factory means of preventing unauthor- uled process. Before the at the start of operations and at inter- start of packaging operations, both the vals of sufficient frequency to ensure container and closure sterilizing sys- that the conveyor speed is as specified tem and the product filling and closing in the scheduled process. Such meas- system shall be brought to a condition urements and recordings should be of commercial sterility. A system shall be recording tachometer may be used to provided to stop packaging operations, provide a continuous record of the or alternatively to ensure segregation speed. A means of preventing changes of any product packaged when the in flame intensity and unauthorized packaging conditions fall below sched- speed changes on the conveyor shall be uled processes. A lock, or a notice from man- requirement may be accomplished by agement posted at or near the speed diverting product away from the filler, adjusting device that provides a warn- by preventing containers from entering ing that only authorized persons are the filler, or by other suitable means. The surface tempera- scheduled process, all such product ture of at least one container from shall be segregated and handled in ac- each conveyor channel shall be meas- cordance with §113. In the event of ured and recorded at the entry and at loss of sterility, the system(s) shall be the end of the holding period at inter- returned to a condition of commercial vals of sufficient frequency to ensure sterility before resuming packaging op- that the temperatures specified in the erations. Observations and meas- measurements and recordings should urements of operating conditions shall be done at intervals not to exceed 15 be made and recorded at intervals of minutes. Critical factors ess Materials specified in the scheduled process shall be measured and recorded on the proc- §113. Regular observations frequency to ensure that the factors shall be maintained during production are within the limits specified in the runs for gross closure defects. At intervals mal processing of foods wherein critical of sufficient frequency to ensure proper factors such as water activity are used in closure, the operator, closure super- conjunction with thermal processing. The visor, or other qualified container clo- methods and controls used for the man- sure inspection person shall visually ufacture, processing, and packing of examine either the top seam of a can such foods shall be as established in randomly selected from each seaming the scheduled process and shall be op- head or the closure of any other type of erated or administered in a manner container being used and shall record adequate to ensure that the product is the observations made. The time and temperature of seam cans, each can should be exam- processing and other critical factors ined for cutover or sharpness, skidding specified in the scheduled process shall or deadheading, false seam, droop at the crossover or lap, and condition of be measured with instruments having inside of countersink wall for evidence the accuracy and dependability ade- of broken chuck. Such measurements quate to ensure that the requirements and recordings should be made at inter- of the scheduled process are met. Addi- measurements shall be made and re- tional visual closure inspections shall corded at intervals of sufficient fre- be made immediately following a jam quency to ensure that the critical fac- in a closing machine, after closing ma- tors are within the limits specified in chine adjustment, or after startup of a the scheduled process. All pertinent observations shall er or not specifically mentioned in this be recorded. When irregularities are part, for the thermal processing of low- found, the corrective action shall be re- acid foods in hermetically sealed con- corded. These systems containers from each seaming station shall be operated or administered in a to ensure maintenance of seam integ- manner adequate to ensure that com- rity.

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