Guidelines for single-unit packages of drugs approved by the Board of Directors, American Society of Hospital Pharmacists December 2, 1966.
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Dosage Forms↗
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[Drugs in various packagings].
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Drug Packaging↗
Death by obstruction: sudden death resulting from impromptu ingestion of drugs.
Over an 18-month period, the department of Forensic Medicine and Science at the University of Glasgow investigated four rather unusual drug-related deaths. In all cases, death was due to the obstruction of the airway by a foreign body after an attempt to evade arrest. In all cases, the obstruction was drug packages of various shapes and sizes. Results of toxicology revealed levels of drugs that may have had a significant respiratory effect on the deceased in three of the cases. Rupturing of the packages and hence leakage of drugs being conducive to death was obvious in only one case.
Adult↗
Forensic isotope ratio mass spectrometry of packaging tapes.
Pressure sensitive adhesive tape (brown parcel tape) is employed in a great many criminal activities such as the restraint of individuals during robbery and offences against the person, the enclosure of explosive devices and the packaging and concealment of controlled drugs. Packaging materials are ubiquitous in modern society and are produced in such vast quantities that it is increasingly difficult to distinguish between different products or to link materials to a common source. This study demonstrates the potential of stable isotope ratio mass spectrometry to characterise parcel tapes based on a number of properties. The carbon isotopic signature, derived from the substrate polymer, associated additives and adhesive is highly characteristic of a particular tape and allows samples from different sources to be readily distinguished. Further discrimination may be achieved by the incorporation of deuterium and oxygen isotopic data and by analysis of the isolated backing polymer. Recovery of intact tape from simulated forensic samples proved straightforward and the isotopic signature of the tape did not appear to be affected by adverse storage conditions.
Forensic Sciences↗
Modeling drug information for a prescription-oriented knowledge base on drugs.
There exists little theoretical analysis how to represent knowledge on drugs required for computerized drug-prescription applications. A work package drug information modeling is described which was part of the European OPADE project. We describe the content and structure of a Drug Knowledge Base (DKB) designed to meet the requirements of decision-support systems in the domain of drug therapy, and to facilitate data transfer from various information sources. The definition of the DKB content is derived from the analysis of information requirements at the various stages of the process of the clinical usage of drugs (prescribing, administration, and follow-up). The DKB structure results from the classification of the various data items along two dimensions: (1) entities in the pharmaco-therapeutic domain for which information must be defined (the PharmacoTherapeutic Group, the Component, the ManufacturedPreparation, and the Presentation), and (2) the validity score of the pharmaco-therapeutic information (international, national, or local).
Drug Administration Schedule↗
Strategy for determining extractables from rubber packaging materials in drug products.
The migration of substances from rubber packaging materials into drug products can be significant with certain packaging materials in contact with organic solvent systems. Recommendations for testing drug products for leachables are continually evolving to address new developments. Testing packaging materials using simulated solvents is not always an acceptable protocol for the pharmaceutical industry. We describe a rational strategy for evaluation of the drug product for packaging extractables. A profile of the extractables from rubber packaging materials was made with a range of organic solvents and stress conditions to provide information on substances to target in the drug product. The drug product was evaluated to determine if the matrix would cause interferences that might inhibit detection of the found extractables. Analytical methods were selected based on these findings. The procedures were validated according to FDA guidelines. A stability program using time and storage conditions as variables provided information for acceptance criteria. This same strategy can be used on other types of pharmaceuticals and packaging materials.
Drug Packaging↗
Functional ability of patients to manage medication packaging: a survey of geriatric inpatients.
This study measured the prevalence of difficulty experienced by elderly inpatients in opening and removing tablets from a range of common commercial medication packagings and in breaking a bar-scored tablet in half. One hundred and twenty elderly patients admitted to a teaching hospital acute geriatric service were tested for their ability to open the container and remove a tablet from it. They were rated as 'able' or 'unable' to do so. In all, 94 patients (78.3%) were unable to break a tablet or open one or more of the containers. Of the 111 patients taking medication at the time of their admission, 46 (41.4%) were unable to perform one or more tasks necessary to gain access to medications in their own treatment regimen. The factors that were significantly and independently associated with inability to open containers were poor vision, impaired general cognitive function, and female sex. Many of the drug packagings in common use significantly impede access by elderly patients to their medications.
Activities of Daily Living↗
Comparative study of Saudi-marketed products and US drug labeling.
Drug package inserts from ten nonsteroidal antiinflammatory drugs marketed in Saudi Arabia were compared with their corresponding US labels to determine possible differences in their information content. These variations were assessed with special regard to the number of words used and the type of the information provided. The study showed that inserts of Saudi-marketed products generally conveyed limited and incomplete information. Possible adverse reactions, drug--drug interactions, and date of revision often were not included, although this information was present on the corresponding US labels. Comparisons of the package inserts of the same product from various pharmaceutical companies show wide variations in the amount of information provided. Determining the minimal level of information that must be included by the manufacturer in the package insert and the establishment of firm international guidelines by the World Health Organization could effectively reduce such variations.
Anti-Inflammatory Agents, Non-Steroidal↗
[Drug flow. Good manufacturing practices, good clinical practices].
On a worldwide basis, the drug development circuit in clinical trials undergoes a general movement towards improvement which is sensitive to the degree of quality. The methods used to achieve this are found at the interface of Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP). They consist primarily of two types, for which examples are given here: strengthening of controls (verification of the resemblance of test drugs in double-blind comparison by a "jury" and computerized systems of drug accountability), improvement in "compliance with therapy at the site of investigation" (use of more "intelligent" drug packages and labels).
Clinical Trials as Topic↗
Calculation of doses of drugs in solution: are medical students confused by different means of expressing drug concentrations?
INTRODUCTION: Our hypothesis was that clinical medical students find the different means of expressing the concentration of drugs in solution confusing. We are concerned that lack of formal teaching on this topic may make students liable to make drug dosing errors after they have qualified. Administering the wrong volume of a drug may have serious consequences for patient safety. STUDY DESIGN AND PARTICIPANT GROUP: Web-based electronic multiple-choice examination of clinical medical students. METHODS: We asked clinical medical students at our university three multiple-choice questions concerning the concentration of lidocaine (lignocaine) and epinephrine (adrenaline) in solution and the maximal recommended dose of lidocaine. The incorrect options were wrong by factors of between 4 and 1000. RESULTS: One hundred and sixty-eight clinical students out of 350 contacted responded to an invitation to participate (response rate 48%). Twenty-seven percent answered every question incorrectly and 10% answered all three correctly. The mean score for all students was only 1.24 out of 3 (standard error 0.96). However, final-year students performed significantly better (p = 0.016), implying that some knowledge had been acquired informally. Their higher mean score resulted from correctly identifying the amount of epinephrine (p = 0.005) and lidocaine (p = 0.018) more frequently. Only 27% knew the maximal recommended dose of lidocaine, with no difference between years (p = 0.724). CONCLUSIONS: A substantial majority of medical students are unable to calculate the mass of a drug in solution correctly. There is evidence that some students are picking up this skill during the course, because final-year students performed significantly better than first-year students. Modern medical student pharmacology teaching is highly sophisticated, encompassing genomics, molecular and cell biology. The ability to calculate drug doses safely appears to have been overlooked. Students should be familiar with these concepts, so as to avoid dose errors and associated morbidity, mortality and cost when they begin prescribing. To simplify calculations, drug packaging should express the concentration of drugs in solution solely as mass per unit volume, e.g. milligrams per millilitre.
Clinical Competence↗
Body smuggling of illicit drugs: two cases requiring surgical intervention.
The smuggling of illicit drugs by concealing them within the human body has become a widespread practice. Those individuals who transport packaged drugs are commonly known as "body packers" or "mules". "Body stuffers," on the other hand, are individuals who emergently place the contraband in a body orifice when they sense apprehension is imminent. In the latter instance, the drugs are not well packaged for transportation by human "consumption," hence the high risk for leakage. These individuals require prompt surgical attention under two circumstances: when they are found to suffer from drug overdosage caused by inadvertent leakage or when obstruction in the body is caused by the drug-laden bags. Two such cases are reported. The first patient presented with acute drug overdose and required an emergency laparotomy. The second patient presented with pyloric obstruction and was treated by endoscopic removal of the bag. One must be aware that these patients are walking time bombs, carrying drugs that may be well packed but have the potential to deliver a lethal dose without warning. Knowledge of the type of drug and type of packaging are essential in managing these patients. The overall plan should be close observation, careful monitoring, conservative therapy, and expectant rapid surgical intervention as needed.
Adult↗
Prescription drugs; revocation of final guideline patient package inserts and withdrawal of draft guideline patient package inserts--Food and Drug Administration. Notice.
The Food and Drug Administration (FDA) is revoking the final guideline patient package inserts for 5 classes of drugs and is withdrawing the draft guideline patient package inserts for 5 other classes of drugs. Elsewhere in this issue of the Federal Register, the agency is revoking the regulations that established general requirements for the preparation and distribution of patient package inserts for prescription drug products. Those regulations had established a pilot program that would have been applied to 10 classes of drugs for 3 years. This notice revokes the draft and final guidelines which described how manufactures might comply with the regulations with respect to affected classes of drug.
Drug Labeling↗
Obstruction of critical information on over-the-counter medication packages by external tags.
BACKGROUND: Over-the-counter (OTC) medication packages are important sources of information for consumers during product selection and use. Consumers may not be able to access information from OTC packages if external tags, namely price or anti-theft tags, are improperly placed. OBJECTIVE: To determine the amount and type of information concealed by anti-theft tags and price tags affixed on OTC drug packages. METHODS: A field study was performed by evaluating packages containing acetaminophen and combinations of acetaminophen in stores located in Houston. Five packages for 4 products selected from each store after an initial survey for presence of an external tag were examined. A data collection sheet was prepared that extracted the type and amount of information concealed by these tags. Data were analyzed by performing descriptive analyses to provide an understanding of the information obscured. RESULTS: A total of 24 stores were considered in the study, and 67 products and 285 packages were evaluated. External tags, both anti-theft and price tags, obscured significant amounts of information on the principal display panel (53.4%) and the Drug Facts panel (47.7%) of OTC packages. These tags concealed crucial information on various aspects of labels such as brand names (42.3%), product description (36.3%), warnings (51.5%), uses (10.4%), and purposes (7.2%). CONCLUSIONS: Results suggest that improper use of external tags clearly obscured important information on OTC medication packages necessary for consumers to make informed decisions regarding product selection and use. Tagging practices should be altered to allow consumers full access to drug information on the product.
Advertising↗
Photodegradation products of propranolol: the structures and pharmacological studies.
Recently, single-dose drug packaging systems, allowing the administration of multiple drugs in a single pill, have become popular for the convenience of the patient. The quality of drugs and an accurate measurement of their photostabilities within this system, however, have not been carefully addressed. Drugs that are unstable in light should be carefully handled to protect their potency and ensure their safety. Propranolol (1), a beta-adrenergic receptor antagonist, is widely used for angina pectoris, arrhythmia, and hypertension. Due to its naphthalene skeleton, this drug may be both light unstable and a photosensitizing agent. In this study, we isolated three photodegraded products of propranolol (1): 1-naphthol (2), N-acetylpropranolol (3), and N-formylpropranolol (4). The structures of these compounds were determined by spectroscopic methods and chemical syntheses. We also examined the acute toxicities of these substances in mice and their binding to beta-adrenergic receptors using rat cerebellum cortex membranes. Although the photoproducts isolated in this study did not exhibit any acute toxicity or significant binding to beta-adrenergic receptors, these results serve as a warning to single-dose packaging systems, as propranolol (1) must be handled carefully to protect the compound from light-induced degradation.
Adrenergic beta-Antagonists↗
Dispensing error leading to alendronate ingestion.
OBJECTIVE: To report a case of medication dispensing error by administration of similarly packaged drugs. CASE SUMMARY: A 6-year-old East Indian boy with asthma was mistakenly given alendronate, a bisphosphonate, for 3 months instead of montelukast, a leukotriene-receptor antagonist. Symptoms of esophageal irritation developed and disappeared on discontinuation of alendronate. DISCUSSION: Alendronate and montelukast have very similar packaging and are available in dosages that also can be similar for some patients. Alendronate caused symptoms of irritative gastritis in this child before the error was identified. This case report emphasizes one of the possible sources of medication dispensing errors: a mistaken identification due to similar packaging (confirmation bias). Manufacturers can help to prevent medication errors in many ways; in this case, more distinct packaging would have decreased the risk of error. A standard bar-coding scheme among manufacturers could lead to an important improvement in the safety of medication dispensation. Practitioners are also encouraged to report such errors to the United States Pharmacopoeia Medication Errors Reporting Program. CONCLUSIONS: With increased awareness of medication errors, healthcare practitioners, manufacturers, and patients should take precautionary steps to prevent dispensing errors and their consequences.
Acetates↗
Patient compliance with crucial drug regimens: implications for prostate cancer.
Understanding of patient compliance with crucial drug regimens has improved markedly since 1986, based on data from two objective methods for monitoring drug dosing by ambulatory patients. Electronic monitoring records times and dates of drug package use, and chemical markers, incorporated into drug dosage forms, are assayed in plasma. These methods remove the camouflage that masks many poor compliers. In contrast, other methods (returned tablet counts, interviews, questionnaires) allow patients easily to censor evidence for delayed or omitted doses. The new methods show many more and larger errors of omission in both trials and practice than previously believed. One patient in about six is punctually compliant, but a modest majority of patients make errors probably too small to attenuate or otherwise modify the actions of all but the most unforgiving medicines. About a third of patients delay or omit many prescribed doses, thus attenuating or otherwise modifying the actions of all but the most forgiving drugs. One patient in about six takes little medicine, though camouflaged as a good complier. Similar patterns of delayed and omitted does prevail, essentially independent of drug, disease, prognosis, or symptoms. In summary, patients take the prescribed dose at intervals longer than prescribed--often by hours, sometimes by days, occasionally by weeks. The clinical and economic consequences of these lapses in dosing are unique to the treatment situation and the severity of disease and comorbidity. The new methods have not yet been applied to androgen-blocking agents, but if the findings resemble those with, e.g. tamoxifen in breast cancer, it will doubtless trigger some rethinking about failed treatment, trial design, and clinical management.
Androgen Antagonists↗
[Radiation sterilization of drugs].
Radiation sterilization can be carried out on the final packaged drug, is applicable to heat or ethylene oxyde sensitive compounds and is eased in control and monitoring. Most of the drugs seem to be not affected by irradiation, however it is necessary to be established that any traces of radiolytic products formed are not toxic. E.S.R. is a good detection method for irradiated drug.
Pharmaceutical Preparations↗
HOSPITAL PACKAGES AND DISCOUNTS COMPLICATE DRUG MARKETING SCENE.
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Drug Industry↗