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Intro -- Contents -- Preface -- Chapter 1 -- Federal Authority to Regulate the Compounding of Human Drugs( -- Summary -- Background -- Federal Regulation of Compounded Drugs -- Compounding Before the 1938 Food, Drug, and Cosmetic Act -- The 1938 Food, Drug, and Cosmetic Act -- Kefauver-Harris Drug Amendments of 1962 -- Food and Drug Administration Modernization Act of 1997 and Compounding -- FDAMA and Federal Authority after Thompson v. Western States Medical Center -- Limits on Federal Authority to Regulate Compounded Drugs -- End Notes -- Chapter 2 -- FDA's Authority to Regulate Drug Compounding: A Legal Analysis( -- Summary -- Background -- Thompson v. Western States Medical Center23 -- 2002 FDA Compliance Policy Guide -- Medical Center Pharmacy v. Mukasey -- Issues with Current FDA Authority to Regulate Drug Compounding -- End Notes -- Chapter 3 -- State of Disarray: How States' Inability to Oversee Compounding Pharmacies Puts Public Health at Risk( -- Executive Summary and Results in Brief -- Background -- NECC and the Outbreak of Fungal Meningitis -- Regulation of Compounding Pharmacies-Federal Role -- A Historic View of the Federal Regulation of -- Compounding Pharmacies -- Ambiguity of Agency Authority and Industry Litigation Has Led to Regulatory Confusion -- Regulation of Compounding Pharmacies-State Role -- Post-NECC: Massachusetts and Other State Actions -- Investigation and Methodology -- Findings -- Appendix A -- Additional Findings -- Appendix B -- Appendix C -- End Notes -- Chapter 4 -- Compounding Pharmacies, Compounding Risk( -- Executive Summary -- Safety Problems at Compounding Pharmacies: The Federal Role -- Safety Problems at Compounding Pharmacies: The State Role -- Appendix A. A Timeline of Media Reports -- and FDA Enforcement Actions on -- Compounding Pharmacies

Testimony issued by the General Accounting Office with an abstract that begins "Drug compounding--the process of mixing, combining, or altering ingredients--is an important part of the practice of pharmacy because there is a need for medications tailored to individual patient needs. Several recent compounding cases that resulted in serious illness and deaths have raised concern about oversight to ensure the safety and quality of compounded drugs. These concerns have raised questions about what states--which regulate the practice of pharmacy--and the Food and Drug Administration (FDA) are doing to oversee drug compounding. GAO was asked to examine (1) the actions taken or proposed by states and national pharmacy organizations that may affect state oversight of drug compounding, and (2) federal authority and enforcement power regarding compounded drugs. This testimony is based on discussions with the National Association of Boards of Pharmacy (NABP) and a GAO review of four states: Missouri, North Carolina, Vermont, and Wyoming. GAO also interviewed and reviewed documents from pharmacist organizations, FDA, and others involved in the practice of pharmacy or drug compounding."

Abstract
Managing exposure to cytotoxic drugs is difficult because of high toxicity and lack of health-based exposure limits. Cytotoxic drugs are often prepared and supplied to hospitals by compounding pharmacies. These pharmacies often use a combination of cytotoxic drug safety cabinets (CDSC), respiratory protective equipment (RPE), disposable coveralls, and gloves to reduce the risk of exposure. However, work practices play a crucial role in the overall effectiveness of these controls. We assessed the impact of enhanced work practices on the effectiveness of these controls.
We reviewed the work practices through direct observations and took surface wipe samples for Cyclophosphamide before and after the recommended improvements to evaluate the impact. The surface wipe samples were taken from the CDSC and compounding room (red zone), the secondary change room (yellow), and the control areas (green). We compared the results with the respective adopted performance-based surface limits (PBSLs).
Before improvements, the cyclophosphamide levels in each zone and on the reusable RPE exceeded the PBSLs. The cyclophosphamide levels ranged between <0.003 and 2.3 µg/100 cm2, with the highest level inside the CDSC. After improvements, the cyclophosphamide levels ranged between <0.003 and 0.3 µg/100 cm2, and there was no exceedance of PBSLs.
The work practices are crucial to the effectiveness of the CDSC and personal protective equipment for handling cytotoxic drugs. Surface wipe sampling is a handy tool for evaluating work practices. In addition, we recommend monitoring cyclophosphamide levels in the urine to determine the overall effectiveness of controls.

On May 22. 2013, the Senate Health, Education, Labor and Pensions (HELP) Committee unanimously approved S.959, "The Pharmaceutical Compounding Quality and Accountability Act," and S.957, "The Drug Supply and Security Act," (now incorporated into S. 959 as an amendment). Congressional efforts to enact comprehensive legislation to improve drug safety and secure the nation's drug supply chain have lingered for over a decade. The lack of federal uniformity has allowed a patchwork of state legislation to emerge, attracting the less scrupulous to those states with the lowest security. The issue finally gained traction among HELP Committee members when 55 people died and 741 more became ill after contracting fungal meningitis from contaminated steroid injections made by the New England Compounding Center (NECC). Committee member Sen. Pat Roberts (R-KS) stated that given prior reports of problems with NECC, this tragedy could have been averted but for a "shocking failure to act" by NECC, state and federal regulators, and Congress.

This article has been retracted: please see INNOVATIONS in pharmacy retraction policy (https://pubs.lib.umn.edu/index.php/innovations/policies). This article has been retracted by the Editor and Publisher due to the inappropriate use of previously published work. Extemporaneous compounding takes place in community and hospital pharmacies. There are usually specialist compounding pharmacies in major towns and cities, but any pharmacy may undertake compounding as long as they have appropriate facilities according to state-based legislation (e.g. allocated clean bench, specific compounding equipment). Although development is a continuous process, companies are customizing features to meet the majority of patient needs, but the very nature of the process cannot meet all patient needs. The risk-benefit ratio of using traditionally compounded medicines is favorable for patients who require specialized medications that are not commercially available, as they would otherwise not have access to suitable treatment. However, if an FDA-approved drug is commercially available, the use of an unapproved compounded drug confers additional risk with no commensurate benefit. Published reports of independent testing by the FDA, state agencies, and others consistently show that compounded drugs fail to meet specifications at a considerably higher rate than FDA-approved drugs. Compounded sterile preparations pose the additional risk of microbial contamination to patients. In the last 11 years, three separate meningitis outbreaks have been traced to purportedly 'sterile' steroid injections contaminated with fungus or bacteria, which were made by compounding pharmacies. The 2012 outbreak has resulted in intense scrutiny of pharmacy compounding practices and increased recognition of the need to ensure that compounding is limited to appropriate circumstances. Article Type: Review

chapter 1. H.R. 3204 : the journey and expected destination -- chapter 2. The world of human drug compounding : hope and change -- chapter 3. Pharmacy compounding : the supply chain world -- chapter 4. Track and trace : not hide and seek -- chapter 5. Land of the giants : and land of the totes -- chapter 6. The customer/patient touchpoint : literally and electronically : internet pharmacies, pill mills, and other lurking dangers -- chapter 7. When things go bump in the night : reverse logistics -- chapter 8. All those lettered government agencies -- chapter 9. Pulling it all together : public policy and other items of note -- chapter 10. Drug quality and security hall of fame.

Extemporaneous compounding takes place in community and hospital pharmacies. There are usually specialist compounding pharmacies in major towns and cities, but any pharmacy may undertake compounding as long as they have appropriate facilities according to state-based legislation (e.g. allocated clean bench, specific compounding equipment). Although development is a continuous process, companies are customizing features to meet the majority of patient needs, but the very nature of the process cannot meet all patient needs. The risk-benefit ratio of using traditionally compounded medicines is favorable for patients who require specialized medications that are not commercially available, as they would otherwise not have access to suitable treatment. However, if an FDA-approved drug is commercially available, the use of an unapproved compounded drug confers additional risk with no commensurate benefit. Published reports of independent testing by the FDA, state agencies, and others consistently show that compounded drugs fail to meet specifications at a considerably higher rate than FDA-approved drugs. Compounded sterile preparations pose the additional risk of microbial contamination to patients. In the last 11 years, three separate meningitis outbreaks have been traced to purportedly 'sterile' steroid injections contaminated with fungus or bacteria, which were made by compounding pharmacies. The 2012 outbreak has resulted in intense scrutiny of pharmacy compounding practices and increased recognition of the need to ensure that compounding is limited to appropriate circumstances.

Nowadays, registered drugs available on market do not always meet the needs of individual patients. This emphasizes importance of pharmaceutical skills and knowledge required for drug compounding. The need for compounded drugs has been driven by: limited choice of doses and dosage forms of registered drugs available on market (especially for pediatric patients), shortage of the orphan drugs, and requirements for combinations of two or more active pharmaceutical ingredients in the same dosage form. Furthermore, the problem of sudden drug shortages can be solved by drug compounding which is of great importance for every health care system. Current opinion of pharmaceutical practitioners concerning drug compounding is defined by documents such as: Ph. Eur 7.7 monograph Pharmaceutical Preparations (04/2013:2619), EU resolution CM/ResAP (2011)1, USP34/NF29 monographs 795 and 797, and Good Pharmacy Practice (part Good Compounding Practice). ; U današnje vreme dostupni registrovani lekovi ne zadovoljavaju uvek potrebe pojedinačnih bolesnika, čime se ističe značaj znanja i veština farmaceuta prilikom izrade različitih magistralnih i galenskih lekova. Potreba za izradom magistralnih i galenskih lekova nastaje kao rezultat ograničenog izbora doza/jačina lekovitih supstanci u registrovanim lekovima ili nepostojanja odgovarajućih farmaceutskih oblika (posebno za decu), ali i nepostojanja odgovarajućih kombinacija dve ili više lekovitih supstanci u istom obliku, ili lekova za retke bolesti. Za zdravstveni sistem svake zemlje je od velikog značaja da se izradom magistralnih ili galenskih preparata, kao zamenom za određene registrovane lekove, reši problem nestašica, kada je to moguće ili obezbede potrebni lekovi za bolesnike, koji se iz različitih razloga ne mogu proizvoditi u farmaceutskoj industriji. Stav farmaceutske struke o izradi magistralnih preparata pre svega je definisan dokumentima kao što su: monografija Farmaceutskih preparata (04/2013:2619) u sedmom dodatku Evropske farmakopeje (Ph. Eur. 7.7), Rezolucija Saveta Evrope CM/ResAP (2011)1, monografije 795 i 797 u Američkoj farmakopeji (USP34/NF29) i u Dobroj apotekarskoj praksi (DAP) (Farmaceutska komora Srbije, 2013), deo Dobra praksa u izradi lekova.

Aim: to analyze the factors influencing compounding pharmacy extemporaneous drug fomulation and an overview of the most common errors in writing 1st form prescriptions. Tasks: 1. Rate extemporaneous drug production regulation and formulation in Lithuania and abroad. 2. Examine the formulations of compounded extemporaneous drugs in compounding pharmacy. 3. Examine the most common errors in 1stform extemporaneous drug prescriptions. Methodology: Theoretical. To review and describe research, publications and articles related to the master's thesis topic. Empirical. The study was carried out using a document analysis. The study analyzed 364 1st form extemporaneous drug prescriptions. Statistical. Data were analyzed using statistical program SPSS 20.0 version. Results: The study showed that as many as 66% of the tested recipes do not meet the requirements of Legal Acts of the Republic of Lithuania. The study determined the most common prescription errors. The most common mistake - unwritten doctor's phone number - 62% and 11% of prescriptions by doctors incompletely or not at all posted dosing instructions, 9% of the prescriptions were not written in the patient's outpatient card number, or address, 9% of the prescriptions were missing prescription date and expiration date, 7% of prescriptions doctors misspelled the name of the active material, 5% of the prescriptions were mistaken in a pharmaceutical form or it was not written at all, 2% of the prescriptions patient's age was written wrong, 1% of the prescriptions were written incorrectly amounts of active ingredients or not written at all. An analysis of the pharmacy recipe showed, that the formulations of compounded extemporaneous drugs in compounding pharmacy is dominated by ointments (40%), of which 62% is hormone ointments; solutions (18%) are intended for external use; powder (54%). The factors influencing compounding pharmacy extemporaneous drug fomulation are patients with skin diseases, doctors - dermatologists, pediatricians, patient age (children and infants), oncology, addictions patients. Conclusions: 1. A Europe in general is regulated by European Council Directive 2001/83/EB, but compounding activity rather falls under the national competencies of individual European countries. In the United States production of pharmacies is regulated by three government agencies: State pharmacy board, the FDA and DEA. In European countries extemporaneous pharmaceutical preparations consist of 3-5% of all recipes. The most common compounded pharmaceutical forms in Europe are powder, capsules, and liquid form preparations. 2. The factors influencing compounding pharmacy extemporaneous drug fomulation are: patients with skin diseases, doctors - dermatologists, pediatricians, patient age (children and infants), oncology, addictions patients. 3. The study found a 1st form prescriptions error rate, which is 66%. The majority of errors recorded in the \"Information about the doctor" section –the phone number of physician was not written.