American Academy of Pediatrics Committee on Drugs: Prescription drug advertising direct to the consumer.
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Academies and Institutes↗
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Results for “Drug Prescriptions”
Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.
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Managing the intricate Web of prescription drugs.
Prescription drug costs are the fastest rising component of health care and are contributing to the dramatic increase in health care costs. Emergence of generic drugs, employer recognition and increased consumer knowledge are already forcing enormous change on the industry. This article explains the factors affecting the current financial pressure of prescription drugs, solutions and tactics that employers can immediately act on and the variables that employers need to be aware of in order to take appropriate action.
Cost Control↗
Food and Drug Administration--Prescription drug products; patient package inserts requirements. Final rule.
The Food and Drug Administration [FDA] adopts final regulations establishing requirements and procedures for the preparation and distribution of patient package inserts for prescription drugs for human use. The package inserts will inform the patient about the drug product. This action is intended to promote the safe and effective use of prescription drug products by patients and to ensure that patients have the opportunity to be informed of the benefits and risks involved in the use of prescription drug products. The agency intends to apply the regulations to 10 drugs or drug classes during an initial implementation program. Further evaluation of the costs and benefits of the program will guide the agency in deciding whether to extend, revise, or defer these requirements.
Drug Labeling↗
Impact of generosity level of outpatient prescription drug coverage on prescription drug events and expenditure among older persons.
OBJECTIVES: This study examined the impact of drug coverage generosity on older persons' prescription events (fills) and expenditures. METHODS: A cross-sectional study was conducted of 6237 older persons from the 1995 Medicare Current Beneficiary Survey. Dependent variables were per capita prescription events and expenditures. Independent variables were insurance type and drug coverage generosity. Control variables included sociodemographic and health status factors. RESULTS: Regardless of insurance type, per capita prescription events increased as drug coverage generosity improved and then decreased at the most generous level. Per capita prescription expenditures increased as generosity improved; with generous prescription coverage, prescription expenditures were approximately 3 times those with Medicare only. CONCLUSIONS: Even when factors that affect drug use and insurance selection are controlled, prescription coverage generosity influences prescription use.
Aged↗
[Legal liability aspects of physician's drug prescription and drug use].
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Drug Prescriptions↗
The Medicare Prescription Drug Improvement and Modernization Act: prescription drugs and academic medicine.
The Medicare Prescription Drug, Improvement, and Modernization Act (MMA) provides universally available prescription drug benefits to elderly and disabled Medicare beneficiaries for the first time. This paper first discusses three controversial features of this legislation: (1) the form of the prescription drug benefit package; (2) the use of competing private plans; and (3) the uncertainty about the future cost of the new prescription drug benefit. The paper then evaluates the implications for academic medicine of the prescription drug benefit and other MMA legislative provisions aimed at improving the quality of medical practice and shifting away from acute care. Ultimately, the health of seniors and the efficient use of public funds in the new prescription drug benefit depend centrally on the prescribing practices of physicians. Academic medicine should turn its attention to training the next generation of physicians to be more effective agents and advocates for their patients in their use of pharmaceuticals.
Academic Medical Centers↗
Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; policies, requirements, and administrative procedures. Food and Drug Administration, HHS. Final rule.
The Food and Drug Administration (FDA) is issuing a final rule to set forth procedures and requirements implementing the Prescription Drug Marketing Act of 1987 (PDMA), as modified by the Prescription Drug Amendments of 1992 (PDA) and the FDA Modernization Act of 1997 (the Modernization Act). The final rule sets forth requirements for the reimportation and wholesale distribution of prescription drugs; the sale, purchase, or trade of, or the offer to sell, purchase, or trade, prescription drugs that were purchased by hospitals or health care entities, or donated to charitable organizations; and the distribution of prescription drug samples. FDA is also amending certain sections of the regulations entitled "Guidelines for State Licensing of Wholesale Prescription Drug Distributors" to make them consistent with this final regulation.
Drug Industry↗
Prescription drug abuse in Canada and the diversion of prescription drugs into the illicit drug market.
Prescription drug abuse has received considerable attention in media reports in recent years. The purpose of this article is to describe the Canadian situation and context with regards to prescription drug abuse and the diversion of psychotropic prescription drugs into the illicit drug market, with a focus on the need for more data and interventions. Canada ranks within the top 10% of countries in the use of benzodiazepines, opioid prescriptions and stimulants. There are many ways that prescription drugs are diverted into the illicit market and varied reasons for use and abuse. Prescription drug abuse is further related to a number of negative consequences, including overdose. While seniors and women have been the primary focus for research in Canada on prescription drug abuse, adolescents and young adults have received less attention. Systematic epidemiological data specifically on prescription drug abuse in the Canada context are lacking and are needed in order to more clearly understand the reasons for the phenomenon and to develop and implement appropriate interventions.
Adolescent↗
[Development of use of subsidized prescription drugs. A comparison of drug consumption requiring subsidy in the county of Storstrøm during the periods 1 January--30 April 1991 and 1 January--30 April 1992].
In all counties in Denmark, the consumption of subsidized prescribed drugs is registered. The drugs are listed in accordance with the international anatomical-therapeutical-chemical classification system and the consumption is listed in defined daily doses and prices. Comparing the first four months of 1991 with the first four months of 1992 in a Danish county (Storstrøms Amt) shows a general increase in the amount of prescribed drugs (mean 11.0%). Ulcer-drugs, antihypertensiva, antibiotics and analgetics have increased more than 20%. The increase in prices has been 3.8%. It is concluded that these sort of statistics justify the debate on drug prescriptions and act as a tool for monitoring drug prescriptions in general practice for wanted groups of drugs. Further refinements of the statistics can be made. The increase in county grants in "running prices" has been nearly constant over the last ten years, except for 1990 due to the introduction of a special law.
Denmark↗
Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; policies, requirements, and administrative procedures; delay of effective date; reopening of administrative record. Food and Drug Administration, HHS. Final rule; delay of effective date; reopening of administrative record.
The Food and Drug Administration (FDA) is delaying until October 1, 2001, the effective date and reopening the administrative record to receive additional comments regarding certain requirements of a final rule published in the Federal Register of December 3, 1999 (64 FR 67720). The other provisions of the final rule become effective on December 4, 2000. The final rule implements the Prescription Drug Marketing Act of 1987 (PDMA), as modified by the Prescription Drug Amendments of 1992 (PDA) and the FDA Modernization Act of 1997 (the Modernization Act). FDA is delaying the effective date for certain requirements relating to wholesale distribution of prescription drugs by distributors that are not authorized distributors of record. FDA is also delaying the effective date of another requirement that would prohibit blood centers functioning as "health care entities" to act as wholesale distributors of blood derivatives. The agency is taking this action to address numerous concerns about the provisions raised by affected parties.
Drug Industry↗
[Drug prescription and drug monitoring in crenotherapy].
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Balneology↗
Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; policies, requirements, and administrative procedures; delay of effective date. Final rule; delay of effective date.
The Food and Drug Administration (FDA) is further delaying, until December 1, 2006, the effective date of certain requirements of a final rule published in the Federal Register of December 3, 1999 (64 FR 67720). In the Federal Register of May 3, 2000 (65 FR 25639), the agency delayed until October 1, 2001, the effective date of certain requirements in the final rule relating to wholesale distribution of prescription drugs by distributors that are not authorized distributors of record, and distribution of blood derivatives by entities that meet the definition of a "health care entity" in the final rule. The agency further delayed the effective date of these requirements in three subsequent Federal Register notices. Most recently, in the Federal Register of January 31, 2003 (68 FR 4912), FDA delayed the effective date until April 1, 2004. This action further delays the effective date of these requirements until December 1, 2006. The final rule implements the Prescription Drug Marketing Act of 1987 (PDMA), as modified by the Prescription Drug Amendments of 1992 (PDA), and the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). The agency is taking this action to address concerns about the requirements in the final rule raised by affected parties. As explained in the SUPPLEMENTARY INFORMATION section, FDA is working with stakeholders through its counterfeit drug initiative to facilitate widespread, voluntary adoption of track and trace technologies that will generate a de facto electronic pedigree, including prior transaction history back to the original manufacturer, as a routine course of business. If this technology is widely adopted, it is expected to help fulfill the pedigree requirements of the PDMA and obviate or resolve many of the concerns that have been raised with respect to the final rule by ensuring that an electronic pedigree travels with a drug product at all times. Therefore, it is necessary to delay the effective date of Sec. Sec. 203.3(u) and 203.50 (21 CFR 203.3(u) and 203.50) until December 1, 2007 to allow stakeholders time to continue to move toward this goal. In addition, the further delay of the applicability of Sec. 203.3(q) to wholesale distribution of blood derivatives by health care entities is necessary to give the agency additional time to consider whether regulatory changes are appropriate and, if so, to initiate such changes.
Chemistry, Pharmaceutical↗
Revisiting "the origins of compulsory drug prescriptions".
It has been argued that today's prescription drug market originated in the arbitrary acts of the US Food and Drug Administration (FDA), which in 1938 issued regulations creating a class of drugs that could be sold by prescription only. On the basis of the FDA's administrative records, I argue that the 1938 regulations on prescription drug labeling were initiated by industry and then agreed to by the FDA; that contemporaries understood and accepted the reasons for restricting the use of certain drugs; and that the subsequent evolution of these regulations is best understood as an FDA effort to limit industry abuses of the prescription labeling system. This decade-long war of position ended when drug manufacturers persuaded the US Congress to enshrine their version of prescription labeling in law in a highly politicized struggle over government's role in the economy.
Drug Industry↗
[Long-term effects of prescription drugs in 174 patients treated for myocardial infarction, followed up from 4 to 5 years (the DEVENIR study)].
The aim of this study was to document changes in drug prescription after myocardial infarction. One hundred and seventy four men with typical myocardial infarction recensed by the Toulouse MONICA centre between 1989 and 1990 were followed up for 4.5 years. A copy of their drug prescription was obtained during the acute phase of infarction, at the time of discharge from hospital or clinic, after 6 months, and finally, after 4.5 years after infarction. During the acute phase, the majority of patients received nitrate derivatives, platelet antiaggregants, calcium antagonists, betablockers and antiarrhythmics. Between hospital discharge and the sixth month, the prescription of lipid lowering drugs quadrupled (from 8 to 33%; p < 0.00001) and those of platelet anti-aggregants decreased (from 82 to 70%; p < 0.01). The prescriptions of other drugs remained relatively stable. Between the 6th month and the 4th year of follow-up the only prescription to increase significantly was that of ACE inhibitors (from 14 to 23%; p < 0.03). The other prescriptions were maintained: platelet anti-aggregants (70% at 6 months vs 75% at 4.5 years), nitrate derivatives (59 vs 51%), betablockers (51 vs 52%), calcium antagonists (51 vs 48%), lipid lowering drugs (33 vs 42%), diuretics (3 vs 6%) and inotropic agents (2 vs 2%). Overall analysis showed an increase in the prescriptions of lipid-lowering agents (p < 0.00001) and ACE inhibitors (p < 0.002). On the other hand, the prescriptions of calcium antagonists and nitrate derivatives tended to decrease. These results show that the treatment of patients with coronary artery disease is based on drugs of proven efficacy, reflecting the impact of large scale therapeutic trials on everyday medical practice.
Adult↗
A 1-year study of drug prescriptions and adverse drug reactions in psychiatric hospital practice.
Drug prescribing habits and adverse drug reaction occurrence were investigated in a psychiatric hospital ward for chronic resident patients, and the usefulness of a drug prescription and adverse event (AE) routine monitoring programme in this setting was assessed. A computerized data base was established and updated bimonthly with clinical data concerning each patient. In particular, information about drug prescriptions was routinely obtained from the clinical records, stored in the data base and periodically retrieved and analysed. The ward doctors were required to report on a form the AEs, which were subsequently examined by a panel of clinical pharmacologists and hospital consultants, to assess their relationship with drug treatments. Moreover, the data base was periodically scrutinized, to search for further AEs. Drug prescription monitoring, besides providing valuable information about drug utilization, allowed identification of some questionable issues (e.g. polypharmacy, low frequency of treatment revisions). The AE monitoring system proved to be effective and the participation of the ward doctors was satisfactory. It is concluded that in this psychiatric hospital setting a drug prescription and AE routine monitoring programme can provide useful information and promote improvement of the quality of care.
Journal Article↗
Distribution of blood derivatives by registered blood establishments that qualify as health care entities; Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; delay of applicability date. Final rule; delay of applicability date.
The Food and Drug Administration (FDA) is further delaying, until December 1, 2008, the applicability date of a certain requirement of a final rule published in the Federal Register of December 3, 1999 (64 FR 67720) (the final rule). The final rule implements the Prescription Drug Marketing Act of 1987 (PDMA), as modified by the Prescription Drug Amendments of 1992 (PDA), and the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). The provisions of the final rule became effective on December 4, 2000, except for certain provisions whose effective or applicability dates were delayed in five subsequent Federal Register notices, until December 1, 2006. The provision with the delayed applicability date would prohibit wholesale distribution of blood derivatives by registered blood establishments that meet the definition of a "health care entity." In the Federal Register of February 1, 2006 (71 FR 5200), FDA published a proposed rule specific to the distribution of blood derivatives by registered blood establishments that qualify as health care entities (the proposed rule). The proposed rule would amend certain limited provisions of the final rule to allow certain registered blood establishments that qualify as health care entities to distribute blood derivatives. In response to the proposed rule, FDA received substantive comments. As explained in the SUPPLEMENTARY INFORMATION section of this document, further delaying the applicability of Sec. 203.3(q) (21 CFR 203.3(q)) to the wholesale distribution of blood derivatives by health care entities is necessary to give the agency additional time to address comments on the proposed rule, consider whether regulatory changes are appropriate, and, if so, to initiate such changes.
Biological Products↗
Indices of drug misuse for prescription drugs.
Few studies of prescription-drug misuse have taken into account the numbers of prescriptions dispensed for specific drugs. Using data from the Drug Abuse Warning Network (DAWN) and the National Prescription Audit, we calculated indices of drug misuse for specific prescription drugs that are used mainly in outpatient settings and are either benzodiazepines, barbiturates, other sedative-hypnotics, analgesics, or CNS stimulants. In 1983-1985 the drugs associated with the highest numbers of DAWN medical examiner-reported drug-misuse deaths were codeine, diazepam, propoxyphene, phenobarbital, and secobarbital. However, the drugs with the highest indices of DAWN medical examiner-reported drug-misuse deaths/100,000 dispensed prescriptions were methamphetamine, methaqualone, amobarbital, secobarbital, and glutethimide. An index of fatality risk, calculated as 100 x DAWN medical examiner-reported drug-misuse deaths/DAWN emergency room-reported drug-misuse episodes, suggested that the risk of death from a glutethimide-associated drug-misuse episode had increased 92% from 1975-1979 to 1983-1983 and in 1983-1985 was the highest for the drugs studied. These indices might assist public health authorities attempting to design effective strategies to efficiently address the problem of prescription-drug misuse.
Cause of Death↗
Senior citizens and the burden of prescription drug outlays: what lessons for the Medicare prescription drug benefit?
This article uses data from a cohort of elderly and retired persons over the 1996-2001 period in the US to (i) determine the extent to which changes in socioeconomic or demographic characteristics, particularly age, income and education, impact the total amount that is spent on prescription drugs and (ii) to analyse the predictors of individual out-of-pocket (OOP) prescription drug outlays among the same cohort and determine whether age, race, sex, income, education, marital status and health status have an influence on these. The analysis considers the implications for elderly individuals who choose to participate in the new Medicare Part D drug benefit, labelled the Medicare Prescription Drug, Improvement, and Modernisation Act of 2003. The results highlight the necessity for the Medicare prescription drug benefit to carefully target the eldest among the elderly, who are most in need and are in danger of becoming trapped in the so-called Medicare 'doughnut hole', i.e. incur high prescription drug outlays, without adequate coverage. The study also finds evidence that women, those who are not married, middle income elderly and those in poor health, who purchase drugs more intensively, are at risk of incurring significant prescription OOP drug outlays.
Age Factors↗