Effects of legislation restricting pack sizes of paracetamol and salicylate on self poisoning in the United Kingdom: before and after study.
(9/194)
OBJECTIVE: To evaluate the effects on suicidal behaviour of legislation limiting the size of packs of paracetamol and salicylates sold over the counter. DESIGN: Before and after study. SETTING: UK population, with detailed monitoring of data from five liver units and seven general hospitals, between September 1996 and September 1999. SUBJECTS: People who died by suicidal or accidental overdose with paracetamol or salicylates or who died of undetermined causes; patients admitted to liver units with hepatic paracetamol poisoning; patients presenting to general hospitals with self poisoning after taking paracetamol or salicylates. MAIN OUTCOME MEASURES: Mortality from paracetamol or salicylate overdose; numbers of patients referred to liver units or listed for liver transplant; numbers of transplantations; numbers of overdoses and tablets taken; blood concentrations of the drugs; prothrombin times; sales to pharmacies and other outlets of paracetamol and salicylates. RESULTS: Numbers of tablets per pack of paracetamol and salicylates decreased markedly in the year after the change in legislation on 16 September 1998. The annual number of deaths from paracetamol poisoning decreased by 21% (95% confidence interval 5% to 34%) and the number from salicylates decreased by 48% (11% to 70%). Liver transplant rates after paracetamol poisoning decreased by 66% (55% to 74%). The rate of non-fatal self poisoning with paracetamol in any form decreased by 11% (5% to 16%), mainly because of a 15% (8% to 21%) reduction in overdoses of paracetamol in non-compound form. The average number of tablets taken in paracetamol overdoses decreased by 7% (0% to 12%), and the proportion involving >32 tablets decreased by 17% (4% to 28%). The average number of tablets taken in salicylate overdoses did not decrease, but 34% fewer (2% to 56%) salicylate overdoses involved >32 tablets. After the legislation mean blood concentrations of salicylates after overdose decreased, as did prothrombin times; mean blood concentrations of paracetamol did not change. CONCLUSION: Legislation restricting pack sizes of paracetamol and salicylates in the United Kingdom has had substantial beneficial effects on mortality and morbidity associated with self poisoning using these drugs. (+info)
Impact of prepackaging antimalarial drugs on cost to patients and compliance with treatment.
(10/194)
OBJECTIVE: To examine the extent to which district health teams could reduce the burden of malaria, a continuing major cause of mortality and morbidity, in a situation where severe resource constraints existed and integrated care was provided. METHODS: Antimalarial drugs were prepackaged into unit doses in an attempt to improve compliance with full courses of chemotherapy. FINDINGS: Compliance improved by approximately 20% in both adults and children. There were 50% reductions in cost to patients, waiting time at dispensaries and drug wastage at facilities. The intervention, which tended to improve both case and drug management at facilities, was well accepted by health staff and did not involve them in additional working time. CONCLUSION: The prepackaging of antimalarials at the district level offers the prospect of improved compliance and a reduction in the spread of resistance. (+info)
Occurrence of coring in insulin vials and possibility of rubber piece contamination by self-injection.
(11/194)
Coring is reported to occur because rubber pieces are shaved off from a rubber stopper when a needle is inserted into the rubber stopper of transfusion liquid formulation. We verified whether coring really occurs in insulin vials of self-injecting patients. We collected insulin cartridges from 30 hospitalized patients and used the primary injection (trial injection), the secondary injection and the cartridge remaining preparation as samples. We observed the rubber pieces using a microscope and measured the shape, number of pieces. The occurrence rate of coring was 73% for the primary injection, 47% for the secondary injection and 97% for the cartridge remaining preparation. The rubber pieces in the primary injection and the secondary injection which went through the needle are mostly in aggregate shape and the rubber pieces in the cartridge remaining preparation which did not go through the needle are mostly in needle-like shape. A number of small rubber pieces are found in both the primary injection and the secondary injection, indicating a high possibility that rubber pieces may be injected under subcutaneous tissue. The coring is considered to occur because needles are repeatedly inserted and rotated at the same spot. It is required to improve the structure to mount a needle to the pen-type injector in future. Coring is a very serious problem from the medical and pharmaceutical points of view. Further study should be made on the implication to latex allergy and lipodystrophy. (+info)
Use of the Medication Event Monitoring System to estimate medication compliance in patients with schizophrenia.
(12/194)
OBJECTIVE: To determine the feasibility of using the Medication Event Monitoring System (MEMS) to estimate medication compliance in patients with schizophrenia or schizoaffective disorder. SUBJECTS AND SETTING: Fourteen of 35 consecutive patients admitted to a psychiatric inpatient hospital with schizophrenia or schizoaffective disorder who met eligibility requirements and gave informed consent. INTERVENTION: After random assignment to either risperidone or typical antipsychotic treatment, medication upon discharge from hospital was dispensed in a bottle with a MEMS cap which recorded the number of bottle openings and the date and time of each opening. The first 6 patients were asked to return monthly for data downloading. The next 8 were asked to return weekly during the first month and every 2 weeks thereafter; they were also paid $5 for returning each bottle. OUTCOME MEASURES: MEMS data collected over a 6-month period and hospital readmission data. RESULTS: Patient medication compliance data were collected from 10 (71%) of 14 patients during the first month, from 7 (58%) of 12 (2 patients dropped out) during the second and from 5 (45%) of 11 (a third patient dropped out) during months 3-6. Mean compliance rates were 63% for the first month and ranged from 56% to 45% over the next 5. First-month compliance rates were significantly lower for those who were subsequently readmitted to hospital (n = 7) than for those who were not (p < 0.01). CONCLUSIONS: Electronic monitoring devices can be used to estimate compliance with medication regimens in patients with severe schizophrenic disorders, but there are methodological improvements that can be made to increase data recovery and compliance, and these are discussed. (+info)
Microbial contamination of topical medicaments used in the treatment and prevention of pressure sores.
(13/194)
Topical medicaments used in the treatment and prevention of pressure sores in patients in three hospitals were examined for Pseudomonas aeruginosa and Staphylococcus aureus contamination. Contamination rates were found to vary between hospitals and were affected by differences in the packaging of the product and in the method of application used by the nursing staff. (+info)
The success of immunizations in nearly eliminating many vaccine-preventable diseases has resulted in an increase in the need to study risks from vaccines, combination or otherwise. The well-known limitations associated with prelicensure trials have led many to hope that postlicensure studies can address safety issues. This article reviews measures that have been or should be taken to meet this expectation: establishment of clinical immunization safety assessment centers, standardization of case definitions for vaccine adverse events, use of the Vaccine Identification Standards Initiative to improve the accuracy and efficiency with which vaccination records are transferred, integration of vaccine safety monitoring into immunization registries, establishment (and enlargement) of the Vaccine Safety Datalink project, use of innovative analytic tools for better signal detection, and implementation of various methods to overcome confounding by contraindication. Only by investing in vaccine safety infrastructure at a level commensurate with investments in vaccine development can we hope to retain the public's confidence in immunization. (+info)
Child-resistant packaging for certain over-the-counter drug products. Final rule.
(15/194)
Pursuant to its 3-0 vote to do so, the Consumer Product Safety Commission (CPSC or Commission) is issuing a rule to require child-resistant (CR) packaging on drugs (OTC switched drugs) approved by the Food and Drug Administration (FDA) for over-the-counter (OTC) sale that contain active ingredients previously available only in prescription drugs. Current Commission regulations require CR packaging for most oral drug products containing prescription-only active ingredients.However, prior to issuance of this rule there was no general requirement to maintain CR packaging of such drug products in forms subsequently approved by the FDA for OTC sale. The Commission is also revoking the current prohibition on granting a petition for an exemption from a CR packaging requirement prior to FDA approval of the drug product in question. The Commission takes these actions under authority of the Poison Prevention Packaging Act of 1970, as amended. (+info)
Reversed phase-high performance liquid chromatographic (RP-HPLC) method to measure migration of semi-volatile compound, vanillin, in ipratropium bromide inhalation solution.
(16/194)
Ipratropium bromide, a bronchodilator, is used as an inhalation solution. Commercial ipratropium bromide solution products are packaged in low-density polyethylene (LDPE) vials, through which semivolatile compounds are reported to migrate. In this article, a specific reversed phase-high performance liquid chromatographic method to assay vanillin, a semivolatile compound, in ipratropium bromide solution is described. The method was validated for a concentration range for vanillin from 30 ng/mL to 1,600 ng/mL. Migration of vanillin was assessed in two commercial preparations, ATROVENT (ipratropium bromide) Inhalation Solution packaged in a secondary foil pouch and a generic ipratropium bromide inhalation solution packaged in a carton. Levels of vanillin detected in ATROVENT after 6 months of storage at 40 degrees C and 75% RH were below the limit of detection (11 ng/mL). Significant migration of vanillin was observed after 1 month in the generic product and reached 165 ng/mL to 999 ng/mL in three months under the same storage conditions. It is concluded that this method can be readily used to measure vanillin in commercial preparations of ipratropium bromide inhalation solution. The results strongly indicate that a protective secondary packaging material is critical in preventing migration of semivolatile compounds. This study result is in agreement with the FDA's recommendation to consider even the secondary packaging components as potential sources of contamination and the use of an overwrap (typically aluminum foil) to decrease the overall permeability. (+info)