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Biomedical subjects

A C van Grootheest

Publications and source records attributed to A C van Grootheest.

At least 19 recordsLinked to original sources
PubMed2007

Post Launch Monitoring of food products: what can be learned from pharmacovigilance.

Post Launch Monitoring (PLM) is one of the new approaches that are used in assessing the safety of novel foods or ingredients. It shares a close resemblance with procedures applied in the field of medicines, where Post Marketing Surveillance (PMS) has been carried out since the beginning of the 1960s. For this reason, Unilever and the Netherlands Pharmacovigilance Centre Lareb, maintaining the national reporting scheme in the Netherlands for adverse drug reactions, have been working together to optimize the Unilever's Post Launch Monitoring service. As a result of this cooperation a practical model for conducting PLM for food products has been developed. This model is also applicable for consumer products in general. The system allows for coding and assessing reports and the early detection of 'signals' of unintended health reactions. The methodological issues surrounding reporting of possible health reactions and practical issues surrounding coding and assessment of the reports that were encountered in the first period of this partnership are discussed. In addition, similarities and differences concerning PMS and PLM are described.

Adverse Drug Reaction Reporting Systems↗
PubMed2005

Uterine perforation in women using a levonorgestrel-releasing intrauterine system.

OBJECTIVE: To determine an estimated incidence of uterine perforations related to the insertion of a levonorgestrel-releasing intrauterine system (LNG IUS) and to identify possible risk factors. DESIGN: Retrospective, case report study. SETTING: Hospitals in Limburg, the Netherlands. METHODS: Gynecologists in hospitals in Limburg were asked about uterine perforations related to the insertion of a LNG IUS between 1999 and 2002. The charts of the reported perforations were studied. Data on the patient, doctor, insertion, diagnosis and removal were collected for every reported uterine perforation. RESULTS: In Limburg, the estimated incidence of uterine perforations related to the insertion of a LNG IUS is 2.6 per 1000 insertions. Insertion in lactating women, even beyond 6 weeks after delivery, was shown to be an important risk factor. CONCLUSIONS: Complete registration of complications provides a greater insight into the actual incidence of LNG IUS-related uterine perforations and their possible consequences. This may eventually lead to a decrease in complications.

Adult↗
PubMed2005

[Direct reporting of side effects by the patient: favourable experience in the first year].

OBJECTIVE: To determine the results of establishing a station at which patients can report the side effects of drugs. DESIGN: Descriptive. METHOD: Since 1 April 2003, patients may submit reports of possible adverse drug reactions directly to the Netherlands Pharmacovigilance Centre Lareb. The reports submitted during the period from 1 April 2003 to 31 March 2004 were analysed and compared with the reports submitted by doctors and pharmacists. RESULTS: In the first year, 276 reports were submitted by patients and 3131 by doctors and pharmacists. The reports from patients usually contained sufficient medical information and more frequently referred to serious adverse reactions than reports by health professionals. The reports from patients relatively often concerned psychotherapeutic agents, notably antidepressants. CONCLUSION: Based on the positive results during the first year, the Netherlands Pharmacovigilance Centre Lareb has decided to continue the reporting station for patients. Reports submitted by patients are currently part of the core responsibility of Lareb: the detection of signals of new adverse drug reactions.

Databases, Factual↗
PubMed2005

The role of hospital and community pharmacists in pharmacovigilance.

In this paper, we give an overview of the role pharmacists actually have and could have in collecting reports of adverse drug reactions (ADRs) and more widely in pharmacovigilance. In the literature, several ways are mentioned in which the pharmacist, both the community pharmacist and the hospital pharmacist, can contribute to the safe use of drugs. In addition to their responsibilities regarding drug dispensing and compliance, they can have a substantial role in ADR reporting. Especially, hospital pharmacists can play a significant role in ADR reporting because the most serious adverse drug events occur in hospitals, and ADRs account for a substantial proportion of hospital admissions. Community pharmacists, however, can also play an important role in ADR reporting. This is, for example, the case in the Netherlands where community pharmacists contribute substantially, both in numbers and in quality of ADR reports. The contribution of the pharmacist to pharmacovigilance should, however, not be limited to ADR reporting. The various pharmaceutical disciplines could also greatly enhance our understanding of the nature of ADRs. If those involved in pharmaceutical disciplines can rise to this challenge, they will significantly help deepen our insights into ADRs.

Adverse Drug Reaction Reporting Systems↗
PubMed2004

[Notifications to the Netherlands Pharmacovigilance Foundation Lareb of the expulsion of a vaginal contraceptive ring (NuvaRing) and of pregnancy during the use of it].

Netherlands Pharmacovigilance Foundation Lareb expulsion of the vaginal contraceptive ring NuvaRing was reported 8 times between February 2003 and April 2004. Moreover, in two of these reports pregnancy was reported. In that same period, Lareb received 10 more reports of pregnancy during the use of the ring, in which expulsion was not mentioned explicitly. Additional information on these cases was collected by questionnaire. Expulsion of the ring is described in the product information. The ring should then be placed back within 3 h. However, the Lareb reports show that expulsion of the ring is not always noticed by the user. In those cases the contraceptive efficacy of this method is questionable. The physician should be alert to pre-existing risk factors that increase the chance of expulsion of the ring, and should provide extra detailed advice about the right way of placing the ring, the risk of expulsion and the importance of replacing it in time.

Consumer Product Safety↗
PubMed2004

[Severe adverse reactions after the use of sulphur hexafluoride (SonoVue) as an ultrasonographic contrast agent].

European Medicines Agency (EMEA) recently took precautionary measures to limit the use of the ultrasonographic contrast agent sulphur hexafluoride (SonoVue) in patients with cardiac disease. Throughout Europe a number of serious allergic reactions with probable secondary cardiovascular problems have been reported. In addition to this, there have been 3 reports of a fatal outcome soon after the administration of SonoVue. For all of these patients there was a risk of serious cardiac complications as a consequence of underlying cardiac problems. In The Netherlands 3 anaphylactic reactions have been reported, two in women aged 59 and 70 years respectively, and one in a man aged 80 years.

Aged↗
PubMed2003

[Leopold Meyler (1903-1973): a pioneer in the field of side affects of drugs].

In 1951, more than a decade before the first rumblings of the thalidomide catastrophe, a remarkable book appeared in the Netherlands under the authorship of Leopold Meyler. It appeared a year later in an English translation, as Side effects of drugs. This was a remarkable book at a time that medical interest in drugs--and particularly new drugs--was limited almost entirely to their proven or possible therapeutic benefits. Meyler was a specialist in internal medicine in Groningen. He was Jewish and was forced to go into hiding during World War II. He suffered a great deal during this time and after the war he was admitted to a sanatorium where he was treated for tuberculosis. It was here that he was advised to start the systematic collection of adverse-drug reactions reported in literature. Initially there was quite a lot of criticism of his work but it gradually gained recognition and he was appointed the first professor of Clinical Pharmacology at Groningen University in 1968. In his own time his was a lone voice crying in the wilderness. Had his voice been heeded earlier, the extent of the thalidomide disaster might well have been much more limited. His work still continues to contribute to the safe use of drugs.

Drug-Related Side Effects and Adverse Reactions↗
PubMed2003

Intensive monitoring of new drugs based on first prescription signals from pharmacists: a pilot study.

BACKGROUND: Intensive monitoring can be a valuable tool in the early detection of adverse drug reactions, especially of new drugs. Aim of this pilot study was to investigate the practical possibilities of a system of intensive monitoring, using the pharmacy computer system to detect the first dispensing of a new drug. METHOD: Eight pharmacists were asked to monitor, using their computer system, when a general practitioner prescribed the target drug (rofecoxib). The pharmacists were also requested to provide the researchers at Lareb with an overview of the patient's medication history. Subsequently, the pharmacist sent the prescribing physician an envelope containing information about the project and a reporting form (all provided by Lareb), which the GP was requested to return to Lareb after the next visit of the patient. The items on the questionnaire concerned characteristics of the patient (anonymous), indication, dose and information about possible adverse drug reactions. RESULTS: During a 4-week period, the participating pharmacists signalled 44 first prescriptions of rofecoxib. For each of these signals, the pharmacist provided Lareb with the medication history of the patient involved. Of the prescribing GPs who had been sent the report form, 70.5% (n = 31) returned the form. Twenty-one of the 31 forms were returned within 4 weeks. The medication histories showed that in 43 of the 44 cases, the dispensing of the target drug was indeed the first delivery. The participating pharmacists and GPs were also sent an evaluation form. All pharmacists returned their evaluations, indicating an overall motivation to participate in the proposed system. In total, seven GPs returned their evaluation forms, three of whom had not reported adverse drug events to the national spontaneous reporting centre before. CONCLUSION: Although the number of participants in this trial was small, we conclude that pharmacists and prescribing physicians are able and willing to contribute to an intensive monitoring system for new drugs.

Adverse Drug Reaction Reporting Systems↗
PubMed2001

[Uneasiness about the safety of bupropion as an aid to smoking cessation unjustified ].

A report in a national newspaper on Thursday 26 April 2001, linked the anti-smoking drug bupropion to 41 deaths. From the reports of suspected adverse reactions received by the Netherlands Pharmacovigilance Foundation, it appears that more than half the cases concerned patients at risk of developing smoking-related diseases. In 15 cases, the simultaneous use of bupropion and another antidepressant (10 patients), theophylline (1 patient) or insulin (4 patients) was reported, even though these combinations may lead to an increase in the risk of seizures. Furthermore, 2 patients were reported to have been taking anti-epileptics, despite the fact that use of bupropion is contra-indicated in patients with a seizure disorder. The results seem to illustrate that the guidelines described in the product information are not being adhered to in all cases. Provided that bupropion is used according to the guidelines in the product information, this new aid in smoking cessation is considered an effective and safe drug. It is highly unlikely that bupropion has contributed to any deaths. If prescribed appropriately and in combination with counselling (e.g. minimal intervention strategy), bupropion is as yet the most effective aid in helping people stop smoking.

Adverse Drug Reaction Reporting Systems↗
PubMed2001

[Side effects of sildenafil: findings from two years practical experience].

Sildenafil has been registered for the treatment of erectile dysfunction since 1998. World wide a large number of patients were reported, dying of acute heart disease after using sildenafil. Therefore the patient instruction text was adapted. Simultaneous use of sildenafil and nitrates is contraindicated because of serious decrease of the blood pressure. The use of sildenafil can lead to physical stress in patients with a history of heart disease and a treadmill test assessment is advisable. In two years 38 adverse reactions were seen in 25 Dutch patients. The Dutch reports (three cardiovascular deaths since the introduction) also show the dilemmas in the assessment of the safety of sildenafil: is it the underlying disease or is it the drug that causes death? Further research into the adverse reactions has to be done, therefore reporting suspected side effects of sildenafil is important.

Adverse Drug Reaction Reporting Systems↗
PubMed2001

[Delirium due to increase in clozapine level during an inflammatory reaction].

Between January 1999 and May 2000, the Netherlands Pharmacovigilance Foundation LAREB received five reports of patients with clozapine intoxication attributed to inflammation. The reports all concerned men with schizophrenia, aged 63, 54, 41, 45 en 42 years. The occurrence of increased clozapine levels during inflammation, and normalisation after recovery, strongly suggest a causal relationship. No other possible explanations were found. A three to five-fold increase occurred in most instances, but one patient experienced a ten-fold increase compared with the basal levels of clozapine. Three of the patients developed a delirium as an intoxication symptom, probably due to anticholinergic effects on the central nervous system. In case of an inflammatory reaction in patients on clozapine treatment, the physician should be aware of the possibility of clozapine intoxication and delirium. Measuring clozapine levels during infection and dosing based on these levels can minimise the adverse effects of clozapine intoxication.

Adult↗
PubMed2001

[Risk of convulsions due to the use of bupropion as an aid for smoking cessation].

Bupropion is a new aid in smoking cessation. Since marketing of this product in the Netherlands (from December 1999 on), 7 cases of (possible) convulsions have been reported. In 3 cases there was a contraindication in the form of a history of epilepsy. The four other cases concerned tonic-clonic epileptic seizures in patients with no history of epilepsy and no combination with other medication. In view of the seriousness of this, already known, side effect of bupropion, physicians ought to be sensitive to situations with increased risk of this side effect. In addition it is advised to explain to the patient the proper use of bupropion, which is not comparable to nicotine chewing gum and should be swallowed whole due to the slow release properties of the tablet.

Adverse Drug Reaction Reporting Systems↗
PubMed1999

Attitudinal survey of voluntary reporting of adverse drug reactions.

AIMS: Voluntary adverse drug reaction (ADR) reporting schemes have operated since the early sixties in many Western countries. It is generally recognized, however, that only a small proportion of ADRs is actually reported. The current survey was conducted to assess attitudes towards reporting of ADRs, and to study which types of ADRs are reported. METHODS: A questionnaire seeking reasons for nonreporting was sent to a random sample of 10% of medical practitioners in The Netherlands in October 1997. After 6 weeks, a reminder was sent to those who had not responded. RESULTS: One thousand four hundred and forty-two (73%) questionnaires were returned, of which 94% were complete. The percentage of GPs (51%) which had ever reported an ADR to the national reporting centre was significantly higher than the percentage of specialists (35%), who reported more often to the pharmaceutical industry (34% vs 48%). 86% of GPs, 72% of surgical specialists and 81% of medical specialists had ever diagnosed an ADR, which they had not reported. Uncertainty as to whether the reaction was caused by a drug (72%), the ADR being trivial (75%) or too well known (93%) were the most important reasons for not reporting. 18% were not aware of the need to report ADRs, 22% did not know how to report ADRs, 38% did not have enough time, 36% thought that reporting was too bureaucratic and only 26% of Dutch physicians knew which ADRs to report. A serious ADR, an unlabelled ADR, an ADR to a new drug, history of reporting of one or more ADRs, and specialty were all independently associated with reporting of 16 hypothetical ADRs. Surgical and medical specialists tended to report less often than GPs. CONCLUSIONS: There is a considerable degree of underreporting, which might partly be explained by lack of knowledge and misconceptions about spontaneous reporting of adverse drug reactions.

Adverse Drug Reaction Reporting Systems↗