International Journal of Risk & Safety in Medicine - Volume 27, issue 2 - Journals

Pharmacovigilance of herbal medicines

Authors: Gromek, Kamila | Drumond, Nélio | Simas, Paula

Article Type: Research Article

Abstract: The importance of herbal remedies in pharmacovigilance systems is becoming one of the primary tasks, due to the constantly ascending potential of herbal products and herbal medicines worldwide. Nowadays, the drug development is focused on finding new active compounds or combinations, but costs are simultaneously growing, which makes herbal medicines an attractive, harmless and cheaper alternative to synthetic drugs. Like all drugs, herbal are not free of risk and many studies suggest for potential adverse reactions and interactions. Available statistics show that some herbal products, used in traditional medication for generations, may possess carcinogenic, hepatotoxic, cardiotoxic and other severe …actions. Evaluation of the safety should include at least in vitro and in vivo genotoxicity assays, long-term rodent carcinogenicity tests (for drugs intended to be continuously used for >3 months or intermittently for >6 months), reproductive and developmental toxicity studies in some cases and examination of the effects on drug-metabolizing enzymes. Drug safety of herbal medicines should be developed, focusing on specific groups of patients. Show more

Keywords: Herbal drugs, pharmacovigilance, quality control, drug safety, traditional medicine, alternative medicine

DOI: 10.3233/JRS-150643

Citation: International Journal of Risk & Safety in Medicine, vol. 27, no. 2, pp. 55-65, 2015

Price: EUR 27.50

Trust-level risk identification guidance in the NHS East of England

Authors: Simsekler, M.C. Emre | Card, Alan J. | Ward, James R. | Clarkson, P. John

Article Type: Research Article

Abstract: BACKGROUND: In healthcare, a range of methods are used to improve patient safety through risk identification within the scope of risk management. However, there is no evidence determining what trust-level guidance exists to support risk identification in healthcare organisations. This study therefore aimed to determine such methods through the content analysis of trust-level risk management documents. METHOD: Through Freedom of Information Act, risk management documents were requested from each acute, mental health and ambulance trust in the East of England region of NHS for content analysis. Received documents were also compared with guidance from other safety-critical industries …to capture differences between the documents from those industries, and learning points to the healthcare field. RESULTS: A total of forty-eight documents were received from twenty-one trusts. Incident reporting was found as the main method for risk identification. The documents provided insufficient support for the use of prospective risk identification methods, such as Prospective Hazard Analysis (PHA) methods, while the guidance from other industries extensively promoted such methods. CONCLUSION: The documents provided significant insight into prescribed risk identification practice in the chosen region. Based on the content analysis and guidance from other safety-critical industries, a number of recommendations were made; such as introducing the use of PHA methods in the creation and revision of risk management documents, and providing individual guidance on risk identification to promote patient safety further. Show more

Keywords: Healthcare risk management, risk identification, patient safety, health policy

DOI: 10.3233/JRS-150651

Citation: International Journal of Risk & Safety in Medicine, vol. 27, no. 2, pp. 67-76, 2015

Price: EUR 27.50

Direct-to-physician and direct-to-consumer advertising: Time to have stringent regulations

Article Type: Research Article

Abstract: BACKGROUND: Direct to physician advertisements and direct to consumer advertisement (DTCA) is a well-known marketing strategy of pharmaceutical companies. Studies from the West and also from the Indian sub-continent revealed several lacunae in such advertisements. OBJECTIVES: The present study was carried out to understand the international and national scenario regarding the lacunae in drug advertisements and the opinion of both physicians and patients regarding DTCA. METHODS: The present study was conducted after obtaining approval from the institutional ethics committee. Warning letters (WLs) issued to pharmaceutical companies by United States Food and Drug Administration (USFDA) and …Therapeutic Goods Administration (TGA) due to discrepancies in the advertisements were analyzed for reasons that were grouped into one of the following categories: overstatement of efficacy; unapproved indication; lack of adequate directions to use; omission of adverse effects; misleading claims; advertisement made for an unapproved drug (investigational new product). Drug advertisements in Current Index of Medical Specialties (CIMS) April–July 2014 issue was also analyzed for lacunae depending on categories as mentioned above. Physicians and patients in a tertiary care medical college and hospital were administered a validated questionnaire exploring their views about crucial aspects of DTCA. Descriptive statistics was used for each of the categories. RESULTS: A total of 93 WLs issued by USFDA and 36 by TGA were assessed. Majority of the WLs by USFDA were issued for omission of adverse effects (61/93, 65.6%) followed by misleading claims (54/93, 58.1%). Similarly, WLs by TGA were also mainly issued for the presence of misleading claims (35/36, 97.2%) followed by overstatement of efficacy (26/36, 72.2%) and CIMS evaluation had revealed that 78/92 (84.8%) advertisements omitted adverse effects, 20/92 (21.7%) had misleading claims, 9/92 (9.8%) had unapproved indications and 7/92 (7.6%) overstated the efficacy. With regard to the opinion regarding DTCA, 69.9% physicians had a patient discussing DTCA that was clinically inappropriate. One hundred (64.5%) out of 155 physicians opined that DTCA encourage patients to attend physicians regarding preventive healthcare. On the contrary, 82/155 (52.9%) physicians felt that DTCA would damage the same. Similarly, 69 out of the total 100 patients felt that drug advertisements aid them to have better discussions with their treating physicians. Surprisingly, a large majority (91/100) were of the opinion that only safe drugs are allowed to be advertised. CONCLUSION: To conclude, from the findings of this study both the physicians and patients should be cautious and not overzealous while dealing with drug advertisements or promotional literature. More stringent scrutiny and issue of WLs or blacklisting of indulging pharmaceutical companies are mandatory by the regulatory agency to contain the same. Show more

Keywords: DTPA, DTCA, drug advertisements

DOI: 10.3233/JRS-150644

Citation: International Journal of Risk & Safety in Medicine, vol. 27, no. 2, pp. 77-83, 2015

Price: EUR 27.50

Suicidal risk from TADS study was higher than it first appeared

Authors: Högberg, Göran | Antonuccio, David O. | Healy, David

Article Type: Research Article

Abstract: Completed suicides are a major cause of death in adolescents in Sweden. Forensic analysis of completed suicides in children and adolescents shows there is one completed suicide per 1000 children taking a selective serotonin re-uptake inhibitor (SSRI). In order to elucidate these events we undertook a study of the results and reporting of suicidal events in the Treatment of Adolescents with Depression Study (TADS). We conclude that a major, albeit underreported, finding in the TADS was the significant increase of suicidal events in the adolescents on antidepressant medication in comparison to the group on placebo medication. The proportions of suicidal …events were 11% and 2.7% respectively. This increased risk of suicidal events might be related to the high incidence of medication with an SSRI in the group of completed suicides among Swedish adolescents. Show more

Keywords: SSRIs, suicide, adolescent depression, TADS, CBT

DOI: 10.3233/JRS-150645

Citation: International Journal of Risk & Safety in Medicine, vol. 27, no. 2, pp. 85-91, 2015

Price: EUR 27.50

Are the SSRI antidepressants safe in pregnancy? Understanding the debate

Authors: Urato, Adam C.

Article Type: Research Article

Abstract: BACKGROUND: Rates of antidepressant use during pregnancy are rising worldwide. It is, therefore, essential to determine the effects of these medications in pregnancy and on the developing fetus. OBJECTIVE: To review the two main explanatory models for understanding the effects of antidepressant use during pregnancy and compare the evidence to support them. METHODS: Review, synthesis, and discussion of the available literature. RESULTS: The preponderance of the basic science, animal data, and human studies supports the view that the Harmful Chemical Model is the best explanatory framework for understanding the effects of the SSRI …antidepressants during pregnancy. They do not appear to be helpful medications that produce better outcomes for moms and babies. They are not like using insulin in pregnant diabetics. Their profile fits more with a harmful chemical exposure. CONCLUSIONS: The totality of the scientific evidence convincingly suggests that the SSRI antidepressants are chemicals that do cause fetal harm and that the FDA should strongly consider changing the FDA Category from C to D for the entire class. This move would provide appropriate warning to the public while still allowing for use in selected cases. Show more

Keywords: Antidepressants, pregnancy, serotonin

DOI: 10.3233/JRS-150646

Citation: International Journal of Risk & Safety in Medicine, vol. 27, no. 2, pp. 93-99, 2015

Price: EUR 27.50