Complementary and alternative medicine: Pharmacovigilance in Malaysia and predictors of serious adverse reactions

Rahman, Sameerah Shaikh Abdul; Aziz, Zoriah

doi:10.1111/jcpt.13106

Cited by 10 publications

(4 citation statements)

References 30 publications

(35 reference statements)

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“…From a total number of 74 997 ICSR reports in the database, 930 involved CAM products. 5 Malaysia started consumer reporting to improve compliance level from recent times. 6 Various guidance documents are being prepared with the aim of developing a uniform framework towards assuring patient safety while expediting the availability of biosimilar products.…”

Section: Pv System In Malaysiamentioning

confidence: 99%

Pharmacovigilance in India and five ASEAN countries (Malaysia, Singapore, Thailand, Indonesia, Philippines): A comparison study

Dutta¹,

Banerjee²,

Pramanik³

et al. 2021

IJCAAP

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The World Health Organization (WHO) defines PV as the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other possible drug-related problems (WHO 2004). In 1968, during the 16th World Assembly the 16.36 resolution called for "a systematic collection of information on serious adverse drug reactions during the development and particularly after medicines have been made available for public use". This led to the formation of the WHO Programme for International Drug Monitoring (PIDM) in 1968. PV systems should include all entities and resources that protect the public from medicines-related harm (adverse reactions, poor product quality, medication errors, and therapeutic ineffectiveness), whether in personal healthcare or public health services. The PV system safeguards the public through efficient and timely identification, collection, and assessment of medicine-related adverse events and by communicating risks and benefits. The WHO has provided technical and normative leadership on PV since the development of the first voluntary notification scheme in 1961. As of January 2016, 123 countries have joined the WHO PIDM, and in addition 28 associate members are awaiting full membership. WHO has defined norms and guidelines for PV and has allowed information sharing among the participant countries. Another WHO PV-related activity is the work of the Council for International Organizations of Medical Sciences (CIOMS) which was established jointly by WHO and UNESCO in 1949. Starting with the publication of the Suspect Adverse Reaction Report Form (CIOMS Form I) by the CIOMS working group II, other CIOMS publications have greatly shaped the direction of PV. CIOMS publications have also greatly influenced the development of International Conference on Harmonization of Technical requirements for Registration of Pharmaceuticals for Human Use (ICH) E2A-E2F guidelines in drug safety. The standards for the electronic transmission of regulatory information regarding the individual case safety report (ICSR) has been changing over the last decade. The ICH adopted the E2B (R2) in February 2001 and the E2B (R3) in 2005, is being developed as the proposed harmonized international standards for health products safety reporting. These ICH guidelines have facilitated the adoption of harmonized standards for PV activities. This study contributes to filling the gap in the understanding of the PV systems capacity in Indian and five ASEAN countries namely Malaysia,

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Section: Pv System In Malaysiamentioning

confidence: 99%

Pharmacovigilance in India and five ASEAN countries (Malaysia, Singapore, Thailand, Indonesia, Philippines): A comparison study

Dutta¹,

Banerjee²,

Pramanik³

et al. 2021

IJCAAP

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show abstract

“…Additionally, some complementary medicines have limited supervision by the regulatory agencies favoring the presence of some medicines of poor quality, counterfeit products, or complementary medicine adulterated with allopathic drugs (such as non-steroidal anti-inflammatory drugs [NSAIDS], corticosteroids or other substances non-described in their components); and finally, frequently the prescription of complementary therapies is accomplished by incomplete or unreliable information that could mislead patients to a loss of confidence on the conventional scientific treatment, placing their trust in the alternative therapies. Nevertheless, complementary therapies are not harmless, and studies have identified adverse drug reactions linked to the use of complementary and alternative medicine products [ 16 ]. However, as described above, a major problem in the treatment of chronic diseases is the high frequency of withdrawals from the treatments.…”

Section: Introductionmentioning

confidence: 99%

Complementary Therapies and Their Association with Problems in Therapeutic Adherence to Conventional Synthetic DMARDs in Rheumatoid Arthritis: A Cross-Sectional Study

Santiago-Garcia,

Gamez-Nava,

Avalos-Salgado

et al. 2023

Healthcare

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The use of complementary therapies is highly prevalent among patients with rheumatoid arthritis (RA). Nevertheless, the use of complementary medicine could involve problems in the following of scientifically accepted treatments. To date, there is limited information regarding the association of nonconventional therapies with problems regarding compliance with the treatment. Therefore, the objective of this study was to identify whether the utilization of complementary therapies is associated with a high risk of problems regarding therapeutic adherence to conventional synthetic disease-modifying anti-rheumatic drugs (cs-DMARDs) in RA patients. A survey was performed with RA patients in an outpatient rheumatology clinic in a university hospital; the use of complementary therapies, as well as their type, was identified. To assess problems with therapeutic adherence, we used the four-item Morisky–Green scale. A comprehensive assessment of clinical and therapeutic characteristics was performed. Univariable and multivariable models were performed to identify the risk of problems with therapeutic adherence in users of complementary therapies. In total, 250 RA patients were included; 92% used complementary therapies. Of them, the most frequently used were herbal medicine (65%), homeopathy (64%), and cannabis and its derivatives (51%). In the univariable logistic regression analysis, the factors associated with problems in the therapeutic adherence to cs-DMARDs were age (p = 0.019), the presence of other comorbidities (p = 0.047), and the use of complementary therapies (p = 0.042). After controlling for potential confounders, the use of complementary therapies increased the risk of problems with therapeutic adherence to cs-DMARDs (adjusted OR = 2.84, 95% CI = 1.06–7.63, p = 0.037). We concluded that the use of complementary therapies increases the risk of problems with therapeutic adherence. Therefore, for physicians and healthcare professionals, the early identification of the use of nonconventional therapies in their RA patients is required, followed by a directed discussion with their patients about the risks and benefits to which they could be exposed to complementary therapies.

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“…Public health education on mislabeling, misbranding, false claims, and adulteration is required to minimize the risk to consumers while the U.S. Food and Drug Administration works to update the current regulations for dietary supplements ( Crawford et al, 2020 ) [E]. Studies have shown that adverse drug reactions (ADRs) of herbal products are vastly underreported globally; however, serious ADRs have been found in 26–41% of available reports, primarily skin and appendage disorders followed by liver and biliary disorders ( Shaikh Abdul Rahman & Aziz, 2020 ) [R]. This high incidence of serious ADRs which often implies death, a life-threatening reaction, hospitalization, prolonged hospital course, or significant disability should lead to increased vigilance ( World Health Organization, 2002 ) [S].…”

Section: Introductionmentioning

confidence: 99%

“…This high incidence of serious ADRs which often implies death, a life-threatening reaction, hospitalization, prolonged hospital course, or significant disability should lead to increased vigilance ( World Health Organization, 2002 ) [S]. Patients with comorbidities, chronic illness, and/or requirements for polypharmacy make it difficult to pinpoint which substance is responsible for the ADR ( Eisner, 2001 [R]; Shaikh Abdul Rahman & Aziz, 2020 [R]).…”

Section: Introductionmentioning

confidence: 99%