Is the provision of paediatric oral liquid unlicensed medicines safe?

Rawlence, Elizabeth; Lowey, Andrew; Tomlin, Stephen; Auyeung, Vivian

doi:10.1136/archdischild-2016-312132

Cited by 14 publications

(17 citation statements)

References 10 publications

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“…Medications that are not available in commercially prepared oral liquid formulations require compounding, or manipulating the dosage form (eg, mixing a crushed tablet in a liquid to create an oral liquid form). This process carries several risks, including formulation failure (ie, the medication is rendered inert through the compounding process), microbial contamination, compounding error (ie, the compound is made with an incorrect medication or amount of medication), or dosing errors from the use of non-standard recipes (eg, a caregiver does not realise that one pharmacy compounds a different strength of oral liquid from another and delivers the wrong dose) 56. While no data are available to quantify these risks, the US Food and Drug Administration has reported that up to 33% of pharmacy made compounds fail quality testing 7…”

Section: Challenges Of Giving Oral Liquid Medicationsmentioning

confidence: 99%

“…To reduce measurement errors, medications should be measured using oral syringes, and pharmacists can demonstrate the appropriate volumes for administration each time a prescription is filled 10. When necessary, compounded medications should be made in licensed compounding pharmacies (local regulations vary) that use well referenced, standardised recipes and employ rigorous checking processes 6. Clinicians and caregivers are encouraged to call and ask pharmacies about the availability of oral liquids and the compounding practices at individual pharmacies.…”

Section: What Can Parents and Caregivers Do To Encourage Children To mentioning

confidence: 99%

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Giving oral medicines and supplements to children

Dersch‐Mills

Kaplan

2020

BMJ

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Section: Challenges Of Giving Oral Liquid Medicationsmentioning

confidence: 99%

Section: What Can Parents and Caregivers Do To Encourage Children To mentioning

confidence: 99%

Giving oral medicines and supplements to children

Dersch‐Mills

Kaplan

2020

BMJ

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“…Although compounded and manipulated medicines serve an important unmet medical need for the paediatric population, they cannot be viewed as equivalent to commercial forms 4 . When compared to manufacturing standards (Good Manufacturing Practices) required by regulatory agencies for commercial products, compounding/manipulation has multiple inherent limitations (Table 1), which can translate into suboptimal adherence due to bad taste, exposure to unsafe ingredients, under dosing with therapeutic failure or overdosing with unintended adverse events 5–7 . Furthermore, the lack of bioavailability data for most compounded/manipulated medicines administered to children is rarely known to prescribers despite the fact that these manipulations can interfere with the integrity of the active pharmaceutical ingredient (API) and affect systemic drug exposure with therapeutic consequences.…”

Section: Introductionmentioning

confidence: 99%

“…4 When compared to manufacturing standards (Good Manufacturing Practices) required by regulatory agencies for commercial products, compounding/manipulation has multiple inherent limitations (Table 1), which can translate into suboptimal adherence due to bad taste, exposure to unsafe ingredients, under dosing with therapeutic failure or overdosing with unintended adverse events. [5][6][7] Furthermore, the lack of bioavailability data for most compounded/ manipulated medicines administered to children is rarely known to prescribers despite the fact that these manipulations can interfere with the integrity of the active pharmaceutical ingredient (API) and affect systemic drug exposure with therapeutic consequences. The potential impact of manipulation on drug bioavailability is well illustrated by a cross-over trial evaluating the pharmacokinetics of lopinavir/ritonavir tablets (Kaletra) in human immunodeficiency virus (HIV)-infected children.…”

mentioning

confidence: 99%

From paediatric formulations development to access: Advances made and remaining challenges

Litalien

Bérubé

Tuleu

et al. 2022

Brit J Clinical Pharma

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Developing suitable paediatric formulations and ensuring access to them by the greatest number of the 2.2 billion children worldwide are equally important to provide optimal pharmacotherapy. This review focuses on the progress made over the last two decades with paediatric oral formulations with respect to evidence for acceptability and dosing flexibility of liquid and solid oral dosage forms. It also discusses the clinical needs for, and the access to, paediatric formulations for existing authorised medicines. A significant body of new knowledge now supports the acceptability of solid oral dosage forms in children, resulting in an increasing number of medicines commercialised as multiparticulates, including minitablets that are starting to be brought to market. However, there are gaps with these formulations that deserve more research. Even though efforts have been made to identify medicines in need of age-appropriate formulations, there is no common priority list shared internationally. Such prioritisation would help to develop paediatric formulations with the greatest potential for providing a health benefit to children worldwide. In addition, available data highlight that paediatric formulation access is fragmented and unequal, with commercialisation of suitable paediatric formulations too often limited to some countries/regions. We propose actions to better align decisions during the development of paediatric formulations and promote a more globalised approach to facilitate registration pathways between different jurisdictions. Furthermore, discussions about alignment between approval, pricing and reimbursement processes should also happen, leaving working in siloes behind us. It is time for adults to start thinking outside the box for children.

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“…47 Varying timelines required to access the medicines, inconsistent bioequivalence in the products available and short expiry dates preventing automatic stock re-ordering were some of the issues highlighted by the participants and reported previously in the literature. 19,48,49 This led to an increased need to negotiate shared goals with the patient as part of a patient-centred approach, with patients needing to maintain and manage communication across settings and often to take responsibility for initiating the ordering of further supplies, critical to ensure the best possible outcomes. 50,51 The resulting increased involvement of patients in their care had to be achieved by maintaining the balance of providing additional information about unlicensed "special" medicines without causing concern.…”

mentioning

confidence: 99%

<p>Unlicensed “Special” Medicines: Understanding the Community Pharmacist Perspective</p>

Wale¹,

Ireland²,

Yemm³

et al. 2020

IPRP

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Objective: Community pharmacy staff are responsible for obtaining and supplying unlicensed "special" medicines to patients in primary care. Less well-defined parameters for safe and effective use of unlicensed compared to licensed medicines, along with issues around maintaining consistency between care settings or among manufacturers, have been associated with increased risks. This study aimed to explore the views and experiences of community pharmacy staff on accessing and supplying unlicensed "special" medicines to patients in Wales and the perceived impact of challenges faced on patient care. Methods: A qualitative, phenomenological approach was employed, involving semistructured interviews with pharmacists and pharmacy technicians working at one small chain of community pharmacies in Wales. The interview schedule focused on the personal experiences and perceptions of the participants on the processes involved in accessing and supplying unlicensed "special" medicines from a community pharmacy. Interviews were audio-recorded and transcribed verbatim. Results: A total of six participants completed the interview. Three main themes were constructed from inductive thematic analysis of the transcribed interviews: requirement for additional patient responsibilities; influences on the confidence felt by pharmacy staff when accessing and supplying unlicensed "special" medicines; and continuity of supply. Conclusion: This study gives a preliminary insight into the views and experiences of community pharmacy staff in Wales when accessing and supplying unlicensed "special" medicines. Further research is required to see if these views and experiences are representative of community pharmacy staff across the country.

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Is the provision of paediatric oral liquid unlicensed medicines safe?

Cited by 14 publications

References 10 publications

Giving oral medicines and supplements to children

Giving oral medicines and supplements to children

From paediatric formulations development to access: Advances made and remaining challenges

<p>Unlicensed “Special” Medicines: Understanding the Community Pharmacist Perspective</p>

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