DESK REVIEWS | 07.05.01. Are any antidementia medications approved by National Medicines Regulatory Authority?

DESK REVIEW | 07.05.01. Are any antidementia medications approved by National Medicines Regulatory Authority?

Yes. These are: donepezil, galantamine, rivastigmine, and memantine.

There are four major types of anti-dementia medications approved by the Hospital Authority Drug Formulary in Hong Kong (Hospital Authority Drug Formulary, 2020, April 10; Institute of Mental Health Castle Peak Hospital, 2020), including Donepezil (Aricept), Rivastigmine (Exelon), Galantamine (Reminyl), and Memantine (Ebixa). They are commonly used in treating dementia for slowing down disease progression, maintaining functioning, deferring decline, and alleviating behavioural and emotional problems. Apart from that, other drugs may be also used to ease some distressing symptoms relating to dementia at different stages, such as depression, anxiety, sleeping disorder, and antipsychotics (Social Welfare Department, 2018).

References:

Hospital Authority Drug Formulary. (2020, April 10). HA DRUG FORMULARY (v15.4 – w.e.f.10 Apr 2020)

Institute of Mental Health Castle Peak Hospital. (2020). Anti-dementia agents.

Social Welfare Department. (2018). Dementia Awareness Kit.

Clinical Practice Guidelines (CPGs) for management of dementia published by the Indian Psychiatric Society (Shaji. et al., 2018) lists the following approved anti-dementia drugs (Cholinesterase Inhibitors):

  • Donepezil
  • Rivastigmine
  • Galantamine
  • Rivastigmine Transdermal Patch
  • Donepezil Extended Release
  • NMDA Antagonist Memantine.
References:

Shaji, K.S., Sivakumar, P.T., Rao, G.P., Paul, N., (2018). Clinical Practice Guidelines for Management of Dementia. Indian J. Psychiatry 60, S312–S328. https://doi.org/10.4103/0019-5545.224472

There is coverage for dementia medications according to the National Formulary 2015 (there are amendments in 2017, 2018 but not affecting Alzheimer’s drugs). Covering is only available for donepezil (classified as anticholinesterase). It can only be obtained at health facilities at level 3 (tertiary hospitals/type A hospitals according to BPJS) and can only be prescribed for mild to moderate Alzheimer’s. Coverage is 30 tablets per month for both film-coated tablets 5mg and for dispersible tablets 10mg.

Based on telephone enquiries made with local pharmacies by the STRiDE Jamaica team and leading psychiatrist who provides dementia care, antidementia medications available in Jamaica as of April 2020, include:

Acetylcholinesterase inhibitors:

  1. Donepezil (Aricept)
  2. Galantamine (Exelon)
  3. Rivastigmine (Reminyl)

Anti-psychotic, Anti-depressants or anti-anxiety:

  1. Haloperidol
  2. Risperdal
  3. Escitalopram
  4. Lorazepam

Aricept (5mg & 10mg), and Palixid (5mg and 10mg) are frequently carried, while Reminyl (8 mg) and Exelon (3mg, 4.5mg, 5mg & 10mg) are also approved for sale in Jamaica but are not as widely available.

Most drugs are approved by the National Medicines Regulatory Authority but not included on the essential drug list of drugs in Kenya (Ministry of Health, 2016a) and are unavailable in public facilities. For instance, Donepezil is mostly available in private facilities (Mokaya et al., 2016).

References:

Ministry of Health. (2016a). Kenya Essential Medical Supplies List 2016. Nairobi, Kenya. http://publications.universalhealth2030.org/uploads/KEMSL-2016Final-1.pdf

Mokaya, J., Dotchin, C. L., Gray, W. K., Hooker, J., & Walker, R. W. (2016). The accessibility of Parkinson’s disease medication in Kenya: results of a national survey. Movement Disorders Clinical Practice, 3(4), 376–381. https://doi.org/10.1002/mdc3.12294

 

According to the Clinical Guidance[1] for Cognitive Impairment, the recommended medicines are cholinesterase inhibitors for management of dementia and antipsychotic medications for the management of challenging behaviours (CENETEC, 2017).

[1] Diagnóstico y Tratamiento de la Demencia Alzheimer. http://www.cenetec.salud.gob.mx/descargas/gpc/CatalogoMaestro/393_IMSS_10_Demencia_Alzheimer/EyR_IMSS_393_10.pdf

References:

CENETEC. (2017). Diagnóstico y Tratamiento de la Enfermedad de Alzheimer. Guía de Evidencias y Recomendaciones: Guía de Práctica Clínica. Guia de Practica Clinica. http://www.cenetec-difusion.com/CMGPC/IMSS-393-10/RR.pdf

Yes. Donepezil, rivastigmine, galantamine, and memantine are all approved for use in NZ. However, only Donepezil (generic) and Rivastigmine transdermal patch (generic) are subsidised by the government.

No medications can be sold or prescribed in South Africa without the South African Health Products Regulatory Authority’s (SAHPRA) approval. Anti-dementia medications are available in South Africa, for example:

Acetylcholinesterase inhibitors:

  1. Donepezil (Aricept)
  2. Rivastigmine (Exelon)
  3. Galantamine (Reminyl)
  4. Memantine (Ebixa)

Anti-depressants:

  1. Citalopram
  2. Sertraline
  3. Mirtazapine
  4. Agomelatine
  5. Escitalopram
  6. Venlafaxine

These medications are prescribed as treatment guidelines by the South African Society of Psychiatrists (SASOP) (Emsley et al., 2013) that primarily guides the private sector in psychiatric practice. It is unclear to what extent these are adopted by the public sector, especially considering the health care system’s challenges in maintaining medicinal stocks and supplies at health care facilities.

Anti-dementia medications are expensive and not all medical insurance schemes will pay for these (Truter, 2013). Dementia is not listed as a chronic condition and, therefore, do not cover full costs of anti-dementia drugs as chronic medication.

References:

Emsley, R., Seedat, S., & Van Staden, W. (2013). South African Journal of Psychiatry PART 2 The South African Society of Psychiatrists (SASOP) Treatment Guidelines for Psychiatric Disorders Head of Publishing The South African Society of Psychiatrists (SASOP) Treatment Guidelines. South African Journal of Family Practice, 19(No. 3), 196. https://doi.org/DOI:10.7196/SAJP.474

Truter, I. (2013). Antipsychotic drug prescribing to patients with dementia in a South African patient population. African Journal of Pharmacy and Pharmacology, 7(41), 2755–2762. https://doi.org/10.5897/ajpp2013.3893