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Shortage of supply (update) Clinical Directors Medicines Information 12th January 2015 Haloperidol injection 5mg/1ml (AmCo Ltd)

Description of product affected

Haloperidol injection is licensed for the rapid control of the symptoms of hostility,
aggression, hyperactivity, disruptive and violent behaviour, confusion, emotional
withdrawal, hallucinations and delusions associated with acute and chronic
schizophrenia, mania, and hypomania, and organic brain syndrome. It is also
licensed for the treatment of nausea and vomiting.
Update

Shortages are continuing and may extend for up to 12 months.
MMPS have imported haloperidol injection for use in LTHT and the Leeds Hospices.
However, we do not anticipate meeting the overall demand for haloperidol injection.
In view of the continuing shortage, stocks will be removed from
ward/department areas and centralised in dispensary locations
across the Trust. Theatre Recovery, Critical Care, and A&E will
continue to hold a small emergency supply.
Use of haloperidol is expected to be prioritised for the treatment of delirium and use in
rapid tranquillisation.
Currently, haloperidol 5mg tablets, 1.5 mg tablets and haloperidol oral liquid are
available at LTHT and community pharmacies. Haloperidol 0.5mg capsules are only
available at LTHT.
Alternative agents and management options
Haloperidol is used in a variety of clinical areas within the Trust. Below are potential
alternative options for the most common uses.
Responsibility for prescribing remains with the individual clinician. If unsure,
please seek advice from an appropriate specialist.

Palliative care indications:

1.
Nausea and Vomiting:

Interim management of nausea and vomiting in palliative care by generalists:

Haloperidol is widely used for the management of nausea/vomiting (N&V) in palliative
care, and is particularly useful when the nausea and vomiting is due to stimulation of
the chemoreceptor trigger zone (CTZ) e.g. opioids, intestinal obstruction or
hypercalcaemia. Haloperidol is considered an essential drug in palliative care, and
although there are other anti-emetics available, they all have their limitations and may
only be useful in certain situations and for specific patients.4 Like haloperidol,
levomepromazine act on dopamine receptors in the CTZ but has a broader range of
action. It is usually reserved for N&V that is unresponsive to more specific agents or
that is multifactorial in origin. It is a possible alternative agent but is more sedating,
unlike haloperidol, which has minimal sedative properties at the low doses used for
nausea and vomiting.2, 3. Metoclopramide also acts on the CTZ against dopamine
receptors but has additional prokinetic properties that may limit use in some
situations.

Potential treatment options (see also current BNF for dosing advice):

Elicit cause of nausea if possible and correct any reversible factors. ii) Review anti-emetic drug history. If haloperidol is felt to be the most suitable drug and the oral route is viable ( the patient can swallow, they are not vomiting and the GI tract is functioning) consider oral haloperidol iii) If an injectable alternative is needed other antiemetics are available depending of the cause of the nausea and vomiting and the patient's individual characteristics. iv) Levomepromazine (usual starting dose 2.5mg to 6.25mg, maximum 12.5mg in 24 hours) could be considered if targeted antiemetics are ineffective or unsuitable.
If needed, seek specialist palliative care advice.

2.
Delirium:

Interim management of delirium in palliative care by generalists:
Initial non drug management:
 Identify and manage the underlying cause or combination of causes.  Ensure effective communication and reorientation (for example, explaining where the person is, who they are, and what your role is) and provide reassurance.  Consider involving family, friends and carers to help with this.  Ensure that people are cared for by a team of healthcare professionals familiar  Avoid moving people within and between wards or rooms unless necessary. 7
Potential treatment options (see also current BNF for dosing advice):

If delirium symptoms are not resolved and the person is in distress consider the
following drug management:
For patients with mild to moderate distress: i) Use oral haloperidol whenever possible. ii) If subcutaneous route is necessary, start with levomepromazine 6.25mg s/c, if necessary repeat within one hour then seek advice from specialist palliative care.3
For patients with severe distress and NOT an immediate danger to themselves or
others:
i) Use oral haloperidol whenever possible. ii) If subcutaneous route is necessary, start with levomepromazine 12.5mg s/c, if necessary repeat the dose within one hour then seek advice from specialist care.3 Consider lower doses 2.5mg to 6.25mg of levomepromazine for elderly, frail patients
and those with hepatic impairment and seek advice as needed. Metabolism is chiefly
hepatic but levomepromazine can cause additive drowsiness in patients with renal
failure.
Levomepromazine is more sedating than haloperidol. If there are concerns about the
use of potentially sedative medication, or other concerns regarding the use of
levomepromazine, other injectable antipsychotics are available, seek specialist
advice.
If a patient is not responding to the advised doses do not hesitate to seek specialist
palliative care advice.

For patients with an immediate danger to themselves or others:
Seek advice from psychiatry

3.
Agitation associated with delirium in the imminently dying:
Interim management of agitation associated with delirium in the
imminently dying - advice for generalists:

Use oral haloperidol whenever possible. If subcutaneous route is necessary, start with levomepromazine 6.25mg s/c, if necessary can repeat within one hour. Maximum 25mg daily in 24 hours.3 If ineffective or not tolerated, or concerned about dosing seek specialist palliative care advice.
Non palliative care indications
Rapid tranquilisation
The NICE guideline on management of violence and aggression recommends use of
either intramuscular lorazepam on its own or intramuscular haloperidol combined with
intramuscular promethazine for rapid tranquillisation in adults.5 The Maudsley
prescribing guidelines for managing acute disturbances or violent behaviour
recommend the following parenteral options: lorazepam, promethazine, olanzapine,
and aripiprazole, whilst haloperidol is considered a last resort drug.6
Potential treatment options (see also current BNF for dosing advice):
For non-psychotic patients
:
1st line - Lorazepam PO/ IM
2nd line - Promethazine PO/IM

For psychotic patients:
1st line - Olanzapine PO/IM
2nd line – Aripiprazole IM
References
1. Amdipharm Mercury Company Limited. Haloperidol Injection BP 5mg/ml. SPC:
date of revision 20/01/2014 2. Dickman A, Schneider J. The Syringe Driver 2011; 3rd ed. 3. Twycross et al. Palliative Care Formulary, 5th Ed. 4. Personal communication. Margaret Gibbs, Specialist Senior Pharmacist, St Christopher's Hospice, 28 Sept 2015 5. NICE. Violence and aggression: short-term management in mental health, health and community settings. NICE guideline, published: 29 May 2015: 6. Maudsley Prescribing Guidelines in psychiatry 2015. Use of psychotropic drugs in special patient groups. Table 7.29 7. NICE. Delirium: Prevention, diagnosis, management. NICE Clinical Guideline, published July 2010:
Acknowledgements

 Margaret Gibbs, Specialist Senior Pharmacist, St Christopher's Hospice
 Carol Paton. Chief Pharmacist, Oxleas NHS Foundation Trust.  Steve Wanklyn, Consultant Pharmacist, Pal iative and End of Life Care, Guy's and St Thomas' NHS Foundation Trust
Original document prepared by:
Guy's and St Thomas' NHS Foundation Trust Medicines Information Centre
Prepared [30 Sep 2015]
Document modified in consultation with:
 Lisa Nicholson, Advanced Pharmacist in Palliative Medicine. LTHT, Nov 2015
 Sue Ayers, Advanced Clinical Pharmacist in Palliative Medicine. LTHT, Nov 2015  Dr Suzanne Kite, Consultant in Palliative Medicine and Lead Clinician, Nov 2015  Dr Adam Hurlow, Consultant in Palliative Medicine, LTHT, Nov 2015  Dr Suzie Gillon, Consultant in Palliative Medicine, LTHT, Nov 2015  Dr Annette Edwards, Consultant in Palliative Medicine, Wheatfields Hospice &  Dr Lynne Russon, Consultant in Palliative Medicine, Wheatfields Hospice & LTHT,  Michael Dixon, Clinical Pharmacist, Leeds And York Partnership Trust

For all correspondence please contact:
Leeds Medicines Information Service ext 66504
Disclaimer: The content of some of this memo is based on clinical opinion from
practitioners. Users should bear this in mind in deciding whether to base their policy
on this document. Individual trusts should ensure that procedures for unlicensed
medicines are followed where a foreign import drug is required in the interim.

Source: http://www.leedsformulary.nhs.uk/docs/4.haloperidolshortagemiadviceDec15.pdf

Ourparentsourselves_release_con_021716

Embargoed until February 17, 2016 at 2:00 p.m. EST Media Contacts: Rebecca Porterfield Sandwich Generation Take Note: Your Parents May Not Be Getting Care They Need Worse, They Could Also Be Taking Risky Medicines Lebanon, N.H. (February 17, 2016) – Members of the "sandwich" generation can attest to how much time their aging parents spend inside the health care system, because they often accompany them on their succession of visits to the doctor's office, lab, or hospital. Yet despite the fact that on average Medicare recipients spend more than half a month a year (17.1 days) in contact with the health care system, all those visits don't always add up to good care. Depending on where they live, these patients too often don't receive medical care that reflects the best evidence available and, despite progress, many still receive potentially harmful medications, according to a new report from the Dartmouth Atlas Project. The report, "Our Parents, Ourselves: Health Care for an Aging Population," is a review of how adults ages 65 and older, a population predicted to surge from 43.1 million in 2012 to 83.7 million by 2050, receive health care in the U.S., based on 2012 Medicare data. It is also a roadmap for caregivers and patients, especially those with multiple ongoing health problems or dementia. "Our bodies change as we age, and our priorities change, too, as the number of years ahead are fewer than the years behind us," said Julie P.W. Bynum, MD, MPH, associate professor of The Dartmouth Institute for Health Policy & Clinical Practice and the report's lead author. "The information in this report is a good starting point for patients and their caregivers to begin a conversation with their doctor about certain aspects of their care." "The findings from this report will generate meaningful conversation about the care for our aging population and identify areas of action for consumers, advocates, health systems, and policy makers," said Terry Fulmer, PhD, RN, FAAN, president of The John A. Hartford Foundation, which funded the report. "This action is especially needed for older adults with multiple, ongoing health problems or dementia who face complex challenges when navigating the health care system and advocating for the best care possible." The report highlights several items that individuals caring for aging parents should be mindful of:

Dialogue sep 2010.indd

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