Gabapentin and Pregabalin

November 2019

Disclaimer

Does it matter?

Indications for use

Licensed indication Pregabalin Gabapentin

Generalized anxiety disorder Yes No

Peripheral and central neuropathic pain Yes No

Peripheral neuropathic pain Yes Yes

Adjunctive therapy for focal seizures

with or without secondary generalization

Yes Yes

Monotherapy for focal seizures with or

without secondary generalization

No Yes

Migraine prophylaxis No Unlicensed but BNF

contains dosing

information

Menopausal symptoms (in women with

breast cancer)

No Unlicensed but BNF

contains dosing

information

Fibromyalgia No No

Clinical practice

Moderate-quality evidence shows that oral pregabalin at doses of 300 mg or 600 mg daily has an important effect on pain in some people with moderate or severe neuropathic pain after shingles, or due to diabetes.

Low-quality evidence suggests that oral pregabalin is effective after trauma due to stroke or spinal cord injury. Pregabalin appears not to be effective in neuropathic pain associated with HIV. Very limited evidence is available for neuropathic back pain, neuropathic cancer pain, and some other forms of neuropathic pain.

Commonly prescribed for pain

Moderate-quality evidence that oral gabapentin at doses of 1200 mg daily or more has an important effect on pain in some people with moderate or severe neuropathic pain after shingles or due to diabetes.

Prescribing rates up: 2007-2012 : pregabalin up by by 350%, gabapentin up by 150%

10 x increase in gabapentinoid prescribing between 2000 and 2015 from 0.21% to 2.1 % of the population in UK prescribed these drugs

Many scripts off label

Cartagena F, Farias L, et al Prescribing Patterns in Dependence Forming Medications. Public Health Research Consortium 2017 http://phrc.lshtm.ac.uk/papers/PHRC_014_Final_Report.pdfhttps://www.cochrane.org/CD007076/SYMPT_pregabalin-chronic-neuropathic-pain-adultshttps://www.cochrane.org/CD007938/SYMPT_gabapentin-chronic-neuropathic-pain-adults

What’s happening?

Often co-prescribed with opioids

Concomitant treatment with gabapentin/pregabalin and opioids is associated with a significant increase in the risk of opioid-related death

This effect is more pronounced the higher the dose of gabapentinoid (1.8g gabapentin per day or more; 300mg pregabalin per day or more

Withdrawal - short term Irritability

AnxietyAgitationRestlessnessExcessive sweatingSensitivity to lightHeadacheConfusion or disorientationFeverHallucinationsRapid heart rate or heart palpitationsCatatonia or inability to moveStatus epilepticus

Why worry?

Gabapentinoids are associated with an increased risk of:

• suicidal behaviour,

• unintentional overdoses,

• head/body injuries, and

• road traffic incidents and offences.

• Pregabalin was associated with higher hazards of these outcomes than gabapentin

Participants aged 15-24 were the most vulnerable group

Associations between gabapentinoids and suicidal behaviour, unintentional overdoses, injuries, road traffic incidents, and violent crime: population based cohort study in Sweden

https://www.bmj.com/content/365/bmj.l4021

Why worry?

2 big meta analyses of gabapentinoid misuse suggest:

1.6% in the general community misuse Pregabalin / Gabapentin

3 - 68% of opioid misusers also misuse Pregabalin / Gabapentin, with patients with mental health/substance misuse issues being particularly at risk

Dependence: the need to continue taking a medicine to maintain a state of normality and avoid symptoms of withdrawal

Evidence of use for no medical purposes – (Estimates)

1.6% prevalence of gabapentinoid misuse in the general population and a

Prevalence from 3% to 68% among populations with opioid use disorder (PHE review)

Envoy KE, et al. Abuse and misuse of pregabalin and gabapentin. Drugs 2017; 77(4):403–26. https://www.ncbi.nlm.nih.gov/pubmed/28144823

CD regulations relate to the secure safe management and use of Controlled Drugs

• includes the whole journey of a CD from ordering / prescribing through delivery and storage through to administration / destruction

April 2019

1st April 2019 Pregabalin and gabapentin became Controlled Drugs

Schedule 3

words and figures

28 days

No emergency supply

No repeat dispensing by paper FP10 RD or electronic repeat dispensing (different to repeat prescribing)

September 2019

Dependence forming

medication prescribing

Prescribing trends

Numbers receiving long term scripts

Geographical differences

• Openprescribing.net

What should make me

concerned

Co-morbidities – respiratory, renal, elderly, frail suicidal behaviours, Substance misuse

Co-prescribing– especially opioids

Its not working

Rising doses risk increases

No clear indication

No clear timely review

Where else are they sourcing medication from? Private prescribing?

The third WHO Global Patient

Safety Challenge:Medication

Without Harm

Moments for Medication

safety

Primary health care facility consults

Referrals to another health care facility

or to another health care professional

Pharmacy visits

Admissions to a health care facility;

Transfers to another health care facility;

Discharges from a health care facility;

Treatment and care at home / nursing

home / hospice

What can we do

• Risks

• Polypharmacy

• Transitions

Raise a concern / report an incident

https://www.cdreporting.co.uk

CDAO contacts: https://www.cqc.org.uk/guidance-providers/controlled-drugs/controlled-drugs-accountable-officers

Questions?