Dear Contractor

Evidence of harm from fake or illicit benzodiazepines

The Department of Health has issued a letter (attached) highlighting the availability of, and harm from, illicit drugs sold as benzodiazepines – particularly when used in conjunction with alcohol and with drugs with a respiratory depressant effect including gabapentinoids and opioids.

Summary

This letter is directed at all those who are in contact with people who use drugs and is aimed at increasing awareness to the possibility of overdose arising from illicit drugs sold as benzodiazepines, helping with the recognition of the possible symptoms of overdose, and advising on how to respond appropriately.

The letter includes the following sections:

  • Information for professionals on illicit drugs sold as benzodiazepines
  • Harm reduction advice and information for wider circulation
  • Actions advised
  • Other sources of information
  • Reporting intelligence

Action

Contractors should:

(a) Make their dispensing teams aware of the content of this letter.

CPNI colleagues will continue to support contractors on these matters.

Kind regards

Mike

Sent on behalf of Prof Mike Mawhinney | Head of Regulatory Affairs

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Dear Colleague,

Updated HSCB Interim Protocol for COVID-19 Testing – Version 6.1 issued 23rd July 2020

HSCB has updated and released version 6.1 of the COVID-19 Interim Protocol for Testing.

A number of aspects have been updated within this version of the protocol and they are easily identifiable.  Please bring this updated v6.1 interim testing protocol to the attention of all your Pharmacy teams.

You will note page 17 includes a new section on antibody testing.As stated, there is considerable uncertainty about the significance of a positive test result for antibodies. While it means than an individual has had COVID-19 at some time in the past this does not indicate that the individual cannot be re-infected with the virus, or pass it on to others, or have protective immunity.  In view of this uncertainty, the approach to antibody testing over the next few months will be to offer testing to health and care workers in hospital and community settings, including independent contractors as part of a seroprevalence study.  CPNI is currently working with HSCB colleagues to develop operational arrangements which will provide access to antibody testing for community pharmacy teams.

Version 6.1 replaces version 5.1 issued by HSCB on 23rd May and contained in CPNI Contractor Update # 99.

Please do not hesitate to contact your local HSCB office should you require any additional information.

Yours sincerely

SENT FOR AND BEHALF OF GERARD GREENE | Chief Executive

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Dear Colleague,

A newly published survey by epilepsy charities Epilepsy Action, Epilepsy Society and Young Epilepsy found one in ten (11%) women who are currently taking the epilepsy medicine valproate are unaware of the possible risk of birth defects if taken in pregnancy. Furthermore, one in five (18%) don’t know that, when taken in pregnancy, the medicine could also cause learning and developmental delays in children.

Under the current regulations, valproate must no longer be used for women and girls who are able to become pregnant unless there is a Pregnancy Prevention Plan (PPP) in place. The PPP, mandatory at prescription, is an intervention from the MHRA designed to make sure patients are fully aware of the risks of valproate use in pregnancy and the need to avoid becoming pregnant.

The survey found that many women with epilepsy are still not receiving information from health professionals about the risks of valproate, leaving their potential future children at risk of harm.

“Valproate dispensing from the pharmacist

  • Just under half of respondents (49%, 251/514) said they had had no discussion with their pharmacist about the risks associated with taking valproate during pregnancy. Only 14% (72/514) said they had this discussion every time they collected a prescription.
  • 29% (150/514) of respondents stated that when their valproate was dispensed in a plain package, the box never had a sticker with the warning pictogram. Only 60% (306/514) of respondents stated that a prescription in a manufacturer’s packaging always included the warning pictogram.
  • Over half (51%, 261/514) of respondents said they had never received the Patient Card from their pharmacist when receiving their prescription”

The full report can be accessed here: https://www.epilepsysociety.org.uk/News/women-still-unaware-risks-around-epilepsy-medicines-pregnancy-charity-survey-finds-07-07-2020#.Xxq-dJ5Kg2x

Reminder:

PHARMACISTS are asked to take the following IMPORTANT ACTIONS:

  • Provide a Patient Card every time you dispense a valproate medicine to ALL female patients. Please also note that the outer boxes of valproate are being changed in order to include a removable patient card, to be detached and given to the female patient at the time of dispensation.
  • When dispensing any valproate preparation to female children, adolescents, women of childbearing potential, or pregnant women check that their prescriber has discussed the risks of exposure in pregnancy with them and they are aware of these and subsequently they are taking effective contraception unless already pregnant.
  • If the prescriber has not discussed the risks with the patient or the patient is not taking effective contraception, tell them to contact their GP or specialist for an urgent follow-up appointment.
  • Advise the patients not to stop valproate medication and to immediately contact their GP or specialist in case of suspected pregnancy.
  • Ask if they have received the Patient Guide and provide a copy if they have not received this or no longer have it in their possession.
  • Dispense valproate in the original package with the outer warning and avoid repacking. In the situations where this cannot be avoided, always provide a copy of the package leaflet, patient card, and add a warning sticker to the outer box.

To order new or further PPP materials, please contact Sanofi medical information department on 0845 372 7101 or email UK-Medicalinformation@sanofi.com.

Please share this important information with all pharmacy staff.

Yours sincerely

SENT FOR AND BEHALF OF GERARD GREENE | Chief Executive

Dear Contractor

Update: cannabis-based medicinal products

The Department of Health has issued a letter summarising and updating information in respect of cannabis-based medicinal products (attached). This letter is addressed mainly to those who are in the position of deciding whether to prescribe cannabis-based medicinal products.

Summary

Since 1 November 2018 specialist doctors on the Specialist Register of the General Medical Council have been able to decide whether to prescribe cannabis-based medicinal products where there is an unmet clinical need.

The letter highlights recent developments in this area and some new resources that have been developed to support the making of clinical decisions.  The letter covers a number of areas including:

Re-scheduling of Epidyolex® and insertion of a new definition under the Misuse of Drugs Regulations (Northern Ireland) 2002;

NICE Clinical Guidance and Technology Appraisals;

Refractory Epilepsy Specialist Clinical Advisory Service (RESCAS);

Frequently Asked Questions (FAQs).

Action

Contractors should:

(a) Be aware of the content of this letter for access where appropriate.

CPNI colleagues will continue to support contractors on these matters.

Kind regards

Mike

Sent on behalf of Prof Mike Mawhinney | Head of Regulatory Affairs

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Dear Contractor

Update to Serious Shortage Protocols: Fluoxetine 40mg Capsules

The Department of Health has issued updated information (attached) on the Serious Shortage Protocol (SSP) which was issued on 20 May 2020 in respect of fluoxetine 40mg capsules.

Summary

The SSP was issued with an end date of Monday 20 July 2020, but this has now been extended and the SSP will end on Monday 10 August 2020.  Details of the SSP are available on the BSO website and can be accessed via this link:

www.hscbusiness.hscni.net/services/3063.htm

Action

Contractors should:

  • Brief their dispensing teams on the extension of the SSP.

CPNI colleagues will continue to support contractors on these matters.

Kind regards

Mike

Sent on behalf of Prof Mike Mawhinney | Head of Regulatory Affairs

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UPDATED SURVEY LINK

Dear Colleague,

We have received feedback from contractors that the previous HSCB survey link was having technical issues. If you are having difficulties, please use the following alternate survey link: https://www.surveymonkey.co.uk/r/65ZCGG7

Please note, the updated survey link requires the survey to be completed in one go, information cannot be saved.

The closing date for completion of the survey is Friday 24th July 2020.  

If you are still having issues, please contact your local HSCB office or the CPNI office.

Yours sincerely

SENT FOR AND BEHALF OF GERARD GREENE | Chief Executive

Also see CPNI COVID19 ContractorUpdate #114 RE: HSCB Survey Deadline *** Fri 24 Jul-20 *** sent 20 July 2020 @ 09:23