2019 – What is in store for community pharmacy?

17 Dec 2018

Superintendent update on what is in store for community pharmacy in 2019

Dear Superintendent,

As 2018 draws to a close, my update today includes a brief overview of some of the key events/topics that will be affecting community pharmacy in 2019 and beyond, including relevant deadlines for compliance.

  • Please scroll over the blue and underlined sentences to open resources and support.


What’s in store for you in 2019?

During 2019, the main events/topics affecting members will be:

  • Q1 2019 – GPhC inspection reports to be published (Great Britain)
  • Saturday 9 February 2019 – Falsified Medicine Directive comes into force
  • Friday 15 February 2019 – Quality Payments Scheme review date (England)
  • Friday 29 March 2019 – Brexit day
  • 31 March 2019 – Data Security and Protection toolkit (England)


General Pharmaceutical Council (GPhC) plans (England, Scotland and Wales)

On 6 December 2018, the GPhC Council held a meeting and agreed the following for 2019/20 – please note more details are to follow:

  • There will now be three types of inspections: intelligence-led, routine and themed
  • As a general rule, inspections are to be unannounced
  • Each principle will have four possible results: ‘standards not all met’, ‘standards met’, ‘good practice’, and ‘excellent practice’
  • Inspection outcomes will be either ‘standards met’ or ‘standards not met’
  • Inspection reports will be published from Quarter 1 2019/20
  • Examples of notable practice will be shared in a ‘knowledge hub’ on the new website


The GPhC has not yet published their response to the consultation yet; however, the consultation analysis report is available.


Falsified medicines Directive (FMD)

The FMD comes into force on 9 February 2019. The NPA will ensure that you are aware of any major developments, including the funding and implementation aspects of the process.

The Pharmacy Services team has produced a range of SOPs to support members in implementing the FMD requirements, available from the dedicated NPA FMD website. A new “FMD: next steps checklist” has also been published.


Quality Payments Scheme (QPS) (England only)

NHS England published updated “Quality Payments: Guidance for the February 2019 review point” (QP guidance) on 27 November 2018. There are a number of new requirements introduced in this guidance. I have summarised the key points below.

  • Use NHSBSA Manage Your Service portal to submit declarations (previously you used the SNAP survey tool)
  • Check whether you have met the Gateway Criteria through Manage Your Service – the portal will not allow you to continue with your declarations without meeting all five Gateway criteria

There are significant changes to some of the quality criteria. I have summarised the new requirements and the number of quality points now allocated to each criterion. Furthermore, the NPA Pharmacy Services team has developed a new resource to include a key date checklist, summary and actions to take.

Quality points:

Patient safety (Total of 60 points)

Written patient safety report updated since 28 June 2018 – you can use details from my Medication Safety Officer (MSO) reports. Plus look-alike-sound-alike (LASA) incidents proactive risk assessment, management and reporting (via the NPA Incident Reporting Platform) – we have also updated the “Look-alike sound-alike items” document. (20 points)

80% of registered pharmacy professionals to have completed the Centre for Pharmacy Postgraduate Education (CPPE) risk management training and develop a risk review – a template and example are available for you to use. (20 points)

Complete the Specialist Pharmacy Service audit of NSAIDs and gastro-protection for patients over 65 years, notify their GP and share learnings. Submit audit results via the NHS Business Services Authority (BSA) audit data collection tool. (20 points)

We have produced a number of resources that can be used to reduce patient safety incidents; these include:

As a Medication Safety Officer (MSO), I would like to advise pharmacy teams in England and Scotland to continue to report all patient safety incidents through the NPA’s reporting tool; this allows us to collate learning’s from the reported incidents and share the learnings nationally as well as ensure that the right professional support is available for you.

Clinical effectiveness (20 Points)

Asthma review and personalised asthma action plan for children and spacer device. The asthma review requirements have changed – see page 36 of the QP guidance for more details.

Public health (15 points)

HLP Level 1 and 80% of pharmacy staff to have successfully completed the CPPE children’s oral health training assessment.

Digital / urgent care (2.5 points)

Pharmacy NHS 111 Directory of Service (DoS) entry is up-to-date, including bank holiday opening hours; access DoS Updater to confirm/update your pharmacy’s details.


Brexit – potential impact on medicines supply chain and medicines shortages

Brexit day is currently expected to be 29 March 2019 although there is great political uncertainty surrounding Brexit.

New legislation has been proposed by the Department of Health and Social Care (DHSC) that would give pharmacists the legal authority to substitute medicines in-line with a Serious Shortages Protocol (SSP) to be implemented by the DHSC in an event of a serious national medicines shortage. There are a number of areas that require clarification.

We will keep you updated as we receive clarification / further information from the DHSC and/or MHRA.


DSP toolkit (England only)

The new Data Security and Protection (DSP) Toolkit (previously known as Information Governance (IG) toolkit) is now available to complete. The deadline for submission for the 2018/19 IG return is 31 March 2019.

To help pharmacy contractors, I have summarised key points:

  • Register on the DSP Toolkit registration page – the pharmacy’s ODS code is required
  • Guidance on the DSP Toolkit is available on the NHS Digital website
  • If a pharmacy contractor completes the “General Data Protection Regulation (GDPR) Workbook for Community Pharmacy”, the number of DSP Toolkit questions will decrease considerably
    • A new DSP Incident Reporting Tool for data security and protection incidents is included in the DSP Toolkit which has been developed to reflect the GDPR reporting requirements; it replaces the SIRI reporting tool which was part of the previous IG toolkit
  • NHS Digital and PMR suppliers have agreed to pre-populate answers to some technical questions within the DSP Toolkit; the following PMR suppliers have started to prepare text: Cegedim, EMIS, Positive Solutions and RxWeb
  • Pharmacy multiples using the batch submission feature in the DSP Toolkit should register and start completing a “master” Head Office submission

Further information can be found on the NHS Digital website. The NPA will provide guidance over the coming months to help support members undertake the DSP Toolkit.


How to improve your business


In this update I also wanted to share with you some useful statistics shared by IQVIA* that show the top growing OTC classes and key products driving growth from May 2018 – August 2018 where pharmacies can maximize OTC sales (the figures represent value sales, absolute value growth / growth %).

OTC Class Top 3 growth products % growth in product share
Weight loss products Alli, XLS, Adios ·         + 100%
Travel Maloff Protect, Paludrine/Avloclor, Paludrine ·         + 93.8%
Miscellaneous Glucogel, Nelsons Arnica, Glucotabs ·         + 90.2%
Ear care Earcalm, Otex, Earol ·         + 51.5%
Calm/sleep/mood Sleep Aid, Phenergan, Bach Flower remedy ·         + 50.4%
Pain relief Ibuprofen tablets 400mg, Paracetamol capsules, Co-codamol ·         + 36%
Urinary and reproductive care Viagra Connect, Canesten cream/Combi, Emerres Una ·         + 33.6%
Antiemetics Scopoderm TTS, Kwells, Avomine ·         + 31.9%
Eye care Hylo Forte, Optrex, Optrex infected eyes ·         + 21.8%
Digestion / intestinal Bisacodyl, Imodium, Dioralyte ·         + 8.7%

*REF: IQVIA – A Win-Win scenario for Community Pharmacy – Grow your business by improving patient compliance & outcomes presentation to the NPA, October 2018


Areas where members are potentially losing money

Over the last year, members have approached me, and the Pharmacy team, with their current financial situation. Advice given is tailored; however, it includes the following topics.

Check owing prescriptions regularly in the current climate where there are many drug shortages

Ensuring payment for prescriptions and services (such as MURs, NMS, CMS) are claimed every month and submitted correctly

Updating knowledge of the Drug Tariff and how to claim appropriate fees and allowances; use the following NPA resources:

Ask wholesalers to see if they can send you a weekly report breaking down your generics, parallel imports (PI), ethical and any lines that you have purchased above Drug Tariff price – this routine weekly spend report could help manage expenditure and anticipate purchase ledger in advance.

Quick reminders

Oral lidocaine-containing teething products GSL to P switch

These products for use in teething have been reclassified from a status of General Sales List (GSL) to Pharmacy-only (P) medicine by the Medicines and Healthcare products Regulatory Agency (MHRA).

The new packaging bearing the ‘P’ logos will be available from early 2019. In the meantime, pharmacies are required to move the existing ‘GSL’ labelled packs behind the counter and only supply the products under the supervision of the pharmacist who will need to provide parents/carers with new instructions.

Further information can be found in my superintendent update published 13 December 2018.


CD instalment wording for Christmas 2018/New Year 2019

Instalment Controlled Drug (CD) prescriptions covering pharmacy closure days over the Christmas and New Year period will need to have the correct wording on them to ensure that a legally valid  supply can be made.

Where prescriptions are missing any legal requirements or the instructions are ambiguous, pharmacists are advised to send these prescriptions for amendment by the prescriber to ensure that that all supplies are made legally. Verbal requests by the prescriber do not allow the pharmacist to deviate from the legal instructions on the prescription.

  • Check all instalment CD prescriptions in preparation for the holiday period to ensure any errors can be resolved during the working week
  • Ensure sufficient stock is available to cover all supplies for the holiday period
  • Alert patients of the pharmacy’s opening times over the holiday period by using reminder cards, leaflets or posters

Further information, including approved Home Office (HO) wording, can be found in the news story published 6 December 2018.


New resource

Cannabis oil and cannabidiol (CBD)-containing products

From 1 November 2018, The Misuse of Drugs (Amendments) (Cannabis and Licence Fees) (England, Wales and Scotland) Regulations 2018 (The MDR 2018) defined ‘cannabis-based products for medicinal use(CBPM), some of which can now be prescribed as Schedule 2 Controlled Drugs (CDs). The Pharmacy Services team has developed the “Cannabis oil and cannabidiol-containing products: guidance on sale and supply (updated December 2018) to assist you and your team. The guidance includes a statement from our professional indemnity team regarding the sale / supply of cannabis products.


The NPA Pharmacy Services team will continue to produce resources and offer advice and support to pharmacy contractors through 2019. 

I wish you and all pharmacy colleagues a very happy Christmas and all the best in 2019!

For further information please contact the NPA Pharmacy Services team on 01727 891800 or email at:  pharmacyservices@npa.co.uk.

Kind regards,


Leyla Hannbeck MSc, FRPharmS, MBA
NPA Director of Pharmacy
Medication Safety Officer’