Procurement Induction for Pharmacy Trust Buyers

Procurement Induction for Pharmacy Trust Buyers Introduction This paper is designed to cover those items that pharmacy trust buyers (i.e. the person in the trust responsible for managing the sourcing and procurement of medicines) need to understand in order to perform their duties efficiently. It is meant to supplement the trust induction programme and to be completed over the first 6 months of employment. It also details further educational opportunities. NB It may be worth finding a pharmacy buyer from another trust who can help you work through this document and answer any questions you might have. If you need a suggestion ask your procurement specialist or consortium chair to nominate someone.

Use of This Document This document provides a checklist of subjects the trust buyer should be familiar with and understand. In some cases links or even material has been provided but this is not meant to be a training resource. A lot of the content here is covered in much greater detail by the procurement training courses or websites detailed at the end of this document. Your procurement specialist can assist if you can’t find information about a topic. Subjects are categorised but not very well as it is often difficult to be specific.

NB Suggestions for additions would be welcome to [email protected]

A) Environmental Awareness Understand the role of the following organisations a. ABPI http://www.abpi.org.uk/Pages/default.aspx b. BGMA http://www.britishgenerics.co.uk/ c. BAPW http://www.bapw.net/ d. NCHA http://www.clinicalhomecare.co.uk/ e. National Homecare Medicines Committee (NHMC) f. https://www.gov.uk/government/collections/commercial-medicines-unit-cmu g. Chartered Institute of Procurement and Supply (CIPS) http://www.cips.org/ i. Training Opportunities h. MHRA https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency i. Product Licences ii. Manufacturing Licences iii. Specials Licences iv. How to obtain update bulletins on licence status of your suppliers https://www.gov.uk/government/collections/licences-to-manufacture-or-wholesale-in-medicines#approved- licences-suspensions-and-revocations

MHRA Update Bulletins

v. Wholesaler Dealers Licence 1. How to obtain one https://www.gov.uk/government/publications/medicines-notes-for-applicants-and-holders-of-a- wholesale-dealer-licence-or-broker-registration 2. Good Manufacturing and Distribution Practice https://www.gov.uk/good-manufacturing-practice-and-good-distribution-practice 3. Checklist for WDL inspection from South London

WDL Inspection Checklist i. Care Quality Commission (CQC) http://www.cqc.org.uk/ j. NICE https://www.nice.org.uk/ i. NICE TAs and obligation to supply. ii. Patient Access Scheme Liaison Unit (PASLU) (see pricing later) https://www.nice.org.uk/about/what-we-do/patient-access-schemes-liaison- unit k. Procurement and Distribution Group of GHP (PDIG) http://www.ghp.org.uk/groups/UAS@GK i. Symposia ii. Available Training Sponsorship iii. Training l. NHS Structures & Concepts i. Commissioners 1. NHS England 2. CCGs 3. Commissioning Support Units (CSUs) 4. Tariff Payment of Medicines and pass through medicines 5. The concept of gain shares 6. Medicines Optimisation and the link to procurement 7. Medicines Optimisation Groups (e.g. LPP or PrescQIPP) 8. Specialist Pharmacy Services (A collection of pharmacy specialists (MI, procurement, QA) working for NHS England to provide specialist advice to the NHS). m. Organisation of Medicines Procurement in the NHS i. Purchasing Consortia ii. Procurement Specialist Pharmacists and their role. iii. Regional Procurement Groups (Strategic and Operational) iv. Collaborative Procurement Hubs. n. Commercial Medicines Unit (CMU) https://www.gov.uk/government/collections/commercial-medicines-unit-cmu i. Role of Pharmacy Market Support Group (PMSG) ii. Role of National Pharmacy Supplies Group (NPSG) iii. How contracts operate and are organised

Contracting nArrangements Medicines CMU

iv. Products and Services List

Products and Services List

v. CMU Local buyer Each region has a local buyer attached to them. Your local buyer is VITAL to you and should be first point of contact for contract issues. Find out who they are! B) Pricing of Medicines a. Pharmaceutical Price Regulation Scheme (PPRS) http://www.abpi.org.uk/our-work/commercial/pprs/Pages/default.aspx https://www.gov.uk/government/publications/pharmaceutical-price-regulation-scheme-2014 b. Patient Access Schemes and PASLU https://www.nice.org.uk/about/what-we-do/patient-access-schemes-liaison-unit c. Reference Pricing d. Commercial Disclosure Agreements (CDAs) and Prices. e. Drug Tariff Category A B C E and M prices f. Hospital List Prices g. Wholesaler discounts and Agency Schemes h. Cancer Drug Fund.

C) CMU Contract Prices and IT Support Functionality

CMU Reports Summary a. PHARMEX This system collects trust purchase data (including price) to allow CMU to calculate contract requirements and populate the reports below via an automatic monthly upload for most pharmacy systems. You should contribute if possible. b. Pharmacy catalogue https://www.cmu.nhs.uk/PharmacyCatalogue/formlogin.mth?returnurl=/PharmacyCatalogue/SplashPage.mth You can obtain a log in to the CMU pharmacy catalogue which can be downloaded if required and lists i. Contract prices specific to your trust ii. Contract changes you need to enact iii. Contract start and end dates. c. Benefits Report http://nww.cmu.nhs.uk/apps/Pages/PharmexDownload.aspx This report details the effect of contract changes and captures savings made. It will be of great interest to your Chief Pharmacist. d. PharmaQC http://gov.cmu.ims.gov.uk/security/login.asp?redirect=/PharmaQC This allows you to see QA assessments of packs (PQA scores) and view images of packaging. [NB it is an nww web address so has to be accessed via an NHS network]. e. Medication Safety Bulletins After each contract QA issue a medication safety bulletin which lists the products awarded with a medium or high PQA score and which region they have been awarded to. You may decide to take some risk mitigation steps. f. Reporting issues with the contract. Send these to [email protected] or talk to your local buyer (or both)! g. Reporting of Product Defects If you have an issue with a product, particularly if on a CMU contract then you should report it to QA. See here a list of the reporting mechanisms.

QA Reporting schemes explained h. Contract Variance This report identifies lines which have been bought above the contract price. Whilst it is not perfect it is a useful check that you have entered the contract details onto your system correctly. To see your report log on to your PHARMEX download http://gov.cmu.ims.gov.uk/pharmexdownloadportal/ Once you have checked your report you might need to respond to CMU. See process documented here.

Process for Responding to CV

i. Adjudicating Contracts You need to know how to adjudicate.

j. Supply Performance Reports CMU produce a report which summarises supply issues by supplier and hence performance. This only works if you report supply issues to [email protected] k. EDIS This website https://www.cmu.nhs.uk/edis/Login.aspx allows you to register any commercial interests you might need to declare before you can adjudicate a CMU contract. Your local CMU buyer can help if you need it. l. Sid4Gov https://sid4gov.cabinetoffice.gov.uk/ This is a website catalogue of potential suppliers. The link gives an explanation. It is potentially useful to identify details of unknown suppliers.

D) Sourcing Your most important function is to ensure patients have medicines available to treat them. Next you should minimise costs to the trust.

a. Sources of Information on Availability of Products. i. Google ii. BNF iii. Wholesaler Catalogues (on line) iv. Electronic Medicines Compendium (EMC) http://www.medicines.org.uk/emc/ v. Supplier catalogues vi. MIMS vii. Chemist and Druggist viii. MHRA ix. Rarely Used Medicines (RUM) List http://www.medicinesresources.nhs.uk/en/Communities/NHS/SPS-E-and-SE-England/Medicines- Information/Discontinuation-Supply-Shortage-Memos/Rarely-Used-Medicines-RUM-List/ x. Pharmaceutical Importers xi. Specials Manufacturers xii. PharmaQC Gives a list of products tendered which may still be available (and their PQA scores) Go for a low PQA product for preference. http://nww.cmu.nhs.uk/security/login.asp?redirect=/PharmaQC xiii. DM&D http://www.ppa.org.uk/systems/pcddbrowserv2_3new/browser.jsp Search under Actual Medical Product Details (AMP) gives a list of manufacturers for a generic molecule. Not an exact test but may give a lead. NB the site is very clunky. xiv. Pro File (source of NHS manufactured products) http://www.pro-file.nhs.uk/Default.aspx xv. Specialist Hospitals (contact pharmacy buyer) xvi. Procurement Specialist When all else fails!!! b. What is Parallel Trading? c. What is NHS Supply Chain and what do they supply? d. Sources of Information for Patent Expiration (MI or CMU or Procurement Specialist) e. MHRA Notifications on recalls rescinded MLs or WDLs. https://www.gov.uk/drug-device-alerts/email-signup https://www.gov.uk/government/publications/suspended-licences-for-manufacturers-and-wholesalers-of-medicines f. Supplier Appraisals (Checking of a new supplier) Sorts of things to look for would be i. Do they have the necessary licences (manufacturing, specials manufacturing, Wholesaler Dealers etc). ii. Could check whether they have any existing CMU contracts (yes is good). iii. Could check a Dunn and Bradstreet assessment for financial viability. iv. Could check for an NHS QA assessment (ask your QA pharmacist). v. Could check SID4GOV (DoH database of suppliers). https://sid4gov.cabinetoffice.gov.uk/login? logout=1&alert=bG9naW5fMQ==&ref=L2Rhc2hib2FyZD9pbml0PU16ZzFOemMlM0Q= g. Supplier Evaluations h. Market Management Principles i. Shortages These are all too frequent and need managing. Mostly the solution is phoning to find stock but there are some sources of information. i. Guys and St Thomas report This is specific to Guys but contains a lot of information. E mail [email protected] to be added to the mailing list. ii. CMU send out regular updates. Available from your local buyer. iii. Supplier Performance CMU prepare supplier performance scores / ratings at adjudication. These should be used to inform decision making. We should award to suppliers with better supply records. iv. Royal Pharmaceutical Society have published Best Practice standards for managing medicines shortages in secondary care in England. http://www.rpharms.com/support-pdfs/managing-medicines-shortages-in-secondary-care.pdf v. American Society Hospital Pharmacists (ASHP) Have a website but is obviously US specific. http://www.ashp.org/shortages vi. EMA have a website on shortages which may be helpful http://www.ema.europa.eu/ema/index.jsp? curl=pages/regulation/document_listing/document_listing_000376.jsp&mid=WC0b01ac05807477a6

E) Stock Holding It is vital to hold enough stock to supply but not too much to be wasteful. Concepts are covered in courses and web training but you should understand:- a. Stock turns b. Economic Order Quantity (EOQ) c. Stock Control Performance Indicators d. ABC Stock Categorisation. e. Kraljic Matrix f. Just In Time (JIT)

Stock Control Toolkit

g. How your Pharmacy System manages stock

JAC JAC (2) Ascribe

h. How your pharmacy system manages i. Ordering ii. Inventory iii. Invoicing iv. Credits i. The role of auditors (internal and external to the trust) j. The Pharmacy Procurement Audit Tool

Audit Tool

k. Medical Gas Cylinder Stock Management

Medical Gas Security of Storage Management Medical Gas Cylinders l. Reallocation of Unused Stock It is much better not to have ordered stock you don’t need in the first place! (see above). But if you have stock of significant value with reasonable shelf life try the following:- i. For most items e mail your consortium colleagues and ask them to order from you. ii. For highly specialised products look on Define to see which trusts use the line and contact them. iii. Ask you procurement lead for help. F) Law This is covered in courses and web training. a. Contract Law b. OJEU c. Competition Act d. Medicines Act e. Unlicensed Medicines i. Policy for Managing ii. Risk assessment Process iii. RPS Standards http://www.rpharms.com/pharmacy-practice-resource/specials.asp iv. National QA Committee Guidance f. Retention of Records Document http://www.medicinesresources.nhs.uk/en/Communities/NHS/SPS-E-and-SE-England/Reports-Bulletins/Retention-of- pharmacy-records/ g. Corporate Social Responsibility h. Duthie Requirements i. ABPI Code of Practice j. Controlled Drugs licenses, fees and returns https://www.gov.uk/controlled-drugs-licences-fees-and-returns G) Ethics a. RPS Guidance b. Office Government Commerce Guidance c. CIPS Guidance d. Environmental Issues e. Waste Reduction

H) Negotiating

I) Outsourced Services a. Outpatients See terms of Reference of Outsourced Outpatients Contract Managers Group (OOCMG) or join same.

OOCMG Terms Reference b. Homecare i. RPS Homecare Handbook ii. RPS Standards for Homecare Document iii. Hackett Report iv. Regional Homecare Lead v. National Homecare Medicines Committee Role vi. Tips and Advice

Self Help Homecare Outputs

J) Training Opportunities a. Three Day Procurement Course This is run in London and East of England under the Pharmacy Education and Training Programme. http://www.lpet.nhs.uk/ b. NHS Pharmacy Procurement The website www.nhspharmacyprocurement.com (sponsored by BMS) contains procurement theory. c. PDIG Website This contains an introduction to procurement useful for non procurement staff or pre registration pharmacists of student technicians. http://www.ghp.org.uk/groups/UAS@GK/ERHQIE/VNUQCH d. CMU Courses CMU do a range useful courses at £50 each day. http://ccs.cabinetoffice.gov.uk/about-government-procurement-service/government-procurement-training/course- schedule e. CIPS CIPS host links to a lot of formalised training and have their own ladder of training qualifications that are recognised by professional buyers in all specialties. Several pharmacy buyers have undertake these course and can comment. PDIG also sponser some CIPS assisted training courses. http://www.cips.org/ f. Crown Commercial Services The Crown Commercial Service run web based training packages including courses on EU procurement law which are free to access. http://www.eoecph.nhs.uk/hub-training.htm g. East of England Collaborative Procurement Hub For members the EoE hub run free management training courses. Non members can pay to attend. Throughout the year, the Hub offers free legal training seminars for member organisations, NHS Commercial Alliance members and associates, including CCGs/commissioners. These are typically led by external consultants, such as legal firms Mills & Reeve and Bevan Brittan. The seminars cover a wide range of topics which are generally procurement related. Most sessions take place at Victoria House, Fulbourn, Cambridge, unless otherwise stated. http://www.eoecph.nhs.uk/hub-training.htm

Kevan Wind 22nd June 2015.