MEDICINES PURCHASING FOR SAFETY POLICY
Version / 2Name of responsible (ratifying) committee / Formulary and Medicines Committee
Date ratified / 16 January 2015
Document Manager (job title) / Director of Medicines Management and Pharmacy
Date issued / 06 February 2015
Review date / 31 January 2018
Electronic location / Clinical Policies
Related Procedural Documents / Medicines Management Policy; Unlicensed Medicines Policy; Adverse Drug Reaction Reporting Guidelines; Policy for the Management of Adverse Events and Near Misses (including Serious Untoward Incidents)
Key Words (to aid with searching) / Medicines, Purchasing, Safety, Procurement, Drugs
Version Tracking
Version / Date Ratified / Brief Summary of Changes / Author1 / 20.11.2009 / Initial Document / Bhulesh Vadher
2 / 16.01.2015 / Review and rewrite / Richard Eyles
CONTENTS
QUICK REFERENCE GUIDE 3
INTRODUCTION 4
PURPOSE 4
SCOPE 4
DEFINITIONS 4
DUTIES AND RESPONSIBILITIES 6
PROCESS 7
MEDICATION ERROR / RISK REPORTING SYSTEM 8
TRAINING REQUIREMENTS 8
REFERENCES AND ASSOCIATED DOCUMENTATION 8
EQUALITY IMPACT STATEMENT 9
MONITORING 10
APPENDIX 1 - MEDICINE ERROR, INCIDENT AND DEFECT REPORTING SYSTEMS 11
APPENDIX 2 - PURCHASING OPIOID MEDICINES FOR SAFETY 12
QUICK REFERENCE GUIDE
For quick reference the guide below is a summary of actions required. This does not negate the need for the document author and others involved in the process to be aware of and follow the detail of this policy.
- PHT will endeavor to purchase licenced products rather than unlicenced alternatives as the first choice to treat patients
2. If possible medicines will be purchased using a CMU or Regional contract.
3. Where possible all contracted medicines will be assigned a MEPA score by QA specialists
4. All purchases of medicines must be from an approved pharmaceutical supplier
5. Products purchased will be reviewed in light of any incidents reported where the product itself was a contributory factor.
6. Use of unlicensed products will be reviewed annually to assess the appropriateness of their use and the existence of satisfactory licenced alternatives.
1. INTRODUCTION
The use of all medicines may not only incur a risk of an adverse drug reaction (ADR) but also of a clinical incident such as an inappropriate reconstitution or administration error. These types of medication error risks can and should be minimised by “Purchasing for Safety” in the first instance.
All NHS pharmacy staff assume a duty of care when supplying a medicine. In order to reduce the number/frequency of incidents caused by medication errors it is essential that all risks are identified and assessed. Following risk identification and assessment action must be taken to minimise the possibility of a patient safety incident
Effective procurement of the right medicine is an important tool in the risk reduction process. This includes Clinical Pharmacists not only assessing a product's clinical effectiveness and ADR potential but also it's safety in use when responding to a request for a new medicine. Medicines should only be purchased if they are of a suitable quality, safe to use and fit for purpose. Moreover it is essential that the procurement process assesses the capabilities of the supply chain to the hospital to ensure that products are genuine, have been correctly stored and are available when required.
2. PURPOSE
The purpose of this policy is to provide a consistent trust-wide approach to the safe and timely procurement of medicines including opioids (as a result of NPSA 2008 RRR05 Reducing Dosing Errors with Opioids – see Appendix 2) and any subsequent alerts which include specific Purchasing for Safety guidance which ensures the timely provision of medication and that relevant legislation and government guidance is adhered to.
3. SCOPE
This policy applies to all medicines purchased for Portsmouth Hospitals NHS Trust and all staff involved in medicines management from the decision to purchase to the point of administration.
‘In the event of an infection outbreak, flu pandemic or major incident, the Trust recognises that it may not be possible to adhere to all aspects of this document. In such circumstances, staff should take advice from their manager and all possible action must be taken to maintain ongoing patient and staff safety’
4. DEFINITIONS
Adverse Drug Reaction (ADR)
Any noxious, undesired, or unintended response to a drug, which occurs at dosages used for prophylaxis, diagnosis, therapy, or modification of physiologic functions
CE Mark
a symbol applied to products to indicate that they conform with relevant EU directives regarding health and safety or environmental protection
Commercial Medicines Unit (CMU)
Part of the Department of Health responsible for National and Regional contracting for Medicines.
Duopoly
A situation in which two companies owns all or nearly all of the market for a given type of product or service.
Generic Medication
A term to identify non-brand name medications. Typically, a generic medication is a pharmaceutical equivalent to a branded medication product and has identical strength, dosage form, and concentration.
JAC
The PHT Pharmacy Medicines Management and Electronic Prescribing Solution
Licensed Medicine
Medicinal product for human use, which has been determined by the MHRA to be industrially produced for marketing purposes, have required efficacy, reliability and quality for human use. Medicines legislation (specifically The Medicines for Human Use Regulations 1994/SI 3144) requires that medicinal products are licensed before they are marketed in the UK.
Medecator
A web-based pharmaceutical e-procurement solution provided by AAH
Medication Error Potential Assessment (MEPA)
A risk score that reflects a product's suitability for use, based upon a wide number of factors e.g. clarity of labelling, packing, availability of patient information
Medicines and Healthcare products Regulatory Agency (MHRA)
The UK government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe.
Monopoly
A situation in which a single company owns all or nearly all of the market for a given type of product or service.
National Reporting and Learning System (NRLS)
The world’s most comprehensive database of patient safety information, the successor to the National Patient Safety Agency
Pharmaceutical Market Support Group (PMSG)
An operational sub-committee of the National Pharmaceutical Supply Group
Pharmacy Manufacturing Unit (PMU)
PHT's MHRA licenced pharmaceutical manufacturing unit based at Farlington
Powergate
Independent commercial e-procurement software
Quality Assurance (QA)
A system under which it is ensured that all products and services are of high quality and will satisfy the expectations of patients, carers and health care professionals.
Reconstitution
The preparation of a drug using a diluent for administration to a patient.
Regional Drug Purchasing Centre (RDPC)
The PHT Pharmacy Procurement and Distribution Hub
The Trust (PHT)
Portsmouth Hospitals NHS Trust
Unlicensed Medicine
A medicinal product not licensed for use with the UK by the MHRA; but may be used by individual patients on the direct personal responsibility of a doctor or dentist registered in the UK.
5. DUTIES AND RESPONSIBILITIES
5.1 Regional and National Quality Control
5.1.1 Assesses contracted products according to an assessment tool developed by the National NHS QA Committee and attributes a MEPA score to each product. All medicines included onto a NHS CMU contract have a product licence or are CE marked.
5.1.2 Will upload product assessments onto the PharmaQC database which is accessible by the Pharmacy Department.
5.2 Pharmaceutical Market Support Group
5.2.1. Ensures that all awards made for CMU contracted lines do not introduce any additional risk into the supply chain.
5.2.2. Utilises supplier performance measurement as undertaken by NHS CMU when adjudicating awards. Where possible, those suppliers who provide not only the highest quality product but also the best price and service are awarded contracts.
5.2.3. Ensures that National guidance such as that from the NRLS and MHRA is taken into consideration at the adjudication stage.
5.2.4. Ensures that market management is delivered by ensuring monopoly or duopoly markets are not created as part of the adjudication process for critical pharmaceutical products.
5.3. Regional Procurement Lead
5.3.1. Is responsible for representing the views of the Wessex & Thames Valley Region at PMSG in relation to preferred suppliers for generic awards.
5.3.2. Leads tenders for the region for products not covered by CMU contracts.
5.3.3. Feeds back concerns and general procurement issues from the region's members to relevant National committees.
5.4. Formulary and Medicines Committee
5.4.1. Is the ratification forum for this policy and is responsible for ensuring that the safety considerations are taken into account for any new product requests.
5.4.2. Provides feedback to the author of the document. If amendments are required these must be completed and the document re-submitted to the Committee.
5.5. Director of Medicines Management and Pharmacy
5.5.1. Has responsibility for ensuring processes are in place to support this policy
5.5.2. Will ensure that all the medicines management systems in the Trust are efficient and robust.
5.5.3. Will ensure that systems to reduce the risk of medication errors are built into medicine management processes and so safety will occur as a matter of course.
5.5.4. Will ensure that National best practice will be utilised to develop systems to limit the risk of medication errors.
5.6. Clinical Pharmacists
5.6.1. Will ensure that the appropriate level of clinical/pharmaceutical scrutiny is carried out when presented with a request to provide a new drug for a patient.
5.7. The Pharmacy Department Procurement Lead
5.7.1. Will endeavour to purchase licenced products rather than unlicenced alternatives as the first choice to treat patients.
5.7.2. Will ensure that where feasible that all orders for pharmaceuticals are placed for lines contracted by NHS CMU or Regional Contracts where available.
5.7.3. Will ensure that where feasible ‘ready to use’ products are purchased.
5.7.4. Will report products which are deemed not suitable for use within the Trust to CMU.
5.7.5. When purchasing generic products off-contract, will obtain as first line, products assessed by QA and listed on the PharmaQC database as suitable alternatives. Where overlabelled or pack-down products are required this work will be placed with PHT PMU. Where PMU is unable to undertake this work e.g. due to capacity or capability issues, the requesting pharmacist will undertake a risk assessment exercise in conjunction with the Pharmacy Risk Team to consider alternatives e.g. other drugs, dispensary pack-down etc.
6. PROCESS
6.1. All purchases for medicinal products will be made from trusted sources of supply to ensure the suitability of products purchased and minimise the possibility of counterfeit medicines.
6.2. Suppliers and wholesalers are required to hold an appropriate licence from the MHRA and this will be checked for authenticity by the pharmacy procurement staff.
6.3. The government holds a list of inspected suppliers who hold or have successfully held a public sector contract; this data base (SID) is held on their website at https://sid4gov.cabinetoffice.gov.uk/. This may be utilised by the pharmacy procurement staff to check the status of any new suppliers prior to including the supplier onto the pharmacy system.
6.4. Any concerns with a supplier will be raised with CMU and if deemed necessary audit reports undertaken to access the supplier performance.
6.5. Safe and secure methods of procurement (e.g. e-procurement via Powergate/Medecator) should be utilised to minimise the potential for error during the process. Telephone orders should be used as a last resort or in an emergency. The trading status of suppliers not set up on JAC to trade electronically should be reviewed annually. Suppliers should only be moved to e-procurement if they can show that the chosen method feeds directly into their stock control system and therefore eliminates re-keying errors.
6.6. New products, including unlicenced manufactured products and unlicenced imports, should be entered on JAC by the Pharmacy IT Team upon receipt of an appropriately completed form to ensure that all products are described to the same standards.
7. MEDICATION ERROR / RISK REPORTING SYSTEM
7.1. Systems for reporting patient safety incidents and defects in medicine and medical devices will integrate with the Trust clinical governance reporting streams.
7.2. External reporting schemes as outlined in Appendix 1 will be actioned where relevant by pharmacy staff.
8. TRAINING REQUIREMENTS
Training of staff will occur at induction, and during appropriate update training. On-call pharmacists will be trained prior to commencing their on-call duties. A copy of this policy should also be available to consult if guidance is needed
9. REFERENCES AND ASSOCIATED DOCUMENTATION
Alert 20. Safer Practice with injectable medicines. 2007. National Patient Safety Agency http://www.nrls.npsa.nhs.uk/resources/?entryid45=59812
Reducing Dosing Errors with Opioids 2008 National Patient Safety Agency http://www.nrls.npsa.nhs.uk/resources/?entryid45=59888
Ensuring safer practice with high dose ampoules of diamorphine and morphine - Safer Pratice Notice 2006 National Patient Safety Agency http://www.nrls.npsa.nhs.uk/resources/?entryid45=59803
Pharmaceutical Market Support Group (PMSG)
http://nww.cmu.nhs.uk/Medicines/Strategicgroups/pages/PharmaceuticalMarketSupportGroup.aspx
Quality Assurance And Risk Assessment Of Licensed Medicines For The NHS NHS Pharmaceutical Quality Assurance Committee http://www.qcnw.nhs.uk/docs/QA%20&%20Risk%20Assessment%20of%20licensed%20Medicines%20for%20the%20NHS.pdf
PharmaQC Database http://nww.cmu.nhs.uk/Medicines/pharmaQCdatabase/LandingPage.htm
Purchasing for Safety Project: Injectable Medicines CMU http://nww.cmu.nhs.uk/Purchasingforsafetyinjectablemedicines/Pages/LandingPage.aspx
Duthie Report Royal Pharmaceutical Society http://www.rpharms.com/support-pdfs/safsechandmeds.pdf
Medicines Management Policy PHT http://www.porthosp.nhs.uk/Downloads/Policies-And-Guidelines/Clinical-Policies/Medicines_Management.doc
Adverse Drug Reaction – Drug Therapy Guideline PHT http://pht/Departments/Pharmacy/Drug%20Therapy%20guidelines/Adverse%20Drug%20Reaction%20Reporting.doc
Policy for the Management of Adverse Events and Near Misses PHT http://www.porthosp.nhs.uk/Downloads/Policies-And-Guidelines/Management-Policies/Adverse_Incidents_and_Near_Misses_Management_Policy.doc
10. EQUALITY IMPACT STATEMENT
Portsmouth Hospitals NHS Trust is committed to ensuring that, as far as is reasonably practicable, the way we provide services to the public and the way we treat our staff reflects their individual needs and does not discriminate against individuals or groups on any grounds.