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A ny prescriber approved by The Human Medicines Regulations 2012 can issue a private prescription for a medicine licensed in the UK. 1 A private prescription is one where charges are to be met in full by the patient rather than partially or wholly by the NHS. This article sets out key aspects of the legal frame- work governing private prescribing in the UK, including internet prescription services. It also highlights the need for the GMC to issue comprehensive guid- ance and education on prescribers’ responsibilities, risks and liabilities. Who can issue a private prescription? The Human Medicines Regulations 2012 cover the sale, use and production of medicines as well as prescribing rights in the UK. Various healthcare professionals may issue prescriptions according to a two-tier system of independent pre- scribers and supplementary prescribers. 2 Independent prescribers, also known as “appropriate practitioners” in the leg- islation, are individuals who can prescribe on their own initiative medicines licensed in the UK. They include: doctors, dentists, nurse independent prescribers, pharma- cist independent prescribers, optometrist independent prescribers, and European Economic Area (EEA) health profession- als. 1 Different types of prescribers may have different restrictions on prescribing, however. For example: • Some doctors, including those in their first year of practice and those returning after a long break from practice, have restricted prescribing rights. 3,4 • An optometrist independent prescriber cannot prescribe a controlled drug or medicine for parenteral administration. 1 • An EEA health professional cannot pre- scribe a “controlled drug”(defined below). 1 Supplemental prescribers are individuals who can prescribe medicines in accor- dance with a “clinical management plan”. Since 2012, they include some pharma- cists, registered midwives, registered nurses, chiropodists, podiatrists, physio- therapists, radiographers and registered optometrists. 1 When can a private prescription be issued to NHS patients? An NHS patient may be provided with a private prescription, rather than an NHS prescription (or FP10), where a drug is only available by private prescription or where the patient requests both an FP10 and a private prescription. 5 Northern Ireland, Scotland and Wales have abol- ANALYSIS n Prescriber 19 March 2015 z 19 prescriber.co.uk A guide to private prescribing Sarah Steele BA(Hons), LLB, PhD, DPhil Andreas Freitag Dr.med.univ, MSc, Patricia McGettigan BSc, MD, FRCPI, FRACP, Gavin Giovannoni MBBCh, PhD, FRCP, FRCPath and Allyson M Pollock MB, ChBMSc, FFPH, FRCGP Under what circumstances can healthcare professionals issue a private prescription? This article explores the various options. Figure 1. Any approved prescriber can issue a private prescription SPL

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Page 1: A guide to private prescribing - Allyson Pollock · 2015-03-17 · work governing private prescribing in the UK, including internet prescription services. It also highlights the need

Any prescriber approved by TheHuman Medicines Regulations 2012

can issue a private prescription for a medicine licensed in the UK.1 A privateprescription is one where charges are tobe met in full by the patient rather thanpartially or wholly by the NHS. This articlesets out key aspects of the legal frame-work governing private prescribing in the UK, including internet prescriptionservices. It also highlights the need forthe GMC to issue comprehensive guid-ance and education on prescribers’responsibilities, risks and liabilities.

Who can issue a private prescription?The Human Medicines Regulations 2012cover the sale, use and production ofmedicines as well as prescribing rights inthe UK. Various healthcare professionalsmay issue prescriptions according to atwo-tier system of independent pre-scribers and supplementary prescribers.2

Independent prescribers, also knownas “appropriate practitioners” in the leg-islation, are individuals who can prescribeon their own initiative medicines licensedin the UK. They include: doctors, dentists,nurse independent prescribers, pharma-cist independent prescribers, optometristindependent prescribers, and EuropeanEconomic Area (EEA) health profession-als.1 Different types of prescribers mayhave different restrictions on prescribing,however. For example:• Some doctors, including those in theirfirst year of practice and those returningafter a long break from practice, haverestricted prescribing rights.3,4

• An optometrist independent prescribercannot prescribe a controlled drug or

medicine for parenteral administration.1

• An EEA health professional cannot pre-scribe a “controlled drug”(defined below).1

Supplemental prescribers are individualswho can prescribe medicines in accor-dance with a “clinical management plan”.Since 2012, they include some pharma-cists, registered midwives, registerednurses, chiropodists, podiatrists, physio-therapists, radiographers and registeredoptometrists.1

When can a private prescriptionbe issued to NHS patients?An NHS patient may be provided with aprivate prescription, rather than an NHSprescription (or FP10), where a drug isonly available by private prescription orwhere the patient requests both an FP10and a private prescription.5 NorthernIreland, Scotland and Wales have abol-

ANALYSIS n

Prescriber 19 March 2015 z 19prescriber.co.uk

A guide to private prescribingSarah Steele BA(Hons), LLB, PhD, DPhil Andreas Freitag Dr.med.univ, MSc, Patricia McGettigan BSc, MD, FRCPI,FRACP, Gavin GiovannoniMBBCh, PhD, FRCP, FRCPath and Allyson M PollockMB, ChBMSc, FFPH, FRCGP

Under what circumstancescan healthcare professionalsissue a private prescription?This article explores thevarious options.

Figure 1. Any approved prescriber can issue a private prescription

SPL

Page 2: A guide to private prescribing - Allyson Pollock · 2015-03-17 · work governing private prescribing in the UK, including internet prescription services. It also highlights the need

ished prescription charges. In England,the NHS prescription charge is currently£8.05 per item for up to three months’supply. Some medicines may be obtainedmore cheaply by private prescription.

In some circumstances DH policyapplicable in England and Wales, or pre-scribing laws, require a private prescrip-tion be issued (see Table 1).

When can an NHS prescriptionbe offered to a private patient?Private patients are individuals who fundtheir healthcare either on a pay-as-you-gobasis or via medical insurance and theymust fund prescription charges in thesame way. Where a private arm of a hospi-tal or private provider treats a NHS patientin the course of NHS-funded care, thispatient does not become a private patientand should be provided with an FP10.

Under current guidance, patients whoare eligible for NHS care, but who haveopted to pay privately for services thatcould have been provided by the NHS,can at any stage request a transfer to theNHS and will be afforded the same treat-ment as they would have received hadthey opted for NHS treatment allalong.17Alternatively, following a privateconsultation the consultant may make awritten recommendation for medicationto an NHS practitioner whereupon theNHS practitioner can accept this adviceand issue an FP10. The NHS practitionercannot charge for issuing the FP10.14

Importantly, they acquire liability for bothprescribing and monitoring (see discus-sion below).

Individuals not eligible for NHS treat-ment because of residency require-ments18 include British citizens livingabroad and non-EEA nationals who arenot eligible to receive free NHS care dur-ing their stay in the UK. The latter groupis expected to increase as a result of thepassage of the Immigration Act 2014 andrelated guidance to implement existingregimens for charging for NHS servicesfor visitors and non-EEA migrants.15

How can a private prescription beissued and received?A private prescription can be issued onany piece of paper except in the case ofcontrolled drugs. It must be signed in ink

and written so as to be indelible,1 andmust include the address of the pre-scriber, the date of prescription issue orthe date after which it may be dispensed,the prescriber’s professional group (doc-tor, pharmacist, etc), the name andaddress of the patient (and age if under12 years).16

Under the Misuse of Drugs Act 1971,“dangerous or otherwise harmful drugs”are designated as “controlled drugs” (CDs),categorised in five schedules, and subjectto specific prescribing rules. For CDs inschedules 2 and 3 (eg opioids, tramadol,some benzodiazepines), a special form isrequired for all private prescription.20

Private prescriptions can be dis-pensed at a hospital or community phar-macy or through authorised onlinedispensers. All retail pharmacies in theUK, including those providing internet-based dispensing services, must be reg-istered with the Royal PharmaceuticalSociety of Great Britain.21 Owing to therise of illegal online dispensers operatingin the UK and from abroad, the GeneralPharmaceutical Council has issued inter-net-specific ‘logo’ schemes and guidancefor pharmacies operating online serv-ices.22 According to their professionalguidance, pharmacists may refuse to dis-pense private prescriptions where theprescription appears to not be authenticor where, in their professional judgement,dispensing would be unsafe.23

Legal and professional issues The acts of private prescribing and con-verting private prescriptions to NHS pre-scriptions both give rise to multiplepotential legal and professional issuesand potential sanctions. The HumanMedicines Regulations 2012, in concertwith the Medicines Act 1968 and Misuseof Drugs Regulations, as well as manyother pieces of legislation, common law,and guidance, all govern the act of privateprescribing.24

The laws governing private prescrib-ing also vary based on whether thepatient is a private or an NHS patient atthe time of prescribing. Private patientsenter into a contractual relationship bypaying for services, and therefore, unlikeNHS patients whose relationship withtheir provider is a statutory one, haverecourse to both contract and tort withregard to failures or harms.25 It can be dif-ficult to ascertain whether a patient is anNHS or private patient when they arereceiving a private prescription, and thefollowing case studies illustrate commonclinical scenarios and what prescribersshould consider before acting.

Case study 1A patient attends an NHS clinic and asksher specialist consultant (in this case anoncologist) for a private prescription fora drug, which is not available on the NHS,and which the patient usually receives as

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Table 1. Medications available on private prescription only

• Travel vaccines: vaccines not funded by the NHS must be prescribed on privateprescription.6 They include hepatitis B, Japanese encephalitis, some meningitisvaccines, rabies, tick-borne encephalitis, tuberculosis, and yellow fever.7

• Malaria prophylaxis: DH guidance is that prophylaxis medication should beprescribed as a private prescription.8

• Treatment while travelling: when individuals leave the UK, the NHS ceases to haveresponsibility for their care.9 For UK residents, the NHS will supply medication forup to three months,10 or where the individual is going abroad for more than threemonths, a lesser supply that is sufficient to get to the destination and find analternative supply.8

• Blacklist drugs: a list of products identified as not to be reimbursed by the DH andtherefore they may not be prescribed on the NHS.11–13 To avoid breaching theirNHS “terms of service”, doctors must issue a private prescription.14

• Selected List Scheme: under this scheme, only those patients fulfilling certaincriteria can receive an NHS prescription.15 If a patient does not meet the criteria,or wishes a greater quantity than provided, a private prescription is required.

• Drugs being self-prescribed or prescribed for someone with whom the prescriberhas a “close personal relationship”.16

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a private prescription from her privateconsultant. The clinician is not sure ifthey can issue such a script.

The DH and NHS guidance is that NHSresources should never be used to subsi-dize private care, thus private treatmentmust be distinct from NHS treatment.26

According to the NHS Litigation Authority,the NHS Clinical Negligence Scheme forTrusts (CNST) and the insurance held byeach Trust exclude private prescribing byNHS clinicians.27 Most clinicians have per-sonal indemnity insurance with profes-sional organisations including theMedical Defence Union or MedicalProtection Society. While personal insur-ance is not required by law, the GMC setsout a duty for doctors to hold adequateinsurance to ensure patients are not “dis-advantaged if they make a claim about aclinical care” provided in the UK.28 Thiscreates a professional obligation for clini-cians to hold sufficient indemnity coverin the event they issue private prescrip-tions and to ensure they do not mix publicand private care.

The clinician should also be awarethat by issuing a prescription they acceptpersonal responsibility for both the act ofprescribing and for monitoring the patient(A doctor is not guilty of negligence if shehas acted in accordance with a practiceaccepted as proper and responsible by aresponsible body of medical practition-ers).29 At present, the GMC Good Practicein Prescribing details professional obliga-tions in prescribing and monitoring,

establish clear duty. This assumes thatthe prescribing clinician has knowledgeof the patient’s medical history, currentmedications, and is competent to man-age the products prescribed. The clinicianalso accepts responsibility for monitoring the patient and for arranging appropriatefollow-up for the treatment, includingrepeat prescriptions.

Case study 2A patient under the care of an NHS con-sultant may benefit from a high-cost treat-ment, which has not yet been appraisedand recommended for funding by NICEand is hence not funded by the NHS. Thisdrug would be taken concurrently withhis/her NHS treatment. The NHS consult-ant is unsure how to proceed.

Where a combination of drugs will beadministered concurrently, some of whichare not presently NHS funded, and thereare no patient safety concerns, the NHSrequires that the patient fund all his/hercare for all drugs and treatment.26 Thepatient will therefore become a privatepatient for this treatment. The patientshould provide written consent to receiveprivate care, and should be provided withinformation on costs, the likely outcomeof the treatment, and a strategy shouldthey be unable to continue funding.26

Where a patient is unable to fundsuch treatment privately, an exemptioncan be sought from the NHSCommissioning Board for funding for thewhole treatment on the grounds that the

patient is in “exceptional circumstances”;that is, seeking an individual fundingrequest. Where there are concerns aboutpatient safety, the Trust itself must applyto the NHS Commissioning Board for anindividual funding request, with specificdetail as to why the clinician feels that thepatient would be put at risk in separatingprivate and NHS care. The Board maythen seek expert opinion on patientsafety in making its decision.26

If the treatment proceeds privately, themedical practitioner must be satisfied toaccept responsibility and ensure that theyand the hospital hold appropriate insurancefor private patients (as detailed in Casestudy 1). Also, the clinician should maintainclear records of the separation of care.

Case study 3A patient is seen in a hospital outpatientclinic in England by an NHS consultant. Thepatient requests two prescriptions – privateand NHS for the same drug – so that shecan decide which is the least expensive wayof obtaining the drug at her communitypharmacy. (In Scotland, Wales andNorthern Ireland, there are no prescriptioncharges, so this situation will not arise.)

This case may present liabilities if the pre-scribing doctor is providing a greater thanusual supply of the medication especiallyif such a supply exceeds the recom-mended treatment duration or could leadto an overdose, or be otherwise unsafe forthe patient. The clinician must make clearboth the dose and duration of treatment

n ANALYSIS l Private prescribing

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Prescriber 19 March 2015 z 23prescriber.co.uk

to the patient. However, the issuing of twoprescriptions is ill-advised and potentiallymuch more dangerous than the potentialsavings to the patient, and this practiceshould be professionally discouraged.

Case study 4A doctor is experiencing back pain and asksa medical colleague, who is also a friendand distant relation), to write a private pre-scription to be dispensed at the hospitalpharmacy to allow him to finish the shift.

In 2013, the GMC issued guidanceinforming doctors that they must avoidprescribing for themselves or “anyonewith whom they have a close personalrelationship”.24 While the GMC does notspecify the relationships included in thislist, it certainly applies to family andfriends, and disciplinary proceedingshave applied to colleague prescribing.30

The guidance states that prescribingshould only take place in exceptional cir-cumstances, specifically where no otherprescriber is available to assess and pre-scribe without a delay and that the treat-ment is immediately necessary to save alife, avoid serious deterioration in health,or alleviate otherwise uncontrollable painor distress.24 In such cases, the GMCadvises that the prescriber should imme-diately make a clear record justifying whythere was no other alternative, and alsoinform their own, or the other person’s,GP about which medicines have been pre-scribed.24 The GMC has pursued a num-ber of actions against individuals on thebasis of this kind of prescribing behav-iour, with a number experiencing sanc-tions, making clear that only in veryexceptional cases will this prescribing beprofessionally tolerated.29

ConclusionPrescribers must be fully trained to recog-nise their responsibilities around privateprescriptions and converting private pre-scriptions to NHS FP10 prescriptions.

References1. The Human Medicines Regulations 2012,SI 2012/1916. London. TSO.2. Review of prescribing, supply & administra-tion of medicines: Final Report. London: NHSResponseline; March 1999. http://bit.ly/

1GbeBPH.3. Medical Act 1983 (as amended), SI1983/c54. London. TSO. Part II, Sections 15,44D. 4. Fiona Hawker. Junior doctors must only workin approved practice settings for first 12 monthsafter qualification. http://bit.ly/1zSiGB2.5. General Practitioners Committee.Prescribing in General Practice. BMA. May2013. http://bit.ly/18EHQge.6. National Health Service (General MedicalServices Contracts) Regulations 2004. SI2004/291. London. TSO. Regulation 24,Schedule 5. 7. NHS Choices. Which travel vaccinations arefree? http://bit.ly/1wDQvKx.8. NHS Executive. Malaria Prophylaxis:Regulation permitting GPs to charge for pre-scribing or providing anti-malarial drugs. FHSL(95) 7. London. February 1995. 9. NHS Choices Moving abroad: planning foryour healthcare. http://bit.ly/Kz2rGM.10. NHS Choice. Can my GP prescribe extramedication to cover my holiday? http://bit.ly/1APjo66.11. NHS (General Medical Services Contracts)(Prescription of Drugs etc.) Regulations 2004.SI 2004/291. London. TSO. Part XVIIIA, repro-ducing Schedule 1.12. NHS Business Services Authority. DrugTariff Guidance Note. http://bit.ly/1APjo66.13. NHS Prescription Service. Drug Tariff. June2014. www.ppa.org.uk/ppa/edt_intro.htm.14. Lymn. JS. The New Prescriber. Chichester:Wiley-Blackwell, 2010.15. NHS (General Medical Services Contracts)(Prescription of Drugs etc.) Regulations 2004.SI 2004/291. London. TSO. Part XVIIIB, repro-ducing Schedule 2. 16. General Medical Council. Good practice inprescribing and managing medicines anddevices. (updated: 29 April 2014)http://bit.ly/1DvMapH.17. Department of Health. Guidance on NHSpatients who wish to pay for additional privatecare. Report: 11512, 2009. 18. Immigration Act 2014. SI 2004/c.22.London. TSO. Section 39.19. NHS Business Services Authority. SaferManagement of Controlled Drugs – Controlleddrug prescribing. http://bit.ly/1aIDq8T.20. Royal Pharmaceutical Society. RoyalPharmaceutical Society. www.rpharms.com/home/home.asp.21. General Pharmaceutical Council. Internetpharmacy. www.pharmacyregulation.org/registration/internet-pharmacy.22. Royal Pharmaceutical Society. Getting themedicines right. www.rpharms.com/previous-projects/getting-the-medicines-right.asp?23. See for example, the list of common ques-

tions asked of the Thyroid Patient Advocacy bypractitioners listed at http://tpauk.com/main/?page_id=1538.24. Reynolds v Health First Medical Group[2000] Lloyd’s Rep. Med. 240.25. NHS Commissioning Board.Commissioning Policy: Defining the bound-aries between NHS and Private Healthcare.Reference: NHSCB/CP/12. April 2013.26. NHS Litigation Authority. Clinical Claims.www.nhsla.com/Claims/Pages/Clinical.aspx.27. General Medical Council. Good practice inprescribing and managing medicines anddevices. (updated: 29 April 2014) www.gmc-uk.org/guidance/ethical_guidance/14316.asp.28. Bolam v Friern Hospital ManagementCommittee (1957) 1 WLR 582 (QBD). 29. Oxtoby, K. ‘Doctors’ self prescribing’. BMACareers. 10 Jan 2012. http://bmj.co/ 1BPCiMH.

Declaration of interestsNone to declare.

Sarah Steele is a lecturer, Andreas Freitagis a research assistant, and AllysonPollock is professor at the Global Health,Policy and Innovation Unit, Queen Mary,University of London, London; DrMcGettigan is a clinical pharmacologist atthe William Harvey Research Institute,Barts and the London School of Medicineand Dentistry, London; and GavinGiovannoni is professor of neurology atthe Neuroscience and Trauma Centre,Blizard Institute, Barts and the LondonSchool of Medicine and Dentistry, London

KEY POINTS

n The guidance on private prescribing should be consolidated to be more accessibleto clinicians engaged in this practice andprofessional bodies advising them.

n Clinicians need to be aware of theprofessional obligation to hold indemnityinsurance to cover private prescribing if theyprescribe and/or practice privately.

n Clinicians acting on another clinician’s adviceor converting a private prescription to an NHSprescription need to be aware that they acceptliability for both prescribing and formonitoring the patient.

n The practice of issuing an NHS prescriptionand a private prescription simultaneously forthe same item/s is ill-advised and should beprofessionally discouraged.