PATIENT GROUP DIRECTION FOR LIPOPROTEIN APHERESIS

PATIENT GROUP DIRECTION for THE CLINICAL NURSE SPECIALIST IN APHERESISto administer lipoprotein apheresis AT HAREFIELD HOSPITAL

HEART DIVISION - HAREFIELD

Authors: / Nurse Consultant in Cardiology
Specialist Pharmacist
Consultant Cardiologist
Approved by: / Non Medical Prescribing Group
Signed by:
Chairman –
Ratified by: / Medicines Management Board
Signed by:
Chairman –
Issue Date: / June 2014
Version: / 8.0
Review Date: / June 2016
Expiry Date / June 2016

A doctor for the speciality must be consulted during the development of the PGD from the outset and throughout the whole process. This person will give support to the use of a PGD over prescribing.

Date approved: June 2014 / Next review date: June 2016 / Expiry date: June 2016
Version: 8.0 / Page 1 of 30
PATIENT GROUP DIRECTION FOR LIPOPROTEIN APHERESIS

YOU MUST BE AUTHORISED BY NAME, UNDER THE CURRENT VERSION OF THIS PGD BEFORE YOU ATTEMPT TO WORK ACCORDING TO IT

Clinical Condition
Indication / Lipoprotein apheresis is a dialysis type treatment indicated for patients who, despite optimum medication and dietary control, continue to have cholesterol levels which are higher than desirable. The majority of patients who require lipoprotein apheresis will have a genetic abnormality of cholesterol metabolism, familial hypercholesterolaemia (FH). Lipoprotein apheresis treatment is generally life-long.
Inclusion criteria / Patients who meet the HEART UK Lipoprotein apheresis guidelines for lipoprotein apheresis treatment are referred to the Nurse Consultant in Cardiology for consideration for lipoprotein apheresis. These patients will usually have concomitant, significant ischaemic heart disease.
Exclusion criteria
If any of the following apply the PGD CANNOT be used and the patient must be referred to a prescriber /
  • Patients whose pre and post lipid screen shows minimal change after at least 4 full lipoprotein apheresis treatment sessions or who frequently fail to attend for treatment will be discussed with the referring Cardiology Consultant, regarding the benefit of continuing further treatment sessions.
  • Patients with any haemostatic or clotting abnormalities e.g. haemophilia will be excluded.
  • Patients with a known allergy to heparin or ACD-A will be excluded.
  • Patients with a known allergy to sheep/lamb will be excluded from using the LIFE 18 device
  • Patients with poor IV access who cannot have permanent central access or formation of an AV fistula will be excluded.
  • Patients who do not wish to undergo treatment.

Action if patient declines or is excluded / Patients excluded from this direction will be referred back to the relevant Consultant for further management.
Refer to doctor or manager / Patients, who do not tolerate the lipoprotein apheresis session e.g. unacceptable crescendo of ischaemic pain attributable to the procedure/ recurrent vasovagal episodes, will be referred back to Cardiology Consultant (N.B. This should be rare.)
Further Information / Pregnancy & breast feeding
Any patient who is pregnant or breast feeding must be discussed with the relevant consultant prior to commencing treatment or continuing treatment if they are already undergoing treatment. If the decision is made that the patient is to continue apheresis during pregnancy / breast feeding any drugs other than those used to set up the machine must be prescribed by the consultant in charge of the patient’s care.
Monitoring Prior to lipoprotein Apheresis
  • Blood pressure, pulse and weight will be monitored prior to lipoprotein apheresis treatment to ensure they are within patient’s ‘usual’ range. CNS in Apheresis to record values onto the lipoprotein apheresis audit form (see Extracorporeal Service Information leaflet)
Advice from Cardiology Consultant or Registrar to proceed with session will be sought if these values are outside patient’s ‘usual’ range.
  • Venous Blood Monitoringfor the following will be taken –
Full lipid screen, including Apo A and Apo B (non-fasting) prior to every session
FBC – monitoring particularly Hb
Clotting screen for INR and APTT once a month
Urea, electrolytes and LFTs(including corrected calcium) “
Albumin “
Ferritin every 3 months
Full lipid screen, including Apo A and Apo B (non-fasting) after every session
  • All requested blood results will be screened by CNS in Apheresis undertaking the treatment.
  • Blood results will generally be available after the apheresis session has taken place. Advice from Cardiology Consultant or Registrar to proceed with subsequent session will be sought if any values (apart from lipid screen and antibody levels) are outside ‘normal’ adult range as reported by Trust’s Pathology Department.
Monitoring During Lipoprotein Apheresis
  • Heart rate will be monitored every 30 minutes throughout the treatment. Blood pressure will be monitored if clinically indicated using a non-invasive blood pressure machine. CNS in Apheresis to record values onto the lipoprotein apheresis audit form (see Extracorporeal Service Information leaflet)
  • If anginal pain is experienced during treatment, then the treatment will be suspended temporarily and up to two spraysof Glyceryl Trinitrate preparation administered via the sublingual route. If the pain resolves, the treatment may be continued.
  • If chest pain still persists following the above – then the session will be terminated early. Administration of the Glyceryl Trinitratepreparation and/or early termination of procedure will be recorded onto the Problems/Comments section of the lipoprotein apheresis audit form (see Extracorporeal Service Information leaflet).
  • If the patient’s blood pressure or heart rate drops associated with symptoms of feeling light-headed, the treatment will be suspended temporarily; the patient will be laid flat and up to 500ml Sodium Chloride 0.9%/Isoplex will be administered. If the symptoms resolve, the treatment can be continued. If not, then the session will be terminated early.
Monitoring Post Lipoprotein Apheresis
  • Blood pressure and pulse after everysession.
  • Following lipoprotein apheresis, venous blood measurement for full lipid screen after every session.
  • Any adverse reactions to a treatment session will be recorded onto the
Problems/Comments section of the lipoprotein apheresis audit form (see Extracorporeal Service Information leaflet)
Concomitant Medication Precautions and Contraindications / A full drug history will be taken by the CNS in Apheresis prior to initiation of lipoprotein apheresis and the following advised, where appropriate:
  • Anti-hypertensive agents may need to be omitted on the day of treatment but can usually be taken after the session has finished. Whether anti-hypertensive agents will need to be omitted depends on the patient’s blood pressure (BP) and symptoms during and after the procedure. The BP is monitored as clinically indicated throughout apheresis. The heart rate is monitored every 30 minutes.
  • Omit any Low Molecular Weight Heparins on the day of lipoprotein Apheresis.
  • All other anti-anginal medication should be taken as per usual.
  • Remind patient to bring his/her own prescribed GlycerylTrinitrate spray/tablets to every apheresis session.
  • Angiotensin Converting Enzyme inhibitor (ACEi) drugs are contraindicated with the DX21 machine as these medicines inhibit the catabolism of bradykinin. Bradykinin is also produced in the Liposorber column. Should blood be returned to the patient with high concentrations of bradykinin, then anaphylactoid-like reactions could occur, including shock if severe. (Angiotensin II antagonists are permitted and patients may be converted to these as an alternative to ACEi, since the Angiotensin II antagonists do not inhibit bradykinin breakdown).Patients are advised not to take diuretics on the day of treatment
The CNS in Apheresis will refer any patient taking concurrent ACEi to referring Cardiology Consultant/Registrar for medication alteration to Angiotensin II antagonist – if this is appropriate. Patients need to have ceased their ACEi for at least 2-3 weeks prior to commencement with lipoprotein apheresis with the DX-21 machine.
ACEi are NOT contraindicated with the HF440 machine and the LIFE 18 machine.
Drug Details
Name, form & strength of medicine / Sodium chloride 0.9% infusion 1 L
Legal Status / POM
Route/Method / To extracorporeal circuit/Intravenous
Dosage and frequency / Rinsing of apheresis machines;
Life 18 – 10-15 x 1L bags(dependant on patient weight)
DX21 – 2-3 x 1L bags
HF440 – 3 x 1L bags
Apheresis treatment;
HF440 – 2 x 1L bags
Blood return from apheresis machine;
DX21 – 1 x 1L bag
Hypotension during apheresis treatment;
Up to 500ml
Duration of treatment / Duration of lipoprotein apheresis treatment
Maximum or minimum treatment period / N/A
Quantity to supply/ administer / Rinsing of apheresis machines;
Life 18 – 10-15 x 1L bags (dependant on patient weight)
DX21 – 2-3 x 1L bags
HF440 – 3 x 1L bags (rinsing and priming)
Apheresis treatment;
HF440 – 2 x 1L bags
Blood return from apheresis machine;
DX21 – 1 x 1L bag
Hypotension;
Up to 500ml over 10-15 minutes
Repeated dose instructions / Patients attend for lipoprotein apheresis every 2 weeks. Occasionally treatment is performed weekly.
Other precautions / Use with caution in patients with impaired renal function, peripheral or pulmonary oedema.
A maximum of 500ml Sodium Chloride 0.9% may be given over 10-15 minutes in the event of hypotension during lipoprotein apheresis treatment. If the patient remains hypotensive medical help must be sought.
Side effects / Administration of large doses may give rise to sodium accumulation, oedema and hyperchloraemic acidosis.
Name, form & strength of medicine / Sodium chloride 0.9% infusion 1 L contd.
Patient Monitoring / Patient’s heart rate to be monitored every 30 minutes during treatment. Blood pressure will be recorded as clinically indicated. All vital signs will be recorded on treatment sheet (see Extracorporeal Service Information leaflet)
Advice to patient/carer / N/A
Follow up / Patient’s GP will be written to regarding outcome/progress of treatment.
Additional background information / N/A
Drug Details
Name, form & strength of medicine / Glycine-HCL 0.2M infusion
Legal Status / No product licence for this sterile fluid as manufactured by Baxter to the specification required by Miltenyi-Biotec. Treat as POM
Route/Method / To extracorporeal circuit
Dosage and frequency / Regeneration of adsorbers – Life 18 machine
2-3 bags of 5L required for each treatment
Duration of treatment / Duration of lipoprotein apheresis treatment
Maximum or minimum treatment period / N/A
Quantity to supply/ administer / 2-3 bags of 5L for each treatment
Repeated dose instructions / Patients attend for lipoprotein apheresis every 2 weeks. Occasionally treatment is performed weekly.
Other precautions / Not to be given directly to the patient
Side effects / N/A – used in extra-corporeal circuit only
Patient Monitoring / N/A – used in extracorporeal circuit only.
Advice to patient/carer / N/A - used in extracorporeal circuit only
Follow up / Patient’s GP will be written to regarding outcome/progress of treatment.
Additional background information / N/A
Drug Details
Name, form & strength of medicine / Phosphate Buffered Saline (PBS) infusion (Therasorb™ - PBS (30mM PO4)). Containing in 100ml: Sodium Chloride 620.6mg, Disodium Hydrogen Phosphate 335.4mg, Sodium Dihydrogen Phosphate Dihydrate 83.9mg
Legal Status / No product licence for this sterile fluid as manufactured by Baxter to the specification required by Miltenyi-Biotec. Treat as POM
Route/Method / To extracorporeal circuit
Dosage and frequency / Neutralisation of adsorbers – Life 18 machine
2-3 bags of 3L required for each treatment
Duration of treatment / Duration of lipoprotein apheresis treatment
Maximum or minimum treatment period / N/A
Quantity to supply/ administer / 2-3 bags of 3 L
Repeated dose instructions / Patients attend for lipoprotein apheresis every 2 weeks. Occasionally treatment is performed weekly.
Other precautions / Not to be given directly to the patient
Side effects / N/A - used in extra-corporeal circuit only
Patient Monitoring / N/A – used in extracorporeal circuit only.
Advice to patient/carer / N/A - used in extracorporeal circuit only
Follow up / Patient’s GP will be written to regarding outcome/progress of treatment.
Additional background information / N/A
Drug Details
Name, form & strength of medicine / Phosphate Buffered Saline (PBS) Azide
containing 0.115% Disodium Hydrogen, Phosphate & 0.02%, Potassium Dihydrogen, Phosphate with 0.01% Sodium Azide infusion
Legal Status / No product licence for this sterile fluid as manufactured by Miltenyi-Biotec to their specification. Treat as POM
Route/Method / To extracorporeal circuit
Dosage and frequency / 2 x 1L bottles required for preservation of Therasorb columns between treatments – Life 18 machine
Duration of treatment / Duration of lipoprotein apheresis treatment
Maximum or minimum treatment period / N/A
Quantity to supply/ administer / 2 x 1L bottles required for each treatment
Repeated dose instructions / Patients attend for lipoprotein apheresis every 2 weeks. Occasionally treatment is performed weekly.
Other precautions / Not to be given directly to the patient.
Side effects / N/A - used in extracorporeal circuit only
Patient Monitoring / N/A – used post treatment
Advice to patient/carer / N/A - used in extracorporeal circuit only
Follow up / Patient’s GP will be written to regarding outcome/progress of treatment.
Additional background information / N/A
Drug Details
Name, form & strength of medicine / Acid Citrate (ACD-A) infusion containing 0.8% Acid Citrate Monohydrate & 2.2% Sodium Citrate Dihydrate
Legal Status / POM
Route/Method / To extracorporeal circuit/Intravenous
Dosage and frequency / Anticoagulation for the Life 18 and DX 21 apheresis machines. Acid Citrate is used as the anticoagulant for the extracorporeal circulation. It is not for direct intravenous infusion, but some will be returned to the patient via the ‘venous’ limb.
In the Life 18 machine the infusion is delivered at a rate of 1ml for every18ml of blood processed within the blood cell separator.
In the DX 21 machine the infusionis delivered at a rate of 2.0-5.0% of the blood flow rate of the machine.
1-2 x 500ml bags required for each treatment
Duration of treatment / Duration of lipoprotein apheresis treatment
Maximum or minimum treatment period / N/A
Quantity to supply/ administer / 1-2 x 500ml bags for each treatment
Repeated dose instructions / Patients attend for lipoprotein apheresis every 2 weeks. Occasionally treatment is performed weekly.
Other precautions / None
Side effects / Hypocalaemia
Patient Monitoring / Patient’s heart rate to be monitored every 30 minutes during treatment. Blood pressure will be recorded as clinically indicated. All vital signs will be recorded on treatment sheet (see Extracorporeal Service Information leaflet)
Advice to patient/carer / Patients are advised to watch for signs of hypocalcaemia – tetany, tingling lips. If these symptoms occur they should take an additional calcium carbonate tablet. If this does not improve symptoms, patient to call the apheresis unit.
Follow up / Patient’s GP will be written to regarding outcome/progress of treatment.
Additional background information / N/A
Drug Details
Name, form & strength of medicine / Compound Sodium Lactate (Hartmann’s) infusion 1L
Legal Status / POM
Route/Method / To extracorporeal circuit/Intravenous
Dosage and frequency / 1 bag of 1 Litre infusion Compound Sodium Lactate (Hartmann’s) with 3 - 5 ml of Heparin Sodium (preservative-free)1000 units per ml used to prime DX21 apheresis machine
Duration of treatment / Duration of lipoprotein apheresis treatment
Maximum or minimum treatment period / N/A
Quantity to supply/ administer / Priming of DX21 apheresis machine
1 x 1L g bag containing 3-5ml of Heparin Sodium (preservative free) 1000 units per ml to extra corporeal circuit
Repeated dose instructions / Patients attend for lipoprotein apheresis every 2 weeks. Occasionally treatment is performed weekly.
Other precautions / Not to be used for rinsing of machine
Side effects / Administration may give rise to lactic acidosis
Patient Monitoring / Patient’s heart rate to be monitored every 30 minutes during treatment. Blood pressure will be recorded as clinically indicated. All vital signs will be recorded on treatment sheet (see Extracorporeal Service Information leaflet)
Advice to patient/carer / N/A
Follow up / Patient’s GP will be written to regarding outcome/progress of treatment.
Additional background information / N/A
Drug Details
Name, form & strength of medicine / Isoplex intravenous infusion 500ml
Legal Status / POM
Route/Method / To extracorporeal circuit/Intravenous
Dosage and frequency / Priming of HF440 apheresis machine – 2 x 500ml bags to extracorporeal circuit
Treatment using HF440 machine – 4 x 500ml bags
Hypotension – up to 500ml
Duration of treatment / Duration of lipoprotein apheresis treatment
Maximum or minimum treatment period / N/A
Quantity to supply/ administer / 2 x 500 ml bags may be used to prime the HF440 machine for patients who suffer from recurrent hypotensionrequiring repeated infusions of sodium chloride during treatment.
Up to 500ml Isoplex may also be given to patients who suffer from hypotension during treatment over 10-15 minutes
Repeated dose instructions / Patients attend for lipoprotein apheresis every 2 weeks. Occasionally treatment is performed weekly.
Other precautions / A maximum of 500ml Isoplex may be given in the event of hypotension during lipoprotein apheresis treatment. If the patient remains hypotensive medical help must be sought.
Side effects / Severe anaphylactic or anaphylactoid reactions have been reported following the intravenous administration of Isoplex. These are rare, having an incidence of between 1 in 6,000 and 1 in 13,000 units. However, they may be more likely to occur if Isoplex is given rapidly to normovolaemic patients, and may be assumed to be more hazardous in patients with known allergic conditions such as asthma.
Refer to SPC for more information.
Patient Monitoring / Patient’s heart rate to be monitored every 30 minutes during treatment. Blood pressure will be recorded as clinically indicated. All vital signs will be recorded on treatment sheet (see Extracorporeal Service Information leaflet)
Advice to patient/carer / N/A
Follow up / Patient’s GP will be written to regarding outcome/progress of treatment.
Additional background information / N/A
Drug Details
Name, form & strength of medicine / Sodium chloride 0.9% flush – 10ml ampoule
Legal Status / POM
Route/Method / Intravenous slow bolus
Dosage and frequency / 5-10ml as a flush to ensure patency of the intravenous cannulae
Duration of treatment / Duration of lipoprotein apheresis treatment
Maximum or minimum treatment period / N/A
Quantity to supply/ administer / 5-10mlSodium Chloride 0.9% injection (to cannula/line) before administering any other intravenous medicines and/or connecting patient cannulae to the apheresis machine. Additional flushes may be required during treatment if there is a potential problem with cannula patency.
Repeated dose instructions / Patients attend for lipoprotein apheresis every 2 weeks. Occasionally treatment is performed weekly.
Other precautions / N/A
Side effects / Sodium chloride flush must be given slowly to avoid extravasation of fluid into surrounding tissues.
Patient Monitoring / Patient’s heart rate to be monitored every 30 minutes during treatment. Blood pressure will be recorded as clinically indicated. All vital signs will be recorded on treatment sheet (see Extracorporeal Service Information leaflet)
Cannulae will be observed for signs of extravasation.
Advice to patient/carer / N/A
Follow up / Patient’s GP will be written to regarding outcome/progress of treatment.
Additional background information / N/A