TEAM TRAINING: VACCINATIONS

Shingles

In this series of articles, we provide pharmacists with information to develop and implement OTC team training sessions, aimed at ensuring safe and suitable recommendations, and appropriate pharmacist referral. Thanks to the team at totalhealth and Haven Pharmacies for this month’s topic: Shingles.

What is Shingles?

Shingles (Herpes Zoster) is a painful rash the occurs when a nerve underneath the skin becomes infected by the varicellazoster virus, the same virus that causes chicken pox. Unlike chicken pox, shingles is usually confined to one area of the body, although it may spread around the body depending on where the infected nerve lies and travels. Most people become infected with chicken pox during childhood; shingles is a reactivation of that virus.

Signs and Symptoms

The first sign of shingles is usually a tingling sensation or pain in one area of the skin. It may be accompanied by a headache or feeling generally unwell. The rash usually appears a few days later. Shingles rash is usually characterised by red blotches that quickly develop into fluid-filled blisters. Blisters may continue to develop for up to a week. Swelling under the rash and pain may also be experienced. Blisters slowly dry up and transform to scabs. Scarring can often occur. Pain is usually localised to the location of the rash but can be very severe.

Treatment

Anyone suspected of being infected must be referred to their GP immediately for treatment. Prescription treatments may include: • Pain Killers • Antiviral Medicines • Steroids.

Self-Care

Patients diagnosed with shingles may benefit from OTC pain relief (provided it is safe with any prescription medication – always refer to the pharmacist). The following advice may also help relieve discomfort:

• Keep the rash clean and dry to reduce risk of further infection

• Wear loose-fitting clothing

• Apply a cool compress on the rash site several times a day.

It is not recommended to use antibiotic or antibacterial creams on a shingles rash, or to let dressing or plasters stick to a raw rash. Simple emollients or calamine lotion can be used to ease itching, and nonadhesive plasters can be used to cover weeping blisters.

Transmission

As already mentioned, shingles is the result of the reactivation of varicellazoster virus in those who have previously been infected with chicken pox. You cannot catch shingles from somebody with shingles. Reactivation of that virus is usually due to a lowered immune system, because of illness, immune-suppression, stress, or age. People who have NOT had chicken pox may be at risk of developing chicken pox when encountering someone who has shingles. The infection is spread through direct contact with a ‘live’ rash, i.e., skin-to-skin contact with a shingles rash before it has scabbed over.

Consider:

Reflect on the following in assessing your own knowledge and your team’s training:

 Is your knowledge up to date on shingles symptoms?

 Are you familiar with shingles treatments, both Rx and OTC?

 Is your knowledge up to date on shingles risk factors, including transmission risks?

 Is your team aware of what patients must be referred to the pharmacist?

Key Points:

Ensure your team understands and is confident explaining the following:

 The OTC treatment options for patients experiencing shingles

 Those people that should particularly be avoided by someone infected with shingles

 The patients who should be referred to the pharmacist and why

 How shingles is spread and how to avoid transmission.

Risks and Complications

There are potentially severe consequences associated with shingles infection, as well as with the transmission of chicken pox by those with shingles infection. In some cases, shingles can lead to complications, such as postherpetic neuralgia, where pain lasts for several months after the rash has gone. This is usually experienced by older people or those with a weakened immune system. There is also a risk of post-viral fatigue syndrome following a shingles infection. Those infected with shingles should especially avoid: • Pregnant people who have not had chickenpox before • People with a weakened immune system – e.g., someone having chemotherapy • Babies less than 1 month old.

Vaccination

There are two shingles vaccines licenced for administration by pharmacists in Ireland. Neither is part of the National Immunisation Plan and therefore must be paid for by recipients. Those who may benefit from shingles vaccination include: • Those aged over 50 • Anyone aged 18 and over with a compromised immune system • Those who have not had chicken pox before.

Actions:

Your action plan for Shingles should include the following:

 Your team has been trained on shingles symptoms and treatments

 You have the appropriate range of products available

 The risk factors and transmission dangers associated with shingles

 WWHAM Protocol forms the basis of all interactions at the OTC counter

 Update your CPD record.

YOUR PATIENTS AGED 50 YEARS OF AGE OR OLDER ARE AT INCREASED RISK OF DEVELOPING SHINGLES.1 YOU CAN PREVENT IT.2,3

SHINGRIX demonstrated >90% efficacy against shingles in all age groups aged 50 years of age or older, based on pooled data from two large, phase 3 randomised control trials.2,3

SHINGRIX IS NOW AVAILABLE

For more information on SHINGRIX, please scan the QR code.

Shingrix powder and suspension for injection in vials (Please refer to SmPC before prescribing) Composition: After reconstitution, one dose (0.5 mL) contains: Varicella Zoster Virus glycoprotein E antigen1,2 50 micrograms. (1 adjuvanted with AS01B containing: plant extract Quillaja saponaria Molina, fraction 21 (QS-21) 50 micrograms, 3-O-desacyl-4’-monophosphoryl lipid A (MPL) from Salmonella minnesota 50 micrograms, 2 glycoprotein E (gE) produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology). Therapeutic indications: Prevention of herpes zoster (HZ) and post-herpetic neuralgia (PHN) in adults 50 years of age or older and in adults 18 years of age or older at increased risk of HZ. The use of this vaccine should be in accordance with official recommendations. Posology and method of administration: For intramuscular injection only, preferably in the deltoid muscle. Primary Vaccination: Initial dose of 0.5 ml followed by a second 0.5 ml dose 2 months later. For flexibility the 2nd dose can be administered between 2 and 6 months after the first dose. For subjects who are or might become immunodeficient or immunosuppressed and whom would benefit from a shorter vaccination schedule, the 2nd dose can be given 1 to 2 months after the initial dose. Booster doses: need not established. Contraindications: Hypersensitivity to the active substances or any of the excipients. Special warnings and precautions for use: The name and the batch number of the administered product should be clearly recorded. Appropriate medical treatment and supervision should be readily available in case of an anaphylactic event. Administration of Shingrix should be postponed in subjects suffering from an acute severe febrile illness. However, the presence of a minor infection, such as cold, should not result in deferral. A protective immune response may not be elicited in all vaccinees. Never administer intravascularly or intradermally; subcutaneous administration not recommended as it may lead to an increase in transient local reactions. Caution in individuals with thrombocytopenia or any coagulation disorder since bleeding may occur following intramuscular administration. Syncope can occur following, or before any vaccination as a psychogenic response. This can be accompanied by several neurological signs such as transient visual disturbance, paraesthesia and tonic-clonic limb movements during recovery. It is important that procedures are in place to avoid injury from faints. There are no data to support replacing a dose of Shingrix with another HZ vaccine. There are limited data to support the use of Shingrix in individuals with a history of HZ and in frail individuals including those with multiple comorbidities. The benefits and risks of HZ vaccination should be weighed on an individual basis. Interactions: Shingrix can be given concomitantly with unadjuvanted inactivated seasonal influenza vaccine, 23-valent pneumococcal polysaccharide vaccine (PPV23) or reduced antigen diphtheriatetanusacellular pertussis vaccine (dTpa). The vaccines should be administered at different injection sites. Fertility, pregnancy and lactation: There were no effects on male or female fertility in animal studies. It is preferable to avoid the use of Shingrix during pregnancy. The effect on breast-fed infants of administration of Shingrix to their mothers has not been studied. It is unknown whether Shingrix is excreted in human milk. Effects on ability to drive and use machines: Shingrix may have a minor influence on the ability to drive and use machines in the 2-3 days following vaccination. Undesirable effects: Very common (≥1/10): Headache, GIT symptoms, myalgia, injection site reactions, fatigue, chills, fever. Common (≥1/100 to <1/10): injection site pruritus, malaise. Uncommon (≥1/1000 to <1/100): lymphadenopathy, arthralgia. Rare (≥1/1000 to <1/100): Hypersensitivity reactions. Legal Category: POM A. Marketing Authorisation Number: EU/1/18/1272/001. Marketing Authorisation Holder: GlaxoSmithKline Biologicals S.A., Rue de l’institut 89, B-1330 Rixensart, Belgium. Further information is available from GlaxoSmithKline (Ireland) Ltd. 12 Riverwalk, Citywest Business Campus, Dublin 24. Telephone: 01-4955000. Code: PI-7757. Date of preparation: March 2021.

Adverse events should be reported directly to the Health Products Regulatory Authority (HPRA) on their website: www.hpra.ie. Adverse events should also be reported to GlaxoSmithKline on 1800 244 255.

References : 1. Gauthier et al. Epidemiology and costs of herpes zoster and postherpetic neuralgia in the United Kingdom. Epidemiol infecti. 2009 137 38-47. 2. Lal H et al. Efficacy of an adjuvanted herpes zoster subunit vaccine in older adults. N Engl J Med. 2015; 372(22):2087-96. 3. Cunningham AL et al. Efficacy of the herpes zoster subunit vaccine in adults 70 years of age or older. N Engl J Med. 2016; 375(11):1019-32.

Prescribing

Pharmacist Prescribing: Learning from international models and opportunities for pharmacists in Ireland

Independent and supplementary/collaborative prescribing, also known as non-medical prescribing, has been introduced in many countries in recent decades. Since 2007, nurses and midwives in the Republic of Ireland have been able to become registered prescribers with An Bord Altranais, upon completion of a programme of study1. The contribution of independent prescribers to the quality and safety of patient care has been studied and discussed within published literature.

Pharmacist prescribers can make a meaningful impact on patient care, enhancing timely access to care which is delivered in a safe and effective manner. Focusing on a specialty or specific clinical area helps pharmacists to become established and integrated as prescribers in a multidisciplinary team. Within secondary care pharmacist prescribers have been demonstrated to make a positive contribution to the management of acute conditions in addition to the ongoing management of chronic conditions through outpatient clinics2,3. There are also studies currently being conducted to understand the contribution of pharmacist prescribers to care home or nursing home settings4 . A Cochrane review examining prescribing by medical and nonmedical prescribers for chronic disease management in primary and secondary care concluded that specific outcomes such as the extent of diabetes control, adverse events and patient adherence were comparable when care was overseen by a medical practitioner or independent prescriber5. Furthermore, a study examining prescribing errors has demonstrated that independent pharmacist prescribers make fewer errors than their medical counterparts6. It is reasonable to say that pharmacist prescribers make a meaningful and highquality contribution to patient care. I have been Programme Lead for Independent and Supplementary Prescribing at the University of Leeds since 2016 so I have first-hand experience of the education of trainee prescribers who are pharmacists, nurses, midwives, physiotherapists, paramedics and podiatrists. Since I joined the University, more than 500 healthcare professionals working in many different practice settings across Yorkshire and the Humber, including small and large hospitals, GP surgeries, community pharmacies, prison and custody settings, nursing homes and palliative care have completed the prescribing programme at Leeds. Having arrived as a novice Lecturer in Pharmacy Practice to the University in 2015, scarcely aware of the existence of prescribing pharmacists, it has been a source of pride (and sometimes bemusement) that I could play such an instrumental role in the progression of the profession in the UK, while longing to see similar advancements in Ireland.

The UK could be considered to have the most advanced model of independent and supplementary prescribing, which has evolved over time, having existed in some form since 1992. It was introduced following the publication of the Cumberlege Report (1986) and the Crown Report (1989), these reports suggested that patient care would be enhanced by permitting nurses to prescribe medications, although limited these items to the Nurse Prescriber Formulary7 . From 2003, pharmacists were permitted to become supplementary prescribers, and in 2006 could become independent prescribers. Independent prescribing powers enable pharmacists to prescribe licensed and unlicensed medications, and controlled drugs, although there are some exceptions (i.e. drugs prescribed to treat addiction)8 . Supplementary prescribing is defined as a partnership between an independent prescriber and supplementary prescriber to implement an agreed patient specific clinical management plan (CMP) with the patient’s agreement, particularly but not only in relation to prescribing for a specific non-acute medical condition or health need affecting the patient. For example, if managing a patient with hypertension, the supplementary prescriber might be able to implement dose adjustments or introduce new medications to the management plan, provided this has been set out in the CMP and has been agreed with an independent prescriber. At present in the UK, becoming an independent or supplementary prescriber requires that the pharmacist undertakes an accredited training programme with a Higher Education Institution (HEI) and completes a specified period of training in practice. There is an established model of funding of prescribing programmes and accreditation of these programmes by professional regulators. Health Education England (HEE), an executive non-departmental public body of the Department of Health and Social Care, which commissions places on prescribing training programmes in HEIs. Usually commissioned places can only be offered to healthcare professionals working within the geographical proximity of the HEI and providing care to patients through the NHS. Those who wish to attend an HEI outside of their geographical area or those caring for patients outside of the NHS, can opt to pay privately for a place on an accredited course. A large part of the success of the prescribing pharmacist role within the UK is the development of roles such as advanced clinical pharmacists in secondary care or GP based pharmacists where prescribing is a fundamental part of effective care, and also the allocation of specific funding for training of these pharmacists. There are currently around 9000 pharmacists registered as prescribers in the UK, representing approximately 15% of the total number of registered pharmacists 9. However, this number will increase considerably in the coming years, as from this academic year onwards, prescribing training will be integrated into the MPharm curriculum, such that pharmacists will be automatically permitted to prescribe upon initial registration with the General Pharmaceutical Council (GPhC) or Pharmaceutical Society of Northern Ireland (PSNI)10 . Until now only pharmacists who were more than two years qualified could apply to complete a prescribing programme offered by one of the more than forty accredited HEIs within the UK. These courses focus primarily on developing pharmacists’ clinical evaluation, communication, diagnostic and decision-making skills. Courses usually combine a number of face-to-face study days as well as online learning materials. All teaching, learning and assessment materials are mapped to the thirty-two learning outcomes defined by the GPhC11 . The Royal Pharmaceutical Society’s Core Competency Framework for All Prescribers, which details the skills, knowledge and behaviours that all prescribers should demonstrate, also informs teaching and assessment for many courses. The RPS Framework can also assist with planning learning and undertaking reflection when working as prescriber12 . During the period of learning with the HEI, pharmacists are also required to complete 90 hours in practice under the supervision of a Designated Prescribing Practitioner (DPP). DPPs can be a medic, pharmacist, nurse or allied health professional with more than 3 years’ prescribing experience and who have sufficient training or experience of clinical supervision in the workplace. During this period of supervised practice, pharmacists have an opportunity to develop the knowledge and skills specifically relevant to their specialist area so that they can become a competent prescriber. It is therefore essential that a trainee pharmacist prescriber has the

Written by Mary-Claire Kennedy PhD SFHEA MRPharmS, Programme Lead for Independent and Supplementary Prescribing, University of Leeds

full support of their employer and the clinical team they work with, as they will need to work closely with these individuals to gain a sufficient depth and breadth of experience in practice.

Other International Models

Many other countries have a version of independent and supplementary/collaborative prescribing for pharmacists, although the latter is most common. I will mention a few different models here to give you a sense of the various approaches that are adopted by different countries. Prescribing rights for pharmacists in Canada differ between provinces. Pharmacist practising within the province of Alberta are permitted to prescribe all Schedule 1 drugs (those requiring a prescription) and blood products. There are no lists of drugs; instead, all pharmacists are expected to limit their prescribing to situations where they have an adequate understanding of the patient, the condition being treated, and the drug being prescribed. Pharmacists may not prescribe drugs regulated by the Controlled Drugs and Substances Act such as narcotics, benzodiazepines and anabolic steroids. Prescribing pharmacists can order laboratory tests, access laboratory test results and authorise the administration of medications and blood products. Pharmacists are reimbursed for their prescribing in a deal brokered between the advocacy body, Pharmacists Association of Alberta and Alberta Health13 .

One of the key drivers for independent prescribing in New Zealand was the number of GPs due to retire within the next decade, this mirrors issues with the number of GPs in Ireland that have been widely discussed within the media. Prescribing powers were therefore broadened to other groups of healthcare professionals in New Zealand to enable equitable access to healthcare and timely access to medications. Pharmacist prescribers must work collaboratively with a medical prescriber whereas nurse prescribers can work independently 14. Recently a further 200 medications were added to the list of medications that be prescribed by pharmacists. However, the number of registered pharmacist prescribers remains relatively low with only 37 currently registered as such in New Zealand. These pharmacists generally work as part of a multidisciplinary team15 . There are four broad models of prescribing in place in the USA, patient specific collaboration of prescribing through collaborative prescribing agreements (CPAs), population specific prescribing, state-wide protocols and class specific prescribing16. CPAs create a formal practice relationship between pharmacists and other health care professionals, whereby the pharmacist assumes responsibility for specific patient care functions that are otherwise beyond their typical “scope of practice,” but aligned with their education and training. Services can include initiation and modification of drug therapy. The extent of the services authorised under the collaborative agreement depends on the state’s statutory and regulatory provisions, and the specific agreement between the pharmacist and other health care professionals. There are acknowledged to be a number of opportunities for further development of pharmacist prescribing in the USA including standardisation of prescriptive authority and giving pharmacists greater access to electronic medical records16 .

Prescribing Pharmacists in Ireland: The opportunities and challenges

The role of pharmacist prescribers differs considerably among countries, this is likely to be a product of many different factors such as health service systems and structure, the legislative context and the perceived need for pharmacist prescribers by key stakeholders. A common feature amongst many countries is the evolution of prescribing powers over time, initially restricted to a limited formulary or collaborative/ supplementary prescribing and moving to independent or autonomous prescribing over time, with fewer restrictions on what can be prescribed. Additionally, the introduction of independent and supplementary prescribing rights is rarely implemented in isolation, they are combined with advanced practice skills such as diagnostic and clinical decision-making skills, which further enable the pharmacist to work autonomously and effectively in a range of settings. The Future of Pharmacy Practice report identified opportunities for pharmacist prescribing in Ireland17. Indeed, there are pockets of innovative practice within some of our hospitals, striving to upskill pharmacists as prospective prescribers, supported by medical staff. However, there are undoubtedly several major changes required before such an advancement can be widely introduced in Ireland. Firstly, there is the legislative change which would rely upon the support and leadership of key stakeholders. Training and education programmes would need to be established and models of funding for such programmes considered. Support of medical and nursing colleagues will be essential for training of pharmacist prescribers in practice. There is also the challenge of placing pharmacists within roles and practice settings where their contribution as a prescriber is routinely incorporated into the delivery of care to patients, such as outpatient clinics or GP-based consultations. Consideration also needs to be given to pay and reimbursement for an enhanced role and responsibility. Perhaps of greatest consequence is the acceptability of pharmacist prescribers to other groups of healthcare professionals, to patients and to the pharmacy profession itself. It must be acknowledged that gaining annotation as a prescriber without then utilising the skill will not benefit the healthcare system nor will introduction of the qualification with relatively few pharmacists seeking to become annotated as prescribers. In other words, there must be a determination and willingness for the profession to embed prescribing as part of our professional practice. Gaining acceptability and support is likely to be incremental. Perhaps starting with supplementary/collaborative prescribing could provide evidence of the value of pharmacist prescribers. Over time, as has been the case in many countries, this can evolve into a greater breadth of prescribing powers.

References available on request.

With each additional comorbid condition, the risk for pneumococcal pneumonia multiplies compared to healthy adults of the same age2

1 underlying condition

2.1x

increased risk 2 underlying conditions

4.2x

increased risk >3 underlying conditions

9.2x

increased risk These underlying conditions included2:

Alcoholism

Asthma

Chronic cardivascular disease

Chronic liver disease

Chronic pulmonary disease

Current smokers

Diabetes

Help prevent pneumococcal pneumonia with the proven protection of Prevenar 131,3

Proven to reduce the risk of community-acquired pneumonia: Results from the Community-Acquired Pneumonia Immunisation Trial in Adults (CAPiTA) – one of the largest vaccine efficacy trials ever conducted in older adults.3,4

ABBREVIATED PRESCRIBING INFORMATION Prevenar 13* Suspension for Injection Pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed)

Presentation: Each 0.5ml dose of Prevenar 13 contains 2.2 micrograms of each of the following pneumococcal polysaccharide serotypes: 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F and 4.4 micrograms of pneumococcal polysaccharide serotype 6B. Each pneumococcal polysaccharide is conjugated to CRM197 carrier protein and adsorbed on aluminium phosphate. 1 dose (0.5 ml) contains approximately 32 µg CRM197carrier protein and 0.125 mg aluminium. Indications: Active immunisation for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants, children and adolescents from 6 weeks to 17 years of age. Active immunisation for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in adults ≥18 years of age and the elderly. Dosage and Administration: The immunisation schedules for Prevenar 13 should be based on official recommendations. It is recommended that infants who receive a first dose of Prevenar 13 complete the vaccination course with Prevenar 13. For intramuscular injection. Infants aged 6 weeks-6 months: Three dose primary series: The recommended immunisation series consists of four doses, each of 0.5ml. The primary infant series consists of three doses, with the first dose usually given at 2 months of age and with an interval of at least 1 month between doses. The first dose may be given as early as six weeks of age. The fourth (booster) dose is recommended between 11 and 15 months of age. Two dose primary series: Alternatively, when Prevenar 13 is given as part of a routine infant immunisation programme, a series consisting of three doses, each of 0.5ml, may be given. The first dose may be administered from the age of 2 months, with a second dose 2 months later. The third (booster) dose is recommended between 11 and 15 months of age. Preterm infants (< 37 weeks gestation): In preterm infants, the recommended immunisation series consists of four doses, each of 0.5 ml. The primary infant series consists of three doses, with the first dose given at 2 months of age and with an interval of at least 1 month between doses. The first dose may be given as early as six weeks of age. The fourth (booster) dose is recommended between 11 and 15 months of age. Unvaccinated infants and children ≥ 7 months of age: Infants 7-11 months: Two doses, each of 0.5 ml, with at least a 1 month interval between doses. A third dose is recommended in the second year of life. Children aged 12-23 months: Two doses, each of 0.5 ml, with at least a 2 month interval between doses. Children and adolescents aged 2-17 years: one single dose of 0.5 ml. Prevenar 13 vaccine schedule for infants and children previously vaccinated with Prevenar (7-valent) (Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F): Infants and children who have begun immunisation with Prevenar may switch to Prevenar 13 at any point in the schedule. Children aged 12-59 months: Children who are considered completely immunised with Prevenar (7-valent) should receive one dose of 0.5 ml of Prevenar 13 to elicit immune responses to the 6 additional serotypes. This dose of Prevenar 13 should be administered at least 8 weeks after the final dose of Prevenar (7-valent). Children and adolescents aged 5-17 years: One single dose of Prevenar 13 if they have been previously vaccinated with one or more doses of Prevenar. This dose of Prevenar 13 should be administered at least 8 weeks after the final dose of Prevenar (7-valent). Adults ≥18 years of age and the elderly: One single dose. The need for revaccination with a subsequent dose of Prevenar 13 has not been established. Regardless of prior pneumococcal vaccination status, if the use of 23 valent polysaccharide vaccine is considered appropriate, Prevenar 13 should be given first. Special Populations: Individuals who have underlying conditions predisposing them to invasive pneumococcal disease (such as sickle cell disease or HIV infection) including those previously vaccinated with one or more doses of 23-valent pneumococcal polysaccharide vaccine may receive at least one dose of Prevenar 13. In individuals with an haematopoietic stem cell transplant (HSCT), the recommended immunisation series consists of four doses of Prevenar 13, each of 0.5 ml. The primary series consists of three doses, with the first dose given at 3 to 6 months after HSCT and with an interval of at least 1 month between doses. A fourth (booster) dose is recommended 6 months after the third dose. Contra-indications: Hypersensitivity to any component of the vaccine or to diphtheria toxoid. As with other vaccines, the administration of Prevenar 13 should be postponed in subjects suffering from acute, severe febrile illness. However, the presence of a minor infection, such as a cold, should not result in the deferral of vaccination. Warnings and Precautions: Do not administer intravascularly. Appropriate medical treatment and supervision must be readily available in case of a rare anaphylactic event. This vaccine should not be given as an intramuscular injection to individuals with thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection, but may be given subcutaneously if the potential benefit clearly outweighs the risks of administration. Prevenar 13 will only protect against Streptococcus pneumoniae serotypes included in the vaccine, and will not protect against other microorganisms that cause invasive disease, pneumonia, or otitis media. As with any vaccine, Prevenar 13 may not protect all individuals receiving the vaccine from pneumococcal disease. Individuals with impaired immune responsiveness, whether due to the use of immuno-suppressive therapy, a genetic defect, human immunodeficiency virus (HIV) infection, or other causes, may have reduced antibody response to active immunization. Safety and immunogenicity data are available for a limited number of individuals with sickle cell disease, HIV infection, or with an HSCT. Safety and immunogenicity data for Prevenar 13 are not available for individuals in other specific immuno-compromised groups (e.g., malignancy or nephrotic syndrome) and vaccination should be considered on an individual basis. Infants and children aged 6 weeks to 5 years: Prevenar 13 does not replace the use of 23-valent pneumococcal polysaccharide vaccine in at risk children ≥ 24 months of age. Children ≥ 24 months of age at high risk, previously immunised with Prevenar 13 should receive 23-valent pneumococcal polysaccharide vaccine whenever recommended. The potential risk of apnoea and the need for respiratory monitoring for 48-72 hours should be considered when administering the primary immunisation series to very premature infants (born ≥ 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity. When Prevenar 13 is administered concomitantly with Infanrix hexa (DTPa-HBV-IPV/Hib), the rates of febrile reactions are similar to those seen with concomitant administration of Prevenar (7-valent) and Infanrix hexa. Increased reporting rates of convulsions (with or without fever) and hypotonic hyporesponsive episode (HHE) were observed with concomitant administration of Prevenar 13 and Infanrixhexa. Antipyretic treatment should be initiated according to local guidelines for children with seizure disorders or with a history of febrile seizures and for all children receiving Prevenar 13 simultaneously with vaccines containing whole cell pertussis. Adults aged 50 years and older: When Prevenar 13 was given concomitantly with trivalent inactivated influenza vaccine (TIV), the immune responses to Prevenar 13 were lower compared to when Prevenar 13 was given alone, however, there was no long-term impact on circulating antibody levels. The immune responses to Prevenar 13 were noninferior when Prevenar 13 was given concomitantly with quadrivalent inactivated influenza vaccine (QIV) compared to when Prevenar 13 was given alone. As with concomitant administration with trivalent vaccines, immune responses to some pneumococcal serotypes were lower when both vaccines were given concomitantly. Fertility, Pregnancy & Lactation: There are no data from the use of pneumococcal 13-valent conjugate in pregnant women. It is unknown whether pneumococcal 13-valent conjugate is excreted in human milk. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. Side Effects: Analysis of postmarketing reporting rates suggests a potential increased risk ofconvulsions, with or without fever, and HHE when comparing groups which reported use of Prevenar 13 with Infanrix hexa to those which reported use of Prevenar 13 alone. Adverse reactions reported in clinical studies or from the post-marketing experience for all age groups are listed in this section per system organ class,in decreasing order of frequency and seriousness. The frequency is defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (≤ 1/10,000), not known (cannot be estimated from available data). Infants and children aged 6 weeks to 5 years: Very common (≥ 1/10): Decreased appetite, fever, pyrexia, irritability, any vaccination-site erythema, induration/swelling or pain/tenderness, somnolence, poor quality sleep. Vaccination-site erythema or induration/swelling 2.5cm – 7.0 cm (after the booster dose and in older children [age 2-5 years]. Common (≥ 1/100 to < 1/10): Vomiting, diarrhoea, rash, pyrexia >39 °C, vaccination-site movement impairment (due to pain), vaccination-site erythema or induration/swelling 2.5cm – 7.0cm (after infant series). Uncommon (≥ 1/1,000 to < 1/100): Convulsions (including febrile convulsions), urticaria or urticaria-like rash, vaccination-site erythema, induration/swelling >7.0cm, crying. Rare: Hypersensitivity reaction including face oedema, dyspnoea, bronchospasm, hypotonic-hyporesponsive episode. Not known: Lymphadenopathy (localised to the region of the vaccination site), anaphylactic/anaphylactoid reaction including shock, angioedema, erythema multiforme, vaccination site urticaria, vaccination-site dermatitis, vaccination-site pruritus, flushing. In clinical studies infants vaccinated at 2, 3 and 4 months of age, fever ≥ 38°C was reported at higher rates among infants who received Prevenar (7-valent) concomitantly with Infanrix hexa than in infants receiving Infanrix hexa alone. After a booster dose at 12 and 15 months of age, the rate of fever ≥ 38°C was greater in infants who received Prevenar (7 valent) and Infanrix hexa at the same time compared to infants receiving Infanrix hexa alone. These reactions were mostly moderate (less than or equal to 39°C) and transient. Additional information in special populations: Apnoea in very premature infants (≤ 28 weeks of gestation). Children and adolescents aged 6 to 17 years of age: Very common (≥ 1/10): Decreased appetite, irritability, any vaccination-site erythema, induration/swelling or pain/ tenderness, somnolence, poor quality sleep, vaccination-site tenderness (including impaired movement). Common (≥ 1/100 to < 1/10): Headaches, vomiting, diarrhoea, rash, urticaria or urticaria-like rash, pyrexia. Additional information in special populations: Children and adolescents with sickle cell disease, HIV infection or an HSCT transplant have similar frequencies of adverse reactions, except that headaches, vomiting, diarrhoea, pyrexia, fatigue, arthralgia, and myalgia were very common. Adults ≥18 years of age, and the elderly: Very common (≥ 1/10): Decreased appetite, headaches, diarrhoea, vomiting,(in adults aged 18 to 49 years), rash, chills; fatigue; vaccination-site erythema; vaccination-site induration/swelling; vaccination-site pain/tenderness (severe vaccination-site pain/ tenderness very common in adults aged 18 to 39 years); limitation of arm movement (severe limitation of arm movements very common in adults aged 18 to 39 years), arthralgia; myalgia. Common (≥ 1/100 to < 1/10): Vomiting (in adults aged 50 years and over), pyrexia(very common in adults aged 18 to 29 years). Uncommon (≥ 1/1,000 to < 1/100): Nausea, hypersensitivity reaction including face oedema, dyspnoea, bronchospasm, lymphadenopathy localized to the region of the vaccination site. Additional information in special populations: Adults with HIV infection have similar frequencies of adverse reactions, except that pyrexia and vomiting were very common and nausea common. Adults with an HSCT have similar frequencies of adverse reactions, except that pyrexia and vomiting were very common. For full prescribing information see the Summary of Product Characteristics. Legal Category: S1A. Package Quantities: Pack of 1 single-dose prefilled syringe (with separate needle) or pack of 10 single- dose pre-filled syringes. Marketing Authorisation Numbers: Single-dose pre-filled syringe (with separate needle) pack of 1: EU/1/09/590/002, single-dose pre-filled syringe pack of 10: EU/1/09/590/003. Marketing Authorisation Holder: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium. For further information on this medicine please contact: Pfizer Medical Information on 1800 633 363 or at EUMEDINFO@pfizer.com. For queries regarding product availability please contact: Pfizer Healthcare Ireland, Pfizer Building 9, Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24 + 353 1 4676500. Date of preparation: 11/2018. *Trade mark. Ref: PN 11_0 IE.

To AVC or not to AVC, that is the question

Making Additional Voluntary Contributions (AVC’s) to your existing employer-funded pension scheme is perhaps the most underutilised tax break currently available. Why is this?

Written by Kieran Moore QFA, SIA, Director,Moore Wealth Management Ltd

Moore Wealth Management has been advising the Irish Pharmacy Community for over 20 years with extensive knowledge of the sector. They can be contacted at 086-3801868, kieran@mwm.ie or www.mwm.ie

We all remember the popularity of the government SSIA savings accounts Introduced in the Finance Act 2001. This was primarily because both the message and benefits were clear. The SSIA was structured so that the Government contributed one euro for every four invested by the account holder. The maximum contribution was ¤254 per month. A great deal for all concerned, the government topped up your investment by 25% effectively giving you a return of at least 25% before any other investment returns were considered.

So how does this compare to the benefits currently offered by AVC’s?

Let’s look at a case study to see. John aged 50 owns a Pharmacy for the last 10 years and currently pays himself ¤80,000 and his spouse Mary also aged 50 has a salary of ¤30,000. The revenue commissioners at their respective ages will permit employer pensions contributions of circa 80% of both salaries. With this in mind, they currently have annualised employer contributions to two company paid pensions of ¤64,000 and ¤24,000 respectively. They also have ¤50,000 surplus cash sitting on deposit earning nothing and are looking to invest these funds for the longer term. If john increases his salary to ¤100,000 and makes an AVC contribution of ¤30,000 (using his full 30% allowance) into the existing employer pension before the tax deadline this year his taxable salary will reduce to ¤70,000. If Mary’s salary is increased to ¤40,000 with another AVC for her of ¤12,000 reducing her taxable salary to ¤28,000. The following benefits will accrue to them

• The combined taxable income has decreased from ¤110,000 to ¤98,000 with an estimated saving on tax, PRSI and levies of ¤5,700 • The ¤42,000 invested in the

AVC’s only cost them ¤25,200 thanks to the government tax break. In other words, the immediate return on the ¤25,200 was 67%.

So, the benefits of an AVC are almost 3 times better than the offer the government made under the terms of the very popular SSIA scheme.

But the benefits do not stop there, here is some of the other benefits that John and Mary can now enjoy. • All investment returns on the funds invested in AVC’s will be free of tax for the duration of the contract (unlike SSIA investment returns which were taxable). This gross roll-up of returns will add significantly to the final overall pension pot. • Because employer contributions are linked to salary and service, the increased salaries will now trigger two additional sets of increases. Annual contributions for John can increase to ¤80,000 per annum and for Mary she can increase to ¤32,000. • Back service credits for additional employer pension contributions will also be created going back ten years, these would be approximately ¤150,000 for John and ¤90,000 for Mary. In total in year one approximately ¤272,000 of additional funds could be extracted from the company to the pensions free of all income tax. With an additional ¤32,000 every year thereafter. • The company can claim the pension contributions against its profits and therefore reduce its corporation tax liability. Over ten years even with no investment growth the pensions would be boosted by the following

John

AVC’s ¤300,000 Lump sum employer contributions ¤150,000 Additional employer annual contribution ¤160,000 Additional pension contributions ¤610,000

Mary

AVC’s ¤120,000 Lump sum employer contributions ¤90,000 Additional employer annual contribution ¤80,000 Additional pension contributions ¤290,000 So, by increasing John and Mary’s salaries and using an AVC to offset the tax on these increases we could achieve the following benefits

• Reduce income tax

• Boost their pensions • Reduce corporation tax There is no doubt that AVC’s should play a larger role in your financial planning, especially for those of you who have both personal and corporate cash deposits. As we have explained in a previous article the erosion of the purchasing power of funds left on deposit in the medium to longer term is dramatic. Using these funds toward increased employer contributions or introducing AVC’s would be an excellent starting point in tax efficiently growing your wealth. AVC’s are permissible by the revenue on the following agerelated scale as a percentage of salary to a maximum allowable salary of ¤115,000

Age Percentage Limit

Under 30 15 %

30-39

20 %

40-49

25 %

50-54

55-59

30 %

35 %

60 or over 40 %

In other significant pension news

You may have heard in recent changes that there have been significant changes to the regulation of the type of pension that most of you as business owners are operating at the moment that you need to be aware of.

The Technical Piece

Institutions for Occupational Retirement Provision(IORP II) a European Directive was transposed into Irish law in April 2021. Ireland, like other EU Member States, had the option to exempt pension schemes with under 100 members from certain onerous and costly requirements but decided not to. While 100-member schemes would be significant to remove from the regulations, the fact that onemember pension arrangements like yours were not exempted came as a major shock. Ireland has a high number of these that operate under a trust system that falls under IORP II unlike other countries where there isn’t a requirement for a trust meaning the level of compliance and regulation on your schemes is already very high. Under threat of penalty from the pensions authority for the pension holder, the trustee and the life office, all the major providers of pensions in Ireland withdrew from the market and in the process cut off the only viable pension funding option for business owners at a time when we are continually told about the looming pensions timebomb. In a nutshell, the pensions authority has put the same requirements that govern large schemes (500+ members) onto schemes with one member.

The idea of schemes for one member under a trust arrangement recognized the nature of starting and running your own business where due to cashflow you may not be in a position to fund your pension in the early years. It recognized the peaks and troughs and rewarded entrepreneurship for building a business. The structure allowed for a backdated contribution to your pension for past service where you had not been in a position to save for your future. Take a scenario where a 50-yearold business owner with ten years of service to date on a salary of ¤75,000 had not been able to fund a pension. Under revenue maximum funding calculations the option to extract ¤580,000 from the business tax-free was available. Under the only option now available with these changes which is a PRSA the same person could fund their pension to the amount of ¤22,500, a near 96% decrease.

PRSAs were typically not recommended for business owners for the following reasons • Lower Allocations – that means 100% of your contribution may not reach your fund and be swallowed up in life company charges • Higher fees • Limited fund choices

• Benefit in Kind on employer contributions which did not apply to one member schemes • No ability to contribute for back service as a tax-efficient means of extracting company cash. • More limited monthly contribution levels

Industry Response

Due to the threat of fines and sanctions from the pensions authority the providers were left with no option but to stop the set up of any new schemes. Despite intensive talks and lobbying the authority have refused to change their stance and currently the market is looking at various options that satisfy IORPS II. These include potentially a retail master trust arrangement but there is no estimate on when this will be available. This is a very fluid matter and we will have further updates as they arise.

Possible changes in Pipeline for Finance Bill 2022?

• Similar tax relief structures for pension contributions to PRSAs as one member schemes – This will involve the removal of BIK on employer contributions above current limits

• Proposal to provide in scheme drawdown as opposed to ARF

• PRSA – An individual pension for life

• No new Personal Retirement

Bond or Personal Pension contracts

What do you do if you already have a one-member scheme

• There is a 5-year derogation for existing schemes which means

that apart from investment restrictions on unregulated investments such as direct property which came into place in April 2021 your scheme does not change. • What you have you hold – the rules are not retrospective but future investment decisions must adhere to the new rules.

• The governance, policy, and procedures changes, while not required until 2026 will in general be applied by trustees as best practice in advance of this date • Trustee Annual Report optional before 2026

Opportunity

What this has shown to current pension holders is that you hold a supremely tax-efficient vehicle for accumulating retirement wealth and extracting funds from your business and are in an enviable position. As per the examples shown if you have accumulated cash in your business and want to contribute for backdated service now would be a good time to have a consultation to determine if this is an option for you. Before you finalise your income tax return this year, seek advice on how to integrate the tax, investment and retirement planning to its greatest effect. The example earlier illustrates that if you are utilising all the tax breaks and revenue allowances for pensions permissible it can greatly enhance your ability to create wealth. Perhaps it starts with a simple AVC.

News

Pre-Budget Submission on Diabetes

Diabetes Ireland presented its Pre-budget Submission 2023 to the Minister for Health Stephen Donnelly TD recently and called on him and the Government to take a number of immediate actions to improve diabetes healthcare services for people with diabetes nationwide.

Diabetes is a serious global public health issue which has been described by the World Health Organisation as one of the top ten most challenging health problems in the 21st century with a high individual, social and economic burden. According to the International Diabetes Federation Diabetes Atlas 2021 Ireland is ranked 7th in the world for diabetes related health expenditure per person and in the Euro Diabetes Index 2014, Ireland was placed 20th out of 30 countries in the rank for the access to and quality of care and its outcomes One of the reasons for this low score was the lack of a diabetes registry, which helps to monitor the outcomes and supports health-services planning. Since 2014 nothing has changed in this matter and Ireland is still one of the very few countries in Europe which does not have a registry or routinely undertaken annual national audits of diabetes clinical services and diabetes outcomes. Both these issues need to be addressed as a priority in the coming budget. Dr Kate Gajewska, Research and Advocacy Manager, Diabetes Ireland said, “If the HSE wants to aspire to deliver high-quality diabetes care, they need to know how many people live with diabetes in Ireland and where those people live. They also need to regularly monitor the standard of clinical care being provided along with diabetes outcomes. Only then can they begin to effectively plan staffing resources, determine the cost of providing care and improve health outcomes for our community.” There is no accurate figure available for the number of people living with diabetes in Ireland, but based on the Scottish prevalence data and the newest census, we estimate there are now approximately 300,000 people living with diabetes in Ireland. Furthermore, recent research has identified diabetes as the most prevalent chronic condition in people between 45 to 74 years of age in Ireland further implies the necessity of having access to appropriate data and health information so better decision making and planning can be undertaken.

Conjunctivitis: Infectious and Non-Infectious

Conjunctivitis, also known as red or pink eye, is an eye conditions caused by infection or allergies. We recently spoke to Theresa Lowry Lehnen (PhD), Clinical Nurse Specialist and Associate Lecturer South East Technological University for a further insight into the infectious and non-infectious diagnosis of this very common and prevalent condition.

Conjunctivitis, also known as red or pink eye, is an eye conditions caused by infection or allergies. We recently spoke to Theresa Lowry Lehnen (PhD), Clinical Nurse Specialist and Associate Lecturer South East Technological University for a further insight into the infectious and non-infectious diagnosis of this very common and prevalent condition. Conjunctivitis can be acute or chronic and infectious or noninfectious. Viruses and bacteria are the most common infectious causes. Theresa explains, “Non-infectious conjunctivitis includes allergic, toxic, and cicatricial conjunctivitis, as well as inflammation secondary to immune-mediated diseases and neoplastic processes.2 Prevalence of conjunctivitis varies according to the underlying cause, which may be influenced by the patient’s age, as well as the season of the year.” Viral conjunctivitis is the most common cause of infectious conjunctivitis both overall and in the adult population and is more prevalent in summer. Theresa points out that the signs and symptoms of viral conjunctivitis at presentation are variable - it usually does not require treatment, she says. “Bacterial conjunctivitis is the second most common cause of infectious conjunctivitis, with most uncomplicated cases resolving in 1 to 2 weeks. Bacterial conjunctivitis is responsible for the majority of cases in children and occurs more frequently in winter. The majority of bacterial conjunctivitis cases are self-limiting and no treatment is necessary in uncomplicated cases. However, conjunctivitis caused by chlamydia or gonorrhoea and conjunctivitis in contact lens wearers should be treated with antibiotics. Allergic conjunctivitis occurs most often in spring and summer. Treatment with antihistamines and mast cell stabilisers usually alleviates the symptoms.”1 Treatment with antihistamines and mast cell stabilizers alleviates the symptoms of allergic conjunctivitis.

Symptoms

The classic symptoms of the three most common types of conjunctivitis are:2 Viral: symptoms of itching and tearing, history of recent upper respiratory tract infection, watery discharge, inferior palpebral conjunctival follicles, tender pre-auricular lymphadenopathy. Bacterial: symptoms of redness and foreign body sensation, morning matting of the eyes, white-yellow purulent or mucopurulent discharge, conjunctival papillae, infrequently pre-auricular lymphadenopathy. Allergic: symptoms of itching or burning, history of allergies/atopy, watery discharge, oedematous eyelids, conjunctival papillae, no pre-auricular lymphadenopathy.

Diagnosis

“A focused history and ocular examination are important for making a diagnosis and appropriate decisions about the treatment and management of conjunctivitis,” says Theresa. Labs and cultures are rarely indicated to confirm the diagnosis of conjunctivitis. Cultures and cytology are usually reserved for cases of recurrent conjunctivitis, those resistant to treatment, suspected gonococcal or chlamydial infection, suspected infectious neonatal conjunctivitis, and adults presenting with severe purulent discharge.1, 2 “Ocular history includes timing of onset, prodromal symptoms, unilateral or bilateral eye involvement, associated symptoms, previous treatment and response, past episodes, type of discharge, and presence of pain, itching, eyelid characteristics, periorbital involvement, vision changes, photophobia, and corneal opacity.2 The ocular exam should focus on visual acuity, extraocular motility, visual fields, discharge type, shape, size and response of pupil, the presence of proptosis, corneal opacity, foreign body assessment, tonometry, and eyelid swelling.2 “Eye discharge type and ocular symptoms can help determine the cause. A purulent or mucopurulent discharge is often due to bacterial conjunctivitis, a watery discharge is more characteristic of viral conjunctivitis and itching is associated with allergic conjunctivitis. However, clinical presentation is often nonspecific and relying on the type of discharge and patient symptoms does not always lead to an accurate diagnosis.1 “Similar to redness and discharge, other common signs and symptoms of conjunctivitis are nonspecific and can make determining the underlying cause more difficult.” For example, she told us, itching is historically correlated with allergic conjunctivitis and while in the context of watery discharge and a history of atopy this is likely the case, one study found that 58% of patients with culture-positive bacterial conjunctivitis also reported itchy eyes.2 Papillae, a nonspecific finding in conjunctivitis can be present in both infectious and noninfectious conjunctivitis. Theresa adds, “Papillae, small elevations usually under the superior tarsal conjunctival, with central vessels are often present in bacterial conjunctivitis, allergic conjunctivitis, and contact lens intolerance. Papillae in chronic allergic conjunctivitis can lead to a cobblestone appearance of the conjunctiva.2 While also non-specific, the presence of follicles, in conjunction with other findings, can help differentiate the aetiology of conjunctivitis. Follicles are small elevated yellow-white lesions found at the junction of the palpebral and bulbar conjunctiva and are a lymphocytic response often present in chlamydial and adenoviral conjunctivitis.2 “Differential diagnosis can include glaucoma; iritis; keratitis; episcleritis; scleritis; pterygium; corneal ulcer; corneal abrasion; corneal foreign body; subconjunctival haemorrhage; blepharitis; hordeolum; chalazion; contact lens over use and dry eye. Other signs and symptoms that can point to diagnosis other than conjunctivitis include localised redness, redness not including the entire conjunctiva, ciliary flush, elevated intraocular pressure, vision loss, moderate to severe pain, hypopyon, hyphema, pupil asymmetry, decreased pupil response, and trouble opening the eye or keeping it open.2 It is important to differentiate conjunctivitis from other causes of “red eye” associated with severe sight- or life-threatening consequences.” Theresa also notes that while presentations can often overlap, a systematic approach including a thorough history and ocular exam should safely out rule acute sight7 threatening diagnoses and identify the likely cause of conjunctivitis.7

Viral Conjunctivitis

Image: creative commons. https:// creativecommons.org/ Viruses are responsible for up to 80% of all cases of acute conjunctivitis. She continues, “Clinical accuracy in diagnosing viral conjunctivitis is less than 50% compared with laboratory confirmation and many cases

An interview with Theresa LowryLehnen (PhD), CNS, GPN, RNP, South East Technological University

keeping it open.2 It is important to differentiate conjunctivitis from other causes of “red eye” associated with severe sight- or life-threatening consequences. presentations can often overlap, a systematic approach should safely out rule acute sight-threatening diagnoses and identify

Viral Conjunctivitis

Image: creative commons. https://creativecommons.org/ Viruses are responsible for up to 80% of all cases of acute conjunctivitis. “Clinical accuracy in diagnosing viral conjunctivitis is less than 50% compared with laborato confirmation and many cases are misdiagnosed as bacterial conjunctivitis. Between 65% and 90% of cases of viral conjunctivitis are caused by adenoviruses, conjunctival fever and epidemic keratoconjunctivitis, two of the common associated with viral conjunctivitis. “Pharyngo-conjunctival fever (PCF) caused by HAdV types 3, 4 and 7 is usually characterised by the presence of fever, pharyngitis, periauricular lymphadenopathy, and acute follicular conjunctivitis. Additional ocular surface findings include oedema, hyperaemia, and petechial

Incubation and communicability are estimated to be 5 to 12 days and 10 to 14 days, 94 Conjunctivitisrespectively.1 “Conjunctivitis caused by the herpes simplex virus is usually unilateral. The discharge is thin and watery, and accompanying vesicular eyelid lesions may occur. Topical and oral antivirals are recommended, however, topical corticosteroids should be avoided because they potentiate the virus and may cause harm.1 “Herpes zoster virus, responsible for shingles, can involve ocular tissue, especially if the first and second branches of the trigeminal nerve are involved. Eyelids are the most common site of ocular involvement, followed by the conjunctiva. Corneal complication and uveitis may occur. Patients with suspected eyelid or eye involvement or those presenting with Hutchinson sign (vesicles at the tip of the nose, which has high correlations with corneal involvement) should be referred for a thorough ophthalmic evaluation. Treatment usually consists of a combination of oral antivirals and topical steroids.”1

are misdiagnosed as bacterial conjunctivitis. Between 65% and 90% of cases of viral conjunctivitis are caused by adenoviruses, which can produce pharyngoconjunctival fever and epidemic keratoconjunctivitis, two of the common clinical entities associated with viral conjunctivitis. “Pharyngo-conjunctival fever (PCF) caused by HAdV types 3, 4 and 7 is usually characterised by the presence of fever, pharyngitis, periauricular lymphadenopathy, and acute follicular conjunctivitis. Additional ocular surface findings include oedema, hyperaemia, and petechial haemorrhages of the conjunctiva as a result of interaction between proinflammatory cytokines and conjunctival vasculature. “This condition is self-limited, often resolving spontaneously in two–three weeks without any treatment.6 The most severe ocular manifestation of adenoviral infection is epidemic keratoconjunctivitis (EKC) which affects both the conjunctiva and cornea, leaving behind long-lasting and permanent ocular surface changes and visual disturbances. Serotypes,8, 19, 37 and less frequently serotype 4 were believed to be associated with EKC, but more recently, HAdV-D53 and HAdV-D54 have been identified in several outbreaks and thought to be responsible for the majority of EKC cases.6 Ocular manifestations of EKC include conjunctival discharge, follicular conjunctivitis, corneal sub epithelial infiltrates (SEI), corneal scarring, development of conjunctival membranes and pseudo membranes and symblepharon formation.6 “Lymphadenopathy occurs in up to 50% of viral conjunctivitis cases and is more prevalent in viral conjunctivitis compared with bacterial conjunctivitis. Treatment with antihistamines and mast cell stabilizers alleviates the symptoms of allergic conjunctivitis. Viral conjunctivitis secondary to adenoviruses is highly contagious and spreads through direct contact example via contaminated fingers, medical instruments, swimming pool water, or personal items.” Incubation and communicability are estimated to be 5 to 12 days and 10 to 14 days, respectively.1 “Conjunctivitis caused by the herpes simplex virus is usually unilateral. The discharge is thin and watery, and accompanying vesicular eyelid lesions may occur. Topical and oral antivirals are recommended, however, topical corticosteroids should be avoided because they potentiate the virus and may cause harm.1 PHARMACYNEWSIRELAND.COM

“Herpes zoster virus, responsible for shingles, can involve ocular tissue, especially if the first and second branches of the trigeminal nerve are involved. Eyelids are the most common site of ocular involvement, followed by the conjunctiva. Corneal complication and uveitis may occur. Patients with suspected eyelid or eye involvement or those presenting with Hutchinson sign (vesicles at the tip of the nose, which has high correlations with corneal involvement) should be referred for a thorough ophthalmic evaluation. Treatment usually consists of a combination of oral antivirals and topical steroids.”1

Bacterial Conjunctivitis

Images: creative commons. https://creativecommons.org/ Bacterial conjunctivitis can be contracted from infected individuals or result from abnormal proliferation of the conjunctival flora. “Contaminated fingers, oculogenital spread, and contaminated fomites are common routes of transmission. Certain conditions such as compromised tear production, disruption of the natural epithelial barrier, abnormality of adnexal structures, trauma, and immunosuppressed status can predispose to bacterial conjunctivitis. Bacterial conjunctivitis is much more common in children than adults, and the pathogens responsible vary depending on the age group. The most common pathogens responsible for bacterial conjunctivitis in adults are staphylococcal species, followed by Streptococcus pneumoniae and Haemophilus influenzae. In children, the condition is often caused by H influenzae, S pneumoniae, and Moraxella catarrhalis. The infection usually lasts 7 to 10 days.1, 2 “Hyperacute bacterial conjunctivitis presents with decreased vision and a severe copious purulent discharge. There is often accompanying eyelid swelling, eye pain on palpation, and preauricular adenopathy. It is often caused by Neisseria gonorrhoeae and carries a high risk for corneal involvement and subsequent corneal perforation. Treatment for hyperacute conjunctivitis secondary to N gonorrhoea is intramuscular ceftriaxone, and concurrent chlamydial infection should be managed accordingly. Conjunctival hyperemia, mucopurulent discharge, and lymphoid follicle formation are hallmarks of chlamydial conjunctivitis. Discharge is often purulent or mucopurulent, however, patients often present with mild symptoms for weeks to months. “Chlamydial conjunctivitis is often acquired via oculogenital spread or other intimate contact with infected individuals and in new-borns the eyes can be infected after vaginal delivery by infected mothers. Treatment with systemic antibiotics such as oral azithromycin and doxycycline is efficacious. Patients and their sexual partners must be treated and a coinfection with gonorrhoea should be investigated.”1, 2, 6 Chronic bacterial conjunctivitis is used to describe any conjunctivitis lasting more than 4 weeks. Staphylococcus aureus, Moraxellalacunata, and enteric bacteria are the most common causes. Ophthalmologic consultation should be sought for management. Signs and symptoms include red eye, purulent or mucopurulent discharge, and chemosis. Theresa adds that incubation and communicability are estimated to be 1 to 7 days and 2 to 7 days, respectively. “Bilateral mattering and adherence of the eyelids, lack of itching, and no history of conjunctivitis are strong positive predictors of bacterial conjunctivitis,” she says. “Severe purulent discharge should always be cultured and gonococcal conjunctivitis should be considered. Conjunctivitis not responding to standard antibiotic therapy in sexually active patients warrants a chlamydial evaluation. The possibility of bacterial keratitis is high in contact lens wearers, who should be treated with topical antibiotics and referred to an ophthalmologist. A patient wearing contact lenses should be asked to remove them.”1, 6

Allergic conjunctivitis

Image: creative commons. https:// creativecommons.org/ Allergic conjunctivitis is the

inflammatory response of the conjunctiva to allergens such as pollen, animal fur and other environmental antigens. Incubation and communicability are estimated to be 5 to 12 days and 10 to 14 days, Redness and itching are the most respectively.1 consistent symptoms.2 “Ocular allergic conditions “Conjunctivitis caused by the herpes simplex virus is usually unilateral. The discharge is thin can be classified into three main categories: IgE-mediated and watery, and accompanying vesicular eyelid lesions may occur. Topical and oral antivirals reactions, including seasonal are recommended, however, topical corticosteroids should be avoided because they allergic conjunctivitis (SAC) and perennial allergic conjunctivitis potentiate the virus and may cause harm.1 (PAC); combined IgE and non-IgEmediated reactions, including VKC “Herpes zoster virus, responsible for shingles, can involve ocular tissue, especially if the first and AKC; and non-IgE-mediated reactions, including giant papillary and second branches of the trigeminal nerve are involved. Eyelids are the most common site conjunctivitis (GPC) and contact of ocular involvement, followed by the conjunctiva. Corneal complication and uveitis may dermatoconjunctivitis (CDC).6 Bacterial Conjunctivitis occur. Patients with suspected eyelid or eye involvement or those presenting with Hutchinson “Treatment involves avoidance sign (vesicles at the tip of the nose, which has high correlations with corneal involvement) of the offending antigen and the use of saline solution or should be referred for a thorough ophthalmic evaluation. Treatment usually consists of a artificial tears to dilute and combination of oral antivirals and topical steroids.”1 remove the allergens. Topical decongestants, antihistamines, mast cell stabilisers, nonsteroidal Bacterial Conjunctivitis anti-inflammatory drugs and chlamydial infection should be managed accordingly. Conjunctival hyperemia, mucopurulent corticosteroids may be indicated. Steroids must be used judiciously Images: creative commons. https://creativecommons.org/discharge, and lymphoid follicle formation are hallmarks of chlamydial conjunctivitis. and only when indicated.”1, 7Discharge is often purulent or mucopurulent, however, patients often present with mild Treatment and ManagementBacterial conjunctivitis can be contracted from infected individuals or result from abnormal symptoms for weeks to months. proliferation of the conjunctival flora. “ Theresa concludes by adding that effective management Chlamydial conjunctivitis is often acquired via oculogenital spread or other intimate contact of conjunctivitis includes timely diagnosis, appropriate “Contaminated fingers, oculogenital spread, and contaminated fomitesare common routes of Images: creative commons. https://creativecommons.org/ with infected individuals and in new-borns the eyes can be infected after vaginal delivery by differentiation of the various aetiologies, and appropriate treatment. transmission. Certain conditions such as compromised tear production, disruption of the natural epithelial barrier, abnormality of adnexal structures, trauma, and immunosuppressed Bacterial conjunctivitis can be contracted from infected individuals or result from abnormal proliferation of the conjunctival flora. infected mothers. Treatment with systemic antibiotics such as oral azithromycin and doxycycline is efficacious. Patients and their sexual partners must be treated and a coinfection with gonorrhoea should be investigated.” 1, 2, 6 “Most acute bacterial conjunctivitis infections are self-limiting and do not require status can predispose to bacterial conjunctivitis. Bacterial conjunctivitis is much more common in children than adults, and the pathogens responsible vary depending on the age “Contaminated fingers, oculogenital spread, and contaminated fomitesare common routes of transmission. Certain conditions such as compromised tear production, disruption of the Chronic bacterial conjunctivitis is used to describe any conjunctivitis lasting more than 4 topical antibiotics. Acute bacterial conjunctivitis is usually unilateral group. The most common pathogens responsible for bacterial conjunctivitis in adults are natural epithelial barrier, abnormality of adnexal structures, trauma, and immunosuppressed weeks. Staphylococcus aureus, Moraxellalacunata, and enteric bacteria status can with yellow-white mucopurulent staphylococcal species, followed by Streptococcus pneumoniae and Haemophilus influenzae.predispose to bacterial conjunctivitis. Bacterial conjunctivitis is much more common causes. Ophthalmologic consultation should be sought for management. In children, the condition is often caused by H influenzaecommon in children than adults, and the pathogens responsible vary depending on the age , S pneumoniae discharge and symptoms usually , and Moraxella group. resolve within 5-7 days without treatment. If topical antibiotics are catarrhalis. The infection usually lasts 7 to 10 days. 1, 2The most common pathogens responsible for bacterial conjunctivitis in adults are Signs and symptoms include red eye, purulent or mucopurulent discharge, and staphylococcal species, followed by Streptococcus pneumoniae and Haemophilus influenzae. considered necessary a delayed prescription for 3 days should be considered to see if symptoms resolve with self-care and without antibiotic eye drops.7 “Hyperacute bacterial conjunctivitis presents with decreased vision and a severe copious purulent discharge. There is often accompanying eyelid swelling, eye pain on palpation, and In children, the condition is often caused by H influenzae, S pneumoniae, and Moraxella catarrhalis. The infection usually lasts 7 to 10 days. 1, 2 Theresa adds that incubation and communicability are estimated to be 1 to 7 days and 2 to 7 days, respectively. “ “Antibiotic ointments last preauricular adenopathy. It is often caused by Neisseria gonorrhoeae and carries a high risk Hyperacute bacterial conjunctivitis presents with decreased vision and a severe copious “Bilateral mattering and adherence of the eyelids, lack of itching, and no history of longer than drops, however for corneal involvement and subsequent corneal perforation. Treatment for hyperacute purulent discharge. There is often accompanying eyelid swelling, eye pain on palpation, and conjunctivitis are strong positive predictors of bacterial conjunctivitis,” she says. “ they tend to interfere with vision. Chloramphenicol is not conjunctivitis secondary to N gonorrhoea is intramuscular ceftriaxone, and concurrent preauricular adenopathy. It is often caused by Neisseria gonorrhoeae and carries a high risk purulent discharge should always be cultured and gonococcal conjunctivitis should be for corneal involvement and subsequent corneal perforation. recommended in pregnancy or Treatment for hyperacute considered. Conjunctivitis not responding to standard antibiotic therapy in sexually active conjunctivitis secondary to N gonorrhoea is breastfeeding. In 2021 the Summary of Product Characteristics for intramuscular ceftriaxone, and concurrent patients warrants a chlamydial evaluation. The possibility of bacterial keratitis is high in Chloromycetin® 0.5% Redi-Drops contact lens wearers, who should be treated with topical antibiotics and referred to an was updated to contra-indicate ophthalmologist. A patient wearing contact lenses should be asked to remove them. use of the drops in children under 2 years. This is due to a risk of toxicity Allergic conjunctivitis from boron. This excipient is not present in the ointment formulation and the contra-indication applies to the drops only.”7 “Antibiotic drops are indicated for complicated bacterial conjunctivitis, in conjunctivitis caused by gonorrhoea or chlamydia, and in bacterial conjunctivitis in contact lens Image: creative commons. https://creativecommons.org/ wearers.5 The recommended treatment for gonococcal Allergic conjunctivitis is the inflammatory response of the conjunctiva to allergen pollen, animal fur and other environmental antigens. Redness and itching are the most consistent symptoms. 2 “Ocular allergic conditions can be classified into three main categories: IgE reactions, including seasonal allergic conjunctivitis (SAC) and perennial allergic conjunctivitis

HSE (2021). Conjunctivitis: Antibiotic Prescribing. Available at: https://www.hse.ie/eng/services/ list/2/gp/antibiotic-prescribing/conditions-and-treatments/skin-soft-tissue/conjuncitivitis/ conjuncitivitis-ophthalmology.html

conjunctivitis is ceftriaxone 1gm IM, and it is also recommended to treat for concurrent chlamydial infection with 1gm azithromycin orally. The neonatal dosing for gonococcal conjunctivitis is 25 to 50mg/kg ceftriaxone IV/IM with a max dose of 125mg, with 20mg/ kg azithromycin PO once daily for three days.2 “Viral conjunctivitis due to adenoviruses is usually selflimiting, and treatment should target symptomatic relief including cold compresses and saline solution or artificial tears.2

“Herpes simplex keratitis requires antiviral therapy such as aciclovir or ganciclovir and the patient should be reviewed by an ophthalmologists to monitor for complications.2 Treatment of herpes zoster conjunctivitis includes a combination of oral antivirals and topical steroids, however, steroids should only be part of therapy in consultation with ophthalmology. Antiviral doses differ from those used for herpes simplex and consist of oral acyclovir 800mg five times a day, oral famciclovir 500mg TDS, or oral valacyclovir 1g TDS for 7 to 10 days.”3, 4 Topical corticosteroids are not recommended for cases of bacterial or viral conjunctivitis, except for herpes zoster, as they can prolong the condition or potentiate the infection, resulting in complications including corneal damage and blindness.1, 2 “Treatment for allergic conjunctivitis consists of allergen avoidance, artificial tears, cold compresses, and a wide range of topical agents. Topical agents include topical antihistamines alone or in combination with vasoconstrictors, topical mast cell inhibitors and topical glucocorticoids for refractory symptoms. Oral antihistamines can also be used in moderate to severe cases of allergic conjunctivitis.1, 2 “Any patient with moderate to severe pain, vision loss, corneal involvement, severe purulent discharge, conjunctival scarring, recurrent episodes, lack of response to therapy, or herpes simplex keratitis should receive a prompt referral to an ophthalmologist. In addition, patients requiring steroids, contact lens wearers, and those with photophobia should also be referred to an ophthalmologist. 2 “Viral and bacterial conjunctivitis can spread by direct contact and have high transmission rates. Patient education is important to prevent transmission and the importance of hand hygiene should be highlighted.

Caution with steroids/ antibiotic- steroid combination drops

“Steroids should be used with caution. Steroid drops or combination drops containing steroids should not be used routinely. Topical steroids are associated with cataract formation and can cause an increase in eye pressure, leading to glaucoma. 1 if an undiagnosed corneal ulcer secondary to herpes, bacteria, or fungus is present, steroids can also worsen the condition, leading to corneal erosion and blindness.1

Complications

“Complications of acute conjunctivitis are rare. However, patients who fail to show improvement should be referred to an ophthalmologist for further evaluation. Patients with HZV conjunctivitis are at the highest risk of complications including corneal complications and uveitis, and should always see an ophthalmologist for close re-evaluation. Patients with N. gonorrhoea are also at high risk for corneal involvement and secondary corneal perforation and should be treated appropriately,” 2 she concludes.

References available on request