Introduction to Community Pharmacy Practice and Responding to Symptoms

Summary

This document provides information about community pharmacy practice, differentiating between prescription and OTC medications. It details the criteria for switching a prescription-only medicine (POM) to an over-the-counter (OTC) status. Various examples are provided throughout the document. The role of pharmacists in illness management and dealing with customer symptoms is highlighted.

Full Transcript

Introduction to Community Pharmacy Practice and Responding to Symptoms Background 1- Community pharmacists are the most accessible healthcare professional, where no appointment is needed to council a pharmacist and the patient can receive a free advice anywhere without long waiting ti...

Introduction to Community Pharmacy Practice and Responding to Symptoms Background 1- Community pharmacists are the most accessible healthcare professional, where no appointment is needed to council a pharmacist and the patient can receive a free advice anywhere without long waiting times at clinics or at other health facilities. 2-Medications include Over-The-Counter medications (OTC) as well as prescription only medications (POM). Nonprescription (or OTC) products are a group of pharmaceuticals considered to be sufficiently safe for use without the intervention of a physician. Note: in UK. They refer to prescribed medicines as prescription-only medicines (POMs), while medicines provided by a pharmacy without a prescription but under the supervision of pharmacists are under the “P” classification. In addition, medicines sold without a pharmacist’s supervision (e.g. Paracetamol and ibuprofen) classified as General Sale List (GSL) so they can be sold anywhere, such as supermarkets). 3-Because over-the-counter medications are used so frequently. It is important to know the differences between prescription and over-the-counter medications..Table 1: differences between prescription and over-the-counter medications POM medications OTC medications Require a written order or prescription Can be bought without a from a physician, dentist, or nurse.prescription.practitioner Are prescribed for the treatment of a minor Are intended for relief of minor.or major medical problem.ailments Are usually more powerful and have Are considered safe if warnings.more side effects than OTC medications.and directions are followed 4-For pharmacists to safely and effectively manage minor ailments requires consid- erable knowledge (about the diseases and their clinical signs and symptoms) and skill (mainly communication skills). 1.The switch of prescription -only –medicine (POM) to OTC status The availability of drugs over the counter varies from country to country. Generally, drugs will be accorded OTC status if they fulfill various criteria: 1-The condition for which they are used can be reliably self-diagnosed. 2-Where there is no evidence of irreversible or serious adverse reactions. 3-Where their use does not require medical supervision or monitoring by a doctor. Figure 1 OTC Approval processes in the UK. (MHRA: Medicines and Healthcare products Regulatory Agency).Table 2: History of switching from POM to OTC )‫) لالطالع‬ Year Examples 1983.Oral ibuprofen, Loperamide 1991.Nicotine gum 1992.Vaginal imidazoles, Nicotine patches 1994.H2 antagonists , Minoxidil , Beclomethasone nasal spray 2001.Emergency hormonal contraceptive 2004.*Omeprazole, Simvastatin 2005.Chloramphenicol eye drop 2006.Sumatriptan 2010.Tamsulosin 2013 FDA approved Oxybutynin transdermal patch for women with of.overactive bladder (OAB) 2014 Nexium 24 HR (esomeprazole magnesium) 2016 The FDA has approved adapalene (a retinoid-like drug) (Differin® Gel 0.1%) for OTC use. It is the first retinoid-based 2 acne treatment to be made available OTC. 2017 -Reclassification of Viagra (sildenafil) in the UK o treat erectile dysfunction. (New Zealand made the move in 2014, and Poland in 2016). -Reclassification of (atovaquone/proguanil) in the UK for malaria prevention. *Simvastatin represents a milestone in the deregulation of drugs to OTC status, in that it is the first drug licensed to prevent serious chronic condition. Note: when certain drug being OTC, not means that it is OTC in all strengths, in all dosage forms, for all indications, for all ages, in all countries, and in the same maximum dose or duration as when it is use by Rx ( as POM) (table 3) Table-3 Examples Not in all strengths Omeprazole 10 and 20 mg are OTC while 40 mg is POM Not in all dosage forms Omeprazole tablet and capsule are OTC while injection is POM Not for all indications Omeprazole is OTC for gastro-esophageal reflux disease (GERD) while for ulcer it is POM Not for all ages Omeprazole is OTC for adults over 18 years. However, it can be used by Rx (as POM) below this.age Not in all countries Simvastatin (10 mg tablet) is OTC in UK but not in …USA, Canada The maximum dose The max. Daily dose for OTC Omeprazole is 20 mg and duration of the for max. 4 weeks. However, larger doses for longer drug may be lower than.duration are allowed with its POM use that allowed with its POM use.Note: the process of switching may occur in reverse way (i.e., from OTC to POM) The UK has had two recent reclassifications return to POM (domperidone and oral diclofenac) due to cardiac risks. Drug Year of Reason reverse switching 3 Domperidon Reclassified Studies found that domperidone was associated with e (Motilium) from OTC to a small increased risk of serious cardiac side effects POM in including QT-prolongation, arrhythmia and sudden 2014 death. in UK Diclofenac Reclassified In 2013, a Europe-wide review concluded that tablets from OTC to systemic diclofenac is associated with a small POM in increased risk of arterial thromboembolic events, 2015 similar to that of COX-2 inhibitors particularly if used in UK.at high doses and for long-term treatment [Cyclo-oxygenase-2 selective inhibitors, Diclofenac (150 mg daily) and ibuprofen (2.4 g daily) are associated with an increased risk of thrombotic events] (BNF-70). Future deregulations The following table (highlights some future candidates that are potential POM to OTC switches in UK) ‫الجدول لالطالع‬ Responding to symptoms in Community pharmacy Responding to symptoms is a major activity for the community pharmacist. Many customers visit the community pharmacies each day with various symptoms 4 for which they are seeking advice. This requires a greater focus from the pharmacists on illness management, rather than on product selling. Pharmacists will consider 1 of 3 recommendations during each encounter involving symptom presentation: (1) Provide assurance that drug therapy is unnecessary. (2) Suggest treatment with non-drug measures, OTCs, or both. (3) Refer the patient to appropriate medical personnel. As a general rule, the following indicate a higher risk of a serious condition and should make the pharmacist consider referring the patient to the doctor:.Long duration of symptoms-1.Recurring or worsening problems-2.Severe symptoms-3 Failed medication (one or more appropriate medicines used already, -4.without improvement).Suspected adverse drug reactions (to prescription or OTC medicine)-5 Danger symptoms (Blood in the sputum, vomit, urine or faeces would be -6.examples of such symptoms, as would unexplained weight loss) :Getting information from the patient The following steps highlight the key considerations you should think about when someone asks for your advice (as a pharmacist) about a particular symptom or condition they have. :Picking up on non-verbal cues-1 Assessment of the patient begins the moment the patient enters the pharmacy and this 'first impression' can be very helpful in giving you clues to their state of health. For example, does the patient look well or poorly? For people who appear in discomfort or look visibly poorly, this might influence your decision to treat or refer. :Questioning-2 Arriving at a diagnosis is a complex process. In medicine it is based on three kinds of information: patient history; physical examination; and the results of inves- tigations. Currently, physical examination and using diagnostic tests are rarely used in community pharmacy practice. Pharmacists rely almost exclusively on questioning patients when deciding whether to offer treatment or perhaps refer the patient for further evaluation. 5 Studies have shown that an accurate patient history (gained from asking questions alone) is a powerful diagnostic tool. The ability to ask good questions to gain the appropriate information is therefore critical. Acronyms Acronyms have been developed to help pharmacists remember which questions should be asked. WHAM is the best known and simplest acronym to remember and has been advocated by many as a useful tool in gaining information from patients. ?W–Who is the patient and What are the symptoms ?H–How long have the symptoms been present A–Action taken? (Any action taken by the patient should be established, including.the use of any medication to treat the symptoms) :M – Medication being taken? There are four obvious reasons for this A medicine may be causing the symptoms.A medicine may indicate a disease state the patients have The patient may already be taking a medicine the pharmacist is about to.recommend and which is not providing relief Medications that are recommended may interact with existing treatment Some patients do not yet understand why the pharmacist needs to ask questions before recommending treatment. :Outcomes from the consultation-3 The final step in prescribing for minor ailments is telling the patient what course of action you feel is most appropriate. This could be referral to another healthcare professional, giving advice or supplying a product. :A-Treatment and advice For many therapeutic groups there is a wide variety of products available, often in various combinations. The pharmacist should take into account the efficacy, potential side-effects, interactions, cautions and contraindications. When selecting a product, the patient's needs should be borne in mind. Factors such as prior use, formulation and dosage regimens should be considered. For example, antacids are available in both tablets and liquid form. Liquids tend to have a quicker onset of action than tablets but can be inconvenient for a patient to carry around with them or take to work. 6 Non-drug treatment should also be offered where appropriate. For example, advice on increasing dietary fibre and fluids is an essential part of the management of conditions such as constipation and hemorrhoids. :B-Timescales One of the key things is telling the patient what action to take if the symptoms do not improve. Here, a defined treatment timescale should be used (this is the length of time for which the problem might be treated before the patient sees the doctor). The timescales given to each condition can vary. (The patient should seek medical attention if the cough does not improve in 7-10 days. While adult patient with diarrhea seek medical attention if the diarrhea does not improve in 2 days). Children and the elderly These two patient groups have the highest usage of medicines per person compared with anyone else. Care is needed in assessing the severity of their symp- toms as both groups can suffer from complications. For example, the risk of dehydration is greater in children with fever or the elderly with diarrhoea. Children should be offered sugar-free formulations to minimize dental decay and elderly people often have difficulty in swallowing solid dose formulations. It is also likely that the majority of elderly patients will be taking other medications for chronic disease and the possibility of OTC-POM interactions should be considered. Pregnancy The potential for OTC medicines to cause teratogenetic effects is real. The safest option is to avoid taking medication during pregnancy, especially in the first trimester. Many OTC medicines are not licensed for use in pregnancy and breastfeeding because the manufacturer has no safety data or it is a restriction on their availability OTC. Table 3: examples of some OTC Medicines to be avoided during )‫)لالطالع‬ pregnancy Medicines Advice in pregnancy Antihistamines - non- Manufacturers advise avoidance as limited sedating human trial data, but animal data suggest low risk Fluconazole Avoid Systemic Avoid in first trimester as mild fetal 7 sympathomimetics malformations have been reported Minoxidil (e.g. Regaine) Avoid Selenium (e.g. Selsun) Manufacturers advise avoidance :Interactions of OTC medicines with other drugs Medicines that are available for sale to the public are relatively safe. However, there are some important drug-drug interactions to be aware of when recommending OTC medicines. These are listed in Table 4. Table 4: Some examples of interactions of OTC drugs )‫)لالطالع‬ Medicine Possible interactions Outcome Antihistamines – Opioid analgesics, Increased sedation sedating anxiolytics, hypnotics and antidepressants Antacids (containing ,Tetracyclines, quinolones Decreased absorption Ca, Mg, and AL) ACE inhibitors Fluconazole Anticoagulants Enhanced anticoagulant effect Rifampicin Decreases fluconazole levels Atorvastatin Increased atorvastatin levels that can. lead to muscle pain/myopathy Systemic Beta-blockers Antagonism of antihypertensive effect sympathomimetics Evidence-based medicine (EBM) and over-the-counter (OTC) drugs 1- Evidence-based medicine (EBM) emphasizes the use of evidence from well designed and conducted research in healthcare decision-making. 2-Although evidence-based medicine (EBM) is widely used for prescribed drugs, it is not currently utilized for OTC medicines in community pharmacies. 3-With regard to efficacy, pharmacists should be aware that many OTC medicines have little or no evidence base. Therefore, products with proven efficacy should constitute first-line treatment. Community pharmacists should stop selling over-the-counter (OTC) medicines that have little evidence of efficacy if they want to ensure the best treatment for patients. 4-The OTC products sold in pharmacies can be split into three categories. A-The products for which scientific evidence is lacking. 8 B-The second category is OTC medicines with a basis in science but which lack clear evidence of effectiveness. One example is the use of cough medicines (drug combinations can be illogical such as an expectorant with a cough suppressant). Systematic reviews of cough medicines show a lack of effectiveness. Although products in the second category may often be requested by the public, certainly, the lack of evidence of effectiveness must be communicated clearly to patients. ‫ كفاتح للشهية وبالتالي مسمن ولكن انظر ما يقول كتاب معتمد ككتاب‬Cyproheptadine ‫ومثال آخر هو استعمال دواء‬ ‫عن هذا االستعمال‬: Martindale Cyproheptadine has been widely used as an appetite stimulant, but in the long- term appears to have little value in producing weight gain and such use is no longer generally recommended. There has been concern that cyproheptadine was being promoted and used inappropriately as an appetite stimulant in some developing countries. C-In the third group are OTC medicines for which there is clear evidence of effectiveness, and which can be sold with confidence. Many of these have been used for many years and have data to support their use, such as antifungal creams, painkillers, triptans, and chloramphenicol eye drops. :Current situation in Iraq In many countries including Iraq (which contain more than 11000 community pharmacy) it was found that in many cases the Iraqi pharmacist was not asking enough or appropriate questions and therefore had insufficient information to advice optimally the patient about their symptoms. It was also found that the pharmacists do not employ a safe and structured approach when responding to patients’ symptoms and they fail to differentiate between a symptom that might suggest a more serious pathology or one.which can be easily managed with an OTC product Useful references that regulate the managements of common illness by OTC drugs 1- Community Pharmacy: A Guide to the Management of Minor Ailments. Dheyaa Jabbar Kadhim. 2018. 9 2-Symptoms in the pharmacy. A guide to the managements of common illness. 9th edition By Alison Blenkinsopp and Paul Paxton.2023. Community Pharmacy. Symptoms, Diagnosis and Treatment. By Paul Rutter.5th -3.edition.2021 10

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