Questions:
1. Demonstrate knowledge and understanding of the fundamental principles of pharmacology in nursing practice?
2. Demonstrate knowledge and application of the safe ordering, receiving, storage and disposal of medicines?
3. Eplain how legal and ethical framework underpin safe and effective medicines and management and administration?
4. Demonstrate an understanding and knowledge of the principles of supply and administration via a Patient Group Direction (PGD)?
5. Explain and discuss the advantages and disadvantages of working in partnership with patient/clients and carers in relation to self administration and medicines?
Answers:
Learning outcome 1
Drug name: Omeprazole
Trade names: Antra, Acimax, Gastroloc, Aspra, Losec, Omepral, Opal, Omez, Mopral, Zegacid, Segazole etc.
Generic name: Omeprazole
Rationale for choice:
Omeprazole is used for the treatment of gastroesophageal reflux disease or GERD. It may also be used for the treatment of conditions that involve excess stomach acid. It is also used to induce healing to the esophagus that is damaged by the excess acid of the stomach.
It can be used along with the antibiotics in order to promote healing in case of gastric ulcer, which is caused by Helicobacter pylori (Fuccio, 2007).
What it does?
Omeprazole is a proton pump inhibitor that acts as an antisecretory compound. This drug acts by inhibiting H+/K+ ATPase enzyme system that is present on the surface of the parietal cells of the intestine in order to inhibit the secretion of gastric acid (Shea et al., 2014). As the drug blocks the enzyme syste that is associated with the acid pump, it is called gastric acid pump inhibitor.
Why is it prescribed?
It is prescribed for the treatment of-
Gastroesophageal reflux disease- in this disease condition, the acid produced in the stomach reaches to the esophagus and causes a painful burning sensation in the throat or the chest (Oderda & Monzani, 2010).
Zollinger Ellison syndrome- it is a rare disease in which the tumor present in the duodenum or the pancreas secretes hormone that induces the production of excess acid by the stomach (Fendrich, 2012).
Peptic ulcer: this disease is caused by the bacteria Helicobacter pylori that cause sores in the stomach lining, which become prone to damage by the acid of the stomach (Hou, 2014).
Erosive esophagitis: this disease condition appears due to the damage of the tissue in the esophagus lining (Oderda & Monzani, 2010).
The kind of patients who need it:
This medicine is not applicable to all. Before using the medicine some important things should be taken under consideration. If the person is allergic to the medicine, then the medicine is not prescribed to the person. The person should also inform the doctor if he or she has any other type of allergy before taking the medicine (Elazzazy, Eziada & Zaidan, 2012).
The medicine should not be used in children below the age of 16 years, as the safety of the medicine has not been proven in case of children. This medicine is not generally prescribed to the older persons. Again there is no study regarding the effect of the medicine on the pregnant women. It is not known to be associated with any types of birth defects (Källén, 2001).
The medicine should not be used or the doses should be changed if the patient is having other medicines such as Rilpivirine, Bosutinib, Atazanavir, Clozapine, Dasatinib, Indinavir, Ledipasvir, Nilotinib, Pazopanib etc. (Zhou, Li, Yu & Zeng, 2013). The patients with other medical problems such as liver disease, diarrhea, osteoporosis, hypomagnesemia and seizures etc. should inform the doctor regarding the medical issues (Zhang, 2014).
The length of time they will be on it:
The length of time the drug can be used depends on the diseases for which the drug is used, the dose that is prescribed, the severity of the diseases and the other medications that are used by the patient. Depending on these factors the doctor may prescribe for 14 days to 4- 8 weeks.
How is it administered and why?
The administration of the drug depends upon the form of the drug that is used for the patient.
Using the drug as oral suspension or powder:
For this purpose, the powder is mixed with 2 tablespoon of water (using any other liquid is not acceptable) in a cup. Then the solution is stirred properly and should be drunk immediately. After that the cup is refilled with water and the content is drunk again (Aouinti, 2013).
Using the drug as a delayed released oral suspension:
For this the packet of the drug containing 2.5 mg powder is mixed in a container that contain 5ml of water (any other types of liquid should not be used). In case of packets containing 10mg of the drug, the content is mixed with 15 ml of water. In both the cases after stirring well, the mixture is left for about 2- 3 minutes in order to let the mixture get thicken. Then the mixture is drunk within 30 minutes. Just before taking the mixture it is again stirred well (Deglin & Vallerand, 2009).
As capsules:
While taking as capsule, the capsule should be swallowed as a whole. Opening, breaking, crushing or chewing of the capsule should not be done.
In cases, if swallowing is not possible, the capsule should be opened and the pellet should be sprinkled in about tablespoon of applesauce. The obtained mixture should immediately be swallowed along with a glass of water. Care should be taken that the applesauce is soft and not hot, so that it can be swallowed easily in order to avoid chewing.
In case of patients in which the drug is administered through nasogastric tube, at first 5 ml of water is taken in a catheter tipped syringe and then 2.5 mg of the drug is added. The syringe is shaken and then left for 2-3 minute in order to let the suspension thicken. Then the medicine is given through the nasogastric tube within 30 minutes (Jordan, 2008).
Doses:
There are different doses of the medicine for different persons. The patients should follow the dose prescribed by the doctor. The strength of the medicine is the determinant factor for the amount of medicine to be taken. The medical problem for which the medicine is prescribed decides the number of doses per day, the time gap between successive doses and the duration of the medication. The average dose for different diseases and for different age groups is listed below.
If the medicine is taken as capsule, tablets or delayed release capsule, the dose depends on the type of disease for which the medicine is prescribed. In case of duodenal ulcers, the dose for the adults is 20mg/ day. In case of duodenal ulcers caused by H. pylori, the dose for adults is 20 or 40 mg, that can be used once, twice or thrice a day as per the advice of the doctor (Paw & Shulman, 2013). For gastric ulcer, the adult dose is 40mg/ day and for gastroesophageal reflux disease, the dose is 20mg/ day and for erosive esophagitis, the adult dose is 20mg /day. In case of Zollinger Ellison syndrome, the dose is 60mg/ day. For the children, the dose is strictly followed as per the prescription of the doctor.
If the medicine is taken as powder or suspension, the dose is again dependent on the disease for which the medicine is prescribed. In case of seriously ill patients suffering from gastrointestinal tract bleeding, the dose for adults is 40mg, twice with an interval of 6-8 hrs for the first day and from the second day 40mg/ day for about 14 days. For duodenal ulcers, the adult dose is 20mg / day for 28 days or more. In case of gastric ulcer, 40gm/ day for 28 days or more and in case of gastroesophageal reflux disease, the dose is 20 mg/ day. Again for the children, the dose is strictly followed as per the prescription of the doctor.
Timing of the doses:
The medicine should be taken as per the instruction of the doctor. It can be taken either before the meal or along with the meal and morning is generally the preferred time. The oral suspension of omeprazole powder should be taken with an empty stomach, about one hour before the consumption of meal (Shrivastava & Khan, 2012). In case of the patients who are receiving continuous food through the pipes, the feeding should be discontinued about 3 hours prior to the administration of the medicine.
Any relevant legislation and policy
Relevant legislation include, Human Medicines Regulations 2012, the Misuse of Drugs Act 1971, the Misuse of Drugs (Safe Custody) Regulations 2001 and the Controlled Drugs (Supervision and Management and Use) Regulations 2006.
Distribution:
How it’s absorbed?
As the drug, omeprazole is labile to acid; the capsule is coated by a granule formulation. As a result, the drug remains intact in the intestine and the absorption of the drug starts as soon as the capsule leaves the stomach. Rapid absorption of the drug occurs in the intestine, which can be indicated by the level of the drug in plasma that obtains a peak value within 0.5 to 3.5 hours and the completion of absorption occurs within 3-6 hours (Andersson, ROhss, Bredberg & Hassan-Alin, 2001).
Metabolism:
The system that is used by the drug in order to metabolize is the cytochrome P450 enzyme system (Hu, Xu, Hu, Mei & Xu, 2007).
Bioavailability:
Bioavailability of the drug is around 30-40 % in case of the dose of 20-40 mg. after repeated dose of the drug, the systemic bioavailability is about 60% (Waterbeemd, Lennernäs & Artursson, 2003).
Half life:
In case of the healthy adults, the plasma half life of the drug is 0.5 – 1 hour.
Excretion:
How it’s excreted:
The unchanged drug is excreted from the body, mainly in the form of unused metabolites. The excretion occurs through the urinary system of the body. About 77% of the drug is excreted through the urine in the form of 6 metabolites. Among these, two metabolites are identified as hydroxyomeprazone and the carboxylic acid derivative of hydroxyomeprazone (Mirvish, Davis, Lisowyj & Gaikwad, 2008). The rest of the unused drug is excreted through the feces. The other three metabolites are found in the plasma as the sulfone and sulfide derivative of the drug and hydroxyomeprazole.
Cautions (patient’s renal failure)
Precaution should be taken in case of the patients with renal impairment. Acute renal impairment can occur as a result of intestinal nephritis as a side effect of the drug. This in turn led to the increase in the level of plasma creatinine that may result renal failure. The common symptoms include malaise, rash, fever, lethargy, nausea and weight loss etc (Hepburn & Goldlust, 2003).
Stock item or individualized to patients
The drug is available for the patients in different form. The right form of the drug that should be taken depends on the choice of the physicians and the health condition of the patient. The different choices of the drug include-
Capsule:
The available capsules of the drug generally have a pink body that is attached to a dark pink cap and filled with the pellet of the drug. There is a print of “OME 20” both on the cap and the body, for the 20 mg dose of the capsule.
The non- medicinal ingredients that are included in the capsule include- lactose, iron oxide red, potassium chloride, microcrystalline cellulose, hypromellose phthalate, croscarmellose sodium, hypromellose, carrageenan, dibutyl sebacate, polysorbate, povidone, titanium dioxide, talc and water.
Tablet:
Tablets are available in 10 mg and 20 mg doses. The characteristics of the 10 mg tablets include round, pink, biconcave, delayed release tablet in which there is a print of ‘P 10’. On the other hand, he20 mg tablets are generally round, red- brown, biconcave, delayed release tablet in which there is a print of ‘P 20’.
In both the cases, the non- medicinal ingredients include- copovidone, eudragit, colloidal silicon dioxide, FD&C Blue No. 1, FD&C Yellow No. 6, lecithin, lactose monohydrate, microcrystalline cellulose, simethicone, shellac glaze, sodium lauryl sulfate, titanium dioxide, iron oxide, sodium stearyl fumarate, triethyl citrate, FD&C Red No. 40 and red iron oxide.
The other available forms include- powder and liquid form and injectable form.
What happens when it arrives the ward:
When the drug arrives in the ward, it is stored properly to maintain the usability of the drug. The drug is stored in a dry condition below 250C and exposure to moisture and sun light is prevented.
Learning outcome 2
Safe ordering:
The drug is available over the counter all over the country. The brand name of the drug is Prilosec. The can be bought from the medicine store but should be used as per prescribed by the doctor.
Safe receiving
The drug is under the POM category, so it can only be received from a pharmacist as per the prescription of the physician. After, the drug is received it should be properly stored in order to avoid any damage to the drug components.
How is it stored?
The drug should be stored in a air tight container and preferably at room temperature. Keeping the drug at refrigerator should be avoided. It should be kept away from moisture, heat and direct light and most importantly away from the reach of the children. The drug should not be stored in the kitchen or bathroom. For Prilosec Delayed Release Capsule, the temperature of storage is 15°C to 30°C (59°F to 86°F) and for Delayed Release oral suspension, the temperature of storage is 20°C to 25°C (68°F to 77°F).
The omeprazole liquid should be stored in refrigerator. The liquid should be immediately placed into the refrigerator after the use (Plumb, 2011). If the liquid is not returned to the refrigerator for more than 24 hours, then it is advised to avoid the use of the liquid and buy a fresh one. The liquid can be used until it turns brown in color.
Disposal of the medicine
When the medicine becomes out dated, it should be disposed as per the instruction of the pharmacist. The medicine must not be disposed in waste water i.e. in the toilet or in the sink. It should not be thrown in the house hold garbage (Chealth.canoe.com, 2015). One should ask his or her pharmacists in order to dispose the drug. As per the standard procedure of disposal, the drug is mixed with a solvent that is combustible and then the solution is burnt in a chemical incinerator that also contains a scrubber and a afterburner (Estren, 2013).
Relevant legislation and policy for the process
The proper disposal of the drug is governed by certain regulations. These include, Control of Substances Hazardous to Health (COSHH) Regulations 2002 and Hazardous Waste Regulations 2005. Both these acts deal with the proper disposal of the unused and expired drugs.
Learning outcome 3
Discuss legislation that governs this omeprazole
The legislations that govern the administration of medication include-
The Medicines Act 1968- according to the act, the medicines are characterized as-
Prescription only medicine (POM), that are available according to the prescription of a physician.
Pharmacy medicines (P), that are obtained only from the pharmacists. This type of medicines can be purchased without any prescription.
General sales list or GSL medicines can be purchased from any shop. Prescription is not required for buying this type of medicine.
Human Medicines Regulations 2012- this legislation deals with the authorization of the medical products, that are meant for human use; manufacturing of the drugs and import, sale and distribution of the drug.
The Misuse of Drugs Act 1971- under the act the offences include- unlawful possession of a controlled drug and involving in the supply of controlled drug.
The Misuse of Drugs (Safe Custody) Regulations 2001- this act deals with the supply, import, export and possession of drugs that are dangerous and harmful.
The Controlled Drugs (Supervision and Management and Use) Regulations 2006- under this act, the controlled drugs are sub divided into 5 schedules depending on their usefulness in the therapy and the potential misuse.
Control of Substances Hazardous to Health (COSHH) Regulations 2002- This act deals with proper disposal of the expired drugs in order to avoid health hazards.
Hazardous Waste Regulations 2005- this act also deals with the dispose of the unused and expired drugs (Hpc-uk.org, 2015).
Prescription only medicines (POM)
The prescription only medicines are the medicines or the pharmaceutical drugs that are available based on a medical prescription given by a physician in order to prevent the potential misuse of these drugs and drug abuse (Alexander, O’Connor & Stafford, 2011). Under this, certain drugs can only be purchased if the prescription of the doctor refers the use of the drug. The short form that is used for the prescription drug in North America is ‘Rx’.
In the United Kingdom, the prescription only drugs come under the Medicines Act 1968. Prescribing the drug is also included under the legislation. Under this act, if a person possesses a prescription only medicine without any legal prescription by a doctor, it is not considered as a criminal offence unless, the drug and the category are not under the Misuse of Drug Act 1971 (Hpc-uk.org, 2015). The medical prescriptions can be given by the authorized medical practitioners and the qualified as well as experienced pharmacists and nurses. The prescribing limits of the health visitors and the district nurses are limited and they cannot prescribe all kinds of prescription only drugs.
In the UK, most of the prescriptions are NHS prescriptions, but the authorized private practitioners can also offer prescriptions to their patients.
Omeprazole is a prescription only medicine. It cannot be sold to the people without proper prescription by a physician.
General sales list (GSL)
The general sales list medicines can be defined as the medicines that can be bought from a number of outlets i.e. super markets, general stores, shops, pharmacies, petrol stations and news agents etc. (Mohajir, 2005). These type of medicine can be sold without prescription, because they are considered safe for the human and don’t need a pharmacist’s supervision. The GSL medicines are under strict control regarding the use, strength, administration route and pharmaceutical form. Restriction is also employed regarding the maximum daily dose (Light, 2013).
The classes of drugs that are not included under this category include- eye drops, enemas, eye ointments, products that are used for parenteral administration and the products that are used for irrigation of the bladder, rectum, vagina and wounds etc. (Droege, Maniscalco, Daniel & Baldwin, 2007). This type of medicine is also regulated by the Medicines Act 1968.
Controlled drug (which category)
In order to control the supply and possession of listed drugs, the United Kingdom introduced the Misuse of Drugs Act 1971 that categorized certain listed drugs as controlled drugs (Nhs.uk, 2015). These kinds of drugs mostly include some amphetamine like stimulants that are used for Attention deficit hyperactivity disorder, some strong opiates that are used for pain management etc. (Nutt, King, Saulsbury & Blakemore, 2007).
The act classifies the controlled dugs into 5 schedules depending on their usefulness in the therapy and the potential misuse.
Schedule 1 (CD licence): these don’t have any medical use and as a result the supply and the possession of the drugs are restricted, for example, LSD and cannabis etc.
Schedule 2 (CD): these drugs include morphine, secobarbital, remifentanil, glutethimide, pethidine, amphetamine, diamorphine and cocaine. The export of these drugs requires proper licence. The administration of these drugs is only carried out by the physicians.
Schedule 3 (CD- no register): the drugs that are included in this category are the minor stimulant drugs that are not generally misused. The drugs under this category include- mazindol, diethylpropion, midazolam, buprenorphine, meprobamate, pentazocine, temazepam and phentermine etc.
Schedule 4: For these types of drugs, no safe custody or prescription is required. The drugs include- benzodiazepines, fencamfamin, zolpidem and mesocarb.
Schedule 5: include certain drugs that are exempt from all control due to their low level of presence.
Learning outcome 4
Is this drug ever supplied as a PGD
Yes, the drug omeprazole is supplied as PGD or Patient Group Direction. So, it can be used for the patients by the nurses and other health care professionals without individualized prescription.
What do we mean by PGD (define term)
The term Patient Group Direction can be defined as the documents the permits the supply of drugs under the category of POM or the prescription only medicines to a patient group without prescribing individually. This approach is taken by the UK government in order to make certain POM drugs available to certain group of people or to the public under certain circumstances (Gov.uk, 2015).
How do PGD’s work
In order to be used as PGD, it should be signed by a doctor and approved by a pharmacist. After the approval the PGD allows the nurses and other pharmacists to supply medicines without any individual prescription (Bissell, Savage & Anderson, 2006).
Which drugs are examples of PGD?
The drugs that are included in the PGD category include Finasteride for restoration of hair in case of male baldness, Orlistat for weight loss, Sildenafil for Erectile dysfunction, Ulipristal acetate and Levonorgestrel for hormonal contraception in emergency , Norethisterone for delay of period etc.
The strength, quantity, frequency of intake and dose of the medicines are needed to be specified in the PGD (Baileff, 2007).
Who can administer a PGD
Under the guidelines of NICE, a doctor needs to sign a PGD, which is then approved by a pharmacist. The signed and approved PGD can act as a direction for the nurse to administer the prescription only medicine to the patient based on their own assessment of the condition of the patient without referring further to the physician for individualized prescription.
The following health care professionals can administer PGD- dieticians, dental hygienists, midwives, dental therapists, nurses, optometrists, occupational therapists, paramedics, orthoptists, pharmacists, prosthetists and orthotists, radiographers, physiotherapists and language therapists etc.
Learning outcome 5
SAM-Self-administration of medication
Define Self-administration of medication (SAM)
The process of Self- Administration of Medication (SAM) can be defined as the process which gives the patient the independence of administering their own medicine while being admitted to the hospital (Grantham, McMillan, Dunn, Gassner & Woodcock, 2006).
Not all the patients are given the independence of self administration of medicine. To be capable of availing the facility, the patient should have the following features i.e. the patient should be cognitively functional, he or she should have adequate manual performing skills i.e. he or she should be able to do his or her daily basic functions (Ahmed, Chiran & Chattington, 2013). The patient should have sufficient knowledge regarding the administration of the medicine so that they will be able to control their medication properly and he or she should agree to take his or her own medication.
The medicines that are not used for SAM include- the injectable medications for example insulin injection, controlled drugs, drug doses that is variable for example warfarin, medicines that are given for short period of time, for example antibiotics and cytotoxics.
Benefits of Self-administration of medication (SAM)
The benefits of Self- Administration of Medication include, it allows the patients to retain their independence while being in the hospital, under the care of the nurses. In this case the responsibility of drug administration is shifted to the patient from the nurse. It helps the patients to maintain their self esteem. This practice acts as an encouragement to the patients to know more about the medications that are given to them. This practice is also associated with increased dignity as well as privacy. The patients become aware of the problems that may arise during the administration of the medication and the problems can be solved before the discharge of the patient, which in turn helps the use of the medicine by the patient at home. It facilitates patient centered care and promotes better involvement of the patient. Another benefit of the process is that it reduces the rate of readmission. It promotes the education of the patient regarding the medicine as well as the disease (Manias, 2006).
The disadvantages of Self-administration of medication (SAM)
There are several advantages of self- administration of medication. But the potential disadvantages of the process cannot be overlooked. The disadvantages include, there is potential problem with maintaining the proper dose of medicine in case of self administration. Self administration by the patient often leads to intentional or accidental overdose of the medicine or under dosage. It also generates non-compliance. The bonding between the patient and the health care professions become lose.
Is the drug suitable for use in a Self-administration of medication (SAM) scheme?
No, the drug is not used for self administration by the patient at hospital. Because, the proper dose of administration of the drug is very necessary, as over dose is associated with a number of health complications. So, while in the hospital, under the care of the health professionals, the self administration of the drug is not allowed (Richardson, Brooks, Bramley & Coleman, 2014).
Conclusion:
The discussion provides a clear idea regarding the drug omeprazole, which is used for controlling the excess production of stomach acid. The drug comes under the prescription only medicine category and should be strictly used as per the advice of the doctor. The side effects and the complications of the drug should be considered while using the drug and the physician should be provided with all round information regarding the health history and prior medication of a patient before the physician can prescribe omeprazole to the patient. Proper use of the drug will lead to faster recovery which in turn requires all round knowledge regarding the drug.
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