Cold, flu or COVID-19: differential diagnosis

Cold, flu or COVID-19: differential diagnosis

Excerpt from: The Pharmaceutical Journal, 24 Sep 2020, By Michael Dowdall & Kristoffer Stewart

Cold and flu share some symptoms and, if managed effectively, are often self-limiting and resolve within a couple of weeks in people without pre-existing conditions. However, some of their symptoms are similar to those seen in COVID-19 infections, which will present a challenge for healthcare professionals. Below is an overview of the main differences between the symptoms for cold, flu and COVID-19.

Table: Comparison of COVID-19, flu and cold symptoms

COVID-19

Symptoms

The novel coronavirus SARS-CoV-2, commonly referred to as COVID-19, typically causes mild upper respiratory infections.

The main symptoms include:

  • A high temperature — the skin feels hot to touch on the chest or back;
  • A new, continuous cough — coughing a lot for more than one hour, or three or more coughing episodes in 24 hours (if a patient usually has a cough, it may be worse than usual);
  • A loss or change in sense of smell or taste.

Most people with coronavirus will have at least one of these symptoms, with the severity ranging from mild to severe

Colds

Symptoms

A cold is caused by a mild viral infection of the nose, throat, sinuses and upper airways.

Children aged under six years are at greatest risk of colds, but healthy adults can also expect to have two or three colds annually.

Symptoms usually appear gradually and include:

  • A sore throat;
  • A blocked or runny nose;
  • Sneezing;
  • A cough;
  • A raised temperature.

Generally, patients may feel unwell but are able to continue daily activities as normal.

More severe symptoms, including headache and aching muscles, can also occur, although these are generally associated more with flu. Symptoms usually resolve within one to two weeks.

Influenza

Symptoms

Flu symptoms typically come on very quickly (within a few hours) and tend to be more widespread than those seen in a cold. These may include:

  • A sudden fever – a temperature of 38°C or above;
  • An aching body;
  • Feeling tired or exhausted;
  • A dry cough;
  • A sore throat;
  • A headache;
  • Difficulty sleeping;
  • Loss of appetite;
  • Diarrhoea or stomach pain;
  • Feeling sick and being sick.

The symptoms are similar for children, but they can also experience pain in their ear and appear less active. Patients with flu will likely describe feeling exhausted and too unwell to carry on daily activities as normal.

Red flags

Patients may require referral if:

  • Sudden chest pain, shortness of breath, or difficulty breathing is experienced;
  • There is blood in their sputum;
  • They have cold, clammy, or pale and mottled skin, or their lips turn blue;
  • They become confused;
  • They are difficult to rouse;
  • They have little or no urine output;
  • A new, severe, non-blanching rash develops;
  • Their cold or flu symptoms worsen or do not improve within 14 days.

Patients with long-term conditions or with weakened immune systems may require referral to their physician.

Children or babies aged under five years who seem very unwell or whose condition is worsening should be referred to urgent care immediately.

Important infection control and self-care measures

Infection control

  • Wash hands often with warm water and soap for at least 20 seconds;
  • Avoid touching your nose, eyes and mouth to prevent virus entry;
  • Use tissues when you cough or sneeze and throw these away as quickly as possible;
  • Wear a face covering in enclosed spaces or where the two-metre social distancing rule cannot be maintained.

Self-care measures

  • Maintain fluid intake;
  • Drink hot drinks;
  • Gargle salt water to relieve a sore throat;
  • Take time to rest;
  • Stay at home and recover, normal symptom durations are:
    • Sore throat: 7–8 days;
    • Common cold: 14 days;
    • Cough or bronchitis: 21 days

Source:

The Pharmaceutical Journal, PJ September 2020 online, online | DOI: 10.1211/PJ.2020.20208379

Current Recommendations and Practice of Immunization during Pregnancy & Lactation

Current Recommendations and Practice of Immunization during Pregnancy & Lactation

Contributed by: Dr. Collins E. M. Okoror, MBBS (Ib), MBA, PDip (HRM), FWACS (OBGYN), FMCOG, MPH (RFH)

Consultant Obstetrician and Gynaecologist, UK

Immunization during pregnancy

There is no evidence of adverse pregnancy outcomes from the vaccination of pregnant women with inactivated virus, bacterial, or toxoid vaccine. Live vaccines are generally contraindicated during pregnancy because of the theoretical risk of harm to the foetus if transmission of the vaccine strain to the foetus occurs. Live vaccines can be given during reproductive planning, prior to conception, with the advice to avoid pregnancy for at least 28 days following immunization. Pregnancy should be delayed for at least 3 months following the administration of live herpes zoster vaccine. However, when benefits outweigh this theoretical risk, vaccination with a live attenuated vaccine may be considered (e.g., during a rubella outbreak). There have so far been no significant adverse effects to the foetus associated with live attenuated vaccines including monovalent rubella vaccines, combined measles-mumps-rubella (MMR) vaccines, and oral polio vaccines. The contraindication of MMR-containing vaccines should be considered a purely precautionary measure.

Pregnancy should not preclude women from immunization as the benefits of vaccination generally outweigh the potential risks of exposure to a particular infection to the mother or her foetus/newborn if the vaccine is unlikely to cause harm.

Immunization during breastfeeding

Inactivated or live-virus vaccines given to nursing mothers do not affect the safety of breastfeeding for mothers or their infants. Live viruses in vaccines can replicate in the mother but most have been shown not to be excreted in breastmilk. Inactivated, recombinant, subunit, polysaccharide, and conjugate vaccines, as well as toxoids, pose no risk for mothers who are breastfeeding or for their infants.

There are few vaccines that should be avoided during breastfeeding. Live replicating smallpox vaccine is contraindicated in lactating women due to the theoretical risk for contact transmission from mother to infant. If post-exposure prophylaxis is required, suspend breastfeeding and close contact with baby avoided until scab falls off. Yellow fever vaccine is not recommended due to probable mother-to-baby transmission of yellow fever vaccine strain virus. Avoid oral typhoid vaccine as its safety is not known; inactivated typhoid vaccine should be used if indicated. Bacille Calmette-Guérin (BCG) vaccine should generally be avoided. Live herpes zoster vaccine should also be avoided during breastfeeding.

References:

  1. Centers for Disease Control and Prevention. (2016, August). Guidelines for vaccinating pregnant women. Pregnancy and Vaccination. https://www.cdc.gov/vaccines/pregnancy/hcp-toolkit/guidelines.html
  2. Ezeanolue, E., Harriman, K., Hunter, P., Kroger, A., & Pellegrini, C. (2020, March 25). General Best Practice Guidelines for Immunization. Best Practices Guidance of the Advisory Committee on Immunization Practices (ACIP). https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/index.html
  3. Kimberlin, D. W., Brady, M. T., Jackson, M. A., & Long, S. S. (2018). Red Book: 2018 Report of the Committee on Infectious Diseases (31st ed.). American Academy of Pediatrics.
  4. Public Health Agency of Canada. (2018, April). Immunization in pregnancy and breastfeeding: Canadian Immunization Guide. https://www.canada.ca/en/public-health/services/publications/healthy-living/canadian-immunization-guide-part-3-vaccination-specific-populations/page-4-immunization-pregnancy-breastfeeding.html#p3c3a8
  5. World Health Organization. (2013). Immunization during pregnancy [Global Vaccine Safety]. WHO; World Health Organization. http://www.who.int/vaccine_safety/committee/topics/influenza/pregnancy/Jun_2013/en/

FDA Approves Ivermectin Lotion for Non-prescription Use to Treat Head Lice

FDA Approves Ivermectin Lotion for Non-prescription Use to Treat Head Lice

[FDA News Release, October 27, 2020] – The U.S. Food and Drug Administration has approved Ivermectin lotion 0.5% for nonprescription use for the topical treatment of head lice infestations in patients 6 months of age and older. Sklice (Ivermectin lotion, 0.5%) was initially approved for this indication in 2012 as a prescription drug. The OTC approval was granted to makers of Sklice through a process called a prescription (Rx)-to-OTC switch.

“The Rx-to-OTC switch process aims to promote public health by increasing consumer access to drugs that would otherwise only be available by prescription,” said Theresa Michele, M.D., acting director of the Office of Nonprescription Drugs in the FDA’s Center for Drug Evaluation and Research. “Today’s approval expands access to another effective topical treatment for the thousands of people with head lice.”

Sklice is a single-use lotion with ivermectin 0.5% as the active ingredient, for the topical treatment of head lice infestations in patients 6 months of age and older. Sklice is for external use only and should only be used on the scalp and dry hair in accordance with label directions. Sklice is not approved for any other use.

Pediculosis capitis or head lice are caused by Pediculus humanus var. capitis (P. h. capitis). The arthropods are transmitted from human to human via direct contact – sharing of combs, brushes, towels. Pruritus is a common complaint associated with the infestation. The nits are usually seen at the base of the hairs.

Head lice are most common among children, individuals with long hair, homeless people and refugees. School children who share school caps, hairbrushes and combs, pillowcases are particularly vulnerable.

In Nigeria, Permethrin 1% cream rinse is the currently approved treatment for P. capitis (NSTG, 2016).

Sources:

  1. FDA News Release, October 27, 2020
  2. FDA: Treating and Preventing Head Lice
  3. SKLICE® Prescribing Information
  4. Nigeria’s Standard Treatment Guidelines (NSTG), 2016 ed.

FDA recommends avoiding use of NSAIDs in pregnancy at 20 weeks or later because they can result in oligohydramnios

FDA recommends avoiding use of NSAIDs in pregnancy at 20 weeks or later because they can result in oligohydramnios

[FDA Drug Safety Communication, October 15, 2020] – The U.S. Food and Drug Administration (FDA) is warning that use of NSAIDs (Nonsteroidal Anti-Inflammatory Drugs) around 20 weeks gestation or later in pregnancy may cause fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment.

These adverse outcomes are seen, on average, after days to weeks of treatment, although oligohydramnios has been infrequently reported as soon as 48 hours after NSAID initiation.

Oligohydramnios is often, but not always, reversible with treatment discontinuation.

Complications of prolonged oligohydramnios may include limb contractures and delayed lung maturation. In some post-marketing cases of impaired neonatal renal function, invasive procedures such as exchange transfusion or dialysis were required.

NSAIDs are commonly used to relieve pain and reduce fevers. They include medicines such as aspirin, ibuprofen, naproxen, diclofenac, and celecoxib. After around 20 weeks of pregnancy, the unborn babies’ kidneys produce most of the amniotic fluid, so kidney problems can lead to low levels of this fluid. Amniotic fluid provides a protective cushion and helps the unborn babies’ lungs, digestive system, and muscles develop.

What should pregnant women do?

Pregnant women should not use NSAIDs at 20 weeks or later unless specifically advised to do so by your health care professional because these medicines may cause problems in your unborn baby. Talk with your health care professional about the benefits and risks of these medicines during pregnancy before using them, especially at 20 weeks or later. Because many OTC medicines contain NSAIDs, it is important to read the medication labels to find out if the medicines contain NSAIDs. If you are unsure if a medicine contains NSAIDs, ask a pharmacist or health care professional for help.

Other medicines, such as paracetamol, are available to treat pain and fever during pregnancy. Talk to your pharmacist or health care professional for help deciding which might be best.

What should health care professionals do?

FDA recommends that health care professionals should limit prescribing NSAIDs between 20 to 30 weeks of pregnancy and avoid prescribing them after 30 weeks of pregnancy. If NSAID treatment is determined necessary, limit use to the lowest effective dose and shortest duration possible. Consider ultrasound monitoring of amniotic fluid if NSAID treatment extends beyond 48 hours and discontinue the NSAID if oligohydramnios is found.

As currently described in the NSAID labels, avoid prescribing NSAIDs at 30 weeks and later in pregnancy because of the additional risk of premature closure of the fetal ductus arteriosus.

The above recommendations do not apply to low-dose 81 mg aspirin prescribed for certain conditions in pregnancy.

Source:

FDA Drug Safety Communication, October 15, 2020

Fluoroquinolones and the risk of QT Prolongation

Fluoroquinolones and the risk of QT Prolongation

Fluoroquinolones are broad spectrum antibiotics, authorised for a wide range of indications. Those currently authorised in Nigeria include: Ciprofloxacin, Gemifloxacin, Levofloxacin, Moxifloxacin, Nalidixic acid, Norfloxacin, Ofloxacin, Pefloxacin, Sparfloxacin. There are also several combination products.

The potential for fluoroquinolones to cause QT prolongation is recognised and has been previously considered on the basis of available data for the individual substances, as reflected in the product specific information. A further recent European review of study and postmarketing data in relation to QT prolongation and fluoroquinolones concluded that the risk of QT prolongation does not appear to be similar across this class of antibiotics, but that substances may be classified according to their potential to prolong QT interval and precipitate cardiac events (i.e., ventricular arrhythmia).

As Moxifloxacin has been associated with an established potential for increased risk of QT prolongation, prescribers are reminded to use Moxifloxacin only when it is considered inappropriate to use antibacterial agents that are commonly recommended or when these have failed for the treatment of:

  • acute bacterial sinusitis,
  • acute exacerbations of chronic bronchitis,
  • community acquired pneumonia (except severe cases) and
  • mild to moderate pelvic inflammatory disease.

Following assessment of the available evidence, Ciprofloxacin, Levofloxacin and Ofloxacin are considered to have a lower potential to induce QT interval prolongation. It is important to note that in the context of conditions which favour the development of QT prolongation e.g. hypokalaemia, hypomagnesaemia, bradycardia, patients with congenital or acquired QT prolongation, some fluoroquinolones have the potential to induce life-threatening Torsades de Pointes (e.g. Moxifloxacin).

For further information and the complete list of fluoroquinolones considered as part of the review please see the following link: http://www.ema.europa.eu/docs/en_GB/document_library/Report/2011/01/WC500100459.pdf

Source:

  1. Irish Medicines Board (DHPCs). Fluoroquinolones and the risk of QT Prolongation. Safe Notices, 2011 Apr 5. Available from: https://www.hpra.ie/docs/default-source/Safety-Notices/apr-5th-fluoroquinolones_dhpcs.pdf?sfvrsn=0

Hope is Biology

Hope is Biology

Is there a therapeutic basis for hope? Probably yes and this is a must-read for every clinician. One patient’s review of his doctor.

Culled from: A Prescription For Healing, Newsweek, June 6, 1993

Hi, Doc! I saw your picture and the article about you in the paper. Didn’t recognize you at first. Maybe because you were smiling. I never saw you do that before. It changed your whole appearance. Pretty impressive story. Congratulations! The paper spelled out how you’re responsible for providing advanced surgical care from laser surgery to oncology. Wow!

You wouldn’t remember my face if you saw it. You did the job on me six months ago. A lot of bladders must have passed under your scalpel in the interim. Actually, you didn’t seem to recognize me then, until you had my folder in your hand. I remember the file number. So that’s who this is from – Bladder # 139.

I understand your not recognizing me. No hard feelings. In your office you were always busy, running from one examining room to another. Or you were on the phone: to the hospital, another doctor, a lab, another patient. Nurses ran after you with papers. When you did get to me – you were always at least a half hour late – you frowned over your Ben Franklin glasses as though I had made some mistake. I was never a person, just a case.

I was scared, so I asked questions. But this seemed to annoy you. My layman’s ignorance was so profound, your expression seemed to say, that, really, there was no point in any discussion. I simply wouldn’t understand.

You pulled no punches. I guess in becoming a great surgeon you forgot those early courses in doctor/patient relations: that patients tend to panic and imagine the worst; that they need reassurance. You said outright that I had two malignant tumors that must be removed at once. That meant cancer. The word scared the hell out of me. I broke out in a sweat. But you didn’t seem to notice. You frowned your usual frown and said that radiation or chemotherapy were not options. You gave no explanation and I was too clobbered to ask.

“Speak to my nurse,” you said. “She’ll arrange the details, tell you what to do and set up the surgery date.” Then you were out the door, your white coat flapping, as comforting as an ice-water douche. You were certainly no kindly healer; rather a competent master plumber, assaying a faulty drainage system and prescribing the necessary repairs-to it, not me. There was no compassion in your kit. Maybe you think that’s so much mush. Well, it’s not. Along with scanners, beepers, lasers, faxes and imaging machines, hope and reassurance can save lives, reduce pain and speed recovery. But that’s not your department, is it? That’s head stuff, for psychiatrists and psychologists. You deal directly with the biology of life.

Hope is biology, Doc. You did nothing to lessen my fears. You didn’t reassure me by explaining (as my M.D. brother-in-law did, after it was all over) that my type of tumor was common, easily excised and, if followed by periodic inspection, not likely to shorten my life or impede my functions. A doctor’s ability to reassure a patient can help to activate the body’s healing system. Positive emotions, like faith, love and determination are biochemical realities. It seems to me, Doc, that you overlooked the mind’s power to heal.

Because of you I suffered needlessly, night after night, unable to sleep because of what lay ahead. I barely ate, my mind obsessed. Would you eradicate all the cancer? Had it spread? Was this the beginning of the end? How could my family get along without me?

Compassion is good medicine:

After the operation I lay worrying, in intermittent pain, three tubes draining, sedating and replenishing me; every movement agony. Would I make it? I asked for you, Doc. The nurse explained you had been in several times while I was unconscious. Couldn’t you have managed one visit while I was awake? Just to say that I was doing fine.

I know you’re not heartless. You did tell my wife the operation was a success. But that’s all. How was I going to be? The nurse explained that you had a very busy schedule, but if anything went wrong she would call you. Like what? Everything was going wrong. One night I got tangled in my tubes when I had a hurry call and couldn’t make it to the john. No one told me that this was normal, that the medication frequently did that. I thought I was dying. Somehow you might have found a minute to drop by, to tell me the cancer was gone, how well my recovery was going. But you didn’t. Compassion is not mere handholding. It is good medicine. Here’s a big word I’ve just learned: psycho-neuroimmunology – the interaction between the brain, the endocrine system and the immune system. In short: the degree to which belief becomes biology.

Your hospital thinks you’re super. You’ve saved many lives and made others more comfortable. You put in grueling days, carry a crushing load, operate in life-or-death crises. Yet, there is no visible indication that you have the slightest feeling for your patients. You are so immersed in the functioning of the organism you are repairing that you seem to forget that each is a person – a thinking creature of hopes and fears, joys and sorrows. And, sometimes, like yourself, a leader in his chosen field.

What should you do about all this, Doc? Possibly nothing. But, couldn’t you lighten your caseload? Use some of your precious time to listen to your patients with an unhurried mind and an open heart? Try viewing them as whole people, not merely the containers of malfunctioning parts? Understanding all the factors (including the emotional) leading up to an illness can be as important as the identification of the actual pathology.

Just as a thousand-mile journey begins with one step forward, a step forward for you would be to erase that perpetual frown, that expression of annoyance at uninformed, fearful laymen and replace it with a smile and a few encouraging words. I know you can do it, Doc. Because I have that smiling picture of you from the newspaper.

Source:

  1. Newsweek (1993, June 6). A Prescription For Healing. Available from: https://www.newsweek.com/prescription-healing-193844

Treating Chronic Primary Pain: Draft NICE Guideline (August 2020)

Treating Chronic Primary Pain: Draft NICE Guideline (August 2020)

Contributed by: Anuolu Bank-Oni, PharmD, CDE, BCGP

As defined by the National Institute for Health and Care Excellence (NICE) guideline, chronic primary pain is present in one or more parts of the body and lasts for more than three months. Chronic pain negatively impacts the physical, emotional, and social well-being of the patient. The economy also shares in the burden, as chronic pain increases healthcare costs while reducing work productivity.

Treating chronic pain can be challenging because each patient requires a tailored care plan. Finding the balance between the benefits and risks of available treatment options requires the collaboration of the physician and the patient. The physician should ensure the patient actively participates in creating their treatment plan.

NICE recently published draft guidance on the assessment and management of chronic pain in patients aged 16 years and older.

Non-pharmacological management of chronic primary pain

Supervised group exercise, acceptance and commitment therapy (ACT) or cognitive behavioural therapy (CBT) are recommended for patients with chronic primary pain. Acupuncture or dry needling may be considered but more research is required to determine long-term benefits.

The guideline does not recommend biofeedback or electrical therapies (TENS, ultrasound and interferential therapy). Manual therapy requires additional research, as there is insufficient evidence to issue a recommendation regarding its use.

Pharmacological management of chronic primary pain

The guideline recommends against the use of most of the currently prescribed pain medications, by any route, to patients aged 16 years and older to manage chronic primary pain. These include:

  • antiepileptics including gabapentinoids, (except when gabapentinoids are prescribed as part of a clinical trial for complex regional pain syndrome)
  • antipsychotics
  • benzodiazepines
  • corticosteroids
  • ketamine
  • local anaesthetics (except as part of a clinical trial for complex regional pain syndrome)
  • local anaesthetic/corticosteroid combinations
  • non-steroidal anti-inflammatory drugs (NSAIDs)
  • opioids
  • paracetamol

According to NICE, studies showed that these medications have limited/no benefit in managing chronic primary pain. Conversely, there was an increased risk of addiction and misuse with opioids, benzodiazepines, gabapentinoids. Other adverse effects observed include gastrointestinal bleeds with NSAID, and impaired psychological and physical functioning with benzodiazepines.

Instead, antidepressants (duloxetine, fluoxetine, paroxetine, citalopram, sertraline or amitriptyline) are listed as therapeutic options, recognising this would be off-label use. Benefits and risks should be discussed with the patient.

Studies indicate that antidepressants improve quality of life, pain and psychological distress compared with placebo. However, most of the evidence available involved women with fibromyalgia.

It is important to remember that patients who discontinue antidepressants, opioids, gabapentinoids or benzodiazepines may experience withdrawal symptoms. NICE is developing a guideline on withdrawal management.

Patients who are currently on any of these medications should be educated on the most recent available evidence. Physicians should discuss the risks associated with continuing the medications and possible alternatives.

Conclusion

Chronic primary pain affects a significant portion of the population and poses a burden to patients and the community. Long term, deprescribing will reduce the risk of adverse effects and promote the appropriate use of medications. More research is required to determine the most appropriate treatment options for chronic primary pain.

Reference

  1. Chronic pain: NICE guideline DRAFT (August 2020). [online] Available at: <https://www.nice.org.uk/guidance/gid-ng10069/documents/draft-guideline> [Accessed 11 August 2020]

The Use of PPIs and Risk of COVID-19: Is there a Connection?

The Use of PPIs and Risk of COVID-19: Is there a Connection?

There is evidence of an independent, dose-response relationship between the use of anti-secretory medications and COVID-19 positivity; individuals taking PPIs twice daily have higher odds for reporting a positive test when compared to those using PPIs up to once daily, and those taking the less potent H2RAs are not at increased risk. This is the finding of an observational study published in The American Journal of Gastroenterology, July 7, 2020. The online survey enrolled 53,130 adults.

Previous study has shown that pH ≤3 impairs the infectivity of severe acute respiratory syndrome coronavirus 1 (SARS-CoV-1). Based on the findings of the current study, this appears to be the case for SARS-CoV-2.

According to the study authors, because SARS-CoV-2 uses the angiotensin converting enzyme 2 receptor to invade and rapidly replicate in enterocytes, an increase in gastric pH >3 due to the use of PPIs could allow it to more easily enter the gastrointestinal tract, which would lead to enteritis, colitis and systemic spread to other organs, including the lungs.

Information Sheet and FAQs About Proton Pump Inhibitors (PPIs) and Risk of COVID-19

Members of the American College of Gastroenterology (ACG) leadership team partnered with the study authors to prepare a brief overview of the research, discuss its findings, and address potential implications for clinical care.

The group addressed the following questions:

  1. What are the main results of the study?
  2. Do patients need to stop their PPIs right now because of this study?
  3. How might you use the results of this study to advise patients taking PPIs?
  4. Why was this study performed?
  5. What are the limitations of the study?

Click here for details: https://webfiles.gi.org/

Sources:

  1. Almario CV, Chey WD, Spiegel BMR. Increased risk of COVID-19 among users of proton pump inhibitors. Am J Gastroenterol 2020. Available online: https://journals.lww.com/ajg/Documents/AJG-20-1811_R1(PUBLISH%20AS%20WEBPART).pdf
  2. The American Journal of Gastroenterology. Information Sheet and FAQs About Proton Pump Inhibitors (PPIs) and Risk of COVID-19. Available online: https://webfiles.gi.org/links/media/ACG_Almario_et_al_Info_Sheet_and_FAQs_About_PPIs_COVID19_07072020_FINAL.pdf

NDMA in ER Metformin: Several companies voluntarily recalling the diabetes medicine

NDMA in ER Metformin: Several companies voluntarily recalling the diabetes medicine

[FDA Update, July 13, 2020] – FDA is alerting patients and health care professionals to several voluntary recalls of extended-release (ER) metformin due to possible contamination with nitrosodimethylamine (NDMA) above the acceptable intake limit.

Note that FDA testing has not shown NDMA in immediate-release (IR) metformin products (the most commonly prescribed type of metformin).

IMPORTANT LINKS

Search database of recalled metformin products: https://www.fda.gov/drugs/drug-safety-and-availability/search-list-recalled-metformin-products

QA on NDMA impurities in metformin products: https://www.fda.gov/drugs/drug-safety-and-availability/questions-and-answers-ndma-impurities-metformin-products

Information about nitrosamine impurities in medications: https://www.fda.gov/drugs/drug-safety-and-availability/information-about-nitrosamine-impurities-medications

Guidance for the use of oral contraception

Guidance for the use of oral contraception

Contributed by: Dr. Collins E. M. Okoror, MBBS (Ib), MBA, PDip (HRM), FWACS (OBGYN), FMCOG, MPH (RFH)

Consultant Obstetrician and Gynaecologist

Combined oral contraception (COC)

The COCs are an effective form of contraception combining the effect of both the progesterone and oestrogen hormones. Basically, they exhibit their contraceptive effects by inhibiting ovulation, thickening of the cervical mucus and thinning of the endometrium. They should be taken for consecutive days at about the same time of the day. Various forms are available at different proportions of the hormones.

COC containing ≤30 µg of ethinylestradiol (EE) with levonorgestrel (LNG) or noresthisterone (NET) is considered the first choice. Microgynon, a 2nd generation COC, containing 30 µg of EE and 150 µg of LNG, has become the first choice in women requesting COCs.

The second line 2nd generation COC pills include:

  • Low strength NET and EE e.g. Loestrin,
  • Standard strength NET and EE e.g. Brevinor, and
  • Phased COC EE and LNG e.g. Logynon.

The 3rd generation COCs have an increased risk of venous thromboembolism, patients should be assessed and counselled for this when they are being considered. They contain standard strength and low strength of desogestrel (DSG) and EE as first and second lines, respectively. Examples

  • Standard strength e.g. Marvelon, Desofem (DSG 150 µg & EE 30 µg)
  • Low strength e.g. Mercilon (DSG 150 µg & EE 20 µg).

Initiating COCs

The COCs are best started within the day 1–5 of the cycle. When started after day 5, an additional barrier method of contraception should be used for the first 7 days of initiation. Pregnancy test should be done after 3 weeks if unprotected sexual intercourse (UPSI) has occurred since the last period or if a woman who is amenorrhoeic and with negative pregnancy test has had UPSI in the last 3 weeks.

Switching pills

It is not uncommon to switch pills for perceived or actual adverse effects. Some of the conditions necessitating pills switch include:

Breakthrough bleeding – Before switching brand, check for compliance, exclude pregnancy, drug-drug interaction, infection and local causes of bleeding per vaginam. A switch should be made to the standard strength 2nd generation COC or the 3rd generation COC when the earlier is not available or to the triphasic COC when the earlier two are not available.

Nausea or headache – Pregnancy and eye pathologies should be excluded in these circumstances before switching brands. Where appropriate, a switch should be made to the low strength 2nd generation COC or the low strength 3rd generation COC where the earlier is not available.

Acne, bloatedness, or breast tenderness – A switch should be to the standard strength 3rd generation COC. Where this is unavailable or inappropriate, the client should be referred to the doctor for further evaluation.

Weight gain – Clients should be offered general advice on diet, exercises and being healthy. Where a switch is necessary, it should be to the standard strength 3rd generation COC.

Reduced libido – This may be psychological (e.g., relationship issues, less motivation) and should necessitate a referral to the doctor for evaluation.

Mood swings – Take medical history to determine if the patient is experiencing mood changes all the time or in relation to withdrawal bleed. If it is ascertained that the mood swings are caused by the Microgynon after detailed history, a switch should be made to standard strength 3rd generation COC.

Switching to another brand

When switching pills, the hormone-free interval (HFI) should be omitted, and the new pills commenced the next day i.e. day 22 of the previous pills or within day 1–2 of HFI. If 3–7 hormone-free pills or days are taken, the new brand should be commenced with barrier methods for the first 7 days. It is important to carry out a thorough evaluation of the client before considering a switch to another brand of COC.

Switching to progesterone-only pill (POP)

When switching from COC to POP, it should be started without a break within the day 1–2 HFI or during week 2–3 of COC. When the switch is necessary during week 1 of COC or day 3-7 HFI and in absence of UPSI since start of HFI, additional barrier method should be used for 2 days.

Progesterone-only pills (POP)

The progesterone only contraceptive pills are effective alternatives for clients in whom the oestrogen effects of the COC are undesirable or contraindicated and have no contraindication to the POPs. They have similar mechanisms of action with COC, though at varying degrees. Various forms are available, but the common ones are the NET 350 µg, LNG 30 µg and DSG 75 µg. While NET and LNG administration allows for a 3-hour missed pill window, DSG POP allows a window of 12 hours and is therefore, an option for those who have trouble in complying with stricter dosage regimen of other POPs.

Initiating POP

Like the COC, it is best taken daily at the same time each day beginning from day 1–5 of the cycle. When started after day 5, an additional barrier method of contraception should be used for the first 2 days of initiation. Pregnancy test should be done after 3 weeks if UPSI has occurred since the last period or if a woman who is amenorrhoeic and with a negative pregnancy test has had UPSI in the last 3 weeks.

References

  1. Faculty of Sexual and reproductive Healthcare (FSRH). Combined hormonal contraception. London, UK: Clinical Effectiveness Unit, FERH; January 2019 (amended July 2019).
  2. Faculty of Sexual and Reproductive Healthcare (FSRH). Progestogen-only pills. London, UK: Clinical Effectiveness Unit, FSRH; March 2015 (amended April 2019).
  3. Telford and Wrekin Clinical Commissioning Group. Guidelines for initiation and switching of combined oral contraception. Telford, UK: Telford and Wrekin CCG; December 2016. Available at: https://www.telfordccg.nhs.uk/your-health/medicines-management/prescribing-guidelines/sexual-health-1/2242-oral-contraception-flowchart-and-guidance-v2/file